CN114414793A - A device for synchronously detecting the concentration of multiple analytes in body fluids - Google Patents

Abstract

The invention relates to the technical field of clinical routine biochemical index detection dry chemistry, and discloses a device for synchronously detecting the concentration of multiple analytes in body fluid, wherein reagent strips are accurately placed in grooves of a lower shell and then are clamped with an upper shell to form an integral testing device; meanwhile, through the plurality of sampling holes and the plurality of display holes on each reagent strip, the test of various items can be simultaneously carried out, and the tested items can be combined differently according to the test purpose, so that the kit is more convenient and practical in the aspects of clinical application of emergency departments, endocrinology departments, town medical cooperation agencies and remote mountain medical stations of hospitals.

Description

A device for synchronously detecting the concentration of multiple analytes in body fluids

technical field

The invention relates to the technical field of clinical routine biochemical index detection and dry chemical detection, in particular to a device for synchronously detecting the concentrations of multiple analytes in body fluids.

Background technique

The dry chemical method can directly add the liquid test sample to the dry reagent strips of different items produced in a specific production, and use the moisture of the tested sample as a solvent to cause a specific enzymatic or chemical reaction, and use the reflection photometry or electrode method for quantitative analysis. It can accurately and quickly measure the sample results; the general test time is 2min-4min, the operation is simple, the volume is small and easy to carry, no reagent preparation and sample processing are required, and the sensitivity is high; it can replace the wet chemical method for emergency specimens for clinical testing , which can be used for rapid auxiliary tests in hospitals and community outpatient clinics, and can also be used for monitoring the condition of individuals and family members with routine chronic diseases.

At present, the most common dry chemical test devices on the market are single test or two and three tests. When there are few test items, the judgment of symptoms is relatively limited, and the diagnosis of most diseases, such as liver function, kidney function, chronic diseases ( High blood sugar, high blood lipids), the results of multiple projects are needed as a reference; the vertical 8-hole (US5962215) US patent has the problems of decreased edge hole position test accuracy and poor diffusion time, and direct finger puncture requires a large amount of blood , the piercing is deeper, causing the patient to feel aggravated; in clinical applications, although large-scale biochemical instruments can accurately test multiple items at the same time, it needs to extract the patient's venous blood, which is complicated to obtain samples, and the biochemical instruments are expensive and bulky. , the operation requires professional technicians, the use site is limited, and it is difficult to implement in the clinical application of hospital emergency departments, endocrinology departments, township medical cooperatives and medical stations in remote mountainous areas.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a device for synchronously detecting the concentrations of various analytes in body fluids, which is more convenient and practical in clinical application in hospital emergency departments, endocrinology departments, township medical cooperatives and medical stations in remote mountainous areas.

In order to achieve the above object, the present invention provides a device for synchronously detecting the concentrations of multiple analytes in body fluids, the device for synchronously detecting the concentrations of multiple analytes in body fluids includes an upper casing, a lower casing and a plurality of reagent strips, The lower casing has a handle, the upper casing is detachably connected to the lower casing and is located on one side of the lower casing, the lower casing includes a second body and a plurality of fixing columns, the The second body has a groove, and the groove faces one side of the reagent strip, a plurality of the fixing posts are fixedly connected to the second body, and are located on the side of the second body close to the reagent strip;

A plurality of the reagent strips all include a fixed layer, a diffusion layer, a separation layer and a color development layer, the fixed layer has a plurality of fixed holes and three color development holes, and the plurality of the fixed holes all pass through the fixed layer, The three color developing holes all pass through the fixing layer, the fixing layer is connected with the fixing column through the fixing holes, the color developing layer is fixedly connected with the fixing layer, and is located away from the second On the main body side, the separation layer is fixedly connected to the color developing layer and is located on the side away from the fixed layer, and the diffusion layer is fixedly connected to the separation layer and is located on the side away from the color developing layer.

Wherein, the diffusion layer includes a first diffusion layer and a second diffusion layer, the second diffusion layer is fixedly connected with the separation layer and is located on the side away from the color developing layer, and the first diffusion layer is connected to the separation layer. The second diffusion layer is fixedly connected and located on the side away from the separation layer.

Wherein, the lower casing has a plurality of detection holes and a plurality of hexagonal prism holes, a plurality of the detection holes are located on the side close to the color developing hole, and a plurality of the hexagonal prism holes are located on a side close to the upper casing side.

Wherein, the upper casing includes a first body, a plurality of hexagonal prisms and a plurality of drainage blocks, and the plurality of hexagonal prisms are fixedly connected with the first body and are located on the side of the first body close to the lower casing , a plurality of the drainage blocks are fixedly connected with the first body, and are located on the side of the first body close to the lower casing.

Wherein, the first body has a plurality of injection holes, and the plurality of injection holes are respectively located on one side of the plurality of the drainage blocks.

Wherein, a plurality of the injection holes are all in a funnel-shaped structure.

A device for synchronously detecting the concentrations of various analytes in body fluids of the present invention is provided by accurately inserting reagent strips into the grooves of the lower casing, and then snapping with the upper casing to form an integral testing device. The entire device is simple to operate and has a structure It is compact, and the handle on the lower casing is convenient for hand-held testing of the entire device, and the lower casing fixes multiple reagent strips, which can prevent the reagent strips from drifting and affect the repeatability of the results; at the same time, through multiple reagent strips The injection hole and the multiple display holes on each reagent strip can test various items at the same time, and the tested items can be combined in different ways according to the test purpose. The clinical application of the medical station is more convenient and practical.

Description of drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained according to these drawings without creative efforts.

FIG. 1 is a schematic structural diagram of a device for synchronously detecting the concentrations of multiple analytes in a body fluid provided by the present invention.

FIG. 2 is a schematic structural diagram of the upper casing provided by the present invention.

FIG. 3 is a schematic structural diagram of another side of FIG. 2 provided by the present invention.

FIG. 4 is a schematic structural diagram of the lower casing provided by the present invention.

FIG. 5 is a top view of the lower casing provided by the present invention.

6 is a schematic structural diagram of the reagent strip provided by the present invention.

FIG. 7 is a schematic structural diagram of the first embodiment of the handle provided by the present invention.

FIG. 8 is a schematic structural diagram of a second embodiment of the handle provided by the present invention.

FIG. 9 is a schematic structural diagram of a third embodiment of the handle provided by the present invention.

1-upper shell, 2-lower shell, 3-reagent strip, 4-handle, 21-second body, 22-fixed column, 31-fixed layer, 32-first diffusion layer, 33-second diffusion layer , 34-separation layer, 35-chromogenic layer, 311-fixed hole, 312-colored hole, 23-detection hole, 24-hexagonal hole, 25-groove, 11-first body, 12-hexagonal column, 13-Drainage block, 14-Injection hole, 41-Arrow, 42-Lateral protrusion, 43-Spot-shaped protrusion, 44-Wave-shaped protrusion.

Detailed ways

The following describes in detail the embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein the same or similar reference numerals refer to the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary, and are intended to explain the present invention and should not be construed as limiting the present invention.

In the description of the present invention, it should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", The orientations or positional relationships indicated by "horizontal", "top", "bottom", "inside", "outside", etc. are based on the orientations or positional relationships shown in the accompanying drawings, which are only for the convenience of describing the present invention and simplifying the description, rather than An indication or implication that the referred device or element must have a particular orientation, be constructed and operate in a particular orientation, is not to be construed as a limitation of the invention. In addition, in the description of the present invention, "plurality" means two or more, unless otherwise expressly and specifically defined.

Please refer to FIG. 1 to FIG. 9 , the present invention provides a device for synchronously detecting the concentrations of multiple analytes in body fluids. A reagent strip 3, the lower case 2 has a handle 4, the upper case 1 is detachably connected to the lower case 2, and is located on one side of the lower case 2, and the lower case 2 includes A second body 21 and a plurality of fixing posts 22 , the second body 21 has a groove 25 , the groove 25 is facing the side of the reagent strip 3 , a plurality of the fixing posts 22 and the second body 21 Fixed connection, and is located on the side of the second body 21 close to the reagent strip 3;

A plurality of the reagent strips 3 include a fixed layer 31, a diffusion layer, a separation layer 34 and a color developing layer 35. The fixed layer 31 has a plurality of fixing holes 311 and three color developing holes 312. 311 all penetrate the fixing layer 31 , the three color developing holes 312 all penetrate the fixing layer 31 , the fixing layer 31 is connected to the fixing column 22 through the fixing holes 311 , and the color developing layer 35 It is fixedly connected to the fixing layer 31 and is located on the side away from the second body 21 . The separation layer 34 is fixedly connected to the color rendering layer 35 and is located on the side away from the fixing layer 31 . The layer is fixedly connected to the separation layer 34, and is located on the side away from the color developing layer 35;

The diffusion layer includes a first diffusion layer 32 and a second diffusion layer 33. The second diffusion layer 33 is fixedly connected to the separation layer 34 and is located on the side away from the color rendering layer 35. The layer 32 is fixedly connected to the second diffusion layer 33 and is located on the side away from the separation layer 34;

The lower casing 2 has a plurality of detection holes 23 and a plurality of hexagonal prism holes 24, the plurality of the detection holes 23 are located on the side close to the color developing hole 312, and the plurality of the hexagonal prism holes 24 are located close to the color developing hole 312. The upper casing 1 side.

In this embodiment, the upper case 1 and the lower case 2 are 32-42mm long and 28mm-32mm wide, the handle 4 and the lower case 2 are integral, and the inner space between the upper case 1 and the lower case 2 is integrated. The height of the cavity is 0.8mm-1.2mm. In this application, the number of the detection holes 23 is 9, which are arranged in 3×3 holes, and the hole spacing is 10mm horizontally and 5.5mm vertically; there are also 14 1.3mm- 1.6mm hexagonal prism hole 24; the number of the reagent strips 3 is 3, each reagent strip 3 has three color developing holes 312, and the three color developing holes 312 correspond to the three detection holes 23 respectively, which can be synchronized Test a variety of items, and the tested items can be combined according to the purpose of the test. Among them, every three detection holes 23 form a group, located in a group of inner cavity structures of the lower casing 2, and are connected to the fixing holes 311 on the reagent strip 3 through the fixing column 22 on the lower casing 2, and the reagent strip is connected to the The position of 3 is fixed to prevent the offset from affecting the repeatability of the results; the length of the diffusion layer or separation layer 34 can be connected to cover the corresponding three color developing holes 312, or can be separated, the color developing layer 35 is loaded with different test items. liquid, to be handled separately.

The lower shell 2 has four main structural designs: one is that the three anti-skid design patterns at the handle 4 are used to facilitate the loading of force when handling or inserting the card case; the second is that the lower shell 2 has a total of 9 detection holes. 23 are arranged in a horizontal and vertical 3×3 arrangement, which promotes uniform blood diffusion and reduces the reaction time difference between the holes. There are six fixing columns 22 , which can be accurately inserted into the fixing holes 311 at both ends of the reagent strip 3 , so as to fix the reagent strip 3 and improve the repeatability of the test results.

Further, the upper casing 1 includes a first body 11 , a plurality of hexagonal prisms 12 and a plurality of drainage blocks 13 , and the plurality of hexagonal prisms 12 are fixedly connected to the first body 11 and located on the first body 11 Close to the side of the lower casing 2, a plurality of the drainage blocks 13 are fixedly connected to the first body 11, and are located on the side of the first body 11 close to the lower casing 2; the first body 11 has a plurality of injection holes 14, and the plurality of injection holes 14 are respectively located on one side of the plurality of the drainage blocks 13; the plurality of the injection holes 14 are all funnel-shaped structures.

In this embodiment, the sample injection hole 14 is designed in a funnel shape, with an angle of 30°-45°, and there are 14 hexagonal prisms 12 of 1.2-1.5mm on the side close to the lower shell 2, which can be connected with the lower shell 2. The hexagonal prism holes 24 of the body 2 are closely combined, and the vertical strip-shaped concave-convex drainage blocks 13 on the reverse side corresponding to the three injection holes 14. The upper casing 1 has three main structural designs: one is that the front is designed as a funnel-shaped three injection holes 14, is to make the blood dripped in the hole to seep down quickly, the second is the vertical strip-shaped concave-convex drainage block 13 on the reverse side corresponding to the three injection holes 14 is to allow the blood to spread quickly and accelerate the reaction process, and the third is the inner side. The 14 clamping columns are designed as hexagonal columns 12, which can effectively prevent the loosening of the upper and lower clamping shells.

Further, the handle 4 has vertical arrows 41 and protrusions, and the protrusions include transverse protrusions 42 , point-shaped protrusions 43 and wave-shaped protrusions 44 .

In this embodiment, there are three design solutions at the handle 4: the first one is three horizontal protrusions 42 and vertical arrows 41 pointing to the pattern, the second one is three rows of dotted protrusions 43 and the vertical arrow 41 pointing to the pattern , and the third is a pattern of three rows of wavy protrusions 44 and vertical arrows 41 pointing.

Through the previous application and practice, it is found that the sample input area on the front of the upper casing 1 of the device is designed in a funnel shape, which is close to the principle of the funnel, which can effectively promote the infiltration of the test sample and avoid the boundary in the design of the injection hole 14. The infiltration effect is slow; the vertical strip-shaped concave-convex drainage structure on the opposite side of the three sample input areas of the upper casing 1 of the device can generate uniform pressure on the test strip and accelerate the diffusion of the blood sample. The handle 4 of the lower shell of the device is designed with three horizontal protrusions 42, point protrusions 43, wavy protrusions and vertical arrows 41, which can effectively play the role of easily inserting the test instrument and preventing it from falling off; The verification found that the fixing columns 22 at both ends of the inner cavity of the lower casing 2 of the device can effectively fix the reagent strips 3 put in, preventing offset and affecting the repeatability of the results; in addition, the entire lower casing 2 The inner height of the cavity and the hexagonal shape of the buckle are designed according to long-term application and repeated verification. On the one hand, it can accelerate the reaction of the test strip, and on the other hand, it can well prevent the loosening of the device.

Practical effect: After the testing device is put into the dry test strips of the 9 items to be tested, combined with the testing instrument, individual patients can operate and monitor the disease by themselves, without the restrictions of personnel, location and time, and can be based on the patient's monitoring goals. Choose products with different testing and monitoring scopes, which can quickly and accurately evaluate and monitor patients with cardiovascular disease, liver function, kidney function, glucose metabolism, and abnormal fat metabolism. Patients with chronic diseases do not need to go to the hospital frequently and stay at home when their condition is stable. It can evaluate and monitor its own condition in real time; in terms of clinical application, it can directly collect the fingertip blood of the subject to be tested, and the sample does not need to be processed. Convenient and practical.

Structural effect: The synchronous detection device has a total of 9 holes. The injection hole 14 on the front of the upper shell is designed into a funnel shape to solve the boundary effect and make the blood seep down quickly. The inner vertical stripe corresponding to the injection hole 14 is uneven The drainage structure can promote the uniform diffusion of the blood sample and accelerate the reaction process; the three patterns of the handle 4 are designed to prevent falling off and are easy to insert and take on the tester; the fixed column 22 can firmly cover the sample injection at both ends of the reagent strip 3 The hole 14 can effectively fix the reagent strip 3 to prevent offset and affect the repeatability of the results; in addition, the height of the cavity of the entire cartridge and the hexagonal shape of the buckle can accelerate the reaction process of the reagent strip 3 and prevent the reagent strip 3 from moving. effect.

Unique effect: This synchronous detection device is designed through long-term design concept, repeated verification and experience accumulation, and is superior to other similar products in all aspects. First, it has the advantages of strong practicability, reasonable structure design, uniform and fast sample diffusion, etc. , Second, the test seat cartridge is made of ABS material, which has low cost and can withstand high and low temperature. Third, the synchronous detection device is placed in the reagent strip 3 and combined with the supporting handheld portable tester. It can accurately and quickly test 9 items at the same time. Small in size, convenient and easy to carry; the synchronous detection device is superior to other similar products in terms of appearance design, practicability and internal structure, and is currently the only device in China that can simultaneously detect the concentration of multiple analytes in body fluids with 9 holes.

In terms of product design, the present invention only needs to accurately place the test strip of the item to be tested into the inner cavity of the synchronous detection device of the present application, and then insert the upper and lower shells into the matching tester without gaps, and the device is combined with the dry reagent. After the overall volume is small, it is easy to carry and transport, and it can be used in a wide range of fields without space and time restrictions. The collected fresh whole blood, serum or plasma is dropped into the center of the three injection holes 14 on the front of the device three times. The results of 9 items can be tested within 4 minutes. The test samples do not need to be processed in advance. The test sample may also be intravenously anticoagulated whole blood, serum or plasma. The whole testing process is easy to operate, requires less blood, is easy to implement, and is small in size.

The above disclosure is only a preferred embodiment of the present invention, and of course, it cannot limit the scope of rights of the present invention. Those of ordinary skill in the art can understand that all or part of the process for realizing the above-mentioned embodiment can be realized according to the rights of the present invention. The equivalent changes required to be made still belong to the scope covered by the invention.

Claims (6)

1. A device for simultaneously detecting the concentration of multiple analytes in a body fluid,

the device for synchronously detecting the concentrations of multiple analytes in body fluid comprises an upper shell, a lower shell and a plurality of reagent strips, wherein the lower shell is provided with a handle, the upper shell is detachably connected with the lower shell and is positioned on one side of the lower shell, the lower shell comprises a second body and a plurality of fixing columns, the second body is provided with a groove, the groove faces one side of the reagent strips, and the plurality of fixing columns are fixedly connected with the second body and are positioned on one side, close to the reagent strips, of the second body;

the reagent strips comprise a fixing layer, a diffusion layer, a separation layer and a color development layer, the fixing layer is provided with a plurality of fixing holes and three color development holes, the fixing holes penetrate through the fixing layer, the three color development holes penetrate through the fixing layer, the fixing layer is connected with the fixing columns through the fixing holes, the color development layer is fixedly connected with the fixing layer and is positioned on one side far away from the second body, the separation layer is fixedly connected with the color development layer and is positioned on one side far away from the fixing layer, and the diffusion layer is fixedly connected with the separation layer and is positioned on one side far away from the color development layer.

2. The device for simultaneously detecting the concentration of multiple analytes in a body fluid according to claim 1,

the diffusion layer comprises a first diffusion layer and a second diffusion layer, the second diffusion layer is fixedly connected with the separation layer and is positioned on one side far away from the color development layer, and the first diffusion layer is fixedly connected with the second diffusion layer and is positioned on one side far away from the separation layer.

3. The device for simultaneously detecting the concentration of multiple analytes in a body fluid according to claim 1,

the lower shell is provided with a plurality of detection holes and a plurality of hexagonal prism holes, the detection holes are positioned at one side close to the color development holes, and the hexagonal prism holes are positioned at one side close to the upper shell.

4. The device for simultaneously detecting the concentration of multiple analytes in a body fluid according to claim 1,

the upper shell comprises a first body, a plurality of hexagonal prisms and a plurality of drainage blocks, the hexagonal prisms are fixedly connected with the first body and are positioned on one side, close to the lower shell, of the first body, and the drainage blocks are fixedly connected with the first body and are positioned on one side, close to the lower shell, of the first body.

5. The device for simultaneously detecting the concentration of multiple analytes in a body fluid according to claim 4,

the first body is provided with a plurality of sample holes, and the plurality of sample holes respectively penetrate through one side of the drainage block.

6. The device for simultaneously detecting the concentration of multiple analytes in a body fluid according to claim 5,

the plurality of sample inlets are funnel-shaped structures.

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