Multi-parameter integrated detection chip and device for blood and body fluid analysis

Abstract

The utility model discloses a multi-parameter integrated detection chip and device for blood body fluid analysis, which comprises a chip body, a cementing layer and a sealing layer, wherein the chip body is provided with a sample adding port, at least one imaging cavity and at least one optical density cavity; one or more imaging areas which are communicated with one another are arranged in the imaging cavity, and a height difference exists between the imaging areas and the imaging cavity; the chip body is also provided with a liquid separation flow channel, and the imaging cavity and the optical density cavity are communicated with the sample adding port through the liquid separation flow channel; and the sealing layer is attached to the chip body through the cementing layer, so that the imaging cavity, the optical density cavity and the liquid separation flow channel form a closed cavity structure. According to the utility model, a planar microfluid network structure is adopted, and gravitational potential energy and capillary effect cooperate to drive samples to autonomously shunt to different functional cavities, react with preloaded dry reagents and perform in-situ measurement, so that the operation process is simplified, and the risk of personal error is reduced.

Description

Technical Field

[0001] This utility model relates to the field of blood and body fluid analysis technology, and in particular to a multi-parameter integrated detection chip and device for blood and body fluid analysis. Background Technology

[0002] Currently, the in vitro diagnostics (IVD) field is exhibiting a dual-track development trend: on the one hand, it focuses on the high-end upgrading of central laboratories, meeting the precise diagnostic needs of complex diseases by improving automation levels, throughput, and sensitivity; on the other hand, it extends towards point-of-care testing (POCT), achieving real-time and decentralized diagnosis and treatment scenarios through equipment miniaturization and ease of operation. Given China's vast territory and large population, the centralized diagnosis and treatment model relying solely on large hospitals and central laboratories is no longer sufficient to meet the needs of primary healthcare. Therefore, my country has taken the reform of the hierarchical medical system as a starting point, extending basic medical services to community hospitals, township health centers, and other primary care institutions to build a multi-tiered medical service network. Against this backdrop, developing POCT equipment that combines high sensitivity, excellent repeatability, accurate quantitative capabilities, and simplified operation has become a core breakthrough for improving the efficiency of primary care and optimizing the allocation of medical resources.

[0003] Blood and body fluid analysis technology, as a core means of clinical diagnosis, provides crucial evidence for the screening and monitoring of diseases such as anemia, infection, and blood disorders through quantitative detection and morphological analysis of components such as red blood cells and white blood cells in whole blood samples. Currently, mainstream technologies exhibit a differentiated development pattern. On one hand, flow cytometry combined with multi-physical parameter detection technology, based on the flow cytometry framework, integrates Coulter impedance method, Mie laser scattering theory, and fluorescence labeling technology to form a high-precision, multi-dimensional data acquisition system. A typical example of this technology is the five-part differential hematology analyzer, which integrates precision modules such as sheath fluid devices, high-pressure microporous tubes, multi-wavelength laser sources, and high-sensitivity photomultiplier tubes, requiring a fluid path control system and optical calibration components. Although it boasts advantages such as high detection efficiency and excellent classification accuracy, it suffers from significant drawbacks such as large equipment size, high maintenance costs, and strong dependence on consumables, making it difficult to adapt to the needs of primary healthcare institutions and mobile healthcare scenarios. On the other hand, digital microscopic image analysis technology uses a fully automated microscopic imaging system combined with image processing algorithms to achieve intelligent identification and classification statistics of blood cell morphological characteristics. Typical equipment consists of a miniaturized microscope lens, a microfluidic chip carrier system, and an embedded processor, eliminating the need for traditional liquid circuit designs and avoiding cross-contamination through disposable test cards. Its technological advantages lie in its lightweight design, fully automated operation, and zero maintenance costs, making it particularly suitable for point-of-care testing scenarios such as emergency departments and community clinics. However, current digital microscopic image analysis technology suffers from significant process fragmentation: for core indicators such as red blood cell count, white blood cell differential, platelet volume, and hemoglobin concentration, a step-by-step operation process is required, including multiple sample dispensings, independent reaction system construction, and discrete detection modules. This results in high operational complexity and a significant risk of human error, severely limiting testing efficiency and result consistency. This technological bottleneck makes it difficult for primary healthcare institutions to conduct reliable blood routine screenings under resource-limited conditions. Utility Model Content

[0004] The purpose of this invention is to provide a multi-parameter integrated detection chip and device for blood and body fluid analysis. The chip adopts a planar microfluidic network structure, which drives the sample to autonomously flow to different functional cavities through the synergistic effect of gravitational potential energy and capillary effect, reacting with pre-loaded dry reagents and performing in-situ measurements. This simplifies the operation process and reduces the risk of human error.

[0005] To achieve the above objectives, the following technical solution is adopted:

[0006] A multi-parameter integrated detection chip for blood and body fluid analysis includes a chip body, an adhesive layer, and a sealing layer. The chip body has a sample application port, at least one imaging cavity, and at least one optical density cavity. The imaging cavity has one or more interconnected imaging regions with a height difference between the imaging regions and the imaging cavity. The chip body also has a liquid distribution channel, and the imaging cavity and optical density cavity are connected to the sample application port through the liquid distribution channel. The sealing layer is attached to the chip body through the adhesive layer so that the imaging cavity, optical density cavity, and liquid distribution channel form a closed cavity structure.

[0007] Furthermore, the chip body has a first outflow channel communicating with the imaging cavity, and the chip body also has a first vent hole penetrating into the first outflow channel.

[0008] Furthermore, the chip body has a second outflow channel communicating with the optical density cavity, and the chip body also has a second vent hole penetrating into the second outflow channel.

[0009] Furthermore, the diameter of the stir bar is smaller than the inner diameter of the optical density cavity, and larger than the width of the liquid distribution channel and the second outflow channel connected to the optical density cavity.

[0010] Furthermore, a stir bar is also arranged inside the optical density cavity; the stir bar is made of a magnetic material.

[0011] Furthermore, the lower part of the inner wall of the optical density cavity is provided with an annular groove in a ring-shaped structure.

[0012] A multi-parameter integrated detection device for blood and body fluid analysis is also provided, including the detection chip described above, and a temperature control unit for controlling the reaction temperature of the detection chip;

[0013] A dual-wavelength illumination unit is used to provide red and green light illumination for optical density measurement;

[0014] A microscopic illumination assembly, comprising a transmission illumination unit and a fluorescence excitation unit, is used to provide basic illumination and excite reagents pre-loaded with fluorescent labels;

[0015] Image acquisition unit, used for image acquisition;

[0016] The three-dimensional translation drive mechanism is used to drive the detection chip to translate along the X and Y axes, and to drive the image acquisition unit to move up and down along the Z axis.

[0017] The stirring drive unit is used to drive the stir bar to move within the optical density cavity.

[0018] By adopting the above solution, the beneficial effects of this utility model are:

[0019] This invention employs a planar microfluidic network structure, which uses gravitational potential energy and capillary effect to drive the sample to autonomously divert to different functional cavities for reaction with pre-loaded dry reagents and in-situ measurement, simplifying the operation process and reducing the risk of human error. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the structure of Embodiment 1 of the present invention;

[0021] Figure 2 This is a schematic diagram of the structure of Embodiment 2 of this utility model;

[0022] Figure 3 for Figure 1 A bottom view;

[0023] The following are explanations of the labels in the attached diagram:

[0024] 1. Chip body; 2. Adhesive layer; 3. Sealing layer; 11. Sample dispensing port; 12. Imaging cavity; 13. Optical density cavity; 14. Imaging area; 15. First outflow channel; 16. First vent; 17. Second outflow channel; 18. Second vent; 131. Annular groove. Detailed Implementation

[0025] The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.

[0026] Reference Figures 1 to 3 As shown, this utility model provides a multi-parameter integrated detection chip for blood and body fluid analysis, including a chip body 1, an adhesive layer 2, and a sealing layer 3. In one embodiment, the chip body 1 has a sample application port 11, at least one imaging cavity 12, and at least one optical density cavity 13. The imaging cavity 12 has one or more interconnected imaging regions 14, and there is a height difference between the imaging regions 14 and the imaging cavity 12. The chip body 1 also has a liquid distribution channel, and the imaging cavity 12 and the optical density cavity 13 are connected to the sample application port 11 through the liquid distribution channel. The sealing layer 3 is attached to the chip body 1 via the adhesive layer 2, so that the imaging cavity 12, the optical density cavity 13, and the liquid distribution channel form a closed cavity structure.

[0027] Continue to refer to Figures 1 to 3As shown, in this embodiment, the chip comprises three parts: a chip body 1, an adhesive layer 2, and a sealing layer 3. An imaging cavity 12, an optical density cavity 13, and a liquid distribution channel are located on one side of the chip body 1, and a sample dispensing port 11 penetrates the chip body 1. The chip body 1 includes one or more parallel light-transmitting planes, each plane forming the top of the cavity's internal region. The sealing layer 3 is a light-transmitting plane parallel to the chip body 1, forming the bottom of the cavity's internal region. The adhesive layer 2 is used to adhere the chip body 1 and the sealing layer 3, so that the imaging cavity 12, the optical density cavity 13, and the liquid distribution channel form a closed cavity structure. A sample can be injected through the sample dispensing port 11, and the imaging cavity 12 can receive a portion of the sample (the imaging cavity 12 has one or more...). Multiple interconnected imaging regions 14, with a height difference between the imaging regions 14 and the imaging cavity 12 (i.e., the imaging regions 14 are protrusion structures set within the imaging cavity 12), and the imaging cavity 12 is preloaded with dry reagents, which react independently with the sample flowing into the cavity for microscopic imaging of cells and tangible objects in the sample. The optical density cavity 13 can receive another portion of the sample, and the optical density cavity 13 is also preloaded with dry reagents, which react independently with the sample flowing into the optical density cavity 13 for measuring the optical density of the sample. At the same time, a stir bar is placed inside the optical density cavity 13, which can move within the optical density cavity 13 under external force to mix the sample and preloaded dry reagents within the optical density cavity 13.

[0028] In one embodiment, the chip body 1 has a first outflow channel 15 communicating with the imaging cavity 12, and the chip body 1 also has a first vent 16 extending into the first outflow channel 15; the chip body 1 has a second outflow channel 17 communicating with the optical density cavity 13, and the chip body 1 also has a second vent 18 extending into the second outflow channel 17. The vent 18 facilitates the expulsion of air from the cavity.

[0029] To prevent the stir bar from flowing out of the optical density cavity 13, in one embodiment, the diameter of the stir bar is smaller than the inner diameter of the optical density cavity 13, and larger than the width of the liquid distribution channel and the second outflow channel 17 communicating with the optical density cavity 13. Meanwhile, in a preferred embodiment, the stir bar is made of a magnetic material. The component for driving the movement of the stir bar can be a magnetic drive component, which may include a rotary motor, a connecting cylinder connected to the output shaft of the rotary motor, a mounting cylinder connected to the outer wall of the connecting cylinder, and a magnet installed inside the mounting cylinder. Thus, when the rotary motor operates, it drives the magnet to rotate, and the magnet can drive the stir bar to move through magnetic attraction, thereby achieving the stirring function.

[0030] In one embodiment, the lower part of the inner wall of the optical density cavity 13 is further provided with an annular groove 131 in a ring structure, and the gas bubbles generated in the cavity can migrate into the groove under the drive of pressure difference.

[0031] Two specific implementation designs are provided below:

[0032] Example 1:

[0033] like Figure 1 As shown, in this embodiment, the chip includes three imaging cavities 12 and one optical density cavity 13. Each cavity is connected to the sample application port 11 through a liquid distribution channel, and an imaging region 14 is provided in each imaging cavity 12. The heights of the three imaging regions 14 and the optical density cavity 13 are 200um, 100um, 400um, and 2000um, respectively.

[0034] The chip body 1 includes multiple parallel cavity top planes, and through exhaust ports and sample loading ports 11, which are injection molded from light-transmitting resin; the sealing layer 3 is a light-transmitting plane parallel to the chip body 1, forming the bottom of the cavity area, and is made of flat glass; the chip body 1 and the sealing layer 3 are bonded together by an adhesive layer 2 (pressure-sensitive double-sided adhesive) to maintain a parallel and stable height difference between the two; each imaging cavity 12 and the optical density cavity 13 has an exhaust port at the rear, and the air inside is discharged through the exhaust port when the sample flows into the cavity.

[0035] In this embodiment, the optical density cavity 13 is pre-loaded with dried hemolysin; the optical density cavity 13 is connected to the sample inlet 11 through a liquid distribution channel, the width of which is 1 mm; the optical density cavity 13 is connected to the vent through an outlet channel, the width of which is 1 mm; a stir bar with a diameter of 1.2 mm is placed inside the optical density cavity 13, the interior of which is made of stainless steel and the surface is covered with inert polystyrene. The stir bar can be driven by an external magnet to mix the sample and reagent. In addition, an annular groove 131 with a ring structure is formed in the lower part of the inner wall of the optical density cavity 13. The height difference between the groove and the upper surface of the cavity is 0.2 mm, and the width is 0.8 mm. Small cavities in the cavity migrate to the groove under the pressure difference.

[0036] Example 2:

[0037] like Figure 2 As shown, in this embodiment, the chip includes an imaging cavity 12 and an optical density cavity 13. The cavity is connected to the sample application port 11 through a liquid distribution channel. The imaging cavity 12 is provided with three interconnected imaging regions 14. The heights of the three imaging regions 14 and the optical density cavity 13 are 200um, 100um, 400um, and 2000um, respectively.

[0038] The chip body 1 includes multiple parallel cavity top planes, and through exhaust ports and sample loading ports 11, and is injection molded from light-transmitting resin; the sealing layer 3 is a light-transmitting plane parallel to the chip body 1, forming the bottom of the cavity area, and is made of flat glass; the chip body 1 and the sealing layer 3 are bonded together by an adhesive layer 2 (pressure-sensitive double-sided adhesive) to maintain a parallel and stable height difference between the two; the rear of the imaging cavity 12 and the rear of the optical density cavity 13 are each provided with an exhaust port, and the air inside is discharged through the exhaust port when the sample flows into the cavity.

[0039] In this embodiment, the optical density chamber 13 is pre-loaded with lyophilized C-reactive protein antibody reagent; the optical density chamber 13 is connected to the sample inlet 11 through a dispensing channel, the width of which is 1 mm; the optical density chamber 13 is connected to the vent through an outflow channel, the width of which is 1 mm; a stir bar with a diameter of 1.2 mm is placed inside the optical density chamber 13, the interior of which is made of stainless steel and the surface is covered with inert polystyrene. The stir bar can be driven by an external magnet to mix the sample and reagent. In addition, an annular groove 131 with a ring structure is formed in the lower part of the inner wall of the optical density chamber 13. The height difference between the groove and the upper surface of the chamber is 0.2 mm, and the width is 0.8 mm. Small cavities in the chamber migrate to the groove under the pressure difference.

[0040] In addition, a multi-parameter integrated detection device for blood and body fluid analysis is also provided, including the aforementioned detection chip, and further including...

[0041] A temperature control unit is used to control the reaction temperature of the detection chip. The temperature control unit includes a heating element to heat the detection chip.

[0042] A dual-wavelength illumination unit is used to provide red and green light illumination for optical density measurement;

[0043] A microscopic illumination assembly, comprising a transmission illumination unit and a fluorescence excitation unit, is used to provide basic illumination and excite reagents pre-loaded with fluorescent labels;

[0044] The image acquisition unit includes an objective lens, a tube lens, a filter, and an image sensor, and is used for image acquisition.

[0045] The three-dimensional translation drive mechanism can adopt the transmission method of motor lead screw to drive the detection chip to perform translational motion along the X and Y axes, and drive the image acquisition unit to perform lifting motion along the Z axis;

[0046] The stirring drive unit is used to drive the stir bar to move within the optical density cavity 13. In a feasible embodiment, the stir bar is made of a magnetic material. The stirring drive unit includes a rotary motor, a connecting cylinder connected to the output shaft of the rotary motor, a mounting cylinder connected to the outer wall of the connecting cylinder, and a magnet installed in the mounting cylinder. When the rotary motor is running, it can drive the magnet to run, and the magnet can drive the stir bar to move through magnetic attraction, thereby realizing the stirring function.

[0047] The above are merely preferred embodiments of the present utility model and are not intended to limit the present utility model. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A multi-parameter integrated detection chip for blood and body fluid analysis, comprising a chip body, an adhesive layer, and a sealing layer, characterized in that, The chip body has a sample application port and at least one imaging cavity and at least one optical density cavity. The imaging cavity has one or more interconnected imaging regions, and there is a height difference between the imaging regions and the imaging cavity. The chip body also has a liquid distribution channel, and the imaging cavity and optical density cavity are connected to the sample application port through the liquid distribution channel. The sealing layer is attached to the chip body with an adhesive layer so that the imaging cavity, optical density cavity and liquid distribution channel form a closed cavity structure.

2. The multi-parameter integrated detection chip for blood and body fluid analysis according to claim 1, characterized in that, The chip body has a first outflow channel communicating with the imaging cavity, and the chip body also has a first vent hole penetrating into the first outflow channel.

3. The multi-parameter integrated detection chip for blood and body fluid analysis according to claim 1, characterized in that, The chip body has a second outflow channel that communicates with the optical density cavity, and the chip body also has a second vent hole that extends into the second outflow channel.

4. The multi-parameter integrated detection chip for blood and body fluid analysis according to claim 1, characterized in that, The optical density cavity is also equipped with a stir bar, which is made of a magnetic material.

5. The multi-parameter integrated detection chip for blood and body fluid analysis according to claim 4, characterized in that, The diameter of the stir bar is smaller than the inner diameter of the optical density cavity, but larger than the width of the liquid distribution channel and the second outflow channel connected to the optical density cavity.

6. The multi-parameter integrated detection chip for blood and body fluid analysis according to claim 1, characterized in that, The lower part of the inner wall of the optical density cavity is also provided with an annular groove.

7. A multi-parameter integrated detection device for blood and body fluid analysis, comprising the detection chip as described in any one of claims 1 to 6, characterized in that, include Temperature control unit, used to control the reaction temperature of the detection chip; A dual-wavelength illumination unit is used to provide red and green light illumination for optical density measurement; A microscopic illumination assembly, comprising a transmission illumination unit and a fluorescence excitation unit, is used to provide basic illumination and excite reagents pre-loaded with fluorescent labels; Image acquisition unit, used for image acquisition; The three-dimensional translation drive mechanism is used to drive the detection chip to translate along the X and Y axes, and to drive the image acquisition unit to move up and down along the Z axis. The stirring drive unit is used to drive the stir bar to move within the optical density cavity.

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