CN118067591A - Consumable for blood analysis - Google Patents
Consumable for blood analysis Download PDFInfo
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- CN118067591A CN118067591A CN202410461563.4A CN202410461563A CN118067591A CN 118067591 A CN118067591 A CN 118067591A CN 202410461563 A CN202410461563 A CN 202410461563A CN 118067591 A CN118067591 A CN 118067591A
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- blood analysis
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- counting
- copper needle
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- 238000004159 blood analysis Methods 0.000 title claims abstract description 52
- 210000004027 cell Anatomy 0.000 claims abstract description 52
- 210000003743 erythrocyte Anatomy 0.000 claims abstract description 42
- 210000000265 leukocyte Anatomy 0.000 claims abstract description 36
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 claims abstract description 22
- 229910052802 copper Inorganic materials 0.000 claims abstract description 21
- 239000010949 copper Substances 0.000 claims abstract description 21
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- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention discloses a consumable for blood analysis, which comprises a group of counting tanks, namely a red blood cell disposable blood analysis counting tank and a white blood cell disposable blood analysis counting tank, wherein the disposable blood analysis counting tank is divided into a left chamber and a right chamber, the consumable comprises a buckle, a suction nozzle, a lower shell, a negative copper needle, a positive copper needle and an upper shell, the negative copper needle and the positive copper needle are arranged on the lower shell, the suction nozzle is arranged on the bottom surface of the lower shell, the buckle buckles the suction nozzle, and the lower shell covers the upper shell. The disposable blood analysis counting cell has a small structure, two counting cells are inserted to measure the red blood cells and the white blood cells, the special structure can measure more important indexes of blood, the consumable adopts a microfluidic design, namely a technology for controlling micro-volume fluid in a micro-channel, various complex biological and chemical analyses are realized by accurately controlling the flow and the mixing of the fluid, and the analysis efficiency and the analysis accuracy are greatly improved.
Description
Technical Field
The invention relates to a clinical laboratory blood analysis consumable, in particular to a consumable for blood analysis.
Background
Blood analyzers are widely used in clinical testing. The main function is to count white blood cells, red blood cells and platelets, and the tested data are compared with the standard range of values to judge the occurrence of diseases. Manual counting is a gold standard and a reference standard for white blood cell classification, but the classification speed is very slow, the accuracy is greatly influenced by human factors, and the manual counting is not suitable for large-scale sample detection. The large blood analyzer has many advantages, including high accuracy, abundant detectable indexes, large flux and the like, and is very suitable for occasions with fine depth detection and low time efficiency requirements.
On the other hand, such devices are too bulky and heavy, and are poorly portable, requiring specific detection sites and specialized detection personnel to work with multiple reagent consumables, which can have many limitations in the context of immediate detection requirements, and are not suitable for use in basic level or remote hard areas. And the existing blood analyzer is complicated in liquid, and is easy to age and leak liquid for a long time, so that harmful bacteria are bred, the test result is influenced, and the health of personnel is also influenced.
Consumable materials are put into the blood analyzer, and the traditional design concept of integrating detection pores into the detection instrument is inconvenient to take and place, and the cost is greatly increased due to cleaning and regular maintenance. The consumable on the market has single function, only can measure three categories of white blood cells, and if red blood cells are to be measured, the consumable needs to be large, so that the portable requirement can not be met. And the consumable materials on the market are high in manufacturing and processing cost, complex in process and unfavorable for large-scale assembly and production.
Disclosure of Invention
In order to solve the problem that consumables are inconvenient to carry and detect, the invention provides a consumable for blood analysis.
The invention provides the following technical scheme:
Aiming at the short plate of the traditional large-scale analyzer in the aspects of portability and instant detection, an impedance method blood cell detection system suitable for instant detection POCT (Pointofcare) is researched and designed, cell signals are successfully extracted from the interference of numerous noise (hydrodynamic noise, thermal noise and electronic noise, mechanical vibration and electromagnetic interference and the like), and quantitative detection of human blood cells is realized.
A consumptive material for blood analysis, the consumptive material includes a set of counting cell, is red blood cell disposable blood analysis counting cell and white blood cell disposable blood analysis counting cell respectively, and two cavities about disposable blood analysis counting cell divide into, and one cavity is the application of sample chamber, and another cavity is the waste liquid recovery chamber, and disposable blood analysis counting cell includes buckle, suction nozzle, inferior valve, negative pole copper needle, anodal copper needle, epitheca, negative pole copper needle, anodal copper needle are installed on the inferior valve, inferior valve bottom surface installation suction nozzle, and the suction nozzle is buckled to the buckle, and lower cap is in the epitheca.
Further, a small air exhaust hole is formed in the hollow column of the lower shell in the waste liquid recovery cavity, a barrier wall is arranged between the two cavities, a middle through hole is formed in the barrier wall, and a through cell micropore is formed in the bottom of the sample adding cavity.
Further, the red blood cell disposable blood analysis counting cell is used for measuring red blood cell count and platelet count, and the white blood cell disposable blood analysis counting cell is used for measuring white blood cell count.
Further, the positive electrode copper needle and the negative electrode copper needle are arranged below the micro-pore of the passing cell.
Further, the hollow column is tapered.
Further, the waste liquid recovery cavity realizes measurement of serum amyloid A and C-reactive protein.
The separated blood analysis consumable (namely the disposable blood analysis counting cell) designed by the invention gets rid of the traditional design concept that the detection small holes are integrated in the detection instrument, innovatively separates the cell micro-holes from the analysis instrument, and embeds the cell micro-holes in the analysis consumable to be designed into an independent detection module.
The disposable blood analysis counting cell is divided into a white blood cell counting cell and a red blood cell counting cell, and the two consumables can be independently inserted into an instrument for use, so that WBC or RBC and WBC can be independently detected: white Blood Cell (White Blood Cell), RBC: red Blood Cells (Red Blood Cells), and two consumables can be spliced and then inserted into an instrument for use, so that WBC and RBC can be detected simultaneously. The blood analysis consumable is disposable, convenient and sanitary, cross infection is avoided, and the problem of small hole blockage is solved from a new angle.
Compared with the prior art, the invention has the beneficial effects that:
The separating blood analysis consumable (namely the disposable blood analysis counting cell) is adopted, the cell micropores are creatively independent from the analysis instrument, the consumable is small, meanwhile, the two counting cells are inserted into the separating blood analysis consumable to measure the red blood cells and the white blood cells, and the special structure can measure more important blood indexes. The structural advantages are as follows:
(1) Single person designs, convenient high-efficient: the consumable adopts a single-person design, which means that an independent consumable bag is used for each detection, and the problem of cross contamination is not required to be worried about. The design not only improves the detection accuracy, but also enables the operation to be more convenient and efficient, and is particularly suitable for basic medical institutions and environments with high workload.
(2) Environmental protection and stability: the consumable material is made of recyclable or biodegradable materials, is environment-friendly and sustainable, and reduces pollution to the environment; the consistency and stability of consumable production are ensured by using the most advanced femtosecond laser drilling technology at present. Ensuring the stability and reliability of the device in the detection process. The high-quality environment-friendly consumable can provide accurate detection results and help doctors to make correct diagnosis.
(3) Maintenance-free characteristics, reduced operating cost: the consumable of the invention has the characteristic of maintenance-free, which means that frequent cleaning and periodic maintenance are not needed in the use process, thereby greatly reducing the maintenance cost and personnel burden of medical institutions. Meanwhile, the design also prolongs the service life of the instrument and improves the overall economic benefit.
(4) High precision and high efficiency: the design of the consumable adopts micro-flow control, which is a technology for controlling micro-volume fluid in a micro-channel, and various complex biological and chemical analyses are realized by precisely controlling the flow and the mixing of the fluid. Thus, sample processing, reagent mixing and reaction analysis can be completed in a tiny channel, and the analysis efficiency and accuracy are greatly improved. The micro-fluidic technology can accurately control the flow of the sample and the reagent, and realize the efficient analysis of the micro-sample. This not only reduces the consumption of the sample, but also shortens the detection time and improves the working efficiency.
(5) Safe and pollution-free: the waste liquid recovery cavity is specially designed in the consumable, SAA and CRP measurement can be realized in the waste liquid recovery cavity, and SAA: serum amyloid A (Serum Amyloid A), CRP: after the equipment test is finished, all samples flow into a waste liquid recovery cavity, and biological pollution is avoided.
Drawings
FIG. 1 is a schematic view of an apparatus for blood analysis according to the present invention.
FIG. 2 is an exploded view of the apparatus for blood analysis of the present invention.
FIG. 3 is an exploded view of the disposable blood analysis counting cell consumable of the present invention.
FIG. 4 is a perspective view of a disposable blood analysis counting cell consumable of the present invention.
FIG. 5 is a front view of a disposable blood analysis count cell consumable of the present invention.
FIG. 6 is a block diagram of a consumable pumping element of the present invention.
FIG. 7 is a diagram of a combination of consumables (red blood cell and white blood cell) according to the present invention.
FIG. 8 is a graph of CRP measurement data of the present invention.
FIG. 9 is a diagram of SAA measurement data according to the present invention.
FIG. 10 is a flow chart of the present invention when insertion of two consumables is detected.
FIG. 11 is a flow chart of the present invention when insertion into a red blood cell count cell is detected.
FIG. 12 is a flow chart of the present invention when an insertion into a white blood cell count cell is detected.
In the figure: 1. the waste liquid recycling device comprises an upper shell, 2, a lower shell, 3, a screen, 4, a screen bearing plate, 5, a pressure tank upper shell, 6, a pressure tank lower shell, 7, a printer module, 8, a battery pressing plate, 9, a battery, 10, a consumable pressing cover, 11, a consumable upper shell, 12, a disposable blood analysis counting tank, 121, a red blood cell counting tank, 122, a white blood cell counting tank, 13, a consumable mounting seat, 14, a spring column pressing plate, 15, a shielding upper shell, 16, a probe plate, 17, a shielding lower shell, 18, a consumable air extracting piece, 181, a red blood cell extracting opening, 182, a white blood cell extracting opening, 19, a consumable module supporting plate, 20, a pump, 21, a pump mounting plate gold, 22, a red blood cell extracting valve, 23, a white blood cell extracting valve, 24, a pump connecting valve, 25, a bearing plate, 26, a pressure tank supporting column, 27, a screen supporting column, 28, a spring column, 29, a collision bead, 30, a consumable component bearing column, 31, a buckle, 32, 33, a lower shell, 34, a negative copper needle, 35, a positive copper needle, 36, an upper shell, 37, a small hole, a middle hole, 39, a hollow cavity, a waste liquid recycling hole, 310 and a hollow cavity.
Description of the embodiments
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
As shown in fig. 3, the consumable for blood analysis according to the present invention includes a set of counting cells, which are a disposable erythrocyte blood analysis counting cell and a disposable leucocyte blood analysis counting cell, respectively, the disposable blood analysis counting cell includes a buckle 31, a suction nozzle 32, a lower case 33, a negative copper needle 34, a positive copper needle 35, and an upper case 36, the negative copper needle 34 and the positive copper needle 35 are mounted on the lower case 33, the suction nozzle 32 is mounted on the bottom surface of the lower case 33, the suction nozzle 32 is buckled by the buckle 31, and the lower case 33 is covered on the upper case 36.
As shown in fig. 4, the disposable blood analysis counting cell is divided into a left chamber and a right chamber, one chamber is a sample adding chamber 311, the other chamber is a waste liquid recovery chamber 310, a hollow column 312 of a lower shell 33 in the waste liquid recovery chamber 310 is provided with an air suction small hole 37, a middle through hole 38 is arranged between the two chambers, and a cell micropore 39 is arranged at the bottom of the sample adding chamber 311. The anode to cathode copper needles 34 are under the cell microwells 39.
The hollow column 312 is designed into a cone shape, and the cone-shaped hollow column 312 is provided with a small air suction hole 37, so that air suction is facilitated.
The waste liquid recovery cavity 310 is arranged in the consumable, so that measurement of serum amyloid A and C-reactive protein is realized, and after equipment testing is finished, all samples flow into the waste liquid recovery cavity completely, so that biological pollution is avoided.
SAA and CRP measurements can be achieved using the waste recovery chamber 310. SAA, serum amyloid A, is an acute phase protein. When the body is subjected to inflammatory stimuli such as tissue injury, infection or trauma, liver cells synthesize large amounts of SAA and release them into the blood, so that the SAA level in the blood increases rapidly in a short time. This makes SAA a sensitive parameter for assessing the progress of acute phase reactions. In the case of infection, bacterial infection results in a significant increase in SAA, while other viral infections besides adenovirus also result in an increase, but to a lesser extent than bacterial infection. Thus, SAA can be used to aid in the identification of bacterial infections and other types of viral infections. In addition, SAA can also be used to monitor rejection following organ transplant surgery, evaluate the efficacy of antibacterial agents, and determine indications of withdrawal.
CRP, a C-reactive protein, is also an acute phase protein. CRP can rise rapidly in the blood following infection or acute trauma. It is a sensitive indicator for the identification of bacterial and viral infections, as bacterial infections generally result in a significant elevation of CRP, whereas the elevation is generally milder or normal at the time of viral infection. Furthermore, the magnitude of the rise in CRP is positively correlated with the extent of infection and inflammation and can therefore be used to assess the severity of inflammatory responses.
When SAA and CRP are co-detected, they can provide more comprehensive information. For example, when both are elevated, an inflammatory infection is typically indicated in the body, and such infection is likely bacterial. At this time, doctors can formulate and adjust the treatment scheme according to the change of the indexes, effectively control infection, reduce the risk of complications and improve the cure rate.
The cell begins to detect when passing through cell micropore 39, and the detection is finished when liquid reaches middle via hole 38, and structural design is made according to the direction of internal air flow, adopts the overhead tank to provide stable pressure, lets the cell in the liquid flow more stable in the counting cell, and the test is more reliable.
According to the Coulter principle, in a constant current designed circuit, particles suspended in electrolyte can replace the electrolyte with the same volume when the electrolyte passes through the cell micropores, so that the resistance between the inner electrode and the outer electrode of the small pore tube is instantaneously changed, and potential pulses are generated. The size and number of pulses is proportional to the size and number of particles. Thus, by measuring the potential pulse, the size and number of particles can be determined.
Performance verification using the blood analysis consumables of the present invention:
The instrument is named as BK160, and the test comparison prototype is AU480, and is a full-automatic biochemical analyzer manufactured by Beckman Coulter.
The verification content:
table 1: CRP vs AU480 deviation table
Table 2: SAA vs AU480 deviation table
Summary of the verification:
as shown in fig. 8 and 9, the testing performance of the instrument of the present invention can meet the performance requirements of industry standards.
The consumable of the invention can be used in special instruments, and two counting tanks can be inserted simultaneously for measuring the erythrocyte and the leucocyte.
Referring to fig. 1-4, an apparatus for blood analysis of the present invention includes an upper housing 1, a lower housing 2, a consumable detection module, a display module and a printer module 7, wherein the display module is located at the center of the upper housing 1, the consumable detection module is contained in a space formed between the upper housing 1 and the lower housing 2, the consumable detection module includes a pressure tank, a pump 20, a three-valve assembly and a consumable cartridge module, the consumable cartridge module has a consumable air extraction member 18, the three-valve assembly includes a red blood cell extraction valve 22, a white blood cell extraction valve 23 and a pump connection valve 24, the pump 20 is connected with the pressure tank through the pump connection valve 24, the pressure tank is connected with the red blood cell extraction valve 22 and the white blood cell extraction valve 23 through a pipeline, the red blood cell extraction valve 22 and the white blood cell extraction valve 23 are connected with the consumable air extraction member 18, and the consumable detection module is used for blood cell counting function.
The pressure tank consists of a pressure tank upper shell 5 and a pressure tank lower shell 6, and the pressure tank lower shell 6 is connected with a pressure tank support column 26 and then locked on a bearing plate 25.
The display screen module is used for instrument operation and display interface, and realizing information interaction with a user. The display screen module comprises a screen 3, a screen bearing plate 4 and a screen support column 27, wherein the screen 3 is arranged on the screen bearing plate 4, the screen bearing plate 4 is fixed on the screen support column 27, and the screen support column 27 is locked on the bearing plate 25.
The instrument for blood analysis of the invention further comprises a battery 9, wherein the battery 9 is locked with the receiving plate 25 by using the battery pressing plate 8.
The pump 20 is mounted on a pump mounting plate gold 21, and the pump mounting plate gold 21 is mounted on a receiving plate 25.
A receiving plate 25 is mounted in the lower housing 2 for receiving the large components.
Consumable cartridge module includes that from the top down sets up consumable epitheca 11, disposable blood analysis count pond 12, consumable mount pad 13, spring post clamp plate 14, shielding epitheca 15, probe plate 16, shielding inferior valve 17, consumable air extraction piece 18, consumable module backup pad 19, connects gradually consumable mount pad 13, spring post clamp plate 14, shielding epitheca 15, probe plate 16, shielding inferior valve 17, consumable air extraction piece 18, consumable module backup pad 19 adoption screw, and consumable epitheca 11 lock is on consumable module backup pad 19, swing joint has consumable gland 10 on the consumable epitheca 11.
The whole consumable insertion module plays roles of receiving consumables, stabilizing consumables, compacting consumables, guaranteeing air tightness and facilitating taking out, wherein as shown in fig. 7, the internal structure design of the consumable installation seat 13 enables two counting cells to be inserted simultaneously for measuring erythrocyte and leucocyte, and the consumable insertion module can be inserted independently for measuring only leucocyte or erythrocyte; in addition, the consumable air extraction member 18 is structured so that it (air extraction opening) ensures tightness in contact with the suction nozzle 32, and at the same time, stable pressure output can be ensured from the air extraction opening.
As shown in fig. 6, the consumable air extracting part 18 is provided with a red blood cell extracting opening 181 and a white blood cell extracting opening 182.
Firstly, sealing an upper pressure tank shell 5 and a lower pressure tank shell 6 into a pressure tank in a glue filling mode, and locking the pressure tank on a bearing plate 25 after the pressure tank is connected with a pressure tank support column 26 by screws;
Then, after the consumable mounting seat 13, the spring column pressing plate 14, the shielding upper shell 15, the probe board 16, the shielding lower shell 17, the consumable air suction piece 18 and the consumable module supporting plate 19 are sequentially connected through screws, the consumable upper shell 11 is locked on the consumable module supporting plate 19, the consumable module supporting plate 19 is connected to the consumable component receiving column 30 through screws, and then the consumable component receiving column 30 is connected to the corresponding position of the receiving plate 25 through a locking screw mode. Locking the red blood cell extraction valve 22, the white blood cell extraction valve 23 and the pump connecting valve 24 at corresponding positions on the bearing plate 25, and connecting the consumable gland 10 on the upper shell 1 in a bolt manner;
The latch 29 is pressed into the fixing groove of the upper case 1. The assembled bearing plate 25 and the lower shell 2 are locked together by self-tapping screws from the back, then the battery 9 is clamped on the fixed position of the lower shell 2, and the battery 9 is buckled with the bearing plate 25 by the battery pressing plate 8 to be locked together;
Finally, the upper shell 1 and the lower shell 2 are buckled, and the screws are locked from below for fixation.
The specific test flow is as follows (consumable in flow chart is disposable blood analysis counting cell):
As shown in FIG. 10, when two counting cells are inserted in place, the system detects that the pump and the pump connecting valve are simultaneously opened, the negative pressure of the pressure tank is stopped when the negative pressure reaches-30 kpa, the pump and the pump connecting valve are closed, the red blood cell extracting valve is opened at the moment, the red blood cell counting cell starts to measure, after the measurement is finished, the red blood cell extracting valve is closed, the pump and the pump connecting valve are opened to enable the pressure tank to be stopped after the pressure is stabilized at-30 kpa, and the white blood cells are measured after the white blood cell extracting valve is opened, at this moment, the detection of the red blood cells and the white blood cells is completed.
When the red blood cells are required to be measured independently, only the red blood cell counting cell is required to be inserted independently, after the red blood cells are inserted in place, the system is successfully detected, the pump and the pump connecting valve are opened, the pump and the pump connecting valve are closed after the pressure tank reaches-30 kpa, the red blood cell extraction valve is opened at the moment, the red blood cells are started to be measured, and the red blood cell measurement is completed when the measurement is prompted to be successful.
When the white blood cells are required to be measured independently, only the white blood cell counting tank needs to be inserted independently, after the white blood cells are inserted in place, the system is successfully detected, the pump and the pump connecting valve are opened, the pump and the pump connecting valve are closed after the pressure tank reaches-30 kpa, the white blood cell extraction valve is opened at the moment, the white blood cells are measured, and the white blood cell measurement is completed when the measurement is prompted to be successful.
Through the brand-new design of the disposable consumable chamber, the measurement of key parameters such as white blood cell count, red blood cell count and platelet count, hemoglobin concentration, CRP and the like can be realized.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (6)
1. A consumable for blood analysis, characterized by: the consumptive material includes a set of counting cell, is red blood cell disposable blood analysis counting cell and white blood cell disposable blood analysis counting cell respectively, and two cavities are controlled in disposable blood analysis counting cell divide into, and one cavity is application of sample chamber (311), and another cavity is waste liquid recovery chamber (310), and disposable blood analysis counting cell includes buckle (31), suction nozzle (32), inferior valve (33), negative electrode copper needle (34), anodal copper needle (35), epitheca (36), negative electrode copper needle (34), anodal copper needle (35) are installed on inferior valve (33), inferior valve (33) bottom surface installation suction nozzle (32), and buckle (31) withhold suction nozzle (32), inferior valve (33) lid in epitheca (36).
2. A consumable for blood analysis according to claim 1, characterized in that: the hollow column of the lower shell (33) in the waste liquid recovery cavity (310) is provided with an air suction small hole (37), a middle through hole (38) is arranged between the two cavities, and the bottom of the sample adding cavity (311) is provided with a cell micropore (39).
3. A consumable for blood analysis according to claim 1, characterized in that: the erythrocyte disposable blood analysis counting cell is used for measuring erythrocyte count and platelet count, and the leucocyte disposable blood analysis counting cell is used for measuring leucocyte count.
4. A consumable for blood analysis according to claim 1, characterized in that: and a positive-to-negative copper needle (34) below the cell microwell (39).
5. A consumable for blood analysis according to claim 1, characterized in that: the hollow post (312) is tapered.
6. A consumable for blood analysis according to claim 1, characterized in that: the waste liquid recovery chamber (310) enables measurement of serum amyloid A and C-reactive proteins.
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CN118067590A (en) * | 2024-04-17 | 2024-05-24 | 南京佰抗生物科技有限公司 | Instrument for blood analysis |
Citations (10)
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