Whole blood separation and purification equipment for light and moderate chylemia

Abstract

The invention relates to the technical field of component blood preparation, and discloses light and moderate chylemia whole blood separation and purification equipment which is used for separation and purification work of chylemia whole blood. Through arrangement of a mounting plate, a cover body and an objective table, a detection position is arranged between a first bulge and a second bulge, the mounting plate is kept in a vertical state by utilizing the cover body, and the objective table is arranged on the mounting plate; detection personnel can adjust the height of the blood bag to enable the serum layer to be located in the detection position between the second protrusion and the first protrusion for detection, it is ensured that the thickness of the serum layer is kept consistent during detection, and therefore chylemia is subjected to indexing through an optical detection method, errors caused by manual judgment are reduced, chylemia plasma capable of being directly used is screened out, and the detection efficiency is improved. The dependence on the experience of operators is reduced, the detection process is simplified, and the loss of plasma caused by detection loss is reduced.

Description

Technical Field

[0001] The invention relates to the technical field of component blood preparation, and in particular to a whole blood separation and purification device for mild to moderate chylous blood. Background Art

[0002] In clinical practice, serum is used as, however, since the hospital's blood resources generally come from voluntary blood donations, and the blood resources obtained from free blood donations are generally whole blood, at the same time, voluntary blood donations are generally spur of the moment, and there is no guarantee that the donors are in a fasting state when donating blood. For example, when shopping or digesting food after a meal, they see a free blood donation vehicle and donate blood on a whim, and the quality of the donated blood cannot be guaranteed, resulting in a high level of chyle in the whole blood in the blood bank and a serious shortage of blood in the hospital.

[0003] Although there are technologies for separating and purifying chylomicronized blood in the prior art, for example, the invention patent with announcement number CN109939470B of Langfang Central Blood Station discloses a simple method and device for filtering chylomicronized plasma, which separates and purifies chylomicronized plasma by refrigeration, standing, centrifugal separation, and filtering chylomicronized plasma through a membrane filter and an ultrafiltration membrane filter, thereby reducing the waste of blood due to severe chylomicronization and avoiding the waste of blood resources.

[0004] However, when the chylomicron content of serum is too high, it will not only cause clogging of membrane filters and ultrafiltration membrane filters, seriously affecting the separation and purification efficiency of plasma, but also, during the filtration process, the membrane may be blocked by chylomicrons, making it impossible for components in serum to pass through the membrane, resulting in component loss. For example, the serum used in blood transfusion is mainly used for cross-matching tests to ensure the compatibility of donor and recipient blood. If the key components in the serum (such as antibodies) are insufficient, cross-matching tests may fail, leading to transfusion reactions such as hemolysis. If the necessary immune components are lacking in the serum, immunological tests may not be performed effectively, affecting the correct assessment of the patient's immune status. In some cases, certain components in serum (such as immunoglobulins) are essential for the treatment of certain diseases. If these components are removed or reduced, the effectiveness of the treatment may be affected.

[0005] In this case, it is necessary to rely on the experience of medical staff and screen the chylomicron degree to screen out the serum that can be used. In clinical practice, the plasma dilution multiple is used as the chylomicron index. Chylomicron with a chylomicron index ≤ 2 is mild chylomicron, chylomicron with a chylomicron index of 3-5 is moderate chylomicron, and chylomicron with a chylomicron index > 5 is severe chylomicron. The chylomicron needs to be taken out and the degree of chylomicron is determined by the dilution multiple. Under the condition that blood resources are stored in plasma bags and storage containers, and the amount of chylomicron in the whole blood of the blood bank remains high, and at the same time, the hospital is seriously short of blood, the dilution method is used to determine the chylomicron degree of blood resources and the chylomicron is screened and graded, which undoubtedly reduces the recovery rate of chylomicron. Summary of the invention

[0006] The present invention aims to provide a whole blood separation and purification device for mild to moderate chylomicron blood, so as to reduce the loss of chylomicron blood fractionation and improve the recovery and utilization rate of chylomicron blood.

[0007] To achieve the above-mentioned purpose, the present invention adopts the following technical scheme: a whole blood separation and purification device for mild to moderate chylomicron blood, used for separation and purification of whole blood with chylomicron blood, comprising a centrifugal stratification unit for centrifugally separating whole blood stored in a plasma bag and a grading screening unit for grading and screening the plasma layer after stratification of the whole blood. The whole blood with chylomicron blood is stored in a whole blood bag and is divided into a plasma layer and a red blood cell layer after passing through the centrifugal stratification unit. The grading screening unit comprises a grading unit for detecting the plasma layer and dividing the whole blood with chylomicron blood into mild to moderate chylomicron blood and severe chylomicron blood and a grading unit for grading and screening the whole blood with chylomicron blood after grading. A screening unit for separation, the dividing unit includes a box and a detector, the box includes a shell and a cover, a mounting plate is hinged between the shell and the cover, a detecting part is arranged on the mounting plate, the detecting part includes a first protrusion, a partition is arranged in the shell, a second protrusion opposite to and coaxial with the first protrusion is arranged on the partition, a detecting position is arranged between the first protrusion and the second protrusion, the detector includes a light source and a receiving component, the light source is fixed on the detecting part and can emit light, the receiving component is fixed on the partition and connected with the light source, and the light passes through the first protrusion, the detecting position and the second protrusion in sequence to reach the receiving component.

[0008] At present, most of the blood used in clinical practice comes from blood stations, and the blood resources of blood stations come from voluntary blood donations. Blood donors first use fingertip blood to conduct rapid tests on blood type, hemoglobin, transaminase, hepatitis B surface antigen and other indicators at the blood donation site, and use rapid test reagents to preliminarily exclude people who are not suitable for blood donation. Blood is collected from those who pass the rough screening and rapid test. The collected blood must undergo extremely strict laboratory tests. Two sets of test reagents are used, and testing instruments that meet international standards are used to conduct initial and retests of six items: transaminase, hepatitis B, hepatitis C, AIDS, syphilis, and blood type. Blood that passes the test will be sent to the component preparation department. The white blood cells that are most likely to carry pathogens are filtered out through a leukocyte filter; the blood is separated to separate red blood cells and plasma respectively; plasma is prepared, and the plasma must be separated again and then undergo a series of integration, filtration, illumination and other virus inactivation preparation processes, and then low-temperature quick freezing and other treatments are placed in a freezer at a specified temperature for storage. Chyle blood can usually only be discovered when the blood is separated and stored in a blood bag. Traditional methods for detecting chyle blood include visual inspection and dilution methods, but these methods have problems such as strong subjectivity, low efficiency, and complex operation. For example, the visual inspection method needs to rely on the personal experience of medical staff, but relying solely on the supervisory experience of medical staff is bound to lead to misjudgment, and the screening efficiency is low. The dilution method can refer to Appendix A of GB 18469-2001, which requires taking out plasma and using dilution colorimetry to obtain the chylomicron index to determine the chylomicron degree of plasma. The operation is relatively cumbersome and requires the consumption of some raw materials as test materials. Although the amount consumed each time is not much, due to the particularity of the blood source, a single person donates 200-400ml of blood at a time, or a single person donates blood at a time and stores it in a blood bag, so that the existing blood bags are divided into 200ml, 300ml and 400ml. Taking the detection of 200ml blood bags as an example, each time the chylomicron degree of plasma is detected, at least 2ml of plasma is consumed, and plasma accounts for about 55% of the whole blood. When the material to be detected is whole blood, the loss of a single bag of blood is 1.8%.

[0009] The beneficial effects of this scheme are as follows: through the setting of the first protrusion and the second protrusion, the tester can adjust the height of the blood bag to ensure that the serum layer is located between the second protrusion and the first protrusion, so as to ensure that the thickness of the serum layer remains consistent during the test, thereby reducing the error of human judgment. At the same time, the plasma layer is graded through optical detection to screen out the chylomicronized plasma that can be directly used, thereby reducing the detection loss and the dependence on the operator's experience. At the same time, the inspection process can be simplified and the loss of plasma due to graduation can be reduced.

[0010] Furthermore, the detection position is provided with a loading platform, which is located below the second protrusion. The setting of the loading platform facilitates the operator to place the blood bag to be detected, simplifies the detection process, and improves the detection efficiency.

[0011] Furthermore, the stage is slidably arranged on the partition. At present, the blood bags for whole blood donation in China are mainly divided into three types: 200 ml, 300 ml and 400 ml. The single blood donation of a single person is 200-400 ml. Through the sliding stage, the operator can freely adjust the height of the stage to adapt to blood bags of different specifications, so as to ensure that the serum layer is located between the detection position between the first protrusion and the second protrusion, so that the light emitted by the light source just passes through the serum layer, and ensure the reliability of the detection result.

[0012] Furthermore, a hinged portion for hinged connection with the shell is provided in the middle of the mounting plate. When the mounting plate is hinged with the shell through the middle portion, the mounting plate can be driven to collide with the stage when the cover is unfolded. This solution uses the first protrusion and the second protrusion to optically detect the serum in the blood bag. During the detection, the first protrusion and the second protrusion squeeze the blood bag, which inevitably causes red blood cells or platelets that should be below the serum layer to be squeezed into the serum layer. By setting the hinged position of the mounting plate and the shell, each time the cover is opened, the mounting plate will collide with the stage, causing the blood bag placed on the stage to vibrate, causing the red blood cells or platelets squeezed into the serum layer to settle under the action of the vibration, thereby reducing the workload of subsequent separation.

[0013] Furthermore, the screening unit includes a plasma clamp, a plasma separation bag and a connecting tube. The plasma layer of mild to moderate chylous blood is separated by the plasma clamp. The connecting tube is provided with a flow control clamp for controlling the flow of the pipeline. When the plasma layer of mild to moderate chylous blood is separated by the plasma clamp, the connecting tube is respectively connected to the whole blood bag and the plasma separation bag.

[0014] Furthermore, the screening unit also includes a temporary storage bag for preservative solution, which is connected to the connecting tube, and the temporary storage bag for preservative solution stores blood cell preservative solution.

[0015] Furthermore, the connecting tube is a three-way tube, on which a pipe clamp is provided, which is arranged between the three-way tube and the plasma separation bag and between the three-way tube and the temporary storage bag of the preservation solution, and the plasma separation bag and the temporary storage bag of the preservation solution are connected with the whole blood bag through the three-way tube.

[0016] Furthermore, the graduation unit also includes a severe chylous plasma standard solution, which is a standard solution with a chylous index of 5. When the detected transmittance is greater than or equal to the transmittance of the severe chylous plasma standard solution, the detected plasma is severe chylous plasma.

[0017] Furthermore, a bag sealing machine is included for sealing the plasma bag and the red blood cell storage bag. By using the bag sealing machine, after the plasma separation is completed, the obtained suspended red blood cells and plasma can be sealed in time to avoid the separated suspended red blood cells and plasma from being contaminated due to improper storage.

[0018] Furthermore, the receiving component is a turbidity sensor, an absorbance sensor or a transmittance sensor, and the light source is adapted to the receiving component.

[0019] Combining all the above technical solutions, the advantages and positive effects of the present invention are as follows:

[0020] First, this solution indirectly obtains the milkiness of plasma through optical sensors such as turbidity sensors, absorbance sensors or transmittance sensors, accurately distinguishes the milkiness of plasma, reduces errors caused by operator experience, and at the same time, with the help of the presence of reference materials, further enhances the reliability of grading and screening; secondly, this solution uses the presence of connecting tubes and tees to connect blood bags, plasma separation bags and storage fluid temporary bags into one, and uses the presence of plasma clamps and pipe clamps to allow plasma and storage fluid to go their own way, directly obtaining plasma and red blood cell suspension, and using a bag sealing machine to seal the separated plasma and suspended red blood cells in corresponding blood bags, respectively, to reduce the probability of blood contact with the external environment and reduce the risk of contamination. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is a flow chart of an embodiment of the present invention;

[0022] Figure 2 This is a schematic diagram of blood bag connection according to an embodiment of the present invention;

[0023] Figure 3 A three-dimensional diagram of the indexing unit housing according to an embodiment of the present invention;

[0024] Figure 4 This is a schematic diagram of the internal structure of the indexing unit housing according to an embodiment of the present invention;

[0025] Figure 5 This is a schematic diagram of the working state of an embodiment of the present invention;

[0026] Figure 6 It is a structural schematic diagram of the expanded state of the dividing unit box body in embodiment 4 of the present invention. DETAILED DESCRIPTION

[0027] The following is further described in detail through specific implementation methods:

[0028] The figure marks in the drawings of the specification include: cover body 1, first mounting part 11, mounting plate 2, detection part 21, second mounting part 211, second protrusion 212, first hinge part 221, second hinge part 222, third hinge part 223, shell 3, partition 31, first protrusion 311, stage 32, receiving component 41, light source 42, blood bag 511, plasma storage bag 512, preservation solution temporary storage bag 513, tee 521, first pipe clamp 522, second pipe clamp 523.

[0029] Example 1

[0030] Embodiment 1 is basically as attached Figure 1-5 As shown, Figure 1-5 The device for separating and purifying whole blood with mild to moderate chylomicronized blood shown in the figure comprises a centrifugal separation unit, a grading unit and a screening unit. The centrifugal separation unit comprises a refrigerator and a centrifuge. The refrigerator is used to refrigerate and keep the blood bag 511 still, and the centrifuge is used to centrifugally stratify the blood bag 511 after refrigeration and branching.

[0031] The graduation unit includes a photometer, which includes an optical detection component and a housing. The optical detection component includes a light source 42 and a receiving component 41. The light source 42 can be the photometer light source 42 disclosed in application number 202222332275.8. The receiving component 41 can be the photometer body disclosed in application number 202222332275.8. The detection principle is not described here in detail. During the detection, the serum layer is placed between the light source 42 and the receiving component 41. The light emitted by the light source 42 passes through the serum layer to reach the receiving component 41, thereby obtaining the transmittance of the serum layer.

[0032] like Figure 3 , Figure 4 As shown, the box includes a shell 3, a cover 1 and a mounting plate 2. A partition 31 is arranged in the middle of the shell 3, and a loading platform 32 is slidably arranged on the partition 31. The partition 31 divides the shell 3 into a dark cavity and an experimental cavity. A first protrusion 311 is arranged on the partition 31. The receiving component 41 is bonded to the partition 31 and is located in the dark cavity to avoid interference of ambient light on the detection of the receiving component 41. A first mounting portion 11 is arranged at the left end of the cover 1, and a blackout curtain is hinged on the first mounting portion 11. The cover 1 is hinged at the upper end of the mounting plate 2. The mounting plate 2 is rotatably arranged inside the experimental cavity of the shell 3. The upper end of the mounting plate 2 is provided with a first hinge. The cover 1 is hinged to the mounting plate through the first hinge 221, and the mounting plate 2 is hinged to the housing 3 through the second hinge 222. A detection portion 21 is provided in the middle of the mounting plate 2. The detection portion 21 includes a second protrusion 212 and a second mounting portion 211. The detection position is between the second protrusion 212 and the first protrusion 311. After the blood bag 511 is centrifuged and layered, the height of the stage 32 is adjusted so that the plasma layer is located between the detection position between the second protrusion 212 and the first protrusion 311. The cover 1 is closed so that the mounting plate 2 is in a vertical state. Figure 5 As shown, at this time, the second protrusion 212 is coaxial with the first protrusion 311, and the light source 42 emits light. The light passes through the plasma layer to reach the receiving component 41, and the absorbance of the plasma layer is obtained by the receiving component 41. The top of the dark cavity is covered by the cover body 1. At the same time, the experimental cavity is shaded by the blackout curtain to ensure that the dark cavity is in a light-free environment, thereby isolating light pollution in the environment, preventing ambient light from affecting the receiving component 41 in the dark cavity, and ensuring the reliability of the detection result.

[0033] The screening unit includes a plasma clamp, a plasma separation bag, a temporary storage bag 513 for the preservation solution, and a connecting tube. The plasma clamp can refer to the "Automatic plasma separation clamp using absorbance detection" disclosed in the Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army, document number: CN216696057U, to achieve accurate separation of plasma and red blood cell plasma. Figure 2 The connecting pipe shown in the figure includes a tee 521, and the three interfaces of the tee 521 are respectively connected with pipelines to form a tee pipe. The three pipelines of the tee pipe are respectively connected with the blood bag 511, the plasma storage bag 512 and the temporary storage bag 513 of the preservation solution, wherein the pipeline connecting the tee pipe with the plasma storage bag 512 is provided with a first pipeline clamp 522, and the pipeline connecting the tee pipe with the temporary storage bag 513 of the preservation solution is provided with a second pipeline clamp 523. The temporary storage bag 513 of the preservation solution temporarily stores the preservation solution. When separated, the blood bag 511, the plasma storage bag 512 and the temporary storage bag 513 of the preservation solution are connected through the tee pipe to form the following figure: Figure 2 In the structure shown, the flow direction in the three-way pipe is controlled by the first pipe clamp 522 and the second pipe clamp 523. When the plasma in the blood bag 511 is separated by the plasma clamp, the first pipe clamp 522 is opened and the second pipe clamp 523 is closed until the plasma clamp stops working. Then, the first pipe clamp 522 is closed and the second pipe clamp 523 is opened, and the preservation solution temporary storage bag 513 is placed in the plasma clamp. Through the pressure of the plasma clamp, the preservation solution in the preservation solution temporary storage bag 513 enters the blood bag 511 to obtain a blood cell suspension.

[0034] The specific implementation process is as follows:

[0035] When using, Figure 1 As shown, whole blood is stratified to obtain a cell layer and a plasma layer after being refrigerated, allowed to stand and centrifuged. The height of the stage 32 is adjusted according to the capacity of the blood bag 511 to be tested. Subsequently, the centrifuged blood bag 511 is placed on the stage 32, and the mounting plate 2 is rotated to a vertical state to observe whether the serum layer is located at the detection position between the first protrusion 311 and the second protrusion 212. If the serum layer is located at the detection position, the cover body 1 is closed to detect the serum transmittance. If the serum layer is not located at the detection position, the height of the stage 32 is adjusted to ensure that the serum layer is located at the detection position.

[0036] Before the test begins, the testers select moderate chylosing and severe chylosing as reference standards based on experience, and check the selected reference standards to distinguish mild chylosing, moderate chylosing and severe chylosing. During the test, the chylosing is divided into mild chylosing, moderate chylosing and severe chylosing according to the test results. Mild chylosing is directly layered through plasma clamps to obtain finished plasma and suspended red blood cells. Moderate chylosing is layered through plasma clamps to obtain crude plasma and suspended red blood cells. The crude plasma is subjected to centrifugal layering again to obtain finished plasma. Severe chylosing is subjected to membrane filtration and component supplementation to obtain finished plasma and suspended red blood cells.

[0037] Example 2

[0038] Embodiment 2 is basically the same as Embodiment 1, except that a shading plate is covered on the top of the dark cavity, and the shading plate ensures that the dark cavity is always in a light-free environment, thereby ensuring the reliability of the receiving component 41.

[0039] At the same time, a reference substance is also included, which is chylous plasma with a chylous index of 5. The reference substance is used for comparison to avoid misdetection caused by problems with the light source 42 or the receiving component 41.

[0040] Example 3

[0041] Example 3 is basically the same as Example 2, except that the receiving component 41 is a turbidity sensor with model APMS-11GVCF-KIT, and the light source 42 is a light source 42 adapted to the receiving component 41. When in use, chylous plasma with a chylous index of 5 is first selected as a reference substance, and the turbidity of the reference substance is measured as a reference value. When the detected turbidity is less than the reference value, it is mild to moderate chylous plasma.

[0042] Example 4

[0043] Example 4 is basically the same as Example 1, except that a third hinge portion 223 is further provided in the middle of the mounting plate 2, and the mounting plate 2 is hinged to the shell 3 through the third hinge portion 223. After the detection is completed, the cover body 1 is opened to drive the mounting plate 2 to rotate, so that the mounting plate 2 collides with the edge of the stage 32, thereby vibrating the blood bag 511 placed on the stage 32, so as to avoid the problem that during the detection, the blood bag 511 is clamped by the first protrusion 311 and the second protrusion 212, causing the red blood cells or platelets in the lower layer to be squeezed into the serum layer and attached to the inner wall of the blood bag 511, resulting in incomplete separation of the serum layer when separated by the plasma clamp, or causing the blood cell layer or platelets and other substances to be mistakenly separated into the serum layer.

[0044] The above is only an embodiment of the present invention, and common knowledge such as the known specific technical solutions and / or characteristics in the solution is not described in detail here. It should be pointed out that the technical means for solving the problems in the above-mentioned embodiments of the present invention can be used in combination to solve multiple technical problems at the same time. For those skilled in the art, several modifications and improvements can be made without departing from the technical solution of the present invention, which should also be regarded as the scope of protection of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.

Claims

1. A whole blood separation and purification device for mild to moderate chylomicronized blood, used for the separation and purification of whole blood with chylomicronized blood, characterized by: The invention comprises a centrifugal stratification unit for centrifugally dividing whole blood stored in a plasma bag and a grading screening unit for grading and screening the plasma layer after stratification of the whole blood. The chylomicron whole blood is stored in the whole blood bag and is divided into a plasma layer and a red blood cell layer after passing through the centrifugal stratification unit. The grading screening unit comprises a grading unit for detecting the plasma layer and dividing the chylomicron whole blood into mild to moderate chylomicron and severe chylomicron and a screening unit for separating the chylomicron whole blood after grading. The grading unit comprises a box body and a detector. The box body comprises a shell and a cover body. A mounting plate is hinged between the shell and the cover body. A detection part is arranged on the mounting plate. The detection part comprises a first protrusion. A partition is arranged in the shell. A second protrusion opposite to and coaxial with the first protrusion is arranged on the partition. A detection position is arranged between the first protrusion and the second protrusion. The detector comprises a light source and a receiving component. The light source is fixed on the detection part and can emit light. The receiving component is fixed on the partition and connected to the light source. The light passes through the first protrusion, the detection position and the second protrusion in sequence to reach the receiving component.

2. The whole blood separation and purification device for mild to moderate chylomicronized blood according to claim 1, characterized in that: The detection position is provided with a loading platform, and the loading platform is located below the second protrusion.

3. The whole blood separation and purification device for mild to moderate chylomicronized blood according to claim 2, characterized in that: The loading platform is slidably arranged on the partition.

4. The whole blood separation and purification device for mild to moderate chylomicronized blood according to claim 3, characterized in that: A hinged portion for hinged connection with the shell is arranged in the middle of the mounting plate. When the mounting plate is hinged with the shell through the middle portion, the mounting plate can be driven to collide with the loading platform when the cover body is unfolded.

5. The whole blood separation and purification device for mild to moderate chylomicronized blood according to claim 1, characterized in that: The screening unit includes a plasma clamp, a plasma separation bag and a connecting tube. The plasma layer of mild to moderate chylous blood is separated by the plasma clamp. The connecting tube is provided with a flow control clamp for controlling the flow of the pipeline. When the plasma layer of mild to moderate chylous blood is separated by the plasma clamp, the connecting tube is connected to the whole blood bag and the plasma separation bag respectively.

6. The whole blood separation and purification device for mild to moderate chylomicronized blood according to claim 5, characterized in that: The screening unit also includes a temporary storage bag for the preservation solution, which is connected to the connecting tube, and the storage bag for the preservation solution stores blood cell preservation solution.

7. The whole blood separation and purification device for mild to moderate chylomicronized blood according to claim 6, characterized in that: The connecting tube is a three-way tube, on which a pipe clamp is arranged, and the pipe clamp is arranged between the three-way tube and the plasma separation bag and between the three-way tube and the temporary storage bag of the preservation solution. The plasma separation bag and the temporary storage bag of the preservation solution are connected with the whole blood bag through the three-way tube.

8. The whole blood separation and purification device for mild to moderate chylomicronized blood according to claim 7, characterized in that: The graduation unit also includes a severe chylous plasma standard solution, which is a standard solution with a chylous index of 5. When the detected transmittance is greater than or equal to the transmittance of the severe chylous plasma standard solution, the detected plasma is severe chylous plasma.

9. The whole blood separation and purification device for mild to moderate chylomicronized blood according to claim 8, characterized in that: It also includes a bag sealing machine for sealing blood plasma bags and red blood cell storage bags.

10. The whole blood separation and purification device for mild to moderate chylomicronized blood according to claim 1, characterized in that: The receiving component is a turbidity sensor, an absorbance sensor or a transmittance sensor, and the light source is adapted to the receiving component.

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