Novel blood storage device for in-vitro hemolysis experiment

Abstract

The invention provides a novel in-vitro hemolysis experiment blood storage device which comprises a flexible blood storage bag body, a blood inlet and a blood outlet, and the peripheral edge of the flexible blood storage bag body is of an arc-shaped structure; the blood inlet is fixedly formed in the edge of one side of the flexible blood storage bag body, and the blood inlet is communicated with the interior of the flexible blood storage bag body; the blood outlet is fixedly installed on the edge of the side, opposite to the blood inlet, of the flexible blood storage bag body. According to the novel blood storage device for the in-vitro hemolysis experiment, the blood inlet and the blood outlet are distributed in the edges of the two opposite sides of the flexible blood storage bag body, and the central axis of the blood outlet and the central axis of the blood inlet are not located on the same straight line; meanwhile, the central axis of the blood outlet is parallel to the central axis of the blood inlet, so that blood can be prevented from easily forming a blood stagnation area at a place far away from the port, and the accuracy of an in-vitro hemolysis experiment is ensured.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a novel blood storage device for in vitro hemolysis experiments. Background Art

[0002] The hemolysis test is a test of the rupture and dissolution of red blood cells in the human body. It is mainly used for the etiology diagnosis of hemolytic anemia. Hemolysis refers to the rupture and dissolution of red blood cells. Many physical and chemical factors can cause hemolysis. Blood bags are required in the in vitro hemolysis test. The blood bag consists of three parts: the blood inlet, the bag body and the blood outlet. It is also commonly used in in vitro hemolysis experiments. There are detailed provisions for the specifications and indicators of blood bags in various standards, such as the aforementioned international standard ASTM F1814-2013 and the national standard GB14232.1-2020. The blood bags used are also described in some literature. The blood bags used in most experiments are commercial blood bags made according to the international standard ASTM F1814-2013. They are characterized by the blood inlet and outlet being set on the same side of the blood bag, and most of them are opened on the bottom at the same time. For example:

[0003] The blood bag disclosed in the Chinese patent with publication (announcement) number CN216310819U has a blood inlet and a blood outlet arranged on the same side of the blood bag;

[0004] The blood collection and transfusion bag disclosed in the Chinese patent with publication (announcement) number CN201591750U has a blood flow inlet and a blood flow outlet arranged on the same side of the blood bag.

[0005] Setting the blood inlet and outlet on the same side of the blood bag will make it easy for blood to form a blood stagnation area far away from the port, which will affect the accuracy of the in vitro hemolysis experiment.

[0006] Therefore, a new blood storage device for in vitro hemolysis experiment is proposed which can solve the above problems. Summary of the invention

[0007] The present invention aims to solve the problems raised in the background technology and provides a novel blood storage device for in vitro hemolysis experiments.

[0008] The specific technical solutions are as follows:

[0009] A novel in vitro hemolysis experiment blood storage device comprises: a flexible blood storage bag body, which is used for storing blood in an in vitro hemolysis experiment system. The peripheral edges of the flexible blood storage bag body are all arc-shaped structures. When the interior is filled with blood, the bag body of the flexible blood storage bag body is diamond-shaped. The flexible blood storage bag body has a blood inlet and a blood outlet.

[0010] As a preferred embodiment of the present invention, the blood inlet is fixedly mounted on one side edge of the flexible blood storage bag body, and the blood inlet is communicated with the interior of the flexible blood storage bag body; the blood outlet is fixedly mounted on one side edge of the flexible blood storage bag body opposite to the blood inlet, and the blood outlet is communicated with the interior of the flexible blood storage bag body, a central axis of the blood outlet is not in the same straight line as a central axis of the blood inlet, and the central axis of the blood outlet is arranged parallel to the central axis of the blood inlet.

[0011] As a preferred solution of the present invention, different angle scale lines α and different flow scale lines are printed on two opposite corners of the flexible blood storage bag body, and the flow scale lines are arranged corresponding to the angle scale lines α.

[0012] As a preferred embodiment of the present invention, the angle scale line α includes angle scale line α1, angle scale line α2 and angle scale line α3, one ends of the angle scale line α1, angle scale line α2 and angle scale line α3 intersect, and the other ends of the angle scale line α1, angle scale line α2 and angle scale line α3 are separated.

[0013] As a preferred embodiment of the present invention, the flow scale line includes a flow scale line 1, a flow scale line 2 and a flow scale line 3, one end of the flow scale line 1, the flow scale line 2 and the flow scale line 3 intersects, and the other ends of the flow scale line 1, the flow scale line 2 and the flow scale line 3 are separated.

[0014] As a preferred solution of the present invention, it also includes two clamps for clamping the flexible blood storage bag body along the angle scale line α and the flow scale line respectively.

[0015] As a preferred solution of the present invention, the clip is replaced by an adhesive tape, which is made along different scale lines and can be pressed together when in use.

[0016] As a preferred solution of the present invention, the inner diameter of the blood inlet and the inner diameter of the blood outlet are both not less than 6 mm.

[0017] As a preferred solution of the present invention, the flexible blood storage bag is a medical polyethylene bag.

[0018] As a preferred embodiment of the present invention, the specific design of the novel in vitro hemolysis experiment blood storage device includes the following steps:

[0019] Three-dimensional modeling of a new blood storage device for in vitro hemolysis experiment S1

[0020] S1.1 Initial geometric model of a new blood storage device for in vitro hemolysis experiment

[0021] Abaqus was selected as the solver for establishing the initial geometric model of the new in vitro hemolysis experiment blood storage device;

[0022] S1.2 Three-dimensional model of the new in vitro hemolysis test blood storage device after filling

[0023] Generate the flexible blood storage bag, blood inlet and blood outlet of the new in vitro hemolysis test blood storage device in Soildworks;

[0024] S1.3 Optimization design of a new blood storage device for in vitro hemolysis experiments

[0025] The design of blood inlet and blood outlet on opposite sides is adopted, and on this basis, a new diamond-shaped blood storage device for in vitro hemolysis experiment is designed;

[0026] Flow field simulation of S2 new blood storage device for in vitro hemolysis experiment

[0027] S2.1 Meshing and boundary conditions

[0028] Before conducting finite element analysis, the model processed in SolidWorks needs to be imported into ANSYS ICEM CAD for meshing, and then imported into ANSYS Fluent for calculation settings and hemodynamic analysis;

[0029] S2.2 Flow field simulation of a new blood storage device for in vitro hemolysis experiment

[0030] By setting the control equations, boundary conditions and calculation methods, the flow field simulation of the new in vitro hemolysis experiment blood storage device was carried out in Ansys Fluent. The calculation results were post-processed, and the vector diagram, cloud diagram and streamline diagram of the corresponding surface were generated after the observation surface was established.

[0031] S3 in vitro experimental verification

[0032] A hemolysis experiment platform was built, and a new in vitro hemolysis experiment blood storage device was placed on the platform for hemolysis experiment. After collecting the serum, the degree of hemolysis was determined using an enzyme marker, thereby calculating the free hemoglobin index and related indices. The real flow field data was obtained by building a PIV shooting platform, and the control results were compared with the computational fluid dynamics simulation results.

[0033] The present invention has the following beneficial effects:

[0034] The novel in vitro hemolysis experiment blood storage device provided by the present invention is mainly composed of a flexible blood storage bag body, a blood inlet and a blood outlet, wherein the blood inlet and the blood outlet are distributed on the opposite side edges of the flexible blood storage bag body, and the central axis of the blood outlet is not on the same straight line as the central axis of the blood inlet. At the same time, the central axis of the blood outlet is parallel to the central axis of the blood inlet, which can prevent blood from easily forming a blood stagnation area far away from the port, thereby ensuring the accuracy of the in vitro hemolysis experiment. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 A schematic diagram of the structure of a novel blood storage device for in vitro hemolysis experiments provided by an embodiment of the present invention;

[0036] Figure 2 A schematic front view of the structure of a novel in vitro hemolysis experiment blood storage device provided by an embodiment of the present invention;

[0037] Figure 3 A schematic diagram of the top view of the novel in vitro hemolysis experiment blood storage device provided by an embodiment of the present invention;

[0038] Figure 4 A design flow chart of a novel in vitro hemolysis experiment blood storage device provided by an embodiment of the present invention;

[0039] Figure 5 This is a diagram of the flow field simulation results of the novel in vitro hemolysis experiment blood storage device provided in an embodiment of the present invention.

[0040] In the attached figure:

[0041] 1. Flexible blood storage bag body; 2. Blood inlet; 3. Blood outlet; 4. Clip. DETAILED DESCRIPTION

[0042] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0043] Among them, the drawings are only used for illustrative explanations, and they only represent schematic diagrams rather than actual pictures, and should not be understood as limitations on this patent; in order to better illustrate the embodiments of the present invention, some parts of the drawings may be omitted, enlarged or reduced, and do not represent the size of the actual product; for those skilled in the art, it is understandable that some well-known structures and their descriptions in the drawings may be omitted.

[0044] The same or similar numbers in the drawings of the embodiments of the present invention correspond to the same or similar parts; in the description of the present invention, it should be understood that if the terms "upper", "lower", "left", "right", "inner", "outer", etc. appear, the orientation or position relationship indicated is based on the orientation or position relationship shown in the drawings, which is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, the terms describing the position relationship in the drawings are only used for illustrative purposes and cannot be understood as a limitation on this patent. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0045] In the description of the present invention, unless otherwise clearly specified and limited, if the term "connection" or the like appears to indicate the connection relationship between components, the term should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two components or the interaction relationship between two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0046] Example

[0047] The novel in vitro hemolysis experiment blood storage device provided in this embodiment is as follows: Figure 1-Figure 3 As shown, it comprises: a flexible blood storage bag body 1, a blood inlet 2 and a blood outlet 3.

[0048] The flexible blood storage bag 1 is used for storing blood in an in vitro hemolysis experiment system, and the peripheral edges of the flexible blood storage bag 1 are all arc-shaped structures. When the flexible blood storage bag 1 is filled with blood, the bag body of the flexible blood storage bag 1 is in a diamond shape;

[0049] The blood inlet 2 is fixedly mounted on one side edge of the flexible blood storage bag body 1, and the blood inlet 2 is connected to the interior of the flexible blood storage bag body 1;

[0050] Among them, the blood outlet 3 is fixedly installed on the edge of the side opposite to the blood inlet 2 of the flexible blood storage bag body 1, and the blood outlet 3 is connected with the interior of the flexible blood storage bag body 1. The central axis of the blood outlet 3 is not on the same straight line as the central axis of the blood inlet 2, and the central axis of the blood outlet 3 is arranged parallel to the central axis of the blood inlet 2.

[0051] The novel in vitro hemolysis experiment blood storage device adopting the above technical solution is mainly composed of a flexible blood storage bag body 1, a blood inlet 2 and a blood outlet 3, wherein the blood inlet 2 and the blood outlet 3 are distributed on the opposite side edges of the flexible blood storage bag body 1, and the central axis of the blood outlet 3 is not on the same straight line as the central axis of the blood inlet 2. At the same time, the central axis of the blood outlet 3 is parallel to the central axis of the blood inlet 2. At the same time, when the inside is filled with blood, the bag body of the flexible blood storage bag 1 is diamond-shaped, which can prevent blood from easily forming a blood stagnation area far away from the port, thereby ensuring the accuracy of the in vitro hemolysis experiment.

[0052] In order to adjust the flow rate of blood in the flexible blood storage bag 1, different angle scale lines α and different flow scale lines are printed on two opposite corners of the flexible blood storage bag 1, and the flow scale lines are set corresponding to the angle scale lines α. The set angle scale lines α include angle scale lines α1, angle scale lines α2 and angle scale lines α3. One ends of the angle scale lines α1, angle scale lines α2 and angle scale lines α3 intersect, and the other ends of the angle scale lines α1, angle scale lines α2 and angle scale lines α3 are separated. The set flow scale lines include flow scale lines 1, flow scale lines 2 and flow scale lines 3. One ends of the flow scale lines 1, flow scale lines 2 and flow scale lines 3 intersect, and the other ends of the flow scale lines 1, flow scale lines 2 and flow scale lines 3 are separated.

[0053] In order to facilitate the adjustment of the blood flow rate in the flexible blood storage bag body 1, two clamps 4 are provided for clamping the flexible blood storage bag body 1 along the angle scale line α and the flow scale line respectively.

[0054] When using, follow Figure 3 As shown, by clamping different angle scale lines α and flow scale lines with the clamp 4 , adaptation to different flow rates of the hemolysis circuit can be achieved.

[0055] In order to further reduce the risk of blood stagnating in a region far from the port, the inner diameter of the blood inlet 2 and the inner diameter of the blood outlet 3 are both set to be no less than 6 mm.

[0056] In order to meet the needs of clinical use, the flexible blood storage bag body 1 is a medical polyethylene bag body.

[0057] It is worth noting that, in addition to the clamping method of the clamp 4, the novel in vitro hemolysis experiment blood storage device can also be manufactured by making adhesive tapes with different scale lines, and pressing the adhesive tapes together by hand or machine when in use. This method can quickly and conveniently seal the plastic bag, and the adhesive tape is not easy to fall off.

[0058] In summary, the novel in vitro hemolysis experiment blood storage device provided in this embodiment has the following advantages:

[0059] The novel in vitro hemolysis experiment blood storage device is mainly composed of a flexible blood storage bag body 1, a blood inlet 2 and a blood outlet 3, wherein the blood inlet 2 and the blood outlet 3 are distributed on the opposite side edges of the flexible blood storage bag body 1, and the central axis of the blood outlet 3 is not on the same straight line as the central axis of the blood inlet 2. At the same time, the central axis of the blood outlet 3 is parallel to the central axis of the blood inlet 2, which can prevent blood from easily forming a blood stagnation area far away from the port, thereby ensuring the accuracy of the in vitro hemolysis experiment.

[0060] When in use, connect the blood inlet 2 and the blood outlet 3 to the blood supply circuit. Figure 3 As shown, by clamping different angle scale lines α and flow scale lines with two clamps 4 , adaptation to different flow rates of the hemolysis circuit can be achieved.

[0061] The specific design process of the novel in vitro hemolysis experiment blood storage device provided in this embodiment is as follows:

[0062] Three-dimensional modeling of a new blood storage device for in vitro hemolysis experiment S1

[0063] S1.1 Initial geometric model of a new blood storage device for in vitro hemolysis experiment

[0064] Abaqus is a powerful finite element software for engineering simulation. It can solve problems ranging from relatively simple linear analysis to many complex nonlinear problems. It can analyze complex solid mechanics and structural mechanics systems, especially capable of handling very large and complex problems and simulating highly nonlinear problems. In this embodiment, Abaqus is selected as the solver for establishing the initial geometric model of the new in vitro hemolysis experiment blood storage device.

[0065] S1.2 Three-dimensional model of the new in vitro hemolysis test blood storage device after filling

[0066] In order to add the learned blood inlet and blood outlet to the geometric model of the new in vitro hemolysis experiment blood storage device after filling, the blood inlet and blood outlet of the new in vitro hemolysis experiment blood storage device were generated in Soildworks (an easy-to-use design tool based on feature, parametric and solid modeling, which can create fully related three-dimensional solid models. There may or may not be constraints between entities).

[0067] S1.3 Optimization design of a new blood storage device for in vitro hemolysis experiments

[0068] Since the existing novel in vitro hemolysis experiment blood storage devices all have the blood inlet and blood outlet arranged on the same side, the blood is prone to form a blood stagnation area far away from the port. Therefore, in order to improve the fluidity of the blood, this embodiment designs a design in which the liquid inlet and the blood outlet are on opposite sides, and on this basis designs a rhombus-shaped novel in vitro hemolysis experiment blood storage device, such as Figure 1 Shown

[0069] Flow field simulation of S2 new blood storage device for in vitro hemolysis experiment

[0070] S2.1 Meshing and boundary conditions

[0071] Before conducting finite element analysis, the model processed in SolidWorks needs to be imported into ANSYS ICEM CAD (which has powerful CAD model repair capabilities, unique mesh "sculpting" technology, mesh editing technology, and extensive solver support capabilities) for meshing, and then imported into ANSYS Fluent for calculation settings and hemodynamic analysis.

[0072] S2.2 Flow field simulation of a new blood storage device for in vitro hemolysis experiment

[0073] By setting the control equations, boundary conditions and calculation methods, the flow field simulation of the new in vitro hemolysis experiment blood storage device is carried out in Ansys Fluent. The calculation results are post-processed, and after the observation surface is established, vector diagrams, cloud diagrams, streamline diagrams, etc. of the corresponding surface can be generated, such as Figure 5 shown.

[0074] S3 in vitro experimental verification

[0075] By building a hemolysis experiment platform, the new in vitro hemolysis experiment blood storage device was placed in the platform for hemolysis experiment. After collecting serum, the degree of hemolysis was determined using an enzyme marker, thereby calculating the free hemoglobin index and related indexes. The real flow field data was obtained by building a PIV shooting platform, and the results were compared with the computational fluid dynamics simulation results. Figure 5 shown.

[0076] It is worth noting that this embodiment selects the configuration with the best fluid dynamics performance at a standard flow rate of 5 L / min as the final configuration; the clamp line is also designed for different flow conditions, which is suitable for in vitro hemolysis experiments under flow conditions of 2 to 7 L.

[0077] It can be seen from the above simulation calculation results that the central axis of the blood outlet 3 and the central axis of the blood inlet 2 of the novel in vitro hemolysis experiment blood storage device provided in this embodiment are not on the same straight line, and the central axis of the blood outlet 3 and the central axis of the blood inlet 2 are parallel to each other, which can avoid the blood from easily forming a blood stagnation area far away from the port, thereby ensuring the accuracy of the in vitro hemolysis experiment.

[0078] The above are only preferred embodiments of the present invention, and are not intended to limit the implementation methods and protection scope of the present invention. Those skilled in the art should be aware that all solutions obtained by equivalent substitutions and obvious changes made using the description and illustrations of the present invention should be included in the protection scope of the present invention.

Claims

1. A novel blood storage device for in vitro hemolysis experiment, characterized in that: include: A flexible blood storage bag (1) is used for storing blood in an in vitro hemolysis experiment system. The peripheral edges of the flexible blood storage bag (1) are all arc-shaped structures. When the flexible blood storage bag (1) is filled with blood, the bag body is diamond-shaped. The flexible blood storage bag (1) has a blood inlet (2) and a blood outlet (3).

2. The novel in vitro hemolysis experiment blood storage device according to claim 1 is characterized in that: The blood inlet (2) is fixedly mounted on one side edge of the flexible blood storage bag body (1), and the blood inlet (2) is communicated with the interior of the flexible blood storage bag body (1); the blood outlet (3) is fixedly mounted on one side edge of the flexible blood storage bag body (1) opposite to the blood inlet (2), and the blood outlet (3) is communicated with the interior of the flexible blood storage bag body (1), the central axis of the blood outlet (3) is not in the same straight line as the central axis of the blood inlet (2), and the central axis of the blood outlet (3) is arranged parallel to the central axis of the blood inlet (2).

3. The novel in vitro hemolysis experiment blood storage device according to claim 1 is characterized in that: Different angle scale lines α and different flow scale lines are printed on two opposite corners of the flexible blood storage bag body (1), and the flow scale lines are arranged corresponding to the angle scale lines α.

4. The novel in vitro hemolysis experiment blood storage device according to claim 3 is characterized in that: The angle scale line α includes an angle scale line α1, an angle scale line α2 and an angle scale line α3, one end of the angle scale line α1, the angle scale line α2 and the angle scale line α3 intersects, and the other ends of the angle scale line α1, the angle scale line α2 and the angle scale line α3 are separated.

5. The novel in vitro hemolysis experiment blood storage device according to claim 4 is characterized in that: The flow scale lines include flow scale line 1, flow scale line 2 and flow scale line 3, one ends of the flow scale line 1, flow scale line 2 and flow scale line 3 intersect, and the other ends of the flow scale line 1, flow scale line 2 and flow scale line 3 are separated.

6. The novel in vitro hemolysis experiment blood storage device according to claim 5 is characterized in that: It also comprises two clamps (4) for clamping the flexible blood storage bag body (1) along the angle scale line α and the flow scale line respectively.

7. The novel in vitro hemolysis experiment blood storage device according to claim 6, characterized in that: The clip (4) is replaced by an adhesive tape, which is made along different scale lines and can be pressed together when in use.

8. The novel in vitro hemolysis experiment blood storage device according to claim 6 is characterized in that: The inner diameter of the blood inlet (2) and the inner diameter of the blood outlet (3) are both not less than 6 mm.

9. The novel in vitro hemolysis experiment blood storage device according to any one of claims 1 to 8, characterized in that: The flexible blood storage bag (1) is a medical polyethylene bag.

10. The novel in vitro hemolysis experiment blood storage device according to any one of claims 1 to 9, characterized in that: The specific design of the novel in vitro hemolysis experiment blood storage device includes the following steps: Three-dimensional modeling of a new blood storage device for in vitro hemolysis experiment S1 S1.1 Initial geometric model of a new blood storage device for in vitro hemolysis experiment Abaqus was selected as the solver for establishing the initial geometric model of the new in vitro hemolysis experiment blood storage device; S1.2 Three-dimensional model of the new in vitro hemolysis test blood storage device after filling Generate the flexible blood storage bag, blood inlet and blood outlet of the new in vitro hemolysis test blood storage device in Soildworks; S1.3 Optimization design of a new blood storage device for in vitro hemolysis experiments The design of blood inlet and blood outlet on opposite sides is adopted, and on this basis, a new diamond-shaped blood storage device for in vitro hemolysis experiment is designed; Flow field simulation of S2 new blood storage device for in vitro hemolysis experiment S2.1 Meshing and boundary conditions Before conducting finite element analysis, the model processed in SolidWorks needs to be imported into ANSYS ICEM CAD for meshing, and then imported into ANSYS Fluent for calculation settings and hemodynamic analysis; S2.2 Flow field simulation of a new blood storage device for in vitro hemolysis experiment By setting the control equations, boundary conditions and calculation methods, the flow field simulation of the new in vitro hemolysis experiment blood storage device was carried out in Ansys Fluent. The calculation results were post-processed, and the vector diagram, cloud diagram and streamline diagram of the corresponding surface were generated after the observation surface was established. S3 in vitro experimental verification A hemolysis experiment platform was built, and a new in vitro hemolysis experiment blood storage device was placed on the platform for hemolysis experiment. After collecting the serum, the degree of hemolysis was determined using an enzyme marker, thereby calculating the free hemoglobin index and related indices. The real flow field data was obtained by building a PIV shooting platform, and the control results were compared with the computational fluid dynamics simulation results.

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