Blood storage bag and manufacturing method thereof

Abstract

The invention relates to the technical field of medical equipment, in particular to a blood storage bag and a manufacturing method thereof. The blood storage bag comprises a shell, a bag body, an exhaust and blood sampling dual-purpose tube, a limiting piece, a first reinforcing piece, a second reinforcing piece and a third reinforcing piece. The bag body is provided with a blood inlet, a blood outlet and an exhaust and blood sampling dual-purpose opening; the exhaust and blood sampling dual-purpose tube is connected with the exhaust and blood sampling dual-purpose port; the limiting piece limits the bag body to form a first arc-shaped part. The exhaust and blood sampling dual-purpose tube is arranged at the top of the bag body, so that the bag has the exhaust and blood sampling functions; by arranging the limiting piece, formation of blood flow field vortexes in the bag body can be optimized, it is guaranteed that blood is fully mixed in a flow field, and a static dead zone is avoided; the first reinforcing piece, the second reinforcing piece and the third reinforcing piece are arranged, the structural stability of the bag body and all the pipelines can be guaranteed, and therefore the problems that in the using process, due to the fact that the pipelines and the connecting positions are prone to distortion and deformation, the blood flow speed is unstable, pressure changes suddenly, and hemolysis is abnormal are solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical instrument equipment, in particular to a blood storage bag and a manufacturing method thereof. BACKGROUND

[0002] Hemolysis experiment is an experiment for evaluating the degree of red blood cell rupture (hemolysis) of blood under the action of mechanical, chemical or physical factors, and is widely used in blood storage research of medical instruments (such as blood pumps, extracorporeal circulation pipelines). When evaluating hemolysis damage of continuous flow blood pumps such as extracorporeal circulation, extracorporeal membrane oxygenation (ECMO) and artificial heart, experiments are generally carried out according to the ASTM F1841-97 standard. The standard stipulates that the blood volume used in one experiment is 450±45 mL, the experimental circuit needs to be sealed, the blood needs to be mixed uniformly to avoid stratification and local coagulation, and the blood storage bag is required to have a blood sampling port.

[0003] However, the current blood storage bag for hemolysis experiment has the following three problems: first, the existing blood storage bag has imperfect exhaust mechanism, resulting in residual gas in the bag, which may interfere with the experimental process; second, the pipeline and the connection are prone to twisting and deformation during use, causing unstable blood flow rate and pressure mutation, resulting in abnormal hemolysis; third, the internal flow field of the traditional bag body is not optimized, and there are obvious fluid stagnation areas, which produce static dead zones and affect the accuracy of the hemolysis experiment. Therefore, whether the blood can be mixed uniformly, exhausted quickly and the pipeline and the connection do not twist and deform during use is a key factor affecting the blood storage bag. SUMMARY

[0004] The present application provides a blood storage bag and a manufacturing method thereof to solve the defects of poor exhaust function, easy twisting and deformation of the pipeline and the connection, and dead zones in the existing blood storage bag.

[0005] The present application provides a blood storage bag, comprising: a shell; a bag body arranged in the shell and having a blood inlet port, a blood outlet port and an exhaust and blood sampling dual-purpose port; an exhaust and blood sampling dual-purpose tube connected with the exhaust and blood sampling dual-purpose port; a limiting piece arranged in the shell and limiting the bag body to form a first arc-shaped portion, the first arc-shaped portion being located between the blood inlet port and the blood outlet port, and blood forming a vortex in the bag body under the guidance of the first arc-shaped portion; a first reinforcing piece arranged between the shell and the blood inlet port; a second reinforcing piece arranged between the shell and the blood outlet port; a third reinforcing piece arranged between the shell and the exhaust and blood sampling dual-purpose tube.

[0006] The blood storage bag provided by the application, the limiting member has an arc-shaped protrusion, the arc-shaped protrusion is arranged close to the blood outlet, and the included angle between the blood inlet and the arc-shaped protrusion is greater than the included angle between the blood outlet and the arc-shaped protrusion.

[0007] The blood storage bag provided by the application, the limiting member has an arc-shaped protrusion, the arc-shaped protrusion is arranged on the median line of the connection between the blood inlet and the blood outlet, and the included angle between the blood inlet and the arc-shaped protrusion is equal to the included angle between the blood outlet and the arc-shaped protrusion; or, The arc-shaped protrusion is arranged away from the blood outlet, and the included angle between the blood inlet and the arc-shaped protrusion is less than the included angle between the blood outlet and the arc-shaped protrusion.

[0008] The blood storage bag provided by the application, the bag body is further formed with a second arc-shaped part and a third arc-shaped part, when the bag body is in a full state, the second arc-shaped part is arranged on one side of the blood outlet, the third arc-shaped part is arranged on one side of the blood inlet, the distance between the third arc-shaped part and the blood inlet is greater than the distance between the second arc-shaped part and the blood outlet, and the radius of the circle fitted by the third arc-shaped part is less than the radius of the circle fitted by the second arc-shaped part.

[0009] The blood storage bag provided by the application, the bag body is further formed with a second arc-shaped part and a third arc-shaped part, when the bag body is in a full state, the second arc-shaped part is arranged on one side of the blood outlet, the third arc-shaped part is arranged on one side of the blood inlet, the distance between the third arc-shaped part and the blood inlet is equal to the distance between the second arc-shaped part and the blood outlet, and the radius of the circle fitted by the third arc-shaped part is equal to the radius of the circle fitted by the second arc-shaped part; or, The distance between the third arc-shaped part and the blood inlet is less than the distance between the second arc-shaped part and the blood outlet, and the radius of the circle fitted by the third arc-shaped part is greater than the radius of the circle fitted by the second arc-shaped part.

[0010] The blood storage bag provided by the application, when the bag body is in a full state, the exhaust blood dual-purpose port is arranged at the top of the bag body.

[0011] The blood storage bag provided by the application, the first reinforcing member, the second reinforcing member and the third reinforcing member are all multilayer annular reinforcing ribs. The blood inlet is inserted into and fixed in the first reinforcing member, the blood outlet is inserted into and fixed in the second reinforcing member, and the exhaust blood dual-purpose tube is inserted into and fixed in the third reinforcing member.

[0012] According to the blood storage bag provided by the application, the shell is further provided with a hanging ring hole, and when the bag body is in a full state, the hanging ring hole is located on the gravity center vertical line of the bag body.

[0013] The application further provides a manufacturing method of the blood storage bag, comprising: determining the shape and / or size of the bag body in the full state according to the CFD simulation; determining the shape and / or size of the limiting piece according to the determined shape and / or size of the bag body.

[0014] According to the manufacturing method of the blood storage bag provided by the application, the step of determining the shape and / or size of the bag body in the full state according to the CFD simulation specifically comprises: presetting a plurality of bag bodies with different shapes and different sizes, and performing CFD simulation experiments on each bag body in the full state; selecting the bag body shape and size with fewer fluid vortexes.

[0015] The application provides a blood storage bag, which comprises a shell, a bag body, an exhaust and blood collection dual-purpose tube, a limiting piece, a first reinforcing piece, a second reinforcing piece and a third reinforcing piece. The bag body is arranged in the shell and has a blood inlet, a blood outlet and an exhaust and blood collection dual-purpose port. The exhaust and blood collection dual-purpose tube is connected with the exhaust and blood collection dual-purpose port. The limiting piece is arranged in the shell and limits the bag body to form a first arc-shaped part between the blood inlet and the blood outlet. The first reinforcing piece is arranged between the shell and the blood inlet. The second reinforcing piece is arranged between the shell and the blood outlet. The third reinforcing piece is arranged between the shell and the exhaust and blood collection dual-purpose tube. The blood storage bag provided by the application can have the functions of exhaust and blood collection by arranging the exhaust and blood collection dual-purpose tube on the top of the bag body. The limiting piece can optimize the formation of the blood flow field vortex in the bag body, ensure the full mixing of blood in the flow field and avoid the generation of a static dead zone. The first reinforcing piece, the second reinforcing piece and the third reinforcing piece can ensure the structural stability of the bag body and each pipeline, thereby avoiding the twisting and deformation of the pipeline and the connection part during use, the unstable blood flow speed, the pressure mutation and the hemolysis abnormality.

[0016] Further, the application further provides a manufacturing method of the blood storage bag, which determines the shape and / or size of the bag body according to the CFD simulation, thereby processing the blood storage bag, ensuring the uniform circulation of blood in the blood storage bag and avoiding the static dead zone. BRIEF DESCRIPTION OF DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings described below are only some embodiments of the present application, and all other drawings obtained by those of ordinary skill in the art without creative work based on these drawings also belong to the protection scope of the present application.

[0018] Figure 1 is a structural schematic diagram of a blood storage bag provided by one of the embodiments of the present application.

[0019] Figure 2 is a CFD simulation schematic diagram of a blood storage bag provided by one of the embodiments of the present application.

[0020] Figure 3 is a CFD simulation schematic diagram of a blood storage bag provided by one of the embodiments of the present application.

[0021] Figure 4 is a CFD simulation schematic diagram of a blood storage bag provided by one of the embodiments of the present application.

[0022] Figure 5 is a CFD simulation schematic diagram of a blood storage bag provided by one of the embodiments of the present application.

[0023] Figure 6 is a CFD simulation schematic diagram of a blood storage bag provided by one of the embodiments of the present application.

[0024] Reference signs: 1: shell; 2: bag body; 21: blood inlet; 22: blood outlet; 23: exhaust and blood collection dual-purpose port; 24: first arc-shaped part; 25: second arc-shaped part; 26: third arc-shaped part; 3: exhaust and blood collection dual-purpose tube; 4: limiting piece; 51: first reinforcing piece; 52: second reinforcing piece; 53: third reinforcing piece; 6: suspension lifting ring hole; 7: two-way valve. DETAILED DESCRIPTION

[0025] In order to make the objects, technical solutions and advantages of the present application clearer, the following will combine the drawings in the present application to clearly and completely describe the technical solutions in the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work also belong to the protection scope of the present application.

[0026] In the description of the present embodiments, it is to be understood that the orientations or positional relationships indicated by the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", and the like are based on the orientations or positional relationships shown in the drawings, and are merely intended for convenience of description and simplification of description, and thus cannot be understood as indicating or implying that the devices or elements indicated thereby must have a particular orientation, be constructed and operated in a particular orientation, and thus cannot be understood as limiting the present embodiments.

[0027] In addition, the terms "first", "second", etc. are merely used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated thereby. Thus, the features defined with "first", "second", etc. can explicitly or implicitly include at least one of the features. In the description of the present embodiments, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise explicitly specified and limited.

[0028] In the present embodiments, unless otherwise explicitly specified and limited, the terms "arrangement", "installation", "connection", "linkage", "fixation", and the like should be understood in a broad sense, for example, can be fixed connection, or detachable connection, or integral; can be mechanical connection, or electrical connection; can be direct connection, or indirect connection through an intermediate medium; can be internal communication of two elements or interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present embodiments can be understood according to the specific circumstances.

[0029] In the present embodiments, unless otherwise explicitly specified and limited, the first feature "on" or "under" the second feature can be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature "above", "over" and "on" the second feature can be that the first feature is directly above or obliquely above the second feature, or only indicates that the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "under" and "under" the second feature can be that the first feature is directly below or obliquely below the second feature, or only indicates that the horizontal height of the first feature is less than that of the second feature.

[0030] The present application is described below in conjunction with Figures 1-6 A blood storage bag is described in the present application, in Figures 2 to 6 In the present application, the inlet represents the blood inlet 21, and the outlet represents the blood outlet 22. The blood storage bag comprises a shell 1, a bag body 2, a dual-purpose exhaust blood collection tube 3, a limiting member 4, a first reinforcing member 51, a second reinforcing member 52, and a third reinforcing member 53.

[0031] The bag body 2 is arranged in the shell 1, and has a blood inlet 21, a blood outlet 22 and an exhaust blood dual-purpose port 23; the exhaust blood dual-purpose tube 3 is connected with the exhaust blood dual-purpose port 23; the limiting piece 4 is arranged in the shell 1 and limits the bag body 2 to form a first arc-shaped part 24 between the blood inlet 21 and the blood outlet 22; the first reinforcing piece 51 is arranged between the shell 1 and the blood inlet 21; the second reinforcing piece 52 is arranged between the shell 1 and the blood outlet 22; and the third reinforcing piece 53 is arranged between the shell 1 and the exhaust blood dual-purpose tube 3.

[0032] Specifically, the shell 1 serves as an installation and support structure of the internal structure of the blood storage bag, and the bag body 2, the limiting piece 4, the first reinforcing piece 51, the second reinforcing piece 52 and the third reinforcing piece 53 are all fixed in the shell 1; the shell 1 can have a rectangular structure, and the top and bottom are processed with round corners, and the radius of the top corner is greater than that of the bottom corner.

[0033] The bag body 2 has a polygonal structure and a fixed maximum volume, about 320 mL after being filled with blood, is made of PVC material, and blood enters the bag body 2 through the blood inlet 21 and is discharged through the blood outlet 22, so as to realize circulation. The exhaust blood dual-purpose port 23 is located at the top of the bag body 2, which can serve as an exhaust port for pre-charging blood and a blood taking port during the experiment. The exhaust blood dual-purpose port 23 is connected with the outside through the exhaust blood dual-purpose tube 3; preferably, the exhaust blood dual-purpose tube 3 is a 2m long PVC tube with a 3 / 8 tube diameter, and the blood capacity of the tube is about 130 mL, which cooperates with the bag body 2 to make the blood capacity of the blood storage bag and the necessary tube in circulation about 450 mL, and the pre-charge volume of the pump head in the loop is generally about 30 mL, which is slightly larger than the loss during exhaust and blood taking in the loop.

[0034] The limiting piece 4 is located at the bottom of the bag body 2, and can constrain the shape of the bag body 2 after being filled with blood. The limiting piece 4 is located between the blood inlet 21 and the blood outlet 22, and supports the wall of the bag body 2 between the blood inlet 21 and the blood outlet 22, so as to form a concave structure (i.e. the first arc-shaped part 24). After the blood enters from the blood inlet 21, it forms a vortex in the bag body 2 under the guidance of the first arc-shaped part 24, so as to ensure that the blood is fully mixed in the flow field and avoid the formation of a static dead zone.

[0035] In addition, the limiting piece 4 also has an auxiliary support function for the bag body 2. When the bag body 2 is filled with blood, the limiting piece 4 can support the bottom of the bag body 2, strengthen the strength of the bottom of the blood storage bag, and make it not easy to bend The first reinforcing member 51, the second reinforcing member 52 and the third reinforcing member 53 are respectively used for fixing the positions of the blood inlet 21, the blood outlet 22 and the exhaust blood dual-purpose tube 3, so as to avoid the distortion and deformation of the pipeline and the connection during use, the unstable blood flow rate, the pressure mutation, the hemolysis abnormality and the stable structure of the blood storage bag.

[0036] The bag body 2 is printed with a hemolysis degree indication color mark, and the hemolysis degree of blood can be judged by comparison with the liquid in the bag. However, the patent does not consider the exhaust function of the bag body 2, and does not avoid the area where the liquid flow rate is too slow, which may cause insufficient mixing of blood. Compared with the above patent, the exhaust blood dual-purpose tube 3 is arranged at the top of the bag body 2, which can have the functions of exhaust and blood collection. Secondly, by arranging the limiting member 4, the formation of the blood flow field vortex in the bag body 2 can be optimized, the blood can be fully mixed in the flow field, and the static dead zone is avoided. In addition, the first reinforcing member 51, the second reinforcing member 52 and the third reinforcing member 53 are arranged, which can ensure the structural stability of the bag body 2 and each pipeline.

[0037] A new type of in vitro hemolysis experiment blood storage device (publication number: CN119112663A) is disclosed in the prior art, which proposes a blood storage bag with inlet and outlet not on one side, and carries out flow field simulation. However, the blood storage bag of this way does not set an exhaust port at the high point, which will be very difficult to exhaust in actual operation. At the same time, from the flow field simulation diagram, it can be seen that the blood at the two corners opposite to the inlet and outlet will hardly participate in the circulation, so it has a great influence on the experimental results. It can be seen that on this basis, by arranging the limiting member 4, the formation of the blood flow field vortex in the bag body 2 can be optimized, the blood can be fully mixed in the flow field, and the static dead zone is avoided. In addition, the first reinforcing member 51, the second reinforcing member 52 and the third reinforcing member 53 are arranged, which can ensure the structural stability of the bag body 2 and each pipeline.

[0038] The application provides a blood storage bag, which comprises a shell 1, a bag body 2, an exhaust and blood collection dual-purpose pipe 3, a limiting piece 4, a first reinforcing piece 51, a second reinforcing piece 52 and a third reinforcing piece 53. The bag body 2 is arranged in the shell 1 and has a blood inlet 21, a blood outlet 22 and an exhaust and blood collection dual-purpose port 23; the exhaust and blood collection dual-purpose pipe 3 is connected with the exhaust and blood collection dual-purpose port 23; the limiting piece 4 is arranged in the shell 1 and limits the bag body 2 to form a first arc-shaped part 24 between the blood inlet 21 and the blood outlet 22; the first reinforcing piece 51 is arranged between the shell 1 and the blood inlet 21; the second reinforcing piece 52 is arranged between the shell 1 and the blood outlet 22; and the third reinforcing piece 53 is arranged between the shell 1 and the exhaust and blood collection dual-purpose pipe 3. The blood storage bag provided by the application can have the functions of exhaust and blood collection by arranging the exhaust and blood collection dual-purpose pipe 3 on the top of the bag body 2; the limiting piece 4 can optimize the formation of vortex in the blood flow field in the bag body 2, ensure the full mixing of blood in the flow field and avoid the generation of static dead zones; the first reinforcing piece 51, the second reinforcing piece 52 and the third reinforcing piece 53 can ensure the structural stability of the bag body 2 and the pipelines, thereby avoiding the twisting and deformation of the pipelines and the connection part during use, the unstable blood flow speed, the pressure mutation and the hemolysis abnormality.

[0039] In one of the embodiments of the application, the limiting piece 4 has an arc-shaped protruding part, the arc-shaped protruding part is arranged close to the blood outlet 22, and the included angle between the blood inlet 21 and the arc-shaped protruding part is greater than the included angle between the blood outlet 22 and the arc-shaped protruding part. Figure 1 As shown in the structure, the upper surface of the limiting piece 4 is the arc-shaped protruding part, the lower surface is a plane, and the whole is a fish fin type structure. The limiting piece 4 limits the surface of the bag body 2 between the blood inlet 21 and the blood outlet 22, thereby guiding the direction of the blood flow in the bag body 2, optimizing the formation of the flow field in the bag body 2, making the vortex structure in the bag body 2 less and more concentrated, ensuring the full mixing of blood and avoiding the generation of static dead zones.

[0040] In the above embodiment, the fourth arc-shaped part exists between the limiting piece 4 and the blood inlet 21, the fifth arc-shaped part exists between the limiting piece 4 and the blood outlet 22, and in the structure as shown in Figure 1 The slope of the fourth arc-shaped part is smaller than the slope of the fifth arc-shaped part.

[0041] In the embodiment, the angle between the arc-shaped protrusion and the blood inlet 21 gradually increases in the direction away from the blood inlet 21, and the blood inlet direction of the blood inlet 21 is vertically upward from the bottom of the bag body 2, so the angle between the top of the arc-shaped protrusion and the blood inlet 21 is the largest. Similarly, the angle between the arc-shaped protrusion and the blood outlet 22 gradually increases in the direction away from the blood outlet 22, and the blood outlet direction of the blood outlet 22 is vertically downward from the inside of the bag body 2, so the angle between the top of the arc-shaped protrusion and the blood outlet 22 is the largest. Through the above arrangement, the blood flow is guided, and through the CFD simulation experiment, the blood flow field simulation diagram as shown in Figure 2 is obtained, the vortex is formed near the geometric center of the bag body 2, and only one vortex is formed, which ensures sufficient mixing of the blood flow.

[0042] In one of the embodiments of the application, the limiting piece 4 has an arc-shaped protrusion, the arc-shaped protrusion is located on the median line at the connection between the blood inlet 21 and the blood outlet 22, and the angle between the blood inlet 21 and the arc-shaped protrusion is equal to the angle between the blood outlet 22 and the arc-shaped protrusion; or, the arc-shaped protrusion is arranged away from the blood outlet 22, and the angle between the blood inlet 21 and the arc-shaped protrusion is smaller than the angle between the blood outlet 22 and the arc-shaped protrusion.

[0043] In the embodiment, two different structures of the limiting piece 4 are provided, the limiting piece 4 is provided with an arc-shaped protrusion, but the shapes are different, and the effect of the flow field formed is slightly worse than that of the limiting piece 4 with the structure as shown in Figure 1 . Specifically, taking the example that the arc-shaped protrusion is located on the median line at the connection between the blood inlet 21 and the blood outlet 22, and the angle between the blood inlet 21 and the arc-shaped protrusion is equal to the angle between the blood outlet 22 and the arc-shaped protrusion, the arc-shaped protrusion is a symmetrical arc-shaped structure, and the arc-shaped protrusion is in the middle, and through the CFD simulation experiment, the blood flow field simulation diagrams as shown in Figure 4 and Figure 6 are obtained, and many vortices are generated, and the blood cannot be fully mixed.

[0044] In one of the embodiments of the application, the bag body 2 further forms a second arc-shaped part 25 and a third arc-shaped part 26, and when the bag body 2 is in the full state, the second arc-shaped part 25 is located on one side of the blood outlet 22, the third arc-shaped part 26 is located on one side of the blood inlet 21, the vertical distance between the third arc-shaped part 26 and the blood inlet 21 is greater than the vertical distance between the second arc-shaped part 25 and the blood outlet 22, and the radius of the circle fitted by the third arc-shaped part 26 is smaller than the radius of the circle fitted by the second arc-shaped part 25.

[0045] In the embodiment, when the bag 2 is filled with blood, i.e. the bag 2 is in the inflated state, the second arc-shaped portion 25 and the third arc-shaped portion 26 are respectively located at one side of the blood outlet 22 and the blood inlet 21, the third arc-shaped portion 26 is located higher than the second arc-shaped portion 25 (i.e. the vertical distance between the third arc-shaped portion 26 and the blood inlet 21 is greater than the vertical distance between the second arc-shaped portion 25 and the blood outlet 22), and the second arc-shaped portion 25 forms a more moderate arc than the third arc-shaped portion 26 (i.e. the radius of the circle fitted by the third arc-shaped portion 26 is smaller than the radius of the circle fitted by the second arc-shaped portion 25). In combination with the above-mentioned embodiment with the better effect of the limiting member 4, the structure is as shown in Figure 1 i.e. compared with the distance from the third arc-shaped portion 26, the first arc-shaped portion 24 is closer to the second arc-shaped portion 25 in the horizontal position, so that the blood vortex is located near the geometric center of the bag 2, and the number of vortexes is ensured to be small, and the blood in the bag 2 can be uniformly mixed.

[0046] In one of the embodiments of the present application, the bag 2 further forms the second arc-shaped portion 25 and the third arc-shaped portion 26, and when the bag 2 is in the filled state, the second arc-shaped portion 25 is located at one side of the blood outlet 22, and the third arc-shaped portion 26 is located at one side of the blood inlet 21, the vertical distance between the third arc-shaped portion 26 and the blood inlet 21 is equal to the vertical distance between the second arc-shaped portion 25 and the blood outlet 22, and the radius of the circle fitted by the third arc-shaped portion 26 is equal to the radius of the circle fitted by the second arc-shaped portion 25; or, the vertical distance between the third arc-shaped portion 26 and the blood inlet 21 is less than the vertical distance between the second arc-shaped portion 25 and the blood outlet 22, and the radius of the circle fitted by the third arc-shaped portion 26 is greater than the radius of the circle fitted by the second arc-shaped portion 25.

[0047] In the embodiment, two different structures of the second arc-shaped portion 25 and the third arc-shaped portion 26 are provided, and when the bag 2 is in the filled state, the second arc-shaped portion 25 and the third arc-shaped portion 26 are present, but the shapes of the second arc-shaped portion 25 and the third arc-shaped portion 26 are different from the above-mentioned better embodiment. Specifically, in one of the embodiments, the second arc-shaped portion 25 and the third arc-shaped portion 26 adopt a symmetrical structure design (i.e. the distance between the third arc-shaped portion 26 and the blood inlet 21 is equal to the distance between the second arc-shaped portion 25 and the blood outlet 22, and the radius of the circle fitted by the third arc-shaped portion 26 is equal to the radius of the circle fitted by the second arc-shaped portion 25), i.e. the position and the arc are consistent, and by using the CFD simulation experiment, the following results are obtained Figure 6The blood flow field simulation diagram shown generates more vortexes, and it can be seen that vortexes exist at the top of the inlet, and the blood cannot be fully mixed. Figure 3 and 5 The blood flow field simulation diagram shown generates more vortexes, and it can be seen that vortexes exist at the top of the inlet, and the blood cannot be fully mixed.

[0048] According to the description of the above several embodiments, in the structure shown in Figure 1 The present application provides an optimal size selection of the bag body: the radius of the left circular arc (i.e., the second arc-shaped portion 25) at the top of the bag body 2 is in the range of 70-100 mm; the radius of the right circular arc (i.e., the third arc-shaped portion 26) at the top of the bag body 2 is in the range of 40-65 mm; the slope of the left side of the limiting member 4 is in the range of 70-85 degrees; and the slope of the right side of the limiting member 4 is in the range of 40-50 degrees.

[0049] In one embodiment of the present application, when the bag body 2 is in a full state, the exhaust blood collection dual-purpose port 23 is located at the top of the bag body 2. In this embodiment, by arranging the exhaust blood collection dual-purpose port 23 at the top of the bag body 2, the exhaust blood collection dual-purpose tube 3 is in communication with the exhaust blood collection dual-purpose port 23. From the flow field of each CFD simulation experiment, it can be seen that this position is the most easily exhausted place.

[0050] In one embodiment of the present application, the blood storage bag further comprises a two-way valve 7 arranged at the outlet of the exhaust blood collection dual-purpose tube 3. A two-way valve 7 is arranged at the highest point of blood flow at the top of the blood storage bag, which can serve as an exhaust port for pre-charged blood and a blood taking port during the experiment. Because the valve port is designed at the highest point of the inner cavity arc, the gas in the circuit is gathered upward, and therefore, it is easy to collect and exhaust the gas. It can be understood that, in the structure shown in Figure 1 The two-way valve 7, the exhaust blood collection dual-purpose port 23 and the exhaust blood collection dual-purpose tube 3 are located at the top of the third arc-shaped portion 26. Based on the CFD simulation, the blood flow field in the inner cavity is as shown in Figure 2 It can be seen that almost all the blood can effectively flow and participate in circulation, and the two-way valve 7 exhaust opening is arranged at the topmost position, which is the most easily exhausted place on the flow field. In this way, it can be fully ensured that the effective volume is basically consistent with the volume in the hemolysis index calculation formula, and large errors are not easily caused.

[0051] In one of the embodiments of the present application, the first reinforcing member 51, the second reinforcing member 52 and the third reinforcing member 53 are all multi-layer annular reinforcing ribs. The blood inlet 21 is inserted into the first reinforcing member 51 and fixed, the blood outlet 22 is inserted into the second reinforcing member 52 and fixed, and the exhaust and blood collection dual-purpose tube 3 is inserted into the third reinforcing member 53 and fixed. Specifically, the first reinforcing member 51, the second reinforcing member 52 and the third reinforcing member 53 are all fixed on the corresponding positions of the shell 1. The blood inlet 21 is inserted into the first reinforcing member 51 and fixed, the blood outlet 22 is inserted into the second reinforcing member 52 and fixed, and the exhaust and blood collection dual-purpose tube 3 is inserted into the third reinforcing member 53 and fixed. In this embodiment, the first reinforcing member 51, the second reinforcing member 52 and the third reinforcing member 53 all adopt the structure of annular reinforcing ribs to provide reinforcing function for the respective pipelines.

[0052] In one of the embodiments of the present application, the shell 1 is further provided with a hanging ring hole 6, and when the bag body 2 is in the full state, the hanging ring hole 6 is located on the gravity center vertical line of the bag body 2 for installing a hanging ring. Specifically, in the structure as shown in Figure 1 the bag body 2 adopts an asymmetric design and determines to design the hanging ring on the gravity center vertical line of the liquid storage bag when the liquid storage bag is full, so that when the liquid storage bag is hung, it can greatly ensure that the two-way valve 7 port vertically upward is the highest point of the liquid.

[0053] It should be understood that the bag body 2 is generally made of plastic material and has a certain plasticity, therefore, in order to ensure that the bag body 2 has a specific shape when it is in the full state, that is, has the characteristics of the first arc-shaped part 24, the second arc-shaped part 25 and the third arc-shaped part 26, a limiting groove is processed in the shell 1 for limiting the bag body 2, thereby forming a specific shape.

[0054] The present application also provides a manufacturing method of the liquid storage bag. The manufacturing method of the liquid storage bag specifically comprises the following steps: S1, determining the shape and / or size of the bag body 2 in the full state according to the CFD simulation condition; S2, determining the shape and / or size of the limiting member 4 according to the determined shape and / or size of the bag body 2.

[0055] The present application also provides a manufacturing method of the liquid storage bag, which determines the shape and / or size of the bag body 2 according to the CFD simulation condition, thereby processing the liquid storage bag to ensure that the blood in the liquid storage bag circulates uniformly and avoids static dead zones.

[0056] In one of the embodiments of the present application, the shape and / or size of the bag body 2 in the full state is determined according to the CFD simulation condition, that is, step S1 specifically comprises: S11, a plurality of different shapes and different sizes of the bag 2 are preset, and CFD simulation experiments are carried out on each bag 2 in a full state; S12, the shape and size of the bag 2 are determined by selecting the bag 2 with fewer fluid vortexes.

[0057] It should be understood that during the entire simulation experiment described above, the blood storage bag needs to be full of liquid and free of gas.

[0058] In the above embodiment, a plurality of shapes and sizes of the bag are designed as shown in Figures 1 to 6 The CFD simulation experiments are carried out on each bag in a full state, and the optimal bag shape and size are determined according to the number and distribution of fluid vortexes in each bag; finally, the structure as shown in Figure 1 is selected as the preferred one, and according to the selected bag structure, the specifications and sizes of the limiting groove and the limiting member in the shell are designed and processed, and the bag is placed into the shell.

[0059] The device embodiments described above are only schematic, wherein the units illustrated as separate components can or can not be physically separate, and the components illustrated as units can or can not be units, i.e., can be located in one place or distributed on multiple network units. Part or all of the modules can be selected according to actual needs to achieve the purpose of the embodiment scheme. Those skilled in the art can understand and implement without creative labor.

[0060] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present application, and not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that: it can still modify the technical solutions recorded in the foregoing embodiments, or make equivalent replacement to part of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A blood storage bag, characterized by, The utility model relates to a blood collection device, including: a shell (1); a bag body (2) arranged in the shell (1) and having a blood inlet (21), a blood outlet (22) and a gas-blood dual-purpose outlet (23); a gas-blood dual-purpose tube (3) connected with the gas-blood dual-purpose outlet (23); a limiting piece (4) arranged in the shell (1) and limiting the bag body (2) to form a first arc-shaped part (24), the first arc-shaped part (24) being located between the blood inlet (21) and the blood outlet (22), blood forming a vortex in the bag body (2) under the guidance of the first arc-shaped part (24); a first reinforcing piece (51) arranged between the shell (1) and the blood inlet (21); a second reinforcing piece (52) arranged between the shell (1) and the blood outlet (22); a third reinforcing piece (53) arranged between the shell (1) and the gas-blood dual-purpose tube (3).

2. The blood storage bag of claim 1, wherein The limiting piece (4) has an arc-shaped protruding part, the arc-shaped protruding part being arranged close to the blood outlet (22), and the included angle between the blood inlet (21) and the arc-shaped protruding part being greater than the included angle between the blood outlet (22) and the arc-shaped protruding part.

3. The blood storage bag of claim 1, wherein, The limiting piece (4) has an arc-shaped protruding part, the arc-shaped protruding part being located on the perpendicular bisector of the junction of the blood inlet (21) and the blood outlet (22), and the included angle between the blood inlet (21) and the arc-shaped protruding part being equal to the included angle between the blood outlet (22) and the arc-shaped protruding part; or The arc-shaped protruding part is arranged away from the blood outlet (22), and the included angle between the blood inlet (21) and the arc-shaped protruding part is smaller than the included angle between the blood outlet (22) and the arc-shaped protruding part.

4. The blood storage bag of claim 1, wherein The bag body (2) further forms a second arc-shaped part (25) and a third arc-shaped part (26), and when the bag body (2) is in a full state, the second arc-shaped part (25) is located on one side of the blood outlet (22), the third arc-shaped part (26) is located on one side of the blood inlet (21), the distance between the third arc-shaped part (26) and the blood inlet (21) is greater than the distance between the second arc-shaped part (25) and the blood outlet (22), and the radius of the circle fitted by the third arc-shaped part (26) is smaller than the radius of the circle fitted by the second arc-shaped part (25).

5. The blood storage bag of claim 1, wherein, The bag body (2) further forms a second arc-shaped part (25) and a third arc-shaped part (26), and when the bag body (2) is in a full state, the second arc-shaped part (25) is located on one side of the blood outlet (22), the third arc-shaped part (26) is located on one side of the blood inlet (21), the distance between the third arc-shaped part (26) and the blood inlet (21) is equal to the distance between the second arc-shaped part (25) and the blood outlet (22), and the radius of the circle fitted by the third arc-shaped part (26) is equal to the radius of the circle fitted by the second arc-shaped part (25); or The distance between the third arc-shaped part (26) and the blood inlet (21) is less than the distance between the second arc-shaped part (25) and the blood outlet (22), and the radius of the circle fitted by the third arc-shaped part (26) is greater than the radius of the circle fitted by the second arc-shaped part (25).

6. The blood storage bag of claim 1, wherein When the bag body (2) is in a full state, the exhaust and blood collection dual-purpose port (23) is located at the top of the bag body (2).

7. The blood storage bag according to any one of claims 1 to 6, characterized in that The first reinforcing member (51), the second reinforcing member (52) and the third reinforcing member (53) are all multi-layer annular reinforcing ribs. The blood inlet (21) is inserted into and fixed in the first reinforcing member (51), the blood outlet (22) is inserted into and fixed in the second reinforcing member (52), and the exhaust and blood collection dual-purpose tube (3) is inserted into and fixed in the third reinforcing member (53).

8. The blood storage bag according to any one of claims 1 to 6, characterized in that The shell (1) is also provided with a hanging ring hole (6), and when the bag body (2) is in a full state, the hanging ring hole (6) is located on the gravity center vertical line of the bag body (2).

9. A method of making a blood storage bag, comprising: The method comprises the steps of: According to the CFD simulation condition, the shape and / or size of the bag body (2) in the full state are determined; According to the determined shape and / or size of the bag body (2), the shape and / or size of the limiting member (4) are determined.

10. The method for manufacturing a blood storage bag according to claim 9, characterized in that, The method according to the CFD simulation condition, the shape and / or size of the bag body (2) in the full state are determined, specifically comprising: A plurality of different shapes and different sizes of bag bodies (2) are preset, and CFD simulation experiments are carried out on each bag body (2) in the full state; The bag body (2) shape and size determined by selecting the number of fluid vortices are less.

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