A blood bag with built-in tubing and its compression separation method

Abstract

This invention belongs to the field of medical device technology and discloses a blood bag with built-in tubing and its compression separation method for separating plasma with chylous stratification after high-speed centrifugation. The bag includes a bag body and a tubular assembly disposed on the end face opposite to the side of the bag body that bears the centrifugal force during centrifugation. The tubular assembly includes a separation tube extending into the bag body with its opening always located at the bottom of the bag body on the opposite side of the fixed end. The separation tube has a higher hardness than the bag body. The method involves removing and fixing the bag body after centrifugation, where the upper chyle layer and lower plasma layer are separated. Then, the plasma is pushed out from both sides of the larger area of ​​the bag body by manual squeezing or external squeezing. This invention has a simple structure and low cost, but can avoid the influence of centrifugation while recovering and reusing plasma with high chyle content that is difficult to utilize.

Description

Technical Field

[0001] This invention belongs to the field of plasma separation technology, specifically relating to a blood bag with built-in tubing and its compression separation method. Background Technology

[0002] In the fields of clinical blood transfusion and blood product preparation, post-collection blood processing is a crucial step in ensuring the effective utilization of blood resources. Currently, clinical practice routinely uses multi-unit blood collection bags to collect whole blood. After collection, low-speed centrifugation separates the blood components, dividing the whole blood into an upper plasma layer, a middle white blood cell layer, and a lower red blood cell layer. Red blood cells can be used for transfusions in patients with anemia or traumatic blood loss, while plasma can be used to treat patients with shock, burns, and coagulation disorders, or further processed into blood products such as albumin, immunoglobulins, and coagulation factors. Platelets can be extracted from the white blood cell layer for the treatment of thrombocytopenia. This process forms the core technological foundation for clinical component transfusion and blood product production, and is of great significance in meeting the treatment needs of patients with different conditions and reducing whole blood waste.

[0003] However, with the increasing proportion of high-fat foods in the diet and the rising incidence of metabolic diseases such as obesity and diabetes, the detection rate of high-chylous blood in clinical blood collection has been increasing year by year. This type of blood faces significant utilization challenges due to the presence of chylomicrons: on the one hand, chylomicrons interfere with biochemical indicator detection, failing to meet the quality assessment requirements before clinical transfusion; on the other hand, if used directly for transfusion, chylomicrons may accumulate in the recipient's blood vessels, causing safety risks such as allergic reactions and pulmonary embolism, and cannot be used to prepare clarified blood products. Therefore, in current clinical practice, high-chylous blood is mostly judged as unqualified blood and discarded directly, resulting in a waste of blood resources.

[0004] Even though a few medical institutions have attempted to utilize highly chylous blood, existing separation methods have significant drawbacks: conventional low-speed centrifugation can only cause some large-diameter chylomicrons to float to the surface, failing to remove residual small chylomicrons in the plasma, resulting in slightly turbid plasma after separation, which is difficult to meet clinical standards; some solutions using simple filtration components suffer from low separation efficiency because chylomicrons easily aggregate on the filter membrane surface, causing blockage, and the addition of filtration components increases the complexity and cost of the production process, while potentially causing adsorption loss of functional components such as albumin and coagulation factors in the plasma, making it impossible to achieve efficient and high-quality utilization of highly chylous blood.

[0005] Current technology typically involves a tubing structure at the top of the blood bag connecting to the outside. This allows for the extrusion of the stratified material after centrifugation from the top of the blood bag. However, after centrifugation, the upper layer of chylous blood is a chyle layer. Because the upper part of the blood bag contains tubing needed for collection, some of this tubing becomes blocked after collection. If a separate tube is installed at the top, only the lower plasma layer can pass through first; otherwise, the chyle layer may remain on the tube wall, causing problems. If two tubes are installed at the top of the blood bag, one for extruding the chyle layer and the other for extruding the plasma layer, the chyle layer itself must be extruded first to ensure cleanliness before connecting to the other tube to extrude the plasma layer. However, this method can lead to re-mixing of the already separated plasma and chyle layers. Furthermore, the upper chyle layer generally occupies little space, limiting the operational space for separate extrusion of this layer, resulting in poor extrusion efficiency and easy residue buildup. Summary of the Invention

[0006] To address the problems existing in the prior art, this invention provides a blood bag with built-in tubing and a method for squeezing and separating the blood. Based on the existing blood bag structure for blood collection, it is possible to recover blood directly through high-speed centrifugation and stratification in a low-cost manner.

[0007] The technical solution adopted in this invention is as follows:

[0008] In a first aspect, the present invention provides a blood bag with built-in tubing for separating plasma that has chylous stratification after high-speed centrifugation. The bag includes a bag body and a tube assembly disposed on the end face opposite to the end face of the bag body that bears centrifugal force during centrifugation. The tube assembly includes a separation tube that extends into the bag body and whose opening is always located at the bottom of the inner side of the opposite side of the bag body. The hardness of the separation tube is greater than that of the bag body.

[0009] It's worth noting that the bag structure itself contains a tubular assembly, including tubes for the conventional entry and exit of materials. Externally collected blood enters the blood bag through these tubes for storage. Simultaneously, the bag undergoes high-speed centrifugation. During centrifugation, there is directionality; the blood within the bag is subjected to centrifugal force, resulting in a linear separation of substances. Because the blood experiences centrifugal force, the larger proportion of plasma impacts one end of the bag. Meanwhile, the bottom of the blood bag experiences a uniform force during centrifugation. Conventionally, a bottom tube for separate plasma separation would be ideal. However, with the bottom of the bag itself being a heat-sealed polymer material, vertically positioned tubes would cause stress concentration within this sealed structure, easily leading to bag rupture. Solving this problem would require reinforced and specially designed bottom tube connections, which is costly and difficult to manufacture. Furthermore, the structural characteristics still inherently carry a risk of rupture. Therefore, the tube assembly is positioned on the opposite end, defined by the relative positional relationship along the linear direction of the centrifugal force.

[0010] In conjunction with the first aspect, the present invention provides a first embodiment of the first aspect, wherein the outer surface of the opening of the separating tube is fixedly connected to the inner wall of the bag.

[0011] In conjunction with the first aspect, the present invention provides a second embodiment of the first aspect, wherein the separation tube is a channel formed by penetrating the inner wall of the bag along the thickness direction, and the opening of the channel is located at the inner bottom of the bag away from the tube assembly.

[0012] In conjunction with the second embodiment of the first aspect, the present invention provides a third embodiment of the first aspect, wherein the bag body has a viewing window disposed along the separation tube and used to view the flow state inside the separation tube.

[0013] In conjunction with the first aspect, the present invention provides a fourth embodiment of the first aspect, wherein the separating tube is a channel structure disposed in the bag body and integrally formed with the bag body, one side of the separating tube opening is located on the same side as the bag body tube opening group, and the other side of the separating tube opening penetrates into the inner bottom of the bag body away from the tube body group.

[0014] In conjunction with the first aspect, the present invention provides a fifth embodiment of the first aspect, wherein a conical drainage hood is provided at the opening of the separation tube, and the opening of the conical drainage hood faces the inner bottom of the bag body away from the tube assembly.

[0015] In conjunction with the fifth embodiment of the first aspect, the present invention provides a sixth embodiment of the first aspect, wherein the conical drainage hood is integrally sealed with the inner bottom of the bag body away from the tube body assembly, and a plurality of holes for plasma to flow out are provided on the surface of the conical drainage hood;

[0016] The conical drainage hood is also equipped with a filter membrane to prevent chyme from entering the separation tube.

[0017] In conjunction with the first aspect, the present invention provides a seventh embodiment of the first aspect, wherein the bottom opening of the separation tube is provided with a sealing element that is destroyed by external compression.

[0018] Secondly, the present invention provides a compression separation method using a blood bag with an internal tube as described in any of the above claims, specifically as follows:

[0019] First, after centrifugation, the bag is fixed in place, which is divided into an upper chyle layer and a lower plasma layer. Then, a narrow gap is formed by squeezing the bag from one or both sides near the end of the tube assembly through the provided squeezing structure.

[0020] Then, the compression structure is displaced relative to the bag body, causing the resulting narrow gap to continuously move away from the tube assembly and change position toward the opening of the separation tube. During the movement, the narrow gap has a clearance space to avoid the separation tube.

[0021] When a chyme layer enters the separation tube, the squeezing stops and the separation is completed.

[0022] In conjunction with the second aspect, the present invention provides a first embodiment of the second aspect, wherein a linear narrow gap is formed when the extrusion structure contacts the bag body, the narrow gap being located between the chyle layer and the plasma layer.

[0023] The beneficial effects of this invention are as follows:

[0024] (1) The present invention improves the existing blood bag structure by setting a built-in separation tube structure and then using the density stratification law of high-chyle blood through high-speed centrifugation to accurately separate the chyle layer and the bottom plasma layer. Then, the built-in separation tube is used to contact the lower pure plasma layer and squeeze to effectively separate the plasma without chyle particles, thus converting the originally discarded high-chyle blood into qualified clinically usable plasma and significantly reducing the blood waste rate.

[0025] (2) The port of the separation tube of the present invention is located at the upper part of the bag body, along with other tubes, to avoid the problem of bag breakage during centrifugation caused by the lower part being affected;

[0026] (3) The present invention optimizes the setting position of the separation tube and fixes it to the bag body, which can ensure that the blood stratification is avoided as much as possible during high-speed centrifugation when it forms an independent channel;

[0027] (4) The present invention has an external separation tube structure design that can be integrally formed with the bag body, resulting in lower manufacturing costs. During the squeezing process, it is not affected by the squeezing structure, ensuring smooth discharge of the plasma layer. At the same time, it can reduce external interference in a separate position, making it convenient for manual or visual sensors to determine whether chyme has entered the separation tube.

[0028] (5) The present invention, through the conical drainage hood structure, after being integrally formed and fixed with the bag body, can further improve the separation effect of plasma and chyme through the internal filtration structure;

[0029] (6) This invention utilizes the single-use characteristics of blood bags and provides a destructible sealing structure to prevent blood containing chyme from directly entering the separation tube during centrifugation. When the separation tube is squeezed after centrifugation, the sealing structure can be directly destroyed to connect the separation tube.

[0030] (6) The present invention provides a squeezing separation method for the blood bag structure, which can utilize the clear boundaries of the stratified chyle layer after high-speed separation to form a narrow gap and push to separate as much plasma as possible into the blood bag. Attached Figure Description

[0031] Figure 1 This is an isometric view of the blood bag in an embodiment of the present invention;

[0032] Figure 2 This is a planar schematic diagram of the inside of the blood bag under transparent view in an embodiment of the present invention;

[0033] Figure 3 This is an isometric view of the internal structure of the blood bag after a section is cut open on one side in an embodiment of the present invention;

[0034] Figure 4 This is a schematic diagram of the first single-sided extrusion scheme used in the implementation of this invention;

[0035] Figure 5 This is a schematic diagram of the first double-sided extrusion scheme used in the implementation of this invention;

[0036] Figure 6 This is a schematic diagram of the second unilateral extrusion scheme used in an embodiment of the present invention;

[0037] Figure 7 This is a schematic diagram of the second double-sided extrusion scheme used in the implementation of the present invention;

[0038] Figure 8 This is a plan view of the flat separation tube structure used in an embodiment of the present invention;

[0039] Figure 9 This is a plan view of the side-mounted separation tube structure used in an embodiment of the present invention;

[0040] Figure 10 This is a schematic diagram of the side-mounted separation tube structure and the bottom expansion drainage port used in an embodiment of the present invention;

[0041] Figure 11 This is a plan view of the integrated expansion drainage port used in an embodiment of the present invention;

[0042] Figure 12 This is a schematic diagram illustrating the structural relationship between the separation tube with a viewing window structure and the blood bag in an embodiment of the present invention;

[0043] Figure 13 This is a schematic diagram of the front of the bag body used for displaying a viewing window in an embodiment of the present invention;

[0044] Figure 14 This is a front view of the bag structure using a side-mounted separation tube in an embodiment of the present invention;

[0045] Figure 15 This is a schematic diagram of an extrusion method for a centrally located separator tube structure in an embodiment of the present invention.

[0046] In the diagram: 1-separation tube, 2-bag body, 3-extrusion structure, 4-conical drainage hood, 5-viewing window. Detailed Implementation

[0047] The present invention will be further explained below with reference to the accompanying drawings and specific embodiments.

[0048] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0049] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0050] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0051] In the description of this application, it should be noted that the use of terms such as "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer" to indicate orientation or positional relationships is based on the orientation or positional relationships shown in the accompanying drawings, or the orientation or positional relationships commonly used when the product is in use. These terms are used solely for the convenience of describing this application and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the use of terms such as "first" and "second" in the description of this application is only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0052] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of this application does not imply that the component is required to be absolutely horizontal or suspended, but rather that it may be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but rather that it may be slightly tilted.

[0053] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0054] Example 1:

[0055] This embodiment discloses a blood bag with built-in tubing, which is mainly used for high-speed centrifugation after blood collection for chylous blood with high fat content. After separating the upper chyle layer, the lower plasma layer is taken.

[0056] Specifically, refer to Figures 1-3 This embodiment provides an optimized structure based on the structural characteristics of existing triple-bag blood collection bags, including a sealed bag body 2. It should be noted that the bag body 2 structure in the figure is for illustration only, showing the relative positional relationships between all structures; however, the actual dimensions and the structure of the bag body 2 itself are not limited. Figure 1 The bag 2 shown is in an expanded state. When the bag 2 is not filled with blood plasma, it is flat. When it is actually expanded, it is usually rounded and protruding due to the characteristics of its soft material. The top is flat and the bottom is an arc-shaped bottom.

[0057] In this embodiment, the bag body 2 has two hot melt adhesive sealing end faces, upper and lower. The upper end face in the figure is taken as the upper end face. The upper end face is provided with a tube assembly, which includes a main tube, which is the special structure in this embodiment, the separation tube 1.

[0058] The separating tube 1 is the same as the tubes in the other tube group, with a part at the heat-sealed part at the top of the bag body 2. However, the separating tube 1 also has a part extending into the bag body 2. The part of the separating tube 1 extending into the bag body 2 maintains a straight extension direction until it is close to the bottom of the bag body 2. That is, the separating tube 1 has a tube opening at the bottom of the bag body 2.

[0059] Theoretically, placing the separation tube 1 at the bottom of the blood bag makes it easier to squeeze and separate the plasma. However, when the bag body 2 is centrifuged at high speed, the blood bag is kept in a horizontal or oblique position. The bottom of the entire blood bag acts as a support part, supporting the plasma in the entire blood bag to be separated into layers by centrifugal force. If the separation tube 1 is placed at the bottom, it may cause the separation tube 1 to be punctured by pressure during centrifugation or cause the connection between the bag body 2 and the separation tube 1 to break and leak. Therefore, in this embodiment, the bag body 2 has a built-in separation tube 1, which can prevent the blood bag from breaking during centrifugation.

[0060] Based on the above-described blood bag structure, this embodiment also provides a method for separating chyle and plasma using this blood bag structure, as detailed below:

[0061] After centrifugation, the bag 2 containing the upper chyme layer and the lower plasma layer is removed and fixed. Then, the thickness of the bag 2 is gradually reduced by manually squeezing it from both sides of the larger area, or by squeezing it from the external squeezing structure 3. The plasma inside is compressed and discharged from the only outlet: the separation tube 1. Due to the high-speed centrifugation and stratification, all the chyme is in the upper layer, and the opening of the separation tube 1 is in the lower layer. During squeezing, most of the plasma can be discharged from the separation tube 1.

[0062] Furthermore, the structure of the blood bag is optimized because, during the centrifugation process, the blood bag structure with the built-in separation tube 1 is optimized to prevent the separation tube 1 from collapsing or bending during centrifugation and compression separation, which would affect the separation of plasma chyme and the oscillation during centrifugation, which would affect the chyme stratification.

[0063] One implementation method involves using a rigid polymer material for the separation tube 1. This includes methods where the tube's thickness is the same as the bag body 2 but the base material is different. This ensures the separation tube 1 has a certain degree of flexibility while preventing significant deformation during centrifugation and compression, thus guaranteeing good conductivity. Alternatively, it can be achieved by using the same material but with increased thickness. This also provides different bending properties compared to the bag body 2, preventing the separation tube 1 from remaining unchanged even when the bag body 2 undergoes compression deformation.

[0064] In this implementation, such as Figure 2 As shown, the separation tube 1 is centrally located inside the bag body 2. The inlet and outlet ends of the separation tube 1 are located in the middle of the thermoplastic area at the top of the bag body 2. The separation tube 1 inside the bag body 2 is always positioned in the middle of the bag body 2, with its opening close to the inner bottom surface of the bag body 2.

[0065] Meanwhile, the separation tube 1 can also be set at any position inside the bag body 2, either offset or directly. Figure 2 The left and right sides of the bag 2 in the middle.

[0066] In one embodiment, the separation tube 1 is not limited to material thickness and hardness, as long as it does not bend or collapse and become blocked during compression separation. In this embodiment, to avoid affecting the plasma caused by the separation tube 1 during centrifugation, the separation tube 1 is fixedly connected to the bag body 2. There are several ways to fix it:

[0067] In the single-point fixing method, the separation tube 1 is fixed to the inner wall of the bag body 2 at any position by adhesive or hot melt bonding. Generally, the outer peripheral wall of the tube opening of the separation tube 1 is fixed to the inner wall of the bag body 2. This method can ensure that the two ends of the separation tube 1 are fixedly connected to the bag body 2, thereby minimizing the shaking during centrifugal separation.

[0068] The multi-point fixing method involves setting several fixing points along the length of the separation tube 1 between it and the inner wall of the bag body 2, thereby further improving stability.

[0069] The one-piece molding and fixing method allows the separation tube 1 to be directly molded into the bag body 2 during manufacturing, forming a separate channel on the bag body 2. The upper end of the bag body 2 is provided with a pipe opening that connects to the channel. This method is convenient for manufacturing operations.

[0070] Specifically, refer to Figure 12 The figure shows a partial cross-sectional view of the thickness direction of the bag body 2. It can be seen that the separation tube 1 is made of the same material as the bag body 2, but with different thicknesses. The thickness of the bag body 2 itself is less than the thickness of the three side walls of the separation tube 1. At the same time, the separation tube 1 has a rounded chamfer inside. This setting can effectively improve the stability of the separation tube 1, so that the separation tube 1 can remain unobstructed when the bag body 2 is squeezed and deformed.

[0071] At the same time, refer to Figure 13 On one side wall of the separation tube 1 formed on the surface of the bag body 2, a viewing window 5 structure is formed by reducing the thickness. This structure utilizes the properties of the transparent material of the bag body 2 itself to further improve the light transmittance by forming a thin-walled part, making it convenient to view the color and state of the fluid inside the separation tube 1 from the outside, and providing the possibility to distinguish the flow of plasma during separation.

[0072] The structure of the viewing window 5 includes a continuous arrangement along the length of the separation tube 1 and an equally spaced arrangement. Based on the above embodiment, the viewing window 5 is set to form an integral structure with the bag body 2, which has lower cost and higher observation performance.

[0073] As one implementation method, refer to Figure 8 and Figure 9 The separation tube 1 adopts a flat tube structure. By increasing the width and reducing the thickness, the cross-sectional area is guaranteed. At the same time, the extrusion separation method is used to minimize the impact caused by extrusion. Figure 8 The central separator 1 is centrally located and not fixed. Figure 9 The middle part is fixed to the inner wall of the bag body 2 by fitting it against the bag body 2.

[0074] As one implementation method, refer to Figure 10 and Figure 11 The end of the separation tube 1 has a conical drainage hood 4. The figure shows two ways of setting the conical drainage hood 4, one of which is... Figure 10 One type is the receiving type, where the expansion port faces upwards, which guides the plasma gradually flowing towards the bottom of the bag 2 during the squeezing process to converge into the separation tube 1. Another type is... Figure 11 The inverted design involves placing the expanded opening face down at the bottom of the bag 2, with a gap between the expanded opening and the bottom of the bag 2. After squeezing, the plasma flows from the gap into the separation tube 1 and is discharged.

[0075] Since the end of the separation tube 1 is integrally connected to the bottom of the bag body 2, a certain structural strength can be formed by increasing the inner wall thickness of the separation tube 1 or using a material that is harder than the bag body 2. During the extrusion process, the influence of extrusion force can be avoided as much as possible. At the same time, due to the large connection structure of the conical drainage hood 4 formed with the bottom of the bag body 2, the large force generated on the bottom of the bag body 2 during centrifugal separation is dispersed, avoiding stress concentration.

[0076] Furthermore, for this inverted type, the conical drainage hood 4 and the bag body 2 are integrally formed. The width of the conical drainage hood 4 corresponds to the width of the bag body 2. From the front and side views of the bag body 2, the conical drainage hood 4 is a conical structure that is smaller at the top and larger at the bottom. Several openings are provided on the conical surface of the conical drainage hood 4, which allow the plasma to flow into the separation tube 1 when squeezed out.

[0077] Furthermore, a split manufacturing method is adopted. The bag body 2 itself is formed by heat-sealing the sides of the polymer sheets, or by cutting continuously extruded tubular polymer material to the corresponding length and then heat-sealing the top and bottom ends. When heat-sealing the top and bottom edges of the bag body 2, the top will fix all the tubes in the upper heat-sealed edge. The width of the end of the conical drainage hood 4 at the end of the top separation tube 1 is close to the width of the bottom heat-sealed edge of the bag body 2. It can be embedded into the heat-sealed edge during the heat-sealing process to form a fixed connection. This method is different from the method of setting the tubes separately at the bottom. The end of the conical drainage hood 4 is an extended wide soft structure with the same thickness as the bag body 2 itself. After heat-sealing, it is embedded inside to form an integrated structure, and the force is evenly distributed, without stress concentration. Figure 11 For illustrative purposes only, it shows the full state of blood plasma after the bottom expands to both sides in the thickness direction. In reality, the bottom of the bag 2, when viewed from the outside, has a heat-sealed edge structure that gradually decreases in thickness and eventually forms a uniform thickness. The conical drainage hood 4 is attached to the bottom of the bag 2 inside and expands upward to the maximum state before gradually converging towards the upper part of the separation tube 1.

[0078] In this conical drainage hood 4 technical solution, a polymer filtration structure is also provided. The filtration structure includes two settings: a filter membrane and a filter block. The filter membrane is a polyethersulfone membrane or a cellulose acetate membrane, and the filter block is a flocculent lipophilic adsorption material. It can provide a certain filtration effect when some chylous substances pass through, thereby separating the plasma as much as possible, especially the plasma at the stratification boundary, which will be disturbed and mixed during the squeezing process.

[0079] Furthermore, based on the above-described arrangement of the separation tube 1, this embodiment further optimizes the method of limiting extrusion separation, as follows:

[0080] If manual squeezing is used, the centrifuged and separated bag 2 is placed vertically on the table and then squeezed from the two larger surfaces of bag 2 with one or both hands. During squeezing, to avoid remixing the chyme and plasma, squeeze at the boundary between the chyme and plasma layers, minimizing disturbance to the upper chyme layer. Simultaneously, continuously observe the upper end of the separation tube 1 for any milky white chyme entering; if present, immediately stop the squeezing process to complete the separation.

[0081] While the aforementioned manual squeezing separation method can be used as an operational procedure based on the blood bag structure, there are many uncontrollable factors in the actual process, and the plasma obtained from separation is prone to being substandard or insufficient in quantity. Therefore, an automated squeezing separation method using an external squeezing structure 3 is provided, as follows:

[0082] Keep bag 2 vertically or obliquely fixed. After stabilizing the boundary between the chyle layer and the plasma layer, squeeze the two larger end faces of bag 2 by the squeezing structure 3, which moves towards bag 2 from one or both sides simultaneously. This squeezes the two larger end faces of bag 2 to form a narrow gap at the boundary between the chyle layer and the plasma layer. Then, continuously push the narrow gap towards the bottom of bag 2. While pushing, keep the upper end of bag 2 fixed so that the plasma below the boundary line inside bag 2 is pushed to the opening of separation tube 1 and discharged from bag 2 from separation tube 1. Continue squeezing until the narrow space is close to the opening of separation tube 1. Observe the color and state of the plasma inside separation tube 1 and stop squeezing in time to complete the separation.

[0083] Alternatively, by using an extrusion structure 3 with a flat end face, the bag body 2 can be directly extruded from one or both sides to achieve the extrusion separation effect.

[0084] Furthermore, an automated extrusion device is adopted, which has a fixed platform for fixing the bag body 2. After the bag body 2 is clamped and fixed, the extrusion structure 3 driven by motor or hydraulic / pneumatic pressure extrusion is used to extrude towards the bag body 2. A light sensor is provided on the fixed platform, corresponding to the structure of the bag body 2 with a viewing window 5. By aligning with the viewing window 5 and acquiring the internal color change, it is determined whether the discharged plasma meets the standard. Once the blood plasma color data analysis in the separation tube 1 is found to exceed the threshold, the extrusion stops. The whole process is computer controlled and has a high degree of automation.

[0085] For extrusion structure 3, this embodiment provides two solutions, such as... Figure 4 and Figure 5 As shown, a compression block structure with a flat surface is presented. This compression block can be moved towards the bag body 2 by a linear motor or push rod.

[0086] There are two ways to move the bag. One is to push it flat toward the surface of the bag 2, that is, to squeeze the bag 2 with the entire flat surface. This method is more efficient and the whole mechanical structure is simple.

[0087] Another way is according to Figure 4 and Figure 5 As indicated by the middle arrow, the movement includes two modes: rotational displacement and sliding displacement. First, as shown in the diagram, the lower end of the squeezing block rotates, and the arc-shaped end of its upper part forms a narrow gap between the chyle layer and the plasma layer inside the bag 2. Then, the rotation point is shifted to the upper end of the pushing block, and the squeezing block is rotated diagonally towards the bag 2. In this mode, the narrow gap ensures that the chyle layer is not interfered with by the squeezing action during the squeezing process. Maintaining this narrow gap while continuously squeezing downwards pushes all the plasma below the narrow gap downwards, thus emptying the lower plasma layer.

[0088] The so-called narrow gap refers to the formation of a separation line, that is, the inner walls on both sides of the bag body 2 are infinitely close to forming a sealing line. This sealing line has a certain width and can completely block the chyle layer. In practice, it will be as close as possible to the boundary between the chyle layer and the plasma layer, but always on the side of the plasma layer to avoid mixing part of the chyle layer into the plasma layer.

[0089] Alternatively, by creating a narrow gap at the top, the squeezing block can slide downwards and push the plasma into the separation tube 1, thus changing the narrow gap.

[0090] In both of these compression block methods, for the built-in separation tube 1 structure design, a relief groove is provided on the compression surface of the compression block. This relief groove can compress the bag body 2 to a thickness close to 0 during the compression process. However, since the width of the relief groove is greater than the width of the separation tube 1, when the thickness of most areas of the entire bag body 2 is close to zero, the separation tube 1 is in the relief groove and does not bear direct compression force, thereby avoiding the impact on the separation tube 1 during the compression process.

[0091] Furthermore, the clearance groove in the extrusion block structure includes two methods. One method is to directly create the clearance groove on the flat surface of the entire extrusion block. The depth of the clearance groove is greater than the outer diameter of the separation tube 1. After the bag body 2 is fixed on the fixing platform, the clearance groove is aligned with the inside of the separation tube 1. The other method is to use two extrusion blocks with a gap on one side of the bag body 2 to simultaneously extrude. In this case, the gap between the two extrusion blocks is the clearance groove, which can also achieve the clearance effect.

[0092] In another option, refer to Figure 6 and Figure 7 A rolling extrusion structure 3 is adopted, in which a roller is used on one or both sides to first extrude at the dividing line to form a narrow space, and then one or two rollers are rotated to roll and extrude towards the lower side of the bag body 2, which can also achieve the corresponding extrusion effect.

[0093] In this roller structure, an annular clearance groove can be provided directly in the middle of the roller, or two rollers with collinear axes can be used on one side of the bag body 2 for rolling and squeezing.

[0094] In some embodiments, in order to minimize the impact of the squeezing process on the separation tube 1, the main part of the separation tube 1 is located outside the bag body 2.

[0095] Reference Figure 14In a bag structure 2 with thermoplastic sealing on all four sides, an additional channel is sealed on either side in the vertical direction. This channel can be considered as a strip extension of the bag 2, forming a channel on one side of the bag 2. This channel is the separation tube 1. The upper end of the separation tube 1 can form a separate opening to connect to an external pipeline, and the lower end of the separation tube 1 enters the bag 2 from the bottom side to connect the bag 2 and discharge plasma.

[0096] In some embodiments, the thickness of one side of the bag body 2 can be increased, and a channel can be provided at the thicker part of the inner wall of the bag body 2. An opening connecting to the channel can be provided on the side of the bag body 2 near the bottom, and a pipe opening connecting to the channel can be provided at the upper part of the bag body 2, thereby forming a scheme with an internal separation tube 1.

[0097] In both of the above methods, only the bag body 2 is squeezed during compression, while the separation tube 1 located on one side of the bag body 2 is not subjected to force, thereby further reducing the impact.

[0098] In some embodiments, in order to prevent plasma from entering the separation tube 1 during centrifugation and causing an impact, a sealing element is provided at the opening where the separation tube 1 connects to the bag body 2. This sealing element is a fragile structure, such as a hollow polymer structure with a certain degree of brittleness, which breaks when subjected to external directional compression to restore the unobstructed flow of the separation tube 1.

[0099] Reference Figure 15 In this embodiment, based on the above-mentioned central separation tube 1, a new squeezing method is provided. Referring to the two double dashed lines in the blood bag in the figure, it is used to represent the clamping line formed by using a strip clamp to clamp the blood bag from the separation line between the centrifuged chyle layer and the plasma layer on the side near the plasma layer.

[0100] After clamping, use rollers or extrusion strips to press and rotate the bag body 2 from both sides, avoiding the middle separation tube 1. First, press and rotate 45 degrees inward from the intersection of the clamping line and the point close to the separation tube 1. Then, while maintaining the angle with the separation tube 1, push the extrusion structure 3 downward. Finally, stop extruding when the ends of the extrusion structures 3 close to the separation tube 1 contact the bottom of the bag body 2.

[0101] In this method, the plasma layer material moves downward in a horizontal direction due to downward compression of the central separation tube. Eventually, due to the horizontal compression to the bottom of the bag 2, a certain amount of plasma will accumulate at the bottom and cannot flow out through the separation tube 1. By first rotating to form a cone-shaped compression part near the center, and then the cone-shaped compression part compresses downward, the plasma layer can be allowed to gather towards the center after contacting the bottom of the bag 2, so that more plasma layer material can flow out from the separation tube 1.

[0102] Furthermore, based on the built-in tubing blood bag of Example 1, optimizations were made to address the problems of incomplete separation caused by the contradiction between squeezing pressure and blood activity, and the difference in blood component density. The core improvement lies in the structural design of the separation tube 1 and its pressure adaptation to the squeezing system, as detailed below:

[0103] The separation tube 1 remains fixed along the inner wall of the bag body 2, but the inner diameter of the separation tube 1 decreases in a stepped manner from the bottom opening to the top outlet. That is, the inner diameter of the opening near the bottom of the bag body 2 is set to 1.2 mm, the inner diameter corresponding to the middle of the plasma layer is set to 0.8 mm, and the inner diameter near the top of the tube body is set to 0.6 mm.

[0104] Based on the density differences of blood components, this design guides high-density red blood cells to settle stably along a thicker pipe section, while low-density plasma flows smoothly out along a thinner pipe section, preventing different components from mixing inside the pipe and improving separation purity.

[0105] The separation tube 1 is made of medical-grade modified PP material, which has a higher hardness than the DEHT-free material of the bag body 2. The inner wall of the tube is coated with a 50-100nm thick medical-grade polyethylene glycol coating. This coating significantly reduces platelet adhesion and is compatible with DEHT, DINCH, and other DEHP-free bag materials, preventing detachment or blood adsorption problems caused by poor material compatibility between the tube and bag body 2.

[0106] An arc-shaped buffer section with a radius R of 5 mm is added between the bottom opening of the separation tube 1 and the conical drainage hood 4. The inner wall of the buffer section is frosted. This structure allows the pressure during compression to gradually increase from 0.3 MPa to 0.8 MPa, avoiding instantaneous high pressure that could cause red blood cell rupture and keeping the hemolysis rate below 0.22%.

[0107] Furthermore, optimizations were made to address the issues of residue caused by dead space in the tubing and the inconvenience of connecting to clinical equipment after separation. The improvements lie in the tubing corner structure and outlet design, as detailed below:

[0108] Retaining the aforementioned density gradient pipe and pressure buffer section, all corners of the separation pipe 1 are designed as streamlined rounded corners, replacing the right-angled corners of the separation pipe 1 in the previous scheme. Simultaneously, a 0.5mm thick silicone sealing gasket is added at the fixing point between the pipe and the bag body 2, with a chamfered angle at the contact point between the sealing gasket and the pipe. This design eliminates dead space within the pipe, and combined with a 3° reverse slope in the extrusion direction, reduces blood residue by 80%, avoiding the risk of blood waste or contamination due to dead space residue.

[0109] At the top outlet of separation tube 1, a double-layer medical butyl rubber sealing membrane structure is adopted, with an outer membrane thickness of 0.3 mm and an inner membrane thickness of 0.2 mm.

[0110] When not separated, the double membranes seal the tubing together to prevent blood contamination; when separated, the outer membrane is first pierced with a standard clinical puncture needle, and then the puncture needle is pushed to open the inner one-way valve, which allows for direct connection with the transfusion set and transfer bag.

[0111] Two anti-roll grooves, 2mm deep and 5mm wide, are added to the two sides of the bag body 2 perpendicular to the extrusion direction. The material is the same as that of the bag body 2, which is DEHT material without DEHP. A foldable medical PET pad is embedded in the groove.

[0112] During centrifugation, the pad unfolds to support the bag 2, preventing the separation tube 1 from shifting due to the centrifugal force causing the bag 2 to curl. During compression, the pad folds and is stored in the groove, without affecting the movement of the compression structure 3. This design solves the problem of pipeline flow deviation caused by the bag curling after centrifugation in the above scheme, and reduces the batch-to-batch coefficient of variation of the separation effect.

[0113] Using the viewing window 5 in the above scheme, a 1mm wide residual observation line is added inside the viewing window 5. During squeezing, the blood flow status in the tube is observed through the viewing window 5: when there is no continuous blood flow at the observation line, the controller automatically stops squeezing to avoid excessive squeezing that could damage the tube or cause chyme to enter. This determination method is more accurate than observing the chyme layer.

[0114] The disposable operating adapter adds an operation guide label to the top tube assembly of bag 2, indicating the four-step operation process of puncture, fixation, compression, and docking, and aligns it with the anti-rolling groove and layer marking lines. This design ensures consistency of operation among different medical personnel, shortens operation time, and meets the convenience requirements of clinical emergency blood transfusion scenarios.

[0115] This invention is not limited to the optional embodiments described above, and anyone can derive other various forms of products based on the inspiration of this invention. The specific embodiments described above should not be construed as limiting the scope of protection of this invention; the scope of protection of this invention should be determined by the claims, and the specification can be used to interpret the claims.

Claims

1. A blood bag with inbuilt tubing for separating plasma with chylomicron layering after high speed centrifugation, characterized in that: The application relates to a blood bag with a built-in pipe, which comprises a bag body (2) and a pipe group arranged on the end face opposite to the end face of the bag body (2) which bears centrifugal force during centrifugation, wherein the pipe group comprises a separation pipe (1) which extends into the bag body (2) and has a pipe opening always located on the inner bottom of the side opposite to the fixed end of the bag body (2), and the hardness of the separation pipe (1) is greater than that of the bag body (2). A conical drainage cover (4) is arranged at the pipe opening of the separation pipe (1), the opening of the conical drainage cover (4) faces the inner bottom of the bag body (2) away from the pipe group, the conical drainage cover (4) is integrally connected with the inner bottom of the bag body (2) away from the pipe group, the width of the conical drainage cover (4) corresponds to the width of the bag body (2), and the conical drainage cover (4) is a conical structure with the upper part being small and the lower part being large when viewed from the front and side of the bag body (2). The bag body (2) is formed by heat sealing the high polymer sheet bodies on the two sides, the end part of the conical drainage cover (4) of the separation pipe (1) on the top of the bag body (2) has a width close to that of the heat sealing edge of the bottom of the bag body (2), the end part of the conical drainage cover (4) is embedded into the heat sealing edge during heat sealing of the heat sealing edge, so that the conical drainage cover (4) is fixedly connected with the bag body (2). A plurality of holes for blood plasma outflow are arranged on the surface of the conical drainage cover (4), and a filter film for blocking chyle from entering the separation pipe (1) is further arranged in the conical drainage cover (4). When the bag body (2) is clamped and extruded to separate chyle, the bag body (2) is extruded in a circular manner with the intersection of the clamping line and the separation pipe (1) as the center by 45 degrees, and then the extrusion is continued downward while maintaining the angle state of the separation pipe (1).

2. A blood bag with inbuilt tubing as claimed in claim 1 wherein: The separation pipe (1) is a channel formed by protruding the inner wall of the bag body (2) along the thickness direction and penetrating through, and the opening of the channel is located on the inner bottom of the bag body (2) away from the pipe group.

3. A blood bag with inbuilt tubing as claimed in claim 2 wherein: The bag body (2) is provided with a window (5) arranged along the separation pipe (1) and used for observing the flow state in the separation pipe (1).

4. The blood bag with built-in tubing of claim 1, wherein: The separation pipe (1) is a channel structure arranged in the bag body (2) and integrally formed with the bag body (2), one side pipe opening of the separation pipe (1) is located on the same side as the pipe opening group of the bag body (2), and the other side pipe opening penetrates into the inner bottom of the bag body (2) away from the pipe group.

5. The blood bag with inbuilt tubing as claimed in claim 1 wherein: An occlusion member which is damaged by external extrusion is arranged at the opening of the bottom of the separation pipe (1).

6. An extrusion separation method characterized by: The blood bag with the built-in pipe is used according to the blood bag with the built-in pipe in any one of claims 1-4, and the specific steps are as follows: First, the bag body (2) is fixed after being centrifuged and being divided into an upper chyle layer and a lower blood plasma layer, and a narrow gap is formed on one side or both sides of the bag body (2) close to the end part of the pipe group through the extrusion structure (3) arranged on the bag body (2); Then, the extrusion structure (3) is displaced relative to the bag body (2) to change the position of the narrow gap away from the pipe group and move towards the pipe opening of the separation pipe (1), and the narrow gap has an avoiding space for avoiding the separation pipe (1) during the movement; When the chyle layer enters the separation pipe (1), the extrusion is stopped and the separation is completed.

7. A method of extrusion separation according to claim 6, characterised in that: The linear narrow gap is formed when the extrusion structure (3) contacts the bag body (2), and the narrow gap is located between the chyle layer and the blood plasma layer.

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