WO2009049497A1

WO2009049497A1 - Separation disk for use on multi-cell component mixed liquid separation system and its application method

Info

Publication number: WO2009049497A1
Application number: PCT/CN2008/001727
Authority: WO
Inventors: Jianzhong Jing; Wangzhai Qi
Original assignee: Jianzhong Jing; Wangzhai Qi
Priority date: 2007-10-12
Filing date: 2008-10-13
Publication date: 2009-04-23
Also published as: CN101172207A; CN101172207B

Abstract

A separation disk for use on multi-cell component mixed liquid separation system, comprises a durable hard underpan (8) and a disposable soft bag (6). The hard underpan (8) is a circular pan composed of an inner core (28) and a pedestal (29). A section of continuous lacuna (7) surrounding the central axis of the hard underpan (8) is formed between the inner core (28) and the pedestal (29). The front-end and the back-end of the lacuna (7) are not connected. The part between the outside wall of the lacuna (7) and the outside wall of the hard underpan (8) is transparent. The soft bag (6) is a mono-cavity structure equipped with liquid inlet and outlet pipes. The soft bag (6) can be placed into the lacuna (7). The application method of the separation disk comprises placing it into the liquid separation system, each component of the mixed liquid forming individual component lamellas in the soft bag (6) by centrifugation in terms of their different densities, and extracting the target components after they have accumulated and thickened.

Description

多细胞成分混合液体分离***上的分离盘及应用方法技术领域 Separating disc on multi-cell component mixed liquid separation system and application method

本发明涉及混合液体成分的离心分离，特别是涉及一种多细胞成分混合液体分离***上的分离盘，以及利用含有该分离盘的分离***分离多细胞混合液体中单一成分的方法。背景技术 The present invention relates to centrifugal separation of mixed liquid components, and more particularly to a separation disk on a multi-cell component mixed liquid separation system, and a method of separating a single component in a multi-cell mixed liquid using a separation system containing the separation disk. Background technique

采血机构和科研机构通常使用离心法从多细胞成分混合液体中分离出各种单一成分，用于临床治疗、科学研究或制备原料等应用场合。最常见的是将全血分离出红细胞、粒细胞、单核细胞、血小板和血浆，或将解冻后的冷冻红细胞洗涤分离出红细胞和洗涤液。 Blood collection agencies and research institutions often use centrifugation to separate individual components from a multi-cell component mixture for clinical treatment, scientific research, or preparation of raw materials. The most common is to separate whole blood from red blood cells, granulocytes, monocytes, platelets and plasma, or to wash the frozen red blood cells after thawing to separate red blood cells and washing liquid.

常规处理多细胞成分混合液体的分离***都是采用离心机、输液泵、控制器、在线探测传感器和分离鼓的耐用部分等装置，以及一次性使用的直接接触混合液体的耗材部分。一次性使用的耗材部分通常由塑质材料制成，并由软袋（分离鼓的耗材部分)、输液管路和储存液体的保存袋三个部分组成。 The separation system for conventionally treating a multi-cell component mixed liquid is a device using a centrifuge, an infusion pump, a controller, an in-line detecting sensor, and a durable portion of the separation drum, and a disposable portion of the consumable portion that directly contacts the mixed liquid. The disposable consumable portion is usually made of plastic material and consists of a soft bag (the consumable part of the separation drum), an infusion line, and a storage bag for storing the liquid.

上述分离***的工作原理是：离心机、输液泵和控制器装置通过输液管路将多细胞成分混合液体引入分离鼓软袋之内，同时使分离鼓高速旋转，带动在旋转的分离鼓软袋内的多细胞成分混合液体中的液体和细胞颗粒高速旋转，这些液体和细胞颗粒成分受到离心力场的作用，于是其各种成分作离心沉降运动，并按各自密度或比重或沉降系数的大小分层，当达到离心沉降平衡时，从径向的圆周面至轴心由密度高到低富集排列形成同心圆状的各单一成分层, 以全血作为多细胞成分混合液体的一种为例，将会依次排列形成多细胞成分混合液体中密度最高成分的红细胞层 1、多细胞成分混合液体中密度次高成分的粒细胞层 2、多细胞成分混合液体中密度居中成分的单核细胞层 3、多细胞成分混合液体中密度次低成分的血小板层 4和多细胞成分混合液体中密度最低成分的血浆层 5等成分层，其中由于粒细胞和单核细胞的数量有限，往往形成白膜层界面，各成分层分布状况如图 1所示，图 1是全血在圆形分离盘上离心分离时各成分层的理论分布示意图。 The working principle of the above separation system is: the centrifuge, the infusion pump and the controller device introduce the multi-cell component mixed liquid into the soft bag of the separation drum through the infusion line, and simultaneously rotate the separation drum at a high speed to drive the soft drum of the separation drum in rotation. The liquid and cell particles in the mixed liquid of the multi-cellular component are rotated at high speed. These liquid and cell particle components are subjected to the centrifugal force field, and then various components are subjected to centrifugal sedimentation movement, and according to the respective density or specific gravity or the sedimentation coefficient. When the equilibrium of centrifugal sedimentation is reached, a single concentric layer of concentric circles is formed from a radial circumferential surface to an axial center from a high density to a low enrichment, taking whole blood as a mixed liquid of multicellular components as an example. The erythrocyte layer forming the highest density component in the mixed liquid of the multicellular component, the granulocyte layer of the second highest density component in the mixed liquid of the multicellular component, the mononuclear cell layer of the medium density component in the mixed liquid of the multicellular component mixture will be sequentially arranged. 3, multi-cell components mixed liquid in the dense The low-component platelet layer 4 and the multi-cell component are mixed with the lowest density component of the plasma layer 5 in the liquid layer. Among them, due to the limited number of granulocytes and monocytes, the white film interface is often formed, and the distribution of each component layer is As shown in Fig. 1, Fig. 1 is a schematic view showing the theoretical distribution of each component layer when whole blood is centrifuged on a circular separation disk.

在现有技术中，上述分离鼓的耐用部分主要结构是由内芯和底座组成的同心圆盘，分离鼓的耗材部分是一次性使用软袋。该软袋具有两室结构，安置于内芯与底座间形成的同心圆形腔隙中；该分离鼓可以在离心机连续转动的情况下实现血液单一成分的提取。这种采用耐用的圆盘和一次性的软袋相结合的方式，安全卫生。实践应用中作为一次性使用的软袋，结构相对复杂，制作成本高，使用成本也随之增加；同心圆的分离结构会造成各成分的同心圆层状分布，不易对特定成分造成富集，因此在提取特定成分特别是含量较少的成分时，对设备的控制精度要求高，费时费力，效率低；若应用于自动化采集血液中，易造成供体的体外循环血量较大，不利于身体健康。发明内容 In the prior art, the durable portion of the above-mentioned separation drum is mainly composed of a concentric disc composed of an inner core and a base, and the consumable portion of the separation drum is a disposable soft pouch. The soft bag has a two-chamber structure and is disposed in a concentric circular cavity formed between the inner core and the base; the separation drum can realize the extraction of a single component of blood under continuous rotation of the centrifuge. This combination of durable discs and disposable soft pouches is safe and hygienic. As a single-use soft bag in practical application, the structure is relatively complicated, the production cost is high, and the use cost is also increased; the concentric circle separation structure causes concentric circular layer distribution of each component, and is not easy to enrich the specific component. Therefore, when extracting a specific component, especially a component with a small content, the control precision of the device is high, time-consuming and laborious, and the efficiency is low; if it is applied to the automatic collection of blood, the blood volume of the extracorporeal circulation of the donor is likely to be large, which is disadvantageous for Healthy body. Summary of the invention

本发明的目的在于克服上述现有技术的不足，提供一种多细胞成分混合液体分离***上的分离盘及应用方法。本发明的分离盘用于混合液体分离***上，将多细胞成分混合液体中的各种成分在连续状态下分离和提取，特别是对在混合液^^中含量较少的成分能够充分富集和提取；若用于自动化采血，还可有效地控制血液体外循环量，以利供体健康；同时简化一次性使用软袋的结构，降低其制作成本和使甩成本。 SUMMARY OF THE INVENTION An object of the present invention is to overcome the above deficiencies of the prior art and to provide a separation disc and a method of application on a multi-cell component mixed liquid separation system. The separation disc of the invention is used on a mixed liquid separation system, and the various components in the mixed liquid of the multi-cell component are separated and extracted in a continuous state, in particular, the components having a small content in the mixed solution can be sufficiently enriched. And extraction; if used for automated blood collection, it can effectively control the amount of extracorporeal circulation of blood to benefit donor health; at the same time, simplify the structure of disposable soft bag, reduce its production cost and cost.

本发明的发明思路： The inventive idea of the invention:

本发明同样是利用混合液体不同密度成分受离心力而分层分布的离心沉降分离原理，刻意利用分离盘中非同心圆的弧线状型腔隙空间，在离心力场的作用下，驱使混合液体屮的各种成分按其密度大小而富集，密度高的成分向盘圆周面富集，密度低的成分向盘中央富集，但在弧线状型腔隙内无法像圆形分离盘那样形成同心圆分层分布，密度高的成分只能在弧线状型腔隙内沿着其平滑内壁之间的空间向距离硬底盘圆心轴最远端的腔隙首部迁移或沉降，密度低的成分相反向距离硬底盘圆心轴最近端的腔隙尾部迁移或沉降，因此在弧线状型腔隙内呈单一成分片层状分段分布；同时通过灌流控制技术调控液体输入和抽出的流速流量，利用流体形成的切变力场作用，借以充分富集纯化作为分离目标的单一成分，并使之在最理想状态下被抽取。该装置可以在离心机连续转动的情况下实现多细胞成分混合液体中单一成分的提取。 The invention also utilizes the centrifugal sedimentation separation principle in which the different density components of the mixed liquid are layered and distributed by centrifugal force, and deliberately utilizes the non-concentric arc-shaped cavity space in the separation disc to drive the mixed liquid 在 under the action of the centrifugal force field. The various components are enriched according to their density. The high-density components are concentrated toward the circumferential surface of the disk, and the low-density components are concentrated toward the center of the disk, but they cannot be formed like a circular separation disk in the arc-shaped cavity. Concentric circles, high density components It can only migrate or settle in the arc-shaped cavity along the space between its smooth inner wall to the most distal cavity of the hard disk center axis. The low density component is opposite to the cavity closest to the hard disk center axis. The tail migration or sedimentation is distributed in a single component layer in the arc-shaped cavity. At the same time, the perfusion control technology is used to regulate the flow rate of the liquid input and extraction, and the shear force field formed by the fluid is used. The single component which is the target of separation is fully enriched and purified, and is extracted in the most ideal state. The device can realize the extraction of a single component in a mixed liquid of multi-cellular components while the centrifuge is continuously rotated.

本发明的技术方案： The technical solution of the invention:

一种多细胞成分混合液体分离***上的分离盘，包括耐用的圆形硬底盘和一次性使用的条带状软袋；所述的硬底盘的轴心处设有可将该硬底盘安置于离心机转子轴上的轴孔；所述的硬底盘是由内芯和底座组成的圆形盘，在内芯和底座之间形成一段绕该硬底盘圆心轴一周的且首部和尾部不封闭的连续腔隙，该腔隙的首部位于距离硬底盘的圆心轴的最远端，腔隙的尾部位于距离硬底盘的圆心轴的最近端，腔隙的外侧壁与硬底盘的外侧壁之间部分由透明材料制作；所述的软袋为单腔结构，其长度和横截面与所述的腔隙相应，可置入至所述的腔隙中，软袋上设有进液管和出液管，软袋的中部设有供液体进入的进液管，软袋的两端部分别设有出液管。 A separation disc on a multi-cell component mixed liquid separation system, comprising a durable round hard chassis and a disposable strip-shaped soft pouch; the hard disc has a shaft center at which the hard disc is placed a shaft hole on the rotor shaft of the centrifuge; the hard chassis is a circular disk composed of an inner core and a base, and a section between the inner core and the base is formed around the center axis of the hard chassis, and the head and the tail are not closed. a continuous cavity, the head of the cavity is located at the farthest end from the center axis of the hard chassis, the tail of the cavity is located at the closest end of the central axis of the hard chassis, and the portion between the outer side wall of the cavity and the outer side wall of the hard chassis Made of a transparent material; the soft bag is a single-chamber structure, and its length and cross-section correspond to the cavity, and can be placed into the cavity, and the soft bag is provided with a liquid inlet pipe and a liquid outlet. In the middle of the soft bag, there is an inlet pipe for liquid to enter, and the two ends of the soft bag are respectively provided with a liquid outlet pipe.

作为一种优化方案，所述的腔隙在硬底盘柱截面平面上的投影为一段连续的平滑弧线段。 As an optimization scheme, the projection of the cavity on the plane plane of the hard chassis column is a continuous smooth arc segment.

作为更为优化的一种方案，所述的腔隙在硬底盘柱截面平面上的投影为一段绕圆心轴的螺旋线。 As a more optimized solution, the projection of the cavity in the plane plane of the hard chassis column is a spiral around the central axis.

一种利用上述的含单螺旋线状腔隙的分离盘从全血中分离血浆或红细胞的方法，该方法包括如下步骤： A method for separating plasma or red blood cells from whole blood using the above-described separation disk containing a single spiral linear cavity, the method comprising the steps of:

① 将连接着***管路的一次性使用的单弧线软袋装入到硬底盘的单螺旋线状腔隙中形成分离盘，将分离盘安置于离心机转子上，在完成安置管路、在线检测传感器、输液泵、离心机及其控制***后，启动离心机； ② 该分离盘绕硬底盘的圆心轴转动，抽取全血通过进液管灌入该单弧线软袋中，全血中各成分受离心力场作用依其密度不同在腔隙内富集呈片层状分段分布，用在线检测传感器检测相邻成分层间界面的位置;1 Insert the disposable single arc soft bag connected to the peripheral pipe into the single spiral line cavity of the hard chassis to form the separation disc, place the separation disc on the centrifuge rotor, and complete the installation pipeline. After the on-line detection sensor, the infusion pump, the centrifuge and its control system, start the centrifuge; 2 The separation coil rotates around the center axis of the hard chassis, and the whole blood is pumped into the single arc soft bag through the liquid inlet tube, and the components in the whole blood are concentrated in the cavity by the centrifugal force field according to the density thereof. Segmented distribution, using on-line detection sensors to detect the position of the interface between adjacent components;

③ 从位于腔隙尾部的出液管抽取血浆，同时监测血浆与其相邻成分的界面位置状况，至该界面移动到腔隙尾部的出液管附近时，停止血浆的抽取，然后从位于腔隙首部的出液管抽取红细胞和其他剩余成分一起回输，同时监测红细胞层与其相邻成分的界面位置状况，至该界面移动到腔隙中部的进液管附近时，停止红细胞的抽取，重复本步骤，使分离的目标产物逐渐积累，直至满足分离要求为止； 3 The plasma is drawn from the outlet tube located at the end of the cavity, and the interface position of the plasma and its adjacent components is monitored. When the interface moves to the vicinity of the outlet tube at the tail of the cavity, the plasma is stopped and then located in the cavity. The first outlet tube draws red blood cells together with other remaining components, and monitors the interface position of the red blood cell layer and its adjacent components. When the interface moves to the vicinity of the inlet tube in the middle of the cavity, the red blood cell is stopped and the sample is repeated. a step of gradually accumulating the separated target product until the separation requirement is satisfied;

④ 若以红细胞作为分离的目标成分，则将上述步骤③中的抽取顺序颠倒过来：从位于腔隙首部的出液管抽取红细胞，同时监测红细胞层与其相邻成分的界面位置状况，至该界面移动到腔隙中部的进液管附近时，停止红细胞的抽取，从位于腔隙尾部的出液管抽取血浆和其他剩余成分一起回输，同时监视血浆层与其相邻成分的界面位置状况，至该界面移动到腔隙尾部的出液管附近时，停止血浆的抽取，重复本步骤，使分离的目标产物逐渐积累，直至满足分离要求为止。 4 If red blood cells are used as the target component of separation, reverse the extraction sequence in step 3 above: extract red blood cells from the outlet tube located at the head of the cavity, and monitor the interface position of the red blood cell layer and its adjacent components to the interface. When moving to the vicinity of the inlet tube in the middle of the cavity, the red blood cell is stopped, and the plasma and other remaining components are taken back from the outlet tube located at the tail of the cavity, and the interface position of the plasma layer and its adjacent components is monitored, to When the interface moves to the vicinity of the liquid outlet tube at the tail of the cavity, the plasma extraction is stopped, and this step is repeated to gradually accumulate the separated target product until the separation requirement is satisfied.

为了实现混合液体分层中密度处于中间位置的成分的提取，将所述的腔隙设计进一歩优化，由多段向圆心轴弯曲且首尾相连的平滑弧线段组成腔隙，整个腔隙是连续的，两个相邻的平滑弧线段中的前一弧线段的尾部与下一弧线段的首部相连接，这相邻弧线段的连接处为凸向圆心轴的嵴；为了适应该腔隙的结构，另外在软袋上增设了与腔隙中的嵴数目相同的出液管，增设的出液管在软袋安置于腔隙内时位于嵴后的弧线段中距离圆心轴的最远处。 In order to realize the extraction of the components whose density is in the middle position in the mixed liquid layering, the cavity is designed to be optimized, and the cavity is formed by a plurality of smooth arc segments which are bent to the center axis and connected end to end, and the whole cavity is continuous. The tail of the previous arc segment of the two adjacent smooth arc segments is connected to the head portion of the next arc segment, and the junction of the adjacent arc segments is a convex to the center axis; The structure of the cavity is additionally provided with a discharge pipe having the same number of turns in the cavity as the soft bag, and the added outlet pipe is located at a distance from the center of the arc in the rear of the pocket when the soft bag is placed in the cavity. The farthest point of the shaft.

作为分离混合液体中分离密度次低成分的一种优化方案，设计了具有两个平滑弧线段组成的腔隙，包括位于由连接腔隙首部的第一弧线段和连接腔隙尾部的第二弧线段相连接组成，两个弧线段连接处为凸向圆心轴的嵴，在软袋上增设了一个出液管，该增设的出液管在软袋安置于硬底盘的腔隙中时位于第二弧线段上距离圆心轴最远处，以便于在分离过程中抽取富集在该第二弧线段内的密度次低成分层。 As an optimization scheme for separating the lower density component of the mixed liquid, a cavity having two smooth arc segments is designed, including the first arc segment connected to the head portion of the cavity and the tail portion connecting the cavity portions. The two arc segments are connected, and the two arc segments are connected to the 圆 of the circular mandrel. An outlet pipe is added to the soft bag, and the additional outlet pipe is placed in the soft bag in the cavity of the hard chassis. The middle time is located on the second arc segment farthest from the center axis of the circle, so as to be separated The lower density component layer enriched in the second arc segment is extracted during the process.

一种利用含双弧线腔隙的分离盘在自动化血液采集中分离、浓集和提取全血中单一成分的血小板方法，该方法具体包括如下步骤- A method for separating, enriching and extracting a single component platelet in whole blood by using a separation disk containing a double arc cavity in an automated blood collection, the method specifically comprising the following steps -

① 将连接着***管路的一次性使用的双弧线软袋装入到双弧线状型腔隙硬底盘的双弧线状型腔隙中形成分离盘，并将其安置于离心机转子上，在完成安置管路、在线检测传感器、输液泵、离心机及其控制系统后，启动离心机； 1 Insert a single-use double-arc soft bag connected to the peripheral pipe into the double-arc-shaped cavity of the double-arc-shaped cavity hard chassis to form a separation disc, and place it in the centrifuge rotor First, after completing the installation pipeline, the on-line detecting sensor, the infusion pump, the centrifuge and the control system thereof, the centrifuge is started;

② 该分离盘绕硬底盘的圆心轴转动，抽取全血通过进液管向该软袋中灌入，全血中密度不同的各种成分受离心力场的作用先在第一弧线状型腔隙内聚集呈片层状分段分布，血浆层因密度最低排列于软袋内靠近第一弧线状型腔隙尾部位置，红细胞层因密度最高排列于软袋内靠近腔隙首部位置，其余成分在软袋内沿第一弧线状型腔隙空间依次分段分布，用在线检测传感器检测相邻成分层间界面的位置； 2 The separation coil rotates around the center axis of the hard chassis, and the whole blood is pumped into the soft bag through the liquid inlet tube, and various components of different density in the whole blood are firstly applied to the first arc-shaped cavity by the centrifugal force field. The inner layer is distributed in a layered segment, and the plasma layer is arranged in the soft bag at the lowest position in the soft bag near the tail of the first arc-shaped cavity. The red cell layer is arranged in the soft bag in the soft bag near the head of the cavity, and the remaining components. The segments are sequentially segmented along the first arc-shaped cavity space in the soft bag, and the position of the interface between adjacent component layers is detected by an on-line detecting sensor;

③ 随着全血连续不断地输入和被离心分离，以及有控制地从位于腔隙尾部的出液管抽取血浆，同时从位于腔隙首部的出液管抽取红细胞，使富含血小板的血浆逐渐富集并越过第一弧线段和第二弧线段连接处的嵴，进入第二弧线状型腔隙，第二弧线状型腔隙内的血小板进一步富集形成血小板层，并使其与相邻的血浆层之间的界面保持在第二弧线状型腔隙内，并使血小板层与其相邻的主要由单核细胞和粒细胞组成的白膜层之间的界面继续保持在第一弧线状型腔隙内，重复本步骤以增加血小板富集量； 3 As the whole blood is continuously input and centrifuged, and the plasma is extracted from the outlet tube located at the end of the cavity, and the red blood cells are drawn from the outlet tube located at the head of the cavity, the platelet-rich plasma is gradually formed. Enriching and crossing the ridge at the junction of the first arc segment and the second arc segment, entering the second arc-shaped cavity, and the platelets in the second arc-shaped cavity are further enriched to form a platelet layer, and The interface between it and the adjacent plasma layer remains in the second arcuate cavity and maintains the interface between the platelet layer and its adjacent white membrane layer consisting mainly of monocytes and granulocytes. Repeat this step in the first arc-shaped cavity to increase platelet enrichment;

④ 在血小板富集到一定量时，通过调节由进液管输入全血或回输红细胞的速率，以及由出液管抽取红细胞的速率，利用输入与抽出的流量不同控制第一弧线状型腔隙内血小板层与白膜层之间的界面，并使之靠近嵴; 4 When the platelet is enriched to a certain amount, by adjusting the rate of inputting whole blood or returning red blood cells from the inlet tube, and the rate at which red blood cells are drawn by the outlet tube, the first arc-shaped type is controlled by the difference between the input and the extracted flow rate. The interface between the platelet layer and the white film layer in the cavity, and close to the crucible;

⑤ 通过在短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一弧线状型腔隙进入第二弧线状型腔隙，在嵴处对第一弧线状型腔隙内靠近嵴的血小板层表面产生曳力裹挟起界面上的血小板颗粒随血桨流越过嵴，快速血浆流同时在血小板层表面造成湍流冲击，加速血小板颗粒形成局部浪涌，使第一弧线状型腔隙内的血小板层被反混入血浆层，并随血浆流越过嵴进入第二弧线状型腔隙内，当白膜层临近嵴时，立即停止血浆回输，使白膜层和红细胞层仍留滞在第一弧线状型腔隙内； 5 By rapidly returning the plasma from the inlet tube in a short time, the plasma flow passes directly through the first arc-shaped cavity into the second arc-shaped cavity, and the first arc is at the ridge. Platelet particles on the surface of the platelet layer near the sputum in the shape cavity The granules flow over the sputum with the blood flow, and the rapid plasma flow causes turbulent impact on the surface of the platelet layer, accelerating the local surge of platelet particles, causing the platelet layer in the first arc-shaped cavity to be back-mixed into the plasma layer, and with the plasma. The flow passes through the sputum into the second arc-shaped cavity, and when the tunica layer is adjacent to the sputum, the plasma return is immediately stopped, so that the tunica layer and the red blood cell layer remain in the first arc-shaped cavity;

⑥ 在步骤③、 ⑤期间，血小板层在第二弧线状型腔隙内浓集，可从第二弧线段内距离转动圆心轴最远处的出液管抽取纯化和富集的血小板，这是分离的目标产物； 6 During steps 3 and 5, the platelet layer is concentrated in the second arc-shaped cavity, and the purified and enriched platelets can be extracted from the outlet tube at the farthest point of the rotation of the central axis from the second arc segment. This is the target product of the separation;

⑦ 在步骤⑥期间，剩余的单核细胞层和粒细胞层组成的白膜层仍留滞在第一弧线状型腔隙内，可从出液管抽出，随同上述过程中抽出多余的红细胞、血浆一起回输人体，重复步骤③、 ④、 ⑤、 ⑥、 ⑦，使分离的目标产物逐渐积累，直至满足分离要求为止。 7 During step 6, the remaining monolayers and granules of the leucocytic layer remain in the first arcuate cavity and can be withdrawn from the outlet tube, with the extra red blood cells taken out along with the above process. The plasma is returned to the human body together, and steps 3, 4, 5, 6, and 7 are repeated to gradually accumulate the separated target product until the separation requirement is satisfied.

作为分离混合液体中分离密度居中成分或密度次高成分的一种优化方案，设计了有三个平滑弧线段依次连接成的腔隙，所述的腔隙由首部至尾部分别由第一弧线段、第二弧线段和第三弧线段依次枏连接组成，第一弧线段和第二弧线段连接处为第一崤，第二弧线段与第三弧线段连接处为第二嵴，为了抽取富集在第二弧线段和第三弧线段内的成分，在软袋上相应于腔隙的第二弧线段和第三弧线段上距离圆心轴最远处分别设置有出液管，在第二弧线状型腔隙中，将会富集分离的目标成分，并在第二弧线状型腔隙中的软袋上的出液口抽取。 As an optimization scheme for separating the density-centered component or the second-highest density component in the separated mixed liquid, a cavity is formed in which three smooth arc segments are sequentially connected, and the cavity is respectively composed of the first arc to the tail by the first arc. The segment, the second arc segment and the third arc segment are sequentially connected, and the first arc segment and the second arc segment are connected to each other, and the second arc segment and the third arc segment are connected. Secondly, in order to extract the components enriched in the second arc segment and the third arc segment, the second arc segment corresponding to the cavity and the third arc segment on the soft bag are farthest from the circular mandrel The outlet pipe is respectively provided, and in the second arc-shaped cavity, the separated target component is enriched and extracted at the liquid outlet on the soft bag in the second arc-shaped cavity.

一种利用含有三弧线段腔隙的分离盘在自动化血液采集中分离、浓集和提取全血屮单 ·成分的单核细胞或粒细胞的方法，该方法具体包括如下操作步骤： A method for separating, enriching and extracting whole blood mononuclear cells or granulocytes in an automated blood collection using a separation disk containing a three-arc segment cavity, the method specifically comprising the following steps:

① 将连接着***管路的一次性使用的多弧线状软袋装入多弧线状型腔隙硬底盘上三个弧线段组成的腔隙中形成分离盘，并将其安置于离心机转子上，在完成安置管路、在线检测传感器、输液泵、离心机及其控制***后，启动离心机； 1 Insert a single-use multi-arc soft bag connected to the peripheral pipe into a cavity composed of three arc segments on a multi-arc-shaped cavity hard chassis to form a separation disc and place it in the centrifuge. On the rotor of the machine, after completing the installation pipeline, the on-line detection sensor, the infusion pump, the centrifuge and its control system, start the centrifuge;

② 该分离盘绕硬底盘的圆心轴转动，抽取全血通过进液管灌入到软袋，全血中密度不同的各种成分受离心力场的作用先在第一弧线状型腔隙内聚集呈片层状分段分布，全血中的血桨层因密度最低排列于软袋内靠近第一弧线状型腔隙尾部位置，红细胞层因密度最高排列于软袋内靠近腔隙首部位置，其余成分在软袋内沿第一弧线状型腔隙空间依次分段分布，用在线检测传感器检测相邻成分层间界面的位置； 2 The separation coil rotates around the center axis of the hard chassis, and the whole blood is pumped through the inlet pipe. Soft bag, various components of different density in whole blood are firstly distributed in a first arc-shaped cavity by a centrifugal force field. The blood paddles in whole blood are arranged in softness due to the lowest density. The inside of the bag is close to the tail position of the first arc-shaped cavity, and the red cell layer is arranged in the soft bag at the highest position in the soft bag near the head of the cavity, and the remaining components are sequentially segmented along the first arc-shaped cavity space in the soft bag. , detecting the position of the interface between adjacent component layers by using an on-line detecting sensor;

③ 随着全血连续不断地输入和被离心分离，以及有控制地从位于腔隙尾部的出液管抽出血浆，同时从位于腔隙首部的出液管抽出红细胞，使血浆和血小板逐渐越过第一弧线段和第二弧线段连接处的第一嵴进入第二弧线状型腔隙，同时使血小板层与其相邻的主要由单核细胞和粒细胞组成的白膜层之间的界面保持在第一弧线状型腔隙内，重复本步骤使含有单核细胞和粒细胞的白膜层逐渐加厚； 3 As the whole blood is continuously input and centrifuged, and the plasma is withdrawn from the outlet tube located at the end of the cavity, and the red blood cells are withdrawn from the outlet tube located at the head of the cavity, the plasma and platelets gradually pass over. The first ridge at the junction of the arc segment and the second arc segment enters the second arcuate cavity while causing the platelet layer to be adjacent to its adjacent white membrane layer consisting mainly of monocytes and granulocytes. The interface is maintained in the first arc-shaped cavity, and this step is repeated to gradually thicken the white film layer containing monocytes and granulocytes;

④ 当白膜层增至一定的厚度时，通过调节由进液管输入全血或回输红细胞的速率，以及由出液管抽取红细胞的速率，利用这二者的流量不同来控制第一弧线状型腔隙内血小板层与白膜层之间的界面，并使之靠近第一嵴； 4 When the tunica layer is increased to a certain thickness, the first arc is controlled by adjusting the rate at which the whole blood or the red blood cells are input from the inlet tube, and the rate at which the red blood cells are drawn by the outlet tube. The interface between the platelet layer and the white film layer in the linear cavity and close to the first crucible;

⑤ 以单核细胞作为分离目标，在步骤④完成后，通过在短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一弧线状型腔隙进入第二弧线状型腔隙，在第一嵴处对第一弧线状型腔隙内靠近第一嵴的血小板层和单核细胞层表面产生曳力裹挟起界面上的血小板颗粒和单核细胞颗粒随血浆流越过该第一嵴，快速血浆流也在 ifc血小板层和单核细胞层表面造成湍流冲击，加速血小板颗粒和单核细胞颗粒形成局部浪涌，使第一弧线状型腔隙内的血小板层和单核细胞层被反混入血浆层，并随血浆流越过第一嵴进入第二弧线状型腔隙内，当与单核细胞层相邻的粒细胞层和红细胞层之间的界面临近第一嵴时，立即停止血浆回输，与单核细胞层相邻的粒细胞层和红细胞层仍留滞在第一弧线状型腔隙内原处； 5 With monocytes as the separation target, after the completion of step 4, the plasma flow can be directly and quickly passed through the first arc-shaped cavity into the second arc by rapidly returning the plasma from the inlet tube in a short time. a linear cavity with platelet particles and monocyte particles on the surface of the first arc-shaped cavity near the first layer of the platelet layer and the mononuclear cell layer at the first ridge The plasma flow passes over the first sputum, and the rapid plasma flow also causes turbulent impact on the surface of the ifc platelet layer and the monocyte layer, accelerating the local surge of platelet particles and monocyte particles, making the first arc-shaped cavity The platelet layer and the monocyte layer are back-mixed into the plasma layer and enter the second arc-like cavity as the plasma flows across the first ridge, between the granulocyte layer and the erythrocyte layer adjacent to the monocyte layer. When the interface is close to the first sputum, the plasma reinfusion is immediately stopped, and the granulocyte layer and the red blood cell layer adjacent to the monocyte layer remain in the first arc-shaped cavity;

⑥ 多次重复步骤③至⑤，血小板和单核细胞在第二弧线状型腔隙内得到浓集，短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一和第二弧线状型腔隙进入第三弧线状型腔隙，在第二嵴旁通过血浆流对血小板层表面产生曳力裹挟血小板颗粒和湍流浪涌造成血小板反混，并随血浆流使血小板越过第二嵴进入第三弧线状型腔隙，当与血小板相邻的单核细胞层的界面临近第二嵴时，立即停止血浆回输，然后从位于第二弧线状型腔隙内距离转动圆心轴最远处的出液管抽取纯化和富集的作为目标产物的单核细胞，将上述过程中抽出多余的其他成分回输人体，重复步骤③、 ④、 ⑤、 ⑥，使分离的目标产物逐渐积累，直至满足分离要求为止； 6 Repeat steps 3 to 5 several times, platelets and monocytes are concentrated in the second arc-shaped cavity, and a large amount of rapid return of plasma from the inlet tube in a short time makes the plasma flow directly fast. Passing through the first and second arc-shaped cavities into the third arc-shaped cavity, and generating a dragging platelet particle and a turbulent surge on the surface of the platelet layer by the plasma flow on the second side to cause platelet anti-mixing And with the plasma flow, the platelets pass the second sputum into the third arc-shaped cavity, and when the interface of the mononuclear cell adjacent to the platelet approaches the second sputum, the plasma reinfusion is immediately stopped, and then the second is located. In the arc-shaped cavity, the outlet tube farthest from the rotating central axis extracts and purifies the mononuclear cells as the target product, and extracts the excess components into the human body in the above process, repeating steps 3 and 4. 5, 6, the separation of the target product gradually accumulates until the separation requirements are met;

⑦选择粒细胞作为分离目标，是在在步骤④完成后，通过在短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一弧线状型腔隙进入第二弧线状型腔隙，在第一嵴旁依次对第一弧线状型腔隙内靠近第一嵴的血小板层、单核细胞层、粒细胞层的表面产生曳力裹挟和湍流浪涌反混，并随血浆流越过第一嵴进入第二弧线状型腔隙内，当与其相邻的红细胞层之间的界面临近第一嵴时，立即停止血浆回输，与粒细胞层相邻的红细胞层仍留滞在第一弧线状型腔隙内原处； 7 Selecting granulocytes as the separation target, after the completion of step 4, the plasma flow is directly and quickly passed through the first arc-shaped cavity into the second by rapidly returning the plasma from the inlet tube in a short time. An arc-shaped cavity, in the first arc, sequentially produces a dragging force and a turbulent surge on the surface of the first arc-shaped cavity near the first platelet layer, the mononuclear cell layer, and the granulocyte layer. Mixing, and as the plasma flows past the first sputum into the second arc-like cavity, when the interface between the adjacent red blood cell layer approaches the first sputum, immediately stops the plasma reinfusion, adjacent to the granulocyte layer The red blood cell layer remains in place in the first arc-shaped cavity;

⑧ 多次重复步骤③、④、⑦，使血小板和白膜层细胞在第二弧线状型腔隙内浓集，通过在短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一和第二弧线状型腔隙进入第三弧线状型腔隙，在第二嵴旁依次对第二弧线状型腔隙内靠近第二嵴的血小板层、单核细胞层的表面产生曳力裹挟和湍流浪涌反混，并随血浆流越过第二嵴进入第三弧线状型腔隙，清洗留滞第二弧线状型腔隙内的粒细胞层，当与单核细胞层相邻的粒细胞层的界面临近第二嵴时，立即停止血浆回输，从位于第二弧线状型腔隙内距离转动圆心轴最远处的出液管抽取纯化和富集的作为目标产物的粒细胞层，重复步骤③、 ④、 ⑦、 ⑧，使分离的目标产物逐渐积累，直至满足分离要求为止。 8 Repeat steps 3, 4, and 7 several times to allow platelets and white-skin cells to concentrate in the second arc-shaped cavity. By rapidly returning plasma from the inlet tube in a short time, the plasma flow is directly Quickly passing through the first and second arc-shaped cavities into the third arc-shaped cavity, and next to the second crucible, sequentially adjacent to the second crucible platelet layer in the second arc-shaped cavity The surface of the nuclear cell layer produces dragging and turbulent surge backmixing, and passes through the second sputum into the third arc-shaped cavity, cleaning the granulocyte layer in the second arc-shaped cavity. When the interface of the granulocyte layer adjacent to the monocyte layer is adjacent to the second sputum, the plasma reinfusion is immediately stopped, and is extracted from the outlet tube located farthest from the rotating central axis in the second arc-shaped cavity. Purified and enriched granulocyte layer as the target product, steps 3, 4, 7, and 8 are repeated to allow the separated target product to gradually accumulate until the separation requirement is satisfied.

本发明的技术优点- Technical advantages of the present invention -

1.本发明采用耐用硬底盘加一次性使用软袋的分离盘设计，其最大优点在于节省成本。本发明的软袋和已有的软袋相比，由于本发明采用单腔室结构，因此对软袋的材料要求明显降低，制作工艺也较简单，同样也降低了生产成本和使用成本。 1. The present invention employs a separation disc design of a durable hard chassis plus a disposable soft pouch, the greatest advantage of which is cost savings. Compared with the existing soft bag, the soft bag of the present invention is adopted by the present invention. The single-chamber structure, therefore, the material requirements for the soft bag are significantly reduced, the manufacturing process is also relatively simple, and the production cost and the use cost are also reduced.

2.本发明分离盘上非同心圆的弧线状腔隙使各种成分层可以沿平滑腔隙内壁之间的空间分段分布，进而拉宽了各种单一成分层的带宽，便于有效提取，提高了分离产出率。 2. The non-concentric arc-shaped cavity on the separation disc of the present invention enables various component layers to be distributed along the space between the inner walls of the smooth cavity, thereby widening the bandwidth of various single component layers, and facilitating efficient extraction. , increased separation output rate.

3.在优化设计中采用了两段弧线段组成的腔隙结构，两段弧线段套接处形成嵴，分离过程中应用灌流控制技术，利用多细胞成分混合液体的流体动力学特性，既提高密度居于中间且数量有限的单一成分的浓集程度和分离产出率，又减少了相邻成分的污染干扰，进而提高了提取单一成分的纯度。 3. In the optimization design, a cavity structure composed of two arc segments is used, and two arc segments are formed at the socket to form a helium. The perfusion control technique is applied in the separation process, and the fluid dynamics characteristics of the mixed liquid of the multi-cell component are utilized. It not only increases the concentration and separation yield of a single component with a medium density and a limited number, but also reduces the pollution interference of adjacent components, thereby improving the purity of extracting a single component.

4.在自动化采血分离的应用中，配合分层界面控制和在线传感器的流体密度检测，可以明显提高在单针状态下的采血和回输的效率，并可有效地控制体外循环血量，进而更有效地保护献血员的健康。附图说明 4. In the application of automated blood collection separation, combined with layered interface control and fluid density detection of online sensors, the efficiency of blood collection and return in a single needle state can be significantly improved, and the blood volume of extracorporeal circulation can be effectively controlled. Protect the health of blood donors more effectively. DRAWINGS

图 1是全血作为多细胞成分混合液体在圆形分离盘上离心分离时各成分层的理论分布示意图。 Fig. 1 is a schematic view showing the theoretical distribution of the constituent layers of whole blood as a mixed liquid of a multicellular component on a circular separation disk.

图 2是本发明多细胞成分混合液体分离***上的分离盘的结构示意图。 Fig. 2 is a schematic view showing the structure of a separation disc on the multi-cell component mixed liquid separation system of the present invention.

图 3是本发明多细胞成分混合液体分离***上的分离盘的实施例 1 的单弧线状型腔隙硬底盘的示意图。 Fig. 3 is a schematic view showing a single-arc linear cavity type hard chassis of the embodiment 1 of the separation disk on the multi-cell component mixed liquid separation system of the present invention.

图 4是本发明多细胞成分混合液体分离***上的分离盘的实施例 1 的一次性使用的单弧线软袋结构示意图。 Figure 4 is a schematic view showing the structure of a single-use single-arc soft bag of Example 1 of the separation disc on the multi-cell component mixed liquid separation system of the present invention.

图 5是本发明多细胞成分混^夜体分离***上的分离盘的实施例 1 中两种以上细胞成分混合液体的分离流程图。 Fig. 5 is a flow chart showing the separation of two or more cell component mixed liquids in Example 1 of the separation disk on the multicellular component mixed body separation system of the present invention.

图 6是本发明多细胞成分混合液体分离***上的分离盘的实施例 2 的双弧线状型腔隙硬底盘的示意图。 Figure 6 is a schematic illustration of a double-arc-shaped cavity-type hard chassis of Example 2 of the separation disc on the multi-cell component mixed liquid separation system of the present invention.

图 7是本发明多细胞成分混合液体分离***上的分离盘的实施例 2 中一次性使用的双弧线软袋结构示意图。 Figure 7 is a second embodiment of the separation disc on the multi-cell component mixed liquid separation system of the present invention Schematic diagram of a double-arc soft bag for single use.

图 8是本发明多细胞成分混合液体分离***上的分离盘的实施例 2 中三种以上细胞成分混合液体的分离流程图。 Figure 8 is a flow chart showing the separation of three or more cell component mixed liquids in Example 2 of the separation disk on the multi-cell component mixed liquid separation system of the present invention.

图 9是本发明多细胞成分混合液体分离***上的分离盘的实施例 3 的多弧线状型腔隙硬底盘的示意图。 Figure 9 is a schematic illustration of a multi-arc-shaped cavity hard chassis of Example 3 of the separation disc on the multi-cell component mixed liquid separation system of the present invention.

图 10是本发明多细胞成分混合液体分离***上的分离盘的实施例 3 的一次性使用的多弧线软袋结构示意图。 . 图 11是本发明多细胞成分混合液体分离***上的分离盘的实施例 3 中四种以上细胞成分混合液体的分离流程图。 Figure 10 is a schematic view showing the structure of a single-use multi-arc soft bag of Example 3 of the separation disc on the multi-cell component mixed liquid separation system of the present invention. Figure 11 is a flow chart showing the separation of four or more cell component mixed liquids in Example 3 of the separation disk on the multi-cell component mixed liquid separation system of the present invention.

具体实施方式 detailed description

下面结合附图和具体的实施例来对本发明多细胞成分混合液体分离***上的分离盘的具体应用做进一步的详细说明，但不能以此限制本发明的保护范围。 The specific application of the separation disc on the multi-cell component mixed liquid separation system of the present invention will be further described in detail below with reference to the accompanying drawings and specific examples, but the scope of the present invention should not be limited thereto.

含有多种细胞成分的混合液体诸如血液往往要靠离心设备来分离，进而实现单一细胞成分的提取。该分离***主要包括有离心机、输液泵、控制器、在线探测传感器、分离盘的耐用部分以及一次性使用的耗材。 Mixed liquids containing a variety of cellular components, such as blood, are often separated by centrifugation equipment to achieve extraction of a single cellular component. The separation system mainly includes a centrifuge, an infusion pump, a controller, an on-line detection sensor, a durable portion of the separation disc, and a disposable consumable.

本发明的分离盘属于对分离鼓的设计更新，仍采用耐用的硬底盘和一次性使用的软袋相结合组成，将硬底盘和软袋分体设计以降低制造成本，简化软袋制作要求以降低其生产和使用成本，采用一次性使用的软袋更能符合卫生和安全要求。 The separation disc of the present invention belongs to the design update of the separation drum, and is still composed of a durable hard chassis and a disposable soft bag. The hard chassis and the soft bag are separately designed to reduce the manufacturing cost and simplify the soft bag manufacturing requirements. Reducing the cost of production and use, the use of disposable soft bags is more hygienic and safe.

本发明的分离盘的具体结构如图 2所示，图 2是本发明多细胞成分混合液体分离***上的分离盘的结构示意图。由图可见，本发明多细胞成分混合液体分离***上的分离盘，包括耐用的圆形硬底盘 8和一次性使用的条带状软袋 6; 硬底盘 8作为耐用的设备可以随离心机多次重复使用，并可根据分离要求而随时更换不同的型号；软袋 6则是一次性使用，当处理完成一例混合液体的分离后即实现了其使用价值。所述的硬底盘 8是由内芯 28和底座 29组成的圆形盘，在内芯 28和底座 29之间形成一段绕该硬底盘圆心轴一周的且首部和尾部不封闭的连续腔隙 7，该腔隙 7的首部位于距离硬底盘的圆心轴的最远端，腔隙的尾部位于距离硬底盘的圆心轴的最近端；腔隙的外侧壁与硬底盘的外侧壁之间部分由透明材料制作，硬底盘 8外侧为透明壁 9; 分离***上的在线探测传感器可透过该透明壁 9来监测软袋内不同成分分层界面的位置状况，并反馈给控制器来控制离心机的转速以及液体灌输或抽取的速度；在硬底盘 8的轴心处设有轴孔，该轴孔与离心机的转子轴相应，可将该硬底盘 8套于离心机的转子轴上实现该硬底盘 8的旋转。所述的软袋的为单腔结构，其长度和横截面与所述的腔隙相应，可置入至所述的腔隙中；软袋上设有进液管和出液管，软袋的中部设有供液体进入的进液管，软袋的两端部分别设有出液管。 The specific structure of the separation disk of the present invention is shown in Fig. 2. Fig. 2 is a schematic view showing the structure of the separation disk on the multi-cell component mixed liquid separation system of the present invention. As can be seen, the separation disc on the multi-cell component mixed liquid separation system of the present invention comprises a durable round hard chassis 8 and a disposable strip-like soft bag 6; the hard chassis 8 as a durable device can be used with a centrifuge It can be reused at any time, and can be replaced at any time according to the separation requirements. The soft bag 6 is used once, and its use value is realized when the separation of a mixed liquid is completed. The hard chassis 8 is a circular disk composed of an inner core 28 and a base 29 between the inner core 28 and the base 29. Forming a continuous cavity 7 around the center axis of the hard chassis and having the head and tail not closed, the head of the cavity 7 is located at the farthest end from the center axis of the hard chassis, and the tail of the cavity is located at the center of the hard chassis The proximal end of the shaft; the portion between the outer side wall of the cavity and the outer side wall of the hard chassis is made of a transparent material, and the outer side of the hard chassis 8 is a transparent wall 9; the in-line detecting sensor on the separation system can monitor the soft through the transparent wall 9 The position of the layered interface of different components in the bag, and fed back to the controller to control the speed of the centrifuge and the speed of liquid infusion or extraction; a shaft hole is provided at the axial center of the hard chassis 8, the shaft hole and the centrifuge Corresponding to the rotor shaft, the hard chassis 8 can be placed on the rotor shaft of the centrifuge to effect rotation of the hard chassis 8. The soft bag has a single-chamber structure, and its length and cross-section correspond to the cavity, and can be placed into the cavity; the soft bag is provided with an inlet pipe and a liquid outlet pipe, and the soft bag is provided. The middle portion is provided with an inlet pipe for liquid to enter, and the two ends of the soft bag are respectively provided with a liquid discharge pipe.

将连接着管路的软袋 6安置于硬底盘 8腔隙中形成分离盘，安装在离心机转子轴上，输入混合液体进行离心分离时，多细胞成分混合液体受离心力场的作用和离心腔隙内侧壁的限制，使得原来按照离心径向排列的各种单一成分同心圆层，转而沿平滑腔隙内壁按密度由高至低从首部到尾部分段分布，狭窄的离心空间和非同心圆的弧线状型腔隙等因素加大了各种成分间的分布层宽度，以便有可能根据分离目的来连续提取更为纯化的单一成分。下面结合实施例来对上述分离盘的具体结构和分离过程做进一步的详细阐述。 The soft bag 6 connected to the pipeline is placed in the cavity of the hard chassis 8 to form a separation disc, which is installed on the rotor shaft of the centrifuge, and when the mixed liquid is input for centrifugation, the mixed liquid of the multi-cell component is subjected to the centrifugal force field and the centrifugal chamber. The restriction of the inner side wall of the gap allows the various concentric circular layers which are originally arranged in the radial direction of the centrifugal, and then distributed along the inner wall of the smooth cavity from high to low from the head to the tail, narrow centrifugal space and non-concentric Factors such as a circular arc-shaped cavity increase the width of the distribution layer between the various components, so that it is possible to continuously extract a more purified single component depending on the purpose of separation. The specific structure and separation process of the above separation disc will be further elaborated below in conjunction with the embodiments.

实施例 1 本实施例中涉及到的是一种属于单弧线状型腔隙结构的分离盘，该单弧线状型腔隙特殊化为一段绕硬底盘圆心轴的螺旋线段腔隙。主要用于连续分离多细胞成分混合液体中密度最低成分，如.全血中的血浆，或连续分离多细胞成分混合液体中密度最高成分，如全血中的红细胞。 Embodiment 1 In this embodiment, a separation disc belonging to a single arc-line type cavity structure is specialized, and the single-arc linear cavity is specialized as a spiral section cavity around a circular spindle center axis. It is mainly used to continuously separate the lowest density components in the mixed liquid of multicellular components, such as plasma in whole blood, or to continuously separate the highest density components in the mixed liquid of multicellular components, such as red blood cells in whole blood.

请看图 3、图 4，图 3是本发明多细胞成分混合液体分离***上的分离盘的实施例 1的单弧线状型腔隙硬底盘的示意图。图 4是本发明多细胞成分混合液体分离***上的分离盘的实施例 1的一次性使用的单弧线软袋结构示意图。由图可见，本实施例中所述的硬底盘 8为包括由硬底盘内芯 28和硬底盘底座 29组成的圆形盘状结构，所述的腔隙 7为硬底盘内芯和硬底盘底座之间形成一段绕该硬底盘圆心轴一周的且首部和尾部不封闭的连续腔隙，该腔隙 7的首部位于距离硬底盘的圆心轴的最远端，腔隙的尾部位于距离硬底盘的圆心轴的最近端；腔隙的外侧壁与硬底盘的外侧壁之间部分由透明材料制作，硬底盘 8外侧为透明壁 9; 分离***的在线检测传感器可透过该透明壁来监测软袋内不同成分分层界面的位置状况，并反馈给控制器来控制离心机的转速以及液体灌输或抽取的速度；在硬底盘 8的轴心处设有轴孔，该轴孔与离心机的转子轴相应，可将该硬底盘 8套于离心机的转子轴上实现该硬底盘 8的旋转。硬底盘上的腔隙 7为绕转动轴心的单螺旋线型腔隙，腔隙内部安置一个与腔隙长度和横截面相应的一次性使用的单弧线软袋 6; 该软袋 6设有一个密度最高成分出液管 12，该管在软袋安置于腔隙内部时位于腔隙首部 10的密度最高成分出液管安置处 12 ' ；该软袋 6设有一个密度最低成分出液管 14，该管在软袋安置于腔隙内部时位于腔隙尾部 11 的密度最低成分出液管安置处 14' ；该软袋 6设有一个进液管 13，该管在软袋安置于腔隙内部时位于腔隙中部的进液管安置处 13 ' ；位于腔隙尾部 11 的密度最低成分出液管 14用于抽取作为密度最低成分，若分离全血时将用于抽取血浆，位于腔隙首部 10的密度最高成分出液管 12用于抽取作为密度最高成分，若分离全血时将用于抽取红细胞。本实施例的结构主要用于两种以上细胞成分混合液体中的密度最低成分或密度最高成分的连续分离，如全血中的血浆或红细胞的连续分离、浓集和提取，又如冷冻红细胞的洗涤和分离去除保存液和洗涤液。 3 and FIG. 4, FIG. 3 is a schematic view showing a single-arc linear cavity type hard chassis of Embodiment 1 of the separation disk on the multi-cell component mixed liquid separation system of the present invention. Figure 4 is a schematic view showing the structure of a single-use single-arc soft bag of Example 1 of the separation disc on the multi-cell component mixed liquid separation system of the present invention. As can be seen from the figure, the hard chassis 8 described in this embodiment is comprised of a hard bottom. a circular disc-like structure composed of the inner core 28 and the hard chassis base 29, wherein the cavity 7 forms a section between the inner core of the hard chassis and the base of the hard chassis about the center axis of the hard chassis, and the head and the tail are not closed. a continuous cavity, the head of the cavity 7 is located at the farthest end from the center axis of the hard chassis, the tail of the cavity is located at the closest end of the center axis of the hard chassis; the outer side wall of the cavity and the outer side wall of the hard chassis The intermediate portion is made of a transparent material, and the outer side of the hard chassis 8 is a transparent wall 9; the in-line detecting sensor of the separation system can monitor the position of the layered interface of different components in the soft bag through the transparent wall, and feed back to the controller to control the centrifugation. The rotation speed of the machine and the speed of liquid infusion or extraction; a shaft hole is provided at the axial center of the hard chassis 8, and the shaft hole corresponds to the rotor shaft of the centrifuge, and the hard chassis 8 can be sleeved on the rotor shaft of the centrifuge. The rotation of the hard chassis 8. The cavity 7 on the hard chassis is a single spiral type cavity around the rotation axis, and a single-arc soft bag 6 corresponding to the length and cross section of the cavity is disposed inside the cavity; the soft bag 6 is provided There is a highest density component outlet pipe 12, which is located at the highest density component outlet pipe placement 12' of the cavity head portion 10 when the soft bag is placed inside the cavity; the soft bag 6 is provided with a minimum density component discharge a tube 14, which is located at the lowest density component outlet pipe placement portion 14' of the cavity tail portion 11 when the soft bag is placed inside the cavity; the soft bag 6 is provided with an inlet pipe 13, which is placed in the soft bag Inside the cavity, the inlet pipe placement portion 13' is located in the middle of the cavity; the lowest density component outlet pipe 14 located at the tail portion 11 of the cavity is used for extraction as the lowest density component, and will be used for plasma extraction if the whole blood is separated. The highest density component outlet tube 12 of the cavity head 10 is used for extraction as the highest density component and will be used to extract red blood cells if whole blood is isolated. The structure of the present embodiment is mainly used for continuous separation of the lowest density component or the highest density component in the mixed liquid of two or more kinds of cellular components, such as continuous separation, concentration and extraction of plasma or red blood cells in whole blood, and freezing red blood cells. The preservation solution and the washing solution are removed by washing and separation.

利用本实施例中的该结构分离盘在自动化血液采集中分离提取单一成分的血浆或红细胞的流程如图 5所示，图 5是本发明多细胞成分混合液体分离***上的分离盘的实施例 1中两种以上细胞成分混合液体的分离流程图。分离血浆或红细胞的具体步骤如下： The flow of separating and extracting single component plasma or red blood cells in the automated blood collection by using the structural separation disk in the present embodiment is shown in FIG. 5, and FIG. 5 is an embodiment of the separation disk on the multi-cell component mixed liquid separation system of the present invention. A separation scheme for mixing liquids of two or more kinds of cellular components in 1. The specific steps for separating plasma or red blood cells are as follows:

① 将连接着***管路的一次性使用的单弧线软袋 6装入到硬底盘 8 的单螺旋线状腔隙 7中形成分离盘，并将其安置于离心机转子上，在完成安置管路、在线检测传感器、输液泵、离心机及其控制***后，启动离心机； 1 Insert the disposable single-arc soft bag 6 connected to the peripheral line into the single spiral-like cavity 7 of the hard chassis 8 to form a separation disc, and place it on the centrifuge rotor. After the installation pipeline, the on-line detection sensor, the infusion pump, the centrifuge and its control system, start the centrifuge;

②该分离盘绕硬底盘的圆心轴转动，抽取全血通过进液管 13向该软袋 6中灌入；在转动过程中，受离心力场的作用，全血中的各种成分因密度不同在腔隙内富集呈片层状分段分布，血液中的血浆层因为密度最低排列于软袋内靠近腔隙尾部 11位置，血液中的红细胞层因为密度最高排列于软袋内靠近腔隙首部 10位置，其余成分在软袋内沿腔隙空间依次分段分布；可用在线检测传感器检测相邻成分层间界面的位置； 2 The separation coil rotates around the center axis of the hard chassis, and the whole blood is pumped into the soft bag 6 through the liquid inlet tube 13; during the rotation, the various components in the whole blood are different in density due to the centrifugal force field. The enrichment in the cavity is distributed in a lamellar segmentation. The plasma layer in the blood is arranged in the soft bag at the lowest position near the tail 11 of the cavity. The red blood cell layer in the blood is arranged in the soft bag near the head of the cavity. 10 positions, the remaining components are distributed in sections along the cavity space in the soft bag; the position of the interface between adjacent component layers can be detected by an on-line detecting sensor;

③在步骤②期间，从位于腔隙尾部 11的出液管 14抽取血浆 5，这 3 during step 2, plasma 5 is withdrawn from the outlet tube 14 located at the tail 11 of the lumen, which

, 1 , 1

3 3

是分离的目标产物；同时监测血浆层与其相邻成分的界面位置状况；由于此时全血连续不断输入并被离心分离，其血浆被抽取，而其红细胞部分留滞富集于软袋内，因此该界面逐渐向腔隙尾部移动，至该界面移动到腔隙尾部的出液管 14附近时，停止血浆的抽取；然后从位于腔隙首部 10的软袋密度最高成分出液管 12抽取红细胞 1和其他多余成分一起回输至人体内，以控制体外循环血量，保障自动化采血的安全性；同时监测红细胞层与其相邻成分的界面位置状况；由于此时全血仍然连续不断输入并被离心分离，其红细胞部分被抽取，而其血浆留滞于软袋内，因此该界面逐渐向腔隙首部移动，至该界面移动到腔隙中部的进液管 13 附近时，停止红细胞的抽取；重复本步骤，使分离的目标产物逐渐积累，直至满足分离要求为止。 It is the target product of separation; at the same time, the interface position of the plasma layer and its adjacent components is monitored; since the whole blood is continuously input and centrifuged at this time, the plasma is extracted, and the red blood cell portion is retained in the soft bag, Therefore, the interface gradually moves toward the tail of the cavity, and when the interface moves to the vicinity of the outlet tube 14 at the tail of the cavity, the plasma is stopped; and then the red blood cells are extracted from the highest density outlet 12 of the soft bag at the head portion 10 of the cavity. 1 and other unwanted components are returned to the human body to control the blood volume of extracorporeal circulation, to ensure the safety of automated blood collection; at the same time to monitor the interface position of the red blood cell layer and its adjacent components; at this time, the whole blood is continuously input and is Centrifugal separation, the red blood cell part is extracted, and the plasma is retained in the soft bag, so the interface gradually moves toward the cavity head, and when the interface moves to the vicinity of the liquid inlet tube 13 in the middle of the cavity, the red blood cell is stopped; This step is repeated to allow the separated target product to gradually accumulate until the separation requirement is met.

④若抽取高细胞比容的红细胞是分离的目标成分，则将上述步骤③ 中的抽取顺序颠倒过来。即在步骤②期间，从位于腔隙首部 10的出液管 12抽取红细胞 1，这是分离的目标产物；同时监测红细胞层与其相邻成分的界面位置状况；至该界面移动到腔隙中部的进液管 13附近时，停止红细胞的抽取；然后从位于腔隙尾部 U的出液管 14抽取血浆 5和其他多余成分一起回输至人体内，以控制体外循环血量，保障自动化采血的安全性；同时监视血浆层与其相邻成分的界面位置状况；至该界面移动到腔隙尾部的出液管 14附近时，停止血浆的抽取；重复本步骤，使分离的目标产物逐渐积累，直至满足分离要求为止。 4 If the high cell specific volume red blood cells are extracted as the target component of separation, the extraction order in the above step 3 is reversed. That is, during step 2, red blood cells 1 are extracted from the liquid outlet tube 12 located in the cavity head portion 10, which is the target product of separation; at the same time, the interface position condition of the red blood cell layer and its adjacent components is monitored; to the interface moving to the middle of the cavity When the liquid inlet tube 13 is nearby, the extraction of red blood cells is stopped; then, the blood plasma 5 and other unnecessary components are taken out from the liquid outlet tube 14 located at the tail portion U of the cavity to be returned to the human body to control the blood volume of the extracorporeal circulation, thereby ensuring the safety of automatic blood collection. Simultaneously monitoring the interface position of the plasma layer and its adjacent components; stopping the plasma extraction when the interface moves to the vicinity of the outlet tube 14 at the tail of the cavity; repeating this step to separate The target product gradually accumulates until the separation requirement is met.

实施例 2 Example 2

为了实现混合液体分层中密度处于中间位置的成分的提取，将所述的腔隙设计进一步优化，由多段向圆心轴弯曲且首尾相连的平滑弧线段组成腔隙，整个腔隙是连续的，每个平滑弧线段的曲度不同，两个相邻的平滑弧线段中的前一弧线段的尾部与下一弧线段的首部相连接，这相邻弧线段的连接处为凸向圆心轴的嵴；为了适应该腔隙的结构，另外在软袋上增设了与腔隙中的嵴数目相同的出液管，增设的出液管在软袋安置于腔隙内时位于嵴后的弧线段中距离圆心轴的最远处。 In order to realize the extraction of the components whose density is in the middle position in the mixed liquid layering, the cavity design is further optimized, and the cavity is formed by a plurality of smooth arc segments curved to the center axis and connected end to end, and the entire cavity is continuous. The curvature of each smooth arc segment is different, and the tail of the previous arc segment of the two adjacent smooth arc segments is connected with the head portion of the next arc segment, and the junction of the adjacent arc segments is In order to adapt to the structure of the cavity, in addition to the structure of the cavity, the same number of outlet pipes as the number of turns in the cavity are added to the soft bag, and the additional outlet pipe is placed in the cavity when the soft bag is placed in the cavity Located at the farthest point of the arc axis in the arc segment behind the ridge.

本实施例中涉及的是一种属于双弧线状型腔隙结构的分离盘，除了可用来完成上述实施例 1的分离要求外，主要是用来连续分离、富集和提取在多细胞成分混合液体中的密度次低成分，如全血中的血小板。 In this embodiment, a separation disc belonging to a double-arc-shaped cavity structure is used, which is mainly used for continuous separation, enrichment and extraction in multi-cellular components, in addition to the separation requirement of the above-mentioned Embodiment 1. The second lowest density component in the mixed liquid, such as platelets in whole blood.

请看图 6、图 7，图 6是本发明多细胞成分混合液体分离***上的分离盘的实施例 2的双弧线状型腔隙硬底盘的示意图，图 7是本发明多细胞成分混合液体分离***上的分离盘的实施例 2中一次性使用的双弧线软袋结构示意图。由图可见，本实施例中的含双弧线状型腔隙硬底盘 15上设计了具有两个弧线段组成的腔隙，包括连接腔隙首部的第一弧线段 18和连接腔隙尾部的第二弧线段 16相连接组成，两段弧线段连接处为凸向圆心轴的嵴 17。在腔隙内部安置一个与腔隙长度和横截面相应的一次性使用的双弧线软袋 20，该软袋 20设有一个出液管 12，该管在软袋安置于腔隙内部时位于腔隙首部 10 的密度最高成分出液管安置处 12，；该软袋 20设有一个出液管 14，该管在软袋安置于腔隙内部时位于腔隙尾部 11的密度最低成分出液管安置处 14' ；该软袋 20设有一个进液管 13，该管在软袋安置于腔隙内部时位于第一弧线状型腔隙中部的进液管安置处 13 ' ；该软袋 20设有一个密度次低成分出液管 19，该管在软袋安置于腔隙内部时位于第二弧线段上距离圆心轴的最远处的密度次低成分出液管安置处 19 ' 。位于腔隙尾部的出液管可用于抽取血浆，位于腔隙首部的出液管 12可用于抽取红细胞和其他成分细胞等，在第二弧线段上的出液管 19可用于抽取作为分离目标产物的血小板。硬底盘外侧为透明壁，分离***的在线检测传感器可透过该透明壁来监测软袋内不同成分分层界面的位置状况，并反馈给控制器来控制离心机的转速以及液体灌输或抽取的速度。本实施例中的结构可以依照实施例 1 中的步骤提取在三种以上细胞成分混合液体中的密度最高和最低成分，如全血中的红细胞或血浆外，主要用于在三种以上细胞成分混合液体中的密度次低成分的连续分离，如全血中血小板的连续分离、浓集和提取。 6 and FIG. 7, FIG. 6 is a schematic diagram of a double-arc-shaped cavity hard chassis of the second embodiment of the separation disk on the multi-cell component mixed liquid separation system of the present invention, and FIG. 7 is a multi-cell component mixture of the present invention. A schematic diagram of the structure of a single-use double-arc soft bag in the second embodiment of the separation disc on the liquid separation system. As can be seen from the figure, the double-arc-shaped cavity-shaped hard chassis 15 in this embodiment is designed with a cavity composed of two arc segments, including a first arc segment 18 connecting the cavity header and a connection cavity. The second arc segment 16 of the tail is connected, and the two arc segments are connected by a 嵴 17 convex toward the central axis. A single-use double-arc soft bag 20 corresponding to the length and cross-section of the cavity is disposed inside the cavity, and the soft bag 20 is provided with a discharge pipe 12 which is located when the soft bag is placed inside the cavity The highest density component outlet tube 12 of the cavity head portion 10; the soft bag 20 is provided with a liquid outlet tube 14 which is located at the lowest density component of the cavity tail portion 11 when the soft bag is placed inside the cavity. a tube placement portion 14'; the soft bag 20 is provided with a liquid inlet pipe 13 which is located at a liquid inlet pipe placement portion 13' in the middle of the first arc-shaped cavity when the soft bag is placed inside the cavity; The bag 20 is provided with a second-density component discharge pipe 19 which is located on the second arc segment at the farthest point of the center axis of the lower limit component outlet pipe placement portion 19 when the soft bag is placed inside the cavity. ' . The outlet tube located at the end of the cavity can be used to extract plasma, and the outlet tube 12 located at the head of the cavity can be used to extract red blood cells and other constituent cells, etc. The outlet tube 19 on the second arc segment can be used to extract platelets as a target product of separation. The outer side of the hard chassis is a transparent wall. The in-line detecting sensor of the separation system can monitor the position of the different layered interfaces in the soft bag through the transparent wall, and feed back to the controller to control the speed of the centrifuge and the liquid infusion or extraction. speed. The structure in this embodiment can extract the highest density and the lowest component in the mixed liquid of three or more kinds of cellular components according to the steps in Embodiment 1, such as red blood cells or plasma in whole blood, and mainly used in three or more kinds of cellular components. Continuous separation of sub-low density components in a mixed liquid, such as continuous separation, concentration, and extraction of platelets in whole blood.

利用本实施例中的该结构分离盘在自动化血液采集中分离、浓集和提取全血中单一成分的血小板的流程如 .1 图 8所示，图 8是本发明多细胞 The process of separating, enriching and extracting single-component platelets in whole blood in automated blood collection using the structure separation disk of this embodiment is as shown in Fig. 8, and Fig. 8 is a multicell of the present invention.

5 5

成分混合液体分离***上的分离盘的实施例 2中三种以上细胞成分混合液体的分离流程图。分离血小板的具体步骤为-A separation flow chart of a mixed liquid of three or more kinds of cellular components in Example 2 of the separation disk on the component mixed liquid separation system. The specific steps for separating platelets are -

① 将连接着***管路的一次性使用的双弧线软袋 20装入到双弧线状型腔隙硬底盘 15的双弧线状型腔隙中形成分离盘，并将其安置于离心机转子上，在完成安置管路、在线检测传感器、输液泵、离心机及其控制***后，启动离心机； 1 Insert the disposable double-arc soft bag 20 connected to the peripheral line into the double-arc-shaped cavity of the double-arc-shaped cavity hard chassis 15 to form a separation disc, and place it in the centrifuge On the rotor of the machine, after completing the installation pipeline, the on-line detection sensor, the infusion pump, the centrifuge and its control system, start the centrifuge;

② 该分离盘绕硬底盘的圆心轴转动，抽取全血通过进液管 13向该软袋 20中灌入；在转动过程中，受离心力场的作用，全血中的各种成分因密度不同首先在第一弧线状型腔隙内聚集呈片层状分段分布；其中的血浆层因为密度最低排列于软袋内靠近第一弧线状型腔隙尾部位置，其中的红细胞层因为密度最高排列于软袋内靠近腔隙首部 10位置，其余成分在软袋内沿第一弧线状型腔隙空间依次分段分布; 可用在线检测传感器检测相邻成分层间界面的位置； 2 The separation coil rotates around the center axis of the hard chassis, and the whole blood is pumped into the soft bag 20 through the liquid inlet tube 13; during the rotation process, the various components in the whole blood are different in density due to the centrifugal force field. The first arc-shaped cavity accumulates in a lamellar segmented distribution; wherein the plasma layer is arranged in the soft bag at the lowest position in the soft bag near the tail of the first arc-shaped cavity, wherein the red cell layer has the highest density Arranged in the soft bag near the head portion 10 of the cavity, and the remaining components are sequentially segmented along the first arc-shaped cavity space in the soft bag; the position of the interface between adjacent component layers can be detected by an on-line detecting sensor;

③ 随着全血连续不断地输入和被离心分离，以及有控制地从位于腔隙尾部 11 的出液管 14抽取血浆，同时从位于腔隙首部 10的出液管 12抽取红细胞，使富含血小板的血浆逐渐富集并越过第一弧线段和第二弧线段连接处的嵴 17，进入第二弧线状型腔隙 16;在第二弧线状型腔隙内血小板得到进一步的富集形成血小板层，并使其与相邻的血浆层之间的界面保持在第二弧线状型腔隙内，同时血小板层与其相邻的主要由单核细胞和粒细胞组成的白膜层之间的界面继续保持在第一弧线状型腔隙3 As the whole blood is continuously input and centrifuged, and the plasma is withdrawn from the outlet tube 14 located at the tail portion 11 of the cavity, while red blood cells are drawn from the outlet tube 12 located at the head portion 10 of the cavity, enriching The plasma of the platelets gradually enriches and passes over the 嵴17 at the junction of the first arc segment and the second arc segment, into the second arcuate cavity 16; in the second arcuate cavity, the platelets are further Enrichment forms a platelet layer and maintains its interface with the adjacent plasma layer in the second arc-like cavity, while the platelet layer is adjacent to the main The interface between the nucleus and the uveal layer of granulocytes continues to remain in the first arc-like cavity

18内；重复本步骤多次，以增加血小板富集量； Within 18; repeat this step multiple times to increase platelet enrichment;

④ 在血小板富集到一定量的时候，通过调节由进液管 13输入全血或回输红细胞的速率，以及由出液管 12抽取红细胞的速率，利用这二者的流量不同来控制第一弧线状型腔隙 18 内白膜层与血小板层之间的界面，并使之靠近嵴 17; 4 When the platelet is enriched to a certain amount, by adjusting the rate at which the whole blood or the red blood cells are input from the inlet tube 13, and the rate at which the red blood cells are drawn by the outlet tube 12, the flow rate of the two is used to control the first The interface between the white film layer and the platelet layer in the arc-shaped cavity 18 and close to the crucible 17;

⑤ 然后，通过在短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一弧线状型腔隙进入第二弧线状型腔隙，在嵴 17 处对第一弧线状型腔隙内靠近嵴的血 6小板层表面产生曳力裹挟起界面上的血小板颗粒随血浆流越过嵴，同时根据牛顿第二定律，快速血浆流也在此血小板层表面造成湍流冲击，加速血小板颗粒形成局部浪涌，使第一弧线状型腔隙 18 内的血小板层被反混入血浆层，并随血浆流越过嵴 17进入第二弧线状型腔隙 16内；当白膜层临近嵴时，立即停止血浆回输，以求不裹挟血小板层下面相邻的白膜层细胞，减少后者对血小板层的污染影响；而与其相邻的白膜层和红细胞层仍留滞在第一弧线状型腔隙内原处； 5 Then, by rapidly returning the plasma rapidly from the inlet tube in a short period of time, the plasma flow passes directly through the first arc-shaped cavity into the second arc-shaped cavity, at 嵴17 The surface of the 6-layer layer of blood in the arc-like cavity is close to the surface of the sputum. The platelet particles on the surface of the entangled entanglement pass through the plasma flow, and according to Newton's second law, rapid plasma flow is also caused on the surface of the platelet layer. The turbulent impact accelerates the local surge of platelet particles, causing the platelet layer in the first arcuate cavity 18 to be back-mixed into the plasma layer, and enters the second arcuate cavity 16 as the plasma flows across the crucible 17; When the tunica layer is adjacent to sputum, the plasma reinfusion is immediately stopped, so as not to enclose the adjacent tunica cells below the platelet layer, thereby reducing the influence of the latter on the platelet layer; and the adjacent tunica layer and erythrocyte layer Still remaining in the original arc-shaped cavity;

⑥ 在步骤③、 ⑤期间，血小板层在第二弧线状型腔隙 16内浓集，可从第二弧线段内距离转动圆心轴最远处的出液管 19 抽取纯化和富集的血小板，这是分离的目标产物； 6 During steps 3 and 5, the platelet layer is concentrated in the second arcuate cavity 16 and can be extracted and purified from the outlet tube 19 at the farthest point of the rotation of the central axis from the second arc segment. Platelets, which are the target products of separation;

⑦ 在步骤⑥期间，剩余的单核细胞层和粒细胞层组成的白膜层仍留滞在第一弧线状型腔隙 18内，可从出液管 12抽出，随同上述过程中抽出多余的红细胞、血浆一起回输人体，以控制体外循环血量，保障自动化采血的安全性；重复歩骤③、 ④、 ⑤、 ⑥、 ⑦，使分离的目标产物逐渐积累，直至满足分离要求为止。 7 During step 6, the remaining monolayers and granulosa layers of the leucocytic layer remain in the first arcuate cavity 18 and can be withdrawn from the outlet tube 12, with the exception of the above process. Red blood cells and plasma are returned to the human body to control the blood volume of extracorporeal circulation, and the safety of automatic blood collection is ensured. Repeat steps 3, 4, 5, 6, and 7 to gradually accumulate the separated target products until the separation requirements are met.

实施例 3 Example 3

为了实现混合液体分层中密度处于中间位置的成分的提取，将所述的腔隙设计进一步优化，由多段向圆心轴弯曲且首尾相连的平滑弧线段组成腔隙，整个腔隙是连续的，每个平滑弧线段的曲度不同，两个相邻的平滑弧线段中的前一弧线段的尾部与下一弧线段的首部相连接，这相邻弧线段的连接处为凸向圆心轴的嵴；为了适应该腔隙的结构，另外在软袋上增设了与腔隙中的嵴数目相同的出液管，增设的出液管在软袋安置于腔隙内时位于嵴后的弧线段中距离圆心轴的最远处。 In order to realize the extraction of the components whose density is in the middle position in the mixed liquid layering, the cavity design is further optimized, and the cavity is formed by a plurality of smooth arc segments curved to the center axis and connected end to end, and the entire cavity is continuous. , the curvature of each smooth arc segment is different, two adjacent The tail of the previous arc segment in the smooth arc segment is connected to the head portion of the next arc segment, and the junction of the adjacent arc segment is a 凸 convex toward the center axis; in order to adapt to the structure of the cavity, In addition, an outlet pipe having the same number of turns in the cavity is added to the soft bag, and the additional outlet pipe is located at the farthest point of the arc axis in the rear arc segment when the soft bag is placed in the cavity.

本实施例中涉及的是一种具有三段弧线段组成腔隙结构的分离盘，除了可用来完成上述实施例 1和 2的分离要求外，主要是用来连续分离、富集和提取在多细胞成分混合液体中的密度居中成分或密度次高成分，如全血中的单核细胞 3或粒细胞 2。 The present embodiment relates to a separation disc having a three-section arc segment forming a cavity structure, which is mainly used for continuous separation, enrichment and extraction, except that it can be used to complete the separation requirements of the above embodiments 1 and 2. The multicellular component is a medium-density component or a sub-density component in a mixed liquid, such as monocyte 3 or granulocyte 2 in whole blood.

本实施例中分离盘的结构如图 9 7和图 10所示，图 9是本发明多细胞成分混合液体分离***上的分离盘的实施例 3的多弧线状型腔隙硬底盘的示意图，图 10是本发明多细胞成分混合液体分离***上的分离盘的实施例 3的一次性使用的多弧线软袋结构示意图。由图可见，作为分离混合液体中密度居中成分或密度次高成分的一种优化方案，分离盘中的多弧线状型腔隙硬底盘 24上设计了有三个弧线段依次连接成的腔隙，所述的腔隙由首部至尾部分别由第一弧线状型腔隙 18、第二弧线状型腔隙 16和第三弧线状型腔隙 21依次相连接组成，第一弧线状型腔隙 18和第二弧线状型腔隙 16连接处为第一嵴 22，第二弧线状型腔隙 16与第三弧线状型腔隙 21连接处为第二嵴 23。在腔隙内部安置一个与腔隙长度和横截面相应的一次性使用的多弧线软袋 27，该软袋 27设有一个密度最高成分出液管 12，该管在软袋安置于腔隙内部时位于腔隙首部 10的密度最高成分出液管安置处 12 ' ；该软袋 27设有一个密度最低成分出液管 14，该管在软袋安置于腔隙内部时位于腔隙尾部 11的密度最低成分出液管安置处 14' ；该软袋 27设有一个进液管 13，该管在软袋安置于腔隙内部时位于第一弧线状型腔隙中部的进液管安置处 13 ' ；该软袋 27设有一个密度居中或次高成分出液管 25，该管在软袋安置于腔隙内部时位于第二弧线段上距离圆心轴的最远处的密度居中或次高成分出液管安置处 25 ' ；该软袋 27设有一个密度次低或 /和居中成分出液管 26，该管在软袋安置于腔隙内部时位于第三弧线段上距离圆心轴的最远处的密度次低或 /和居中成分出液管安置处 26 ' 。位于腔隙尾部的密度最低成分出液管 14可用于抽取血浆，位于腔隙首部的密度最高成分出液管 12 可用于抽取红细胞或 /和粒细胞等，在第二弧线段上的密度居中或次高成分出液管 25可用于抽取作为分离目标产物的单核细胞或粒细胞，在第三弧线段上的密度次低或 /和居中成分出液管 26 可用于抽取血小板或 /和单核细胞。硬底盘外侧为透明壁，分离***的在线检测传感器可透过该透明壁来监测软袋内不同成分分层界面的位置状况，并反馈给控制器来控制离心机的转速以及液体灌输或抽取的速度。本实施例中的结构可以依照实施例 1中的步骤提取红细胞或血浆，以及依照实施例 2中的步骤提取血小板外，主要用于分离、富集和提取血液中的密度居中的单核细胞或密度次髙的粒细胞，并具有良好的效果。 The structure of the separation disc in the present embodiment is as shown in Figs. 97 and 10, and Fig. 9 is a schematic view showing the multi-arc-shaped cavity hard chassis of the third embodiment of the separation disc on the multi-cell component mixed liquid separation system of the present invention. Figure 10 is a schematic view showing the structure of the single-use multi-arc soft bag of the third embodiment of the separation disc on the multi-cell component mixed liquid separation system of the present invention. As can be seen from the figure, as an optimization scheme for separating the medium-density component or the second highest density component in the mixed liquid, the multi-arc-shaped cavity hard chassis 24 in the separation disc is designed with three arc segments connected in sequence. a gap, the cavity is composed of a first arc-shaped cavity 18, a second arc-shaped cavity 16 and a third arc-shaped cavity 21, which are respectively connected by a first portion to a tail portion, and the first arc is connected The connection between the linear cavity 18 and the second arc-shaped cavity 16 is a first turn 22, and the second arc-shaped cavity 16 is connected to the third arc-shaped cavity 21 as a second turn 23 . A disposable multi-arc soft bag 27 corresponding to the length and cross section of the cavity is disposed inside the cavity, and the soft bag 27 is provided with a highest density component discharge pipe 12, which is placed in the soft bag in the cavity The innermost portion is located at the highest density component outlet pipe 12' of the cavity head portion 10; the soft bag 27 is provided with a lower density component outlet pipe 14, which is located at the tail portion of the cavity 11 when the soft bag is placed inside the cavity. The lowest density component outlet pipe placement portion 14'; the soft bag 27 is provided with an inlet pipe 13, which is placed in the middle of the first arc-shaped cavity when the soft bag is placed inside the cavity 13'; the soft bag 27 is provided with a density centered or sub-high component outlet pipe 25, which is located at the farthest point of the circular arc from the farthest axis of the second arc segment when the soft bag is placed inside the cavity Or the second highest component outlet pipe placement 25'; the soft bag 27 is provided with a lower density or/and a centered component outlet pipe 26, which is located on the third arc segment when the soft bag is placed inside the cavity The farthest point of the center of the circle Degrees of low or / and centered component outlet tube placement 26 '. The lowest density component outlet tube 14 located at the end of the cavity can be used to extract plasma. The highest density component outlet 12 located at the head of the cavity can be used to extract red blood cells or/and granulocytes, etc., and the density on the second arc segment is centered. Or the second highest component outlet tube 25 can be used to extract monocytes or granulocytes as the target product of separation, and the second lowest density or/and centered component outlet tube 26 on the third arc segment can be used to extract platelets or/and Monocytes. The outer side of the hard chassis is a transparent wall. The in-line detecting sensor of the separation system can monitor the position of the different layered interfaces in the soft bag through the transparent wall, and feed back to the controller to control the speed of the centrifuge and the liquid infusion or extraction. speed. The structure in this embodiment can be used to extract red blood cells or plasma according to the steps in Example 1, and to extract, concentrate and extract density-centered monocytes in blood, in addition to extracting platelets according to the procedure in Example 2. Density of granulocytes, and has a good effect.

利用本实施例中的该结构分离盘在自动化血液采集中分离、浓集和提取全血中单一成分的单核细胞或粒细胞的流程如图 11所示，图 11是本发明多细胞成分混合液体分离***上的分离盘的实施例 3中四种以上多细胞成分混合液体的分离流程图。其具体的操作步骤如下： The flow of separating, enriching and extracting single-component mononuclear cells or granulocytes in whole blood in the automated blood collection using the structural separation disk of the present embodiment is shown in FIG. 11, and FIG. 11 is a multi-cell component mixture of the present invention. A flow chart for the separation of four or more multicellular component mixed liquids in Example 3 of a separation disc on a liquid separation system. The specific steps are as follows:

① 将连接着***管路的一次性使用的多弧线状软袋 27装入多弧线状型腔隙硬底盘 2.4上三个弧线段组成的腔隙中形成分离盘，并将其安置于离心机转子上，在完成安置管路、在线检测传感器、输液泵、离心机及其控制***后，启动离心机； 1 Insert a single-use multi-arc soft bag 27 connected to the peripheral pipe into a cavity formed by three arc segments on the multi-arc-shaped cavity hard chassis 2.4 to form a separation disc and place it On the centrifuge rotor, after completing the installation pipeline, the on-line detection sensor, the infusion pump, the centrifuge and its control system, start the centrifuge;

② 该分离盘绕硬底盘的圆心轴转动，抽取全血通过进液管 13向该软袋 27中灌入；在转动过程中，受离心力场的作用，全血中的各种成分因密度不同首先在第一弧线状型腔隙 18内聚集呈片层状分段分布;全血中的各种成分因密度不同其中的血浆层因为密度最低排列于软袋内靠近第一弧线状型腔隙尾部位置，其中的红细胞层因为密度最高排列于软袋内靠近腔隙首部 10位置，其余成分在软袋内沿第一弧线状型腔隙空间依次分段分布；可用在线检测传感器检测相邻成分层间界面的位置； 2 The separation coil rotates around the center axis of the hard chassis, and the whole blood is pumped into the soft bag 27 through the liquid inlet tube 13; during the rotation process, the various components in the whole blood are different in density due to the centrifugal force field. The first arc-shaped cavity 18 is gathered in a lamellar segmented distribution; the various components in the whole blood are different in density, and the plasma layer is arranged in the soft bag to be close to the first arc-shaped cavity due to the lowest density. The position of the tail of the gap, wherein the red blood cell layer is arranged in the soft bag with the highest density in the vicinity of the first 10 positions of the cavity, and the remaining components are sequentially segmented along the first arc-shaped cavity space in the soft bag; The position of the interfacial layer interface;

③ 随着全血连续不断地输入和被离心分离，以及有控制地从位于腔隙尾部的出液管 14抽出血浆，同时从位于腔隙首部的出液管 12抽出红细胞，使血浆和血小板逐渐越过第一弧线段和第二弧线段连接处的第一嵴 22，进入第二弧线状型腔隙 16，同时使血小板层与其相邻的主要由单核细胞和粒细胞组成的白膜层之间的界面保持在第一弧线状型腔隙 18内；重复本步骤多次，使含有单核细胞和粒细胞的白膜层逐渐加厚；3 as the whole blood is continuously input and centrifuged, and the plasma is withdrawn from the outlet tube 14 located at the end of the cavity while being withdrawn from the outlet tube 12 at the head of the cavity. Red blood cells, such that plasma and platelets gradually cross the first 嵴22 at the junction of the first arc segment and the second arc segment, into the second arcuate cavity 16, while the platelet layer is adjacent to the primary nucleus The interface between the white film layer composed of cells and granulocytes is maintained in the first arc-shaped cavity 18; this step is repeated a plurality of times to gradually thicken the white film layer containing monocytes and granulocytes;

④ 当白膜层增至一定的厚度时，通过调节由进液管 13输入全血或回输红细胞的速率，以及由出液管 12抽取红细胞的速率，利用这二者的流量不同来控制第一弧线状型腔隙 18内血小板层与白膜层之间的界面，并使之靠近第一嵴 22; 4 When the tunica layer is increased to a certain thickness, by adjusting the rate at which the whole blood or the red blood cells are input from the inlet tube 13, and the rate at which the red blood cells are drawn by the outlet tube 12, the flow rate of the two is used to control the difference An arc-shaped cavity 18 between the platelet layer and the white film layer interface, and close to the first 嵴 22;

⑤ 若分离目标是单核细胞的话， 9在步骤④完成后，通过在短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一弧线状型腔隙 18进入第二弧线状型腔隙，在第一嵴 22处对第一弧线状型腔隙内靠近第一嵴 22 的血小板层和单核细胞层表面产生曳力裹挟起界面上的血小板颗粒和单核细胞颗粒随血浆流越过该嵴，同时根据牛顿第二定律，快速血浆流也在此血小板层和单核细胞层表面造成湍流冲击，加速血小板颗粒和单核细胞颗粒形成局部浪涌，使第一弧线状型腔隙 18内的血小板层和单核细胞层被反混入血浆层，并随血浆流越过第一嵴 22进入第二弧线状型腔隙 16内；当与单核细胞层相邻的粒细胞层和红细胞层之间的界面临近第一嵴 22时，立即停止血浆回输，以求不裹挟单核细胞层下面相邻的粒细胞和红细胞，减少后者对单核细胞层的污染影响；而与其相邻的粒细胞层和红细胞层仍留滞在第一弧线状型腔隙内原处； 5 If the separation target is monocyte, 9 after the completion of step 4, the plasma flow can be directly and quickly passed through the first arc-shaped cavity 18 by rapidly returning the plasma from the inlet tube in a short time. a second arc-shaped cavity at the first crucible 22 for generating platelet particles on the surface of the platelet layer and the mononuclear layer near the first crucible in the first arc-shaped cavity and Monocyte particles cross the sputum as the plasma flows, and according to Newton's second law, rapid plasma flow also causes turbulent impact on the surface of the platelet layer and the monocyte layer, accelerating the local surge of platelet particles and monocyte particles. The platelet layer and the mononuclear cell layer in the first arcuate cavity 18 are backmixed into the plasma layer and enter the second arcuate cavity 16 as the plasma flow passes over the first 嵴22; when associated with monocytes When the interface between the adjacent granulocyte layer and the red blood cell layer is close to the first 嵴22, the plasma reinfusion is stopped immediately, so as not to enclose the adjacent granulocytes and red blood cells under the mononuclear cell layer, and the latter is reduced to the single nucleus. cell The contamination effect of the layer; and the adjacent granulocyte layer and red blood cell layer remain in the original arc-like cavity;

⑥ 经多次重复步骤③至⑤后，血小板和单核细胞在第二弧线状型腔隙 16内得到浓集；然后再次在短时间内从进液管 13内大量快速回输血浆，使血浆流直接快速地穿过第一和第二弧线状型腔隙进入第三弧线状型腔隙 21，在第二嵴 23旁通过血浆流对血小板层表面产生曳力裹挟血小板颗粒和湍流浪涌造成血小板反混，并随血浆流使血小板越过第二嵴 23进入第三弧线状型腔隙 21，而起到对留滞第二弧线状型腔隙 16内的单核细胞层进行清洗的作用，减少了相邻成分的污染影响; 当与血小板相邻的单核细胞层的界面临近第二嵴 23时，立即停止血浆回输，以求不裹挟其下面的分离目标产物——单核细胞，以减少单核细胞层的损失；然后从位于第二弧线状型腔隙 16 内距离转动圆心轴最远处的密度居中或次高成分出液管 25 抽取纯化和富集的单核细胞，这是分离的目标产物；将上述过程中抽出多余的其他成分回输人体，以控制体外循环血量，保障自动化采血的安全性；重复步骤③、 ④、 ⑤、 ⑥，使分离的目标产物逐渐积累，直至满足分离要求为止。 6 After repeating steps 3 to 5 a plurality of times, platelets and monocytes are concentrated in the second arc-shaped cavity 16; then, a large amount of rapid return of plasma from the inlet tube 13 is again performed in a short time, so that The plasma flow passes directly through the first and second arcuate cavities into the third arcuate cavity 21, and the second flow 23 produces a dragging platelet particle and turbulence on the surface of the platelet layer by plasma flow. The surge causes platelet back-mixing, and the platelet passes through the second 嵴23 into the third arc-shaped cavity 21 with the plasma flow, and acts as a mononuclear layer in the second arc-shaped cavity 16 The effect of cleaning reduces the contamination effect of adjacent components; when the interface of the mononuclear cell adjacent to the platelet approaches the second 嵴23, the plasma reinfusion is stopped immediately, so as not to The isolated target product, mononuclear cells, is encased to reduce the loss of the mononuclear cell layer; then the density is centered or sub-highest from the farthest point in the second arcuate cavity 16 from the rotating central axis The liquid tube 25 extracts purified and enriched monocytes, which is the target product of the separation; the excess components are extracted into the human body during the above process to control the blood volume of the extracorporeal circulation, and the safety of automatic blood collection is ensured; 4, 5, 6, so that the separated target product gradually accumulates until the separation requirement is met.

⑦ 若分离目标是粒细胞的话，在步骤④完成后，通过在短时间内从进液管 13内大量快速回输血浆，使血浆流直接快速地穿过第一弧线状型腔隙 18进入第二弧线状型腔隙 16,在第一嵴 22旁依次对第一弧线状型腔隙 18内靠近第一嵴 22的血小板层、单核细胞层、粒细胞层的表面产生曳力裹挟和湍流浪涌反混，并随血浆流越过第一嵴 22进入第二弧线状型腔隙 16内；当与其相邻的红细胞层之间的界面临近第一嵴 22时，立即停止血浆回输，以求不裹挟其下面相邻的红细胞，减少后者对粒细胞层的污染影响；而与其相邻的红细胞层仍留滞在第一弧线状型腔隙 18 内原处； 7 If the separation target is granulocytes, after the completion of step 4, the plasma flow is directly and quickly passed through the first arc-shaped cavity 18 by rapidly returning a large amount of plasma from the inlet tube 13 in a short time. The second arcuate-shaped cavity 16 sequentially exerts a drag force on the surface of the platelet layer, the mononuclear cell layer, and the granulocyte layer of the first arc-shaped cavity 18 in the first arc-shaped cavity 18 next to the first weir 22 The wrap and the turbulent surge are backmixed and enter the second arcuate cavity 16 as the plasma flows past the first 嵴22; when the interface between the adjacent erythrocyte layer approaches the first 嵴22, the plasma is immediately stopped Returning, in order not to enclose the adjacent red blood cells below, reducing the pollution of the latter on the granulocyte layer; and the adjacent red blood cell layer remains in the first arc-shaped cavity 18;

⑧ 经多次重复步骤③、④、⑦后，血小板和白膜层细胞在第二弧线状型腔隙 16内得到浓集；然后再次通过在短时间内从进液管 13内大量快速回输血浆，使血浆流直接快速地穿过第一和第二弧线状型腔隙进入第三弧线状型腔隙 21，在第二嵴 23旁依次对第二弧线状型腔隙 21内靠近第二嵴 23的血小板层、单核细胞层的表面产生曳力裹挟和湍流浪涌反混，并随血浆流越过第二嵴 23进入第三弧线状型腔隙 21， '而起到对留滞第二弧线状型腔隙 16内的粒细胞层进行清洗的作用，减少了相邻成分的污染影响；当与单核细胞层相邻的粒细胞层的界面临近第二嵴 23时，立即停止血浆回输，以求不裹挟其下面的分离目标产物——粒细胞，以减少粒细胞层的损失；然后从位于第二弧线状型腔隙 16内距离转动圆心轴最远处的出液管 25 抽取纯化和富集的粒细胞层，这是分离的目标产物；将上述过程中抽出多余的其他成分回输人体，以控制体外循环血量，保障自动化采血的安全性；重复步骤③、 ④、 ⑦、 ⑧，使分离的目标产物逐渐积累，直至满足分离要求为止。 8 After repeating steps 3, 4, and 7 several times, the platelets and the laminar cells are concentrated in the second arc-shaped cavity 16; and then again passed through a large number of quick-returns from the inlet tube 13 in a short time. The plasma is transferred so that the plasma flow passes through the first and second arcuate cavities directly into the third arcuate cavity 21, and the second arcuate cavity 21 is sequentially followed by the second weir 23 The surface of the platelet layer and the mononuclear cell layer adjacent to the second crucible 23 generates dragging and turbulent surge backmixing, and enters the third arc-shaped cavity 21 as the plasma flows over the second crucible 23, The effect of cleaning the granulocyte layer in the second arc-shaped cavity 16 is reduced, thereby reducing the contamination effect of adjacent components; when the interface of the granulocyte layer adjacent to the mononuclear cell layer is adjacent to the second 嵴At 2300, the plasma reinfusion was immediately stopped, so as not to encroach on the isolated target product, granulocytes, to reduce the loss of the granulocyte layer; then the rotation of the central axis from the second arc-shaped cavity 16 The distant outlet tube 25 extracts the purified and enriched granulocyte layer, which is the separated Standard product; the excess components extracted from the above process are returned to the human body to control the blood volume of extracorporeal circulation, and the safety of automatic blood collection is ensured; steps 3, 4, 7, and 8 are repeated to make the target of separation The material gradually accumulates until the separation requirement is met.

毫无疑问，本发明用于多细胞成分混合液体分离***上的分离盘还有其他结构形式变化，并不局限于上述实施例中提到的结构和操作方式，应用本发明的分离盘及分离方法还可以用于其他多细胞成分混合液诸如胸腹水、细胞培养液等中单一成分的提取。总而言之，本发明的保护范围还包括其他对于本领域技术人员来说显而易见的变化和替代。 Needless to say, the separation disc for use in the multi-cell component mixed liquid separation system of the present invention has other structural changes, and is not limited to the structure and operation mode mentioned in the above embodiments, and the separation disc and separation of the present invention are applied. The method can also be applied to the extraction of single components in other multicellular component mixtures such as pleural and ascites, cell culture fluids and the like. In general, the scope of protection of the present invention also includes other variations and alternatives that will be apparent to those skilled in the art.

Claims

WO 2009/049497 权禾 ,j 要求 PCT/CN2008/001727 WO 2009/049497 Quanhe, j request PCT/CN2008/001727

1.一种多细胞成分混合液体分离***上的分离盘，包括耐用的圆形硬底盘和一次性使用的条带状软袋，硬底盘的轴心处设有可将该硬底盘安置于离心机转子轴上的轴孔，软袋上设有进液管和出液管，其特征在于，所述的硬底盘是由内芯和底座组成的圆形盘，在内芯和底座之间形成一段绕该硬底盘圆心轴一周的且首部和尾部不封闭的连续腔隙，该腔隙的首部位于距离硬底盘的圆心轴的最远端，腔隙的尾部位于距离硬底盘的圆心轴的最近端，腔隙的外侧壁与硬底盘的外侧壁之间部分由透明材料制作，所述的软袋为单腔结构，其长度和横截面与所述的腔隙相应，可置入至所述的腔隙中，软袋的中部设有供液体进入的进液管，软袋的两端部分别设有出液管。 1. A separation disc on a multi-cell component mixed liquid separation system comprising a durable round hard chassis and a disposable strip-shaped pouch, the hard chassis having a hard chassis disposed in the centrifuge a shaft hole on the rotor shaft of the machine, the soft bag is provided with a liquid inlet pipe and a liquid outlet pipe, wherein the hard chassis is a circular disk composed of an inner core and a base, and is formed between the inner core and the base. a continuous cavity that is circumferential about the center axis of the hard chassis and that is not closed by the head and tail. The head of the cavity is located at the farthest end from the center axis of the hard chassis, and the tail of the cavity is located closest to the center axis of the hard chassis. The portion between the outer side wall of the cavity and the outer side wall of the hard chassis is made of a transparent material, and the soft bag is a single-chamber structure having a length and a cross-section corresponding to the cavity, and can be placed into the In the cavity, the middle portion of the soft bag is provided with an inlet pipe for liquid to enter, and the two ends of the soft bag are respectively provided with a liquid outlet pipe.

2. 根据权利要求 1 所述的多细胞成分混合液体分离***上的分离盘，其特征在于，所述的腔隙在硬底盘平面上为连续的平滑弧线段。 2. A separation disc on a multi-cell component mixed liquid separation system according to claim 1 wherein said cavities are continuous smooth arc segments in the plane of the hard chassis.

3. 根据权利要求 2所述的多细胞成分混合液体分离***上的分离盘，其特征在于，所述的平滑弧线段为一绕圆心轴的螺旋线段。 The separation disc on the multi-cell component mixed liquid separation system according to claim 2, wherein the smooth arc segment is a spiral segment around a circular mandrel.

4. 一种利用权利要求 3所述的多细胞成分混合液体分离***上的分离盘从全血中分离血浆或红细胞的方法，其特征在于，该方法包括如下步骤： A method for separating plasma or red blood cells from whole blood using a separation disk on a multicellular component mixed liquid separation system according to claim 3, characterized in that the method comprises the following steps:

① 将连接着***管路的一次性使用的单弧线软袋装入到硬底盘的单螺旋线状腔隙中形成分离盘，将分离盘安置于离心机转子上，在完成安置管路、在线检测传感器、输液泵、离心机及其控制***后，启动离心机； 1 Insert the disposable single arc soft bag connected to the peripheral pipe into the single spiral line cavity of the hard chassis to form the separation disc, place the separation disc on the centrifuge rotor, and complete the installation pipeline. After the on-line detection sensor, the infusion pump, the centrifuge and its control system, start the centrifuge;

② 该分离盘绕硬底盘的圆心轴转动，抽取全血通过进液管灌入该单弧线软袋中，全血中各成分受离心力场作用依其密度不同在腔隙内富集呈片层状分段分布，用在线检测传感器检测相邻成分层间界面的位置； 2 The separation coil rotates around the center axis of the hard chassis, and the whole blood is pumped into the single arc soft bag through the liquid inlet tube, and the components in the whole blood are concentrated in the cavity by the centrifugal force field according to the density thereof. Segmented distribution, using on-line detection sensors to detect the position of the interface between adjacent components;

③ 从位于腔隙尾部的出液管抽取血浆，同时监测血浆与其相邻成分的界面位置状况，至该界面移动到腔隙尾部的出液管附近时，停止血桨的抽取，然后从位于腔隙首部的出液管抽取红细胞和其他剩余成分一起回输，同时监测红细胞层与其相邻成分的界面位置状况，至该界面移动到腔隙中部的进液管附近时，停止红细胞的抽取，重复本步骤，使分离的目标产物逐渐积累，直至满足分离要求为止; 3 The plasma is taken from the outlet tube located at the end of the cavity, and the interface position of the plasma and its adjacent components is monitored. When the interface moves to the vicinity of the outlet tube at the tail of the cavity, the extraction of the blood paddle is stopped, and then the cavity is located. The outlet tube of the gap extracts red blood cells and other remaining components Returning and returning, and monitoring the interface position of the red blood cell layer and its adjacent components. When the interface moves to the vicinity of the liquid inlet tube in the middle of the cavity, the red blood cell is stopped, and the step is repeated to gradually accumulate the separated target product until Meet the separation requirements;

④ 若以红细胞作为分离的目标成分,则将上述步骤③中的抽取顺序颠倒过来：从位于腔隙首部的出液管抽取红细胞，同时监测红细胞层与其相邻成分的界面位置状况，至该界面移动到腔隙中部的进液管附近时，停止红细胞的抽取，从位于腔隙尾部的出液管抽取血浆和其他剩余成分一起回输，同时监视血浆层与其相邻成分的界面位置状况，至该界面移动到腔隙尾部的出液管附近时，停止血浆的抽取，重复本步骤，使分离的目标产物逐渐积累，直至满足分离要求为止。 4 If red blood cells are used as the target component of separation, reverse the extraction sequence in step 3 above: extract red blood cells from the outlet tube located at the head of the cavity, and monitor the interface position of the red blood cell layer and its adjacent components to the interface. When moving to the vicinity of the inlet tube in the middle of the cavity, the red blood cell is stopped, and the plasma and other remaining components are taken back from the outlet tube located at the tail of the cavity, and the interface position of the plasma layer and its adjacent components is monitored, to When the interface moves to the vicinity of the liquid outlet tube at the tail of the cavity, the plasma extraction is stopped, and this step is repeated to gradually accumulate the separated target product until the separation requirement is satisfied.

5.根据权利要求 1所述的一种多细胞成分混合液体分离***上的分离盘，其特征在于，所述的腔隙由多段向圆心轴弯曲且首尾相连的平滑弧线段组成腔隙，相邻弧线段的连接处为凸向圆心轴的嵴，软袋的中部还设有与嵴的数目相同的出液管，该出液管在软袋安置于腔隙内时位于嵴后该弧线段距离圆心轴的最远处。 The separation disc on a multi-cell component mixed liquid separation system according to claim 1, wherein the cavity is formed by a plurality of smooth arc segments curved to the center axis and connected end to end to form a cavity. The junction of the adjacent arc segments is a weir that protrudes toward the center axis of the circle, and the middle portion of the soft bag is also provided with the same number of outlet pipes as the weir, and the outlet pipe is located after the soft bag is placed in the cavity. The arc segment is farthest from the center axis of the circle.

6.根据权利要求 5所述的一种多细胞成分混合液体分离***上的分离盘，其特征在于，所述的腔隙由连接腔隙首部的第一弧线段和连接腔隙尾部的第二弧线段相连接组成，两段弧线段连接处为凸向圆心轴的嵴，软袋上位于嵴后的第二弧线段距离圆心轴最远处设置有出液管。 The separation disc on a multi-cell component mixed liquid separation system according to claim 5, wherein the cavity is connected by a first arc segment connecting the head portion of the cavity and a tail portion connecting the cavity The two arc segments are connected, and the two arc segments are connected to the center of the circle, and the second arc segment on the soft bag is disposed at the farthest from the center axis.

7.一种利用权利要求 6所述的多细胞成分混合液体分离***上的分离盘在自动化血液采集中分离、浓集和提取全血中单一成分的血小板方法，其特征在于，该方法具体包括如下步骤： 7. A method for separating, enriching and extracting a single component platelet in whole blood in an automated blood collection using the separation disk on the multi-cell component mixed liquid separation system of claim 6, wherein the method specifically comprises The following steps:

② 该分离盘绕硬底盘的圆心轴转动，抽取全血通过进液管向该软袋中灌入，全血中密度不同的各种成分受离心力场的作用先在第一弧线状型腔隙内聚集呈片层状分段分布，血浆层因密度最低排列于软袋内靠近第一弧线状型腔隙尾部位置，红细胞层因密度最高排列于软袋内靠近腔隙首部位置, 其余成分在软袋内沿第一弧线状型腔隙空间依次分段分布，用在线检测传感器检测相邻成分层间界面的位置; 2 The separation coil rotates around the center axis of the hard chassis, and the whole blood is pumped into the soft bag through the liquid inlet tube, and various components of different density in the whole blood are firstly applied in the first arc by the centrifugal force field. The accumulation in the cavity is in the form of a layered segmentation. The plasma layer is arranged in the soft bag at the lowest position in the soft bag near the end of the first arc-shaped cavity. The red cell layer is arranged in the soft bag with the highest density near the head of the cavity. Position, the remaining components are sequentially segmented along the first arc-shaped cavity space in the soft bag, and the position of the interface between adjacent component layers is detected by an on-line detecting sensor;

③ 随着全血连续不断地输入和被离心分离，以及有控制地从位于腔隙尾部的出液管抽取血浆，同时从位于腔隙首部的出液管抽取红细胞，使富含血小板的血浆逐渐富集并越过第一弧线段和第二弧线段连接处的嵴，进入第二弧线状型腔隙, 第二弧线状型腔隙内的血小板进一步富集形成血小板层，并使其与相邻的血浆层之间的界面保持在第二弧线状型腔隙内，并使血小板层与其相邻的主要由单核细胞和粒细胞组成的白膜层之间的界面继续保持在第一弧线状型腔隙内，重复本步骤以增加血小板富集量； 3 As the whole blood is continuously input and centrifuged, and the plasma is extracted from the outlet tube located at the end of the cavity, and the red blood cells are drawn from the outlet tube located at the head of the cavity, the platelet-rich plasma is gradually formed. Enriching and crossing the ridge at the junction of the first arc segment and the second arc segment, entering the second arc-shaped cavity, and the platelets in the second arc-shaped cavity are further enriched to form a platelet layer, and The interface between it and the adjacent plasma layer remains in the second arcuate cavity and maintains the interface between the platelet layer and its adjacent white membrane layer consisting mainly of monocytes and granulocytes. Repeat this step in the first arc-shaped cavity to increase platelet enrichment;

④ 在血小板富集到一定量时，通过调节由进液管输入全血或回输红细胞的速率，以及由出液管抽取红细胞的速率，利用输入与抽出的流量不同控制第一弧线状型腔隙内白膜层与血小板层之间的界面，并使之靠近嵴； 4 When the platelet is enriched to a certain amount, by adjusting the rate of inputting whole blood or returning red blood cells from the inlet tube, and the rate at which red blood cells are drawn by the outlet tube, the first arc-shaped type is controlled by the difference between the input and the extracted flow rate. The interface between the white film layer and the platelet layer in the cavity, and close to the crucible;

⑤ 通过在短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一弧线状型腔隙进入第二弧线状型腔隙，在嵴处对第一弧线状型腔隙内靠近嵴的血小板层表面产生曳力裹挟起界面上的血小板颗粒随血浆流越过嵴，快速血浆流同时在血小板层表面造成湍流冲击，加速血小板颗粒形成局部浪涌，使第一弧线状型腔隙内的血小板层被反混入血桨层，并随血桨流越过嵴进入第二弧线状型腔隙内，当白膜层临近嵴时，立即停止血浆回输，使白膜层和红细胞层仍留滞在第一弧线状型腔隙内； 5 By rapidly returning the plasma from the inlet tube in a short time, the plasma flow passes directly through the first arc-shaped cavity into the second arc-shaped cavity, and the first arc is at the ridge. In the shape-like cavity, the surface of the platelet layer near the sputum produces a platelet particle on the surface of the sputum. The platelet particles pass through the sputum with the plasma flow. The rapid plasma flow causes turbulent impact on the surface of the platelet layer, accelerating the local surge of platelet particles, making the first The platelet layer in the arc-shaped cavity is back-mixed into the blood paddle layer and enters the second arc-shaped cavity with the blood flow through the sputum. When the tunica layer approaches 嵴, the plasma re-infusion is stopped immediately. The white film layer and the red blood cell layer remain in the first arc-shaped cavity;

⑦ 在步骤⑥期间，剩余的单核细胞层和粒细胞层组成的白膜层仍留滞在第一弧线状型腔隙内，可从出液管抽出，随同上述过程中抽出多余的红细胞、血浆一起回输人体，重复步骤③、 ④、（D、 ⑥、 ⑦，使分离的目标产物逐渐积累，直至满足分离要求为止。 7 During step 6, the remaining monolayer and granulocyte layer are still Retained in the first arc-shaped cavity, can be withdrawn from the liquid outlet tube, and then withdrawn from the body by withdrawing excess red blood cells and plasma together with the above process, repeat steps 3, 4, (D, 6, and 7, to separate The target product gradually accumulates until the separation requirement is met.

8.根据权利要求 5所述的一种多细胞成分混合液体分离***上的分离盘，其特征在于，所述的腔隙由首部至尾部分别由第一弧线段、第二弧线段和第三弧线段依次相连接组成，第一弧线段和第二弧线段连接处为第一嵴，第二弧线段与第三弧线段连接处为第二嵴，软袋上相应于第二弧线段和第三弧线段上距离圆心轴最远处分别都设置有出液管。 The separation disc on a multi-cell component mixed liquid separation system according to claim 5, wherein the cavity is composed of a first arc segment, a second arc segment, and a first to a tail portion, respectively. The third arc segment is connected in sequence, the first arc segment and the second arc segment are connected as the first turn, and the second arc segment and the third arc segment are connected to the second turn, corresponding to the soft bag. A liquid outlet pipe is disposed at a far distance from the center axis of the second arc segment and the third arc segment.

9.一种利用权利要求 8所述的多细胞成分混合液体分离***上的分离盘在自动化血液采集中分离、浓集和提取全血中单一成分的单核细胞或粒细胞的方法，其特征在于，该方法具体包括如下操作步骤： 9. A method for separating, enriching and extracting single-component monocytes or granulocytes in whole blood in an automated blood collection using a separation disk on a multi-cell component mixed liquid separation system according to claim 8, characterized in that Therefore, the method specifically includes the following steps:

② 该分离盘绕硬底盘的圆心轴转动，抽取全血通过进液管灌入到软袋，全血中密度不同的各种成分受离心力场的作用先在第一弧线状型腔隙内聚集呈片层状分段分布，全血中的血浆层因密度最低排列于软袋 2 The separation coil rotates around the center axis of the hard chassis, and the whole blood is pumped into the soft bag through the liquid inlet tube, and various components of different density in the whole blood are first collected in the first arc-shaped cavity by the action of the centrifugal force field. Layered and segmented, the plasma layer in whole blood is arranged in soft bags due to the lowest density.

^Γ内靠近第一弧线状型腔隙尾部位置，红细胞层因密度最高排列于软袋内靠近腔隙首部位置，其余成分在软袋内沿第一弧线状型腔隙空间依次分段分布，用在线检测传感器检测相邻成分层间界面的位置； ^The inside of the ^crucible is close to the position of the first arc-shaped cavity, and the red cell layer is arranged in the soft bag with the highest density in the vicinity of the cavity. The remaining components are distributed in the soft pocket along the first arc-shaped cavity space. , detecting the position of the interface between adjacent component layers by using an on-line detecting sensor;

④ 当白膜层增至一定的厚度时，通过调节由进液管输入全血或回输红细胞的速率，以及由出液管抽取红细胞的速率, 利用这二者的流量不同来控制第一弧线状型腔隙内血小板层与白膜层之间的界面，并使之靠近第一嵴； 4 When the tunica layer is increased to a certain thickness, the whole blood is returned or returned by adjusting the inlet tube. The rate of red blood cells, and the rate at which red blood cells are drawn from the outlet tube, using the flow rates of the two to control the interface between the platelet layer and the white film layer in the first arc-shaped cavity and bringing it closer to the first ;

⑤ 以单核细胞作为分离目标，在步骤④完成后，通过在短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一弧线状型腔隙进入第二弧线状型腔隙，在第一嵴处对第一弧线状型腔隙内靠近第一嵴的血小板层和单核细胞层表面产生曳力裹挟起界面上的血小板颗粒和单核细胞颗粒随血浆流越过该第一嵴，快速血浆流也在此血小板层和单核细胞层表面造成湍流冲击，加速血小板颗粒和单核细胞颗粒形成局部浪涌，使第一弧线状型腔隙内的血小板层和单核细胞层被反混入血浆层，并随血浆流越过第一嵴进入第二弧线状型腔隙内, 当与单核细胞层相邻的粒细胞层和红细胞层之间的界面临近第一嵴时，立即停止血浆回输，与单核细胞层相邻的粒细胞层和红细胞层仍留滞在第一弧线状型腔隙内原处; 5 With monocytes as the separation target, after the completion of step 4, the plasma flow can be directly and quickly passed through the first arc-shaped cavity into the second arc by rapidly returning the plasma from the inlet tube in a short time. a linear cavity with platelet particles and monocyte particles on the surface of the first arc-shaped cavity near the first layer of the platelet layer and the mononuclear cell layer at the first ridge The plasma flow passes over the first sputum, and the rapid plasma flow also causes turbulent impact on the surface of the platelet layer and the monocyte layer, accelerating the local surge of platelet particles and monocyte particles, making the first arc-shaped cavity The platelet layer and the monocyte layer are back-mixed into the plasma layer and enter the second arc-like cavity as the plasma flows across the first ridge, between the granulocyte layer and the erythrocyte layer adjacent to the monocyte layer. When the interface is close to the first sputum, the plasma reinfusion is immediately stopped, and the granulocyte layer and the red blood cell layer adjacent to the monocyte layer remain in the first arc-shaped cavity;

⑥ 多次重复步骤③至⑤，血小板和单核细胞在第二弧线状型腔隙内得到浓集，通过在短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一和第二弧线状型腔隙进入第三弧线状型腔隙，在第二嵴旁通过血浆流对血小板层表面产生曳力裹挟血小板颗粒和湍流浪涌造成血小板反混，并随血浆流使血小板越过第二嵴进入第三弧线状型腔隙，当与血小板相邻的单核细胞层的界面临近第二嵴时，立即停止血浆回输，然后从位于第二弧线状型腔隙内距离转动圆心轴最远处的出液管抽取纯化和富集的作为目标产物的单核细胞，将上述过程中抽出多余的其他成分回输人体，重复步骤③、 ④、 ⑤、 ⑥，使分离的目标产物逐渐积累，直至满足分离要求为止； 6 Repeat steps 3 to 5 several times, platelets and monocytes are concentrated in the second arc-shaped cavity, and the plasma flow is directly and quickly worn by rapidly returning plasma from the inlet tube in a short time. Passing through the first and second arcuate cavities into the third arcuate cavity, and by means of the plasma flow on the surface of the platelet layer, dragging the platelet particles and turbulent surges to cause platelet backmixing, and With the plasma flow, the platelets pass through the second sputum and enter the third arc-shaped cavity. When the interface of the mononuclear cell adjacent to the platelet approaches the second sputum, the plasma reinfusion is stopped immediately, and then the second arc is located. In the shape of the cavity, the outlet tube farthest from the rotating central axis extracts and purifies the mononuclear cells as the target product, and extracts the excess components into the human body in the above process, repeating steps 3, 4, and 5 6, the gradual accumulation of the separated target product until the separation requirement is met;

⑦ 选择粒细胞作为分离目标，是在在步骤④完成后，通过在短时间内从进液管内大量快速回输血浆，使血浆流直接快速地穿过第一弧线状型腔隙进入第二弧线状型腔隙，在第一嵴旁依次对第一弧线状型腔隙内靠近第一嵴的血小板层、单核细胞层、粒细胞层的表面产生曳力裹挟和湍流浪涌反混，并随血浆流越过第一嵴进入第二弧线状型腔隙内，当与其相邻的红细胞层之间的界面临近第一嵴时，立即停止血浆回输，与粒细胞层相邻的红细胞层仍留滞在第一弧线状型腔隙内原处； 7 Select granulocytes as the separation target. After the completion of step 4, the plasma flow can be directly and quickly passed through the first arc-shaped cavity into the second by rapidly returning the plasma from the inlet tube in a short time. An arc-shaped cavity, in the first arc, sequentially creates a dragging force on the surface of the first arc-shaped cavity near the first platelet layer, the mononuclear layer, and the granulocyte layer. The turbulent surge is back-mixed and enters the second arc-shaped cavity as the plasma flows past the first ridge. When the interface between the adjacent red blood cell layer approaches the first ridge, the plasma re-infusion is stopped immediately. The adjacent red blood cell layer of the cell layer remains in the original position in the first arc-shaped cavity;