System for blood cell separation

Abstract

The invention relates to a system for blood cell separation, comprising: a separation chamber (10) comprising a blood inlet port (12), a plasma outlet port (14) and at least one blood cell component outlet port (16) for whole blood separation; a blood pump (20) for pumping whole blood into the blood inlet port; a plasma pump (22) for pumping plasma and / or target cells out of the separation chamber from the plasma outlet port; a red blood cell tube (30) comprising a first end (32) and a second end (34), wherein the first end of the red blood cell tube is connected to the blood cell component outlet port to allow red blood cells to exit the separation chamber; and a drip chamber (40) comprising a storage portion (42) and an inlet (46), wherein the second end of the red blood cell tube is connected to the inlet, wherein the second end of the red blood cell tube extends into the volume of the storage portion for pressure equalization during pumping from the plasma outlet port.

Description

Technical Field

[0001] The present invention relates to a system for blood cell separation according to the preamble of claim 1, and to an infusion device used in such a system. Background Technology

[0002] This type of system includes a separation chamber for whole blood separation, comprising a blood inlet port and a plasma outlet port and a blood cell component outlet port. The system also includes: a blood pump for pumping whole blood into the blood inlet port; and a plasma pump or cell pump for pumping plasma and / or target cells out of the separation chamber. Furthermore, the system includes a red blood cell tube having a first end and a second end, wherein the first end of the red blood cell tube is connected to the blood cell component outlet port to allow red blood cells to leave the separation chamber. Additionally, the system includes an infusion device comprising a storage section and an inlet, wherein the second end of the red blood cell tube is connected to the inlet.

[0003] This type of system is commonly used in the field of blood apheresis, where blood is drawn from a donor / patient. The blood, also known as whole blood, is separated into its main components—plasma and red blood cells—by such a system, and the remainder is then reinfused into the donor / patient. Depending on the application, abnormal pathogenic components may be removed along with the plasma during therapeutic plasma exchange; or abnormal red blood cells may be removed during red blood cell exchange and replaced with healthy cells.

[0004] The separation chamber is typically contained within a centrifuge unit, which is configured to separate blood components by density and size. The final products of blood centrifugation are: sedimented red blood cells outside the separation chamber; an erythrocyte sedimentation rate (ESR) layer in the middle, which contains MNCs (monocytes and monocytes), stem cells, and platelets; and plasma inside the separation chamber.

[0005] Examples of known blood cell separation systems are described in EP 3 509 663 A1. Cell separator.

[0006] During the separation phase, whole blood is separated in the separation chamber into a layer of red blood cells, platelet-rich plasma (PRP), and a layer of mononuclear cells (MNC). The MNC layer accumulates in the separation chamber, while the red blood cells and PRP are returned to the patient / donor.

[0007] Following the separation phase is the so-called overflow phase, in which the MNC layer is pumped out of the separation chamber in a volume-controlled manner, or more precisely, through a volume sensing device, such as an optical sensor that can control the collection clip. When cells are detected, the overflow phase is stopped, and the so-called erythrocyte sedimentation rate (ESR) brown layer phase begins, in which the path back to the patient is closed, and the path to the collection container is opened to collect the MNC.

[0008] However, during the overflow phase, in which the MNC layer is pumped out of the separation chamber, the negative pressure in the separation chamber pulls the fluid back to equalize the negative pressure, which results in (i) first pulling the red blood cell layer into the separation chamber, and (ii) second pulling the whole blood into the separation chamber.

[0009] Unfortunately, the negative pressure pulls the solution back into the separation chamber, making it difficult to accurately collect, especially, smaller, more compact portions of the target cells. Summary of the Invention

[0010] Therefore, the object of the present invention is to provide a system for blood cell separation that allows for easy and accurate collection of target cells, and that is also capable of accurately collecting a higher concentration of target cells in a smaller volume.

[0011] This objective is achieved by means of a system including the features of claim 1.

[0012] Therefore, the second end of the red blood cell tube extends into the volume of the storage section to equalize the pressure during pumping from the plasma outlet port, such as during pumping of the MNC layer.

[0013] The system for blood cell separation described in this article can be automated as mentioned above. Used in cell separators.

[0014] Therefore, in this example, the system may further include: a front panel having a user interface, several pumps, an automatic clamp; and a detector device including an optical sensor for monitoring fluid flow, an intravenous infusion rod for attaching saline and anticoagulant bags, a perfusion bag, and collection containers for target cells and plasma. The separation chamber may be included in a centrifuge compartment comprising a rotor having a mechanism for mounting a chamber retainer for holding the separation chamber. The separation chamber and containers may be connected to each other via a tubing system comprising several tubes. The pumps used in the system may be peristaltic pumps and may deliver blood, blood fractions, and solutions between the aforementioned parts of the system. The system may be controlled by a processor device.

[0015] As suggested in this invention, the second end of the red blood cell tube extends into the volume of the storage section to equalize the pressure during pumping from the plasma outlet port.

[0016] In this document, the term "infusion device" may be used to refer to a device that allows a gas, such as air, to be retained so that the gas does not flow downstream. In this system, the infusion device ensures that the red blood cells and / or plasma returned to the donor / patient are free of air.

[0017] The term "storage section" can be used to refer to a structure, such as a container with a regular or irregular shape, used to hold fluid. Compared to the prior art where the red blood cell tubes are arranged such that their second end is above the volume of the storage section, in this case, the second end of the red blood cell tube extends into the volume of the storage section. Therefore, depending on the fluid level inside the storage section, the second end of the red blood cell tube can be completely submerged in the fluid inside the storage section, i.e., below the fluid level.

[0018] Advantageously, this arrangement, where the second end of the red blood cell tube extends into the storage volume, allows for an increase in the storage volume for the red blood cell fraction, which in turn leads to the avoidance of pressure equalization using whole blood. Therefore, the target cell layer will overflow as a more compact layer compared to overflow in prior art systems, and thus allows for the collection of the same target cells in a smaller volume, where, in prior art systems, the second end of the red blood cell tube does not extend into the storage volume of the infusion unit. Furthermore, by increasing the storage volume for the red blood cell fraction through the extension of the second end of the red blood cell tube into the storage volume for pressure equalization during pumping of the MNC layer, existing systems can be readily improved, as the current functional design of the separation chamber or the infusion unit does not require modification.

[0019] In the example, the second end of the red blood cell tube extends into at least 20% of the volume of the storage section.

[0020] Here, the opening at the second end of the red blood cell tube extends to at least 20% of the volume of the storage compartment. Therefore, when the storage compartment is filled with fluid to more than 80%, the opening at the second end of the red blood cell tube will be submerged in the fluid, meaning that the opening will be below the fluid level.

[0021] In other examples, the second end of the red blood cell tube extends into at least 50% and 80% of the volume of the storage section.

[0022] In the example, the second end of the red blood cell tube extends to the bottom surface of the storage section.

[0023] The bottom surface can be positioned opposite to the inlet of the storage section along the direction of gravity. Therefore, in this example, the opening at the second end of the red blood cell tube can extend substantially as far into the storage section as possible, so that even at a low fluid level, the opening at the second end is still submerged in the fluid inside the storage section.

[0024] In the example, the second end of the red blood cell tube extends to the outlet opening in the bottom surface of the storage section.

[0025] The term "outlet opening" can be used to refer to an opening located on the bottom surface of the storage unit through which fluid inside the storage unit can be returned to the patient / donor.

[0026] In the example, the system includes a cover configured to be placed on the storage section to cover the storage section, wherein an inlet is arranged in the cover, and wherein a second end of a red blood cell tube extends through the cover.

[0027] A lid can cover the storage compartment to prevent dust or other contaminants from entering it. The inlet can be a generally circular opening with a diameter slightly larger than the outer diameter of the red blood cell tube, allowing the red blood cell tube to extend through the opening into the storage compartment and remain in place.

[0028] In the example, the infusion device includes a second inlet configured to connect to a plasma tube that delivers fluid from a plasma outlet port to a storage compartment.

[0029] In addition to fluid from the red blood cell tube entering through this inlet, fluid from the plasma tube can also enter the storage section through the second inlet.

[0030] Depending on the system's operating mode, fluid from the plasma tube can be reintroduced into the patient / donor during the overflow phase.

[0031] In the example, the separation chamber includes another outlet port for blood cell components.

[0032] Advantageously, different types of separation chambers can be used with the system described herein.

[0033] This objective is also achieved by a dripper for a blood cell separation system, specifically for a system as described herein, the dripper comprising: a reservoir and an inlet, wherein the inlet is connectable to a second end of a red blood cell tube, and wherein the second end of the red blood cell tube extends into the volume of the reservoir to equalize pressure during pumping through the system.

[0034] The advantages and beneficial implementation methods described above for the system also apply to the dripper, so reference should be made to the above. Attached Figure Description

[0035] The basic idea of ​​the present invention will then be described in more detail with reference to the embodiments shown in the accompanying drawings. In the drawings:

[0036] Figure 1 A schematic diagram of a system commonly used in the prior art for blood cell separation is shown;

[0037] Figure 2A , Figure 2B A schematic diagram of a separation chamber commonly used in the prior art is shown;

[0038] Figure 3A , Figure 3B A schematic diagram of a system for blood cell separation according to an embodiment of the present invention is shown;

[0039] Figure 4A , Figure 4B A schematic diagram of a dripper commonly used in the prior art is shown; and

[0040] Figure 5A , Figure 5B A schematic diagram of an infusion device according to an embodiment of the present invention is shown. Detailed Implementation

[0041] Figure 1 A schematic diagram of an exemplary system 1 for blood cell separation is shown. System 1 is moved by means of wheels attached to a housing. The illustrated system 1 includes a front panel 100 having an automatic clamp, a pump, and a user interface. The illustrated system 1 also includes a centrifuge compartment 102 containing a separation chamber 10.

[0042] Figure 2A A schematic diagram of an exemplary separation chamber 10 is shown. Figure 2A The separation chamber 10 shown can be a previously installed chamber in... Figure 1 The separation chamber 10 shown is substantially cylindrical and can be connected to a centrifuge unit ( Figure 2A (Not shown) is used in combination to rotate the blood in the separation chamber 10 to separate the blood in the separation chamber 10 into its components. The separation chamber 10 includes a blood inlet port 12 through which whole blood from the donor / patient can be pumped into the separation chamber 10. Figure 2A Also shown are plasma outlet port 14 and blood cell component outlet port 16 disposed along the track direction, opposite to the blood inlet port 12 on the flared section of the separation chamber 10. During the separation process, whole blood is separated into plasma, which can be obtained at plasma outlet port 14, and red blood cells, which can be obtained at blood cell component outlet port 16. Between the plasma and red blood cells is a so-called erythrocyte sedimentation rate (ESR) layer, which includes a mononuclear cell layer containing target cells, i.e., the MNC layer.

[0043] Figure 2B A schematic diagram of another exemplary separation chamber 10 is shown. In addition to the blood inlet port 12, the plasma outlet port 14, and the blood cell component outlet port 16, the separation chamber 10 shown also includes another blood cell component outlet port 18.

[0044] Figure 3A A system 1 for blood cell separation according to an embodiment is shown. As shown, system 1 includes a separation chamber 10, which can be as follows: Figure 2A The separation chamber 10 shown is for separating target cells from whole blood. The separation chamber 10 includes a blood inlet port 12, a plasma outlet port 14, and a blood cell component outlet port 16. The system also includes a blood pump 20 for pumping whole blood into the blood inlet port 12, and a plasma pump 22 for pumping fluid, namely plasma containing target cells and a mononuclear cell layer, i.e., the MNC layer, out of the separation chamber 10 from the plasma outlet port 14.

[0045] exist Figure 3A In this configuration, the red blood cell tube 30 is connected to the blood cell component outlet port 16 to allow red blood cells to leave the separation chamber 10. For example... Figure 3A As shown, the red blood cell tube 30 includes a first end 32 and a second end 34, wherein the first end 32 of the red blood cell tube 30 is connected to the blood cell component outlet port 16, and the second end 34 is in contact with the infusion device 40 of the system 1. As schematically shown, the second end 34 of the red blood cell tube 30 extends into the volume of the storage section 42 to perform pressure equalization during pumping of the MNC layer, which will refer to... Figure 5A and Figure 5B To describe in more detail.

[0046] As mentioned above, refer to Figure 2A and Figure 2B During the separation phase, whole blood is separated into its components. Essentially, red blood cells and plasma fractions are separated in separation chamber 10. During this so-called separation step, an outer layer comprising red blood cells and an inner layer comprising plasma are formed. A layer of erythrocyte sedimentation rate (ESR) brownish-yellow, including a layer of mononuclear cells (MNCs) containing target cells, accumulates as another layer between the red blood cells and plasma fractions in separation chamber 10.

[0047] Once the separation phase is complete, the overflow phase begins, in which plasma is pumped by plasma pump 22 into the storage section 42 of the infusion unit 40, such as... Figure 3A As indicated by the arrow in the diagram. Once the target cell is detected in the plasma, for example by means of an optical sensor (not shown) located in a tubular section near the plasma pump 22, the collection clip (not shown) can be used as follows: Figure 3A The fluid flow shown from the plasma outlet port 14 to the dripper 40 is redirected to a fluid flow from the plasma outlet port 14 to the collection container (not shown) where the target cells are collected.

[0048] The flow rate of blood entering the separation chamber 10 and the flow rate of plasma leaving the separation chamber 10 during the overflow phase result in negative pressure within the separation chamber 10.

[0049] The arrangement of the second end 34 of the red blood cell tube 30 extending into the volume of the storage portion 42 of the dripper 40 allows for an increase in the storage volume for the red blood cell fraction, which in turn leads to the avoidance of using whole blood for pressure equalization. Therefore, compared to overflow in prior art systems, the target cell layer can overflow as a more compact layer, allowing for the collection of a smaller, more compact cell fraction, where, in prior art systems, the second end of the red blood cells does not extend into the storage volume of the dripper.

[0050] Figure 3B Another embodiment of at least a portion of system 1 for blood cell separation is shown. Figure 3B In the embodiment shown, the following methods were used Figure 2B Separation chamber 10.

[0051] Figure 4A and Figure 4B A schematic diagram of a dripper 40 commonly used in the prior art is shown.

[0052] Figure 4A An empty dripper 40 is shown, meaning there is no fluid in the reservoir 42. Figure 4B A dripper 40 filled with fluid is shown. From Figure 4A and Figure 4B It can be observed that the second end 34 of the red blood cell tube 30 is arranged above the storage section 42 and therefore does not extend into the volume of the storage section 42 to achieve pressure equalization during pumping from the plasma outlet port, such as during pumping of the MNC layer.

[0053] The storage compartment 42 is covered by a cap 44 having an inlet 46 to which the second end 34 of the red blood cell tube 30 is attached. The cap 44 includes a second inlet 48 to receive the end of the plasma tube, allowing fluid from the plasma tube to also be inserted into the storage compartment 42. Additionally, Figure 4A and Figure 4B An outlet opening 50 is shown in the bottom surface of the storage section 42.

[0054] Figure 5A and Figure 5B A schematic diagram of an infusion device 40 according to an embodiment is shown. As previously discussed... Figure 4A and Figure 4B As shown, Figure 5A The dripper 40 shown is empty, while Figure 5B A dripper 40 filled with fluid is shown.

[0055] Figure 5A and Figure 5B The dripper 40 shown is with Figure 4A and Figure 4BThe difference in the illustrated drip apparatus is that the second end 34 of the red blood cell tube 30 extends into the volume of the reservoir 42 to equalize pressure during pumping. In the illustrated embodiment, the second end 34 of the red blood cell tube 30 extends into approximately 80% of the volume of the reservoir. In other embodiments, the second end of the red blood cell tube may also extend into the volume of the reservoir 42 to a lesser extent, for example, only into 20% or 50% of the volume of the reservoir 42. In alternative embodiments, the second end of the red blood cell tube may also extend to the bottom surface of the reservoir and / or to an outlet opening located in the bottom surface of the reservoir.

[0056] List of reference numerals

[0057] 1. Systems for blood cell separation

[0058] 10 Separation Chamber

[0059] 12 Blood entry port

[0060] 14. Plasma outlet port

[0061] 16 Blood cell component exit ports

[0062] 18 Another outlet port for blood cell components

[0063] 20 Blood Pumps

[0064] 22. Plasma pump

[0065] 30 red blood cell tubes

[0066] 32 The first end of the red blood cell tube

[0067] 34 The second end of the red blood cell tube

[0068] 40 drip set

[0069] 42 Storage Department

[0070] 44 lids

[0071] 46 Entrances

[0072] 48 Second Entrance

[0073] 50 Exit opening

[0074] 100 Front Panel

[0075] 102 Centrifuge Compartments

Claims

1. A system for blood cell separation, comprising: A separation chamber (10) includes a blood inlet port (12), a plasma outlet port (14) and at least one blood cell component outlet port (16), the separation chamber (10) being used for whole blood separation; Blood pump (20), the blood pump (20) being used to pump whole blood into the blood inlet port (12); A plasma pump (22) is used to pump plasma and / or target cells from the plasma outlet port (14) out of the separation chamber (10). Red blood cell tube (30), the red blood cell tube (30) including a first end (32) and a second end (34), wherein the first end (32) of the red blood cell tube (30) is connected to the blood cell component outlet port (16) to allow red blood cells to leave the separation chamber (10); and The dripper (40) includes a storage section (42) and an inlet (46), wherein the second end (34) of the red blood cell tube (30) is connected to the inlet (46). Its features are, The second end (34) of the red blood cell tube (30) extends into the volume of the storage section (42) to extend to the bottom surface of the storage section (42) to avoid pressure equalization during pumping of whole blood from the plasma outlet port (14), wherein the second end (34) extends to the outlet opening (50) in the bottom surface.

2. The system for blood cell separation according to claim 1, characterized in that, The cover (44) is configured to be placed on the storage section (42) to cover the storage section (42), wherein the inlet (46) is arranged in the cover (44), and wherein the second end (34) of the red blood cell tube (30) extends through the cover (44).

3. The system for blood cell separation according to claim 1 or 2, characterized in that, The dripper (40) includes a second inlet (48) configured to connect to a plasma tube that delivers fluid from the plasma outlet port (14) to the storage section (42).

4. The system for blood cell separation according to claim 1 or 2, characterized in that, The separation chamber (10) includes another blood cell component outlet port (18).

5. A drip device for use in a system for blood cell separation according to any one of claims 1 to 4, the drip device comprising: Storage section (42) and inlet (46), wherein the inlet (46) is connectable to the second end (34) of the red blood cell tube (30). Its features are, The second end (34) of the red blood cell tube (30) extends into the volume of the storage section (42) to extend to the bottom surface of the storage section (42) to avoid pressure equalization during the pumping of whole blood through the system for blood cell separation, wherein the second end (34) extends to the outlet opening (50) in the bottom surface.

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