Cartridge and system

Abstract

To reduce complication in incorporating a reagent into a cartridge for cell treatment.SOLUTION: A cartridge according to an embodiment is a cartridge for performing processing of cells therein, and includes a flow path through which a reagent used for the processing flows, a connection portion for connecting a reagent container containing the reagent to the flow path, and an opening / closing portion for connecting the reagent container to the connection portion and installing the reagent container in the cartridge.SELECTED DRAWING: Figure 4

Description

[Technical Field]

[0001] The embodiments disclosed herein and in the drawings relate to cartridges and systems. [Background technology]

[0002] Conventionally, induced pluripotent stem cells (hereinafter referred to as iPS cells) have been produced manually by skilled workers in facilities such as safety cabinets. Specifically, for the production of iPS cells, closed-system cell production devices that automate predetermined processes such as cell culture, and cell processing devices that allow workers to configure any process are known. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Special Publication No. 2022-511935 Summary of the Invention [Problem to be solved by the invention]

[0004] One of the problems to be solved by the embodiments disclosed in this specification and the drawings is to reduce the complexity of incorporating reagents into a cartridge for cell processing. However, the problems to be solved by the embodiments disclosed in this specification and the drawings are not limited to the above problem. Problems corresponding to the effects of each configuration shown in the embodiments described below can also be positioned as other problems. [Means for solving the problem]

[0005] The cartridge according to the embodiment is a cartridge for processing cells internally, and includes a flow path through which a reagent used for the processing flows, a connection part for connecting a reagent container containing the reagent to the flow path, and an opening / closing part for connecting the reagent container to the connection part and placing it in the cartridge. [Brief explanation of the drawings]

[0006] [Figure 1] FIG. 1 is a perspective view showing an example of the configuration of a cartridge according to an embodiment. [Figure 2] FIG. 2 is a side view showing an example of the configuration of the cartridge according to the embodiment. [Figure 3] FIG. 3 is a block diagram showing an example of the functional configuration of the cell manufacturing system according to the embodiment. [Figure 4] FIG. 4 is a schematic diagram for explaining an example of the procedure for placing a reagent container in a cartridge according to an embodiment. [Figure 5] FIG. 5 is a table showing an example of identification information of the cartridge according to the embodiment. [Figure 6] FIG. 6 is a schematic diagram showing an example of the configuration of a first outer cover according to a first modified example. [Figure 7] FIG. 7 is a schematic diagram showing an example of the configuration of the opening / closing section according to the second modified example. [Figure 8] FIG. 8 is a schematic diagram showing another example of the configuration of the opening / closing section according to the second modified example. [Figure 9] FIG. 9 is a table showing an example of identification information according to the third modified example. [Figure 10] FIG. 10 is a schematic diagram showing an example of display information output by a display unit according to the third modified example. DETAILED DESCRIPTION OF THE INVENTION

[0007] Hereinafter, embodiments of the cartridge and system will be described in detail with reference to the accompanying drawings. The cartridge and system according to the present application are not limited to the embodiments shown below. The embodiments can be combined with other embodiments or conventional techniques to the extent that no contradiction occurs. In the following description, similar components will be given the same reference numerals, and duplicated descriptions will be omitted.

[0008] The cell manufacturing system according to this embodiment comprises a double-structured container (cartridge) having a storage container that houses a closed-system flow path, and a cell manufacturing device in which the cartridge is installed. The cartridge is, for example, a sample processing cartridge. The cartridge is a container for processing cells therein. As will be described later, cell processing performed in the cartridge may include blood cell separation processing, expansion culture processing, factor introduction processing, plate culture processing, recovery processing, etc.

[0009] The details of the cell manufacturing system according to this embodiment will be described below with reference to examples. Fig. 1 is a perspective view showing an example of the configuration of a cartridge 100 in the cell manufacturing system according to this embodiment. Fig. 2 is a side view showing an example of the configuration of the cartridge 100. In this embodiment, the axial direction perpendicular to the bottom surface of the cartridge 100, i.e., the vertical direction, is defined as the Z-axis direction, and two directions perpendicular to the Z-axis direction and perpendicular to each other are defined as the X-axis direction and the Y-axis direction, respectively.

[0010] As shown in FIGS. 1 and 2, the cartridge 100 includes a container 70, a door opening / closing unit 80, a first outer cover 90, and a second outer cover 97.

[0011] First, the configuration housed in the storage container 70 will be described. Here, Fig. 1 shows only the storage container 70, but when the cartridge 100 is assembled, the corresponding units are installed at the positions indicated by the reference symbols described below. Note that the reference symbols in Fig. 1 indicate representative installation positions for each unit, and units are also installed in places where no reference symbol is assigned.

[0012] The storage container 70 accommodates the connection flow path 10, the liquid supply container 20, the culture container 21, the waste liquid container 22, the filter 30, the microflow path 40, and the valve 50. The storage container 70 also includes a pressurization / depressurization port 60. The entire flow path formed by the connection flow path 10, the liquid supply container 20, the culture container 21, the waste liquid container 22, the filter 30, the microflow path 40, etc. forms a closed system to prevent contamination by bacteria and the like from the outside. Hereinafter, the closed system refers to a space that has no communication points with the outside, or where all communication points with the outside are sterilely connected by a sterile filter or the like. Hereinafter, the entire flow path that forms a closed system will be referred to as a closed system flow path.

[0013] The connection flow path 10 is a flow path through which a reagent used for cell processing flows. The connection flow path 10 is also simply referred to as a flow path. The connection flow path 10 is, for example, a pipe for transporting a reagent such as a medium used for cell culture, or a cell suspension containing target cells to be cultured. The connection flow path 10 is composed of, for example, a tube that forms the non-branching portion of the flow path, or a three-way joint that forms the branching portion of the flow path.

[0014] For example, the tubes in the non-branched section are made of a flexible material such as silicon or resin, and the three-way joints in the branched section are made of a relatively hard resin. For example, when the cell manufacturing device connected to the cartridge 100 applies pressure to the fluid supply container 20 via the pressurization / depressurization port 60, liquids such as reagents and cell suspensions stored in the fluid supply container 20 flow through the connecting flow path 10 to the culture container 21.

[0015] The liquid supply container 20 is a container for temporarily storing various liquids such as biological samples and reagents. The liquid supply container 20 is formed of, for example, a hard resin. The liquid supply container 20 is connected to the connection flow path 10 for introducing and discharging liquid, and is also connected to the pressurization / depressurization port 60 for receiving pressure.

[0016] For example, when the liquid supply container 20 temporarily stores liquid, the cell manufacturing device applies pressure to the pressure / pressure port 60, causing the liquid stored inside the liquid supply container 20 to flow into the connecting flow path 10.

[0017] Culture vessel 21 is a vessel for culturing cells to be cultured therein. For example, culture vessel 21 includes a culture dish for holding the cells to be cultured and the culture medium used for culturing, a supply tube for supplying reagents such as the culture medium to the culture dish, a waste liquid tube for draining the liquid in the culture dish and discharging it into waste liquid container 22 when changing the culture medium, and a recovery tube for recovering the cells after culture and discharging them into a subsequent container.

[0018] The waste liquid container 22 stores the waste liquid sent from the connection flow path 10 and generated during a series of cell culture treatments.

[0019] The filter 30 captures necessary components from the biological sample and removes unnecessary components. For example, the filter 30 allows blood cells smaller than a predetermined size to pass through as unnecessary components and captures blood cells equal to or larger than a predetermined size as necessary components.

[0020] The microchannel 40 classifies target cells from a cell suspension obtained by recovering blood cells captured by the filter 30. For example, the microchannel 40 classifies nucleated cells from a cell suspension. As an example, the microchannel 40 classifies nucleated cells from a cell suspension using a known method, such as a method of separating blood cells of different sizes within a cross section of the microchannel 40 by advection due to Dean vortices generated in the spiral microchannel 40 and a lift force resulting from the velocity distribution on the wall surface of the microchannel 40.

[0021] The valve 50 is a unit that switches the connecting flow path 10 between a state in which the liquid cannot pass through the connecting flow path 10 (closed state) and a state in which the liquid can pass through the connecting flow path 10 (open state). By providing a plurality of valves 50 together with the branching portion of the connecting flow path 10 (for example, a three-way joint), it becomes possible to switch the flow path by operating these plurality of valves 50.

[0022] For example, the valve 50 includes a fixed magnetic plate and a magnet that is provided so that it can move toward and away from the magnetic plate. A tube of the connection flow path 10 is provided between the magnetic plate and the magnet. As a result, when no magnetic force is applied from outside the cartridge 100, the magnet and the magnetic plate approach each other due to attractive force, crushing the tube of the connection flow path 10 and closing the connection flow path 10.

[0023] On the other hand, by bringing another magnet (hereinafter referred to as the "open / close magnet") close to the magnet of the valve 50 inside the cartridge 100 from the opposite side to the magnetic plate, outside the cartridge 100, the magnet of the valve 50 can be moved away from the magnetic plate to open the connection flow path 10. The open / close magnet is provided in the cell manufacturing device together with a drive unit for driving it.

[0024] Of the units connected via the connecting flow path 10, the one at the end of the flow path communicates with the inside or outside of the cartridge 100 via a sterile filter. For example, the waste liquid container 22 communicates with the internal space of the cartridge 100 via a sterile filter.

[0025] As a result, the connection flow path 10, the liquid supply container 20, the culture container 21, the waste liquid container 22, the filter 30, the micro flow path 40, and the valve 50 together form a closed system.

[0026] The pressurization / depressurization port 60 is a communication port for receiving the application of positive or negative pressure from the cell manufacturing apparatus, and connects the liquid delivery container 20 to the external space of the cartridge 100 via a sterile filter. When pressure is applied to the liquid delivery container 20 via the pressurization / depressurization port 60, the delivery of liquid within the closed flow path is induced. For example, the pressurization / depressurization port 60 is provided above the liquid delivery container 20 for storing biological samples and reagents.

[0027] As an example, the pressure / pressure port 60 is connected to a regulator of the cell manufacturing apparatus. When the regulator is driven, liquids such as biological samples and reagents stored in the liquid supply container 20 are pushed out by pressure and flow into the connecting flow path 10 connected to the liquid supply container 20.

[0028] The storage container 70 is a container that contains a closed flow path. The storage container 70 has an opening. The cartridge 100 is formed by storing the closed flow path in the storage container 70 and closing the opening. The closed flow path and the storage container 70 form a double closed structure, which can prevent leakage of samples and the like to the outside even in the unlikely event that the closed flow path is damaged. Note that the storage container 70 may have a double or more layer structure, thereby forming the cartridge 100 as a multi-layered container.

[0029] In this embodiment, the container 70 is made of a hard resin, metal, or the like, and has a shape capable of containing a closed flow path, such as a rectangular parallelepiped or cube.

[0030] The container 70 also includes a door opening / closing unit 80. The door opening / closing unit 80 is provided inside the cartridge 100. The functional configuration of the door opening / closing unit 80 will now be described with reference to FIG.

[0031] 3 is a block diagram showing an example of the functional configuration of the cell manufacturing system according to this embodiment. The door opening / closing unit 80 includes an auxiliary storage device 82, a connection interface 83, and a processing circuit 84, and is connected to an opening / closing drive mechanism 81. The door opening / closing unit 80 is then connected to the cell manufacturing apparatus 200 via the connection interface 83.

[0032] The cell manufacturing apparatus 200 is connected to the door opening / closing unit 80 of the cartridge 100 via a connection interface 208. The cell manufacturing apparatus 200 is an example of a cell processing apparatus. The cell manufacturing apparatus 200 is equipped with a reading device 207 (described below) and a processing circuit 209 that controls the reading device 207 and other parts of the cell manufacturing apparatus 200. The processing circuit 84 of the door opening / closing unit 80 performs various processes based on signals from the cell manufacturing apparatus 200, for example.

[0033] The opening / closing drive mechanism 81 is a mechanism for opening and closing an opening / closing section provided in the first outer cover 90, which will be described later. Specifically, the opening / closing drive mechanism 81 is a mechanism for opening and closing a hinged door of the opening / closing section provided in the first outer cover 90. The opening / closing drive mechanism 81 is, for example, a motor. Note that the opening / closing drive mechanism 81 is not limited to a motor, and may be any device that opens and closes the hinged door of the opening / closing section.

[0034] The auxiliary storage device 82 is a storage device that stores various information, such as an HDD (Hard disk Drive), an SSD (Solid State Drive), an integrated circuit storage device, etc. In addition to an HDD or SSD, the auxiliary storage device 82 may be a storage device that reads and writes various information from / to portable storage media such as a CD (Compact Disc), a DVD (Digital Versatile Disc), or a flash memory, or a semiconductor memory element such as a RAM (Random Access Memory).

[0035] The connection interface 83 includes, for example, a communication interface. The communication interface performs data communication with, for example, the cell manufacturing apparatus 200. The communication standard between the communication interface and the network may be any standard, such as a wireless communication standard. The information storage unit will be described in detail later.

[0036] The processing circuitry 84 controls the overall operation of the door opening / closing unit 80 in accordance with information output from the auxiliary storage device 82 or the connection interface 83. For example, the processing circuitry 84 has, as hardware resources, processors such as a CPU (Central Processing Unit), an MPU (Micro Processing Unit), and a GPU (Graphics Processing Unit), and memories such as a ROM (Read Only Memory) and a RAM.

[0037] In addition, processing circuitry 84 may be realized by an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), other complex programmable logic devices (CPLDs), simple programmable logic devices (SPLDs), etc.

[0038] The processing circuitry 84 has, for example, an acquisition function 841, a detection function 842, and a control function 843. The acquisition function 841, the detection function 842, and the control function 843 are each stored in the auxiliary storage device 82 in the form of a program executable by a computer. The processing circuitry 84 executes the acquisition function 841, the detection function 842, and the control function 843 by a processor that executes a program deployed in the memory of the processing circuitry 84 itself.

[0039] That is, the processing circuitry 84 corresponds to a processor that reads out programs from the auxiliary storage device 82 and executes them to realize the functions corresponding to each program. In other words, the processing circuitry 84, in a state where each program has been read out, has the functions corresponding to the read out programs. Note that each function in the detection function 842 and the control function 843 is not limited to being realized by a single processing circuit. A processing circuit may be configured by combining multiple independent processors, and each processor may execute a program to realize each function in the acquisition function 841, the detection function 842, and the control function 843. The processing circuitry 84 that realizes the acquisition function 841, the detection function 842, and the control function 843 is an example of an acquisition unit, a detection unit, and a control unit.

[0040] The processing circuit 84 acquires the identification information output from the connection interface 83 using the acquisition function 841. The acquisition function 841 stores the acquired identification information in the auxiliary storage device 82. Details of the identification information will be described later.

[0041] The processing circuit 84 detects that the door has been opened by the detection function 842. The detection function 842 stores opening information indicating that the door has been opened in the auxiliary storage device 82. The door will be described in detail later.

[0042] The processing circuit 84 controls the entire door opening / closing unit 80 using a control function 843. For example, the control function 843 controls the opening / closing drive mechanism 81 in accordance with the identification information. For example, when the reading device 207 reads the identification information stored in the information storage unit, the control function 843 determines which of the multiple opening / closing units to open based on the identification information of the biological sample container or reagent container, and controls the opening / closing drive mechanism 81.

[0043] 2, the opening of the storage container 70 is covered with a first outer cover 90 and a second outer cover 97. In order to prevent leakage of reagents or samples inside the storage container 70 and to prevent foreign matter from entering the storage container 70 from the outside, it is preferable to provide packing or the like on the portions (frames) of the first outer cover 90 and the second outer cover 97 that come into contact with the storage container 70.

[0044] The container 70 may have a double (multiple) structure for each compartment. For example, when culturing iPS cells, the container may have a double structure divided into a compartment for delivering reagents such as culture media, a compartment for blood cell separation, a compartment for expansion culture, a compartment for factor introduction, and a compartment for plate culture and recovery.

[0045] Next, the first outer cover 90 and the second outer cover 97 will be described. The first outer cover 90 and the second outer cover 97 are members that close the opening of the storage container 70. The first outer cover 90 and the second outer cover 97 are formed of, for example, a hard resin. The first outer cover 90 and the second outer cover 97 are attached to the storage container 70 using fastening parts such as screws so as to cover the opening of the storage container 70.

[0046] The first outer cover 90 also includes a plurality of opening / closing sections, an information storage section, a notification section, and a display section. The plurality of opening / closing sections are opening / closing mechanisms that allow an operator to access connectors for connecting biological sample containers that store biological samples and reagent containers that store reagents. The opening / closing sections are provided on the first outer cover 90 so as to cover the front of a space for installing containers (container installation space) that is provided near the liquid delivery container 20. The opening / closing sections are members for connecting reagent containers to the connectors and installing them in the cartridge 100. For example, the opening / closing sections have a hinged door that opens toward the outside of the cartridge 100. Furthermore, for example, the opening / closing sections may have a sliding door structure that slides along the outer surface of the first outer cover 90.

[0047] The opening / closing unit also has an opening / closing drive mechanism 81 for opening and closing based on control by the processing circuit 84. Specifically, the opening / closing unit has an opening / closing drive mechanism 81 for opening and closing the hinged door based on control by the control function 843 of the processing circuit 84 of the door opening / closing unit 80. It is preferable that the multiple opening / closing units have packing or the like so that the hinged door and the opening are in close contact with each other in the closed state. In other words, it is preferable that the multiple opening / closing units seal the container installation space in the closed state. This realizes a double closed system structure including the container installation space.

[0048] The information storage unit stores identification information for identifying the cartridge 100. A mark that encodes the identification information of the cartridge 100 is attached to the information storage unit. The mark is, for example, a barcode, a one-dimensional pixel code, or a two-dimensional pixel code. The information storage unit is, for example, configured as an RFID (Radio Frequency Identification) tag. In other words, the RFID tag stores identification information for identifying the cartridge 100.

[0049] The notification unit notifies various pieces of information output by the control function 843 of the processing circuit 84. The notification unit is, for example, a speaker.

[0050] The display unit displays various types of information output by the control function 843 of the processing circuit 84. The display unit is, for example, a display. As the display, for example, a liquid crystal display (LCD), an organic electroluminescence display (OLED), or any other display can be used as appropriate.

[0051] Here, the flow of operations by which an operator connects a reagent container to the connection flow channel 10 and places it in the cartridge 100 will be described.

[0052] Fig. 4 is a schematic diagram illustrating an example of the procedure for installing a reagent container in a cartridge 100 according to an embodiment. Fig. 4 shows the first outer cover 90 as viewed from the front of the cartridge 100. Fig. 4 also shows a plurality of opening / closing units 91 and 92 on the first outer cover 90, an information storage unit 93 on the cartridge 100, an alarm unit 94, and a display unit 95. Here, the opening / closing unit 91 corresponds to the connection flow channel 10 in which a biological sample container is to be installed, and the opening / closing unit 92 corresponds to the connection flow channel 10 in which a reagent container is to be installed.

[0053] The biological sample container 201 shown in Fig. 4 comprises an information storage section 202 that stores identification information for identifying the biological sample, and a connector 203 that connects to the connection flow path 10. The reagent container 204 shown in Fig. 4 also comprises an information storage section 205 that stores identification information for identifying the reagent, and a connector 206 that connects to the connection flow path 10. Fig. 4 also shows a reading device 207 that reads the information storage section 202 attached to the biological sample container 201 and the information storage section 205 attached to the reagent container 204.

[0054] The reading device 207 is, for example, a barcode reader capable of optically reading optical marks, and is connected to the cell manufacturing apparatus 200. The information storage units 93, 202, and 205 described above are provided with optical marks, such as barcodes, that encode identification information. The information storage units 93, 202, and 205 may be formed from, for example, RFID tags.

[0055] For example, an operator uses the reading device 207 to read the optical mark attached to the information storage section 93 of the cartridge 100, and the identification information indicated by the optical mark read by the reading device 207 is sent to the connection interface 83 of the door opening / closing unit 80 via the circuitry of the cell manufacturing apparatus 200. In addition, the acquisition function 841 of the door opening / closing unit 80 acquires the identification information through the connection interface 83 and stores the acquired identification information in the auxiliary storage device 82.

[0056] Here, the identification information held by the information holding unit 93 of the cartridge 100 will be described with reference to Fig. 5. Fig. 5 is a table showing an example of the identification information of the cartridge 100 according to this embodiment. Table T1 shown in Fig. 5 is information that associates steps such as cell culture with reagents used in the steps. In other words, the identification information held by the information holding unit 93 of the cartridge 100 is information that includes step information indicating the step such as cell culture, and reagent information indicating the reagent used in the step.

[0057] 5, since different reagents are placed in the cartridge 100 for each process, reagent information relating to different reagents is associated with each process. Note that the identification information of the cartridge 100 may be information including the biological sample in that process.

[0058] Returning to FIG. 4, the control function 843 of the door opening / closing unit 80 controls the alarm unit 94 to output audio information corresponding to the identification information based on the identification information of the cartridge 100. The alarm unit 94 then outputs the audio information. The audio information is, for example, information related to a process included in the process information. The control function 843 of the door opening / closing unit 80 also controls the display unit 95 to display text information corresponding to the identification information based on the identification information of the cartridge 100. The display unit 95 then displays the text information. The text information is, for example, information related to a process included in the process information.

[0059] Next, the procedure for placing the biological sample container 201 in the connection flow channel 10 will be described. For example, an operator uses a reading device 207 to read the information storage unit 202 of the biological sample container 201, and the reading device 207 outputs the identification information stored in the information storage unit 202 to the connection interface 83 of the door opening and closing unit 80. Furthermore, an acquisition function 841 of the door opening and closing unit 80 acquires the identification information output from the connection interface 83 and stores the acquired identification information in the auxiliary storage device 82.

[0060] Furthermore, the control function 843 of the door opening / closing unit 80 controls the alarm unit 94 to output audio information corresponding to the identification information, based on the identification information of the biological sample container 201. The alarm unit 94 then outputs the audio information. Furthermore, the control function 843 of the door opening / closing unit 80 controls the display unit 95 to display text information corresponding to the identification information, based on the identification information of the biological sample container 201. The alarm unit 94 then displays the text information.

[0061] The control function 843 of the door opening / closing unit 80 controls the opening / closing drive mechanism 81 of the opening / closing part 92 based on the identification information of the biological sample container 201 and the identification information of the cartridge 100. For example, when the identification information of the biological sample container 201 is included in the identification information of the cartridge 100, the control function 843 controls the opening / closing drive mechanism 81 of the opening / closing part 92 to operate.

[0062] Also, for example, the control function 843 controls the opening / closing drive mechanism 81 of the opening / closing unit 92 not to operate when the identification information of the biological sample container 201 is not included in the identification information of the cartridge 100. Furthermore, for example, the control function 843 controls the opening / closing drive mechanism 81 of the opening / closing unit 92 not to operate when the identification information of the biological sample container 201 is included in the identification information of the cartridge 100 but the biological sample container 201 is already connected to the connection part of the connection flow channel 10.

[0063] In other words, the control function 843 determines whether there is a shortage of an item based on the identification information of the biological sample container 201 and the identification information of the cartridge 100, and if it determines that there is a shortage of an item, controls the opening / closing drive mechanism 81 of the opening / closing section 92 to operate.

[0064] The opening / closing drive mechanism 81 then opens the opening / closing part 91. The detection function 842 of the door opening / closing unit 80 detects that the opening / closing part 91 has been opened, and controls the notification part 94 to output audio information corresponding to opening information indicating that the opening / closing part 91 has been opened. The notification part 94 then outputs the audio information. With the opening / closing part 91 now open, the operator connects the connection part 203 of the biological sample container 201 to the connection part of the connection flow path 10, and closes the opening / closing part 91.

[0065] Next, a procedure for placing the reagent container 204 in the connection flow path 10 will be described. For example, an operator uses the reading device 207 to read the information storage unit 205 of the reagent container 204, and the reading device 207 outputs the identification information stored in the information storage unit 205 to the connection interface 83 of the door opening and closing unit 80. Furthermore, the acquisition function 841 of the door opening and closing unit 80 acquires the identification information output from the connection interface 83 and stores the acquired identification information in the auxiliary storage device 82.

[0066] Furthermore, the control function 843 of the door opening / closing unit 80 controls the alarm unit 94 to output audio information corresponding to the identification information, based on the identification information of the reagent container 204. The alarm unit 94 then outputs the audio information. Furthermore, the control function 843 of the door opening / closing unit 80 controls the display unit 95 to display text information corresponding to the identification information, based on the identification information of the reagent container 204. The alarm unit 94 then displays the text information.

[0067] The control function 843 of the door opening / closing unit 80 determines which of the multiple opening / closing parts 92 to open based on the identification information of the reagent container 204 and the identification information of the cartridge 100, and controls the opening / closing drive mechanism 81 of the determined opening / closing part 92. For example, when the identification information of the reagent container 204 is included in the identification information of the cartridge 100, the control function 843 determines which of the multiple opening / closing parts 92 to open, and controls the opening / closing drive mechanism 81 of the opening / closing part 92 to operate.

[0068] Also, for example, if the identification information of the reagent container 204 is not included in the identification information of the cartridge 100, the control function 843 determines that none of the multiple open / close units 92 should be opened, and controls the open / close drive mechanism 81 of the open / close units 92 not to operate. Furthermore, for example, if the identification information of the reagent container 204 is included in the identification information of the cartridge 100 but the reagent container 204 is already connected to the connecting part of the connection flow path 10, the control function 843 controls the open / close drive mechanism 81 of the open / close unit 92 not to operate.

[0069] In other words, the control function 843 determines whether an item is in short supply based on the identification information of the reagent container 204 and the identification information of the cartridge 100, and if it determines that an item is in short supply, controls the opening / closing drive mechanism 81 of the opening / closing section 92 to operate.

[0070] Then, the open / close drive mechanism 81 opens the open / close section 92. Furthermore, the detection function 842 of the door open / close unit 80 detects that the open / close section 92 has been opened, and performs control so that the notification section 94 outputs audio information corresponding to opening information indicating that the open / close section 92 has been opened. The notification section 94 then outputs the audio information. With the open / close section 92 now open, the operator connects the connection section 206 of the reagent container 204 to the connection section of the connection flow path 10, and closes the open / close section 92.

[0071] In the above-described embodiment, when the control function 843 of the door opening / closing unit 80 controls the opening / closing drive mechanism 81 of the opening / closing section 91 and the opening / closing section 92 so as not to operate, the notification section 94 or the display section 95 may output information indicating that the relevant container is not a biological sample container 201 or a reagent container 204 in the relevant process and / or information indicating some kind of error.

[0072] As a method for outputting information indicating that the biological sample container 201 or reagent container 204 is not the one for the process, for example, a natural language message such as "This is not the reagent to be used in the process" is output by the notification unit 94 and / or displayed on the display unit 95. In addition, as a method for displaying information indicating some kind of error, for example, a beep is emitted from the notification unit 94 and / or an error icon is displayed on the display unit 95.

[0073] In the above description, the control function 843 of the door opening / closing unit 80 controls the opening / closing drive mechanism 81 of the opening / closing section 91 and the opening / closing section 92. However, the control function 843 may be provided in the processing circuit 209 of the cell manufacturing apparatus 200, and the opening / closing drive mechanism 81 may be driven based on control by the processing circuit 209 of the cell manufacturing apparatus 200. Furthermore, the acquisition function 841 and detection function 842 of the door opening / closing unit 80 may also be provided in the processing circuit 209 of the cell manufacturing apparatus 200, and the auxiliary storage device 82 may also be provided in the cell manufacturing apparatus 200. In this case, the door opening / closing unit 80 does not need to be provided with a processing circuit 84.

[0074] As described above, the cartridge 100 according to the embodiment is a cartridge 100 for processing cells internally, and includes a flow path through which a reagent used for the processing flows, a connection part for connecting a reagent container containing the reagent to the flow path, and an opening / closing part for connecting the reagent container to the connection part and installing it in the cartridge 100.

[0075] Moreover, the cartridge 100 according to the embodiment further includes an information storage unit that stores identification information for identifying the cartridge 100. Furthermore, the cartridge 100 according to the embodiment further includes a detection unit that detects that the opening / closing unit has been opened. The cartridge 100 according to the embodiment includes a plurality of opening / closing units, each having an opening / closing drive mechanism 81 for opening and closing based on the control of a device in which the cartridge 100 is installed.

[0076] In the cartridge 100 of this embodiment, for example, an operator uses a reading device 207 to read an optical mark attached to the information storage unit 93 of the cartridge 100, and the acquisition function 841 of the door opening / closing unit 80 or the processing circuit 209 of the cell manufacturing device 200 acquires identification information including process information indicating a process such as cell culture, and reagent information indicating the reagent used in that process, which is stored in the information storage unit 93 of the cartridge 100.

[0077] In addition, the operator uses the reading device 207 to read the information storage unit 202 of the biological sample container 201 or the information storage unit 205 of the reagent container 204, and the control function 843 of the door opening / closing unit 80 or the processing circuit 209 of the cell manufacturing device 200 controls the alarm unit 94 to output audio information corresponding to the identification information based on the identification information of the biological sample container 201 or the reagent container 204, and the alarm unit 94 outputs the audio information.

[0078] Furthermore, the control function 843 of the door opening / closing unit 80 or the processing circuit 209 of the cell manufacturing apparatus 200 controls the display unit 95 to display text information corresponding to the identification information based on the identification information of the biological sample container 201 or reagent container 204, and the notification unit 94 displays the text information. This allows the operator to know the identification information of the biological sample container 201 or reagent container 204 to be placed in the cartridge 100.

[0079] The control function 843 of the door opening / closing unit 80 or the processing circuit 209 of the cell manufacturing apparatus 200 determines which of the multiple opening / closing sections to open based on the identification information of the biological sample container 201 or the identification information of the reagent container 204 and the identification information of the cartridge 100, and controls the opening / closing drive mechanism 81 of the determined opening / closing section, and the opening / closing drive mechanism 81 opens the opening / closing section. In addition, the detection function 842 of the door opening / closing unit 80 or the processing circuit 209 of the cell manufacturing apparatus 200 detects that the opening / closing section has been opened, and controls the alarm section 94 to output audio information corresponding to the opening information indicating that the opening / closing section 91 has been opened, and the alarm section 94 outputs the audio information.

[0080] Then, the operator connects the connection part of the biological sample container 201 or the reagent container 204 to the connection part of the connection flow path 10 through the opened opening / closing part, and closes the opening / closing part. This allows the operator to prevent incorrect connection of the biological sample container 201 or the reagent container 204.

[0081] Therefore, the cartridge 100 according to the embodiment can reduce the complexity of incorporating reagents into a cartridge for cell processing.

[0082] It should be noted that each of the above-described embodiments can be modified as appropriate by partially changing the configuration or functions of each device. Therefore, the following describes modifications of each of the above-described embodiments as other embodiments. The following mainly describes differences from the above-described embodiments, and omits detailed descriptions of commonalities with the contents already described. The modifications described below may be implemented individually or in combination with the above-described embodiments as appropriate.

[0083] (First Modification) For example, the first outer cover 90 may further include a plurality of notification units for notifying the user of the opening / closing units corresponding to the connection units to which the reagent containers should be connected. The plurality of notification units will now be described with reference to FIG.

[0084] FIG. 6 is a schematic diagram showing an example of the configuration of a first outer cover 90 according to a first modified example. The first outer cover 90 shown in FIG. 6 further includes a plurality of notification units 96 in addition to the first outer cover 90 shown in FIG. 4. The notification units 96 are, for example, light-emitting diodes (LEDs). The notification units 96 are each located near an opening / closing unit, for example, below the opening / closing unit. That is, the notification units 96 are provided at positions corresponding to each of the plurality of opening / closing units.

[0085] The notification unit 96 notifies the user by emitting light corresponding to the reagent container to be placed. The notification unit 96 is controlled by the acquisition function 841 of the door opening / closing unit 80. Specifically, the acquisition function 841 of the door opening / closing unit 80 controls the notification unit 96 to emit light corresponding to the identification information based on the identification information of the reagent container 204. Then, the notification unit 96 emits light.

[0086] Furthermore, the notification unit 96 notifies the user of the opening / closing unit corresponding to the connection unit to which the reagent container should be connected by emitting light. The notification unit 96 is controlled by the detection function 842 of the door opening / closing unit 80. Specifically, when the detection function 842 of the door opening / closing unit 80 detects that the opening / closing unit has been opened, it controls the notification unit 96 to emit light corresponding to the opening information showing that the opening / closing unit 91 has been opened. Then, the notification unit 96 emits light.

[0087] This allows the operator to confirm that the opening / closing section has been opened by the light emitted, and therefore allows connection to the connecting flow path 10 that connects the biological sample container 201 and the reagent container 204 without making an incorrect connection.

[0088] In this modification, the processing circuitry 84 or its functions may also be provided in the cell manufacturing apparatus 200. The auxiliary storage device 82 may also be provided in the cell manufacturing apparatus 200.

[0089] (Second Modification) For example, the hinged door of the opening / closing unit 92 may be provided with a holding portion for holding the connection portion 11 of the connection flow path 10. Here, the holding portion will be described with reference to FIGS.

[0090] 7 and 8 are schematic diagrams showing an example of the configuration of an opening / closing unit 92 according to a second modified example. The opening / closing unit 92 shown in FIG. 7 corresponds to the opening / closing unit 92 shown in FIG. 4. The opening / closing unit 92 shown in FIGS. 7 and 8 shows a state in which the hinged door 921 is open. The opening / closing unit 92 shown in FIGS. 7 and 8 has a holding portion 922 for holding the connecting portion 11 of the connection flow path 10. The holding portion 922 holds the connecting portion 11 of the connection flow path 10 in advance.

[0091] 7 is a diagram showing an example of a mechanism in which the holding portion 922 is provided on the hinged door 921. According to this mechanism, as the opening / closing portion 92 opens, the hinged door 921 rotates and the holding portion 922 moves closer to the operator, allowing the operator to easily access the connection portion 11 held by the holding portion 922. In other words, as the opening / closing portion 92 opens, the holding portion 922 operates so that the holding portion 922 faces the outside of the cartridge 100 through the opening of the opening / closing portion 92.

[0092] The operator removes the connection part 11 of the connection flow path 10 from the holder 922, connects it to the connection part of the reagent container, and places and installs the reagent container in the container installation space 923. Then, the operator closes the hinged door 921 to bring the opening / closing part 92 into the closed state.

[0093] 8 is a diagram showing an example of another mechanism in which the holding portion 922 is provided on the underside of the container installation space 923. The holding portion 922 is installed on the underside of the container installation space 923 via, for example, a spring-loaded hinge, and is biased in a direction in which it leans against the hinged door 921.

[0094] As a result, as the opening / closing portion 92 opens, the holding portion 922 and the connection portion 11 held thereby face the outside of the cartridge 100 through the opening of the opening / closing portion 92, and more preferably, at least a portion of the connection portion 11 operates to protrude from the opening, allowing the operator to easily access the connection portion 11 held by the holding portion 922.

[0095] The operator removes the connection part 11 of the connection flow path 10 from the holder 922, connects it to the connection part of the reagent container, and places and installs the reagent container in the container installation space 923. The operator then closes the hinged door 921 to close the opening / closing part 92. In this modified example, the processing circuit 84 or its functions may also be provided in the cell manufacturing apparatus 200. The auxiliary memory device 82 may also be provided in the cell manufacturing apparatus 200.

[0096] (Third Modification) For example, the display unit 95 may output display information indicating the correspondence between the reagent container and the opening / closing unit to be placed in the container placement space 923. The display information will now be described with reference to FIGS.

[0097] Fig. 9 is a table showing an example of identification information according to the third modified example. Table T2 shown in Fig. 9 assigns colors to each of the reagent containers 204, in comparison with table T1 shown in Fig. 5. In other words, the identification information stored in the information storage unit 93 of the cartridge 100 according to the third modified example is information including process information indicating a process such as cell culture performed in the cartridge 100, reagent information indicating the reagents used in the process, and color information assigning colors to the reagents.

[0098] Fig. 10 is a schematic diagram showing an example of display information output by a display unit according to the third modified example. The display information displayed by the display unit 95 shown in Fig. 10 shows step 951, which is part of the identification information in table T2 shown in Fig. 9, and color information assigned to the reagent in that step. Step 951 shown in Fig. 10 is text information indicating the step "P0-A." Colors 952, 953, 954, and 955 of the color information shown in Fig. 10 correspond to, for example, the step "P0-A," and for example, color 952 is "red," color 953 is "yellow," color 954 is "green," and color 955 is "blue."

[0099] For example, the control function 843 of the door opening / closing unit 80 controls the display unit 95 to display text information and color information corresponding to the identification information based on the identification information of the cartridge 100. In particular, the control function 843 displays color information of the reagent to be placed on a schematic diagram showing the position where the reagent should be placed.

[0100] 10, the display unit 95 displays text information and also displays color information at a position indicating the position of the corresponding reagent on a schematic diagram showing the cartridge 100. This allows the operator to understand the process of the cartridge 100 and the color information corresponding to the identification information of the reagent to be placed in each container placement space 293 of the cartridge 100. The display unit 95 is an example of a display unit that shows the correspondence between the reagent containers to be placed and the opening / closing unit. In this modified example, the processing circuit 84 or its functions may also be provided in the cell manufacturing apparatus 200. The auxiliary memory device 82 may also be provided in the cell manufacturing apparatus 200.

[0101] (Fourth Modification) Instead of the display constituting the display unit according to the third modification, the cartridge 100 according to this modification has a label (step label) showing information about a step such as cell culture performed in the cartridge 100, and a label (reagent installation label) showing the correspondence between the reagent containers and the opening / closing units. The step label and reagent installation label are affixed to, for example, the first outer cover 90. The reagent installation label is an example of a display unit showing the correspondence between the reagent containers to be installed and the opening / closing units.

[0102] The step label displays text indicating information about a step, such as cell culture, that is performed in the cartridge 100. This allows the operator to grasp at a glance the step that is performed in the cartridge 100, and to recognize, for example, the combination of reagents used in the cartridge 100. For example, a combination of reagents for each step is configured as a kit, and the operator can refer to the step label to select the kit for that step.

[0103] The reagent installation label indicates information on which reagent to install in which opening / closing section for use in the cartridge 100. For example, in a kit of the above-mentioned reagent combinations, each reagent is assigned a color, and the reagent installation label of the cartridge 100 indicates the correspondence between the color and the position of the opening / closing section. Specifically, for example, like the notification section 96 in the first modified example, a reagent installation label of a color corresponding to the reagent to be installed is provided for each of the multiple opening / closing sections used to install the reagents. The reagent installation labels are located, for example, near each opening / closing section, for example, below the opening / closing section.

[0104] Furthermore, the corresponding relationship between the color and the position of the opening / closing part on the reagent placement label may be shown in a diagram. In this case, it is sufficient that one reagent placement label is provided for the first outer cover 90, for example.

[0105] The above-described embodiments and modifications have been described using as examples a cell production cartridge, a cell production device, and a cell production system for producing iPS cells, but the embodiments are not limited to these. For example, the above-described embodiments can also be applied to the production of cells other than iPS cells. Furthermore, they can also be applied to cartridges, devices, and systems that only process cells, not just for cell production. The production of iPS cells and the processes involved therein are examples of "cell processing."

[0106] According to at least one of the embodiments described above, in a cartridge for cell processing, it is possible to reduce the complexity of incorporating reagents into the cartridge.

[0107] Although several embodiments have been described, these embodiments are presented as examples and are not intended to limit the scope of the invention. These embodiments can be implemented in various other forms, and various omissions, substitutions, modifications, and combinations of embodiments can be made without departing from the spirit of the invention. These embodiments and their modifications are included within the scope and spirit of the invention, as well as within the scope of the invention and its equivalents as defined in the claims. [Explanation of symbols]

[0108] 10...connection flow path, 11...connection part, 20...liquid supply container, 21...culture container, 22...waste liquid container, 80...door opening / closing unit, 81...opening / closing drive mechanism, 82...auxiliary storage device, 83...connection interface, 84...processing circuit, 90...first outer cover, 91, 92... Opening and closing section, 93... Information storage section, 94, 96... Notification section, 95... Display section, 97... second outer cover, 100... cartridge, 200... cell production device, 201...biological sample container, 202...information storage unit, 203...connection unit, 204...reagent container, 205...information storage unit, 206...connection unit, 207...reading device, 208...connection interface, 209...processing circuit, 841...acquisition function, 842...detection function, 843...control function, 921...swing door, 922...holding part

Claims

1. A cartridge for processing cells therein, a flow path through which a reagent used in the treatment flows; a connecting portion for connecting a reagent container containing the reagent to the flow path; an opening / closing part for connecting the reagent container to the connecting part and placing the reagent container on the cartridge; A cartridge comprising:

2. further comprising an information storage unit that stores identification information for identifying the cartridge; The cartridge of claim 1 .

3. Further provided is a detection unit that detects that the opening / closing unit is opened. The cartridge of claim 1 .

4. A plurality of the opening and closing sections are provided, Further provided is an opening / closing drive mechanism for opening and closing the opening / closing unit, and a control unit for controlling the opening / closing drive mechanism. The cartridge of claim 1 .

5. the cartridge is installed in a cell processing device that controls the execution of processing of the cells within the cartridge, and A plurality of the opening and closing sections are provided, the opening / closing unit has an opening / closing drive mechanism for opening and closing under the control of the cell processing device; The cartridge of claim 1 .

6. A plurality of the opening and closing sections are provided, a plurality of notification units for notifying a user of an opening / closing unit corresponding to the connection unit to which the reagent container should be connected; The cartridge of claim 1 .

7. the plurality of notification units notify the user of the opening / closing unit corresponding to the connection unit to which the reagent container should be connected by emitting light. The cartridge of claim 6.

8. the plurality of notification units notify the user by emitting light corresponding to the reagent container to be installed. The cartridge of claim 7.

9. the opening / closing section has a hinged door that opens toward the outside of the cartridge, The hinged door includes a holding portion for holding a connecting portion for connecting the reagent container. The cartridge of claim 1 .

10. a holder for holding a connection part for connecting the reagent container, the holding portion operates in response to the opening of the opening / closing portion so that the holding portion faces the outside of the cartridge through the opening of the opening / closing portion; The cartridge of claim 1 .

11. A plurality of the opening and closing sections are provided, a display unit that indicates the correspondence between the reagent container to be installed and the opening / closing unit; The cartridge of claim 1 .

12. A system including the cartridge according to claim 5 and the cell processing device, The cell processing device includes a control unit that controls the opening and closing drive mechanism of the installed cartridge. system.

13. the control unit determines which of the plurality of opening / closing units to open based on the identification information of the reagent. The system of claim 12.

14. A system including the cartridge according to claim 6 and a cell processing device in which the cartridge is installed, the cell processing device determines which of the plurality of notification units will notify based on the identification information of the reagent. system.

15. A system including the cartridge according to claim 2 and a cell processing device in which the cartridge is installed, the information storage unit of the cartridge includes an RFID (Radio Frequency Identification) tag; the cell processing device determines a shortage of an item based on the RFID tag in the information storage unit and the RFID tag attached to the reagent container; system.

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