JP7719484B2 - Mixed injection device - Google Patents

Description

The present invention relates to a co-infusion device that performs a co-infusion process in which a drug, such as an anticancer drug, contained in a drug container is injected into an infusion container.

A co-infusion device is known that performs a co-infusion process in which a drug, such as an anticancer drug, contained in a drug container such as a vial is drawn into a syringe and then injected into an infusion container containing an infusion (see, for example, Patent Document 1). If the drug contained in the drug container is a powder, the co-infusion process includes a mixing step in which a solvent, such as an infusion, is injected into the drug container and the drug in the drug container is mixed. The mixing step may also be performed when the drug is a liquid.

JP 2012-250016 A

However, the mixing process can take a relatively long time, and the waiting time until the mixing process is completed can hinder the efficiency of the co-injection process.

The object of the present invention is to provide a co-infusion device that can efficiently perform co-infusion processing, including a mixing process for mixing medicines.

The co-infusion device of the present invention includes a co-infusion processing unit that performs a co-infusion process based on preparation data, including an injection process of injecting a drug from a first container into a second container; a mixing device used in a mixing process that mixes the drug from the first container used in the co-infusion process; and a pre-mixing processing unit that can perform the mixing process before the timing at which the co-infusion process based on the preparation data is started.

The co-infusion device of the present invention also includes a co-infusion processing unit that performs a co-infusion process based on preparation data, including an injection step of injecting a drug from a first container into a second container, and a reservation setting processing unit that can selectively accept the following reservation conditions: a time-specified reservation that executes the co-infusion process based on an execution start timing set by a user operation; an unspecified time reservation that executes the co-infusion process at a timing when the execution start timing is not set by a user operation and no other co-infusion processes are being executed; and an ad hoc reservation that executes the co-infusion process in priority over the preparation data reserved for the time-specified reservation and the unspecified time reservation.

The present invention provides a co-infusion device that can efficiently perform co-infusion processing, including a mixing step for mixing chemicals.

FIG. 1 is a block diagram showing the system configuration of a co-infusion apparatus according to an embodiment of the present invention. FIG. 2 is a perspective view showing the external configuration of the co-infusion device according to the embodiment of the present invention. FIG. 3 is a perspective view of a state in which a part of a storage unit of a co-infusion device according to an embodiment of the present invention is omitted. FIG. 4 is a front view of the co-infusion device according to the embodiment of the present invention with the main door and a part of the front wall removed. FIG. 5 is a perspective view showing a tray used in the co-infusion apparatus according to the embodiment of the present invention. FIG. 6 is a perspective view of the co-infusion device according to the embodiment of the present invention, seen from below. FIG. 7 is a perspective view showing a holding part of a first robot arm of the co-infusion apparatus according to the embodiment of the present invention. FIG. 8 is a perspective view showing a holding part of a second robot arm of the co-infusion apparatus according to the embodiment of the present invention. FIG. 9 is a schematic plan view showing the tray transport unit of the co-infusion apparatus according to the embodiment of the present invention. FIG. 10 is a perspective view showing the mechanism of the tray transport unit of the co-infusion apparatus according to the embodiment of the present invention. FIG. 11 is a perspective view showing an ampoule cutter of the co-infusion apparatus according to the embodiment of the present invention. FIG. 12 is a perspective view showing the internal configuration of the stirring device of the co-infusion apparatus according to the embodiment of the present invention. FIG. 13 is a perspective view showing a medicine reading unit of a co-infusion apparatus according to an embodiment of the present invention. FIG. 14 is a perspective view showing a needle bending detection unit of a co-infusion apparatus according to an embodiment of the present invention. FIG. 15 is a perspective view showing the internal structure of the injection needle attaching/detaching device of the co-infusion apparatus according to the embodiment of the present invention. FIG. 16 is a perspective view showing the internal structure of the injection needle attaching/detaching device of the co-infusion apparatus according to the embodiment of the present invention. FIG. 17 is a diagram showing an example of an image captured by the needle insertion confirmation camera of the co-infusion apparatus according to the embodiment of the present invention. FIG. 18 is a diagram showing the configuration of a storage unit of a co-infusion apparatus according to an embodiment of the present invention. FIG. 19 is a diagram showing the configuration of a storage unit of a co-infusion apparatus according to an embodiment of the present invention. FIG. 20 is a diagram showing the configuration of a storage unit of a co-infusion apparatus according to an embodiment of the present invention. FIG. 21 is a diagram showing the configuration of a storage unit of a co-infusion apparatus according to an embodiment of the present invention. FIG. 22 is a flowchart showing an example of the procedure of the loading preparation process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 23 is a flowchart showing an example of the procedure of the co-infusion control process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 24 is a flowchart showing an example of the procedure of the batch preparation inspection process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 25 is a flowchart showing an example of the procedure of the batch mixing inspection process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 26 is a flowchart showing an example of the procedure of a schedule management process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 27 is a diagram showing an example of a display screen in the schedule management process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 28A is a diagram showing an example of a display screen in a schedule management process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 28B is a diagram showing an example of a display screen in the schedule management process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 28C is a diagram showing an example of a display screen in the schedule management process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 29 is a flowchart showing an example of the procedure of a batch total collection inspection process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 30 is a perspective view showing the external configuration of the co-infusion apparatus according to the embodiment of the present invention. FIG. 31 is a diagram showing an example of a display screen in the schedule management process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 32 is a diagram showing an example of a display screen in the schedule management process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 33 is a diagram showing an example of a display screen in the schedule management process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 34 is a diagram showing an example of a display screen in the schedule management process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 35 is a diagram showing an example of a display screen in the schedule management process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 36 is a flowchart showing an example of the procedure of the loading preparation process executed by the co-infusion apparatus according to the embodiment of the present invention. FIG. 37 is a diagram showing the configuration of a storage unit of a co-infusion apparatus according to an embodiment of the present invention.

[First embodiment]
Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings to help understand the present invention. Note that the following embodiments are examples that embody the present invention and are not intended to limit the technical scope of the present invention.

[Mixed injection device 1]
1 and 2, the co-infusion device 1 according to this embodiment includes a co-infusion control unit 100, a drug loading unit 200, a co-infusion processing unit 300, a storage unit 700, and an agitator 32. In the co-infusion device 1, the co-infusion control unit 100 controls the operation of the co-infusion processing unit 300 and the storage unit 700 based on preparation data, thereby executing a co-infusion process in which a drug, such as an anticancer drug, indicated in the preparation data is injected with a syringe from a first container, such as one or more ampoules or vials, containing a predetermined amount of the drug, into a second container, such as an infusion bag. The co-infusion process also includes a process in which a drug is aspirated from a first container, such as an ampule or vial, with a syringe and injected into a second container, such as another ampule or vial.

[Mixed injection control unit 100]
First, a schematic configuration of the co-injection control unit 100 will be described with reference to Fig. 1. The co-injection control unit 100 includes a first control unit 400 and a second control unit 500 that are communicably connected. The first control unit 400 is provided on the medicine loading unit 200 side, and the second control unit 500 is provided on the co-injection processing unit 300 side.

The division of processing between the first control unit 400 and the second control unit 500 described in this embodiment is merely an example, and each processing procedure, such as the co-infusion processing, may be executed by either the first control unit 400 or the second control unit 500. Another embodiment may also be considered in which the co-infusion control unit 100 has only one control unit or three or more control units. Furthermore, some or all of the processing executed by the first control unit 400 and the second control unit 500 may be executed by an electronic circuit such as an ASIC or DSP.

The first control unit 400 can also communicate with a host system 600, such as an electronic medical record system or a dispensing management system, which inputs preparation data to the co-infusion device 1. The preparation data is preparation data generated based on prescription data, or the prescription data itself. The prescription data includes, for example, the prescription issuance date, patient ID, patient name, patient date of birth, drug information (drug code, drug name, dosage, etc.), dosage form information (oral, topical, etc.), usage information (three times a day after each meal, etc.), type of treatment (outpatient, inpatient, etc.), department, ward, and room. The preparation data also includes, for example, a preparation ID, patient information (patient ID, patient name, etc.), doctor information, drug information, prescribed amount of drug, type of drug container (ampule containing drug solution, vial containing drug solution, vial containing powdered drug, etc.), preparation content information (type and number of drug containers, syringes, and needles used in the mixed injection process, etc.), preparation procedure information (task content, dissolved drug, solvent, amount of dissolved drug, amount of solvent, amount extracted), preparation date, prescription category, administration date, department, ward, designated preparation completion time (or planned start time), required time, etc.

The first control unit 400 is a personal computer equipped with a CPU 401, ROM 402, RAM 403, data storage unit 404, and operation unit 405. In addition, various electrical components provided in the medicine loading unit 200, such as a display 203, a barcode reader 204, and an air purifier 205 (described below), are connected to the first control unit 400.

The CPU 401 is a processor that executes processing in accordance with various control programs. The ROM 402 is non-volatile memory in which programs such as BIOS executed by the CPU 401 are pre-stored. The RAM 403 is volatile or non-volatile memory used by the CPU 401 to expand various control programs and temporarily store data.

The data storage unit 404 is a non-volatile storage device such as a hard disk that stores various application programs and various data for causing the CPU 401 to execute various processes. For example, the data storage unit 404 stores the preparation data input from the host system 600.

The first control unit 400 stores the preparation data input from the host system 600 and the identification information of the tray 101 (described below) corresponding to each of the preparation data in the data storage unit 404. For example, the correspondence between the preparation data and the identification information of the tray 101 is performed by the first control unit 400. It is also possible that information indicating the correspondence between the preparation data and the identification information of the tray 101 is input from the host system 600 to the co-infusion device 1 along with the preparation data.

The data storage unit 404 also stores various databases, such as a needle master, drug master, patient master, doctor master, prescription classification master, medical department master, and ward master. The needle master stores the shape of the needle tip for each type of needle. The shape of the needle tip includes the outer diameter of the needle tube, the angle of the tip, and the length of the cut surface (inclined surface). The drug master also includes information such as the drug code, drug name, JAN code (or RSS), medicine bottle code, classification (dosage form: powder (powder), tablet, liquid medicine, topical medicine, etc.), specific gravity, drug type (ordinary medicine, anticancer drug, poison, narcotic, powerful drug, antipsychotic drug, therapeutic drug, etc.), formulation variations, excipients, precautions, type of medicine container (ampule, vial), medicine capacity per medicine container (predetermined amount), and weight of the medicine container. The medicine master also includes information about the infusion bag 12 containing infusion fluids such as saline or glucose, such as the container type of the infusion bag 12 (soft bag, hard type, AL type), the amount of infusion fluid contained in the infusion bag 12, and the amount of liquid that can be injected into the infusion bag 12.

Furthermore, the data storage unit 404 pre-stores a first co-infusion control program for causing the CPU 401 to execute various processes. The first co-infusion control program may be read from a recording medium such as a CD, DVD, BD, or flash memory by a reading device (not shown) provided in the first control unit 400 and installed in the data storage unit 404.

The operation unit 405 includes various operation units such as a keyboard, mouse, or touch panel that accept various user operations in the first control unit 400.

The second control unit 500 is a personal computer equipped with a CPU 501, ROM 502, RAM 503, data storage unit 504, operation unit 505, etc. Various electrical components provided in the co-infusion processing unit 300, such as a first robot arm 21, a second robot arm 22, a tray transport unit 110, a touch panel monitor 14, an IC reader 101c, an IC reader 15a, a tray confirmation camera 41, and a syringe confirmation camera 42, are connected to the second control unit 500.

The CPU 501 is a processor that executes processing in accordance with various control programs. The ROM 502 is non-volatile memory in which programs such as BIOS executed by the CPU 501 are pre-stored. The RAM 503 is volatile or non-volatile memory used by the CPU 501 to expand various control programs and temporarily store data.

The data storage unit 504 is a hard disk or the like that stores various application programs and various data for causing the CPU 501 to execute various processes. Specifically, the data storage unit 504 pre-stores a second co-infusion control program for causing the CPU 501 to execute the co-infusion process described below. The second co-infusion control program may be read from a recording medium such as a CD, DVD, BD, or flash memory by a reading device (not shown) provided in the second control unit 500 and installed in the data storage unit 504. The data storage unit 504 also stores the same drug master as the data storage unit 404, and the second control unit 500 can reference the drug master. In another embodiment, the second control unit 500 may be configured to acquire information about the drug master via the first control unit 400.

The present invention may also be understood as an invention of the first co-infusion control program, the second co-infusion control program, or a co-infusion control program integrating the first and second co-infusion control programs for causing the CPU 401 and the CPU 501 to execute various processes in the co-infusion control unit 100. The present invention may also be understood as an invention of a computer-readable recording medium on which the first co-infusion control program, the second co-infusion control program, or a co-infusion control program integrating the first and second co-infusion control programs is recorded. Furthermore, the present invention may also be understood as an invention of a co-infusion method including one or more processing procedures executed in the co-infusion device 1.

The operation unit 505 includes various operation units such as a keyboard, mouse, or touch panel that accept various user operations in the second control unit 500.

[Chemical loading section 200]
Next, the general configuration of the medicine loading unit 200 will be described with reference to Figures 2 and 3. Figure 3 is a diagram showing the main internal configuration of the medicine loading unit 200.

As shown in Figures 2 and 3, the drug loading unit 200 is a clean bench equipped with a door 201, a work table 202, a display 203, a barcode reader 204, and an air purifier 205. The drug loading unit 200 and the co-injection processing unit 300 are connected by a tray loading port 114 (see Figure 6) and a tray discharge port 701 (see Figure 21) formed on the side of the co-injection processing unit 300.

The work table 202 is used to perform preparation work for the co-infusion process performed by the co-infusion device 1, and the barcode reader 204, the tray 101, and the like are placed on the work table 202. A tray discharge port 206 that is opened and closed when removing the tray 101 discharged from the storage unit 700 is provided on the front of the work table 202. An IC reader 207 (see Figure 21) that can read information from the IC tag 101b of the tray 101 placed on the work table 202 is also provided within the work table 202. The results of reading by the IC reader 207 are input to the first control unit 400.

The display 203 is a display unit such as a liquid crystal display or organic EL display that displays various information in response to control instructions from the first control unit 400. Specifically, the display 203 displays preparation data that is a candidate for co-infusion in the co-infusion device 1. The barcode reader 204 reads a barcode printed on a prescription or preparation instructions, and inputs the contents of the barcode into the first control unit 400. The air purifier 205 supplies air into the medicine loading unit 200 through a specified filter. The display 203 may be supported, for example, on the front panel 700A (see Figures 18 to 21) of the storage unit 700.

The door 201 is provided on the front of the drug loading unit 200 and is a transparent member that can be opened and closed vertically. As shown in FIG. 2, a user slightly opens the door 201 and places their hand inside the drug loading unit 200 to prepare for the co-infusion process to be performed by the co-infusion device 1. Specifically, as shown in FIG. 5, a tray 101 placed on the work table 202 contains a drug container 10 (an example of a first container), a syringe 11, and an infusion bag 12 (an example of a second container) to be used in the co-infusion process to be performed by the co-infusion device 1. The infusion bag 12 contains a specified amount of infusion fluid, such as physiological saline, glucose, or high-calorie infusion, corresponding to the type of infusion bag 12. The drug contained in the drug container 10 is, for example, an anticancer drug, but may also be a drug other than an anticancer drug. The preparation work includes, for example, a loading work of placing the medicine container 10, the syringe 11, and the infusion bag 12 in predetermined positions on the tray 101 and loading the tray 101 into the storage unit 700. Hereinafter, if the medicine container 10 is an ampoule, the medicine container 10 will be referred to as an ampoule 10A, and if the medicine container 10 is a vial, the medicine container 10 will be referred to as a vial 10B.

As shown in Figure 5, the tray 101 has electronic paper 101a that displays the patient's name, application, etc., in text, and an IC tag 101b (an example of a recording medium) such as an RFID (Radio Frequency Identification) tag from which various information can be read and written. The IC tag 101b is provided on the bottom surface of the tray 101, and stores identification information for identifying the tray 101.

The tray 101 also has an equipment placement section 102 (see Figure 9) on which the medicine container 10 and the injector 11 (syringe 11a, injection needle 11c, cap 11d) are placed, and an infusion bag holding section 103 (see Figure 5) that holds the infusion bag 12. The equipment placement section 102 and the infusion bag holding section 103 are individually detachable from the tray 101.

As shown in Figure 5, the instrument placement section 102 is provided with a support section 102A that supports the ampoule 10A in an inclined position. The ampoule 10A is set in an upright position on the support section 102A at an angle. This prevents chemicals from accumulating in the neck of the ampoule 10A. In addition to the ampoule 10A, an injection needle 11c with the cap 11d attached and other items are also set in an upright position on the support section 102A at an angle.

The injection needle 11c also includes an injection needle equipped with a syringe filter. Specifically, when using the ampoule 10A, an injection needle equipped with a syringe filter is used to prevent fragments from being injected into the infusion bag 12 when the neck of the ampoule 10A is broken from the syringe 11, or to prevent the fragments from flowing into the syringe 11. The syringe filter is generally known as a top-type filter, and has the function of preventing the passage of foreign matter other than medicines. For example, a syringe filter manufactured by Nippon Pall Corporation is commonly known.

On the other hand, the vial bottle 10B and the syringe 11 are set in a horizontal position on the instrument placement section 102, as shown in Figures 5 and 9. At this time, the syringe 11 is in a state where the syringe 11a and the injection needle 11c are separated. Of course, the arrangement within the instrument placement section 102 described here is an example and is not limited to this.

As shown in FIG. 5, the infusion bag holding portion 103 is provided with a chuck portion 140 for fixing the mixed injection port (neck portion) of the infusion bag 12. In the preparation work, the user sets the infusion bag 12 in the infusion bag holding portion 103 while holding it with the chuck portion 140. The infusion bag holding portion 103 also has an engagement hole portion 103a that is used when raising and lowering the infusion bag holding portion 103.

The tray 101 is then stored in the storage unit 700 after the user sets the medicine container 10, the syringe 11, and the infusion bag 12 on it. As described below, the storage unit 700 can store multiple trays 101. As a result, the tray 101 is automatically supplied to the mixed injection processing unit 300 as needed through the tray discharge port 701 and the tray loading port 114 from the storage unit 700. After the mixed injection processing in the mixed injection processing unit 300 is completed, the tray 101 is discharged from the tray discharge port 15 (see Figure 3) of the mixed injection processing unit 300 with the infusion bag 12 still stored therein, or is discharged from the tray discharge port 206 (see Figure 3) of the medicine loading unit 200 via the storage unit 700. The mixed injection processing unit 300 may be provided with an inlet that allows the user to directly supply the tray 101 from the medicine loading unit 200 to the mixed injection processing unit 300.

[Mixed injection processing unit 300]
Next, the schematic configuration of the mixed injection processing unit 300 will be described.

As shown in Figures 2 to 4, the front of the mixed injection processing unit 300 is provided with a main door 301, a syringe removal door 302, a waste storage chamber door 13, a touch panel monitor 14, and a tray discharge port 15.

The main door 301 is opened and closed to access the mixed injection processing chamber 104 provided in the mixed injection processing unit 300, for example, when cleaning the mixed injection processing chamber 104. Furthermore, the mixed injection device 1 can dispense the infusion bag 12 into which a drug has been injected, as well as the syringe 11 filled with a drug. The syringe removal door 302 is opened and closed when removing the syringe 11 from the mixed injection processing chamber 104.

The waste storage chamber door 13 is opened and closed to remove waste from the waste storage chamber 13a, which stores waste such as the medicine containers 10 and syringes 11 after use in the mixed injection process in the mixed injection process chamber 104. The tray discharge port 15 is also opened and closed to remove the tray 101 on which the infusion bag 12 is placed after medicines have been mixed in the mixed injection process in the mixed injection process chamber 104.

The touch panel monitor 14 is a display unit such as a liquid crystal display or organic EL display that displays various information in response to control instructions from the second control unit 500. The touch panel monitor 14 also has a touch panel that accepts touch operations by the user. The touch panel monitor 14 can display, for example, images or videos captured by various cameras described below.

As shown in FIG. 4, the waste storage chamber 13a is provided with a waste container 13b for disposing of liquids such as infusion fluids contained in the infusion bag 12, and a weighing scale 13c for measuring the weight of the waste container. The waste container 13b is detachable from the waste storage chamber 13a when the waste storage chamber door 13 is open. A communication port (not shown) communicating with the waste container 13b is formed above the waste container 13b on the bottom surface of the mixed injection processing chamber 104. The second robot arm 22, described below, can operate the syringe 11 to discard the liquid in the syringe 11 through the communication port into the waste container 13b. The weighing scale 13c has, for example, a load cell that inputs an electrical signal corresponding to the weight of the waste container 13b to the second control unit 500.

As a result, the second control unit 500 can obtain the amount of liquid discarded when discarding the liquid based on the weighing results of the waste container 13b by the weighing meter 13c before and after discarding the liquid into the waste container 13b. For example, the second control unit 500 compares the amount of liquid discarded from the syringe 11 with the amount of liquid discarded determined based on the preparation data, etc., and if the comparison results do not match, displays an error on the touch panel monitor 14, etc. to notify the user. The second control unit 500 also records the comparison results in the data storage unit 504 as history information of the co-infusion process. This makes it possible to accurately check the consistency of the amount of liquid discarded from the syringe 11 and manage the amount of waste liquid.

Incidentally, a case in which the liquid discarded using the syringe 11 is performed may be, for example, when the amount of liquid in the infusion bag 12 during the mixed injection process exceeds the maximum allowable amount preset for the infusion bag 12, and the infusion is extracted from the infusion bag 12 and discarded in advance. In such a case, the second control unit 500 may weigh the amount of liquid extracted from the infusion bag 12 by the syringe 11 using a weighing scale 35 or the like provided in the mixed injection process chamber 104, and compare the amount with the preparation data. Furthermore, the second control unit 500 may compare the weighing result obtained by the weighing scale 35 with the weighing result obtained by the weighing scale 13c.

[Mixed injection processing chamber 104]
3 and 4, the mixed injection processing chamber 104 is provided with a first robot arm 21, a second robot arm 22, an ampoule cutter 31, the agitator 32, a loading shelf 33, a drug reading unit 34, a weighing scale 35, a needle bending detection unit 36, a mixed injection communication port 37, a needle insertion confirmation transparent window 38, and a trash cover 132a. Furthermore, as shown in FIG. 6, a tray confirmation camera 41, a syringe confirmation camera 42, an injection needle attachment/detachment device 43, a needle insertion confirmation camera 44, a germicidal lamp 45, etc. are provided on the ceiling side of the mixed injection processing chamber 104.

[First robot arm 21, second robot arm 22]
The first robot arm 21 and the second robot arm 22 are drive units having an articulated structure, and are provided in a hanging manner with their base ends fixed to the ceiling side of the mixed injection processing chamber 104. For example, the first robot arm 21 and the second robot arm 22 each have 5 to 8 joints. In the mixed injection device 1, each work step in the mixed injection processing is performed by the dual-arm first robot arm 21 and the second robot arm 22.

Specifically, the second control unit 500 individually drives the drive motors provided at each joint of the first robot arm 21 and the second robot arm 22, causing the first robot arm 21 and the second robot arm 22 to perform each task in the co-infusion process. The co-infusion processing unit 300 may have, for example, a configuration with one robot arm, a configuration with three or more robot arms, or a configuration without any robot arms, as long as it has a structure that can perform the co-infusion process.

As shown in FIG. 6, the first robot arm 21 has a holder 25 capable of holding equipment such as the medicine container 10 and the syringe 11, and is capable of moving the holder 25 to any position within a predetermined movable range. The second robot arm 22 has a holder 26 capable of holding equipment such as the medicine container 10 and the syringe 11 and moving them to any position, and of performing operations of aspirating and injecting medicine using the syringe 11. The second robot arm 22 is also capable of moving the medicine container 10, the syringe 11, etc. to any position within a predetermined movable range.

As shown in FIG. 7, the holding unit 25 of the first robot arm 21 includes a pair of gripping claws 25a, a motor 251, two screw shafts 252, 253 rotated by the motor 251, and nut blocks 254, 255 threaded onto the screw shafts 252, 253. The pair of gripping claws 25a are fixed to the nut blocks 254, 255, respectively. The rotation of the screw shafts 252, 253 moves the nut blocks 254, 255, and the pair of gripping claws 25a move toward and away from each other to hold and release the holding unit 25.

The pair of gripping claws 25a have a recess suitable for holding the vial 10B, and also have a recess on the tip side suitable for holding the ampoule 10A. While Figure 7 shows both the ampoule 10A and the vial 10B being held, in reality, only one ampoule 10A or one vial 10B is held.

The holding unit 25 can also hold the syringe 11 or an injection needle 11c with a cap 11d attached using the pair of gripping claws 25a. The second control unit 500 can measure the diameter of the syringe 11 based on the amount of drive of the motor 251 when the syringe 11 is held by the pair of gripping claws 25a of the holding unit 25. Therefore, the second control unit 500 can determine whether the syringe 11 is the syringe specified in the preparation content information of the preparation data.

As shown in FIG. 8, the holding unit 26 of the second robot arm 22 includes a syringe holding unit 261, a plunger holding unit 262, and a moving unit 263. The syringe holding unit 261 includes a pair of gripping claws 261a that hold the syringe 11a of the syringe 11. The pair of gripping claws 261a are gripping units that move toward and away from each other to hold and release the syringe 11a of the syringe 11 by a mechanism similar to the drive mechanism used in the holding unit 25. In addition, the pair of gripping claws 261a have inclined portions 261b that slope downward from the upper end surfaces of the gripping claws 261a toward the opposing surfaces, which face each other.

The plunger holding portion 262 is equipped with a pair of gripping claws 262a that hold the flange of the plunger 11b of the syringe 11. The pair of gripping claws 262a are gripping portions that move toward and away from each other to hold and release the flange of the plunger 11b of the syringe 11 by a mechanism similar to the drive mechanism used in the holding portion 25. A gripping claw 262b is fixed to the upper surface of each of the gripping claws 262a. Each of the gripping claws 262b moves toward and away from each other by moving the pair of gripping claws 262a toward and away from each other, and is a gripping portion that grips not only the syringe 11 but also other equipment such as the medicine container 10. Note that a recess is formed on the upper surface of the opposing side of the pair of gripping claws 262a to accommodate the flange of the plunger 11b. Furthermore, the tips of the pair of gripping claws 262b protrude further forward than the pair of gripping claws 262a, making it easier for the pair of gripping claws 262b to grip objects such as the ampule 10A and the vial 10B. Note that the gripping claws 262b may also be provided on the gripping claws 261a.

The moving unit 263 is capable of moving the plunger holding unit 262 in the direction of movement of the plunger 11b of the syringe 11. The moving unit 263 moves the plunger 11b using a drive mechanism such as a motor, a screw shaft rotated by the motor, a nut block threaded onto the screw shaft, a guide, etc. The plunger holding unit 262 is fixed to the nut block and moves as the nut block moves.

[Tray conveyance section 110]
Further, the mixed injection processing unit 300 is provided with a tray transport unit 110 capable of transporting the tray 101 back and forth between the tray loading port 114 at the right end in FIG. 6 and the tray transport terminal end 110a at the left end.

Figure 9 is a schematic plan view showing an example of the transport path of the tray 101 in the tray transport unit 110. The interior of the tray transport unit 110 is set to a more positive pressure than the interior of the mixed injection processing chamber 104. As shown in Figure 9, the tray transport unit 110 is configured to transport the tray 101 by passing through the rear side of the waste storage chamber 13a, which is located below the mixed injection processing chamber 104 and below the waste lid 132a. This allows access to the waste storage chamber 13a from the front side of the mixed injection device 1. In Figure 9, the tray 101 moving within the tray transport unit 110 is shown with a two-dot chain line to show the transport path of the tray transport unit 110; however, multiple trays 101 do not exist simultaneously within the tray transport unit 110. The tray transport section 110 may be configured to transport multiple trays 101 simultaneously between the tray loading opening 114 and the tray transport terminal end 110a within the tray transport section 110.

The tray transport start section 110b of the tray transport unit 110 is provided with a belt conveyor (not shown) that can pull the tray 101 inserted through the tray loading opening 114 into the interior or eject the tray 101 from the tray loading opening 114. Also provided are IC readers 101c and 15a that can read information from the IC tag 101b provided on the infusion bag holding section 10 of the tray 101. For example, the IC readers 101c and 15a are RFID readers that read information from an RFID tag. The IC reader 101c is provided at the tray transport start section 110b where the tray 101 is loaded from the tray loading opening 114, and the IC reader 15a is provided at the tray transport end section 110a where the tray 101 is ejected from the tray ejection opening 15.

When the second control unit 500 determines based on the output of a sensor (not shown) that the tray 101 has been inserted into the tray transport start section 110b from the tray loading opening 114, it reads information from the IC tag 101b using the IC reader 101c. Furthermore, when the second control unit 500 determines based on the output of a sensor (not shown) that the tray 101 has been inserted into the tray transport end section 110a, it reads information from the IC tag 101b using the IC reader 15a. Similarly, the second control unit 500 can also read information from the IC tag 101b using the IC reader 101c when the tray 101 is transported from the tray transport start section 110b toward the storage unit 700 via the tray loading opening 114. The second control unit 500 then performs a tray verification process to determine the suitability of the tray 101 based on the results of the readings by the IC reader 101c and the IC reader 15a.

Furthermore, when the second control unit 500 determines, for example, based on the output of a sensor (not shown), that the tray 101 has passed through the tray loading port 114 and reached a predetermined position within the tray transport unit 110, it horizontally slides a shutter 111 that connects and shields the tray transport unit 110 and the mixed injection processing chamber 104. When the shutter 111 is opened, the instrument placement unit 102 is exposed within the mixed injection processing chamber 104. Figure 9 shows the instrument placement unit 102 exposed within the mixed injection processing chamber 104.

As shown in Figure 10, the tray transport section 110 is provided with a tray lifting section 112 that raises and lowers the object placement section 102 of the tray 101 that has been moved into the tray transport section 110 through the tray loading opening 114. The tray lifting section 112 lifts the object placement section 102 from below upward, for example, by driving four shafts 112a that are provided so as to be able to rise and fall in the vertical direction.

The second control unit 500 then raises the instrument placement unit 102 using the tray lifting unit 112, and then photographs the image using the tray confirmation camera 41. The tray confirmation camera 41 photographs the medicine containers 10, syringes 11, etc. placed on the predetermined instrument placement unit 102 from above. The second control unit 500 performs image recognition processing using the image captured by the tray confirmation camera 41, and determines whether the number of medicine containers 10 and syringes 11 (syringes 11a and injection needles 11c) indicated in the preparation data are present on the instrument placement unit 102, etc.

10, the tray transport terminal 110a, located in the left space of the mixed injection processing chamber 104, is provided with a bag lifting unit 113 that lifts and lowers the infusion bag holding unit 103. The second control unit 500 transports the tray 101 to the front of the bag lifting unit 113, and then hooks the hook portion 113a of the bag lifting unit 113 into the engagement hole portion 103a from below. The second control unit 500 then rotates the arc gear portion 113b, on which the hook portion 113a is formed, using a motor 113c, thereby lifting the infusion bag holding unit 103 and positioning the mixed injection port of the infusion bag 12 at the mixed injection communication port 37. In addition, the second control unit 500 controls the motor 113c to drive the bag lifting unit 113 to tilt the infusion bag holding unit 103 and point the co-infusion port of the infusion bag 12 upward or downward.

In particular, the second control unit 500 can adjust the inclination angle of the co-infusion port of the infusion bag 12 to a preset inclination angle by controlling the motor 113c to adjust the driving amount of the bag lifting unit 113.

Specifically, the medicine master stores, for each type of infusion bag 12, the upper limit injection amount that can be injected into the infusion bag 12 without air bleeding and the exceptional tilt angle, which is the tilt angle of the mixed injection port of the infusion bag 12 that is set when the upper limit injection amount is exceeded. Then, during the mixed injection process based on the preparation data, if the amount of liquid to be injected into the infusion bag 12 exceeds the upper limit injection amount, the second control unit 500 executes an air bleeding process in which air is previously bled from the infusion bag 12 using the syringe 11. In this case, the amount of air in the infusion bag 12 decreases. Therefore, if the inclination of the infusion bag 12 becomes large, the liquid in the infusion bag 12 may come into contact with the rubber stopper of the mixed injection port of the infusion bag 12, which may result in liquid leakage when the injection needle 11c is removed from the rubber stopper.

In contrast, in the co-infusion device 1, when the amount of liquid injected into the infusion bag 12 is equal to or less than the upper injection limit, the second control unit 500 sets the inclination angle of the co-infusion port of the infusion bag 12 to a predetermined specified angle. The specified angle is, for example, a value set as the inclination angle of the co-infusion port common to multiple types of infusion bags 12.

On the other hand, if the amount of liquid injected into the infusion bag 12 during the mixed injection process exceeds the upper injection limit, the second control unit 500 sets the inclination angle of the mixed injection port of the infusion bag 12 to the exceptional inclination angle. The exceptional inclination angle is an angle at which the mixed injection port of the infusion bag 12 is inclined relative to the vertical direction that is at least smaller than the specified angle. In other words, the exceptional inclination angle is an angle at which the infusion bag 12 is closer to vertical than the specified angle. As a result, when the inclination angle of the mixed injection port of the infusion bag 12 is set to the exceptional inclination angle, the possibility of the liquid in the infusion bag 12 coming into contact with the rubber stopper of the mixed injection port is reduced, and the possibility of liquid leaking when the injection needle 11c is removed from the rubber stopper is reduced. Note that the exceptional inclination angle may also be used, for example, when the type of the infusion bag 12 is a so-called AL type, which has a small amount of air inside.

As shown in FIG. 6, a dome-shaped light 120 and an infusion camera 121 are provided above the tray transport terminal 110a to illuminate the infusion bag 12 transported to the tray transport terminal 110a. The infusion camera 121 is provided in the center of the dome-shaped light 120 and reads the barcode attached to the surface of the infusion bag 12. This allows the second control unit 500 to determine whether the infusion bag 12 is suitable or not based on the information in the barcode read by the infusion camera 121.

[Ampoule cutter 31]
As shown in FIG. 11, the ampoule cutter 31 is provided with a file portion 31a, a dust tray 31b, a head insertion portion 31c, a drive box 31f, a dust box 31g, and a grip portion 31h.

The file portion 31a is a member used to notch the neck of the ampoule 10A, and debris generated during the notching in the file portion 31a falls into the debris tray 31b. Specifically, in the co-infusion device 1, the first robot arm 21 holds the ampoule 10A and slides the neck of the ampoule 10A against the file portion 31a, thereby notching the neck of the ampoule 10A.

The head insertion portion 31c has a hole 31d into which the notched head of the ampule 10A is inserted from below, and a pusher 31e located to the side of the head of the ampule 10A that protrudes upward from the hole 31d. Meanwhile, the drive box 31f has a cam installed therein and a drive motor that drives the cam. When the cam is driven by the drive motor, the cam causes the pusher 31e to reciprocate in a direction toward and away from the head of the ampule 10A.

In the co-infusion device 1, the first robot arm 21 holds the ampoule 10A with the gripping claws 25a and inserts the head of the ampoule 10A into the hole 31d from below, causing the head above the neck to protrude upward. Thereafter, the second control unit 500 drives the drive motor of the drive box 31f to move the pusher 31e in a direction pushing the head of the ampoule 10A, causing the pusher 31e to push and break the head. At this time, the head broken by the pusher 31e falls into the waste box 31g. The gripping portion 31h is used by the user to grip the ampoule cutter 31 when sliding it along a rail 31i (see FIG. 4) that slidably supports the ampoule cutter 31.

[Agitator 32]
The agitator 32 is used when the vial 10B contains a medicine that needs to be dissolved, such as a powdered medicine, and the like, by injecting an infusion or a medicine into the vial 10B to dissolve the medicine and produce a mixed medicine. Specifically, the agitator 32 is used in a mixing step of agitating the medicine in the vial 10B.

As shown in FIG. 12, the agitator 32 includes a roller 32a, a presser 32b, a rotation support 32c, a support base 32d, a horizontal swing mechanism 32e, a support 32f, and a drive motor 32g. The two rollers 32a are arranged facing each other at a predetermined distance. One roller 32a is supported so that it can rotate freely, and the other roller 32a is connected to the drive motor 32g. Each roller 32a is elongated in the axial direction, and the agitator 32 can simultaneously agitate two vials 10B placed on both axial ends of the roller 32a.

The pressing portion 32b is a driven roller used to press down on the vial 10B placed on the roller 32a from above, and rotates as the vial 10B rotates. The rotation support portion 32c rotates the pressing portion 32b in a direction of contacting or moving away from the vial 10B using a drive motor (not shown).

The support base 32d supports the roller 32a, the pressing portion 32b, and the rotation support portion 32c. The horizontal swing mechanism 32e has, for example, a crank mechanism, and is capable of swinging the support base 32d in the axial direction of the roller 32a.

The support portion 32f has U-shaped notches at both axial ends of the roller 32a into which the neck of the vial 10B fits. When the vial 10B is placed on the roller 32a, the neck of the vial 10B engages with the notches. As a result, when the support base 32d is oscillated in the axial direction of the roller 32a by the horizontal oscillating mechanism 32e, the vial 10B oscillates in response to the axial oscillating of the roller 32a, and the chemical in the vial 10B is stirred horizontally.

When the vial 10B is placed between the two rollers 32a and the drive motor 32g is driven, the other roller 32a connected to the drive motor 32g rotates the vial 10B, stirring the chemical in the vial 10B. At this time, the one roller 32a rotates in the same direction as the other roller 32a due to the rotation of the vial 10B. Furthermore, if at least one of the rollers 32a is eccentrically driven, the vial 10B placed on the roller 32a can also be stirred in the vertical direction (up and down).

[Loading shelf 33]
As shown in FIG. 4 , the storage shelf 33 is used to temporarily store the medicine container 10, the syringe 11, and the like during the co-infusion process performed by the co-infusion device 1. The storage shelf 33 is located in a position accessible to both the first robot arm 21 and the second robot arm 22. The vial 10B is placed upright in a predetermined position on the storage shelf 33. Meanwhile, the storage shelf 33 is provided with a tilted holder for holding the ampoule 10A in a tilted position, and the ampoule 10A is placed in a tilted position on the tilted holder. The storage shelf 33 also has a neck-holding hole of a predetermined diameter into which the neck of the syringe 11 fits, and the syringe 11 is temporarily placed with the neck facing downward without the injection needle 11c attached. The size of the storage shelf 33 is preferably determined in advance based on the number of trays 101 that can be accommodated in the storage unit 700. For example, the size of the storage shelf 33 is considered to be a size that can simultaneously accommodate the medicine containers 10 and the syringes 11 and other equipment used in the co-injection process, which corresponds to the number of trays 101 that can be accommodated in the storage unit 700.

[Medicine reading unit 34]
The medicine reading unit 34 reads barcodes that indicate medicine information about the medicine contained in the medicine container 10, such as the ampule 10A and the vial 10B, and are written on labels affixed to the medicine containers 10. Specifically, as shown in FIG. 13 , the medicine reading unit 34 includes two rollers 34a and a barcode reader 34b. The rollers 34a are arranged facing each other at a predetermined distance. One of the rollers 34a is rotatably supported, and the other roller 34a is connected to a drive motor (not shown). The two rollers 34a are driven by the drive motor to rotate the medicine container 10 placed between the rollers 34a in a circumferential direction. This allows the medicine container 10 to rotate once in the circumferential direction, so that the entire label affixed to the medicine container 10 is facing the barcode reader 34b. The barcode reader 34b then reads the barcode from the label of the medicine container 10 as it is rotated by the roller 34a.

[Weighing scale 35]
The weighing scale 35 is used to measure the weight of the syringe 11 in the co-infusion process executed in the co-infusion device 1, and the measurement result by the weighing scale 35 is input to the second control unit 500. The weighing scale 35 is disposed within the movable range of the second robot arm 22 and measures the weight of the syringe 11 placed by the second robot arm 22. Furthermore, it is also possible that a weighing scale that weighs the medicine container 10 or the syringe 11, etc., is provided on the storage shelf 33, separate from the weighing scale 35.

[Needle bending detection unit 36]
14 , the needle bending detection unit 36 is formed with an elongated hole 36a into which the injection needle 11c of the syringe 11 can be inserted and moved. The needle bending detection unit 36 also includes a first optical sensor 361 and a second optical sensor 362 that irradiate and receive detection light across the elongated hole 36a and are arranged so that their detection light beams are non-parallel. That is, the first optical sensor 361 and the second optical sensor 362 irradiate the detection light beams in different directions. The detection results of the first optical sensor 361 and the second optical sensor 362 are input to the second control unit 500.

Then, the injection needle 11c attached to the syringe 11 is inserted into the elongated hole 36a and moved up and down by the second robot arm 22. At this time, when the detection light of each of the first optical sensor 361 and the second optical sensor 362 is blocked by the injection needle 11c, the first optical sensor 361 and the second optical sensor 362 are turned off.

As a result, the second control unit 500 can detect bending of the injection needle 11c using position information of the injection needle 11c when it blocks the detection light. Another possible embodiment is to photograph the injection needle 11c with a camera and detect needle bending by image recognition of the photographed image. If the injection needle 11c is bent, the second control unit 500 can adjust, for example, the needle tip position when the injection needle 11c punctures the rubber stopper of the mixed injection port of the infusion bag 12 using the second robot arm 22, based on the amount of bending of the injection needle 11c.

[Mixed injection communication port 37]
3, the mixed injection communication port 37 is formed in a dome-shaped portion that protrudes outward from the side wall of the mixed injection processing chamber 104, and a notch is formed in the dome-shaped portion in the vertical direction to allow the mixed injection port of the infusion bag 12 to pass through. Therefore, when the infusion bag holding portion 103 rises, the mixed injection port of the infusion bag 12 is positioned within the mixed injection processing chamber 104. This makes it possible for the injection needle 11c of the syringe 11 held by the second robot arm 22 to be inserted into the mixed injection port of the infusion bag 12.

[Transparent window 38 for confirming needle insertion]
The needle insertion confirmation transparent window 38 is a window through which the infusion bag 12 at the tray transport terminal 110a can be seen from the mixed injection processing unit 300, and is used when taking images to confirm that the injection needle 11c of the syringe 11 has been inserted into the infusion bag 12.

[Syringe confirmation camera 42]
As shown in FIG. 6 , the syringe confirmation camera 42 is disposed on the ceiling of the co-infusion processing unit 300. The syringe confirmation camera 42 is used to photograph the syringe 11 to confirm the presence and amount of medicine drawn into the syringe 11. The syringe confirmation camera 42 may photograph an image within a predetermined photographing range, or may be controlled by the second control unit 500 to arbitrarily change the position and size of the photographing range. As will be described later, in the co-infusion device 1, the syringe confirmation camera 42 photographs the syringe 11 and the medicine container 10 at the same time, providing a highly reliable inspection image. The second control unit 500 records the image photographed by the syringe confirmation camera 42 in the data storage unit 404, the data storage unit 504, or a storage unit such as a hard disk provided outside the co-infusion device 1, for example, to inspect the appropriateness of the co-infusion processing performed by the co-infusion device 1 using the image. Then, the second control unit 500 displays the image captured by the syringe confirmation camera 42 on a display device such as the touch panel monitor 14 or the display 203 during the inspection by the user.

[Injection needle attachment/detachment device 43]
15 and 16, in the injection needle attaching/detaching device 43, the tip of the injection needle 11c attached with a cap 11d is inserted upward into a hole 43b of a chuck portion 43a having a notch formed therein. When the motor 43c is driven, a cam mechanism (not shown) widens the hole 43b of the chuck portion 43a, allowing the injection needle 11c to be inserted together with the cap 11d. When the driving of the motor 43c is stopped, the spring 43d maintains the holding state of the cap 11d and the injection needle 11c. When the needle turning motor 43e is driven, gears 43f and 43g rotate, rotating the chuck portion 43a and rotating the cap 11d and the injection needle 11c.

The injection needle 11c and the cap 11d each have a rib that comes into contact when the cap 11d rotates circumferentially while attached to the injection needle 11c. Therefore, when the cap 11d of the injection needle 11c is rotated by the chuck portion 43a, the injection needle 11c rotates together with the cap 11d and is attached to or detached from the syringe 11a. Furthermore, with the injection needle attachment/detachment device 43, the second robot arm 22 can automatically attach and detach the cap 11d to and from the injection needle 11c by moving the syringe 11 toward or away from the chuck portion 43a while the cap 11d is held by the chuck portion 43a. In addition, with the injection needle attachment/detachment device 43, the tip of the injection needle 11c faces upward, so that the tip opening of the syringe 11a from which the injection needle 11c has been removed faces upward, preventing dripping from the neck opening of the syringe 11a.

[Needle insertion confirmation camera 44]
The needle insertion confirmation camera 44 also captures the infusion bag 12 located outside the mixed injection processing chamber 104 and the syringe 11 located inside the mixed injection processing chamber 104 so that they fit within a single image. When the injection needle 11c punctures the rubber stopper of the mixed injection port of the infusion bag 12, the second control unit 500 causes the needle insertion confirmation camera 44 to capture an image in the direction of the needle insertion confirmation transparent window 38. The image captured by the needle insertion confirmation camera 44 is displayed on, for example, the touch panel monitor 14. FIG. 17 is an example of an image captured by the needle insertion confirmation camera 44. This allows the user to confirm from the captured image whether the tip of the injection needle 11c is located within the infusion bag 12. The captured image is stored in a storage unit, such as a hard disk, installed inside or outside the mixed injection device 1 for final inspection, for example. Then, when the user operates the OK button on the touch panel monitor 14 on which the captured image is displayed and it is determined that the co-infusion process has been completed properly, the infusion bag 12 is lowered by the bag lifting section 113 and returned to the tray 101.

[Bactericidal lamp 45]
The germicidal lamp 45 is turned on, for example, three hours before the start of the mixed injection process. As shown in FIG. 6, one of the two germicidal lamps 45 is located between the first robot arm 21 and the second robot arm 22. Therefore, the amount of germicidal light blocked by the first robot arm 21 and the second robot arm 22 is reduced, allowing the mixed injection processing chamber 14 to be sterilized evenly. In addition, the mixed injection processing unit 300 is provided with an exhaust system that sucks air from the mixed injection processing chamber 104 through a slit 104b (see FIGS. 3 and 4) formed in the lower part of the side wall of the mixed injection processing chamber 104 and exhausts it from an exhaust fan (not shown) provided above the mixed injection processing chamber 104. In addition, an air supply system is also provided that cleans outside air from an air intake port formed in the ceiling of the mixed injection processing chamber 104 and guides it to the mixed injection processing chamber 104, etc.

Next, the storage unit 700 will be described with reference to Figures 18 to 21. Figure 18 is a front view of the medicine loading section 200 and the storage unit 700, Figure 19 is a cross-sectional view taken along line I-I in Figure 18, and Figure 20 is a cross-sectional view taken along line II-II in Figure 18. Figure 21 is a schematic diagram showing the internal structure of the storage unit 700. Note that the following explanations may use the up-down, left-right, and front-back directions shown in Figures 18 to 21.

The storage unit 700 includes a tray loading section 710, a lifting unit 800, and a tray transport section 900, and is controlled by the co-infusion control device 100. The tray loading section 710 and the lifting unit 800 are located behind the work table 202, and the tray transport section 900 is located below the work table 202. The storage unit 700 can store multiple trays 101, and the co-infusion control device 100 can transport any of the trays 101 out of the storage unit 700. Note that the specific configuration of the storage unit 700 is not limited to the configuration described here, as long as it can achieve similar functions.

The tray loading section 710 includes a shutter 712 that opens and closes a tray loading opening 711 used to load the tray 101 into the storage unit 700, and a drive unit 713 that opens and closes the shutter 712. The drive unit 713 is, for example, a belt conveyor including a motor, gears, tension rollers, and a belt. When the tension rollers are rotated by the motor and gears, the shutter 712 connected to the belt is opened and closed. When the shutter 712 is opened, the user can load the tray 101 into the lifting unit 800 of the storage unit 700 by sliding the tray 101 rearward on the work table 202. The tray loading opening 711 is located vertically spaced apart from the tray ejection opening 206; specifically, the tray loading opening 711 is located higher than the tray ejection opening 206.

The lifting unit 800 comprises a movable housing 810 supported so as to be able to move up and down in the vertical direction, multiple tray storage sections 811 arranged vertically within the movable housing 810, drive sections 812 and 813 used to load and unload the trays 101 into and from the tray storage sections 811, and a lifting mechanism 820 that moves the movable housing 810 up and down. The movable housing 810 is supported so as to be able to slide up and down, for example, by rail sections (not shown) formed on the inner surface of the housing of the storage unit 700. The movable housing 810 can be lifted and lowered between a state in which at least the uppermost tray storage section 811 is positioned above the tray loading opening 711 and a state in which the lowermost tray storage section 811 is positioned below the tray loading opening 711. In particular, the movable housing 810 moves up and down within a range that allows each of the tray storage sections 811 to be positioned so that the tray 101 can move between the tray storage section 811 and the tray loading section 710, and so that the tray 101 can move between the tray storage section 811 and the tray transport section 900.

The tray storage unit 811 is a belt conveyor including a pair of left and right belts 814 capable of supporting the tray 101, a plurality of tension rollers 815 supporting each of the belts 814 so that they can run, and a magnet gear 816 connected to one of the tension rollers 815. The drive units 812 and 813 are motors capable of rotating the magnet gears 812a and 813a in forward and reverse directions. The magnet gears 812a and 813a can synchronously rotate the magnet gear 816, which is located opposite, by magnetic force. In other words, the drive force of the drive units 812 and 813 is transmitted from the magnet gears 812a and 813a to the magnet gear 816 of the tray storage unit 811 in a non-contact manner. The magnet gear 816 then drives the tension rollers 815 and the belts 814.

Therefore, even when the lifting unit 800 is provided with three or more tray storage sections 811, it is possible to drive each of the tray storage sections 811 using the two drive units 812, 813. Therefore, in the co-infusion device 1, dust generation and costs in the lifting unit 800 can be reduced compared to when a drive unit such as a motor is provided for each tray storage section 811, and the weight of the movable housing 810 that moves in the vertical direction can be reduced.

Here, the magnet gear 812a and the magnet gear 813a are arranged at different positions in the vertical direction. Specifically, the magnet gear 812a is arranged at a position opposite the magnet gear 816 of the tray accommodating unit 811, which is arranged at a position where the tray 101 can be loaded from the work table 202 via the tray loading opening 711. Furthermore, the magnet gear 813a is arranged below the magnet gear 812a, at a position opposite the magnet gear 816 of the tray accommodating unit 811, which is arranged at a position where the tray 101 can move between the tray accommodating unit 811 and the tray transport unit 900.

As a result, the storage unit 700 can effectively utilize the area below the work table 202 to transport the tray 101, for example, between the tray storage section 811 and the tray transport section 900. Hereinafter, the position of the tray storage section 811 at which the tray 101 can be carried from the work table 202 to the tray storage section 811 may be referred to as a first movement position, and the position of the tray storage section 811 at which the tray 101 can be moved between the tray storage section 811 and the tray transport section 900 may be referred to as a second movement position.

The lifting mechanism 820 is a belt conveyor equipped with a motor 821, a pair of left and right belts 822, and multiple tension rollers 823. The motor 821 drives the tension rollers 823 to cause each of the belts 822 to run vertically. Each of the belts 822 is connected to the movable housing 810. The lifting mechanism 820 moves the movable housing 810 vertically by causing each of the belts 822 to run vertically through forward or reverse rotation of the motor 821.

The tray transport unit 900 includes a first transport unit 910, a second transport unit 920, an IC reader 930, and a third transport unit 940. The first transport unit 910 is capable of transporting the tray 101 in the front-to-rear direction, and the second transport unit 920 is capable of transporting the tray 101 in the left-to-right direction. For example, the first transport unit 910, the second transport unit 920, and the third transport unit 940 are each belt conveyors equipped with a motor, gears, tension rollers, belts, etc., and the belts are driven by the motor, gears, and tension rollers to transport the trays 101 held on the belts.

More specifically, the first transport unit 910 is capable of transporting the tray 101 housed in the tray housing unit 811 toward the tray discharge opening 206. The first transport unit 910 is also capable of housing the tray 101 in the tray housing unit 811. The second transport unit 920 is configured to be movable in the vertical direction, and is capable of moving between a usable state in which the tray 101 placed on the first transport unit 910 can be transported in the horizontal direction, and a retracted state (see FIG. 21) in which it is retracted downward from the usable state. The third transport unit 940 is capable of transporting the tray 101 between the second transport unit 920 and the tray discharge opening 701 when the second transport unit 920 is in the usable state.

For example, when transitioning from the retracted state to the usable state, the second transport unit 920 moves upward while holding the tray 101 placed at a predetermined position on the first transport unit 910, thereby enabling the tray 101 to be transported between it and the third transport unit 930. Furthermore, when transitioning from the usable state to the retracted state, the second transport unit 920 moves downward below the first transport unit 910 while holding the tray 101 placed on the second transport unit 920, and hands over the tray 101 to the first transport unit 910.

As a result, in the usable state, the second conveying unit 920 can convey the tray 101 discharged from the tray storage unit 811 onto the first conveying unit 910 to the third conveying unit 940. Furthermore, in the usable state, the second conveying unit 920 can receive the tray 101 supplied from the mixed injection processing unit 300 via the tray discharge port 701 via the third conveying unit 940 and convey it to the first conveying unit 910.

The IC reader 930 is capable of reading information from the IC tag 101b of the tray 101 placed on the first transport section 910 of the tray transport section 900. The identification information of the tray 101 read from the IC tag 101b by the IC reader 930 is input to the second control section 500.

In another embodiment, the co-infusion device 1 may further include a stock shelf capable of storing multiple trays 101, and the storage unit 700 may be configured to be able to freely load and unload trays 101 onto and from the stock shelf. This allows multiple trays 101 to be temporarily stored on the stock shelf and automatically removed as needed. This configuration is suitable, for example, when the co-infusion device 1 has a batch preparation inspection function (described below) and multiple trays 101 that have not been inspected after the co-infusion process are required to be temporarily stored.

The stock shelf may also be provided with a lockable door that can be opened and closed to allow removal of the trays 101 from a position different from the storage unit 700 side relative to the individual storage sections in which the trays 101 are individually stored. This allows, for example, a user to remove the trays 101 from the stock shelf as needed and inspect them all at once, and also makes it possible to limit users who can remove the trays 101 to specific users who hold the door key.

[Mixed injection processing]
Next, an example of a basic processing procedure of the co-infusion processing executed by the co-infusion processing unit 300 being controlled by the co-infusion control unit 100 will be described in the co-infusion device 1. In the co-infusion processing, as described below, the second control unit 500 controls the first robot arm 21, the second robot arm 22, etc., to aspirate medicines from one or more medicine containers 10 with the syringe 11 based on the preparation data, and to inject the medicines from the syringe 11 into another container such as the infusion bag 12.

[Mixed injection process using ampoule 10A]
First, the basic operation of the mixed injection process when the medicine contained in the ampoule 10A is injected into the infusion bag 12 will be described.

When the tray 101 is supplied to the tray transport unit 110, the second control unit 500 reads the identification information of the tray 101 from the IC tag 101b of the tray 101 using the IC reader 101c. Then, if the identification information of the tray 101 matches the identification information previously associated with the preparation data for the mixed injection process, the second control unit 500 opens the shutter 111. Thereafter, the second control unit 500 raises the instrument placement unit 102 of the tray 101 using the tray lifting unit 112 of the tray transport unit 110 to expose it to the mixed injection process chamber 104.

Next, the second control unit 500 photographs the instrument placement unit 102 with the tray confirmation camera 41. Then, the second control unit 500 determines the position and orientation of the instruments, such as the ampule 10A and the syringe 11, placed on the instrument placement unit 102 by image recognition processing based on the image photographed by the tray confirmation camera 41. In particular, the second control unit 500 photographs the instrument placement unit 102 with the tray confirmation camera 41 each time the ampule 10A or the syringe 11 is removed from the instrument placement unit 102, and determines the latest position and orientation of the ampule 10A and the syringe 11 from the photographed image.

The second control unit 500 then causes the first robot arm 21 to temporarily place the syringe 11 placed on the instrument placement unit 102 exposed within the mixed injection processing chamber 104 on the placement shelf 33. The second control unit 500 also causes the first robot arm 21 to set the ampoule 10A placed on the instrument placement unit 102 in the drug reading unit 34. The second control unit 500 then causes the drug reading unit 34 to read information such as the type of drug contained in the ampoule 10A.

The second control unit 500 also uses the first robot arm 21 to set the first injection needle 11c on the injection needle attaching/detaching device 43 and temporarily place the second injection needle 11c on the storage shelf 33. Here, the first injection needle 11c is a needle without a syringe filter, and the second injection needle 11c is a needle with a syringe filter. The injection needle 11c placed on the instrument placing unit 102 has a cap 11d attached, and the cap 11d is attached and detached by the injection needle attaching/detaching device 43. It is also possible that the injection needle 11c is set on the tray 101 while attached to the syringe 11a of the syringe 11. In this case, the step of setting the injection needle 11c on the syringe 11 is omitted.

Then, when all of the objects on the object placement section 102 have been removed, the second control section 500 causes the tray lifting section 112 of the tray transport section 110 to lower the object placement section 102 and return it to the tray 101. The second control section 500 then confirms whether all of the objects on the object placement section 102 have been removed by image recognition processing based on the image captured by the tray confirmation camera 41.

Then, the second control unit 500 closes the shutter 111 and causes the tray transport unit 110 to transport the tray 101 to the tray transport terminal 110a. Next, the second control unit 500 causes the bag lifting unit 113 of the tray transport unit 110 to position the mixed injection port of the infusion bag 12 held by the infusion bag holding unit 103 of the tray 101 at the mixed injection communication port 37 formed in the mixed injection processing chamber 104.

The second control unit 500 then controls the second robot arm 22 to move the ampoule 10A set in the medicine reading unit 34 to the shelf 33. Next, the second control unit 500 controls the first robot arm 21 to remove the syringe 11 from the shelf 33 and set it on the second robot arm 22. The second control unit 500 then controls the second robot arm 22 to move the syringe 11 to the needle attaching/detaching device 43 and set the injection needle 11c on the syringe 11. The second control unit 500 then controls the second robot arm 22 to move the syringe 11 to the needle bending detection unit 36, which detects whether the injection needle 11c is bent. It is also possible that the injection needle 11c attached to the syringe 11 is set on the tray 101. In this case, the step of setting the injection needle 11c on the syringe 11 is omitted.

Next, the second control unit 500 uses the first robot arm 21 to remove the ampoule 10A from the storage shelf 33 and breaks off the top of the ampoule 10A using the ampoule cutter 31. Then, the second control unit 500 uses the first robot arm 21 and the second robot arm 22 to bring the ampoule 10A and the syringe 11 close together and inserts the injection needle 11c of the syringe 11 into the ampoule 10A. Thereafter, the second control unit 500 operates the plunger 11b using the second robot arm 22 to draw into the syringe 11 an amount of medicine predetermined by the preparation data from the ampoule 10A.

At this time, the first robot arm 21 and the second robot arm 22 gradually tilt the posture of the ampoule 10A and the syringe 11. For example, with the mouth of the ampoule 10A facing vertically upward and the injection needle 11c of the syringe 11 facing vertically downward, a certain amount of medicine is drawn up from the ampoule 10A, and then the ampoule 10A is tilted by approximately 10 degrees from the vertical direction to move the medicine toward the mouth (neck). This makes it possible to draw up as much medicine as possible without the tip of the injection needle 11c of the syringe 11 touching the bottom of the ampoule 10A.

Then, the second control unit 500 controls either or both of the first robot arm 21 and the second robot arm 22 to move the ampoule 10A after the medicine has been aspirated and the syringe 11 in a state in which the medicine has been aspirated into the shooting range of the syringe confirmation camera 42. The second control unit 500 then photographs the ampoule 10A and the syringe 11 at the same time using the syringe confirmation camera 42, and records the photographed image in the data storage unit 504 as an inspection image. For example, the syringe confirmation camera 42 photographs a predetermined shooting range. However, it is also conceivable that the second control unit 500 can change the shooting range of the syringe confirmation camera 42 so that the ampoule 10A and the syringe 11, which have been moved by the first robot arm 21 and the second robot arm 22, can be photographed at the same time.

Next, the second control unit 500 replaces the injection needle 11c of the syringe 11 using the first robot arm 21 and the second robot arm 22. Specifically, the second control unit 500 moves the syringe 11 to the needle bending detection unit 36 using the second robot arm 22, and detects whether the injection needle 11c is bent. The second robot arm 22 then moves the syringe 11 to the injection needle attaching/detaching device 43, and attaches the cap 11d to the injection needle 11c. The second control unit 500 then rotates the cap 11d using the injection needle attaching/detaching device 43, and removes the injection needle 11c from the syringe 11. Note that the removal of the injection needle 11c may be performed by rotating the cap 11d using the first robot arm 21 and the second robot arm 22.

The second control unit 500 then opens the waste lid 132a and causes the first robot arm 21 to drop the injection needle 11c held by the injection needle attaching/detaching device 43 together with the cap 11d attached to the injection needle 11c into the waste storage chamber 13a for disposal. The second control unit 500 then causes the first robot arm 21 to set the injection needle 11c with the syringe filter from the storage shelf 33 to the injection needle attaching/detaching device 43. The second control unit 500 then causes the second robot arm 22 to move the syringe 11 to the injection needle attaching/detaching device 43 and attach the injection needle 11c to the syringe 11. In this case, the second control unit 500 also causes the second robot arm 22 to move the syringe 11 to the needle bending detection unit 36, which detects whether the injection needle 11c is bent. In this way, in the co-infusion device 1, the injection needle 11c is replaced when aspirating the medicine from the ampoule 10A and when injecting the infusion into the infusion bag 12, preventing fragments of the ampoule 10A from being mixed into the infusion bag 12.

The second control unit 500 then causes the second robot arm 22 to puncture the injection needle 11c of the syringe 11 into the rubber stopper of the mixed injection port of the infusion bag 12 transported to the tray transport terminal 110a, and injects the mixed medicine in the syringe 11 into the infusion bag 12. Meanwhile, the second control unit 500 opens the waste lid 132a and causes the first robot arm 21 to drop the ampoule 10A into the waste storage chamber 13a for disposal. The second control unit 500 also causes the second robot arm 22 to move the syringe 11 to the injection needle attachment/detachment device 43, attach the cap 11d to the injection needle 11c of the syringe 11, and then drops the syringe 11 into the waste storage chamber 13a for disposal.

Then, the second control unit 500 executes a preparation inspection process to inspect the results of the co-injection process after the co-injection process is completed. In the preparation inspection process, the second control unit 500 displays, for example, various captured images taken during the co-injection process on the touch panel 14, and accepts an operation to complete the inspection of the co-injection process. This allows the user to inspect the appropriateness of the co-injection process while viewing the touch panel monitor 14. Then, when the second control unit 500 accepts the operation to complete the inspection, it transports the tray 101 to the tray discharge port 15, making the tray 101 ready to be removed.

[Mixed injection process using vial 10B]
Next, we will explain the basic operations of the mixed injection process when the medicine contained in the vial bottle 10B is a medicine such as a powder that needs to be dissolved, and the medicine is mixed with an infusion solution and then injected into the infusion bag 12.

When the tray 101 is supplied to the tray transport unit 110, the second control unit 500 reads the identification information of the tray 101 from the IC tag 101b of the tray 101 using the IC reader 101c. Then, if the identification information of the tray 101 matches the identification information previously associated with the preparation data for the mixed injection process, the second control unit 500 opens the shutter 111. Thereafter, the second control unit 500 raises the instrument placement unit 102 of the tray 101 using the tray lifting unit 112 of the tray transport unit 110 to expose it to the mixed injection process chamber 104.

Next, the second control unit 500 photographs the instrument placement unit 102 with the tray confirmation camera 41. Then, the second control unit 500 determines the positions and orientations of the instruments, such as the vial 10B and the syringe 11, placed on the instrument placement unit 102 by image recognition processing based on the image photographed by the tray confirmation camera 41. In particular, the second control unit 500 photographs the instrument placement unit 102 with the tray confirmation camera 41 each time the vial 10B or the syringe 11 is removed from the instrument placement unit 102, and determines the latest positions and orientations of the vial 10B and the syringe 11 from the photographed image.

The second control unit 500 then causes the first robot arm 21 to temporarily place the syringe 11 placed on the instrument placement unit 102 exposed within the mixed injection processing chamber 104 on the placement shelf 33. The second control unit 500 also causes the first robot arm 21 to set the vial 10B placed on the instrument placement unit 102 in the drug reading unit 34. The second control unit 500 then causes the drug reading unit 34 to read information such as the type of drug contained in the vial 10B.

Next, when all of the objects on the object placement section 102 have been removed, the second control section 500 causes the tray lifting section 112 of the tray transport section 110 to lower the object placement section 102 and return it to the tray 101. The second control section 500 then performs image recognition processing based on the image captured by the tray confirmation camera 41 to confirm whether all of the objects on the object placement section 102 have been removed.

Then, the second control unit 500 closes the shutter 111 and causes the tray transport unit 110 to transport the tray 101 to the tray transport terminal 110a. Next, the second control unit 500 causes the bag lifting unit 113 of the tray transport unit 110 to position the mixed injection port of the infusion bag 12 held by the infusion bag holding unit 103 of the tray 101 at the mixed injection communication port 37 formed in the mixed injection processing chamber 104.

Then, the second control unit 500 causes the second robot arm 22 to move the vial 10B set in the medicine reading unit 34 to the storage shelf 33. Meanwhile, in parallel with this movement process, the second control unit 500 causes the first robot arm 21 to set the injection needle 11c of the syringe 11 placed on the instrument placing unit 102 in the injection needle attaching/detaching device 43 with the cap 11d still attached.

Next, the second control unit 500 causes the first robot arm 21 to remove the syringe 11 from the storage shelf 33 and set it on the second robot arm 22. Subsequently, the second control unit 500 causes the second robot arm 22 to move the syringe 11 to the injection needle attaching/detaching device 43 and set the injection needle 11c on the syringe 11. The second control unit 500 then causes the second robot arm 22 to move the syringe 11 to the needle bending detection unit 36, which detects whether the injection needle 11c is bent. It is also possible that the injection needle 11c is attached to the syringe 11a of the syringe 11 and set on the tray 101. In this case, the step of setting the injection needle 11c on the syringe 11 is omitted.

The second control unit 500 then causes the second robot arm 22 to puncture the injection needle 11c of the syringe 11 into the rubber stopper of the mixed injection port of the infusion bag 12 transported to the tray transport terminal 110a, and aspirates the amount of infusion indicated in the preparation data from the infusion bag 12. Meanwhile, the second control unit 500 causes the first robot arm 21 to remove the vial 10B placed on the storage shelf 33.

The second control unit 500 then causes the first robot arm 21 and the second robot arm 22 to bring the vial 10B and the syringe 11 closer to each other, and inserts the injection needle 11c of the syringe 11 into the vial 10B. The second control unit 500 then operates the plunger 11b with the second robot arm 22 to inject the infusion solution in the syringe 11 into the vial 10B. In this way, when the medicine is a powder, the mixed injection process executes a dissolution process in which the infusion solution is extracted from the infusion bag 12 by the syringe 11 and injected from the syringe 11 into the vial 10B. This causes the medicine in the vial 10B to dissolve in the infusion solution. At this time, the syringe 11 and the vial bottle 10B are positioned such that the injection needle 11c of the syringe 11 is facing vertically downward and the mouth of the vial bottle 10B is facing vertically upward.

Next, the second control unit 500 uses the first robot arm 21 to set the vial 10B into which the infusion liquid has been injected onto the agitator 32. As a result, the agitator 32 executes a mixing process in which the medicine and infusion liquid in the vial 10B are mixed. The mixing time in the mixing process is predetermined, for example, depending on the type of medicine. The mixing time may also be predetermined for each combination of medicine and infusion liquid, or may be changed depending on the amount of medicine in the vial 10B. When the agitation process by the agitator 32 is completed, the second control unit 500 uses the first robot arm 21 to remove the vial 10B from the agitator 32.

Here, the second control unit 500 executes a mixing inspection process to inspect the mixing results of the mixing process after the mixing process is completed. In the mixing inspection process, the second control unit 500 controls the first robot arm 21 to move the vial bottle 10B to a posture and position where the bottom or side of the vial bottle 10B can be viewed by the user, and waits for a confirmation operation by the user on the touch panel monitor 15 or the like. Furthermore, the second control unit 500 controls the first robot arm 21 in response to a predetermined operation on the touch panel monitor 15 to execute a swing process to move the vial bottle 10B to multiple states (postures and positions) where the bottom or side of the vial bottle 10B can be viewed by the user from different angles. This allows the user to check the degree of solubility of the chemical in the vial bottle 10B from different angles.

After that, when the confirmation operation is performed, the second control unit 500 advances the processing step of the mixed injection process to the next step. On the other hand, when a predetermined re-mixing operation is performed, the second control unit 500 does not advance the processing step of the mixed injection process to the next step, but instead sets the vial bottle 10B in the mixer 32 again and executes the mixing step again. Note that, during the mixing inspection process, the second control unit 500 may display on the touch panel monitor 15 an image of the bottom or side of the medicine container 10, etc., taken after the mixing step.

The second control unit 500 then causes the first robot arm 21 and the second robot arm 22 to bring the vial 10B and the syringe 11 closer to each other, and inserts the injection needle 11c of the syringe 11 into the vial 10B. The second control unit 500 then operates the plunger 11b with the second robot arm 22, causing the syringe 11 to aspirate the mixed medicine in the vial 10B. At this time, the syringe 11 and the vial 10B are positioned such that the opening of the vial 10B is facing vertically downward, and the injection needle 11c of the syringe 11 is facing vertically upward.

Then, the second control unit 500 controls either or both of the first robot arm 21 and the second robot arm 22 to move the vial 10B after the medicine has been aspirated and the syringe 11 in a state in which the medicine has been aspirated into the shooting range of the syringe confirmation camera 42. The second control unit 500 then photographs the vial 10B and the syringe 11 at the same time using the syringe confirmation camera 42, and records the photographed image in the data storage unit 504 as an inspection image. For example, the syringe confirmation camera 42 photographs a predetermined shooting range. However, it is also conceivable that the second control unit 500 can change the shooting range of the syringe confirmation camera 42 so that the vial 10B and the syringe 11, which have been moved by the first robot arm 21 and the second robot arm 22, can be photographed at the same time.

Then, the second control unit 500 causes the second robot arm 22 to puncture the injection needle 11c of the syringe 11 into the rubber stopper of the mixed injection port of the infusion bag 12 transported to the tray transport terminal 110a, and injects the mixed medicine in the syringe 11 into the infusion bag 12. In this way, the mixed injection process executes an injection process in which the medicine is drawn from the vial bottle 10B by the syringe 11 and the medicine is injected from the syringe 11 into the infusion bag 12.

Meanwhile, the second control unit 500 opens the waste lid 132a and causes the first robot arm 21 to drop the vial 10B into the waste storage chamber 13a for disposal. The second control unit 500 also causes the second robot arm 22 to move the syringe 11 to the needle attachment/detachment device 43, attach the cap 11d to the injection needle 11c of the syringe 11, and then drops the syringe 11 into the waste storage chamber 13a for disposal.

Then, the second control unit 500 executes a preparation inspection process to inspect the results of the co-injection process after the co-injection process is completed. In the preparation inspection process, the second control unit 500 displays, for example, various captured images taken during the co-injection process on the touch panel 14, and accepts an operation to complete the inspection of the co-injection process. This allows the user to inspect the appropriateness of the co-injection process while viewing the touch panel monitor 14. Then, when the second control unit 500 accepts the operation to complete the inspection, it transports the tray 101 to the tray discharge port 15, making the tray 101 ready to be removed.

It is also possible that the medicine contained in the vial bottle 10B is a liquid medicine that does not require dissolution. The mixed injection process in this case is similar to the mixed injection process when the medicine contained in the vial bottle 10B is a powder medicine that requires dissolution, except that the stirring step is not performed, so a description thereof will be omitted. Furthermore, even if the medicine contained in the vial bottle 10B is a liquid, the stirring step may be performed depending on the type of medicine.

[Pre-mixing function]
The mixing process, which may be performed in the co-infusion process, may require a relatively long time, and the waiting time until the mixing process is completed may impede the efficiency of the co-infusion process. In contrast, the co-infusion device 1 according to this embodiment has a pre-mixing function that can execute the mixing process in the co-infusion process before the start timing of the co-infusion process. Specifically, the co-infusion control unit 100 realizes the pre-mixing function by executing a loading preparation process and a co-infusion control process (described below) using the first control unit 400 or the second control unit 500 in accordance with the first co-infusion control program or the second co-infusion control program. Here, the co-infusion control device 100 executing the loading preparation process and the co-infusion control process is an example of a pre-mixing processing unit. The first control unit 400 and the second control unit 500 may enable the pre-mixing function when the medicine container 10 is the vial 10B.

[Loading preparation process]
First, with reference to FIG. 22, an example of the loading preparation process executed by the co-infusion control device 100 will be described.

<Step S1>
In step S1, the first control unit 400 waits for a loading preparation start operation by the user using the operation unit 405 (S1: No). For example, the first control unit 400 determines that the loading preparation start operation has been performed when the user selects the preparation data. Then, when the loading preparation start operation has been performed (S1: Yes), the process proceeds to step S2.

The first control unit 400 not only receives an operation to immediately execute the mixed injection process based on the preparation data as the loading preparation start operation, but also can accept reservations for the preparation data for the estimated completion time indicating the completion time or completion time zone of the mixed injection process. When the completion time zone is reserved, reservations are accepted in one-hour increments, such as between T1 and T2, as the time range in which the mixed injection process should be completed. For example, the first control unit 400 can set reservations for the preparation data up to a preset maximum reservation number equal to the number of tray storage units 811. The reservation process is not limited to being executed at the start of the loading preparation process, but may also be executed at the end of the loading preparation process.

When the estimated completion time is set, the first control unit 400 automatically estimates the required time for the co-infusion process based on the preparation data, and sets the time obtained by subtracting the required time from the estimated completion time as the timing to start executing the co-infusion process. For example, the required time is calculated based on required time table information stored in the data storage unit 404. The required time table contains information for calculating the required time according to the content of the co-infusion process, such as the required time for each step of the co-infusion process, set in advance for each content of the co-infusion process.

The first control unit 400 may also be able to accept reservations for the preparation data for a scheduled start time indicating the start time or completion time zone of the co-infusion process, rather than just the scheduled completion time. When the start time zone is reserved, reservations are accepted in one-hour increments, such as between T1 and T2, as the time range in which the co-infusion process should be started. For example, when the scheduled start time is set for the preparation data, the first control unit 400 sets the scheduled start time as the execution start timing of the co-infusion process. Furthermore, it is also conceivable that reservations for an execution time zone may be accepted in one-hour increments, such as between T1 and T2, as the time range from the start to the completion of the co-infusion process. When the execution time zone is set for the preparation data, the first control unit 400 sets the execution start timing of the co-infusion process so that the co-infusion process is completed within the execution time zone. The first control unit 400 may only be able to reserve the co-infusion process for one of the preparation data. Furthermore, the reservation target is not limited to the scheduled completion time, scheduled start time, or execution time period of the mixed injection process, but may also be the scheduled completion time, scheduled start time, or execution time period of the injection process of injecting the medicinal liquid collected from the medicine container 10 into the infusion bag 12, which is part of the mixed injection process.

<Step S2>
In step S2, the first control unit 400 executes a process of associating the preparation data selected as the processing target with the identification information of the tray 101. Specifically, the first control unit 400 uses the IC reader 207 provided on the work table 202 to read the identification information of the tray 101 from the IC tag 101b of the tray 101 placed on the work table 202. The first control unit 400 then stores the identification information read from the IC tag 101b in the data storage unit 404 as the identification information of the tray 101 corresponding to the preparation data selected as the processing target. For example, the correspondence between the preparation data and the identification information of the tray 101 is managed by table information. The first control unit 400 also transmits information indicating the correspondence between the preparation data and the identification information of the tray 101 to the second control unit 500, which stores the information in the data storage unit 504. This allows the first control section 400 and the second control section 500 to recognize the correspondence between the preparation data and the identification information of the tray 101 based on the correspondence.

<Step S3>
Thereafter, in steps S3 to S8, the first control unit 400 executes a process for assisting the user in setting the medicine container 10, the syringe 11, the infusion bag 12, and other items required for the co-infusion process based on the preparation data on the tray 101. Specifically, in step S3, the first control unit 400 first displays on the display 203 a message and an image instructing the user to read identification information, such as a GS1 data bar, attached to the infusion bag 12, along with information, including the type of the infusion bag 12, contained in the preparation data. The first control unit 400 then reads the identification information of the infusion bag 12 using the barcode reader 204. When the comparison result between the identification information of the infusion bag 12 and the preparation data matches, the first control unit 400 transitions the process to step S4. If the comparison result between the identification information of the infusion bag 12 and the preparation data does not match, the first control unit 400 displays, for example, an error message.

<Step S4>
In step S4, the first control unit 400 displays on the display 203 a message, an image, etc. for guiding the placement of the infusion bag 12 on the tray 101. This allows the user to easily place the infusion bag 12 in a predetermined position in the tray 101.

<Step S5>
In step S5, the first control unit 400 displays on the display 203 a message and an image instructing the reading of identification information such as a GS1 data bar attached to the medicine container 10, together with information including the type of the medicine container 10 contained in the preparation data. Then, the first control unit 400 causes the barcode reader 204 to read the identification information of the medicine container 10, and when the comparison result with the preparation data matches, the first control unit 400 shifts the processing to step S6. Note that when the comparison result between the identification information of the medicine container 10 and the preparation data does not match, the first control unit 400 displays, for example, an error message.

<Step S6>
In step S6, the first control unit 400 displays on the display 203 a message, an image, or the like for guiding the user in arranging the medicine container 10 on the tray 101. This allows the user to easily arrange the medicine container 10 at a predetermined position in the tray 101. Note that, when a plurality of the medicine containers 10 are required, steps S5 to S6 are repeatedly executed.

<Step S7>
In step S7, the first control unit 400 displays on the display 203 a message, an image, or the like for guiding the user in arranging the syringe 11 on the tray 101. This allows the user to easily arrange the syringe 11 in a predetermined position in the tray 101. Note that, if a plurality of syringes 11 are required, step S7 is repeatedly executed.

<Step S8>
When all the information about the equipment necessary for the co-infusion process based on the preparation data has been provided, in the following step S8, the first control unit 400 displays a message that preparation for loading of the preparation data has been completed, and also displays operation keys, etc., for accepting a confirmation operation to that effect.

<Step S9>
In step S9, the first control unit 400 determines whether or not the confirmation operation has been performed, and if the confirmation operation has been performed (S9: Yes), the first control unit 400 transitions the processing to step S10, and keeps the processing waiting in step S9 until the confirmation operation is performed (S9: No).

<Step S10>
In step S10, the first control unit 400 opens the shutter 712 of the containing unit 700. Specifically, the first control unit 400 transmits an instruction to open the shutter 712 to the second control unit 500. In response to this, the second control unit 500 controls the containing unit 700 to open the shutter 712.

The second control unit 500 controls the position of the movable casing 810 so that the unused tray storage section 811 is located at the first movement position before opening the shutter 712. For example, the second control unit 500 may control the storage unit 700 so that the unused tray storage section 811 is located at the first movement position while the storage unit 700 is on standby (not operating). After receiving the opening instruction in step S10, the second control unit 500 may move the movable casing 810 to locate the unused tray storage section 811 at the first movement position. If there are multiple unused tray storage sections 811, the second control unit 500 may select the tray storage section 811 that requires the smallest amount of movement of the movable casing 810 to move to the first movement position, and move it to the first movement position.

For example, the data storage unit 504 stores accommodation table information indicating whether each of the tray accommodation units 811 is in use. The accommodation table information stores identification information of the tray 101 accommodated in each of the tray accommodation units 811 in association with each of the tray accommodation units 811, and trays 101 for which corresponding tray 101 identification information is not stored are unused. The second control unit 500 updates the accommodation table information when the tray 101 is loaded into the tray accommodation unit 811 and when the tray 101 is ejected from the tray accommodation unit 811.

<Step S11>
Then, in step S11, when the tray 101 is accommodated in the tray accommodation portion 811 of the accommodation unit 700, the second control portion 500 executes a process of associating the identification information of the tray 101 with the tray accommodation portion 811. Specifically, the second control portion 500 updates the accommodation table information stored in the data storage portion 504 based on the correspondence between the identification information of the tray 101 and the tray accommodation portion 811. This enables the second control portion 500 to recognize the tray accommodation portion 811 in which each of the trays 101 is accommodated based on the accommodation table information. Whether or not the tray 101 is accommodated in the tray accommodation portion 811 is detected by an optical sensor (not shown) or the like provided in the tray accommodation portion 811.

<Step S12>
Next, in step S12, the second control section 500 controls the accommodation unit 700 to execute a confirmation operation for confirming the correspondence between the tray 101 accommodated in the tray accommodation section 811 and the preparation data. This prevents the wrong tray 101 from being accommodated in the tray accommodation section 811.

Specifically, the second control unit 500 moves the movable housing 810 downward so that the tray accommodation unit 811, which was determined in step S11 to accommodate the tray 101, is positioned at the second movement position. The second control unit 500 then ejects the tray 101 accommodated in the tray accommodation unit 811 to the first transport unit 910 of the tray transport unit 900 and reads the identification information of the tray 101 from the tag 101b of the tray 101 using the IC reader 930 provided on the first transport unit 910. The second control unit 500 then compares the identification information of the tray 101 read by the IC reader 930 with the identification information of the tray 101 corresponding to the preparation data received from the first control unit 400. If the comparison results in a match, the second control unit 500 returns the tray 101 to the tray accommodation unit 811, terminates the loading preparation process, and returns the process to step S1. On the other hand, if the comparison result is a mismatch, the second control unit 500 notifies the display 203 or the like of an error via the first control unit 400 and ejects the tray 101 toward the tray ejection opening 206. This allows the user to remove the tray 101 from the tray ejection opening 206.

[Mixed injection control processing]
Next, an example of the co-infusion control process will be described with reference to FIG.

<Step S21>
In step S21, the second control unit 500 determines whether or not the execution start timing of the co-infusion process has arrived. Specifically, the second control unit 500 determines that the execution start timing of the co-infusion process has arrived when it receives an execution start request from the first control unit 400. If it is determined that the execution start timing has arrived (S21: Yes), the process proceeds to step S211, and if the execution start timing has not arrived (S21: No), the process proceeds to step S22.

For example, when the user uses the operation unit 405 to select the preparation data and immediately start the co-infusion process based on the preparation data, the first control unit 400 transmits a request to the second control unit 500 to start execution of the co-infusion process for the preparation data. Also, when the timing to start execution of the co-infusion process based on the preparation data has been reserved, the first control unit 400 transmits a request to the second control unit 500 to start execution of the co-infusion process for the preparation data when the execution start timing arrives.

The execution start request may include, for example, the execution procedure for the co-infusion process based on the preparation data. It is also possible that the execution procedure for the co-infusion process based on the preparation data has been transmitted in advance from the first control unit 400 to the second control unit 500 and stored in the data storage unit 504, and that the execution start request may include identification information for the preparation data.

<Step S22>
In step S22, the second control unit 500 determines whether the preparation data reserved by the first control unit 400 includes preparation data that is to be subjected to a pre-mixing process in which the mixing step is executed in advance. Specifically, a pre-mixing target flag indicating whether the preparation data is to be subjected to the pre-mixing process is stored in the medicine master in association with each medicine. The second control unit 500 determines that the preparation data is to be subjected to the pre-mixing process when the preparation data includes a medicine that is set as a target of the pre-mixing process by the pre-mixing target flag. The second control unit 500 may also determine whether the preparation data is to be subjected to the pre-mixing process based on the combination of the medicine in the medicine container 10 and the infusion in the infusion bag 12 to be mixed in the mixing step. Note that the second control unit 500 may also determine that the selected preparation data is to be subjected to the pre-mixing process when a user operation to select any of the preparation data as a target of the pre-mixing process has been performed in advance. If it is determined that there is a target for the pre-mixing process (S22: Yes), the process proceeds to step S23, and if it is determined that there is no target for the pre-mixing process (S22: No), the process returns to step S21.

<Step S23>
In step S23, the second control unit 500 determines whether the pre-mixing process is executable. For example, the second control unit 500 may determine whether the co-infusion process is currently being performed, and determine that the pre-mixing process is executable when the co-infusion process is not currently being performed. Furthermore, the second control unit 500 may determine that the pre-mixing process is executable during a specific time period, such as a preset time period during the night or late at night. The indicators for determining whether the pre-mixing process is executable are not limited to those described here. If it is determined that the pre-mixing process is executable (S23: Yes), the process proceeds to step S24. If it is determined that the pre-mixing process is not executable (S23: No), the process returns to step S21. The second control unit 500 may execute the pre-mixing process for the preparation data when a user operation is performed to select the preparation data and start the pre-mixing process.

In addition, in step S23, the second control unit 500 may determine to perform the pre-mixing process on the condition that the required time for the mixing process associated with the drug in the drug container 10 in the drug master is equal to or greater than a predetermined lower limit required time. That is, if the required time for the mixing process is less than the lower limit required time, it is excluded from the pre-mixing process. This results in the pre-mixing process being performed only when the mixing process requires a long time, thereby preventing unnecessary execution of the pre-mixing process. The second control unit 500 may arbitrarily set the lower limit required time in response to a user operation. On the other hand, the second control unit 500 may also determine to perform the pre-mixing process on the condition that the required time for the mixing process associated with the drug in the drug container 10 in the drug master is less than a predetermined upper limit required time. That is, if the required time for the mixing process is equal to or greater than the upper limit required time, it is excluded from the pre-mixing process. In this case, the pre-mixing process is performed only when the mixing step does not require a long time, and delays in the co-injection process based on other preparation data caused by the pre-mixing process are suppressed. Note that the second control unit 500 can arbitrarily set the upper limit required time in response to a user operation.

<Step S24>
In step S24, the second control unit 500 executes the pre-mixing process by controlling the co-infusion processing unit 300 and the storage unit 700. When a plurality of pieces of preparation data to be subjected to the pre-mixing process are reserved, the preparation data to be processed are selected in order in steps S21 to S24, and the pre-mixing process is executed.

The order in which the preparation data are selected to be processed in the pre-mixing process is not limited to an order based on time factors such as the estimated completion time or the execution start timing, which are preset for the preparation data. For example, other embodiments may involve selecting the preparation data in the order in which they are received from the host system 6, or randomly selecting the preparation data. It may also be possible to prioritize the selection of preparation data including drugs that require a long, preset mixing process time, or to determine the order of the preparation data so that the preparation data using the same drug or infusion are consecutive. Furthermore, it may also be possible for an index value indicating the likelihood of clotting after the mixing process is performed to be stored in the drug master, and for the preparation data to be selected in order of drug least likely to clot based on the index value.

Here, we will explain a specific example of the pre-mixing process.

First, the second control unit 500 controls the storage unit 700 to automatically transport the tray 101 associated with the preparation data selected as the processing target from the tray storage section 811 of the storage unit 700 to the tray transport section 110 of the mixed injection processing unit 300. Based on the storage table information, the second control unit 500 identifies the tray storage section 811 in which the tray 101 associated with the preparation data is stored.

Then, the second control unit 500 controls the first robot arm 21 to set the medicine container 10 placed on the tray 101 in the agitator 32 and execute the agitation process in which the agitator 32 agitates the medicine in the medicine container 10.

Specifically, when the tray 101 is supplied to the tray transport unit 110, the second control unit 500 reads the identification information of the tray 101 from the IC tag 101b of the tray 101 using the IC reader 101c. Then, if the identification information of the tray 101 matches the identification information previously associated with the preparation data for the co-infusion process, the second control unit 500 opens the shutter 111. Thereafter, the second control unit 500 raises the instrument placement unit 102 of the tray 101 using the tray lifting unit 112 of the tray transport unit 110 to expose it to the co-infusion process chamber 104.

Next, the second control unit 500 photographs the instrument placement unit 102 with the tray confirmation camera 41. Then, the second control unit 500 determines the positions and orientations of the instruments, such as the medicine container 10 and the syringe 11, placed on the instrument placement unit 102 by image recognition processing based on the image photographed by the tray confirmation camera 41. In particular, the second control unit 500 photographs the instrument placement unit 102 with the tray confirmation camera 41 each time the medicine container 10 or the syringe 11 is removed from the instrument placement unit 102, and determines the latest positions and orientations of the medicine container 10 and the syringe 11 from the photographed image.

The second control unit 500 then causes the first robot arm 21 to temporarily place the syringe 11 placed on the instrument placement unit 102 exposed within the mixed injection processing chamber 104 on the placement shelf 33. The second control unit 500 also causes the first robot arm 21 to set the medicine container 10 placed on the instrument placement unit 102 in the medicine reading unit 34. The second control unit 500 then causes the medicine reading unit 34 to read information such as the type of medicine contained in the medicine container 10.

Next, when all of the objects on the object placement section 102 have been removed, the second control section 500 causes the tray lifting section 112 of the tray transport section 110 to lower the object placement section 102 and return it to the tray 101. The second control section 500 then performs image recognition processing based on the image captured by the tray confirmation camera 41 to confirm whether all of the objects on the object placement section 102 have been removed.

Then, the second control unit 500 closes the shutter 111 and causes the tray transport unit 110 to transport the tray 101 to the tray transport terminal 110a. Next, the second control unit 500 causes the bag lifting unit 113 of the tray transport unit 110 to position the mixed injection port of the infusion bag 12 held by the infusion bag holding unit 103 of the tray 101 at the mixed injection communication port 37 formed in the mixed injection processing chamber 104.

Then, the second control unit 500 causes the second robot arm 22 to move the medicine container 10 set in the medicine reading unit 34 to the storage shelf 33. Meanwhile, in parallel with this movement process, the second control unit 500 causes the first robot arm 21 to set the injection needle 11c of the syringe 11 placed on the instrument placement unit 102 in the injection needle attachment/detachment device 43.

Next, the second control unit 500 causes the first robot arm 21 to remove the syringe 11 from the storage shelf 33 and set it on the second robot arm 22. Subsequently, the second control unit 500 causes the second robot arm 22 to move the syringe 11 to the injection needle attaching/detaching device 43 and set the injection needle 11c on the syringe 11. Thereafter, the second control unit 500 causes the second robot arm 22 to move the syringe 11 to the needle bend detection unit 36, which detects whether the injection needle 11c is bent.

The second control unit 500 then causes the second robot arm 22 to puncture the injection needle 11c of the syringe 11 into the rubber stopper of the mixed injection port of the infusion bag 12 transported to the tray transport terminal 110a, and aspirates the amount of infusion indicated in the preparation data from the infusion bag 12. Meanwhile, the second control unit 500 causes the first robot arm 21 to remove the medicine container 10 placed on the storage shelf 33.

Then, the second control unit 500 causes the first robot arm 21 and the second robot arm 22 to bring the medicine container 10 and the syringe 11 closer to each other, and punctures the medicine container 10 with the injection needle 11c of the syringe 11. Then, the second control unit 500 injects the infusion solution in the syringe 11 into the medicine container 10 by operating the plunger 11b with the second robot arm 22.

It is also possible that a dedicated container containing the infusion liquid to be used in the pre-mixing process is stored in the mixed injection processing chamber 104, and that the infusion liquid in the dedicated container is injected into the medicine container 10 during the pre-mixing process. It is also possible that a plastic ampule containing the infusion liquid to be used in the pre-mixing process is set in advance on the tray 101, and that the infusion liquid in the plastic ampule is used during the pre-mixing process.

Next, the second control unit 500 uses the first robot arm 21 to set the medicine container 10 into which the infusion has been poured onto the agitator 32. This causes the agitator 32 to execute a mixing process in which the medicine and infusion inside the medicine container 10 are mixed. When the agitation process by the agitator 32 is completed, the second control unit 500 uses the first robot arm 21 to remove the medicine container 10 from the agitator 32.

The second control unit 500 then controls the first robot arm 21 to move and place the drug container 10 on the storage shelf 33 within the mixed injection processing unit 300, and stores the position of the drug container 10 on the storage shelf 33 in the data storage unit 504 in association with the identification information of the preparation data. The storage shelf 33 is an example of a first storage unit capable of storing multiple drug containers 10, and the second control unit 500 is an example of a first storage unit when executing the process for placing the drug container 10 on the storage shelf 33 after the mixing process has been performed. The second control unit 500 also controls the first robot arm 21 and the second robot arm 22 to move and place the syringe 11 on the storage shelf 33 within the mixed injection processing unit 300, and stores the position of the syringe 11 on the storage shelf 33 in the data storage unit 504 in association with the identification information of the preparation data. This allows the second control unit 500 to identify the positions of the medicine container 10 and the syringe 11 to be used in the mixed injection process based on the preparation data. Note that the syringe 11 to be used in the pre-mixing process may be a dedicated syringe to be used in the pre-mixing process that is provided in advance on the shelf 33 for each type of infusion.

Meanwhile, the second control unit 500 controls the tray transport unit 110 to return the infusion bag 12 to the tray 101 and move the tray 101 from the tray transport end 110a to the tray transport start 110b. The second control unit 500 then controls the belt conveyor (not shown) provided at the tray transport start 110b of the tray transport unit 110 to supply the tray 101 to the storage unit 700 side via the tray loading port 114. The second control unit 500 then controls the storage unit 700 to store the tray 101 in the tray storage unit 811. The tray storage unit 811 used at this time is associated with the identification information of the tray 101 in the storage table information. Note that in this case as well, the second control unit 500 uses the IC reader 101c and the IC reader 930 to verify the correspondence between the identification information of the tray 101 and the preparation data. In this way, during the pre-mixing process, the tray 101 moves from the storage unit 700 to the mixed injection processing unit 300 side, but the tray 101 is returned to the storage unit 700 without being carried into the mixed injection processing chamber 104. Therefore, contamination of the tray 101 during the pre-mixing process is prevented, and contamination of the tray storage unit 811 on which the tray 101 returned from the mixed injection processing unit 300 is placed is prevented.

In the co-infusion device 1, the syringe 11, the plastic ampule, etc. dedicated to be used in the pre-mixing process can be placed on the shelf 33, and the pre-mixing process may be performed using the dedicated syringe 11, the plastic ampule, etc. For example, in the co-infusion device 1, when a request for refilling the syringe 11 or the plastic ampule, etc. dedicated to be used in the pre-mixing process is performed and a tray containing the dedicated syringe 11 or the plastic ampule, etc. dedicated to be used in the pre-mixing process is loaded into the co-infusion processing unit 300, the second control unit 500 controls the second robot arm 22 to set the syringe 11 or the plastic ampule on the shelf 33. Furthermore, the dedicated syringe 11 or the plastic ampule, etc. dedicated to be used in the pre-mixing process may be placed by a user in a predetermined position on the shelf 33.

If there are multiple currently reserved preparation data sets that share the same combination and concentration of the drug and solvent to be mixed in the pre-mixing process, the pre-mixing process may be performed for only a smaller number of preparation data sets than the total number of preparation data sets. This makes it possible to use the drug containers 10 after the pre-mixing process for the co-infusion process corresponding to any of the multiple preparation data sets. Specifically, the second control unit 500 may reallocate the drug containers 10 corresponding to one of the preparation data sets as drug containers 10 to be used with other of the preparation data sets. This reduces the waste of drug containers 10 when the co-infusion process based on any of the preparation data sets is canceled, compared to when the pre-mixing process is performed for all of the preparation data sets. The second control unit 500 may require a preset user confirmation operation when reallocating the drug containers 10 and the preparation data sets. For example, when the mixed injection process based on the preparation data is started, if the medicine container 10 having the same combination and concentration of medicine and infusion liquid included in the preparation data is already placed on the placement unit 33, the second control unit 500 displays an operation screen for selecting whether or not to use the medicine container 10 in the mixed injection process based on the preparation data. Then, if an operation to use the medicine container 10 is performed on the operation screen, the second control unit 500 uses the medicine container 10 in the mixed injection process.

<Step S211>
On the other hand, if the execution start timing of the co-infusion process has arrived (S21: Yes), the second control unit 500 executes the co-infusion process in the following steps S211 to S212. As described above, the second control unit 500 executes the co-infusion process, for example, when the user performs the immediate start operation or when the reserved execution start timing arrives. That is, the execution start timing of the co-infusion process includes when the reserved execution start timing arrives or when the user performs the immediate start operation. Specifically, in step S211, the second control unit 500 controls the storage unit 700 to automatically supply the tray 101 associated with the preparation data for which the execution start timing has arrived from the tray storage unit 811 of the storage unit 700 to the co-infusion processing unit 300.

At this time, the second control unit 500 may compare the identification information of the tray 101 read from the IC tag 101b of the tray 101 transported from the tray storage unit 811 and placed on the first transport unit 910 with the identification information of the tray 101 associated with the preparation data. If the comparison results in a match, the second control unit 500 supplies the tray 101 to the co-infusion processing unit 300, and if the comparison results in a mismatch, the second control unit 500 notifies an error and ejects the tray 101 toward the tray ejection port 206. This ensures the accuracy of the correspondence between the tray 101 and the preparation data.

<Step S212>
In step S212, the second control unit 500 executes the co-infusion process based on the preparation data. However, if the preparation data is preparation data for which the mixing step has already been executed by the pre-mixing process, the co-infusion process is executed using the medicine container 10 after mixing by the pre-mixing process, and the mixing step is omitted.

Specifically, in the co-injection process, the drug container 10 that was the subject of the pre-mixing process is not removed from the tray 101, and the drug container 10 after the mixing process that was placed on the storage shelf 33 during the pre-mixing process is used. Similarly, in the co-injection process, the syringe 11 that was used in the pre-mixing process is not removed from the tray 101, and the syringe 11 that was placed on the storage shelf 33 during the pre-mixing process is used.

The second control unit 500 omits the mixing step for the medicine container 10 in the co-infusion process that uses the medicine container 10 for which the mixing step has already been executed in the pre-mixing process. This reduces the time required after the timing to start execution of the co-infusion process arrives. Note that the second control unit 500 may also execute the mixing step in the co-infusion process for the medicine container 10 that has been mixed in the pre-mixing process in a shorter execution time than if the pre-mixing process had not been executed.

As explained above, with the co-infusion device 1, the pre-mixing process for the co-infusion process based on the preparation data can be performed by utilizing the time when the co-infusion device 1 is not in use. Therefore, when the co-infusion process based on the preparation data for which the pre-mixing process has been performed is subsequently performed, the time required for the co-infusion process is shortened, making it possible to perform the co-infusion process efficiently.

In the co-infusion device 1, if the co-infusion process for certain preparation data is not executed consecutively after the pre-mixing process for that preparation data, the co-infusion process or the pre-mixing process based on other preparation data may be executed before the timing to start the co-infusion process for that preparation data arrives. That is, in the co-infusion device 1, between the mixing process executed by the pre-mixing processor for one of the preparation data and the injection process executed by the co-infusion processor for that preparation data, at least one of the mixing process and the injection process for the other preparation data may be executed. Therefore, in another embodiment, the execution start timing may be a timing after the mixing process corresponding to one of the preparation data has been executed and at least one of the mixing process and the injection process corresponding to the other preparation data has been executed. For example, it is conceivable that the pre-mixing process is executed sequentially for multiple preparation data, such as overnight, and then the co-infusion process is executed for those multiple preparation data the next morning, etc.

[Bulk preparation audit function]
As described above, in the co-infusion device 1, the preparation inspection process is executed to inspect the results of the co-infusion process after the co-infusion process is completed. However, in this case, the preparation inspection process is executed every time the co-infusion process is completed, and the user needs to check the preparation results each time.

In contrast, the co-infusion device 1 includes the storage unit 700 capable of storing multiple trays 101, as described above. Therefore, the co-infusion device 1 may be equipped with a batch preparation inspection function that stores multiple trays 101 in the storage unit 700 after the co-infusion process has been performed and performs the preparation inspection process collectively for the preparation data corresponding to each tray 101. Specifically, the co-infusion control unit 100 realizes the batch preparation inspection function by executing the batch preparation inspection process described below using the first control unit 400 or the second control unit 500 in accordance with the first co-infusion control program or the second co-infusion control program. The second control unit 500 can enable and disable the batch preparation inspection function in response to a user operation, and the same applies to other functions of the co-infusion device 1. Here, the co-infusion control unit 100 when performing the batch preparation inspection process is an example of a storage processing unit and a preparation inspection processing unit.

[Bulk preparation and inspection processing]
Hereinafter, with reference to FIG. 24, an example of the batch preparation inspection process executed by the co-infusion apparatus 1 when the batch preparation inspection function is enabled will be described.

<Step S31>
First, in step S31, the second control unit 500 determines whether the co-infusion process has been completed. If it determines that the co-infusion process has been completed (S31: Yes), the second control unit 500 proceeds to step S32. If it determines that the co-infusion process has not been completed (S31: No), the second control unit 500 proceeds to step S33.

<Step S32>
In step S32, the second control unit 500 executes a process for stocking the tray 101 containing the infusion bags 12 after the mixed injection process in the storage unit 700. Specifically, the second control unit 500 controls the tray transport unit 110 to return the infusion bags 12 to the tray 101 and move the tray 101 from the tray transport end portion 110a to the tray transport start portion 110b. Subsequently, the second control unit 500 controls the tray transport unit 110 to supply the tray 101 to the storage unit 700 side through the tray loading port 114.

Then, the second control unit 500 controls the storage unit 700 to store the tray 101 in the tray storage portion 811 of the lifting unit 800. At this time, the second control unit 500 updates the storage table information indicating the correspondence between the identification information of the tray 101 and the tray storage portion 811. In addition, before the tray 101 is stored in the tray storage portion 811 of the storage unit 700, the second control unit 500 reads the identification information of the tray 101 with the IC reader 930 and compares the identification information with the identification information of the tray 101 associated with the preparation data.

<Step S33>
In step S33, the second control unit 500 determines whether a predetermined preparation inspection start operation has been performed on the touch panel monitor 14 or the like. For example, the second control unit 500 displays a list of the preparation data for which the co-injection process has been executed on the touch panel monitor 14 in response to a user operation, and when one or more of the preparation data are selected, determines that the preparation inspection start operation has been performed for one or more of the preparation data. Here, if it is determined that the preparation inspection start operation has been performed (S33: Yes), the process proceeds to step S34, and if the preparation inspection start operation has not been performed (S33: No), the process returns to step S31.

<Step S34>
In step S34, the second control unit 500 executes the preparation inspection process for one or more of the preparation data. Specifically, the second control unit 500 sequentially executes the preparation inspection process for one or more of the preparation data selected when the preparation inspection start operation is performed.

The second control unit 500 sequentially ejects the tray 101 corresponding to the preparation data from the storage unit 700 toward the tray ejection port 206 each time the inspection completion operation is performed in the preparation inspection process corresponding to the preparation data, indicating that the result of the mixed injection process is appropriate. This allows the user to remove the tray 101 from the tray ejection port 206. Note that the tray 101 is not ejected until the inspection completion operation is performed. In other words, the second control unit 500 restricts the removal of the tray 101 after the mixed injection process has been performed until the result of the mixed injection process is determined to be appropriate in the preparation inspection process.

In this way, the co-infusion device 1 uses the batch preparation inspection function to execute the preparation inspection process for each of the preparation data in sequence. Therefore, the user does not need to perform a confirmation operation each time the co-infusion process is completed, reducing the burden on the user.

[Bulk mixing inspection function]
Furthermore, as described above, in the co-infusion device 1, the mixing inspection process is executed to inspect the mixing result of the mixing process after completion of the mixing process. Meanwhile, as described above, the co-infusion device 1 includes the storage unit 700 capable of storing a plurality of the trays 101, and may execute the pre-mixing process for a plurality of the medicine containers 10. Here, in the pre-mixing process as well, if the mixing inspection process is executed every time the mixing process is completed, the user needs to check the mixing result each time.

The co-infusion device 1 may therefore be equipped with a batch mixing inspection function that stores the multiple medicine containers 10 after mixing in the mixing steps performed by the multiple preliminary mixing processes on the storage shelf 33 and performs the mixing inspection process collectively on the multiple medicine containers 10. Specifically, the co-infusion control unit 100 realizes the batch mixing inspection function by using the first control unit 400 or the second control unit 500 to perform the batch mixing inspection process described below in accordance with the first co-infusion control program or the second co-infusion control program.

[Bulk mixing inspection processing]
Hereinafter, with reference to FIG. 25, an example of the batch mixing inspection process executed by the co-infusion apparatus 1 when the batch mixing inspection function is enabled will be described.

<Step S41>
First, in step S41, the second control unit 500 determines whether the stirring process has been completed. If it determines that the stirring process has been completed (S41: Yes), the second control unit 500 proceeds to step S42. If it determines that the stirring process has not been completed (S41: No), the second control unit 500 proceeds to step S43.

<Step S42>
In step S42, the second control unit 500 executes a process for stocking the medicine container 10 after the mixing process on the storage shelf 33. Here, the second control unit 500 when executing this process is an example of a placement processing unit. Specifically, the second control unit 500 controls the first robot arm 21 to move the medicine container 10 to the storage shelf 33. Note that the data storage unit 504 stores placement table information indicating a correspondence between identification information of the medicine container 10 and a placement on the storage shelf 33, and the second control unit 500 updates the placement table in step S42.

<Step S43>
In step S43, the second control unit 500 determines whether a predetermined stirring inspection start operation has been performed on the touch panel monitor 14 or the like. For example, the second control unit 500 displays a list of the medicine containers 10 for which the stirring process has been performed on the touch panel monitor 14 in response to a user operation, and when one or more medicine containers 10 are selected, determines that the stirring inspection start operation has been performed on one or more of the medicine containers 10. Here, if it is determined that the stirring inspection start operation has been performed (S43: Yes), the process proceeds to step S44, and if the stirring inspection start operation has not been performed (S43: No), the process returns to step S41.

<Step S44>
In step S44, the second control unit 500 executes the mixing inspection process on one or more of the medicine containers 10 after the mixing process that are placed on the storage shelf 33. Here, the second control unit 500 when executing this process is an example of a mixing inspection processing unit. Specifically, the second control unit 500 executes the mixing inspection process in sequence on one or more of the medicine containers 10 that were selected when the mixing inspection start operation was performed.

The second control unit 500 then permits the use of the medicine container 10 each time the inspection completion operation is performed in the mixing inspection process corresponding to the medicine container 10. In other words, the second control unit 500 restricts the use of the medicine container 10 that has been mixed in the pre-mixing process until the mixing inspection process is executed.

In this way, the co-infusion device 1 uses the batch mixing inspection function to perform the mixing inspection process collectively and sequentially for each of the medicine containers 10 that were the subject of the preliminary mixing process. Therefore, the user does not need to perform a confirmation operation each time the mixing process is completed, reducing the burden on the user.

[Schedule management function]
As described above, the co-infusion device 1 has a schedule management function that can reserve the co-infusion process for one or more of the preparation data. Specifically, the co-infusion control unit 100 realizes the schedule management function by executing a schedule management process described later in accordance with the first co-infusion control program or the second co-infusion control program using the first control unit 400 or the second control unit 500.

[Schedule management process]
An example of the schedule management process will be described below with reference to FIG.

<Step S51>
First, in step S51, the first control unit 400 determines whether or not a reservation setting operation has been performed by the user on the operation unit 405. If the first control unit 400 determines that the reservation setting operation has been performed (S51: Yes), the first control unit 400 proceeds to step S52. If the first control unit 400 determines that the reservation setting operation has not been performed (S51: No), the first control unit 400 proceeds to step S54.

Specifically, when a predetermined operation for displaying the prescription selection screen P0 is performed using the operation unit 405, the first control unit 400 displays the prescription selection screen P0 and accepts a reservation setting operation for the mixed injection process based on the preparation data in response to an operation of the operation unit 405 while the prescription selection screen P0 is being displayed. In the reservation setting operation, the preparation data to be reserved is selected and an expected completion time for the mixed injection process of the preparation data is specified.

Here, FIG. 27 is a diagram showing an example of the prescription selection screen P0. As shown in FIG. 27, the prescription selection screen P0 displays an area A1 in which a list of one or more preparation data items input to the co-infusion device 1 is displayed, and an area A2 in which conditions for extracting the preparation data items displayed in area A1 can be set. Area A1 also includes a selection operation unit A3 in which preparation data items to be reserved can be arbitrarily selected from each of the preparation data items, and an input area A4 in which the estimated completion time for each of the preparation data items can be entered.

The first control unit 400 determines that the reservation setting operation has been performed when the reservation setting key A5 is operated in a state in which the prescription is selected as a reservation target by the selection operation unit A3 on the prescription selection screen P0 and the estimated completion time is entered in the input area A4. Note that the reservation setting operation may also be determined to have been performed on the condition that the prescription is selected as a reservation target by the selection operation unit A3.

In addition, in the reservation setting operation, a scheduled start time for the mixed injection process may be specified instead of a scheduled completion time for the mixed injection process of the preparation data. For example, the scheduled completion time or scheduled start time may be specified by inputting a date and time. Alternatively, the scheduled completion time or scheduled start time may be specified by inputting the time elapsed from the current date and time.

<Step S52>
In step S52, the first control unit 400 determines whether the total number of preparation data already reserved and the current reservation is within a predetermined maximum reservation number. The maximum reservation number is a number predetermined by the specifications of the co-infusion device 1 and corresponds to the number of trays 101 that can be loaded into the co-infusion device 1. For example, in the co-infusion device 1 according to the present embodiment, six trays 101 can be loaded into the storage unit 700, so the maximum reservation number is considered to be six. Here, if the first control unit 400 determines that the total number of reservations is within the maximum reservation number (S52: Yes), it proceeds to step S53. On the other hand, if the first control unit 400 determines that the total number of reservations exceeds the maximum reservation number (S52: No), it displays, for example, a predetermined error message and then returns to step S51.

<Step S53>
In step S53, the first control unit 400 executes a reservation setting process for reserving the co-infusion process based on one or more of the preparation data in response to the reservation setting operation. Here, the first control unit 400 executing the reservation setting process is an example of a reservation setting processing unit. Specifically, the first control unit 400 sets the start timing of the co-infusion process based on the preparation data in accordance with the preparation data and the estimated completion time specified in the reservation setting operation so that the co-infusion process based on the preparation data is completed at the estimated completion time. Information on the start timing of the co-infusion process based on each of the preparation data is stored in the data storage unit 404 as schedule information and is updated by the first control unit 400 in step S53 or step S57 (described later).

For example, the data storage unit 404 stores the required time for each preparation content specified in the preparation data, or stores information for calculating the required time, and the first control unit 400 calculates the required time for the co-infusion process based on the required time. Then, the first control unit 400 sets the execution start timing based on the expected completion time and the required time for the co-infusion process. Note that if the expected start time for the co-infusion process is specified by the reservation setting operation, the execution start timing is set according to the expected start time, for example, the expected start time is set as the execution start timing. Furthermore, the calculation of the required time for the co-infusion process and the setting of the execution start timing may be performed taking into account whether or not the pre-mixing process will be performed.

Then, the first control unit 400 transmits reservation information, such as the execution start timing set for the preparation data, along with the preparation data to the second control unit 500. For example, in addition to the execution start timing, the reservation information also includes information for identifying the preparation data to be reserved and information indicating the correspondence between the identification information of the tray 101 corresponding to the preparation data.

Specifically, as shown in FIG. 27, when the expected completion times are entered in each of the five input areas A4 on the prescription selection screen P0 and the five selection operation units A3 are operated to select the preparation data to be reserved, the first control unit 400 sets the execution start timing for each of the preparation data so that each of the preparation data will be completed within the expected completion time. FIG. 28A is a diagram showing the results of setting the execution start timing for the five preparation data shown in FIG. 27. If the execution start timing cannot be set so that each of the five preparation data will be completed within the expected completion time, the first control unit 400 notifies the user by displaying an error on the display 203.

<Step S54>
In step S54, the first control unit 400 determines whether a reservation change start operation for starting the change of the schedule information has been performed on the operation unit 405, and if the reservation change start operation has been performed (S54: Yes), the first control unit 400 proceeds to step S55. For example, the first control unit 400 determines that the reservation change start operation has been performed when the reservation list key A6 displayed on the prescription selection screen P0 has been operated. If the reservation change start operation has not been performed (S54: No), the process returns to step S51.

<Step S55>
In step S55, the first control section 400 displays a schedule setting screen P1 based on the schedule information on the display 203. Note that Figures 28A to 28C are diagrams showing display examples of the schedule setting screen P1.

As shown in Figures 28A to 28C, the first control unit 400 displays the execution start timing for each of the preparation data along a time axis based on the schedule information on the schedule setting screen P1. Here, the first control unit 400 when executing this process is an example of a display processing unit. This allows the user to easily understand the execution start timing of the co-infusion process corresponding to each of the preparation data by looking at the schedule setting screen P1. Note that the schedule setting screen P1 may also clearly display other information, such as the expected completion time or the expected start time, in addition to the execution start timing of the co-infusion process corresponding to each of the preparation data.

<Steps S56 to S57>
In steps S56 to S57, the first control unit 400 executes a change process for changing the execution start timing corresponding to each of the adjustment data. Here, the first control unit 400 executing such a change process is an example of a change processing unit.

First, in step S56, the first control unit 400 determines whether a change operation has been performed on the operation unit 403 to the execution start timing, estimated start time, estimated completion time, etc. of the preparation data. If it is determined that the change operation has been performed (S56: Yes), the process proceeds to step S57. If it is determined that the change operation has not been performed (S56: No), the process proceeds to step S55.

Then, in step S57, the first control unit 400 executes a process of changing the schedule information in accordance with the change operation. Specifically, the order of the execution start timing of each of the adjustment data is changed in accordance with the execution start timing, scheduled start time, scheduled completion time, etc. of the adjustment data after the change operation.

Specifically, the first control unit 400 can change the execution start timing for each of the preparation data in response to a user operation on the operation unit 405 while the schedule setting screen P1 is displayed. For example, in FIG. 28A, the schedule setting screen P1 displays an example in which five preparation data items with patient IDs "0007," "0004," "0008," "0002," and "0006" have been reserved. In FIGS. 28A to 28C, the display area for each of the preparation data items indicates the start timing of the mixed injection process, the end timing of the mixed injection process, and the interval between them indicating that the mixed injection process is currently being executed. The schedule setting screen P1 may display not only the patient ID but also an order number or the like.

As shown in FIG. 28A, the user may perform the change operation by dragging and dropping the area corresponding to the preparation data having the identification information "0008" on the schedule setting screen P1 to move it later. In this case, the first control unit 400 causes the execution start timing of the preparation data having the identification information "0008" to be delayed and displayed as shown in FIG. 28B. Subsequently, as shown in FIG. 28B, the user may perform the change operation by dragging and dropping the area corresponding to the preparation data having the identification information "0002" to be moved forward. In this case, the first control unit 400 causes the execution start timing of the preparation data having the identification information "0002" to be delayed and displayed as shown in FIG. 28C.

Then, when a predetermined confirmation operation is performed, the first control unit 400 confirms the change in the execution start timing of the preparation data and updates the schedule information. In this way, with the co-infusion device 1, the user can easily change the execution start timing of the preparation data by intuitively moving the execution start timing of the preparation data on the schedule setting screen P1. Note that if the execution times of the co-infusion processes based on multiple pieces of preparation data overlap when the change operation or the confirmation operation is performed, the first control unit 400 notifies the user by displaying a warning message or the like on the schedule setting screen P1 to warn the user of this.

<Step S58>
In step S58, the first control section 400 determines whether or not a reservation change end operation for ending the change of the schedule information has been performed on the operation section 405. If the reservation change end operation has been performed (S58: Yes), the schedule setting screen P1 is closed and the process returns to step S51. If the reservation change end operation has not been performed (S58: No), the process returns to step S55.

In the co-infusion device 1, as described above, when the first control unit 400 determines in the co-infusion control process (FIG. 23) that the execution start timing for the reserved preparation data has arrived (S21: Yes), it notifies the second control unit 500 of this fact, and the co-infusion process based on the preparation data is executed. Here, the first control unit 500 and the second control unit 500 when executing this process are an example of a reservation execution processing unit.

[Bulk full-volume sampling and inspection function]
In the co-infusion process, when the entire amount of medicine in the medicine container 10 is collected, a full-amount collection inspection may be performed, in which the user confirms that no medicine remains in the medicine container 10. For example, after the user is notified of the completion of the full-amount collection each time the full-amount collection is completed, the progress of the co-infusion process may be restricted until the user performs a confirmation operation. In this case, if the entire amount of medicine is collected for multiple medicine containers 10 in the co-infusion process based on the preparation data, the full-amount collection inspection is performed each time full collection is performed for each medicine container 10. Therefore, the user needs to operate the co-infusion device 1 each time full collection of each medicine container 10 is completed.

In response to this, the co-infusion device 1 may be equipped with a batch total collection inspection function that collectively performs a batch total collection inspection on multiple medicine containers 10. Specifically, the co-infusion control unit 100 realizes the batch total collection inspection function by executing a batch total collection inspection process (described below) using the first control unit 400 or the second control unit 500 in accordance with the first co-infusion control program or the second co-infusion control program.

[Bulk full collection and inspection processing]
29, an example of the batch total collection inspection process executed by the co-infusion device 1 when the batch total collection inspection function is enabled will be described below. Note that the batch total collection inspection process is executed together with the co-infusion process.

<Step S61>
In step S61, the second control unit 500 determines whether there are a plurality of the drug containers 10 to be subjected to full collection in the mixed injection process based on the preparation data. If it is determined that there are a plurality of the drug containers 10 to be subjected to full collection (S61: Yes), the process proceeds to step S62. If it is determined that there are no plurality of the drug containers 10 to be subjected to full collection (S61: No), the batch full collection process is terminated.

<Step S62>
In step S62, the second control section 500 determines whether or not collection of the entire amount of any of the plurality of drugs 10 that are the subject of collection has been completed. If it is determined that collection of the entire amount has been completed (S62: Yes), the process proceeds to step S63, and if collection of the entire amount has not been completed (S62: No), the process waits at step S62.

<Step S63>
In step S63, the second control unit 500 controls the first robot arm 21 to place the medicine container 10, which is the target of full collection determined to have been completed in step S62, on the storage shelf 33. At this time, the second control unit 500 associates the medicine container 10 with its arrangement on the storage shelf 33 and stores the association information in the data storage unit 504. The storage shelf 33 is an example of a second storage unit, and the second control unit 500, when executing the process for placing the medicine container 10 on the storage shelf 33 after full collection, is an example of a second storage processing unit. In the present embodiment, the storage shelf 33 is an example of the first storage unit and the second storage unit, but the first storage unit and the second storage unit may be provided separately.

<Step S64>
In step S64, the second control unit 500 determines whether or not full collection has been completed for all of the plurality of medicine containers 10 that are the targets of full collection in the preparation data. If it is determined that full collection has been completed for all of the medicine containers 10 (S64: Yes), the process proceeds to step S65, and if it is determined that full collection has not been completed for all of the medicine containers 10 (S64: No), the process proceeds to step S62.

<Step S65>
In step S65, the second control unit 500 notifies that the full collection of all of the medicine containers 10 that are the targets of full collection in the preparation data has been completed. For example, the second control unit 500 causes the touch panel monitor 14 to display the completion of the full collection. The second control unit 500 may also cause the display 203 to display the completion of the full collection via the first control unit 400.

<Step S66>
In step S66, the second control unit 500 determines whether or not an operation to start a full-volume collection inspection has been performed on the touch panel monitor 14. If it is determined that an operation to start a full-volume collection inspection has been performed (S66: Yes), the process proceeds to step S67, and the process waits in step S66 until an operation to start a full-volume collection inspection is performed (S66: No).

<Step S67>
In step S67, the second control unit 500 sequentially executes a full-amount collection inspection process for inspecting the results of the full-amount collection for each of the medicine containers 10 after the full amount has been collected. Here, the second control unit 500 executing this process is an example of a full-amount collection inspection processing unit. Specifically, in the full-amount collection inspection process, the second control unit 500 controls the first robot arm 21 to move the medicine container 10 so that the bottom or side of the medicine container 10 is in a position and orientation that is visible to the user. Thereafter, upon receiving a user's operation to confirm the inspection of the medicine container 10, the second control unit 500 starts a full-amount collection inspection process for the next medicine container 10. Thereafter, when the full-amount collection inspection process for all of the medicine containers 10 has been completed, the inspection results are stored in the data storage unit 504.

The second control unit 500 may control the first robot arm 21 in response to user operation to change the position of the medicine container 10 to multiple positions that allow the bottom or side of the medicine container 10 to be viewed from multiple angles. This allows the user to view the medicine container 10 from different angles and properly determine whether the entire amount of the medicine container 10 has been properly collected. The second control unit 500 may also sequentially display one or multiple images of the bottom or side of the medicine container 10 that have been previously captured, without changing the medicine container 10 to a position and position that allows it to be viewed.

Furthermore, although the case where the full-volume collection inspection process is executed after all full-volume collections included in the mixed injection process have been completed has been described here, in another embodiment, the second control unit 500 may execute the full-volume collection inspection process during the batch preparation inspection process.

[Pre-inflation function]
In the co-infusion apparatus 1, the second control unit 500 may control the second robot arm 22 to aspirate the infusion solution in the infusion bag 12 using the syringe 11, and then aspirate a predetermined amount of air from the infusion bag 12 before removing the injection needle 11c from the infusion bag 12. This reduces the possibility that the infusion solution will drip from the injection needle 11c when the syringe 11 moves after the injection needle 11c of the syringe 11 is removed from the infusion bag 12.

In contrast, in recent years, special containers known as AL type infusion bags 12, which contain an extremely small amount of air, have become known as the infusion bag 12 used in the mixed injection process. When the infusion bag 12 is a special container, it may not be possible to perform the process of aspirating a predetermined amount of air from the infusion bag 12 as described above. For example, this is because when aspirating air from the infusion bag 12 with the syringe 11, the injection needle 11c of the syringe 11 may come into contact with the infusion solution in the infusion bag 12, resulting in unnecessary aspirating of the infusion solution. Therefore, when the infusion bag 12 used in the mixed injection process is a predetermined special container, the mixed injection device 1 may be equipped with a pre-air injection function that can inject air into the infusion bag 12 in advance.

Specifically, the drug master stored in the data storage unit 404 stores the container type for each infusion bag 12. For example, the drug master stores a special flag indicating whether the infusion bag 12 is a special container such as the AL type. Then, based on the preparation data and the drug master, the first control unit 400 notifies the second control unit 500 that the infusion bag 12 used in the mixed injection process is a special container. As a result, for example, at the start of the mixed injection process, the second control unit 500 executes a pre-air injection process in which a predetermined amount of air is injected into the infusion bag 12.

The timing at which the pre-air injection process starts is not limited to the start of the co-infusion process, as long as it is performed before the suction process of suctioning infusion liquid from the infusion bag 12 or the injection process of injecting liquid into the infusion bag 12 is performed during the co-infusion process. On the other hand, if the infusion bag 12 is not a special container, the pre-air injection process is not performed. Instead of the first control unit 400, the second control unit 500 may determine whether the pre-air injection process is necessary based on the preparation data and the medicine master.

As explained above, when the co-infusion device 1 is equipped with the advance air injection function, it is possible to increase the amount of air in the infusion bag 12 before the suction step or the injection step. Therefore, during the suction step or the injection step, it is possible to suction a predetermined amount of air from the infusion bag 12 before removing the injection needle 11c of the syringe 11 from the infusion bag 12, thereby preventing the infusion from dripping from the injection needle 11c.

[Interrupt processing function]
In the co-infusion device 1, the tray 101 can be temporarily stored in the storage unit 700. Therefore, the co-infusion device 1 may have an interrupt processing function that, when the co-infusion process is being executed, executes the co-infusion process based on other preparation data during the execution of the co-infusion process. This allows the user of the co-infusion device 1 to prioritize the co-infusion process based on the preparation data when highly urgent preparation data occurs.

Specifically, when the preparation data to be interrupted is selected and a predetermined interrupt request operation is performed on the operation unit 405, the first control unit 400 transmits an interrupt request for the preparation data to the second control unit 500. If the second control unit 500 receives the interrupt request while the co-infusion process is being performed, it temporarily suspends the currently executing co-infusion process, executes the co-infusion process based on the preparation data corresponding to the interrupt request, and then resumes the suspended co-infusion process.

For example, when the second control unit 500 interrupts the co-infusion process, it controls the first robot arm 21 and the second robot arm 22 to place the medicine container 10 and the syringe 11 being used in the currently executing co-infusion process on the placement unit 33. The second control unit 500 also controls the tray transport unit 110 to place the infusion bag 12 on the tray 101 and return the tray 101 to the storage unit 700 for storage. The second control unit 500 then controls the storage unit 700 to supply the tray 101 corresponding to the preparation data corresponding to the interrupt request to the co-infusion processing unit 300, and executes the co-infusion process based on the preparation data corresponding to the interrupt request. After that, when the co-infusion process is completed, the second control unit 500 again supplies the tray 101 corresponding to the interrupted co-infusion process from the storage unit 700 to the co-infusion processing unit 300, and resumes the co-infusion process.

[Parallel preparation function]
In the co-infusion device 1, only one each of the infusion bag holding unit 103, the bag lifting unit 113, the co-infusion communication port 37, and the tray conveying unit 110 is provided, and the co-infusion process using the tray 101 is performed individually and sequentially. On the other hand, another embodiment can be considered in which the co-infusion device 1 includes multiple sets of the infusion bag holding unit 103, the bag lifting unit 113, the co-infusion communication port 37, and the tray conveying unit 110. In the co-infusion device 1 configured in this manner, the second control unit 500 can transport multiple trays 101 within the co-infusion device 1, and it is considered to have a parallel preparation function that can perform the co-infusion process based on multiple preparation data substantially in parallel.

Specifically, consider a case where the second control unit 500 executes a first co-infusion process based on first preparation data and a second co-infusion process based on second preparation data substantially in parallel. In this case, the second control unit 500 may execute a process of taking equipment such as the medicine container 10, the syringe 11, and the infusion bag 12 from the tray 101 into the co-infusion processing unit 300 in the second co-infusion process based on the second preparation data while the mixing step is being executed in the first co-infusion process based on the first preparation data.

In addition, while the second control unit 500 is performing the stirring process in the second co-infusion process based on the second preparation data, it may also perform the injection of medicine from the infusion bag 12 to the medicine container 10, or the injection of medicine from the medicine container 10 to the infusion bag 12, in the first co-infusion process based on the first preparation data.

In this way, the co-infusion device 1 equipped with the parallel preparation function can execute multiple preparation data in parallel, making it possible to effectively utilize idle time in each co-infusion process and efficiently execute the co-infusion process based on multiple preparation data.

Second Embodiment
Another embodiment of the present invention will be described below. Specifically, in this embodiment, another example of the schedule management function will be described. Note that the same reference numerals will be used to designate the same configurations and processing procedures as those in the first embodiment, and descriptions thereof will be omitted.

As shown in FIG. 30, the co-infusion device 1 according to this embodiment includes a touch panel monitor 208 that is located in a position that allows operation by another operator, but is different from the operator who performs the work using the operation unit 405 and the display 203. Note that the display and operation using the touch panel monitor 208 described in this embodiment may also be performed using the operation unit 405 and the display 203.

The touch panel monitor 208 includes a display unit such as an LCD display or organic EL display that displays various information in response to control instructions from the first control unit 400, and an operation unit such as a touch panel that accepts touch operations on the display unit. This allows, for example, the operation of placing instruments on the tray 101 using the operation unit 405, the display 203, and the barcode reader 204, and the operation of reserving the preparation data using the touch panel monitor 208 to be performed in parallel.

In the co-infusion device 1 according to this embodiment, the first control unit 400 can also display the prescription selection screen P0 on the touch panel monitor 208. Furthermore, on the prescription selection screen P0, the expected completion time of the preparation data cannot be entered in the input area A3, and the input area A4 is used as a display area for the expected completion time of the preparation data after reservation. When the operation key A5 is operated with the preparation data selected as the reservation target by the selection operation unit A3 on the prescription selection screen P0, or with any preparation data selected in the area A1, the first control unit 400 displays a reservation registration screen P10 for reserving a co-infusion process based on the preparation data on the touch panel monitor 208 for each preparation data. Figure 31 shows an example of the reservation registration screen P10.

As shown in FIG. 31, the reservation registration screen P10 displays information about the preparation data for the reservation, such as a patient code (patient CD) and patient name for identifying the patient, an identification code for identifying the preparation data, and the time required for the mixed injection process based on the preparation data. The time required for the mixed injection process is stored in the data storage unit 404 for each preparation content specified in the preparation data. Calculation information for calculating the required time may also be stored in the data storage unit 404, and the first control unit 400 may calculate the required time for the mixed injection process based on the calculation information.

The reservation registration screen P10 also displays operation keys K11 to K13 for accepting selection of reservation conditions for the preparation data, and an operation key K14 for accepting execution of a reservation for the preparation data. The operation key K11 is an operation key for selecting, as a reservation condition, a reservation without a designated time, which causes the co-infusion process based on the preparation data to be reserved to be executed during idle time when no other co-infusion processes are being executed by the co-infusion device 1. The operation key K12 is an operation key for selecting, as a reservation condition, a temporary reservation, which causes the co-infusion process based on the preparation data to be reserved to be executed in priority over other preparation data reserved by the reservation without a designated time and a reservation with a designated time, which will be described later. Note that when the operation key K12 is selected, if the preparation data has already been reserved by the temporary reservation, the execution order of the preparation data to be reserved can also be selected.

The operation key K13 is an operation key for selecting, as a reservation condition, a time-specified reservation in which the co-infusion process based on the preparation data to be reserved is executed based on an execution start timing preset by a user operation. As described above, the execution start timing is set by inputting the planned completion time of the co-infusion process (corresponding to "preparation end time" in FIG. 31) or the planned start time of the co-infusion process. More specifically, when the operation key K13 is selected, the date and time for executing the co-infusion process based on the preparation data can be set on the reservation registration screen P10. For example, the reservation registration screen P10 shown in FIG. 31 is in a state in which a time-specified reservation is set in which the co-infusion process will be executed by 7:02 PM on August 22nd.

Furthermore, when a time-specified reservation is made on the reservation registration screen P10, a margin time for the estimated completion time of the co-infusion process can also be set. The margin time indicates the range in which the timing of the co-infusion process can be advanced after the estimated completion time is set, and is, for example, the time set for each drug in the pharmaceutical master, or the time input in response to a user operation on the reservation registration screen P10. For example, if the estimated completion time is 19:02 and the margin time is 30 minutes, the timing of the co-infusion process can be changed so that the co-infusion process is completed after 18:32, 30 minutes before the estimated completion time, but before 19:02. Furthermore, if the estimated completion time is 19:02 and the margin time is 30 minutes, the timing of the co-infusion process can be changed so that the co-infusion process is started after 18:32, 30 minutes before the estimated completion time.

Then, when the reservation method and reservation contents for the preparation data to be reserved are set on the reservation registration screen P10 and the operation key K14 is operated, the first control unit 400 determines that the reservation setting operation has been performed (S51: Yes in FIG. 26), and if the total number of reservations is within the maximum number of reservations (S52: Yes), it executes a reservation setting process for each of the preparation data based on the reservation setting operation (S53). Note that the first control unit 400 when executing the reservation setting process is an example of a reservation setting processing unit.

Here, in the reservation setting process of step S53, the first control unit 400 updates the schedule information in the reservation details on the reservation registration screen P10. Specifically, the first control unit 400 can selectively accept the reservation with a specified time, the reservation without a specified time, and the temporary reservation as the reservation conditions through user operation, and updates the schedule information in accordance with the reservation conditions.

When the temporary reservation is made for the preparation data, the first control unit 400 causes the second control unit 500 to execute the co-infusion process based on the preparation data in priority over other preparation data. More specifically, if the co-infusion device 1 is not currently executing co-infusion processes based on other preparation data, the first control unit 400 causes the second control unit 500 to immediately execute the co-infusion process based on the preparation data for which the temporary reservation has been made. Note that in this case, if a co-infusion process based on the preparation data that has already been reserved exists, the start timing of the co-infusion process is reset to at least the timing after the co-infusion process based on the preparation data related to the temporary reservation has been executed.

Furthermore, if a co-infusion process based on other preparation data is currently being executed in the co-infusion device 1, the first control unit 400 may cause the second control unit 500 to execute the co-infusion process based on the preparation data for which the temporary reservation was made after the co-infusion process is completed. Furthermore, if a co-infusion process based on other preparation data is currently being executed, the first control unit 400 may temporarily suspend the co-infusion process and cause the second control unit 500 to execute the co-infusion process based on the preparation data for which the temporary reservation was made. Specifically, the second control unit 500 places the medicine container 10, the syringe 11, and other equipment related to the ongoing co-infusion process on the storage shelf 33, returns the infusion bag 12 to the tray 101, and returns the tray 101 to the tray storage section 811 of the storage unit 700. The second control unit 500 then executes the co-infusion process based on the preparation data related to the temporary reservation, and resumes the suspended co-infusion process after the co-infusion process is completed.

Furthermore, when a reservation without a designated time is made for the preparation data, if the mixed injection process based on the preparation data for which the temporary reservation was made and the mixed injection process based on the preparation data for which the time-designated reservation was made have not been performed, the first control unit 400 causes the second control unit 500 to perform the mixed injection process based on the preparation data for which the reservation without a designated time was made in the order in which the reservations without a designated time were made.

On the other hand, when a time-specified reservation is made for the preparation data, the first control unit 400 sets the execution start timing in the schedule information so that the co-infusion process based on the preparation data will be completed at the expected completion time set for the time-specified reservation. For example, the execution start timing is set to the time obtained by subtracting the required time for the co-infusion process from the expected completion time, and if the execution times of multiple co-infusion processes overlap, the execution start timing is set by advancing the execution start timing of one or more of the co-infusion processes so that the execution times of the multiple co-infusion processes do not overlap. Note that when setting the schedule information, the first control unit 400 does not need to consider the execution start timing of the preparation data related to the time-specified reservation, and sets the execution start timing of each of the preparation data related to the time-specified reservation and the special reservation taking into account the execution start timing of each of the preparation data related to the time-specified reservation and the special reservation.

Furthermore, in step S55, the first control unit 400 causes the touch panel monitor 208 to display a schedule setting screen P11 shown in FIG. 32 instead of the schedule setting screen P1. As with the schedule setting screen P1, the execution start timing of each of the preparation data is displayed along a time axis based on the schedule information on the schedule setting screen P11.

Furthermore, the schedule setting screen P11 displays an indicator section P111 indicating the current time, an indicator section P112 indicating the execution time of the co-infusion process corresponding to each of the preparation data, and an indicator section P113 indicating the changeable range of the execution time of the co-infusion process corresponding to each of the preparation data. In particular, the schedule setting screen P11 also displays, for each of the preparation data, the estimated completion time of the co-infusion process based on that preparation data using text and the indicator section P112. Furthermore, the indicator section P113 is displayed based on the estimated completion time and the leeway time, and is displayed as a line connecting the timing corresponding to the estimated completion time with the timing preceding the estimated completion time by the leeway time. This allows the user to easily determine the execution time and changeable range of each of the co-infusion processes at a glance.

As described above, on the schedule setting screen P11, the first control unit 400 can change the execution time of the co-infusion process based on the preparation data by dragging and dropping the indicator part P112 corresponding to the preparation data. At this time, the first control unit 400 may limit the movable range of the indicator part P112 by dragging and dropping to within the range of the margin time indicated by the indicator part P113. This prevents the execution time of the co-infusion process from being changed beyond the margin time.

In addition, when any preparation data is selected on the schedule setting screen P11 and the reservation edit key K21 is operated to start changing the reservation details for that preparation data, it is also determined in step S56 that the change operation has been performed (S56: Yes). In this case, the first control unit 400 pops up a reservation change screen P12 similar to the reservation registration screen P10 on the schedule setting screen P11, as shown in FIG. 33. Note that the reservation change screen P12 displays information similar to that on the reservation registration screen P10, and the first control unit 400 changes the reservation details of the preparation data in accordance with the operation on the reservation change screen P12.

Furthermore, when the monitor key K22 is operated on the schedule setting screen P11, the first control unit 400 displays information indicating the current status of each of the preparation data on the schedule setting screen P11, as shown in FIG. 34. Specifically, the schedule setting screen P11 displays, for each of the preparation data, a status such as awaiting dispensing, awaiting inspection, preparing, preparation error, or waiting, as well as a preparation time indicating the time required for the mixed injection process based on the preparation data. The status of the preparation data also includes "procured," which indicates that the confirmation process (S2 to S8) when the medicine container 10 or other equipment to be used in the mixed injection process based on the preparation data is placed on the tray 101 has been completed, and "loaded," which indicates that the tray 101 on which the medicine container 10 or other equipment is placed has been loaded into the storage unit 700.

The schedule setting screen P11 also displays an operation unit P114 that accepts operations regarding the mixed injection process based on each of the preparation data, and an operation unit P115 that accepts operations regarding the tray 101 corresponding to each of the preparation data. For example, the operation unit P114 displays various operation keys, such as an inspection key that accepts operations to start an inspection of the mixed injection process based on the preparation data, and a change key that accepts operations to change the reservation details of the mixed injection process. The operation unit P115 also displays an eject key for removing the tray 101 from the tray ejection port 206, etc. Note that if the mixed injection process of the preparation data has not been inspected, the eject key is not displayed on the operation unit P115; the eject key is displayed on the operation unit P115 only if the mixed injection process inspection has been performed.

Furthermore, the schedule setting screen P11 displays a tab key P31 for displaying details of the preparation data selected on the schedule setting screen P11, and a tab key P32 for displaying the status of the co-infusion device 1. When the tab key P31 is selected, the first control unit 400 displays details of the preparation data as shown in FIG. 32, and when the tab key P32 is selected, the first control unit 400 displays the status of the co-infusion device 1 as shown in FIG. 35. For example, the number of unused tray storage sections 811 among the tray storage sections 811 in the storage unit 700 is displayed as the status of the co-infusion device 1.

In another embodiment, the touch panel monitor 208 may be omitted, and the prescription selection screen P0, appointment registration screen P10, schedule setting screen P11, etc. related to the schedule management function may be displayed on the display 203, with user operations being accepted by the operation unit 405.

Furthermore, the storage unit 700 may be used not only to store trays 101 on which equipment such as the drug containers 10 used in the co-infusion process based on the preparation data is placed, but also to store empty trays 101. Specifically, the first control unit 400 executes a process for storing empty trays 101 in the storage unit 700 and a process for ejecting empty trays 101 from the storage unit 700 in response to a user operation. This makes it possible to use the unused tray storage section 811 in the storage unit 700 to store the trays 101, and, for example, allows a working user to retrieve the tray 101 from the storage unit 700 without leaving the drug loading section 200.

[Third embodiment]
In this embodiment, another example of the loading preparation process will be described. Here, Fig. 36 is a flowchart showing another example of the loading preparation process. In the first and second embodiments, a case has been described in which, after the preparation data reservation work is performed (S1), a confirmation process (S2 to S8) is subsequently performed when various instruments are placed on the tray 101 corresponding to the preparation data. That is, in the first and second embodiments, the preparation data reservation work corresponding to the tray 101 and the work of placing the instruments on the tray 101 are performed as a series of operations in this order.

On the other hand, as shown in FIG. 36, in the loading preparation process according to this embodiment, steps S81 and S82 are executed between steps S8 and S9. In this embodiment, the first control unit 400 does not accept the reservation operation in step S1, but does accept the reservation operation in steps S81 and S82.

<Step S81>
First, in steps S2 to S8, a confirmation process is performed when placing equipment such as the medicine container 10, the syringe 11, and the infusion bag 12 on the tray 101 corresponding to the preparation data. In the subsequent step S81, the first control unit 400 displays on the display 203 a selection screen for whether or not to make a time-specified reservation for the mixed injection process based on the preparation data, and accepts the presence or absence of the time-specified reservation through a user operation. Then, in step S81, if it is determined that "with time specification" has been selected (S81: Yes), the process proceeds to step S82. If it is determined that "without time specification" has been selected (S81: No), the process proceeds to step S83.

<Step S82>
In step S82, the first control section 400 displays an operation screen such as the reservation registration screen P10 (see FIG. 31 ) and accepts a reservation for the mixed injection process based on the preparation data. Note that the method for accepting a reservation for the mixed injection process may be the same as in the first embodiment or the second embodiment, and therefore description thereof will be omitted here.

In other words, in the co-infusion device 1 according to this embodiment, the first control unit 400 can reserve a time for the co-infusion process based on the preparation data, provided that the confirmation process has been completed when various instruments are placed on the tray 101 corresponding to the preparation data. Therefore, the work of placing the instruments on the tray 101 and the work of reserving the preparation data corresponding to the tray 101 are performed as a series of operations. As a result, the work of reserving the preparation data is performed on the condition that the instruments have been correctly placed on the tray 101, and the work of reserving the preparation data is prevented from being performed before the instruments have been correctly placed on the tray 101.

[Fourth embodiment]
37 is a diagram showing another embodiment of the storage unit 700. As shown in FIG. 37 , the storage unit 700 according to this embodiment includes a fourth transport unit 950 and a fifth transport unit 960 for temporarily retracting the tray 101 stored in the tray storage section 811. The fourth transport unit 950 can transport the tray 101 in the front-rear direction, and the fifth transport unit 960 can transport the tray 101 in the left-right direction between the first transport unit 910 and the fourth transport unit 950. The fourth transport unit 950 and the fifth transport unit 960 are belt conveyors including a motor, gears, tension rollers, a belt, etc., and the belt is driven by the motor, the gear, and the tension rollers to transport the tray 101 held on the belt.

In addition, in the storage unit 700 according to this embodiment, the tray discharge opening 206 is disposed in front of the fourth transport unit 950 instead of in front of the first transport unit 910. The fourth transport unit 950 is configured to be movable in the vertical direction, and is movable between a usable state in which the tray 101 placed on the fifth transport unit 960 can be transported in the front-rear direction, and a retracted state in which the tray 101 is retracted downward from the usable state. More specifically, the fourth transport unit 950 is capable of transporting the tray 101 placed on the fifth transport unit 960 toward the tray discharge opening 206. That is, in the storage unit 700, the tray 101 stored in the storage unit 700 is transported to the tray discharge opening 206 by the first transport unit 910, the second transport unit 920, the fifth transport unit 960, and the fourth transport unit 950 in that order.

The fourth transport unit 950 and the fifth transport unit 960 can also be used to temporarily evacuate the trays 101 stored in the storage unit 700. Specifically, if all of the tray storage units 811 in the storage unit 700 are in use when the co-infusion process based on the preparation data is executed by the immediate start operation, the trays 101 to be used in the co-infusion process started in response to the immediate start operation cannot be loaded into the co-infusion processing unit 300 via the tray discharge port 701 and the tray loading port 114. In contrast, if all of the tray storage units 811 in the storage unit 700 are in use when the co-infusion process based on the preparation data is executed by the immediate start operation, the second control unit 500 evacuates the trays 101 stored in any of the tray storage units 811 in the storage unit 700 to the fourth transport unit 950 or the fifth transport unit 960. Then, the second control unit 500 controls the storage unit 700 to load the tray 101, on which the medicines and the like to be used in the mixed injection process executed by the immediate start operation, into the tray loading port 114, and executes the mixed injection process. Note that the tray 101 retracted to the fourth transport unit 950 or the fifth transport unit 960 is then returned to the tray storage unit 811.

In particular, when a co-infusion process based on the preparation data is executed by the immediate start operation, if all of the tray storage units 811 in the storage unit 700 are in use, the second control unit 500 evacuates the trays 101 stored in the tray storage units 811 in the storage unit 700 that correspond to the co-infusion process based on the preparation data to be executed next to the fourth transport unit 950 or the fifth transport unit 960. The second control unit 500 then controls the storage unit 700 to load the tray 101, on which the medicines or the like to be used in the co-infusion process executed by the immediate start operation are placed, into the tray loading port 114, and executes the co-infusion process. The tray 101 evacuated to the fourth transport unit 950 or the fifth transport unit 960 is then supplied from the tray discharge port 701 to the co-infusion processing unit 300 by the fifth transport unit 960, the second transport unit 920, and the third transport unit 940.

DESCRIPTION OF SYMBOLS 1 Co-infusion device 10 Medicine container 11 Syringe 12 Infusion bag 21 First robot arm 22 Second robot arm 31 Ampoule cutter 32 Stirring device 33 Loading shelf 34 Medicine reading unit 35 Weighing scale 36 Needle bending detection unit 37 Co-infusion communication port 100 Co-infusion control unit 101 Tray 101a Electronic paper 101b IC tag 101c IC reader 110 Tray transport unit 200 Medicine loading unit 300 Co-infusion processing unit 400 First control unit 500 Second control unit 600 Upper system 700 Storage unit 800 Lifting unit 900 Tray transport unit

Claims (3)

a mixed injection processing unit that performs mixed injection processing of injecting medicine from a medicine container into an infusion container;
A display unit provided in a medicine loading unit used to place the medicine container or the infusion container on a tray on which the medicine container or the infusion container used in the mixed injection process is placed at a predetermined position;
a control unit that executes a display process that displays the type of the medicine container or the type of the infusion container used in the mixed injection process on the display unit, a collation process that collates preparation data to be subjected to the mixed injection process with identification information read from the medicine container or the infusion container by a code reading unit provided in the medicine loading unit, and a reservation process that reserves the timing to perform the mixed injection process based on the preparation data for each of the preparation data ;
A storage unit including a plurality of tray storage units that store the trays, and a tray transport unit that is provided separately from a drive unit that performs the mixed injection processing in the mixed injection processing unit and can move the tray between the mixed injection processing unit and the tray storage unit;
Equipped with
The control unit supplies the tray corresponding to the preparation data from the tray storage unit to the mixed injection processing unit by the tray transport unit, executes the mixed injection processing based on the preparation data, and automatically executes a series of processes of storing the tray, on which the infusion container into which the medicine has been injected by the mixed injection processing, from the mixed injection processing unit to the tray storage unit by the tray transport unit, at the timing corresponding to the preparation data reserved by the reservation processing .
Mixed injection device. The control unit displays information for guiding the placement of the medicine containers or the placement of the infusion containers on the tray on the display unit, and when a user operation indicating that loading preparation is completed is performed after the display, opens one shutter that is provided in the co-infusion device on a movement path of the tray from the medicine loading unit to the plurality of tray storage units and opens and closes the movement path.
The co-infusion device according to claim 1. The control unit displays information for guiding the placement of syringes used in the co-infusion process on the display unit, and when a user operation indicating that loading preparation is completed is performed after the display, the control unit opens one shutter that is provided in the co-infusion device on the movement path of the tray from the drug loading unit to the plurality of tray storage units and opens and closes the movement path.
The co-infusion device according to claim 1.