Contrast agent injection system

Abstract

To provide a contrast medium injection system capable of further safely injecting a contrast medium by acquiring biological information of a patient during medical solution injection.SOLUTION: The contrast medium injection system includes A: a chemical solution injection device (100) that includes a piston drive mechanism (130) and a control circuit (145) for controlling operation thereof, and injects a constant medium to a patient, B: a biological information detector (701) for acquiring biological information of a patient, and C: a data processing unit (155 or the like) for performing data processing using the information from the biological information detector. The data processing unit (a) determines, during operation of the chemical solution injection, whether or not at least one value out of heart rate information, a blood oxygen saturation level, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiration frequency, an aspiration state, and an expiration state is within a prescribed value, and (b), when it is not within the prescribed value, issues an alarm or stops the operation of the piston drive mechanism.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a contrast agent injection system for injecting at least a contrast agent as a drug solution into a patient. In particular, it is an object of the present invention to provide a contrast agent injection system capable of obtaining biological information of a patient during drug solution injection and performing contrast agent injection more safely. Further, the present invention aims to provide a contrast agent injection system capable of recording information on biological changes occurring in a patient during drug solution injection.

Background Art

[0002] Currently, as medical imaging diagnostic devices, CT (Computed Tomography) devices, MRI (Magnetic Resonance Imaging) devices, PET (Positron Emission Tomography) devices, ultrasonic diagnostic devices, angiography imaging devices, etc. are known. When using such imaging devices, it may be necessary to inject a contrast agent, physiological saline, etc. (hereinafter, these are collectively also simply referred to as "drug solution") into a patient.

[0003] Contrast agent injection is basically performed as follows. First, a patient lies on a bed of an imaging device in an examination room, and a drug solution such as a contrast agent is injected into the patient from an injection head also arranged in the examination room. In an operation room adjacent to the examination room, a console used to create data of an injection protocol is arranged. The injection of the contrast agent is started, for example, when a doctor in the imaging room presses a predetermined button of the injection head.

[0004] Regarding an imaging examination using a contrast agent, for example, Patent Document 1 discloses obtaining a patient's heartbeat data at each stage such as the injection stage and the imaging stage of the contrast agent.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0006] By the way, in the injection of a contrast agent, it is desirable to obtain information on the biological changes that occur in the patient during the injection of the drug solution, and to issue an alarm as necessary and automatically stop the operation of the device when an abnormality occurs. In addition, the contrast effect by the contrast agent changes depending on, for example, the heart rate, etc. It is useful from the viewpoints of the reproducibility of the contrast examination and the setting of the next drug solution injection conditions that the drug solution injection device has such biological information of the patient that affects the contrast effect. Also, it is important to record what ecological changes occurred in the patient during the injection of the drug solution.

[0007] Therefore, an object of the present invention is to provide a contrast agent injection system capable of obtaining biological information of a patient during the injection of a drug solution and performing the injection of the contrast agent more safely. Another object of the present invention is to provide a contrast agent injection system capable of recording information on the biological changes that occurred in the patient during the injection of the drug solution.

Means for Solving the Problems

[0008] The configuration of one embodiment of the present invention for solving the above problems is as follows: A: A drug solution injection device that has a piston drive mechanism for moving the piston of a syringe and a control circuit for controlling its operation, and injects a contrast agent into a patient; B: A biological information detector that acquires at least one piece of information among the patient's heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiration state, and expiration state; C: A data processing unit that performs data processing using the information from the biological information detector; and is provided with The data processing unit (a) During the injection operation of the chemical solution, it is determined whether at least one value among the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiration state, and expiration state is within a predetermined range. (b) When it is not within the predetermined range, an alarm is issued or the operation of the piston drive mechanism is stopped. A contrast agent injection system configured as described above.

[0009] Specific examples of the "contrast agent" include a contrast agent with an iodine concentration of 240 mg / ml (for example, at 37°C, viscosity 3.3 mPa·s, specific gravity 1.268 - 1.296), a contrast agent with an iodine concentration of 300 mg / ml (for example, at 37°C, viscosity 6.1 mPa·s, specific gravity 1.335 - 1.371), a contrast agent with an iodine concentration of 350 mg / ml (for example, at 37°C, viscosity 10.6 mPa·s, specific gravity 1.392 - 1.433), etc. Contrast agents used in MRI examinations include gadolinium preparations.

Advantages of the Invention

[0010] According to the present invention, it is possible to provide a contrast agent injection system that can acquire biological information of a patient during chemical solution injection and perform contrast agent injection more safely. It is possible to provide a contrast agent injection system that can record information on biological changes that occur in a patient during chemical solution injection.

Brief Description of the Drawings

[0011]

Figure 1

Figure 2A

Figure 2B

Figure 3

Figure 4

Figure 5

Figure 6A

Figure 6B

Figure 7

[0012] The following description will be given of an embodiment of the present invention with reference to the drawings. Note that the following description will be basically based on one specific embodiment shown in the drawings, but the specific embodiment of each configuration is not limited to a specific one.

[0013] [composition] As shown in FIG. 1, the medical imaging system 1 of this embodiment includes an imaging device 1100, a liquid injector 100, and a biological information detector 701.

[0014] Liquid injector 100 includes injection head 110 and console 150. Alternatively, it may additionally include a power supply box (not shown) incorporating a predetermined control unit. A specific example of injection head 110 is shown in FIG. 2A (described in detail below). Various types of liquid injectors 100 have been known in the past. In one embodiment, the present invention is suitable for use as a liquid injector for MRI, but is not necessarily limited thereto.

[0015] Each component of the system of this embodiment will be described below. 1. Chemical injection device (1) Injection head Injection head 110 is, for example, a two-barrel type that can accommodate two syringes (see FIGS. 1 and 2A). One syringe 200C may be filled with a contrast medium, and the other syringe 200S may be filled with saline. In another embodiment, both syringes may contain contrast medium (of different concentrations).

[0016] (syringe) The configurations of syringes 200S and 200C (hereinafter also simply referred to as syringe 200) are generally as follows. Syringe 200 has a hollow cylindrical cylinder member 221 and a piston member 222 slidably inserted into the cylinder member 221. Note that the syringe may be a pre-filled type pre-filled with a chemical solution in advance, or a suction type in which a chemical solution is suctioned into an empty syringe for use. The "piston member" is not necessarily limited to the one with a long rod as shown in the figure, and may be a so-called rodless type (which can also be simply referred to as a "plunger", etc.).

[0017] (IC tag) An IC tag 225 may be attached to a part of the syringe. Information about the syringe (such as identification information of the syringe, pressure resistance of the syringe, inner diameter of the cylinder member, stroke of the piston member, etc.) and information about the chemical solution filled in the syringe (such as name (e.g., product name), component information such as iodine amount or gadolinium amount, expiration date, chemical solution volume, etc.) are stored in the IC tag 225. The IC tag may have a unique ID unique to the tag. Not limited to the IC tag, barcodes or the like may be used. Basically, any data carrier means may be used as long as it can hold predetermined data.

[0018] (Injection head) As shown in FIG. 2A, the injection head 110 has a housing 111. On the upper surface tip side of the housing 111, two recesses 120a on which syringes 200C and 200S are placed are formed respectively. The recess 120a is a part that functions as a syringe holding part. A plurality of physical buttons for causing various operations to be performed on the injection head 110 are also provided on the upper surface of the housing of the injection head 110. The physical buttons are not particularly limited, and may be the following, for example. A forward button for advancing the ram member, a backward button for retracting the ram member, an accelerator button for increasing the moving speed of the ram member by pressing the forward button or the backward button simultaneously, and a stop button for stopping the operation of the head, etc.

[0019] The injection head 110 has a piston drive mechanism 130 that pushes the piston member 222 of the syringe 200. Two systems of the piston drive mechanism 130 are provided, and each system 130 operates independently. The piston drive mechanism 130 may retract the piston member 222, for example, to draw the medicinal liquid into the syringe. The two piston drive mechanisms 130 may be driven simultaneously or at different times.

[0020] 1, the piston drive mechanism 130 may specifically include a motor 131 as a drive source, a transmission mechanism 132 that converts the rotational output of the drive motor into linear motion, and a ram member 133 that is connected to the mechanism and moves the piston member 222 forward and / or backward. In the case of MRI equipment, non-magnetic structural components such as an ultrasonic motor are used.

[0021] Injection head 110 may be provided with load cell 138 for detecting the force with which the ram member presses piston member 222. The detection result of load cell 138 can be used to obtain, for example, an estimate of the pressure of the medicinal liquid when the medicinal liquid is being injected. This estimate is calculated taking into consideration the needle size, the concentration of the medicinal liquid, the injection conditions, and the like. Alternatively, instead of using load cell 138, the pressure may be calculated based on the motor current of drive motor 131.

[0022] If the syringe has an IC tag 225 attached, injection head 110 may have a reader / writer (not shown) that reads information from IC tag 225 and / or writes information to IC tag 225. This reader / writer may be provided in recess 120a in which syringe 200 is attached. Note that the reader / writer may only have the function of reading information from IC tag 225.

[0023] The injection head 110 may have a control circuit 145 for controlling the operation of the piston drive mechanism 130, etc. The control circuit 145 may be configured as a control circuit having a processor, memory, etc.

[0024] (2) Biosignal detector The biosignal detector 701 has one or more sensors, and performs detection of at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state, and acquires the biosignal of the patient.

[0025] (Pulse oximeter) As the biosignal detector 701, for example, a pulse oximeter may be used. The pulse oximeter in this example has a probe unit 710 that sandwiches a part of the patient's body (for example, a fingertip) as schematically shown in FIGS. 1 and 4, and a control circuit 705 (see FIG. 1) connected thereto. A display for displaying the detection result may not be provided, but the present invention is not necessarily limited thereto.

[0026] Although detailed illustration is omitted, the probe unit 710 is provided with a light emitting element and a light receiving element that irradiate light toward the patient's body. Red light and infrared light are emitted from the light emitting element, and the light that has passed through (or reflected from) a fingertip or the like is measured by the light receiving element. Since the hemoglobin in the blood has different absorbances of red light and infrared light depending on the presence or absence of binding to oxygen, the blood oxygen saturation can be measured by measuring and analyzing the transmitted light or the reflected light. The pulse oximeter may also be able to measure the pulse rate. It may also be able to obtain the pulse wave shape.

[0027] A detection device using a non-magnetic material that does not affect the magnetic field (or whose influence can be ignored) so as to be usable in MRI examination is also useful. In this case, instead of a metal cable, an optical fiber or the like is used for the cable 712 (FIG. 4) for transmitting the signal from the probe unit 710.

[0028] The biosignal detector 701 may have, for example, a wireless module for wirelessly transmitting the acquired biosignal to the outside. In this case, as the wireless method, The wireless module may use wireless LAN, Wi-Fi (registered trademark), Bluetooth (registered trademark), ZigBee (registered trademark), etc. The wireless module is not particularly limited, but may be provided in a unit attached to the fingertip, or may be provided inside a housing that houses control circuit 705 (or in a manner connected to the housing).

[0029] (Electrocardiograph) Furthermore, an electrocardiograph (not shown) may be used to acquire electrocardiogram information of the patient. The electrocardiograph may be connected to the console 150.

[0030] (Other detection devices) Although the pulse oximeter has been a non-contact type that uses a light-emitting element, it may also be a type that acquires biological information by attaching a piezoelectric element (for example, a piezo element) to a part of the patient's body. For example, as schematically shown in Fig. 5, a piezoelectric element unit 730 provided with a contact portion 731 that is a piezoelectric element may be used.

[0031] The piezoelectric element unit 730 may be positioned so that the contact portion 731 directly touches the patient's skin, and the piezoelectric element may directly measure the vibration of the vascular wall of blood vessel A, and the result may be used to obtain at least one of heart rate information, blood pressure information, and pulse wave information.

[0032] The detection result may be output to another device via a wired connection, or may be output to another device wirelessly.

[0033] With regard to the detection device described above, whether it is configured to use a light-emitting element and a light-receiving element or a piezoelectric element, the obtained signal may be appropriately processed to perform data processing to obtain more diverse information. -For example, an estimated value of vascular age (not limited to displaying it as age, but also including several stages of classification, etc.).

[0034] In order to obtain information regarding respiration, it is possible to use a flow sensor (not shown). The flow sensor is a sensor that is used by being interposed in a part of the breathing circuit connected to the patient, converts the flow rate of the flowing gas into an electrical signal, and sends it to a predetermined measuring device or display device. At least one of the exhaled volume, inhaled volume, and respiratory rate may be detected using the flow sensor, and the result may be used by the chemical solution injection device.

[0035] Further, as the biological information detector, as more specific items of the heartbeat information, it may be possible to non-invasively detect the stroke volume, the stroke volume per beat, etc. The "stroke volume" refers to the amount of blood sent out from the heart per minute, and the "stroke volume per beat" refers to the amount of blood ejected by one contraction of the ventricle. As such a detector, for example, it may be of a type that measures the stroke volume by a pressure waveform analysis method using the pulse pressure based on the detection information from a probe unit attached to a fingertip (an example). It may be configured to acquire not only the heartbeat information but also the blood pressure information.

[0036] (3) Console The console 150 has a display 151 for displaying a predetermined image, a touch panel 153, a control unit 155, one or more physical buttons 157, and a storage unit 159 which is a storage medium such as a hard disk in one housing. It also has a data transmission unit 161 for transmitting data to an external network. One or more of these may be provided outside the housing. The console 150 may be used by being placed in an operation room adjacent to the examination room in one example.

[0037] Console 150 is connected to the imaging device 1100 and the injection head 110 respectively. Specifically, the control unit 155 of the console 150 is connected to the control circuit 1103a of the imaging device 1000 so as to be able to transmit and / or receive data. The control unit 155 is also connected to the control circuit 145 of the injection head 110 so as to be able to transmit and receive data. The control unit 155 is also connected so as to be able to receive data from the biological information detector 701.

[0038] Note that in this example, the console 150 integrally configures a control unit, a display, a touch panel, physical buttons, a module for communicating with the injection head, etc. in one housing. However, such an integrated configuration is not an essential matter, and the above-mentioned control unit, display, etc. may be configured as separate devices.

[0039] (Functions of the console) The control unit 155 has functions for controlling the creation of an injection protocol and the execution of an injection, etc. As an example, it may include a "setting screen display unit", an "injection protocol creation unit", an "injection control unit", a "history generation unit", and a "history output unit" (none of which are shown).

[0040] The setting screen display unit corresponds to a function of displaying a screen for setting an injection protocol, specifically, a GUI (Graphical User Interface) for setting an injection protocol on the display 151. The GUI data for setting the injection protocol may be stored in an arbitrary storage device of a chemical solution injection device, an imaging device, a hospital system, or other computers.

[0041] The protocol creation unit corresponds to a function that, for example, accepts an input operation on the touch panel of the display 151 by a doctor or medical staff and creates an infusion protocol reflecting the content. The protocol creation unit creates or changes predetermined parameters of the infusion protocol based on at least one input selected from, for example, the type of chemical solution, the infusion rate of the chemical solution, the infusion volume of the chemical solution, the patient's physical information (e.g., weight), the body part of the patient to be imaged, the imaging site, and the patient's biological information, etc.

[0042] The infusion control unit corresponds to a function that controls the operation of the piston drive mechanism 130 according to the created infusion protocol. The infusion control unit operates only one of the piston drive mechanisms 130 and operates both of them simultaneously.

[0043] The history generation unit corresponds to a function that generates infusion history data (chemical solution infusion data). As the "infusion history data", for example, - an infusion work ID, which is unique identification information for each infusion work, - the date and time of the start and end of the infusion, - the identification information of the chemical solution infusion device, - the infusion conditions of the contrast agent and / or physiological saline, - the infusion results of the contrast agent and / or physiological saline, and - the identification information of the chemical solution and the imaging site, may be at least one of them. It may be at least one of information on the chemical solution used, the infusion volume, the infusion profile representing the infusion rate with respect to the infusion time (in one example, image data of a time-course graph), and the profile representing the infusion pressure with respect to the infusion time (in one example, image data of a time-course graph). Note that in the above, the "infusion conditions" refer to the conditions set before the chemical solution infusion, and the "infusion results" refer to the measured values measured in the actual chemical solution infusion.

[0044] The infusion history data may be information on the chemical solution and the syringe obtained from the IC tag of the syringe, manually input by a doctor or medical staff, or input from an external network or the like.

[0045] The history output unit corresponds to the function of transmitting the injection history data externally. Specifically, it may transmit data to a predetermined external device and / or a database on the network.

[0046] Note that each function of each unit may be executed by a computer according to an implemented program. The program may be stored in advance in a predetermined storage means (for example, a storage unit) in the console.

[0047] The storage unit 159 (see FIG. 1) may store, for example, images displayed on the display 151, GUI data, etc. Also, an algorithm including a calculation formula for setting injection conditions, and data of an injection protocol may be stored. The injection speed may be constant or may change with time. When injecting a contrast agent and physiological saline, information such as in what order these chemical solutions are injected is also included in the injection protocol. Note that information regarding such an injection protocol may be input from an external device connected via an interface (not shown).

[0048] 2. Imaging device The imaging device 1100 is, for example, an X-ray CT device, an MRI device, a PET (Positron Emission Tomography) device, an ultrasonic diagnostic device, an angiography imaging device, etc. The imaging device 1100 includes a gantry, a bed 1103 on which a patient is placed, and a control circuit 1103a (see FIG. 1) that controls the operations of these (the imaging unit 1103b in the gantry and the bed 1103).

[0049] 3. Hospital system The hospital system, as an example, as shown in FIG. 2B, includes an imaging device, a chemical injection device, HIS (Hospital Information Systems) which is a medical record management device, and RIS (Radiology Information Systems) which is an imaging management device. It mainly includes a system for managing examinations using radiation equipment and from treatment reservation to examination results, a PACS (Picture Archiving and Communication Systems) which is a data storage device, an image viewer which is an image viewing device, a printer, etc. It is not necessarily required to have all of these.

[0050] (HIS) HIS is a computer on which a dedicated computer program is installed and has a medical record management system. The electronic medical record managed by the medical record management system may include, for example, data such as a medical record ID which is unique identification information, a patient ID for each patient, personal data such as the patient's name, medical record data regarding the patient's disease, etc. The medical record data may also include personal condition data related to overall treatment, such as the patient's weight, gender, age, etc. HIS may also have one or more of an automatic reception system, an admission / discharge management system, a medical accounting system, a pharmacy management system, a medical appointment system, etc.

[0051] (RIS) RIS is a system mainly for managing examinations using radiation equipment and from treatment reservation to examination results. RIS manages imaging order data with unique identification information. This imaging order data is created based on the electronic medical record obtained from HIS. The imaging order data may include, for example, an imaging work ID which is unique identification information, a work type such as CT imaging or MR imaging, the patient ID and medical record data of the aforementioned electronic medical record, the identification information of the CT device, the date and time of imaging start and end, a body part or imaging site, an appropriate type consisting of a chemical type such as a contrast agent corresponding to the imaging work, an appropriate ID consisting of a chemical ID suitable for the imaging work, etc. It may also include data such as a past contrast examination history and a side effect history of the contrast agent.

[0052] (PACS) PACS is a system that receives image data from various imaging devices (modalities) and stores it in a database. It receives and stores fluoroscopic image data with imaging order data attached from the imaging device.

[0053] (Image Viewer) The image viewer is a computer system such as a workstation, connected to a network, and may enable viewing by doctors and the like by referring to the image data stored, for example, in the PACS.

[0054] (Printer) As the printer, a conventionally known general product can be used, and one or more printers can be provided.

[0055] [Operation] (1) Use of biological information during or before drug injection In the drug injection device according to one aspect of the present embodiment, the biological information detector 701 detects the patient's biological information during and / or before injecting the drug. Specifically, at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state is detected.

[0056] Hereinafter, as an example, it is described that the biological information detector 701 obtains information on blood oxygen saturation (SpO2), heart rate (bpm), and electrocardiogram waveform. Although not limited, in this case, the biological information detector 701 may be a combination of a pulse oximeter and an electrocardiograph.

[0057] The control unit 155 of the console 150 receives the information from the biological information detector 701 and displays the information on blood oxygen saturation 621 (SpO2), heart rate 623 (bpm), and electrocardiogram waveform 625 on the display 151 as shown in FIG. 3 in an example.

[0058] Note that the screen in FIG. 3 assumes the phase of setting and adjusting the injection conditions before injection. In such a phase, when configured to display information such as blood oxygen saturation (SpO2) and heart rate (bpm), more appropriate injection conditions can be set in consideration of the patient's actual biological information.

[0059] Also, during the injection of the drug solution, the biological information of the patient may be detected and displayed on the display 151 in real time. Although illustration is omitted, as an example, the injection pressure may be drawn in real time on the injection screen in text display or graph display. According to the configuration in which the biological information of the patient is displayed in real time during the injection operation, if the value of the biological information exceeds a predetermined reference range, for example, when the heart rate rises extremely, a doctor or medical staff can confirm it and respond promptly.

[0060] In another aspect of the present invention, instead of simply "displaying" the biological information of the patient, the computer detects whether at least one value among heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state is within a predetermined range, and may be configured to issue an alarm when it is not within the predetermined range. For example, it is preferable that the device is configured to issue an alarm when the heart rate rises or falls outside a predetermined range (comparison with the upper limit value or lower limit value).

[0061] The alarm may also be issued when the blood oxygen saturation (SpO2) is below a predetermined reference value or when the pulse is below a predetermined intensity. The alarm is not particularly limited and may be visual notification, auditory notification, or a combination thereof. Regarding the biological information, the reference value serving as a trigger for issuing the alarm may be the default value at the time of shipment, or the changed value changed by the user may be used.

[0062] The above configuration allows doctors and medical professionals to more easily notice abnormalities in patients. By observing changes in vital signs such as pulse rate, respiratory rate, breathing pattern, and blood pressure, it is possible to determine whether side effects of the contrast agent are occurring.

[0063] In addition, the device may be configured to automatically stop operation rather than waiting for a corrective action by a doctor or medical professional. Furthermore, the device may be configured to prohibit liquid injection (prohibit the start of injection (including not entering a standby state, as described below)) if at least one value of the heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state is not within a predetermined range. Specifically, for example, if it is determined that the value of the patient's biological information is not within a predetermined range before liquid injection begins, the liquid injector 100 will not start liquid injection even if an operation to start injection is performed. This configuration can prevent liquid injection from being performed on a patient who is not in the desired biological state, such as an abnormally high heart rate. However, depending on the doctor's judgment, it is also possible that liquid injection can be performed without any problems. Therefore, the device may be configured to accept an operation (e.g., pressing a button or icon, voice input, etc.) to cancel the prohibition on starting injection.

[0064] One possible mode for prohibiting the start of injection is (i) a mode in which the device is in an injection standby state, but the injection operation is not performed even if the operator performs an operation to start injection (e.g., pressing a button or selecting an icon). The present invention may also be configured in such a way that (ii) the device does not transition to the injection standby state in the first place. This will be explained with reference to Figure 7. First, the phases leading up to the start of injection are assumed to be injection condition setting, standby state, and injection start.

[0065] "Injection condition setting" is the phase for setting injection conditions. Once the injection condition setting is completed, for example, when the operator makes a predetermined input (e.g., pressing a button or selecting an icon), it transitions to the "standby state". The "standby state" refers to a state where injection starts if the final predetermined input (e.g., pressing a button or selecting an icon) is made. Although not limited, in order to enter the standby state, a conventionally known predetermined pre-injection start operation (e.g., a check operation to see if the circuit is properly connected, an operation to fill the tube with the chemical solution, etc.) may be performed. Also, means that can visually recognize that it is in the standby state (e.g., a display on the graphical user interface, or the emission mode of the device if it has a light-emitting part) may be utilized.

[0066] (ii) According to the configuration that does not transition to the standby state in the first place as in the aspect of (ii), the operator can know in advance that injection cannot be started, and prevent the device from operating inappropriately (for example, the operator simultaneously performs the start operation of the chemical solution injection device and the start operation of the imaging device, but since injection start is prohibited, only the operation of the imaging device starts).

[0067] Note that after the chemical solution injection is completed, detection of at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state may continue.

[0068] In the present invention, it may be configured to connect a stand-alone pulse oximeter device (configured to have a control unit with a display in addition to the probe unit) to the chemical solution injection device, or it may be configured such that only the probe unit is connected. In the latter case, the control unit on the pulse oximeter device side becomes unnecessary, and there is an advantage that the device can be integrated and the configuration can be simplified. Also, through the screen of the console 150, it becomes possible to perform both chemical solution injection and biological monitoring in the operation room.

[0069] (2) Use of biological information after injection of the chemical solution In the chemical solution injection device according to one embodiment of the present embodiment, at least one piece of information among the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiration state, and expiration state obtained as described above (the result is preferably displayed but not essential) may be stored as a log in a predetermined storage area (either inside or outside the chemical solution injection device).

[0070] For example, a configuration may be adopted in which data is transmitted from the data transmission unit 161 of the chemical solution injection device to a data server (not shown, such as a hospital server) on the network. The type of the data server and the like are not particularly limited, and it may be stored in an HIS server, a RIS server, a PACS server, or the like.

[0071] Among such information as heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiration state, and expiration state, at least one piece of information may be transmitted externally alone, but the following data transmission may also be performed. That is, at least one piece of information among the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiration state, and expiration state may be transmitted externally together with the "chemical solution injection data".

[0072] According to such a configuration, it is possible to retrospectively confirm what kind of chemical solution was actually injected under what conditions, and moreover, since the biological information of the patient during the injection is also included, it is useful even in the case of verifying the contrast effect.

[0073] During the examination, a configuration may be adopted in which the biological information of the patient is transmitted in real time from the data transmission unit 161 of the chemical solution injection device to, for example, the imaging device 1100.

[0074] (3) Examples of more specific data processing As shown in FIG. 6A, biological information is detected at a stage before setting the chemical solution injection conditions, and the current biological information of the patient obtained thereby (at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state) may be automatically input to the console of the chemical solution injection device as at least one parameter for setting the chemical solution injection conditions. Although not limited, the "heart rate" of the patient may be input as one of the parameters. An injection condition determination method may be adopted in which the injection amount of the contrast agent is calculated according to the patient's weight and appropriately corrected according to the heart rate.

[0075] For example, the following injection condition determination may be performed.

[0076] First, determine the amount of the contrast agent to be injected into the patient. The determination of the amount of the contrast agent can be carried out according to various conventionally known methods. For example, a method may be adopted in which an appropriate amount is determined according to the imaging site, the patient's weight, etc. At this time, the determination of the amount may be made in consideration of the parameters of the current biological information of the patient (at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state).

[0077] Next, for example, at the timing immediately before imaging by the imaging device, the heartbeat information of the patient at that time is measured by a pulse oximeter. The "timing immediately before imaging" specifically refers to the timing when the patient lies on the bed of the imaging device and the injection needle is punctured and the contrast agent or the like can be injected from the chemical solution injection device. More specifically, it may be the timing when the "air check operation" (standby state) provided in the chemical solution injection device is performed.

[0078] The "air check operation" refers to the operation performed after the liquid injection conditions have been set, in which the operator confirms that there is no air in the injection circuit to the patient or that the circuit is not blocked, and then presses a specific button. At this stage, the liquid injection device does not operate the piston drive mechanism or other mechanisms, but when a specific button is pressed, it may, for example, change the display content and / or the illumination state of the device's light-emitting element. In the state in which the air check operation has been performed (air check state), the device according to one embodiment of the present invention is configured such that the injection conditions cannot generally be changed. The air check state can also be considered a state in which the device is waiting for the operator to perform an operation to start injection. For example, if an operation other than starting injection is performed, the air check state is canceled and the device transitions to the previous state.

[0079] Next, the console 150 adjusts the amount of contrast agent as needed using the measured heart rate information (e.g., heart rate). This adjustment may be performed by increasing or decreasing the amount of contrast agent using a function f(x), where x is the heart rate, or by using a table showing the relationship between the heart rate x and the corresponding increase or decrease value y. FIG. 8 shows an example of the table. In this example, the range of heart rates is divided into several sections, and an adjustment amount corresponding to each section is set. Specifically, for example, no adjustment is performed in the range of "Section 2," and the amount of contrast agent is reduced in "Section 1," which has a lower heart rate. Furthermore, for "Sections 3" to "Section 6," which have heart rates higher than "Section 2" (Section 6 has a higher value), amounts of contrast agent "y2" to "y5" (Section y5 has a higher value) are added, respectively.

[0080] [Table 1]

[0081] Naturally, the number of sections and the specific amount of adjustment can be set appropriately depending on the part to be imaged, the contrast agent used, etc. For example, adjustments may be made such that when the heart rate is 55 or less, the contrast agent is reduced by 10 ml, when it is between 55 and 65, no adjustment is made, when it is between 65 and 75, 10 ml of contrast agent is added, when it is between 75 and 90, 20 ml of contrast agent is added, when it is between 90 and 105, 25 ml of contrast agent is added, and when the heart rate exceeds 105, 30 ml of contrast agent is added.

[0082] In this way, by readjusting the amount of contrast agent to be injected based on the biological information immediately before imaging, it is possible to inject a more appropriate amount of contrast agent according to the patient's condition.

[0083] When adjusting the amount of contrast agent, for example, if the amount of contrast agent is excessively increased (e.g., category 6 in Table 1), it is also preferable that console 150 notify the operator by displaying a message indicating that the amount of contrast agent will be increased. Naturally, a similar operation may be performed when the amount of contrast agent is excessively decreased. Such a message may be displayed in any of cases where the amount of contrast agent is only increased, only decreased, or both.

[0084] The above technical idea can be expressed as follows: a data processing unit (which may also be referred to as one or more processors), - A process of referring to the patient's heart rate information (e.g., heart rate) before injecting the medicinal liquid; - a process of determining an adjustment amount of the contrast agent corresponding to the heart rate information and adjusting the amount of the contrast agent; and the liquid injector injects the adjusted amount of the contrast agent liquid; System. It can also be expressed as an invention in the category of methods and programs. As a further modification, in addition to or instead of the heartbeat information (not limited to the heart rate, but may also be the stroke volume, etc.), based on other biological information (for example, at least one of blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state), the above-described contrast agent dose adjustment may be performed.

[0085] (Myocardial stress) FIG. 6B is an example of data processing that can be performed in a case where, for example, in a myocardial analysis examination, in addition to an automatic injector for injecting a contrast agent, an automatic injector for injecting a myocardial stress agent is prepared. In this examination, first, there is a phase of injecting a myocardial stress agent, then a resting phase for a certain period of time, and then a phase of injecting a contrast agent. In this series of phases, the biological information of the patient (particularly, the heart rate and blood oxygen saturation) is detected.

[0086] By doing so, for example, it becomes possible to confirm whether the effect of the myocardial stress agent is manifested. Also, if the biological information is saved together with the chemical solution injection data, etc., it becomes possible to confirm the state of the patient during the examination retrospectively.

[0087] As described above, the examples of the present invention have been described with reference to the drawings. However, each of the technical matters described above can be appropriately combined and changed without departing from the spirit of the present invention.

[0088] (Some changes regarding the configuration of the embodiment) (1) In the above embodiment, the configuration in which the chemical solution in the syringe is pressurized by the piston drive mechanism and pushed out has been described. However, a chemical solution injection device provided with a mechanism for sending out a chemical solution from a chemical solution storage container (for example, a flexible chemical solution bag, a hard case such as a bottle, etc.) may be used. As an example, a configuration in which a chemical solution such as a contrast agent is sent out by a tube pump may be used. (2) Although the data processing using information from the biological information detector has been described as being performed by the control unit 155 in the console 150 as an example, the entity performing the data processing may be a control unit other than the control unit 155. A distributed processing may be performed in which some data processing is performed by the control unit 155 and other data processing is performed by other control units.

[0089] (Addendum) This application discloses the following inventions. Note that the reference numerals in parentheses are added for reference purposes and do not limit the present invention in any way. In addition, inventions of the following products described by changing the category expressions (method inventions and program inventions) are also disclosed in this application.

[0090] 1-1.A: A liquid injector (100) for injecting a contrast medium into a patient, the liquid injector having a piston drive mechanism (130) for moving a piston of a syringe and a control circuit (145) for controlling the operation of the piston drive mechanism; B: A biological information detector (701) that acquires at least one of the patient's heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state; C: A data processing unit (155, etc.) that processes data using information from the biological information detector, The data processing unit (a) During the injection of the medicinal solution, determining whether or not at least one value of the heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state is within a predetermined range; (b) If the value is not within the predetermined range, an alarm is issued or the operation of the piston drive mechanism is stopped. A contrast medium injection system (medicinal liquid injection device) configured as described above.

[0091] 1-2.A: A liquid injector (100) for injecting a contrast medium into a patient, the liquid injector having a piston drive mechanism (130) for moving a piston of a syringe and a control circuit (145) for controlling the operation of the piston drive mechanism; B: A biological information detector (701) that acquires at least one piece of information among the patient's heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state, C: A control method for a system comprising a data processing unit (such as 155) that performs data processing using the information from the biological information detector, wherein the data processing unit (a) During the injection operation of the chemical solution, determines whether at least one value among the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state is within a predetermined range; (b) When it is not within the predetermined range, issues an alarm or stops the operation of the piston drive mechanism, The control method having the above.

[0092] 1-3. A control program for performing the above control method, which causes a computer to (a) During the injection operation of the chemical solution, determine whether at least one value among the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state is within a predetermined range; (b) When it is not within the predetermined range, issue an alarm or stop the operation of the piston drive mechanism, The control program for causing the above to be performed.

[0093] 2. The above contrast agent injection system, wherein the chemical solution injection device includes an injection head and a console, and the injection head is usable in an MRI room.

[0094] 3. The above contrast agent injection system, wherein the console has a display, and is configured such that at least one piece of information among the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state is displayed on the display. The above contrast agent injection system.

[0095] 4-1. A: A chemical solution injection device (100) having a piston drive mechanism (130) for moving the piston of the syringe and a control circuit (145) for controlling its operation, and injecting a contrast agent into a patient, B: A biological information detector (701) for acquiring at least one piece of information among the patient's heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiration state, and expiration state, D: A data transmission unit (161) for transmitting data externally, and comprising, The chemical solution injection device is, (c) acquiring at least one piece of biological information among the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiration state, and expiration state from the biological information detector, (d) transmitting the acquired biological information externally via the data transmission unit (161), A contrast agent injection system configured as such.

[0096] 4-2. A: A chemical solution injection device (100) having a piston drive mechanism (130) for moving the piston of the syringe and a control circuit (145) for controlling its operation, and injecting a contrast agent into a patient, B: A biological information detector (701) for acquiring at least one piece of information among the patient's heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiration state, and expiration state, D: A data transmission unit (161) for transmitting data externally, and a control method of a system comprising: The chemical solution injection device, (c) a step of acquiring at least one piece of biological information among the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiration state, and expiration state from the biological information detector, (d) a step of transmitting the acquired biological information externally via the data transmission unit (161), A control method having.

[0097] 4-3. A control program for performing the above control method, causing a computer to (c) obtain at least one piece of biological information from the biological information detector among heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state; (d) transmit the obtained biological information to the outside via the data transmission unit (161); and a control program for causing the above to be performed.

[0098] 5. The contrast agent injection system according to claim 4, wherein the chemical solution injection device (e) transmits the biological information to the outside together with the chemical solution injection data.

[0099] 6. The contrast agent injection system according to the above, wherein the chemical solution injection data is at least one of information regarding the chemical solution used, injection volume, injection profile representing the injection rate with respect to the injection time, and profile representing the injection pressure with respect to the injection time.

[0100] 7. Further, comprising an automatic injector for injecting a drug that changes the patient's heart rate, wherein the chemical solution injection device (f) at least one piece of information among heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state before the drug is injected; (g) at least one piece of information among heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inhalation state, and exhalation state after the drug is injected; and is configured to obtain the above. The contrast agent injection system according to the above.

Explanation of Reference Numerals

[0101] 100 Chemical solution injection device 110 Injection head 111 Housing 130 Piston drive mechanism 138 load cells 145 Control Unit 150 console 161 Data Transmission Unit 200 syringes 222 Piston parts 225 IC tag 701 Biometric Information Detector 705 Control Circuit 710 Probe Unit 730 Piezoelectric element unit 731 Contact part 1100 Imaging device

Claims

1. A: A chemical solution injection device that has a piston drive mechanism for moving the piston of a syringe and a control circuit for controlling the operation thereof, and injects a contrast agent into a patient; B: A biological information detector that acquires the biological information of the patient; C: A data processing unit that performs data processing using the biological information; Comprising: After the setting of the injection conditions of the contrast agent is completed, the biological information detector acquires the biological information of the patient at the timing when a predetermined operation is performed by an operator; The data processing unit adjusts the amount of the contrast agent using the biological information acquired by the biological information detector, and notifies the operator to that effect when the amount of the contrast agent is increased or decreased by the adjustment. A contrast agent injection system configured as described above.

2. The chemical solution injection device includes an injection head and a console. The contrast agent injection system according to Claim 1, wherein the injection head can be used in an MRI room by using non-magnetic structural components.

3. The console has a display. The contrast agent injection system according to Claim 2, configured such that the biological information is displayed on the display.

4.

4. D: A data transmission unit that transmits data to the outside; Further comprising: The chemical solution injection device: (d) Transmits the acquired biological information to the outside via the data transmission unit. The contrast agent injection system according to Claim 1, configured as described above.

5. The chemical solution injection device: (e) Transmits the biological information together with chemical solution injection data to the outside. The contrast agent injection system according to Claim 4.

6. The chemical solution injection data is at least one of information regarding the chemical solution used, the injection amount, an injection profile representing the injection speed with respect to the injection time, and a profile representing the injection pressure with respect to the injection time. The contrast agent injection system according to Claim 5.

7. Furthermore, It is provided with an automatic injector that injects a drug that changes the heart rate of the patient. The chemical solution injection device: (f) Acquires the biological information before the drug is injected; (g) Acquires the biological information after the drug is injected. The contrast agent injection system according to any one of Claims 1 to 6, configured as described above.

8. The data processing unit adjusts the amount of the contrast agent using a function of the biological information. The contrast agent injection system according to any one of Claims 1 to 7.

9. The contrast agent injection system according to any one of claims 1 to 7, wherein the data processing unit adjusts the amount of the contrast agent using a table representing the relationship between the biological information and the increase / decrease value corresponding to the value thereof.

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