JP2022113830A - Contrast medium injection system - Google Patents

Abstract

PROBLEM TO BE SOLVED: 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

COPYRIGHT: (C)2022,JPO&INPIT

Description

The present invention relates to a contrast medium injection system for injecting at least a contrast medium as a liquid medicine into a patient. In particular, it is an object of the present invention to provide a contrast medium injection system capable of obtaining biometric information from a patient during drug injection and performing safer contrast medium injection. Another object of the present invention is to provide a contrast medium injection system capable of recording information on biological changes occurring in a patient during drug injection.

Currently, known diagnostic imaging apparatuses for medical use include a CT (Computed Tomography) apparatus, an MRI (Magnetic Resonance Imaging) apparatus, a PET (Positron Emission Tomography) apparatus, an ultrasonic diagnostic apparatus, an angiography imaging apparatus, and the like. ing. When using such an imaging device, a contrast agent, physiological saline, or the like (hereinafter collectively referred to simply as "medicine") may be injected into the patient.

Contrast medium injection is basically performed as follows. First, a patient lies on a bed of an imaging device in an examination room, and a liquid medicine such as a contrast medium is injected into the patient from an injection head that is also arranged in the examination room. An operating room adjacent to the examination room contains a console used to generate injection protocol data. Injection of the contrast medium is started, for example, by a doctor in the imaging room pressing a predetermined button on the injection head.

Regarding imaging examinations using a contrast medium, Patent Document 1, for example, discloses acquisition of heartbeat data of a patient at each stage such as a contrast medium injection stage and an imaging stage.

JP 2011-183088

By the way, when injecting a contrast agent, information on biological changes that occur in the patient during the injection of the drug solution is acquired, and if an abnormality occurs, an alarm is issued as necessary, or the operation of the device is automatically stopped. It is desirable that the In addition, the contrast enhancement effect of a contrast medium also changes depending on, for example, the heart rate, etc., and having such biological information of the patient that affects the contrast enhancement effect in the drug injection device greatly affects the reproducibility of the contrast enhancement examination and the next time. It is useful from the viewpoint of setting chemical injection conditions. It is also important to record what kind of ecological changes occurred in the patient when the drug solution was injected.

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a contrast medium injection system capable of acquiring biological information from a patient during drug injection and performing safer contrast medium injection. Another object of the present invention is to provide a contrast agent injection system capable of recording information on biological changes that occur in a patient during drug solution injection.

A configuration of one embodiment of the present invention for solving the above problems is as follows:
A: A liquid injection device for injecting a contrast medium into a patient, having a piston driving mechanism for moving the piston of the syringe and a control circuit for controlling the operation thereof;
B: a biological information detector 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, inspiratory state, and expiratory state;
C: a data processing unit that performs data processing using information from the biometric information detector;
with
The data processing unit is
(a) at least one of the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state is at least a predetermined value during the liquid injection operation; determine whether it is within the range of
(b) a contrast injection system configured to issue an alarm or stop operation of said piston drive mechanism if it is not within a predetermined range;

Specific examples of the "contrast agent" include a contrast agent with an iodine concentration of 240 mg/ml (for example, a viscosity of 3.3 mPa s at 37°C and a specific gravity of 1.268 to 1.296), a contrast agent with an iodine concentration of 300 mg/ml ( For example, a contrast medium with a viscosity of 6.1 mPa·s and a specific gravity of 1.335 to 1.371 at 37°C and an iodine concentration of 350 mg/ml (for example, a viscosity of 10.6 mPa·s and a specific gravity of 1.392 to 1.392 to 1.37°C at 37°C). 433), etc. Contrast agents used in MRI examinations include gadolinium preparations.

According to the present invention, it is possible to provide a contrast medium injection system capable of obtaining biometric information from a patient who is injecting a liquid medicine and injecting a contrast medium more safely. It is possible to provide a contrast medium injection system capable of recording information on biological changes that occur in a patient during drug solution injection.

1 schematically illustrates a system in one form of the invention; FIG. It is an appearance perspective view showing an example of an injection head. It is a figure which shows an example of a hospital system. FIG. 4 is a diagram showing an example of an image displayed on the screen of the console; It is a figure which shows typically the probe unit of a biometric information detector. FIG. 4 is a diagram schematically showing a detection unit using piezoelectric elements; It is a figure which shows the procedure of the detection of biometric information, and the setting of chemical|medical-solution injection conditions. FIG. 10 is a diagram showing procedures for injecting a myocardial loading agent and a contrast medium; FIG. 4 is a schematic diagram showing phases from injection condition setting to liquid injection.

Embodiments of the present invention will be described below with reference to the drawings. Note that the following description is basically based on one specific form shown in the drawings, but the specific form of each configuration is not limited to a specific one.

[Constitution]
The medical imaging system 1 of the present embodiment includes an imaging device 1100, a liquid injector 100, and a biological information detector 701, as illustrated in FIG.

The drug injection device 100 includes an injection head 110 and a console 150 . Alternatively, in addition to that, a power supply box (not shown) containing a predetermined control unit may be provided. A specific example of the injection head 110 is shown in FIG. 2A (details will be described later). Various types of liquid injectors 100 are conventionally known. In one form, the present invention is suitable for a chemical injection device for MRI, but is not necessarily limited to this.

Each configuration of the system of this embodiment will be described below.
1. Chemical Injector (1) Injection Head The injection head 110 is, for example, a two-cylinder type one to which two syringes can be attached (see FIGS. 1 and 2A). One syringe 200C may be filled with a contrast medium, and the other syringe 200S may be filled with physiological saline. In other embodiments, both may be contrast agents (different concentrations).

(Syringe)
The configuration of the syringes 200S and 200C (also referred to simply as the syringe 200) is roughly as follows. The syringe 200 has a hollow cylindrical cylinder member 221 and a piston member 222 slidably inserted into the cylinder member 221 . The syringe may be of a pre-filled type in which a chemical solution is filled in advance, or may be of a suction type in which an empty syringe is used by sucking the chemical solution. The "piston member" is not necessarily limited to a long rod as shown in the drawing, and may be a so-called rodless type (which can also be simply referred to as a "plunger" or the like).

(IC tag)
An IC tag 225 may be attached to part of the syringe. The IC tag 225 includes information about the syringe (identification information of the syringe, pressure resistance of the syringe, inner diameter of the cylinder member, stroke of the piston member, etc.) and information of the liquid medicine filled in the syringe (name (eg product name), component information such as the amount of iodine or the amount of gadolinium, the expiry date, the volume of the chemical solution, etc.) are stored. An IC tag may have a unique ID specific to that tag. A bar code or the like may be used instead of the IC tag. Basically, any data carrier means may be used as long as it holds predetermined data.

(injection head)
As shown in FIG. 2A, the injection head 110 has a housing 111, and two recesses 120a are formed on the front end side of the upper surface of the housing 111, on which the syringes 200C and 200S are respectively placed. The recess 120a is a portion that functions as a syringe holding portion. A plurality of physical buttons for causing the injection head 110 to perform various operations are also provided on the upper surface of the housing of the injection head 110 . Although the physical button is not particularly limited, the following may be used. A forward button for advancing the ram member, a reverse button for retreating the ram member, an accelerator button for increasing the moving speed of the ram member when pressed simultaneously with the forward button or the reverse button, and a stop for stopping the movement of the head. buttons etc.

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 mechanism 130 operates independently. Piston drive mechanism 130 may retract piston member 222, for example, to aspirate a medical fluid into a syringe. The two piston drive mechanisms 130 may be driven simultaneously or at separate timings.

Specifically, as shown in FIG. 1, the piston driving mechanism 130 includes a motor 131 that is a driving source, a transmission mechanism 132 that converts the rotational output of the driving motor into linear motion, and a transmission mechanism 132 that converts the rotational output of the driving motor into linear motion. and a ram member 133 for advancing and/or retracting member 222 . In the case of MRI equipment, non-magnetic structural parts such as ultrasonic motors are used.

The injection head 110 may be provided with a load cell 138 for detecting the force with which the ram member presses the piston member 222 . Using the detection result of the load cell 138, for example, it is possible to obtain an estimated value of the pressure of the chemical solution when the chemical solution is being injected. This estimated value is calculated by considering the size of the needle, the concentration of the liquid medicine, the injection conditions, and the like. Alternatively, the pressure may be calculated based on the motor current of the drive motor 131 instead of using the load cell 138 .

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

The injection head 110 may have a control circuit 145 for controlling the operation of the piston drive mechanism 130 and the like. The control circuit 145 can be configured as a control circuit having a processor, memory, and the like.

(2) Biological Information Detector The biological information detector 701 has one or more sensors, heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, and intake state. , and an expiration state to obtain biometric information of the patient.

(pulse oximeter)
As an example of the biological information detector 701, a pulse oximeter may be used. As schematically shown in FIGS. 1 and 4, the pulse oximeter of this example consists of a probe unit 710 that clamps a part of the patient's body (for example, a fingertip) and a control circuit 705 (see FIG. 1) connected thereto. and A display for displaying the detection results may not be provided, but the present invention is not necessarily limited thereto.

Although not shown in detail, the probe unit 710 is provided with a light-emitting element and a light-receiving element that irradiate the patient's body with light. A light-emitting element emits red light and infrared light, and the light-receiving element measures the transmission (or reflection) of these lights through a fingertip or the like. Since hemoglobin in blood has different absorbances of red light and infrared light depending on the presence or absence of bonding with oxygen, oxygen saturation in blood can be measured by measuring and analyzing transmitted light and reflected light. A pulse oximeter may also be capable of measuring pulse rate. Moreover, the pulse wave shape may be obtained.

Sensing devices using non-magnetic materials that do not affect magnetic fields (or have negligible effects) are also useful, so that they can be used in MRI examinations. In this case, the cable 712 (FIG. 4) for transmitting the signal from the probe unit 710 is not a metal cable but an optical fiber or the like.

The biometric information detector 701 may have, for example, a wireless module for wirelessly transmitting the acquired biometric information to the outside. In this case, the radio method is
A wireless LAN, Wi-Fi (registered trademark), Bluetooth (registered trademark), ZigBee (registered trademark), or the like may be used. The wireless module is not particularly limited, but may be provided in a unit attached to a fingertip, or may be installed in a housing (or connected to the housing) that houses the control circuit 705. may be provided.

(Electrocardiograph)
Additionally, an electrocardiograph (not shown) may be utilized to acquire electrocardiogram information of the patient. The electrocardiograph may be used by connecting to console 150 .

(other detection devices)
Although the pulse oximeter is a non-contact type that uses a light-emitting element, it may be one 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.

The piezoelectric element unit 730 is arranged so that the contact portion 731 directly touches the patient's skin, and the piezoelectric element directly measures the vibration of the blood vessel wall of the blood vessel A, and the results are used to obtain heartbeat information, blood pressure information, At least one piece of pulse wave information may be acquired.

Note that the detection result may be output to the other device in a wired manner, or may be output to the other device in a wireless manner.

Regarding the detection device as described above, regardless of whether the configuration uses a light-emitting element and a light-receiving element or a configuration using a piezoelectric element, the obtained signal is appropriately processed, and data processing is performed so as to obtain more diverse information. It may be done.
- For example, an estimated value of blood vessel age (not limited to display as age, but also including several stages of classification, etc.).

A flow sensor (not shown) can be used to obtain information about respiration. A flow sensor is a sensor that is interposed in a part of a respiratory circuit connected to a patient, converts the flow rate of flowing gas into an electrical signal, and sends the electrical signal to a predetermined measuring device or display device. At least one of expiratory volume, inspiratory volume, and respiratory rate may be detected using a flow sensor, and the result may be used in the liquid injection device.

Further, the biological information detector may be one that can non-invasively detect a stroke volume, a stroke volume, etc. as more specific items of the heartbeat information. “Stroke volume” refers to the amount of blood pumped from the heart per minute, and “stroke volume” refers to the amount of blood ejected by one contraction of the ventricles. Say. As such a detector, for example, it may be of a type that measures stroke volume by a pressure waveform analysis method using pulse pressure based on detection information from a probe unit attached to a fingertip (one example). The configuration may be such that not only the heartbeat information but also the blood pressure information can be acquired together.

(3) Console The console 150 includes a display 151 that displays a predetermined image, a touch panel 153, a control unit 155, one or more physical buttons 157, and a storage unit 159 that is a storage medium such as a hard disk. It has inside the 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 placed and used in an operating room adjacent to an examination room in one example.

Console 150 is connected to imaging device 1100 and injection head 110, respectively. Specifically, the control unit 155 of the console 150 is connected to the control circuit 1103a of the imaging apparatus 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. Control unit 155 is also connected to receive data from biometric information detector 701 .

In this example, the console 150 includes a control unit, a display, a touch panel, physical buttons, a module for communicating with the injection head, and the like, which are integrated into one housing. However, such an integrated configuration is not an essential matter, and the control unit, display, etc. as described above may be configured as separate devices.

(console function)
The control unit 155 has a function of controlling creation of an injection protocol, execution of injection, and the like, and examples thereof include a “setting screen display unit”, an “injection protocol creation unit”, an “injection control unit”, and a “history generation unit”. , and a “history output unit” (both not shown).

The setting screen display unit corresponds to a function of displaying on the display 151 a screen for setting the injection protocol, more specifically, a GUI (graphical user interface) for setting the injection protocol. GUI data for infusion protocol settings may be stored in any storage device of the infusion device, imager, hospital system or other computer.

The protocol creating unit corresponds to, for example, a function of receiving an input operation to the touch panel of the display 151 by a doctor or a medical worker and creating an injection protocol reflecting the content of the input operation. The protocol creation unit, for example, at least selects from the type of liquid medicine, injection rate of liquid medicine, injection amount of liquid medicine, patient's physical information (for example, body weight), patient's body segment to be imaged, imaging region, patient's biometric information, etc. Based on one input, correspondingly predetermined parameters of the injection protocol are created or modified.

The injection control section corresponds to the function of controlling the operation of the piston drive mechanism 130 according to the created injection protocol. The injection control unit operates one of the piston drive mechanisms 130 and operates both at the same time.

The history generation unit corresponds to a function of generating injection history data (chemical injection data). Examples of "injection history data" include:
- an injection job ID, which is unique identification information for each injection job;
- date and time of infusion start and end,
- the identification of the dosing device,
- contrast medium and/or saline injection conditions,
- Contrast and/or saline injection results, and
-Identification information of drug solution and imaging part,
may be at least one of Information on the drug solution used, injection volume, injection profile showing injection rate against injection time (example: image data of graph over time), and profile showing injection pressure against injection time (example: graph over time) image data). In the above description, "injection conditions" refer to conditions set before chemical injection, and "injection results" refer to measured values measured during actual chemical injection.

The injection history data may be drug solution information or syringe information 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.

The history output unit corresponds to a function of transmitting injection history data to the outside. Specifically, data may be transmitted to a predetermined external device and/or a database on a network.

Note that each function of each unit may be executed by a computer according to an installed program. The program may be pre-stored in a predetermined storage means (for example, a storage unit) within the console.

The storage unit 159 (see FIG. 1) may store, for example, images displayed on the display 151, GUI data, and the like. Algorithms including calculation formulas for setting injection conditions and data of injection protocols may also be stored. The injection rate may be constant or may vary over time. When injecting a contrast agent and a physiological saline solution, the injection protocol also includes information such as in what order the drug solutions should be injected. Information on such an injection protocol may be input from an external device connected via an interface (not shown).

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, or the like. The imaging apparatus 1100 includes a gantry, a bed 1103 on which a patient is placed, and a control circuit 1103a (see FIG. 1) for controlling the operations of them (the imaging unit 1103b and the bed 1103 in the gantry).

3. Hospital system Hospital system is an abbreviation of HIS (Hospital Information Systems), which is an imaging device, drug injection device, medical chart management device, and RIS (Radiology Information Systems), which is an imaging management device, as shown in FIG. 2B. (mainly a system for managing examinations using radiological equipment and from treatment reservations to examination results), PACS (Picture Archiving and Communication Systems) as a data storage device, an image viewer as an image viewing device, a printer, etc. It is not always necessary to have all of these.

(HIS)
HIS is a computer in which a dedicated computer program is installed, and has a chart management system. An electronic medical record managed by a medical record management system includes 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, and medical record data related to the patient's disease. There may be. The patient's body weight, sex, age, and the like may be registered in the chart data as personal condition data related to treatment in general. The HIS may also include one or more of an automated reception system, an admissions and discharge management system, a medical accounting system, a pharmacy management system, an appointment system, and the like.

(RIS)
The RIS is a system that mainly manages examinations using radiation equipment and treatment reservations to examination results. The RIS manages the imaging order data with unique identification information. This imaging order data is created based on the electronic chart obtained from the HIS. The imaging order data includes, for example, an imaging job ID that is unique identification information, a job type such as CT imaging or MR imaging, the above-mentioned patient ID and medical chart data of the electronic medical chart, identification information of the CT apparatus, date and time of imaging start and end. , a body segment or an imaging region, an appropriate type consisting of a chemical liquid type such as a contrast medium corresponding to the imaging work, and an appropriate ID consisting of a liquid medicine ID suitable for the imaging work. Data such as the history of past contrast examinations and the history of side effects of contrast agents may be included.

(PACS)
PACS is a system that receives image data from various imaging devices (modalities) and stores it in a database. The fluoroscopic image data to which the imaging order data is attached is received from the imaging device and stored.

(image viewer)
The image viewer is a computer system, such as a workstation, connected to a network, and may refer to image data stored, for example, in a PACS for viewing by a doctor or the like.

(printer)
As the printer, conventionally known general products can be used, and one or a plurality of printers are provided.

[motion]
(1) Use of biological information during or before injection of liquid medicine In the liquid injection device according to one aspect of the present embodiment, biological information of the patient is detected by the biological information detector 701 during and/or before injection of the liquid medicine. to detect Specifically, at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state is detected.

In the following description, it is assumed that the biological information detector 701 can obtain information on blood oxygen saturation (SpO2), heart rate (bpm), and electrocardiographic waveform. Although not limited, the biological information detector 701 in this case may be a combination of a pulse oximeter and an electrocardiograph.

Control unit 155 of console 150 receives information from biological information detector 701 and displays blood oxygen saturation 621 (SpO2), heart rate 623 (bpm) and heart rate on display 151, as shown in FIG. Information on the waveform 625 is displayed.

The screen of FIG. 3 assumes a phase of setting and adjusting injection conditions before injection. In such a phase, if it is configured to display information such as blood oxygen saturation (SpO2) and heart rate (bpm), the actual biological information of the patient may also be taken into account to determine more appropriate injection conditions. Settings can be made.

Further, the biological information of the patient may be detected and displayed on the display 151 in real time during the injection of the liquid medicine. Although illustration is omitted, as an example, the injection pressure may be displayed in real time as a text display or a graph display on the screen during injection. According to the configuration in which the patient's biological information is displayed in real time during the injection operation, if the value of the biological information exceeds a predetermined reference range, the doctor or medical staff can confirm it. This means that you can respond quickly (for example, if your heart rate rises too much).

In another aspect of the present invention, rather than simply "displaying" the patient's biometric information, the computer displays heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, and inspiration. It may be configured to detect whether or not the value of at least one of the state and the expiratory state is within a predetermined range, and issue an alarm if it is not within the predetermined range. For example, if the heart rate rises or falls beyond a predetermined range (compare with upper or lower limits), the device is preferably arranged to generate an alarm.

Alarms may also be issued when blood oxygen saturation (SpO2) is below a predetermined reference value or when pulse is below a predetermined strength. The alarm may be, but is not limited to, visual notification, audible notification, or a combination thereof. Regarding biometric information, a default value at the time of shipment may be used as a reference value that triggers an alarm, but a changed value changed by the user may also be used.

According to the above configuration, it becomes easier for a doctor or a medical worker to notice an abnormality in a patient. By observing changes in biological information such as pulse, respiration rate, respiration pattern, and blood pressure, it is possible to determine whether or not the side effects of the contrast medium have occurred.

Additionally, rather than waiting for corrective action by the doctor or medical personnel, the device may be configured to automatically deactivate. In addition, if at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state is not within a predetermined range, the drug solution It may be configured so that injection cannot be performed (prohibiting the start of injection (including not shifting to a standby state as described later)). Specifically, for example, if it is determined that the value of the patient's biological information is not within a predetermined range before the injection of the liquid medicine is started, even if an operation for starting the injection is performed, the liquid injection apparatus 100 does not start the chemical injection operation. According to such a configuration, it is possible to prevent injection of the chemical solution to a patient who is not in a desired biological condition, such as an abnormally high heart rate. However, depending on the doctor's judgment, there may be cases in which liquid injection can be performed without any problems. Therefore, it may be configured to receive an operation (for example, pressing a button or icon, performing voice input, etc.) to cancel the prohibition state of starting injection as described above.

As one aspect of prohibiting the start of injection, for example, (i) in the injection standby state, even if the operator performs an operation (eg, pressing a button or selecting an icon) to start injection, Aspects in which no injection operation is performed are envisioned. In addition to this, the present invention may be configured such that (ii) it does not shift to the injection standby state in the first place. Description will be made with reference to FIG. First, as phases up to the start of injection, it is assumed here that there are respective phases of setting injection conditions, a standby state, and the start of injection.

"Injection condition setting" is a phase for setting injection conditions. After setting the injection conditions, for example, the operator makes a predetermined input (eg, pressing a button or selecting an icon) to shift to the "standby state". "Standby state" refers to a state in which injection is initiated upon a final predetermined input (eg, pressing a button or selecting an icon). Although it is not limited to this, in order to enter the standby state, conventionally known predetermined operations before starting injection (for example, an operation to check whether the circuit is properly connected, an operation to fill the tube with the chemical solution, etc.) are performed. can be anything. In addition, a means for visually recognizing the standby state (for example, display on a graphical user interface, light emitting mode when the device has a light emitting unit, etc.) may be used.

According to the configuration that does not shift to the standby state in the first place, as in the aspect (ii), the operator can know in advance that the injection cannot be started, and the device is operated inappropriately (for example, the operator However, it is possible to prevent a situation in which the start operation of the chemical injection device and the start operation of the imaging device are performed at the same time, but only the operation of the imaging device is started because the start of injection is prohibited.

Even after injecting the drug solution, at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state is continuously detected. good too.

As the present invention, a configuration in which a stand-alone pulse oximeter device (having a configuration having a control unit with a display in addition to the probe unit) is connected to the drug injection device, or a configuration in which only the probe unit is connected Either configuration may be used, but in the latter case, there is an advantage that the control unit on the pulse oximeter device side becomes unnecessary, and the devices can be integrated to simplify the configuration. Also, through the screen of the console 150, it becomes possible to perform both drug injection and biological monitoring in the operation room.

(2) Use of biological information after drug injection In the drug injection device according to one aspect of the present embodiment, heartbeat information, blood At least one of oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state is stored as a log in a predetermined storage area (whether internal or external to the liquid injection device). not available).

For example, data may be transmitted from the data transmission unit 161 of the liquid injector to a data server (not shown, hospital server, etc.) on the network. The type of data server is not particularly limited, and data may be stored in a HIS server, RIS server, PACS server, or the like.

Even if at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state is transmitted to the outside by itself However, the following data transmission may be performed. In other words, at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state is transmitted to the outside along with the "drug injection data". You may do so.

According to such a configuration, it is possible to confirm after the fact what kind of liquid medicine was actually injected under what conditions, and furthermore, the biological information of the patient during the injection is also included. It is also useful when verifying

It should be noted that the biometric information of the patient may be transmitted in real time from the data transmission unit 161 of the liquid injector to the imaging device 1100 during examination.

(3) A more specific example of data processing As shown in FIG. At least one of oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state) is used as at least one parameter for setting conditions for drug solution injection. It may be configured to be automatically input to the console of the device. Without limitation, the patient's "heart rate" may be entered as one of the parameters. An injection condition determination method may be adopted in which the injection amount of the contrast medium is calculated according to the patient's weight and is appropriately corrected according to the heart rate.

For example, the injection conditions may be determined as follows.

First, a determination is made of the amount of contrast agent to be injected into the patient. Determination of the amount of contrast agent can be performed according to various conventionally known methods. For example, a system in which an appropriate amount is determined according to the site to be imaged, the weight of the patient, or the like may be used. At this time, parameters of the patient's current biological information (at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state) are considered. quantity determination may be made.

Next, for example, immediately before imaging by the imaging device, the heartbeat information of the patient at that time is measured by the pulse oximeter. The “timing immediately before imaging” specifically refers to the timing when the patient is lying on the bed of the imaging device, the injection needle is punctured, and a contrast medium or the like can be injected from the liquid injector. More specifically, it may be the timing at which the "air check operation" (standby state) provided to the liquid injector is performed.

"Air check operation" means that the operator confirms that there is no air in the injection circuit to the patient or blockage of the circuit in the phase after the setting of the chemical injection conditions is completed, and then presses a predetermined button. Refers to the action of pressing down. At this stage, the chemical injection device does not particularly operate the piston drive mechanism or the like, but when a predetermined button is pressed, for example, the display contents and/or the lighting state of the light emitting part of the device are displayed. change. In the state where the air check operation is performed (air check state), the device according to one aspect of the present invention is basically configured such that the injection conditions cannot be changed. The air check state can also be said to be a state of waiting for the operator to perform an operation to start injection. state.

The console 150 then uses the measured heartbeat information (heartbeat rate as an example) to adjust the amount of contrast medium, if necessary. This adjustment may be to increase or decrease the amount of contrast agent using the function f(x), where x is the heart rate, or the relationship between the heart rate x and the corresponding increase/decrease value y may be implemented using a table representing FIG. 8 shows an example of the table. In this example, the heart rate range is divided into several divisions, and an adjustment amount corresponding to each division 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 is a lower heart rate. In addition, in "Division 3" to "Division 6" (division 6 has a higher value), which is higher than "Division 2", "y2" to "y5" (the value is higher in y5) corresponding to each The quantity is to be added.

Of course, the number of sections and the specific amount of adjustment can be appropriately set according to the site to be imaged, the contrast agent to be used, and the like. For example, if the heart rate is 55 or less, reduce the contrast medium by 10 ml, if the heart rate is over 55 and 65 or less, do not adjust, if the heart rate is over 65 and 75 or less, add 10 ml of contrast medium, Adjust to add 20 ml of contrast medium if the heart rate is over 90 or less, add 25 ml of contrast medium if the heart rate is over 90 or less than 105, and add 30 ml of contrast medium if the heart rate exceeds 105. may be

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

When adjusting the amount of the contrast medium, for example, if the amount of the contrast medium is excessively increased (eg, Section 6 in Table 1), the console 150 displays to increase the amount of the contrast medium. It is also preferable to be able to notify the operator. Of course, a similar operation may be performed when the amount of contrast medium is excessively reduced. Such indications may be made for either an increase only, a decrease only, or both.

The above technical ideas can be expressed as follows:
A data processing unit (which may be translated as one or more processors) is
- A process of referring to the patient's heartbeat information (heartbeat rate as an example) before injecting the drug solution;
- A process of determining the adjustment amount of the contrast medium corresponding to the heartbeat information and adjusting the amount of the contrast medium;
do
The liquid injection device injects the adjusted amount of liquid medicine,
system. It is also possible to express inventions in the category of methods and the category of programs. As a further modification, in addition to heartbeat information (not limited to heartbeat rate, but may be stroke volume, etc.), or instead of heartbeat information, other biological information (for example, blood oxygen saturation, blood pressure, etc.) information, electrocardiogram information, pulse wave information, body temperature, respiration rate, inspiratory state, and expiratory state), the above-described contrast agent amount adjustment may be performed.

(myocardial load)
FIG. 6B is an example of data processing that can be performed in a case where an automatic injector for injecting a myocardial loading agent is prepared in addition to an automatic injector for injecting a contrast medium, for example, in a myocardial analysis examination. In this examination, first, there is a phase of injecting a myocardial loading agent, followed by a resting phase after a certain period of time, and then a phase of injecting a contrast medium. In this series of phases, the patient's biological information (in particular, heart rate and blood oxygen saturation) is detected.

By doing so, for example, it becomes possible to confirm whether or not the effect of the myocardial loading agent appears. In addition, if the biological information is stored together with drug solution injection data, etc., it is possible to check the patient's condition during the examination after the fact.

Although the examples of the present invention have been described above with reference to the drawings, the respective technical matters described above can be appropriately combined and modified without departing from the gist of the present invention.

(Some changes regarding the configuration of the embodiment)
(1) In the above-described embodiment, a configuration has been described in which the medical solution in the syringe is pressurized and pushed out by the piston driving mechanism. However, a chemical injection device having a mechanism for delivering a chemical solution from a chemical solution storage container (for example, a flexible chemical solution bag, a hard case such as a bottle, or the like) may be used. As an example, a tube pump may be used to deliver a liquid medicine such as a contrast agent.
(2) Although it has been described as an example that data processing using information from the biometric information detector is performed by the control unit 155 in the console 150, the entity that performs the data processing may be another control unit other than the control unit 155. may be Distributed processing may be performed such that some data processing is performed by the control unit 155 and other data processing is performed by other control units.

(Appendix)
This application discloses the following inventions. The symbols in parentheses are for reference and do not limit the present invention. In addition, the inventions of the products described below are also disclosed in the present application by changing the category expressions (inventions of methods and inventions of programs).

1-1. A: A drug injection device (100) for injecting a contrast agent into a patient, having a piston drive mechanism (130) for moving the piston of the syringe and a control circuit (145) for controlling its operation,
B: A biological information detector (701) that acquires at least one of patient heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state. When,
C: a data processing unit (such as 155) that performs data processing using information from the biological information detector;
The data processing unit is
(a) At least one of the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiration rate, inspiratory state, and expiratory state has a predetermined value during the liquid injection operation. determine whether it is within the range of
(b) A contrast medium injection system (medicine injection device) configured to issue an alarm or stop the operation of the piston drive mechanism when the distance is not within a predetermined range.

1-2. A: A drug injection device (100) for injecting a contrast agent into a patient, having a piston drive mechanism (130) for moving the piston of the syringe and a control circuit (145) for controlling its operation,
B: A biological information detector (701) that acquires at least one of patient heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state. When,
C: A method of controlling a system comprising a data processing unit (such as 155) that performs data processing using information from the biological information detector,
the data processing unit
(a) At least one of the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiration rate, inspiratory state, and expiratory state has a predetermined value during the liquid injection operation. a step of determining whether it is within the range of
(b) issuing an alarm or stopping operation of the piston drive mechanism if it is not within a predetermined range;
A control method.

1-3. A control program for performing the above control method,
to the computer,
(a) At least one of the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiration rate, inspiratory state, and expiratory state has a predetermined value during the liquid injection operation. a step of determining whether it is within the range of
(b) issuing an alarm or stopping operation of the piston drive mechanism if not within the predetermined range;
A control program that causes

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

3. The console has a display,
At least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state is configured to be displayed on the display. ,
A contrast injection system as described above.

4-1. A: A drug injection device (100) for injecting a contrast agent into a patient, having a piston drive mechanism (130) for moving the piston of the syringe and a control circuit (145) for controlling its operation,
B: A biological information detector (701) that acquires at least one of patient heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state. When,
D: a data transmission unit (161) for transmitting data to the outside;
with
The chemical injection device is
(c) acquiring at least one biometric information from the biometric information detector out of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state; ,
(d) A contrast agent injection system configured to transmit the acquired biological information to the outside via the data transmission unit (161).

4-2. A: A drug injection device (100) for injecting a contrast agent into a patient, having a piston drive mechanism (130) for moving the piston of the syringe and a control circuit (145) for controlling its operation,
B: A biological information detector (701) that acquires at least one of patient heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state. When,
D: a data transmission unit (161) for transmitting data to the outside;
A control method for a system comprising
The chemical injection device is
(c) acquiring at least one biometric information from heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state from the biometric information detector; a step;
(d) transmitting the acquired biometric information to the outside via the data transmission unit (161);
A control method with

4-3. A control program for performing the above control method,
to the computer,
(c) acquiring at least one biometric information from heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state from the biometric information detector; a step;
(d) transmitting the acquired biometric information to the outside via the data transmission unit (161);
A control program that causes

5. The chemical injection device is
5. The contrast medium injection system according to claim 4, wherein (e) the biological information is externally transmitted together with liquid injection data.

6. The liquid injection data is at least one of information on the liquid used, an injection amount, an injection profile representing an injection speed with respect to an injection time, and a profile representing an injection pressure with respect to an injection time. A contrast injection system as described.

7. moreover,
Equipped with an auto-injector that injects a patient's heart rate-altering drug,
The chemical injection device is
(f) at least one of heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state before the drug is injected;
(g) at least one of heart rate information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state after the drug is injected;
A contrast injection system as described above, configured to obtain a .

100 chemical injector 110 injection head 111 housing 130 piston drive mechanism 138 load cell 145 controller 150 console 161 data transmission unit 200 syringe 222 piston member 225 IC tag 701 biological information detector 705 control circuit 710 probe unit 730 piezoelectric element unit 731 contact Part 1100 imaging device

Claims (7)

A: A liquid injection device for injecting a contrast medium into a patient, having a piston driving mechanism for moving the piston of the syringe and a control circuit for controlling the operation thereof;
B: a biological information detector 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, inspiratory state, and expiratory state;
C: a data processing unit that performs data processing using information from the biometric information detector;
with
The data processing unit is
(a) at least one of the heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state is at least a predetermined value during the liquid injection operation; determine whether it is within the range of
(b) a contrast injection system configured to issue an alarm or stop operation of said piston drive mechanism if it is not within a predetermined range; The chemical injection device comprises an injection head and a console,
2. The contrast agent injection system of claim 1, wherein the injection head is usable in an MRI room. the console has a display;
At least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state is configured to be displayed on the display. ,
3. A contrast agent injection system according to claim 1 or 2. A: A liquid injection device for injecting a contrast medium into a patient, having a piston driving mechanism for moving the piston of the syringe and a control circuit for controlling the operation thereof;
B: a biological information detector 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, inspiratory state, and expiratory state;
D: a data transmission unit that transmits data to the outside;
with
The chemical injector is
(c) acquiring at least one biometric information from the biometric information detector out of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state; ,
(d) The contrast medium injection system configured to transmit the acquired biological information to the outside via the data transmission unit. The chemical injector is
5. The contrast medium injection system according to claim 4, wherein (e) the biological information is transmitted to the outside together with liquid injection data. The drug solution injection data is at least one of information about the drug solution used, an injection volume, an injection profile representing an injection speed with respect to an injection time, and a profile representing an injection pressure with respect to an injection time. Item 6. A contrast medium injection system according to Item 5. moreover,
Equipped with an auto-injector that injects a patient's heart rate-altering drug,
The chemical injector is
(f) at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state before the drug is injected;
(g) at least one of heartbeat information, blood oxygen saturation, blood pressure information, electrocardiogram information, pulse wave information, body temperature, respiratory rate, inspiratory state, and expiratory state after the drug is injected;
Contrast injection system according to any one of claims 1 to 6, configured to obtain a

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