JP6723160B2 - Chemical injection device - Google Patents

Description

The present invention relates to a drug solution injecting system or the like for injecting at least a contrast agent as a drug solution into a patient, and particularly to a drug solution injecting system or the like for injecting a vasodilator and a contrast agent into a patient for, for example, myocardial analysis examination.

Currently, CT (Computed Tomography) apparatus, MRI (Magnetic Resonance Imaging) apparatus, PET (Positron Emission Tomography) apparatus, ultrasonic diagnostic apparatus, angiography (angiography) imaging apparatus and the like are known as medical image diagnostic apparatuses. 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 a patient.

Currently, in order to examine a heart disease such as myocardial ischemia, a vasodilator that applies a load to the myocardium is injected into a patient as a drug solution, and a fluoroscopic image of the heart and its surroundings may be taken. In that case, for example, there is a method of first injecting a vasodilator and then injecting a contrast agent. In this examination, scanning is performed in a state where the effect of the injected drug solution appears, so that a heart cross-sectional image in a loaded state is captured. Subsequently, a neutralizing agent is injected if necessary, and a fluoroscopic image in a resting state in which the myocardium is not loaded is imaged by imaging. Then, the myocardial ischemia evaluation is performed based on the thus obtained cardiac cross-sectional images in both states. There is also a method of first imaging the resting state and then imaging the load state. In that case, naturally, it is not necessary to inject the neutralizing agent between the time when the rest state is imaged and the time when the load state is imaged.

Patent Document 1 discloses a chemical liquid injection system for MRI that can inject a vasodilator or a contrast agent. In the technique of the same document, a myocardial analysis test can be performed using an MRI device.

Patent No. 4623943

By the way, in the case of performing a myocardial analysis test, since there is no problem of exposure of the patient with the MRI apparatus, it is possible to continue imaging for a certain period of time after administering the drug solution to the patient (in other words, for a relatively long time). Dynamic imaging can be performed). On the other hand, generally, in the case of a CT apparatus, it is conventionally not preferable to perform imaging for a long time from the viewpoint of exposure. Further, it is necessary to perform high-speed imaging (for example, imaging at the timing of diastole or systole of the heart) in order to image an object that is moving intermittently such as the heart. As described above, there are some problems in CT imaging.

On the other hand, in recent years, the performance of CT devices has been improved, and myocardial analysis tests using CT devices have also been proposed. If a CT device can perform a myocardial analysis test, an MR device or a SPECT device (a device for performing a nuclear medicine test (also called RI: radioisotope test, etc.) and a device for detecting radiation from a radiopharmaceutical administered to a patient. There is an advantage that it can be easily implemented even in a facility that does not have A myocardial analysis test using such a CT device is simple and useful. Also in this case, it is desired to develop a system capable of injecting a vasodilator as a drug solution into a patient at an appropriate timing and at an appropriate amount and rate.

The present invention has been made in view of such problems, and an object thereof is to automatically inject a vasodilator, a contrast agent, and the like into a patient under appropriate injection conditions for a myocardial ischemia test, for example. It is to provide a system that can. The present application also discloses other inventions for purposes other than the above.

A chemical injection system according to one aspect of the present invention for solving the above problems is as follows:
An infusion pump,
A chemical injection device,
A chemical injection system comprising:
The infusion pump has a piston drive mechanism for moving a piston member of a syringe filled with a drug for myocardial analysis examination,
The chemical injection device,
An injection head having at least a piston drive mechanism for moving a piston member of a syringe filled with a contrast agent,
Display,
And a control unit,
The control unit displays on the display,
It is configured to display a setting screen for setting an injection protocol including the injection operating condition of the injection head and the injection operating condition of the infusion pump.
Chemical injection system.

The “injection operating condition of the infusion pump” may include (i) information such as the injection speed, the injection amount, the injection time, and the injection time (part or all) of the drug solution. Alternatively, (ii) it may include only information on the timing of operation start and/or operation end on the infusion pump side.

(Explanation of terms)
(I. General Description of Chemical Injection Device)
In one form, the “chemical solution injector” includes the following components: a piston drive mechanism, a control unit (control unit), a display, and the like. Here, these components may be provided in any device that constitutes the chemical liquid injector. That is, when the chemical liquid injector includes an injection head, a console, and the like, (i) the injection head may be provided with a piston drive mechanism, and the console may be provided with a control unit and a display. (ii) the injection head And the console may be provided on both sides, and (iii) both the injection head and the console may be provided with a display. Such a control unit (control unit) may be provided, for example, as a part of the imaging device.

An "injection head" basically comprises one or more syringe holders for holding syringes, one or more piston drive mechanisms for advancing and/or retracting pistons of the syringes, and control circuits (controls). Part) and. As a method of mounting the syringe, mainly, (i) a syringe holding portion is formed as a concave portion on the upper surface of the head, and a syringe is set therein, and (ii) the syringe holding portion is a head. There is a so-called front loading type which is formed on the front surface and holds the base end of the syringe. One form of the invention includes any type of injection head. In addition to the one for delivering the drug solution from the syringe, for example, the one for delivering the drug solution by pushing out the drug solution from a predetermined storage body may be included in the “injection head” of the present application.

The “infusion pump” is an independent device provided separately from the injection head. The method of infusion may be any of a roller method, a finger method, a volmetric method, a mid press method, a syringe method (so-called syringe pump) and the like.

An “infusion pump” is, as an example, an injection head, one or more syringe holders for holding a syringe, one or more piston drive mechanisms for advancing and/or retracting a piston of the syringe, and a control. A circuit (control unit).

The drug injector or injection head may have one or more of the following:
-One or more pressure sensors,
-One or more syringe detection sensors (eg magnet sensor, Hall sensor, optical sensor, contact sensor, physical switch, etc.),
-1 or syringe piston detection sensor (eg magnet sensor, Hall sensor, optical sensor, contact sensor, physical switch, etc.),
-One or more tilt sensors,
-One or a plurality of rotation detection sensors (for example, a rotary encoder, or a slit switches light blocking/non-blocking states in response to rotation, thereby generating a pulse signal, which can be used to perform position measurement. Counter, etc.),
-One or more motor current detectors, etc.

The infusion pump may include the above-described parts or elements.

Pressure sensor: The pressure sensor is, for example, for detecting the pressure with which the piston member is pressed, and thus the pressure estimated value of the chemical liquid can be obtained. The pressure sensor may be, for example, a load cell. The load cell should just be provided in the position which can detect the pressure which the ram member of a piston drive mechanism presses a piston member. When using the detection result of the load cell, for example, when obtaining the estimated value of the pressure of the chemical liquid while injecting the chemical liquid, the calculation is performed by the resistance of the injection circuit (for example, the size of the needle), the concentration of the chemical liquid, the injection Conditions may be taken into consideration. In another aspect, a pressure sensor or the like that directly detects the pressure of the chemical liquid may be included. In still another aspect, for example, a switch that is turned on/off with a predetermined pressing force is used, and for example, it is determined that a certain pressure has been reached when the switch is pressed with a predetermined pressing force. It is also possible to adopt a method of doing so.

Syringe detection sensor: The syringe detection sensor detects whether or not a syringe, an adapter, and/or a protective case is attached, or what kind of syringe, adapter, and/or protective case is attached. It is used to judge. Such a sensor may be of a contact type or a non-contact type, and the following may be used, for example: a contact sensor using physical contact, an electricity for electrically detecting an object. Sensors, magnetic sensors, Hall sensors, optical sensors, proximity sensors, etc.

-Tilt sensor: The tilt sensor detects the tilt of the injection head. In general, in this type of injection head, the liquid medicine is sucked into the syringe in such a posture that the front end side (that is, the syringe side) faces upward. On the other hand, the liquid medicine injection is performed in a posture in which the front end side of the injection head is relatively downward (the posture in which the front end side is slightly downward). By using the detection result of the tilt sensor, it is possible to prevent, for example, the chemical liquid suction or the chemical liquid injection in an undesired posture.

-Rotary encoder: A motor of the piston drive mechanism or a rotary encoder for detecting the rotation speed and/or the rotation direction of the feed screw may be provided.

-Motor current detector: It is also possible to calculate the estimated pressure value of the chemical liquid based on the motor current without using a load cell or the like. In this method, the motor current is monitored by the motor current detector during the operation of the motor, and the estimated pressure value of the chemical liquid is obtained based on the motor current.

The drug solution injector or injection head may further include one or more of the following:
-One or more head displays,
-One or more head status indicators,
-One or more physical buttons,
-One or more RFID communication devices,
-One or more data receivers,
-One or more data transmitters, etc.

The infusion pump may include the above-described parts or elements.

Display: The injection head may be provided with a display for displaying predetermined information. The display may be provided, for example, in a part of the housing of the injection head. Alternatively, it may be a sub-display prepared separately from the housing. The display may be a display unit using an LCD (Liquid Crystal Display), an organic EL (Organic Electro-Luminescence) display, or the like, or may be a display unit using an LED (Light Emitting Diode). The contents displayed on this display are not particularly limited, but may be the following: predetermined state display during injecting operation, injecting drug solution conditions, injecting drug solution injecting condition, drug solution. Injection volume, chemical pressure, injection speed, etc.

For example, a part of the housing of the injection head may be provided with a predetermined light emitting part for notifying a doctor or medical staff of a predetermined state of the injection head. As an example of the light source, an LED (Light Emitting Diode) or the like can be used. Such a light emitting unit has a function as a head condition display unit, and can change the emission color and the light emission pattern to notify the doctor or medical staff of various conditions of the injection head.

Physical button: The physical button is not particularly limited, but may be the following one. A forward button for moving the ram member forward, a backward button for moving the ram member backward, an accelerator button for increasing the moving speed of the ram member by pressing the forward button or backward button at the same time, and a stop for stopping the operation of the head. Buttons etc. These physical buttons can be appropriately arranged on the upper surface, side surface, lower surface, rear end surface, etc. of the housing of the injection head. In the case of a two-cylinder injection head, the physical button arrangement for one piston drive mechanism and the physical button arrangement for the other piston drive mechanism may be asymmetric.

RFID communication device: When a syringe, an adapter, or a protective cover is provided with a data carrier means such as an IC tag, a wireless communication device for reading information of the tag may be provided. This wireless communication device may be an RFID reader that simply reads data from an IC tag, or may be an RFID reader/writer that can also write data to an IC tag.

The information recorded in the "data carrier means" includes, for example, (i) a syringe, for example, regarding the filled drug solution, the manufacturer, the type of the drug solution, the product number, and the contained components (particularly, the drug solution is a contrast agent). In this case, it may be one or more pieces of information selected from iodine concentration, etc.), filling amount, lot number, expiration date, and the like. Further, it may be one or more pieces of information selected from a unique identification number such as a manufacturer and a product number, an allowable pressure value, a syringe capacity, a piston stroke, required dimensions of each part, a lot number, and the like regarding the syringe. (Ii) In the case of a drug solution storage container such as a drug solution bag, for example, the manufacturer, the type of drug solution, the product number, and the contained components regarding the contained drug solution (especially, when the drug solution is a contrast agent, the iodine content concentration, etc.) It may be one or more pieces of information selected from a filling amount, a lot number, an expiration date, and the like. “Data carrier means” means a medium capable of storing predetermined data, and specifically, a barcode (one-dimensional barcode, two-dimensional barcode) or an RFID tag (also referred to as an IC tag in this specification). It is included. Preferably, the information can be read without contact.

Data receiver: The data receiver is for receiving data transmitted from the outside to the injection head or the like by wire or wirelessly. In one example, the data receiver may be adapted to receive external data such as: any data generated by the imaging device, any data generated by the hospital system, etc.

-Data transmitter: The data transmitter is for sending predetermined data from the injection head or the like to the outside by wire or wirelessly. As the communication protocol of the data receiver and the data transmitter, a suitable protocol may be adopted as appropriate in consideration of the communication system with the other device as the communication partner. Note that a data transmitter or the like for communicating with an external device may be provided in the console or other device. The data that can be transmitted from the injection head to the outside by the data transmitter may be one or more of the following: the name of the used contrast agent (contrast agent identification information), the total injection amount of the contrast agent. , Contrast agent injection time, contrast agent injection pressure, contrast agent injection rate, set injection protocol, etc. Also, one or more of the following: patient identification information (for example, patient ID), examination identification information (for example, examination ID), information regarding imaging time, and the like. Such information may be transmitted in combination with the information regarding the contrast agent described above.

The injection head and the console may be provided with a communication unit for communicating with an external device. The operation of the piston drive mechanism may be controlled so as to adjust the injection amount of the contrast agent, the injection speed, and the like according to the injection conditions input from the external device via the communication unit. The infusion pump may include such a communication unit.

In addition, the above-described receiver and/or transmitter is provided in the console or in another device (which constitutes a part of the liquid medicine injection device), and the console or the like is provided as an external device (for example, an imaging device or a network device). (Predetermined server, etc.) and may be capable of transmitting and receiving data.

-Abnormality detection: It is preferable that one or more of the following injection abnormalities can be detected using the various sensors described above.
-Failure of injection due to the piston drive mechanism not working properly,
-Injection abnormality due to the syringe not being properly mounted on the injection head,
-Injection abnormality due to lack of sufficient liquid medicine to perform the injection operation in the syringe,
-Abnormal injection due to the catheter or needle not being properly inserted into the patient,
-Injection abnormality due to a kink occurring in the middle of the drug solution route,
-Injection abnormality such that the detected pressure value of the chemical liquid is not within a predetermined range (a predetermined range having an upper limit and a lower limit, a predetermined upper limit, a predetermined lower limit, or the like).

When the liquid medicine is injected, for example, when the liquid medicine passage is clogged, the driving force of the piston drive mechanism exceeds the predetermined range. On the other hand, if the injection needle comes out of the patient, the driving force will fall below the predetermined range. By observing such a change in driving force, it is possible to detect whether or not the liquid medicine is normally injected.
-When the sensor detects that the predetermined amount of the chemical liquid is not normally loaded, the detection result may be transmitted from the communication unit to the outside.
-Other than this, for example, a pressure sensor for measuring the pressure may be provided in the middle of the extension tube to detect whether or not the liquid medicine is injected at a predetermined pressure.

The infusion pump may have the abnormality detection function as described above.

The “medical solution” refers to, for example, a contrast agent, physiological saline, or a mixture thereof, or other liquid agents (for example, vasodilator, beta blocker, etc.).
Specific examples of the “contrast agent” include a contrast agent having an iodine concentration of 240 mg/ml (for example, viscosity at 37° C. of 3.3 Pa·s, specific gravity 1.268 to 1.296), and an iodine concentration of 300 mg/ml ( For example, a contrast agent having a viscosity of 6.1 mPa·s at 37° C. and a specific gravity of 1.335 to 1.371) and an iodine concentration of 350 mg/ml (for example, a viscosity at 37° C. of 10.6 mPa·s and a specific gravity of 1.392 to 1.37). 433) and so on. In addition to the iodine type, a gadolinium type contrast agent used in MRI examination may be used.
As a specific example of the physiological saline of “physiological saline”, physiological saline containing 180 mg of sodium chloride in 20 mL of physiological saline (eg, viscosity at 20° C. of 0.9595 mPa·s, specific gravity of 1.004 to 1. 006) etc.

The “injection protocol” refers to what kind of liquid medicine, how much, how much infusion rate and infusion time, and the like.
The “injection condition” means a condition indicating what kind of chemical solution is injected in what kind of injection pattern. Specifically, it is defined by parameters such as an injection amount, an injection time, and an injection speed.
The “body section” indicates which section of the patient's body is imaged, and corresponds to, for example, the head, chest, abdomen, legs, and the like.
The “imaging region” refers to a region to be imaged (that is, a region to be imaged), and includes, for example, organs such as heart, liver, kidney, blood vessels, and tumor parts.

The “real time” is related to real-time processing by a computer, does not necessarily have to be simultaneous, and may include some delay due to computer processing or the like.

"Module" means not only a tangible element but also, for example, an element of a computer program that performs a predetermined function.
The "computer" is not limited to an integrated circuit generally called a computer, but includes a processor, a microcontroller, a microcomputer, a programmable logic controller, an application specific integrated circuit, and other programmable circuits. Shall be pointed out. It includes a desktop computer, a laptop computer, a tablet computer, or the like. In other words, the “computer” may be any hardware that can read a computer program data and execute a corresponding processing operation. For example, a CPU (Central Processing Unit) is a main component and a ROM ( For example, the hardware includes various devices such as a Read Only Memory, a RAM (Random Access Memory), and an I/F (Interface) unit.

It should be noted that the various means referred to in the present invention may be formed so as to realize their functions. For example, dedicated hardware that exhibits a predetermined function, or a data processing device to which a predetermined function is given by a computer program. , Predetermined functions realized in the data processing device by a computer program, a combination thereof, and the like.

Further, the various means referred to in the present invention do not have to be independent entities individually, and a plurality of means are formed as one device, and some means are part of other means. It is also possible that some of the means and some of the other means overlap.

Further, the storage medium referred to in the present invention may be hardware in which a computer program for causing a computer to execute various processes is stored in advance, and for example, a memory and an HDD (Hard Disc Drive) fixed to the computer. ), a CD (Compact Disc)-ROM and FD that are exchangeably loaded in a computer, a non-volatile memory card (flash memory), or the like.

"Connection"-In this specification, when a predetermined device is connected to another device, it may be either wired connection or wireless connection. In addition, a form in which one device is connected in one direction or two directions so that another device can be controlled can also be expressed as “operably connected/linked”.
“Electrically connected” means that constituent elements are connected to each other so that electric signals can be transmitted in one direction or two directions, and may be in the form of wired connection or wireless connection. .. In addition to the case where the constituent elements are directly connected to each other, the case where the constituent elements are indirectly connected to each other through the other elements is also included.

In one form, the “control unit” has a CPU, a memory, and the like and performs arithmetic processing, and includes a “controller”, a “processor”, a “controller unit (control unit)”, and a “controller circuit (control circuit)”. , “Controller module (control module)”, “processor unit”, “arithmetic unit”, “processor unit”, “processor module” and the like. The "control unit" can be configured with a microcomputer, a microcontroller, a programmable logic controller, an application specific integrated circuit, other programmable circuits, and the like. In the present specification, the “control unit” may physically have one configuration, but two or three or more control units functionally cooperate to form one “control unit”. May be

The basic processing in the control unit is an example. First, the computer program stored in the memory is read, then the data is received from the input device or the storage device according to the instructions of the computer program, and the data is calculated and processed. The data is output to a storage device such as a memory or an output device such as a display.

The “computer program” may read a storage medium storing it by a predetermined device/device/mechanism or the like to operate those computers with a predetermined function. In this case, the storage medium storing the computer program constitutes one form of the present invention. Further, the computer program may be provided via a communication network (Internet in one example). The computer program may be a so-called difference program that can be realized in combination with a program already recorded in the computer.

"Input device/input device" (input means for computer system) includes a keyboard, a mouse, a touch panel, a trackball, a physical switch manually or mechanically operated, a microphone, voice input, a graphical user interface, etc. It may be. Alternatively, the movement of the doctor or the medical staff may be recognized (non-contact in an example) and a predetermined input according to the movement may be recognized.

“Part (which can also be expressed as “element” or “module” etc.)”-in this specification, for example, “(name of function)”+“part” can be realized as a computer function. .. Such “parts (elements, modules, etc.)” may be provided in any device in the system. Further, it is not always necessary to provide the device in one device, and the corresponding function may be provided in a distributed manner in two or more devices. Further, only one or more predetermined “units” may be provided in an external server or the like via a communication network (for example, the Internet). Such “units (modules), modules, etc.” may be various functions that a computer logically has.

The “means” and “section” operate, for example, hardware having a CPU (Central Processing Unit), ROM (Read Only Memory), RAM (Random Access Memory), I/F (Interface) unit, and the like. It may be configured by one or a plurality of software, a sensor, and the like. They may be dedicated mechanisms, may also serve as other means, and may have a logical configuration on a computer system. These specific configurations can be easily configured by those skilled in the art by referring to the present specification.

"Graphical user interface" (GUI) means, for example, visually operating an icon, an image button, a pull-down menu, or a numeric input window on the screen with a cursor or in the case of a touch panel. An interface that can be used.

“Icons” are (i) those which display predetermined information and can be selected by the operator, and (ii) those which are merely for displaying predetermined information and are configured to be selectable. Not included may be included. All or some of the icons displayed on the screen can be selected by touching the respective display locations with a touch pen or the operator's finger, or by a cursor on the screen.

(Basic concept of setting injection protocol)
The amount of contrast agent to be injected into the patient can be determined as follows. That is, in the main injection, the injection amount (ml) of the contrast medium can be calculated by a calculation formula using the patient's weight (kg), a predetermined proportional coefficient, etc. as parameters. This coefficient of proportionality can be determined based on the required amount of iodine per kg body weight of the patient (mgI/kg) and the iodine concentration of the contrast agent (mgI/ml). For example, when the weight of the patient is W (kg), the required iodine amount is I (mgI/kg), and the iodine concentration is C (mgI/ml), the injection amount of the contrast agent is
Formula: Injection amount of contrast medium (ml)=W (kg)×I (mgI/kg)/C (mgI/ml)
Can be calculated by Alternatively, when the necessary iodine amount per unit weight and unit time is I′ (mgI/kg/sec), and the contrast agent injection time is T (sec),
Formula: Injection amount of contrast medium (ml)=W (kg)×(I′ (mgI/kg/sec)/C (mgI/ml))×T (sec)
It is also possible to calculate the injection amount of the contrast agent.

In order to calculate the injection amount of the contrast agent in the main injection, in one example, the patient weight, the required iodine amount, and the iodine concentration are input, and the input data are used by the computer to perform the contrast injection in the main injection. The injection amount of the agent may be calculated. Note that some of these information may be manually input by a doctor or medical staff, read from the IC tag of a syringe, or information stored in an external server (for example, in a hospital system). Electronic medical record).

(II. Imaging device)
The imaging apparatus may be, for example, an X-ray CT apparatus or the like, and generally, an imaging unit (gantry in one example), a bed (bed) on which a patient is placed, and an operation control unit that controls the operations thereof. A data collection unit that collects and processes fluoroscopic imaging data, a main controller that controls the entire operation, and the like. The main controller may be provided as a console, for example. The imaging device may also have one or more displays that display certain information.

Various communication protocols can be used between the devices, such as between the imaging device and the liquid injector, between the other devices of the imaging device, and between the liquid injector and the other device. For example, CANopen, Examples of protocols include HL7 and DICOM.

According to the present invention, it is possible to provide a system capable of automatically injecting a vasodilator, a contrast agent, and the like into a patient under appropriate injection conditions, for example, for a myocardial ischemia test.

It is a figure which shows typically the system of one form of this invention. 1 is a schematic block diagram of the system of the present invention. It is an example of a block diagram of a control unit of the console. It is an example of a hospital system. It is a perspective view showing an injection head, a syringe attached to the injection head, and the like. It is a perspective view showing an injection head and an infusion pump. It is a top view of an infusion pump. It is an example of the operation part of an infusion pump. 1 is an example of a graphical user interface for the system of the present invention. 1 is an example of a graphical user interface for the system of the present invention. 3 is an example of a graphical image of the system of the present invention. 3 is an example of a graphical image of the system of the present invention. It is a flowchart of a myocardial analysis test (load state). It is a system schematic block diagram of another form of this invention. It is a perspective view of the infusion pump of another form of this invention (the whole seen from the front side). It is a perspective view of the infusion pump of FIG. 12 (a part seen from the rear surface side). It is a figure which shows an example of the display content displayed on a display part. It is a figure which shows the example of a display during advance, retreat, and injection. It is a figure which shows the alarm display example regarding a pressure, a syringe, and a ram. It is a state transition diagram (general). It is a state transition diagram (forward and stop). It is a state transition diagram (auto return and stop). It is a state transition diagram (injection and stop).

Embodiments of the present invention will be described below with reference to the drawings. It should be noted 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 form.

The imaging system 1 of the present embodiment includes an imaging device 1100, a drug solution injector 100, and an infusion pump 410, as illustrated in FIG. The imaging system 1 may form a part of a hospital system as illustrated in FIG. 3 (details will be described later).

The chemical injection device 100 includes a plurality of injection heads 110 held by a movable stand 180, and a console 150, for example. The injection head 110 is equipped with a syringe 200C containing a first drug solution (eg, contrast agent) and a syringe 200S containing a second drug solution (eg, physiological saline).

In the following description, the syringes 200C and 200S may be simply referred to as "syringe 200" without distinction. The "injection head" is also called an injector or an injection head.

Hereinafter, each component of the system of the present embodiment will be described in the following order:
1. Chemical injection device (1) Injection head (2) Infusion pump (3) Console 2. Imaging device 3. Hospital system 4. Operation 5. Other embodiments

Note that the infusion pump has some configurations that are functionally common to the injection head, and therefore, for the convenience of description, 1. It should be noted that the device is separate from the drug solution injector, as described in (2).

1. Chemical Injection Device (1) Injection Head The injection head 110 is, for example, configured as a two-cylinder type in which two syringes can be mounted (see FIGS. 1, 2A, and 4 ). One syringe 200C may be filled with a contrast agent, and the other syringe 200S may be filled with physiological saline. In another aspect, both may be contrast agents (with different concentrations), or may be contrast agents and predetermined diluents.

(Syringe)
The configuration of the syringe 200 is roughly as follows. As shown in FIG. 4 and the like, the syringe 200 has a hollow cylindrical cylinder member 221 and a piston member 222 slidably inserted in the cylinder member 221. The cylinder member 221 may have a cylinder flange 221a formed at the base end thereof and a conduit portion 221b formed at the tip end thereof. By pushing the piston member 222 into the cylinder member 221, the drug solution in the syringe is pushed out to the outside via the conduit portion 221b.

The syringe may be a prefilled type that is pre-filled with the drug solution, or may be a suction type in which the drug solution is sucked and used in an empty syringe. The "piston member" is not necessarily limited to the long rod as shown in the drawing, but may be a so-called rodless type (also simply referred to as "plunger"). This also applies to the syringe set in the infusion pump described later.

(tube)
An extension tube 230 is connected to the conduit portion 221b of each syringe 200. The extension tube 230 may be a so-called T-shaped tube or Y-shaped tube, and as shown in FIG. 4, a tube 231a extending from a conduit portion 221b of one syringe 200C to a branch portion and a conduit portion of the other syringe 200S. It may have a tube 231b extending from 221b to the branch portion and a tube 231c extending from the branch portion toward the patient. An injection needle, for example, is connected to the distal end side (not shown) of the tube 231c. The injection needle is punctured into the blood vessel of the patient, and the drug solution in the syringe 200C and/or the syringe 200S is pushed out to inject the drug solution into the blood vessel.

In addition, when simultaneously injecting the contrast agent and physiological saline, a tube called a spiral tube may be used so that both can be mixed well (for example, mixing by Nemoto Kyorindo Co., Ltd.). Tube, "SPIRAL FLOW" tube (registered trademark), etc.). In this spiral tube, a connector (not shown) that produces a swirling flow is provided at the confluence of the contrast medium and physiological saline.

(IC tag)
The IC tag 225 may be attached to a part of the syringe. The IC tag 225 has information regarding the syringe (identification information of the syringe, pressure resistance of the syringe, inner diameter of the cylinder member, stroke of the piston member, etc.), information on the drug solution filled in the syringe (name (for example, product name), The component information such as the iodine amount or the gadolinium amount, the expiration date, the chemical liquid volume, etc.) are stored. The IC tag may have a unique ID unique to the tag. The IC tag may have at least one information selected from the syringe size, the serial number of the syringe, and the drug standardization code. The position where the IC tag 225 is attached is, for example, the outer peripheral surface of the cylinder member 221, and may be, specifically, the vicinity of the cylinder flange on the outer peripheral surface.

(Head structure)
Referring again to FIG. 4, the injection head 110 has, for example, a casing that extends in the front-rear direction, and two concave portions on which the syringes 200C and 200S are mounted are provided on the top end side of the casing. 120a is formed. The concave portion 120a is a portion that functions as a syringe holding portion. The syringe 200 may be directly attached to the recess 120a, or may be attached via predetermined syringe adapters 121 and 122. In FIG. 4, the cylinder adapter 221a of each syringe 200 and the syringe adapters 121 and 122 holding the vicinity thereof are illustrated as an example. The shape and function of the syringe adapter are not limited to particular ones and may be any one.

(Internal structure)
The injection head 110 also has a piston drive mechanism 130 that pushes in the piston member 222 of the syringe 200, as shown in FIGS. 2A and 4. Two systems are provided for the piston drive mechanism 130, and each mechanism 130 operates independently. The piston drive mechanism 130 may retract the piston member 222, for example, in order to suck the drug solution into the syringe. The two piston drive mechanisms 130 may be driven simultaneously or at different timings.

As shown in FIG. 2A, the piston drive mechanism 130 is connected to the motor 131 that is a drive source, the transmission mechanism 132 that converts the rotational output of the drive motor into a linear motion, and the mechanism, and moves the piston member 222 forward and backward. And/or a syringe presser (ram member) 133 for retracting. As such a piston drive mechanism, a known mechanism generally used in a chemical injection device can be used. An actuator other than the motor may be used as the drive source.

Typical piston drive mechanism operations include: chemical injection (ram member advance) and chemical suction (ram member retract). In the “chemical solution injection”, the motor is operated according to a predetermined motor control signal to move the ram member forward, thereby performing the chemical solution injection according to the set injection protocol (injection condition). In the "medical solution suction", the motor is operated in accordance with a predetermined control signal to retract the piston member to suck the chemical solution into the syringe. In the case of a prefilled syringe, it is not necessary to suck the drug solution.

The piston drive mechanism 130 may include a load cell 138 for detecting the force with which the syringe presser member presses the piston member 222. Using the detection result of the load cell, for example, the estimated value of the pressure of the chemical liquid when the chemical liquid is being injected can be obtained. The calculation of the estimated value is performed in consideration of the needle size, the concentration of the drug solution, the injection condition, and the like. Alternatively, the pressure may be calculated based on the motor current of the drive motor 130 instead of using the load cell 138.

When the syringe is provided with the IC tag 225, the injection head 110 has a reader/writer (not shown) that reads information from the IC tag 225 and/or writes information to the IC tag 225. Good. The 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 the information of 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 unit 155 can be configured as a control circuit including a processor and a memory.

As shown in FIG. 4, a plurality of physical buttons for causing the injection head 110 to perform various operations are also provided on the upper surface and the side surface of the housing of the injection head 110. Some of these physical buttons may be configured to illuminate, for example, to notify the operator of certain information.

(2) Infusion Pump The infusion pump 410 is for injecting the drug solution in the syringe 200V and has a piston drive mechanism 430 for moving the piston member of the syringe 200V.

In one example, the syringe 200V is filled with a vasodilator (VD: Vasodilator) which is a myocardial burden agent. In one form, the syringe 200V may be smaller than a contrast agent syringe or the like. For example, it may contain a drug of about 20 to 80 ml.

As the vasodilator, an ATP preparation of adenosine triphosphate (ATP: Adenosine Triphosphate) can be used. The syringe 200V may have a general configuration having a cylinder member 211, a piston member 222 (see FIG. 5B) slidably inserted therein, and the like. When the present device is used for purposes other than the myocardial analysis test, it is of course possible to fill the syringe with another drug solution and mount it on the infusion pump.

As illustrated in FIG. 2A, the piston drive mechanism 430 includes a motor 431 as an example of a drive source, a transmission mechanism 432 that converts an output from the motor into a linear motion and transmits the linear motion, and a presser member 433 that moves forward and backward. Have Instead of the motor, another actuator may be used as a drive source.

The output of the motor 431 may be lower than that of the injection head 110. This is because a vasodilator does not require high-pressure injection as much as injection of a contrast agent. The piston drive mechanism 430 may be configured to move the presser member 433 at a relatively low speed so as to inject the vasodilator at a speed of about 5 to 15 ml/min at a relatively low speed. For example, the infusion rate of ATP, which is a vasodilator, may be about 0.10 to 0.20 mg/Kg/min per patient body weight.

In one form, it is preferable that the infusion pump 410 also has a load cell 438 for detecting the force pressing the piston member. This is because the chemical pressure during injection can be calculated based on the detection result. As described above, a pressure sensor, a switch, or the like other than the load cell may be used. Instead of the load cell, the chemical solution pressure may be calculated by a motor current method.

The configuration related to the exterior of the infusion pump 410 is not particularly limited, but may be as shown in FIG. 5A, for example. In this example, the infusion pump 410 has a housing 411 that houses a motor, a circuit board, and the like, and a syringe holding portion 420a is formed in a part thereof.

The syringe holder 420a may be formed as a recess that receives at least a part of the syringe. For example, a cylinder flange 221a (see also FIG. 5B) of the syringe is inserted in a part of the syringe holder 420a. The flange receiving groove 421 may be formed. Further, in order to prevent the set syringe from coming off, a flange retainer 422 for retaining the syringe from above may be provided. The flange retainer 422 may be configured such that one end thereof is rotatably held by a part of the housing 411, and the distal end side thereof is rotated so as to be above the syringe to retain the syringe from above. The holding method using such a mechanism has a simple structure and can hold well the vasodilator syringe that does not require high-pressure injection.

A part of the housing 411 may be provided with an operation unit 440 having a plurality of physical buttons arranged to switch the operation of the infusion pump 410 (see FIG. 5C).

The operation unit 440 specifically includes one or more of the following-advance button (443a): a button for advancing the presser member. For example, the presser member advances only while it is being pushed.
-Reverse button (443b): A button for retracting the presser member. For example, the presser member retracts only while it is being pressed.
-Return button (445): a button for automatically returning the presser member to the retracted position.
-Stop button (447): a button for stopping the movement of the presser member.
-Power button (449): A button for turning the power on/off.
-Injection start button (449): a button for starting automatic injection. It should be noted that the power button may also be combined.
-Infusion rate switching button (441): A button for switching the infusion rate.

As a specific form, each time the injection speed switching button 441 is pressed, the above-described low speed, medium speed, and high speed may be switched in a loop in order or in reverse order. The speed is not limited to three stages, and the speed may be switched only in two stages, or the speed may be switched in four stages or more.

Although not shown in detail, the infusion pump 410 may have one or more display units (not shown). For example, it may be configured to have a liquid crystal display (LCD) or the like, or may be configured to have an illumination device (LED) or the like. Such a display unit may be configured to display, for example, one or more of information such as a rate during injection of a vasodilator, a remaining amount, an injection amount, and pressure. The display unit may be configured as a 7-segment LED character display unit.

In the present embodiment, as an example, the injection head 110 and the infusion pump 410 are held on a movable caster stand. Specifically, as shown in FIG. 5A, the injection head 110 is rotatable by a mounting portion 181 that is a part of the stand (the syringe side is faced down during injection, and the syringe side is faced up during air bleeding operation). And so you can). On the other hand, similarly, the infusion pump 410 is also rotatable by the holding member 183 which is a part of the stand (the syringe side can be faced down during injection, and the syringe side can be faced up during air bleeding operation). As)). Note that the above-mentioned rotation may be rotation around a horizontal axis, for example.

Other means for holding the injection head 110 and the infusion pump 410 may be, for example, a ceiling-suspended arm. As shown in FIG. 2A, the infusion pump 410 has a power supply unit including an AC cord 495b and a power supply circuit 495a. In this example, an AC power source is illustrated, but it goes without saying that a DC power source such as a battery may be used. In still another aspect, the chemical liquid injector 100 (either the injection head 110 or the console 150) may supply power to the infusion pump 410. In this case, the AC cord 495b and the power supply circuit 495a may be omitted. The power may be supplied via the injection head 110, for example, via the power supply line 197a shown by the broken line in FIG. 2A, and via the console 150, via the power supply line 197b.

(Control circuit)
The infusion pump 410 may have a control circuit 455 for controlling the operation of the piston drive mechanism 430, as shown in FIG. 2A. The control circuit 455 may be configured as a circuit board built in the infusion pump 410. The control circuit 455 may have a communication module with an external device (for example, the console 150 and/or other external device) such as a processor and a memory. This communication may be wired or wireless.

As a mode of being communicatively connected, for example, an infusion pump may be electrically connected to the injection head so as to exchange predetermined signals, information, data and the like. The signals, information, data, etc. that are exchanged may relate to infusion start, infusion stop, and/or infusion end of the infusion pump. It may also relate to the start, stop and/or end of injection of the injection head.

Further, the infusion pump may be electrically connected to the imaging device so as to directly exchange predetermined signals, information, data, and the like.

Referring again to FIG. 2A, the control circuit 455 may be electrically connected to the load cell 438 and configured to utilize the detection result thereof to calculate the current injection pressure of the chemical liquid. In another aspect, the control unit 155 on the console side may perform such calculation using the detection result of the load cell 438 or the like. In the configuration in which the load cell 438 is omitted, the control circuit 455 may be configured to calculate the pressure based on the motor current.

The control circuit 455 or the control unit 155 of the console has data of a predetermined reference value (for example, 2.0 kgf/cm ² : about 30 PSI) as the “pressure limit”, and the current chemical liquid pressure reaches the reference value. Whether or not it is determined. If the determination is Yes, it is configured to execute one or more operations such as issuing an alarm, stopping the infusion operation stop, and recording that effect in the infusion history. Is also preferable.

As a result, not only the injection by the injection head but also the infusion abnormality can be detected not only in the infusion pump, but a safer inspection can be performed. The “pressure limit” may be any value as long as it is suitable for the syringe used. It may be input by a doctor or a medical staff, or may be automatically set from a database or the like in the system.

The control circuit 455 recognizes that various physical buttons (see FIG. 5C) have been pressed, and controls the operation of the infusion pump based on the recognition. Further, the control circuit 455 may be configured to send a signal indicating that various physical buttons (see FIG. 5C) are pressed to the control unit 155 on the console side. The control unit 155 may be configured to perform an operation such as starting or stopping the operation of another device or displaying an alarm based on the signal.

The control circuit 455 may also have a so-called self-check function. That is, whether or not the load cell etc. normally functions automatically when there is a predetermined input (pressing a predetermined physical button once in one example) from a doctor or medical staff, or automatically when the power is turned on. Check program (may be one that confirms whether the resistance value or the like of the load cell is within a predetermined reference value). If the control circuit 455 determines that the load cell or the like has a failure as a result of self-checking, the control circuit 455 may be configured to send a message to that effect to the control unit 155 of the console. The control unit 155 of the console may be configured to display a warning on the display 151 based on the signal. The self-check regarding other than the load cell will be separately described in other embodiments.

Naturally, the trigger for starting the self-check of the infusion pump is not limited to pressing the physical button of the head. For example, when a predetermined icon or the like displayed on the display of the console 150 is selected, the control unit 155 of the console may be configured to cause the infusion pump to perform a self-check.

(3) Console The console 150 may be used by being placed in an operation room adjacent to an examination room such as a CT imaging room, for example. The console 150 has 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 such as a memory or a hard disk, or a part or all of the storage unit 159. doing.

The display 151 may be a touch panel display, but is not limited to this. The console 150 may have a speaker or the like (not shown) for outputting sound and/or voice.

Although not shown in detail, a connection interface for connection with the imaging device, a connection interface for connection with the injection head 110, and a connection interface for connection with the infusion pump 410 are provided.

Note that the console integrally includes, for example, a control unit, a display, a touch panel, a physical button, a module that communicates with an injection head, and a module that communicates with an imaging device, as one form of the present invention. It is a thing. However, in another aspect of the present invention, such an integrated configuration is not an essential matter, and the control unit, the display, etc. as described above may be configured as separate devices. Please note.

(Connection between devices)
The console 150 and the imaging device 1100 are connected to each other. Between the console 150 and the imaging device 1100, predetermined data or electrical signals can be transmitted in one direction or all directions. Thereby, for example, the operation timings of both devices can be synchronized. The device that generates the operation timing trigger may be either a console or an imaging device. A predetermined operation of the imaging device may be started or stopped in response to a predetermined trigger generated by the console 150 or the like. Conversely, a predetermined operation on the drug injection device 100 side may be started or stopped in response to a predetermined trigger generated by the imaging device 1100.

The console 150 and the injection head 110 are connected to each other. As a result, predetermined data or electrical signals can be transmitted and received between the console and the injection head. As the predetermined data or the like, for example, a motor drive signal may be transmitted from the console side to the injection head side according to the injection protocol set on the console side. Further, for example, the detection value of the load cell 138 may be transmitted from the injection head side to the console side.

The console 150 and the infusion pump 410 are connected to each other. As a result, predetermined data or electrical signals can be transmitted and received between the console and the injection head. As the predetermined data or the like, for example, a motor drive signal may be transmitted from the console side to the injection head side according to the injection protocol set on the console side. Further, for example, the detection value of the load cell 438 may be transmitted from the injection head side to the console side.

The connection between the console 150 and the infusion pump 410 does not correspond to “communication” but may be a connection form in which an electric signal is simply given from one to the other. For example, an electrical signal that triggers the start and/or stop of the operation of the infusion pump may be sent from the drug solution injector side. As an example of such a connection, a part of the drug solution injector and a part of the infusion pump may be electrically connected via a terminal or the like.

(Console function)
The control unit 155 has a function of controlling creation of an injection protocol, execution of injection, and the like, and as an example, as illustrated in FIG. 2B,
-Setting screen display unit 155a,
-Injection protocol generator 155b,
-Injection controller 155c,
-History generation unit 155d, and
-History output unit 155e,
May be included.

The setting screen display unit 155a may correspond to a function for displaying a screen for setting the injection protocol, specifically, a GUI (graphical user interface) for setting the injection protocol on the display 151. The GUI data for setting the injection protocol may be stored in any storage device of the liquid injector, the imager, the hospital system or other computer.

The protocol creation unit 155b corresponds to, for example, a function of accepting an input operation on a touch panel or the like of the display 151 by a doctor or a medical staff member and creating an injection protocol in which the content is reflected. The protocol creation unit 155b is based on at least one input selected from, for example, the type of drug solution, the infusion rate of the drug solution, the injecting amount of the drug solution, the physical information of the patient, the body segment of the patient to be imaged, and the imaging site. Correspondingly create or modify certain parameters of the injection protocol.

The injection controller 155c may correspond to the function of controlling the operation of the piston drive mechanism 130 according to the created injection protocol. The injection control unit 155b may operate only one of the piston drive mechanisms 130 and simultaneously operate both of them. The injection controller 155b may also control the operation of the piston drive mechanism 430 of the infusion pump 410.

The history generation unit 155d may correspond to the function of generating the injection history data. As the “injection history data”, for example,
An injection work ID, which is unique identification information for each injection work,
-The date and time of infusion start and end,
-Identification information of the liquid injector,
-Contrast and/or saline injection conditions,
-Identification information of the drug solution or the imaging site,
-Data of the vasodilator used (ATP formulation),
-Infusion conditions (infusion rate, amount, time, etc.) of vasodilator, etc.
-Information on the combination of vasodilator and contrast agent used,
May be at least one of the above.

These may be text data. Further, one of the horizontal axis and the vertical axis may be elapsed time and the other may be image data of a temporal graph of the injection speed. Alternatively, one of the horizontal axis and the vertical axis may be the elapsed time and the other may be image data of a temporal graph of the injection pressure. The injection history data may be information on the drug solution or syringe information acquired 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 155e may correspond to the function of transmitting the injection history data to the outside. Specifically, the data may be transmitted to a predetermined external device and/or a database on the network.

The functions of the units 155a to 155e may be executed by a computer according to installed programs. The program may be stored in advance in a predetermined storage unit (may be the storage unit 159, for example) in the console.

The storage unit 159 (see FIG. 2A) may store, for example, an image displayed on the display 151 or GUI data. In addition, an algorithm including a calculation formula for setting the injection condition, and injection protocol data may be stored. The injection rate may be constant or may change with time. When injecting a contrast agent and physiological saline, information such as the order of injecting the drug solutions is also included in the injection protocol. Note that such information regarding the injection protocol may be input from an external device connected via an interface (not shown). Alternatively, the console 150 may have a slot (not shown), and input may be performed through an external storage medium inserted therein.

As shown in FIG. 2A, the chemical liquid injector of the present embodiment has a power supply unit including an AC cord 195b and a power supply circuit 195a. In this example, the AC power supply provided in the console 150 is illustrated, but it goes without saying that a DC power supply such as a battery may be used.

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 (angiography) imaging device, or the like. As schematically shown in FIG. 1, the imaging apparatus 1000 includes a gantry 1101, a bed 1103 on which a patient is placed, and a control unit 1103a (see FIG. 2A) that controls the operations of the gantry 1101 and the bed 1103. ) And.

Although detailed illustration is omitted, the imaging apparatus 1100 has a data collection unit and the like that collects and processes fluoroscopic imaging data. As the image pickup apparatus 1100 itself, a conventionally known one can be used, and therefore only the main components will be described below. The CT apparatus will be described below as an example.

The gantry 1101 has a central opening through which a patient can pass, through which a patient lying on the bed 1103 can move laterally. Inside the gantry 1101, an X-ray irradiation unit (not shown) that has an X-ray tube, a collimator, and the like that irradiates the patient with X-rays, and a detection unit (not shown that detects X-rays that have passed through the patient). ) Etc. are arranged. The X-ray irradiator and the detector form the imager 1103b, and scan while rotating around the body axis of the patient while maintaining their positional relationship. Data from this scan is acquired by a data acquisition unit (not shown), and fluoroscopic imaging data (projection data) is acquired.

The CT device may be of any type as long as it can irradiate a patient with X-rays from a predetermined direction to obtain a transmission image. As an example, a multi-slice CT apparatus that can obtain cross-sectional images of a patient in three directions may be used.

Since the present invention is intended for the examination of myocardial analysis, it is also preferable that it is an imaging apparatus capable of performing a myocardial hemodynamic examination using an X-ray CT apparatus. An example of examination of blood flow dynamics (perfusion) of the myocardium using an X-ray CT apparatus is performed as follows in an example. That is, a perfusion image is generated by performing imaging after injecting a contrast agent and analyzing the obtained contrast CT data. Usually, such imaging of myocardial perfusion image is performed as a part of a contrast imaging examination of the heart, not an independent examination. For example, in the case of capturing a myocardial perfusion image, in addition to the scanning of the myocardial perfusion image, a scan for cardiac function analysis such as coronary artery and intracardiac wall movement may be performed. Further, attempts have been made to create a myocardial perfusion image in a shorter time while further reducing the injection amount of a contrast agent into a patient and the exposure to X-rays. That is, a technique of acquiring blood flow information from information such as coronary angiography CT image data and myocardial contrast CT image data obtained by the scan for acquiring myocardial image without adding a scan for acquiring blood flow information, etc. Is.

The imaging device is connected to an electrocardiograph 1150 (ECG, see FIG. 2A) so as to be able to perform electrocardiographic synchronized imaging, and synchronizes with the electrocardiographic data acquired thereby (that is, obtains trigger information from the data). It is preferable that it is configured to perform imaging.

3. Hospital System As an example, the hospital system is, as shown in FIG. 3, an imaging device, a drug solution injecting device, a medical record management device HIS, an imaging management device RIS, a data storage device PACS, and an image browsing device. It is equipped with a viewer and printer. Not all of them need to be available.

(HIS)
The HIS is a computer in which a dedicated computer program is installed and has a chart management system. Electronic medical records managed by the medical record management system are, for example,
A medical record ID, which is unique identification information,
-Patient ID for each patient,
-Personal data such as patient name,
-It may include data such as medical record data relating to a patient's disease.

In the medical chart data, the weight, sex, age, etc. of the patient may be registered as personal condition data related to the overall treatment.

(RIS)
The RIS manages imaging order data for imaging fluoroscopic image data from a patient with unique identification information. This imaging order data is created based on an electronic medical chart acquired from HIS. The imaging order data is, for example,
-Imaging work ID, which is unique identification information,
-Work types such as CT imaging and MR imaging,
-Patient ID and medical record data of the electronic medical record,
-CT device identification information,
-Date and time of start and end of imaging,
-Body segment or imaging site,
-Appropriate type consisting of chemical liquid type such as contrast agent corresponding to imaging work,
The data may include data such as a proper ID made up of a chemical liquid ID suitable for the imaging work.

(PACS)
The PACS receives the fluoroscopic image data provided with the imaging order data from the imaging device and stores it.

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

4. Operation (1) Protocol Setting Stage The chemical injection device of the present embodiment operates as follows as an example. First, "injection protocol setting" will be described, and then the injection operation will be described.

As an injection protocol setting screen, the console 150 in this embodiment displays a graphical image as shown in FIG. Specifically, the console 150 initially displays a graphical image in which the human body image 630 is displayed but the infusion protocol window 610 (details below) is not.

The human body image 630 includes a plurality of body classification icons. As an example, the body classification icon may be one or more of a head, a chest, an abdomen, and a lower limb. When the doctor or medical staff selects one (for example, the chest) and then selects an icon (not shown here) indicating a myocardial analysis test, the console 150 displays the infusion protocol window 610.

As the “icon indicating that it is a myocardial analysis test”, for example, when the body classification icon is selected, it may be displayed as a subordinate item (imaging site). Regardless of whether or not the body classification icon has been selected, the icon may be displayed on the screen before the selection. The “icon” may be selected by being touched on the screen and selected, or may be selected by a cursor of a mouse or a trackball. Even if the console 150 recognizes this by pressing a physical button or switch provided on the injection head, console, or other device instead of the icon and displaying the injection protocol window 610, Good. As another form, a myocardial analysis test icon is displayed as one of the body classification icons (head, chest, abdomen, etc.), and by selecting this, the injection protocol window 610 is displayed. May be.

This injection protocol window 610
(I) data of injection conditions of vasodilator,
(Ii) data on the injection conditions of the contrast agent,
(Iii) data of injection conditions of diluted contrast agent,
(Iv) data of physiological saline infusion conditions,
Is graphically displayed in the form of a graph.

(VD condition box)
The vasodilator infusion phase is the first phase. In the graph of the injection protocol window 610 (the horizontal axis is the time axis), the condition box 611 corresponds to the injection condition of the vasodilator. The condition box 611 is displayed at the leftmost position in the graph. The display of the condition box 611 can be changed as appropriate, but in one example, it may include the letters “VD” indicating that it is a vasodilator.

The injection condition of the vasodilator is, for example, that 30 ml to 40 ml of the vasodilator is slowly injected over 200 seconds or longer (more specifically, 220 seconds or 250 seconds). .. Such a predetermined injection condition may be stored in advance in the storage unit 159 (FIG. 2A) or the like as the default condition, and the console 150 may present this as the default condition. However, this condition does not necessarily include information such as the injection rate and injection amount of the vasodilator. That is, in the infusion pump 410, when these conditions are set in advance, it may simply include only the information on the timing of starting the injection of the vasodilator. The end of injection may be determined based on a timer or the like on the infusion pump side, or a trigger signal may be given from the console 150 side.

It should be noted that, in order to realize a relatively low-speed infusion of the vasodilator, the control unit 155 of the console 150 and/or the control circuit 455 of the infusion pump (which may be collectively regarded as one control unit) is infused with the infusion solution. It controls the operation of the piston drive mechanism 430 of the pump 410. For example, the motor 431 may be rotated at a constant speed.

When the operator touches the “VD” condition box 611 in setting the injection protocol, one or more of the parameters such as “injection amount”, “injection time”, and “injection rate” can be arbitrarily modified. It is also preferably configured. Instead of the touch panel type, the box may be selected with a cursor or the like.

(Contrast start delay time display box)
The delay time display box 613 is a box for setting the time from the injection of the vasodilator to the injection of the contrast agent. The delay time display box 613 may be displayed as a selectable icon. In one example, in the vasodilator injection of 250 seconds, the injection of the contrast agent is started when 220 seconds have elapsed. In other words, the injection of the contrast agent is started from 30 seconds before the end of the injection of the vasodilator. In this example, the character indicating the “30” second is displayed in the box 613. This may be what is displayed as the default value.

It is assumed that the timing for starting the injection of the contrast agent varies depending on the patient, the drug used, and the like. Therefore, it is also preferable that when the condition of the time display box 613 is touched, the time can be arbitrarily modified and changed.

FIG. 7 shows an example of how the delay time is changed. When the box to be changed is touched in this way, for example, a ten-key screen 621 or the like is displayed, and the desired numerical value is displayed using the ten-key. It may be configured to allow input. Although this figure illustrates a case where the delay time is changed, the same numeric keypad is used when changing the injection conditions of the above-mentioned vasodilator and/or when changing the injection conditions of a contrast agent or the like described later. The screen 621 may be changed.

(Contrast and physiological saline injection condition box)
In the injection protocol of the present embodiment, next, the injection of the contrast agent, the simultaneous injection of the contrast agent and the physiological saline, and the boost injection of the physiological saline are performed. Infusion protocol window 610 includes these three phases as infusion condition boxes 615, 616, 617, respectively.

The second phase of this injection protocol is the injection of contrast agent. In the injection condition box 615 of FIG. 6, in one example, the injection speed is set to 4.5 ml/sec and the injection amount is set to 70 ml. The injection condition box 615 may be displayed as a selectable icon. In this example, the injection of the contrast agent is started before the completion of the vasodilator, so that the injection of the contrast agent and the injection of the vasodilator are performed simultaneously for 30 seconds (one example).

The third phase of this injection protocol is the simultaneous injection of contrast agent and saline. In the injection condition box 616, for example, the contrast agent and the physiological saline are simultaneously injected at 50:50 (50% dilution), the injection speed is set to 4.0 ml/sec, and the injection amount is set to 20 ml. The injection condition box 616 may also be displayed as a selectable icon.

Note that the dilution ratio of “50:50” is just an example, and another default dilution ratio of an arbitrary ratio (for example, 30:70, 40:60, 60:40, 70:30) is set. May be. When the icon is selected to change the dilution rate, a predetermined graphical user interface is displayed, and by operating it, for example, "50:50" can be changed to another dilution rate. Is also preferable.

This injection is performed subsequent to the injection of the contrast agent (without holding time or the like).

The third phase of this infusion protocol is saline-only infusion. The injection condition box 617 is an example, and the injection speed is set to 4.0 ml/sec and the injection amount is set to 20 ml. The injection condition box 617 may also be displayed as a selectable icon.

This injection is also performed (without holding time etc.) subsequent to the simultaneous injection.

Regarding the injection condition boxes 615, 616, and 617, when the operator touches the condition box, one or more of the parameters such as “injection amount”, “injection time”, and “injection speed” can be arbitrarily modified and changed. Is preferably configured.

The injection condition boxes 615, 616, and 617 may be displayed in the same width regardless of the injection time of each phase. As another aspect, the injection condition boxes 615, 616, and 617 may be displayed in a horizontal width corresponding to the injection time of each phase. It is preferable that each of the boxes 615, 616, and 617 is displayed in a different color because it is easy to visually recognize. For example, the box 615 associated with the contrast agent may be a first color (eg green) and the box 617 associated with saline may be a second color (eg blue). Also, the boxes 616 associated with co-injection may be represented by colors in between, or a portion of the boxes may be represented by a first color and the remaining portion represented by a second color.

In the graph of the injection protocol window 610, the horizontal axis is time as described above, but the start point “0:00” of the elapsed time is even the injection start time of the vasodilator (that is, the start point of the first phase). However, in this example, the contrast agent injection start time (that is, the start point of the second phase) is set, and the elapsed time from here is displayed.

Although not shown in the screen of FIG. 6, it is also preferable that, for example, the scan start timing of the imaging device is displayed in the screen. The “scan start timing” may be set as one piece of information included in the injection protocol. That is, the chemical injection device 100 stores this scan start timing information as an injection protocol, and the chemical injection device 100 transmits a trigger signal to the imaging device 1100 at the scan start timing after the injection is started. Based on the above, the imaging device 1100 may be configured to start imaging. The image pickup apparatus 1100 may perform electrocardiogram-synchronized imaging with reference to the measurement result of the electrocardiograph.

The “scan start timing” is, for example, within a range of 15 seconds to 25 seconds after the start of injection of the contrast agent. This timing may be included in the infusion protocol as default information and, like the other parameters mentioned above, is displayed on-screen and configured to be modified by the physician or health care professional as needed. May be.
(2) A series of injection operations

As an example, a series of examination procedures for myocardial analysis and the injection operation of the system are performed as follows.

First, in step S1 of the flow of FIG. 10, a doctor or medical staff prepares a syringe to be used and attaches it to the injection head 110 and the infusion pump 410. Then, an extension tube is connected to each of the syringes 110 and 410. 2A, for example, contrast agent and saline are infused via the extension tube 230 from the patient's right hand, while vasodilators are infused via the extension tube 235 from the patient's left hand. The connection mode may be as follows.

If necessary, a route for injecting another drug may be provided. Examples of this include drugs that reduce the heart rate. Specifically, it is a drug such as beta blocker having an action of lowering the heart rate by selectively blocking the β1 receptor existing in the heart. It should be noted that this may be injected, for example, through a route additionally connected to a part of the tube 230, and instead of injection using a device, a doctor or the like manually operates the syringe. It may be injected. As a path for injecting the beta blocker, for example, a stopcock (a three-way stopcock in one example) for switching the injection path is provided on the tube 230, and (i) a state in which the beta blocker can be injected, and (ii) ) The state in which a contrast agent or the like can be injected may be switchable.

Returning to the flow of FIG. 10, the injection protocol is set in step S2. In the injection protocol setting (step S2), a doctor or a medical staff operates the console 150. This timing is not particularly limited, and may be performed before or after the circuit connection (S1) or in parallel with the circuit connection.

According to the system of the present embodiment, the default injection protocol is presented by selecting a predetermined icon or the like via the display-like GUI of the console 150. Therefore, it is possible to set very easily without the need to input the injection amount and the injection speed of each phase numerically (apart from the case where the numerical value is finely adjusted).

Even if fine tuning needs to be done to the conditions of the proposed infusion protocol, the physician or health care worker touches boxes 611, 613, 615-617 (see FIG. 6) to change the conditions. You can make changes with this intuitive and simple operation. Moreover, since the overall injection protocol is displayed in a visual graph as shown in FIG. 6, it is easy to make a final confirmation of the set injection protocol. Therefore, it is possible to eliminate an artificial error such as setting the injection condition by mistake.

Next, in step S3, the doctor or the medical staff inputs a predetermined infusion start to the system. Specifically, it may be by pressing a physical button on the injection head, or by touching a predetermined icon on the display of the console, or a combination thereof. Then, in step S4, using this input as a trigger, a series of injection operations according to the injection protocol set by the chemical liquid injector 100 is started.

First, the system operates the piston drive mechanism 430 of the infusion pump 410 as the first phase. For example, the chemical liquid injector 100 may apply an electrical signal as a trigger to the infusion pump 410, and the piston drive mechanism 430 may start the automatic injection in response to the electric signal. The infusion condition of the infusion pump 410 (the infusion rate, the infusion amount, or both of them) may be set by the console 150 or the like and sent to the infusion pump, but this is not the case. May be. That is, it may be set in advance by pushing a physical button on the infusion pump 410 side or through a predetermined user interface (not shown).

The infusion pump 410 automatically injects the vasodilator from the syringe 200V at a relatively low speed and at a constant speed. The injection can be performed under more appropriate conditions and safer than the case of performing the injection manually.

30 seconds before the end of the injection of the vasodilator in the first phase (an example), the drug solution injector 100 then operates the piston drive mechanism 130 of the injection head 110 on the contrast agent side in the second phase. .. As a result, the contrast agent is injected from the syringe 200C at a predetermined speed. Whether or not 30 seconds before the end of the injection of the vasodilator (one example) is determined by, for example, the liquid injector 100 based on the information of the timer (elapsed time measuring unit) in the device. Good.

Next, the chemical liquid injector 100 operates both piston drive mechanisms 130 of the injection head 110 as a third phase after the second phase ends. As a result, the contrast agent and the physiological saline are simultaneously extruded from the syringes 200C and 200S. These drug solutions merge and mix in the extension tube 230 and are injected as a diluted contrast agent.

After that, the chemical liquid injector 100 operates the piston drive mechanism 130 on the physiological saline side of the injection head 110 as the fourth phase after the third phase is completed. Thereby, the physiological saline is injected from the syringe 200S at a constant speed.

In the liquid medicine injection device 100 of the present embodiment, after the injection is started as described above, the injection state is displayed. Specifically, during the injection of the vasodilator, a graphical image 625 as shown in FIG. 8 is displayed on the display 151 of the console 150 as the “state display” in step S5.

In this image, a state where the medicine is injected from the syringe is displayed as a still image or a moving image (as an animation). The amount of drug infused, the amount remaining, or both, may be textually displayed as a number. In addition, the elapsed time from the injection, the remaining time, or both of them may be displayed in text as a numerical value. FIG. 8 shows an example in which “30” sec is displayed in real time as the elapsed time after the start of injection. Further, the remaining time until the start of injection of the contrast agent may be displayed, and for example, a display such as "It is XX seconds until the start of injection of the contrast agent" may be displayed. Blink display (blinking display) may be adopted as one mode of display. Further, as an example, an alarm (anything such as message display, sound or voice generation, etc.) may be generated at a predetermined time until the start of contrast agent injection. Good. Since such a configuration calls attention to X-ray exposure in CT imaging or the like, there is an advantage that a doctor or medical staff can be prompted to perform a safe examination.

After switching to the injection of the contrast agent or physiological saline (that is, after the second phase), the pressure graph (see FIG. 9) of the injected medical solution may be displayed in real time. On this screen, the injection pressure in each phase of the injection of the contrast agent, the injection of the diluted contrast agent, and the injection of the physiological saline solution is calculated based on the detection result of the load cell 138 of the injection head 110 and the like, and is displayed in a graph in real time.

(CT imaging)
According to the set injection protocol, in the present system, the image pickup apparatus is interlocked at a predetermined timing to automatically perform image pickup (step S6). That is, a signal as a trigger is transmitted from the drug solution injector 100 to the imaging device 1100, and the imaging device 1100 captures a fluoroscopic image in a loaded state in which a vasodilator and a contrast agent are injected.

When the boost injection of the physiological saline is completed, the series of injection of the drug solution is ended (step S7).

After that, in step S8, the chemical liquid injector 100 creates injection history data. As described above, the injection history data includes not only the injection amount, injection time, injection speed, injection time, etc. of the contrast agent or physiological saline, but also the injection amount, injection time, injection speed, injection time, etc. of the vasodilator. May be included. For more specific contents, refer to the above description regarding the “injection history generation unit 155d”.

It is saved in step S9. The data is stored in a storage area in any device belonging to the chemical liquid injector 100, or a database or the like connected via a network or the like.

(Action effect)
According to the system of the present embodiment configured as described above, the operation of the injection head (that is, the injection of the contrast agent and the physiological saline solution) and the operation of the infusion pump (that is, the injection of the vasodilator) are set in advance. It can be executed automatically according to the protocol. Therefore, it becomes possible to inject a vasodilator, a contrast agent, physiological saline, etc. at a desired rate, amount, and timing, and it is possible to obtain a good action of the vasodilator on the function of the heart and a good imaging result by the contrast agent. Obtainable. In particular, if a vasodilator is infused in a predetermined amount or more, the heart may be overloaded. Therefore, a dedicated injection device (transfusion solution) different from the injection device for injecting a contrast agent as in the present embodiment is used. According to the configuration in which the injection is performed by the pump, the inspection can be made safer.

In addition, in the injection protocol of the present embodiment, the first phase is a vasodilator injection phase, and the second phase (which may partially overlap) is set as a contrast agent injection phase. According to this, it is possible to obtain a fluoroscopic image in which the myocardium is contrast-enhanced while applying a load to the myocardium with the vasodilator, which is preferable for myocardial analysis.

Furthermore, according to the injection protocol of the present embodiment in which the third phase is the simultaneous injection phase of the contrast medium and the physiological saline, and the fourth phase is the physiological saline boosting phase, the left and right hearts of the heart are Is a preferable protocol for myocardial analysis, because it can uniformly and favorably image.

Regarding the setting of the injection protocol including a plurality of phases, according to the system of the present embodiment, the system does not need to input the injection speed and the injection time of each phase numerically, but the system is configured in advance. It has a GUI (610) for protocol setting such as. In this GUI, a predetermined default value is presented for each phase. The doctor or medical staff may confirm the contents and correct the values as necessary to make the final infusion protocol. In particular, since the conditions of each phase are displayed in boxes 611, 615, 616, 617 and the like in the form of a graph, the contents can be confirmed and corrected very intuitively. Therefore, it is possible to greatly expect a reduction in injection condition setting mistakes.

Further, since it is possible to visually confirm that the vasodilator is currently injected from the graphical image as shown in FIG. 8, it is possible to confirm the injection status even at a console away from the injection head, for example.

Although one embodiment of the present invention has been described above, the present invention is not limited to the above, and various modifications can be made without departing from the spirit of the present invention.
(A1) Although FIG. 1 shows a configuration using one two-cylinder injection head 110 and one single-cylinder infusion pump 410, one injection head is a multi-cylinder provided with three piston drive mechanisms. A formula injection head may be utilized.
(A2) Also, as long as one control unit (control device) can accurately drive a plurality of piston drive mechanisms according to a set injection protocol, for example, a plurality of single-cylinder injection heads are used. It may be one.
(A3) Regarding FIG. 2A, the control unit 155 of the console and the display 151 do not necessarily have to be integrally configured. If the chemical injection device 100 as a whole is provided with a calculation unit corresponding to the control unit 155 and a display for displaying a GUI or the like, for example, the injection protocol can be easily set through the GUI. Because it can be obtained in the same manner. An example has been described in which the control unit 155 of the console gives a command to the infusion pump 410 to control the operation thereof (at least injection start, injection stop, etc.), but in another form, the injection head control unit 145 does not. It may be configured to play a role. In this case, for example, the control units 145 and 455 may be connected to each other via the signal line 198 of FIG. 2A. In the figure, the two are directly connected to each other, but as a matter of course, as long as they can exchange electrical signals or transmit or receive data, they are indirectly connected with other circuits interposed. Good.
(A4) The GUI for setting the injection protocol and the graphical image displaying the injection status may be displayed on a display other than the display of the console. As an example of this, a head display may be provided integrally with the housing of the injection head or installed in the vicinity thereof. The head display may or may not be a touch panel type.
(A5) The infusion pump is not necessarily limited to the vasodilator, but may be one that automatically injects another drug.
(A6) Regarding the operation of the infusion pump, for example, the control circuit of the infusion pump or the control unit of the console calculates the actual injection speed of the liquid medicine and does not exceed a predetermined upper limit value, and/or a predetermined lower limit. It is also preferable to have a function of determining whether the value is below the value or not. It is also preferable that the configuration is such that error guidance is issued when the upper limit value is exceeded or when the upper limit value is exceeded. With such a configuration, it is possible to prevent the damage of blood vessels and the occurrence of misdiagnosis.
(A7) In addition to the vasodilator, a second infusion pump may be provided in the system for injecting another drug. The drug may be a beta blocker agent having a function of lowering the heartbeat. Also in this case, the technical matters of the pump described above as an example of the infusion pump for injecting the vasodilator may be appropriately applied to the second infusion pump. The infusion rate of the second infusion pump may be, for example, 5 ml/min to 15 ml/min.

(A8) In the above-described embodiment, there are a contrast agent injection phase, a diluted contrast agent injection phase, and a physiological saline injection phase. In the diluted contrast agent injection phase, the contrast agent and the physiological saline are mixed at a constant ratio. What was injected was illustrated. However, in this intermediate phase, the so-called “cross injection” (or “trapezoid cross injection”) in which the injection rate of the contrast medium decreases linearly and the injection rate of the saline increases linearly is called. The injection condition as described above may be set.

5. Other embodiments (infusion pump)
An infusion pump according to another embodiment will be described with reference to FIGS. 11 and 12.

The infusion pump A410 of FIG. 12 is similar to that of the above embodiment in that it has a piston drive mechanism and a control circuit electrically connected thereto. However, the specific structure of the piston drive mechanism, the structure for holding the syringe, and the mode of the display unit for displaying various information are different.

It should be noted that in the following description, overlapping description of points common to the above-described embodiment will be omitted, and different points will be mainly described. In addition, in FIGS. 11 to 14, although the alphabetical character “A” is attached to the beginning of the code like “A410”, the numeral portion is attached with the same or corresponding numeral as that of the above-described embodiment. ing. Note that, for convenience of description, in the following, a case in which alphabetical characters such as “A430” and “430” are attached and a case in which they are designated may be mixed. However, the configuration and operation of the infusion pump of the above-described embodiment may be adopted instead of the items described below without departing from the spirit of the present invention.

The infusion pump A410 is for injecting the drug solution in the syringe 200∨, and has a piston drive mechanism A430 for moving the piston member of the syringe.

The infusion pump A410 has a housing, and the control circuit 455 (see FIG. 11) is arranged in the housing. The motor 431 and the transmission mechanism 432 of the piston drive mechanism A430 are also arranged in the housing. On the other hand, the presser member A433 is in a state of protruding to the outside of the housing. The presser member is a member also called a "ram". A member that comes into contact with the piston member is provided at the tip of the presser member, and a pair of elastically openable claws is attached to this member.

Two support bars A481 extend forward from the front end of the housing. In this example, the two support bars A481 are arranged parallel to each other. A syringe holding structure A420 is provided at the front end of the support bar A481.

The syringe holding structure A420 has a syringe holding portion A420a which is formed in a concave shape and receives a part of the syringe. Further, the syringe holding structure A420 has a receiving groove A421 formed in a predetermined depth from the upper surface downward (downward in FIG. 12). The syringe adapter A423 is detachably attached to the receiving groove A421. As a method of holding the syringe with the syringe adapter, more specifically, the method disclosed in JP 2010-213977 A (Applicant: Nemoto Kyorindo Co., Ltd.) can be used. The syringe adapter A423 holds the periphery of the flange portion of the syringe and is detachably mounted in the receiving groove A421.

The specifications of the piston drive mechanism are not particularly limited, but as one example, those capable of injecting the chemical liquid at a pressure of at least 10 PSI, preferably those capable of performing the chemical liquid injection at a pressure of at least 20 PSI. It may be.

The following buttons are arranged on the housing of the infusion pump A410. Note that these are not necessarily all indispensable, and one or some may be omitted:
-Start button (injection start button) A446
-Stop button (stop button) A447
-Speed up button A444
-Speed down button A444
-Auto Return Button (Return Button) A445
-Low speed forward button A443a'
-Medium speed forward button A443a
-Low speed reverse button A443b'
-Medium speed reverse button A443b
-Power button A449

The start button A446 is a button for starting the injection, and the stop button A447 is a button for stopping the injection. The speed-up button A444 is a button for setting (up) the injection speed, and the speed-down button A444 is a button for setting (down) the injection speed. The auto return button A445 is a button for auto return, that is, for automatically moving the presser member to a predetermined retracted position. The auto-return operation is, for example, not executed only by pressing the auto-return button once, but may be executed only when the button is pressed for a long time. The long press time is, for example, 0.5 seconds or more or 2 seconds or more.

The low speed forward button A443a', the medium speed forward button A443a, the low speed reverse button A443b', and the medium speed reverse button A443b are buttons for performing low speed forward, medium speed forward, low speed reverse, and medium speed reverse, respectively. In these buttons, the presser member moves only while being pressed. The power button is a button for turning on/off the power of the pump. The "medium speed" is an example, and may be a speed within the range of 1.0 ml/sec to 3.0 ml/sec. The "low speed" is an example, and may be a speed within the range of 0.1 ml/sec to 1.0 ml/sec.

Further, the following is arranged as a display unit or a display device. These are not all indispensable, and one or some may be omitted: power supply display unit (power emitting unit, power supply LED), status display unit, set speed display unit, time display unit, battery level display unit. , Speed unit display section, pressure over display section, syringe sensor display section (syringe sensor light emitting section, syringe sensor LED), clamp sensor display section (clamp sensor light emitting section, clamp sensor LED). The specific contents of the display unit will be described later with reference to other drawings.

The buttons and the display unit as described above are both electrically connected to the control circuit 455 (see FIG. 11) of the device. The control circuit detects that the button has been pressed, and accordingly operates the device in a predetermined manner. When the control circuit has a predetermined condition (for example, when the value of the detection target reaches a predetermined reference value, when a predetermined button is pressed, etc., but is not limited to these), the control circuit described above is used. The lighting of the display is switched ON/OFF. In addition, turning on/off of a light source (for example, one or a plurality of LEDs) is controlled according to a preset pattern.

The infusion pump A410 has a clamp sensor A477 in this example. The clamp sensor A477 is used to determine whether or not the presser member A433 abuts the piston member (not shown) (including a state in which the sensor reacts although not completely abutted). Although various sensors can be used as the clamp sensor A477, for example, a contact sensor (switch) that performs detection by contacting an object may be used. Alternatively, a sensor that performs non-contact detection may be used. As the non-contact type, various types such as an optical type, a magnetic type, and a capacitance type can be used. As an example, a Hall element, a photoelectric sensor, a CCD sensor, a capacitance type proximity switch, a proximity sensor or the like may be used.

The clamp sensor A477 is electrically connected to the control circuit 455. The control circuit 455 is configured to perform various operation controls according to the detection result of the sensor (details below). In this example, the clamp sensor A477 is arranged on the front surface of the presser member as shown in FIG. More specifically, it is arranged so as to project from the front surface of the presser member.

The infusion pump A410 also has a syringe sensor A478. The syringe sensor A478 is used to determine whether or not the syringe is set at a predetermined position. Although various sensors can be used as the syringe sensor A478, for example, a contact sensor that performs detection by contacting an object may be used. Alternatively, a sensor that performs non-contact detection may be used. As the non-contact type, various types such as an optical type, a magnetic type, and a capacitance type can be used. As an example, a Hall element, a photoelectric sensor, a CCD sensor, a capacitance type proximity switch, a proximity sensor or the like may be used.

The syringe sensor A478 is also electrically connected to the control circuit 455. The control circuit 455 is configured to perform various operation controls according to the detection result of the sensor (details below). The syringe sensor A478 is arranged in a part of the syringe holder 420a. More specifically, it is arranged so as to project from the concave portion of the syringe holding portion.

Note that although one or both of the sensors A477 and 478 are arranged one by one in the example of the drawing, a plurality of sensors may be arranged. Further, the position of arranging the sensor is not necessarily limited to the presser member or the syringe holding portion, and may be any other position.

(Example of operation control)
1. Basic operation of infusion pump The basic operation of the infusion pump A410 is as follows. The order of operations described in the following description can be changed as necessary.

That is, the operator first turns on the power of the pump. The power source may be a physical button A449 provided on a part of the housing as shown in FIG. 13, for example.

The syringe and infusion circuit are then attached to the infusion pump. In one form, it is preferable that the syringe is in a state where air is removed.

Next, the injection conditions are set. The infusion condition may be set on the console of the drug solution injector, transmitted from the console to the infusion pump, and set on the infusion pump side. Alternatively, it may be manually input by the operator. That is, it may be set by the operator pressing the speed up button/speed down button A444 of the infusion pump. As one form, for example, when the button is pressed, the numerical value may be changed in units of 0.01 ml/sec.

When the capacity of the syringe mounted on the infusion pump is constant (that is, when the capacity is a fixed value), the injection time can be calculated using the injection speed and the volume set above. The infusion pump makes this calculation and sets the infusion time. This completes the setting of the "injection condition", that is, the "injection rate" and the "injection time".

Then, the chemical solution is injected. The chemical liquid injection is an example, and may be a total amount injection in which all the chemical liquid in the syringe is injected. A specific example of the conditions for starting the injection will be described later.

The injection circuit and syringe are then removed. Then, turn off the power of the infusion pump.

2. Operation Control Using Clamp Sensor When attaching the syringe to the infusion pump A410, the operator sets the syringe in the syringe holding portion A420a and then advances the presser member A433. This operation is performed, for example, by pressing the forward button. The presser member A433 is advanced until its front end face contacts the rear end face of the piston member of the syringe, and at this position, the pair of claws of the presser A433 holds the piston rear end face. In this state, the rear end surface of the piston contacts the clamp sensor A477. According to the electric signal from the clamp sensor A477, the infusion pump A410 (specifically, the control circuit 455) determines that the syringe is properly attached.

In the present embodiment, even when the chemical solution is injected (for example, after pressing the start button), the detection by the clamp sensor A477 is continuously performed. The control circuit 455 determines, based on the detection result of the clamp sensor A477, whether or not the clamp sensor is OFF (that is, whether or not the syringe is properly attached).

When it is determined that the clamp sensor A477 is OFF in the above determination, the control circuit 455 generates a predetermined alarm. As the alarm, various types of alarms such as sound, voice, a combination of these, a light-emitting unit lighting or blinking, a character display, and the like can be used.

Instead of or in addition to the alarm, control may be performed such that the presser member A433 is not advanced. Specifically, even if the start button A446 is pressed, the control circuit 455 does not operate the piston drive mechanism 430 unless the clamp sensor A477 determines that the syringe is properly mounted.

According to such a configuration, it is possible to prevent the presser member A433 from advancing and improperly injecting the chemical liquid even though the syringe is not properly mounted.

3. Operation Control Using Syringe Sensor When the syringe is set in the syringe holding portion A420a, the syringe comes into contact with the syringe sensor A478 and the sensor is turned on. The control circuit 455 detects that the syringe is set in the syringe holder A420a according to the electric signal of the syringe sensor A478.

The infusion pump A410 of this embodiment may perform the following control. That is, first, it is determined whether or not the syringe is set in the syringe holder 420a based on the result of the syringe sensor A478 as described above.

Next, in the set state, the piston drive mechanism 430 is not operated even if the operator presses any one of "medium speed forward movement", "medium speed backward movement", and "auto return".

With such a configuration, the following advantages can be obtained. That is, the infusion pump A410 in this example injects a drug having a relatively large influence on the physical function of the patient (for example, a drug for controlling the heart rate). Therefore, it is preferable that at least the predetermined amount or more is not injected. Therefore, according to the configuration in which at least the "middle speed forward movement" is prohibited as described above, it is possible to prevent the injection of a predetermined amount or more due to an erroneous operation by the operator. On the other hand, by prohibiting "medium speed reverse" and "auto return", it is possible to prevent blood from being drawn into the liquid medicine tube.

Note that it is not always necessary to prohibit all of "medium speed forward", "medium speed backward", and "auto return". In one form of the invention, only one of them is prohibited. In other forms, two (plural) of them are prohibited.

It is also preferable that the infusion pump A410 be configured to perform the following operation. Specifically, the infusion pump A410 prohibits a manual operation by the operator (for example, advancing and retracting the presser member by pressing a button, or both of them) when the syringe is set. May be. In other words, the infusion pump A410 is configured to allow only automatic infusion according to the programmed drug solution conditions.

With such a configuration, injection under conditions other than the programmed liquid chemical conditions cannot be executed, so it is possible to further prevent injection due to human error.

4. Operation Control Using Combination of Results of Syringe Sensor and Clamp Sensor The detection results of the two sensors described above may be used to perform operation control as shown in the following table. Here, "○" in the table indicates that the operation is possible when the button is pressed, and "x" indicates that the operation cannot be executed even when the button is pressed.
○: Operation is possible ×: Operation is not possible

From the viewpoint of safer injection of the drug solution, it is also preferable that the injection is started when the start button is pressed while the syringe sensor is ON and the clamp sensor is ON. At least when the syringe sensor is OFF, the chemical solution injection does not start even if the start button is pressed, and at least when the clamp sensor is OFF, the chemical solution injection does not start even if the start button is pressed.

It is preferable from the viewpoint of safe chemical injection that the piston drive mechanism is not operated according to the detection result of at least one of the clamp sensor and the syringe sensor. Such operation control may be performed at the timing of injecting the liquid medicine, but when the detection result of at least one of the clamp sensor and the syringe sensor changes during the liquid injection (for example, it is assumed that the syringe is disconnected). May be performed).

5. Status Display During Operation The infusion pump A410 has, for example, a display unit A470 as shown in FIG. The display unit A470 is
-Injection operation display section (status display section) A471,
-Alarm indicator (status display part) A472,
-Injection speed display unit (set speed display unit) A473,
-Infusion time display section A475
-Battery level indicator A474.
have.

The injection operation display unit A471 includes a plurality of segments that emit light as an example. The plurality of segments may be arranged in a circle. It is possible to notify what kind of operation is currently being performed by causing the light emitting unit to issue the plurality of segments in a predetermined pattern according to the operation of the pump. As an example, the display may be performed in a pattern as shown in FIG. During the forward movement, only the front half side of the circle of the plurality of segments of the injection operation display portion A471 is turned on. It may be blinking. During the backward movement, only the rear half of the circle is lit or blinked. During the injection, the individual segments may be sequentially turned on and displayed as if they are rotating.

The alarm indicator A472 includes, in this example, indicators (light emitting units) of “PRS”, “Syringe”, and “RAM”.

"PRS" means pressure. In this example, a display schematically showing the tube is provided as an example. The infusion pump A410 detects the pressure during injection of the chemical liquid, compares the detected pressure with a predetermined limit value, and determines whether the detected pressure has reached (or exceeded) the limit value. When the detected pressure reaches (or exceeds) the limit value, the infusion pump turns on or blinks the "PRS" indicator. This allows the operator to be informed that the pressure limit has been exceeded.

"Syringe" indicates mounting of a syringe. In this example, a display schematically showing a syringe is provided as an example. The infusion pump A410 determines whether or not the syringe is attached based on the detection result of the syringe sensor A478. When an injection operation is attempted (that is, the presser member is moved forward) with the syringe not attached, the infusion pump turns on or blinks the “Syringe” indicator.

"RAM" indicates the clamped state of the presser member. In this example, a display schematically showing the presser member is provided as an example. The infusion pump A410 determines, based on the detection result of the clamp sensor A477, whether the presser member correctly holds the piston rear end surface. If an infusion operation is attempted (i.e. advancement of the presser member) without proper holding, the infusion pump will illuminate or flash the "RAM" indicator.

The injection speed display portion A473 displays the set injection speed. The injection time display portion A475 displays the time until the injection is completed. The battery remaining amount display portion A474 displays the battery remaining amount.

5. Alarm display (warning display)
A configuration may be adopted in which the location where the error has occurred is determined based on the detection results of the various sensors, and the operator is notified of it by an alarm display as shown in FIG. 16, for example.

FIG. 16A shows that the pressure is over, and an alarm display is displayed at the location of the tube (“PRS”). The alarm display may disappear when the pressure returns to within a predetermined reference value.

FIG. 16B shows an abnormal mounting of the syringe, and an alarm display is displayed at the location of the syringe (“Syringe”). The display may be erased by mounting the syringe. Alternatively, the display may be configured to disappear by pressing a stop switch or any other button.

FIG. 16C shows a clamp abnormality, and an alarm display is displayed at the location of the syringe (“RAM”). The display may be erased when it is detected that the syringe is clamped. Alternatively, the display may be configured to disappear by pressing a stop switch or any other button.

6. Specific Description of State Transition FIG. 17 is an example of state transition of the infusion pump. As shown in the figure, the infusion pump may perform a predetermined initialization operation after the power is turned on. A specific example will be described below. Needless to say, the specific operation procedure, timing, time, and the like shown below are merely examples of the present invention.

(Power ON/Self check)
Regarding power-on, the power may be turned on by pressing and holding the power switch. The configuration may be such that the initialization operation (described below) is automatically performed when the power is turned on. Examples of the initialization operation include a self-check for confirming the operation of one or more electric elements in the device. As a specific example, the configuration may be such that the SUM of the data in the storage medium (not shown) inside the pump is checked, and if the SUMs do not match, it is determined to be abnormal. If it is not determined to be abnormal, the initialization is completed and the piston drive mechanism becomes operable. If it is determined to be abnormal, a predetermined alarm may be issued or the operation may be prohibited.

FIG. 18 is an example of state transition of forward movement.
When the low speed forward button is pressed while the limit switch (forward limit, not shown) in the device is OFF, the low speed forward state is entered.
-Release the button,
-Press another button,
-The forward limit is ON,
-The input of the syringe sensor is switched,
-If there is at least one of the pressure reaching a predetermined limit value (10 PSI, 15 PSI in one example), transition to stop. Note that, as described above, the state may be changed to stop according to the detection result of the clamp sensor or the syringe sensor.

The transition from medium speed forward to stop is, for example,
-Release the button,
-Press another button,
-The forward limit is ON,
-The input of the syringe sensor is switched,
-The input of the clamp sensor is switched,
-It may be performed when there is at least one of the pressure reaching a predetermined limit value (in one example, 10 PSI, 15 PSI).

FIG. 19 is an example of a state transition regarding auto return.
When the auto return button is pressed while the limit switch (rear end limit, not shown) in the device is off, auto return is performed. The condition for the transition from the automatic return wait to the automatic return may be long pressing of the button.
-Press another button,
-Rear end limit is ON,
-The input of the syringe sensor is switched,
-The input of the clamp sensor is switched,
If there is at least one of these, transition to stop.

FIG. 20 is an example of a state transition regarding injection.
When the start button is pressed while the limit switch (forward limit, not shown) in the device is OFF, injection is performed on condition that there is no other injection prohibition condition.
-Press another button,
-The forward limit is ON,
-The input of the syringe sensor is turned off,
-The input of the clamp sensor is turned off,
Transition to stop if at least one of the pressures reaches a predetermined limit value (10 PSI, 15 PSI, 30 PSI in one example).

(Appendix 1)
This application discloses the following inventions:
1. A: Infusion pump (410),
B: a chemical injection device (100),
A chemical injection system comprising:
The infusion pump has a piston drive mechanism (430) for moving a piston member of a syringe (200V) filled with a drug for myocardial analysis examination,
The chemical injection device,
An injection head (110) having at least a piston drive mechanism (130) for moving a piston member of a syringe (200C) filled with a contrast agent;
Display (151),
And a control unit (155),
The control unit (155) displays on the display (151),
And a setting screen (GUI) for setting an injection operating condition of the injection head and an injection protocol including the injection operating condition of the infusion pump.
Chemical injection system.

2. Furthermore, it has a storage unit (159) for storing the injection protocol.

3. The injection head (110) also has another piston drive mechanism (130) that moves the piston member of a syringe (200C) filled with diluent or saline.

4. The setting screen (GUI) of the injection protocol includes a vasodilator injection phase as a first phase and a contrast agent injection phase as a second phase.

5. The setting screen (GUI) of the injection protocol further includes a simultaneous injection phase of a contrast agent and physiological saline as a third phase, and a boosted injection phase of physiological saline as a fourth phase.

6. The control unit (155) is configured to display, on the display, a graphical image (650) indicating that the injection of the vasodilator is being performed.

A system according to another aspect is
A: Infusion pump (410),
B: a chemical injection device (100),
A chemical injection system comprising:
The infusion pump has a drive mechanism (430) for injecting a drug for myocardial analysis examination toward a patient,
The chemical injection device,
A piston drive mechanism (130) for moving a piston member of a syringe (200C) filled with a contrast agent;
A control unit (145, 155, or both) for controlling the operation of the piston drive mechanism,
The control unit (145, 155, or both) is
It is also connected to the infusion pump, and is configured to send an electrical signal to the infusion pump at a predetermined timing according to a predetermined infusion protocol.

8. The control unit sends an electrical signal to the infusion pump, which serves as a trigger for starting and/or stopping the operation of the infusion pump.

9. Furthermore, an image pickup device is provided, and the control unit (155) is also connected to the image pickup device.

10. The chemical liquid injector includes a console (150), and the console is provided with the control unit and the display.

11. Furthermore, another infusion pump for injecting another drug (for example, beta blocker) other than the drug for the myocardial analysis test toward the patient is also provided.

(Appendix 2)
This application also discloses the following inventions:
A1. The computer will
A setting screen (GUI) for setting an injection operating condition of the injection head and an injection protocol including the injection operating condition of the infusion pump is displayed.
How the system works.

A2. The method of operating the system as described above, wherein the computer receives an input by an operator on the setting screen (GUI).

A3. The method of operating a system as described above, wherein a computer modifies parameters included in the infusion protocol in response to the input.

A4. The method of operating the system as described above, wherein the computer controls the operation of the injection head and the infusion pump according to the set injection protocol to inject the drug solution for myocardial analysis and at least the contrast agent from the drug solution injector.

A5. The method for operating the system as described above, wherein the computer controls the operation timing of the imaging device connected to the computer by wire or wirelessly according to a set injection protocol.

A6. A method of operating a system, wherein a computer causes a display to display a graphical image indicating that a medical solution for cardiac muscle analysis is being injected during the medical solution injection.

A7. For storage media such as memory,
-Infusion conditions of vasodilator as the first phase,
-Condition injection conditions as the second phase,
Data of the injection protocol including at least (including the case of simple numerical data),
When a predetermined input is made by the operator, the computer reads the data of the injection protocol and displays it on the display.

A8. Furthermore, the third and fourth phases include the conditions of simultaneous injection of a contrast agent and physiological saline and the conditions of injection of physiological saline.

(Appendix 3)
This application discloses the following inventions:
B1. A: Infusion pump (A410),
B: a chemical injection device (100),
A chemical injection system comprising:
The infusion pump is
A piston drive mechanism (430) for moving the piston member of the syringe (200V),
A control circuit (455) electrically connected to it,
And further,
It has at least one of a first sensor (A477) for detecting the piston member of the syringe and a second sensor (A478) for detecting that the syringe is set.
Chemical injection system.

B2. The first sensor is a sensor that detects a piston member.

B3. The second sensor is a sensor that detects the cylinder member of the syringe.

B4-1. When the detection result of the first sensor is OFF (in other words, when the presence of the piston member is not detected based on the detection result of the first sensor), the control circuit receives an input for starting injection. Even if it does, the piston drive is configured not to operate.

B4-2. When the detection result of the second sensor is OFF (in other words, when the presence of the syringe is not detected based on the detection result of the second sensor), the control circuit inputs the start of injection. However, the piston drive is not operated.

B4-3. The control circuit is configured not to operate the piston drive even when an input for starting injection is made when the detection results of the first and second sensors are both OFF.

B5. The control circuit is
-If the detection result of the first sensor is OFF,
-When the detection result of the second sensor is OFF, or
-When the detection results of both the first and second sensors are OFF,
(I) The piston drive is not operated even if the operator presses the forward button,
(Ii) Do not operate the piston drive even if the operator presses the reverse button, or
(Iii) It is configured to perform both (i) and (ii) above. As another aspect, the piston driving operation may be stopped when the above detection is performed during the operation of the piston driving mechanism.

B6-1. Furthermore, the infusion pump,
A first pressure detecting means using a motor current and/or a second pressure detecting means using a pressure sensor.

B6-2. Furthermore, the infusion pump,
A display unit including an alarm indicator (state display unit) for displaying a position where an error is detected is provided.

B7. Infusion pump included in the above system.

1 Imaging system 100 Chemical injection device (contrast injection device)
110 injection head (injector head)
111 housing 121, 122 adapter 120a syringe holding portion (recess)
130 Piston Drive Mechanism 131 Motor 132 Transmission Mechanism 133 Ram Member 138 Load Cell 155 Control Circuit 150 Console 151 Display 153 Touch Panel 157 Physical Button (Switch)
159 Storage section 180 Stand 195a Power circuit 195b AC cord 197a, 197b Power supply line 198 Signal line 200C, 200S, 200V Syringe 221 Cylinder member 222 Piston member 225 IC tag 230 Extension tube 235 Extension tube 410 Infusion pump 411 Housing 420a Syringe holding Part (recess)
422 Pressing member 431 Motor 432 Transmission mechanism 433 Presser member 438 Load cell 440 Operation part 455 Control circuit 495a Power circuit 495b AC code 610 Injection protocol windows 611, 613, 615-617 Box 621 Numeric keypad 625 Graphical image 630 Human body image 1100 Imaging device 1101 Gantry 1103 Bed 1150 Electrocardiograph A410 Infusion pump A420 Syringe holding structure A420a Syringe holding part A421 Receiving groove A423 Syringe adapter A430 Piston drive mechanism A433 Presser member A470 Display part A477 Clamp sensor A478 Syringe sensor A481 Support bar

Claims (10)

An infusion pump,
A contrast medium injection device,
A chemical injection system comprising:
The infusion pump has a drive mechanism for injecting a drug for myocardial analysis examination toward a patient and a control circuit for controlling the operation of the drive mechanism,
The contrast agent injection device includes an injection head having at least a piston drive mechanism that moves a piston member of a syringe filled with a contrast agent, a display, and a control unit.
The control unit is configured to display a setting screen for setting an infusion operating condition of the infusion head and an infusion protocol including the infusion operating condition of the infusion pump on the display, and the infusion pump. , Is configured to send an electrical signal that triggers at least one of the start and stop of its operation,
Chemical injection system. further,
A storage unit for storing the injection protocol,
The chemical injection system according to claim 1. The injection head also has another piston drive mechanism for moving the piston member of a syringe filled with diluent or saline.
The chemical liquid injection system according to claim 1. The setting screen of the injection protocol is
The first phase includes a vasodilator injection phase,
The second phase includes a contrast agent injection phase,
The chemical injection system according to claim 3. The injection protocol setting screen further includes
The third phase includes the simultaneous injection phase of contrast medium and saline,
The fourth phase includes a boosting phase of physiological saline.
The chemical injection system according to claim 4. The control unit displays on the display,
Configured to display a graphical image showing that a vasodilator injection is being performed,
The chemical liquid injection system according to claim 1. An infusion pump,
A contrast medium injection device,
A chemical injection system comprising:
The infusion pump has a drive mechanism for injecting a drug for myocardial analysis examination toward a patient and a control circuit for controlling the operation of the drive mechanism,
The contrast agent injection device,
A piston drive mechanism for moving a piston member of a syringe filled with a contrast agent,
A control unit for controlling the operation of the piston drive mechanism,
The control unit is
It is also connected to the infusion pump, is configured to send an electrical signal to the infusion pump at a predetermined timing according to a predetermined infusion protocol, and starts the operation of the infusion pump. And an electrical signal that triggers at least one of stopping and
Chemical injection system. Furthermore, equipped with an imaging device,
The control unit is also connected to the imaging device,
The chemical liquid injection system according to any one of claims 1 to 7. The contrast medium injection device includes a console,
The console, the control section and the display is provided, the chemical liquid injection system according to any one of claims 1-6. further,
A separate infusion pump for injecting another drug other than the drug for the myocardial analysis test toward the patient is also provided.
The chemical|medical solution injection system as described in any one of Claims 1-9.