WO2016084940A1 - Drug solution injection device - Google Patents

Abstract

This system is provided with an infusion pump (410) and a drug solution injection device (100), the infusion pump having a piston driving mechanism (430) for moving a piston member of a syringe (200V) filled with a drug solution for cardiac muscle analysis testing, and the drug solution injection device having: an injection head (11) having at least a piston driving mechanism (130) for moving a piston member of a syringe (200C) filled with a contrast medium; a display (151); and a control unit (155). The control unit (155) is configured so that a setting screen image (GUI) for setting an injection protocol including an injection operation condition for the injection head and an injection operation condition for the infusion pump is displayed in the display (151).

Description

Chemical injection device

The present invention relates to a drug solution injection system that injects at least a contrast medium as a drug solution into a patient, and more particularly to a drug solution injection system that injects a vasodilator and a contrast medium into a patient for a myocardial analysis test, for example.

Currently, CT (Computed Tomography) devices, MRI (Magnetic Resonance Imaging) devices, PET (Positron Emission Tomography) devices, ultrasonic diagnostic devices, angiographic imaging devices, etc. are known as medical diagnostic imaging devices. ing. When using such an imaging apparatus, a patient may be injected with a contrast medium, physiological saline, or the like (hereinafter collectively referred to simply as “medical solution”).

Currently, in order to examine heart diseases such as myocardial ischemia, a vasodilator that imparts a load on the myocardium is injected into a patient as a drug solution, and fluoroscopic images of the heart and its surroundings are sometimes taken. In this case, for example, there is a method in which a vasodilator is first injected and then a contrast agent is also injected. In this examination, a heart cross-sectional image in a loaded state is taken by performing a scan in a state where the effect of the injected drug solution is exhibited. Subsequently, a neutralizing agent is injected as necessary, and a fluoroscopic image in a resting state in which no load is applied to the myocardium is imaged and imaged. And myocardial ischemia evaluation is performed based on the heart cross-sectional images of both states obtained in this way. There is also a method of imaging a load state after first imaging a resting state. In that case, of course, it is not necessary to inject the neutralizing agent after imaging the resting state to imaging the load state.

Patent Document 1 discloses an MRI chemical injection system that can inject a vasodilator and a contrast medium. In the technique of this document, a myocardial analysis test can be performed using an MRI apparatus.

Japanese Patent No. 4623943

By the way, when performing a myocardial analysis test, since there is no problem of patient exposure with an MRI apparatus, imaging can be continued for a certain period of time after administration of a drug solution to the patient (in other words, for a relatively long time). Dynamic imaging). On the other hand, generally in the case of a CT apparatus, it is not preferable to perform imaging for a long time from the viewpoint of exposure. In addition, in order to image an object that moves intermittently such as the heart, it is necessary to perform high-speed imaging (for example, imaging at the timing of the diastole or systole of 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 myocardial analysis can be performed with a CT device, an MR device or SPECT device (a device for performing a nuclear medicine test (also referred to as RI: radioisotope test)) that detects radiation from a radiopharmaceutical administered to a patient There is an advantage that it can be carried out easily even in a facility not equipped with A myocardial analysis test using such a CT apparatus 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 amount and speed at an appropriate timing.

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 example, for a myocardial ischemia examination. It is to provide a system that can. In addition, this application discloses other inventions other than the above-mentioned objects.

The 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 medicine for myocardial analysis test,
The chemical injection device is
An injection head having at least a piston drive mechanism for moving a piston member of a syringe filled with a contrast agent;
Display,
A control unit,
The control unit is connected to the display.
It is configured to display a setting screen for setting an injection protocol including an injection operation condition of the injection head and an injection operation condition of the infusion pump.
Chemical injection system.

The “infusion operation conditions of the infusion pump” may include information such as (i) the infusion rate of the medicinal solution, the infusion amount, the infusion time, and the infusion time (part or all). Alternatively, (ii) it may simply include information on the timing of the operation start and / or operation end on the infusion pump side.

(Explanation of terms)
(I. General description of the chemical injection device)
In one embodiment, 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 constituting 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 include a piston drive mechanism, and the console may include a control unit and a display. And a console may be provided on both the console and (iii) a display may be provided on both the injection head and the console. Such a control unit (control unit) may be provided as a part of the imaging apparatus, for example.

The “injection head” basically includes one or more syringe holders that hold a syringe, one or more piston drive mechanisms that move the piston of the syringe forward and / or backward, and a control circuit (control). Part). As a mounting method of the syringe, mainly, (i) the syringe holding portion is an example, a so-called side loading type in which the syringe is set as a concave portion on the upper surface of the head, and (ii) the syringe holding portion is the head. There is a so-called front loading type in which the front end portion of the syringe is held on the front surface. One form of the present invention includes any type of injection head. In addition to the one that sends out the chemical solution from the inside of the syringe, for example, a device that sends out the chemical solution by pushing out the chemical solution from a predetermined storage body can be included in the “injection head” of the present application.

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

An “infusion pump” is an example, like an injection head, one or more syringe holders that hold a syringe, one or more piston drive mechanisms that advance and / or retract a piston of the syringe, and control Circuit (control unit).

The chemical injection device or injection head may have one or more of the following:
-One or more pressure sensors,
-One or more syringe detection sensors (eg magnet sensors, hall sensors, optical sensors, contact sensors, physical switches, etc.),
-One 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 according to the rotation switches between light blocking / non-blocking states, thereby generating a pulse signal and using it to perform position measurement Counter that can)
-One or more motor current detectors, etc.

In addition, the infusion pump may be equipped with the above parts or elements.

-Pressure sensor: A pressure sensor is for detecting the pressure which pushes a piston member, for example, and can obtain | require the pressure estimated value of a chemical | medical solution by this. The pressure sensor may be a load cell, for example. The load cell should just be provided in the position which can detect the pressure which the ram member of a piston drive mechanism pushes a piston member. For example, when calculating the estimated value of the pressure of the chemical solution when injecting the chemical solution using the detection result of the load cell, the calculation is performed by calculating the resistance of the injection circuit (eg, the size of the needle), the concentration of the chemical solution, the injection It may be performed in consideration of conditions. In another aspect, a pressure sensor that directly detects the pressure of the chemical solution may be included. In yet another aspect, for example, a switch that is turned on / off with a predetermined pressing force is used. For example, it is determined that a certain pressure is reached when the switch is pressed with a predetermined pressing force. Such a method can also be adopted.

• Syringe detection sensor: The syringe detection sensor detects whether a syringe, adapter, and / or protective case is attached, or what type of syringe, adapter, and / or protective case is attached. It is used for judgment. Such a sensor may be either a contact type or a non-contact type, and for example, the following can be used: a contact sensor using physical contact, an electric for electrically detecting an object. Sensor, magnetic sensor, Hall sensor, optical sensor, proximity sensor, etc.

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

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

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

The chemical injection device or injection head may further have 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.

In addition, the infusion pump may be equipped with the above parts or elements.

Display: A display for displaying predetermined information may be provided in the injection head. The display may be provided, for example, in a part of the casing of the injection head. Alternatively, a sub display prepared separately from the housing may be used. 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 the display are not particularly limited, but may be as follows: a predetermined state display during the injecting operation, conditions for injecting the liquid to be injected, conditions for injecting the liquid to be injected, liquid chemicals to be injected Injection volume, chemical pressure, injection speed, etc.

For example, a predetermined light emitting unit for notifying a doctor or medical staff of a predetermined state of the injection head may be provided in a part of the casing of the injection head. For example, an LED (Light Emitting Diode) can be used as the light source. Such a light emitting unit has a function as a head status display unit, and can notify the doctor or medical staff of various situations of the injection head by changing the light emission color or the light emission pattern.

Physical button: The physical button is not particularly limited, but may be as follows. Advance button for advancing the ram member, Retreat button for retracting the ram member, Accelerator button for increasing the moving speed of the ram member by pressing simultaneously with the advance button or the retract button, and a stop for stopping the head operation Buttons etc. These physical buttons can be appropriately arranged on the upper surface, side surface, lower surface, rear end surface and the like of the casing 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 data carrier means such as an IC tag is attached to the syringe, adapter, or protective cover, a wireless communication device that reads information on 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 (i) a syringe, for example, the manufacturer, the type of the chemical solution, the product number, and the contained components (especially the chemical solution is a contrast medium). In this case, it may be one or a plurality of pieces of information selected from an iodine-containing 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 product number, an allowable pressure value, a syringe capacity, a piston stroke, dimensions of necessary parts, a lot number, and the like regarding the syringe. (Ii) In the case of a chemical solution storage container such as a chemical solution bag, for example, the manufacturer, the type of the chemical solution, the product number, and the contained components (especially if the chemical solution is a contrast agent, the iodine-containing concentration, etc.) It may be one or a plurality of pieces of information selected from a filling amount, a lot number, an expiration date, and the like. “Data carrier means” refers to a medium capable of storing predetermined data. Specifically, a barcode (one-dimensional barcode, two-dimensional barcode) or an RFID tag (in this specification, an IC tag). Say). Preferably, 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 wireless. For example, the data receiver may receive the following data from the outside: arbitrary data generated by the imaging device, arbitrary data generated by the hospital system, and the like.

Data transmitter: The data transmitter is for sending predetermined data from the injection head or the like to the outside by wire or wireless. As a communication protocol for the data receiver and the data transmitter, a suitable protocol may be adopted in consideration of a communication system with another device which is a communication partner. Note that a data transmitter or the like that communicates with an external device may be provided in a 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 contrast agent used (contrast agent identification information), the total injection amount of the contrast agent Contrast agent injection time, contrast agent injection pressure, contrast agent injection speed, 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 console may be provided with a communication unit for communicating with external devices. The piston drive mechanism may be configured to control the operation 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. Such an infusion pump may be equipped with such a communication part.

Note that the above-mentioned receiver and / or transmitter are provided in the console or other equipment (which constitutes a part of the chemical injection device), and the console and the like are external equipment (for example, on an imaging device or a network). The predetermined server or the like) may be configured to be able to transmit and receive data.

Abnormality detection: It is preferable that one or a plurality of injection abnormalities can be detected using the various sensors as described above.
-Injection failure due to malfunction of piston drive mechanism,
-Injection abnormalities due to the syringe not being properly mounted on the injection head,
-Abnormal injection due to insufficient chemicals remaining in the syringe.
-Abnormal injection due to the catheter or needle not being properly inserted into the patient,
-Abnormal injection due to kinks in the middle of the chemical route,
-An injection abnormality such that the pressure value of the detected chemical is not within a predetermined range (a predetermined range having an upper limit and a lower limit, or a predetermined upper limit, a predetermined lower limit, etc.), etc.

-When the chemical solution is injected, for example, when the chemical solution path is clogged, the driving force of the piston drive mechanism exceeds the predetermined range. On the other hand, when the injection needle is removed from the patient, the driving force falls below a predetermined range. By seeing such a change in driving force, it is possible to detect whether or not the chemical solution is normally injected.
-When the sensor detects that a predetermined amount of chemical solution is not normally loaded, the detection result may be transmitted from the communication unit to the outside.
-In addition, for example, a pressure sensor for measuring pressure may be provided in the middle of the extension tube to detect whether the chemical solution is injected at a predetermined pressure.

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

The “medical solution” refers to, for example, a contrast agent, physiological saline, a mixture thereof, or other solution (for example, a vasodilator, a beta blocker, etc.).
Specific examples of the “contrast agent” include a contrast agent having an iodine concentration of 240 mg / ml (for example, a viscosity of 3.3 Pa · s and a specific gravity of 1.268 to 1.296 at 37 ° C.), a contrast agent having an iodine concentration of 300 mg / ml ( For example, a contrast agent having a viscosity of 6.1 mPa · s and a specific gravity of 1.335 to 1.371 at 37 ° C. and an iodine concentration of 350 mg / ml (for example, a viscosity of 10.6 mPa · s at 37 ° C. and a specific gravity of 1.392 to 1.37). 433). In addition to iodine systems, gadolinium-based contrast agents used in MRI examinations may be used.
As a specific example of the physiological saline of “physiological saline”, a physiological saline containing 180 mg of sodium chloride in 20 mL of physiological saline (for example, a viscosity of 0.9595 mPa · s at 20 ° C., a specific gravity of 1.004 to 1.04). 006) and the like.

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

“Real-time” relates to real-time processing by a computer, and does not necessarily have to be simultaneous, and may include a slight delay caused by computer processing or the like.

The “module” means not only a tangible element but also an element of a computer program that performs a predetermined function, for example.
“Computer” is not limited to an integrated circuit commonly referred to as a computer, but includes a wide range of processors, microcontrollers, microcomputers, programmable logic controllers, application specific integrated circuits, and other programmable circuits. Shall point to. A desktop computer, a laptop computer, a tablet computer, or the like is included. In other words, the “computer” may be hardware that can read a computer program and execute a corresponding processing operation. For example, a CPU (Central Processing Unit) is mainly used as a ROM ( It is hardware to which various devices such as a read only memory (RAM), a random access memory (RAM), and an interface (I / F) unit are connected.

The various means referred to in the present invention need only be formed so as to realize the function. For example, dedicated hardware that exhibits a predetermined function, a data processing apparatus provided with a predetermined function by a computer program A predetermined function realized in the data processing apparatus by a computer program, a combination thereof, or the like may be used.

In addition, the various means referred to in the present invention do not have to be independent of each other, a plurality of means are formed as one device, and a certain means is a part of other means. It is also possible that a part of the means overlaps with a part of the other means.

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. For example, a memory and an HDD (Hard Disc Drive) fixed to the computer. ), CD (Compact Disc) -ROM and FD, a non-volatile memory card (flash memory), and the like that can be exchanged into a computer.

“Connection” —In this specification, when a given device is said to be connected to another device, it may be either wired or wireless. In addition, a configuration in which one-way or two-way connection is made so that other devices can be controlled can also be expressed as “operably connected / linked”.
“Electrically connected” means that components are connected so that electrical signals can be transmitted in one direction or in both directions, and may be in either a wired connection or a wireless connection. . In addition to the components directly connected to each other, the case where the components are indirectly connected via other elements is also included.

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

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

The “computer program” may be a program that reads a storage medium storing the program using a predetermined device, device, mechanism, or the like, and operates the computer with a predetermined function. In this case, the storage medium storing the computer program constitutes one aspect of the present invention. Further, the computer program may be provided via a communication network (in the example, the Internet). The computer program may be a so-called differential program that can be realized in combination with a program already recorded in the computer.

“Input device / input device” (input means for a computer system) includes a keyboard, a mouse, a touch panel, a trackball, a physical switch operated manually or by a machine, a microphone, a voice input, a graphical user interface, etc. There may be. The movement of a doctor or medical staff may be recognized (non-contact in one example) and a predetermined input corresponding to the movement may be recognized.

“Part (can also be expressed as“ element ”or“ module ”or the like”) ”— in this specification, for example,“ (function name) ”+“ part ”can be realized as a function of a computer. . Such “parts (elements), modules, etc.” may be provided in any device in the system. In addition, it is not always necessary to have one device, and the corresponding function may be distributed to two or more devices. Furthermore, 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 “parts (elements), modules, etc.” may be various functions logically possessed by the computer.

“Means” and “units” operate, for example, hardware including a CPU (Central Processing Unit), a ROM (Read Only Memory), a RAM (Random Access Memory), an I / F (Interface) unit, and the like. For example, it may be configured by one or a plurality of software and sensors. They may be dedicated mechanisms, may also serve as other means, and may be a logical configuration on a computer system. Those 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, a visual operation by touching an icon, image button, pull-down menu, or numeric input window on the screen with a cursor or in the case of a touch panel. An interface that can be used.

“Icon” means that (i) predetermined information is displayed and can be selected by the operator, and (ii) only predetermined information is displayed and can be selected. It may include both those that are not. All or some of the icons displayed on the screen can be selected by touching each display location with a touch pen, an operator's finger, or the like, or by a cursor on the screen.

(Basic concept of injection protocol setting)
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 agent can be calculated by a calculation formula using the patient's body weight (kg), a predetermined proportionality coefficient, and the like as parameters. This proportionality factor can be determined based on the amount of iodine required per kg patient body weight (mgI / kg) and the iodine concentration of the contrast agent (mgI / ml). For example, when the patient's weight is W (kg), the required iodine amount is I (mgI / kg), and the iodine concentration is C (mgI / ml), the contrast medium injection amount is
Formula: contrast medium injection amount (ml) = W (kg) × I (mg I / kg) / C (mg I / ml)
It can be calculated with Or, when the amount of iodine required per unit weight and unit time is I ′ (mg I / kg / sec) and the injection time of the contrast agent is T (sec),
Formula: contrast medium injection amount (ml) = W (kg) × (I ′ (mg I / kg / sec) / C (mg I / ml)) × T (sec)
It is also possible to calculate the injection amount of contrast medium.

In order to calculate the injection amount of the contrast medium in the main injection, in one example, the patient's weight, the required iodine amount, and the iodine concentration are input, and using these input data, the computer performs the contrast in the main injection. The injection amount of the agent may be calculated. Some of these pieces of information may be manually input by, for example, a doctor or a medical staff, read from an IC tag of a syringe, or information in an external server (for example, a hospital system) Electronic medical records, etc.).

(II. Imaging device)
The imaging apparatus may be, for example, an X-ray CT apparatus or the like. 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 collecting unit for collecting fluoroscopic imaging data, a main controller for controlling 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 predetermined information.

Various communication protocols between devices such as between the imaging device and the chemical injection device, between the other devices of the imaging device, and between the chemical injection device and other devices can be used. For example, CANopen, Protocols such as HL7 and DICOM are listed.

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

1 is a diagram schematically showing a system according to an embodiment of the present invention. It is a typical block diagram of the system of this invention. It is an example of the block diagram of the control part of a console. It is an example of a hospital system. It is a perspective view which shows an injection | pouring head and the syringe etc. with which it is mounted | worn. It is a perspective view which shows an injection | pouring 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. 2 is an example of a graphical user interface of the system of the present invention. 2 is an example of a graphical user interface of the system of the present invention. It is an example of the graphical image of the system of this invention. It is an example of the graphical image of the system of this 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 the present 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, reverse, and injection | pouring. 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. In the following description, the description is basically based on one specific form shown in the drawings, but the specific form of each component is not limited to a specific one.

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

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

In the following description, the syringes 200C and 200S may be simply referred to as “syringe 200” without being distinguished. An “injection head” is also called an injector or an injection head.

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

Since the infusion pump has several functionally common configurations with the injection head, for the convenience of explanation, 1. Although described in (2), it should be noted that the device is different from the chemical solution injection device.

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

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

Note that the syringe may be a prefilled type that is pre-filled with a chemical solution, or a suction type that sucks and uses a chemical solution in an empty syringe. The “piston member” is not necessarily limited to a long rod as illustrated, but may be a so-called rodless type (also simply referred to as a “plunger” or the like). This also applies to a syringe set in an infusion pump described later.

(tube)
An extension tube (extension tube) 230 is connected to the conduit portion 221 b of each syringe 200. The extension tube 230 may be a so-called T-shaped tube or Y-shaped tube. As shown in FIG. 4, the tube 231a extending from the conduit portion 221b of one syringe 200C to the branch portion and the conduit portion of the other syringe 200S. You may have the tube 231b extended from 221b to a branch part, and the tube 231c extended toward a patient from a branch part. For example, an injection needle is connected to the distal end side (not shown) of the tube 231c. This injection needle is punctured into a patient's blood vessel, and the chemical solution is injected into the blood vessel by pushing out the chemical solution in the syringe 200C and / or syringe 200S.

A tube called a spiral tube may be used so that the contrast agent and physiological saline can be mixed well when the contrast agent and physiological saline are simultaneously injected (for example, mixing manufactured by Nemoto Kyorindo Co., Ltd.). Tube, “SPIRAL FLOW” tube (registered trademark), etc.). In this spiral tube, a connector (not shown) for generating a swirling flow is provided at a junction between the contrast agent and physiological saline.

(IC tag)
An IC tag 225 may be attached to a part of the syringe. The IC tag 225 includes information on the syringe (syringe identification information, syringe pressure resistance, cylinder member inner diameter, piston member stroke, etc.), information on the chemical solution filled in the syringe (name (for example, product name), Component information such as iodine amount or gadolinium amount, expiry date, chemical solution 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 a syringe size, a syringe serial number, and a drug standardization code. The position where the IC tag 225 is attached may be, for example, the outer peripheral surface of the cylinder member 221. Specifically, the IC tag 225 may be near the cylinder flange on the outer peripheral surface.

(Head structure)
Referring again to FIG. 4, the injection head 110 has a housing that extends long in the front-rear direction as an example, and two concave portions on which the syringes 200 </ b> C and 200 </ b> S are placed on the top end side of the housing, respectively. 120a is formed. The recessed part 120a is a part that functions as a syringe holding part. 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 flange 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 a specific one, and may be anything.

(Internal structure)
The injection head 110 also has a piston drive mechanism 130 that pushes the piston member 222 of the syringe 200 as shown in FIGS. 2A and 4. Two systems of piston drive mechanisms 130 are provided, and each mechanism 130 operates independently. The piston drive mechanism 130 may retract the piston member 222, for example, for sucking the chemical liquid into the syringe. The two piston drive mechanisms 130 may be driven simultaneously, or may be driven 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 rotation output of the drive motor into a linear motion, and the piston member 222 moves forward and forward. It may have a syringe presser (ram member) 133 to be retracted. As such a piston drive mechanism, a known mechanism generally used in a chemical liquid injector can be used. An actuator other than the motor may be used as the drive source.

Typical operation of the piston drive mechanism includes the following: chemical injection (ram member advance) and chemical suction (ram member reverse). In “chemical solution injection”, a chemical solution is injected in accordance with a set injection protocol (injection condition) by operating the motor in accordance with a predetermined motor control signal and moving the ram member forward. In “chemical solution suction”, a chemical solution is sucked into a syringe by operating a motor in accordance with a predetermined control signal to retract a piston member. In the case of a prefilled syringe, the chemical liquid suction need not be performed.

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

When the IC tag 225 is attached to the syringe, 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. Also good. This reader / writer may be provided in the recess 120a in which the syringe 200 is mounted. Note that the reader / writer may have only a function of reading information from the IC tag 225.

The injection head 110 may have a control circuit 145 for controlling the operation of the piston drive mechanism 130 and the like. The control unit 155 can be configured as a control circuit having a processor, a memory, and the like.

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 top and side surfaces of the casing of the injection head 110. For example, some of these physical buttons may be configured to emit light in order to notify the operator of predetermined information.

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

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

As the vasodilator, an ATP preparation of adenosine triphosphate (ATP) can be used. The syringe 200V may have a general configuration including a cylinder member 211 and a piston member 222 (see FIG. 5B) slidably inserted therein. In addition, when using this apparatus for uses other than a myocardial analysis test | inspection, naturally other chemical | medical solutions may be filled into a syringe and you may mount | wear with an 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 the output from the motor into linear motion and transmits it, and a presser member 433 that moves forward and backward. Have. Other actuators may be used as a drive source instead of the motor.

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

In one form, it is preferable that the infusion pump 410 also has a load cell 438 for detecting a 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 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 containing a motor, a circuit board, and the like, and a syringe holding part 420a is formed in a part thereof.

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

An operation unit 440 in which a plurality of physical buttons for switching the operation of the infusion pump 410 may be provided in a part of the housing 411 (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 being pressed.
-Retreat button (443b): A button for retracting the presser member. For example, the presser member is retracted only while 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 on / off the power.
-Injection start button (449): A button for starting automatic injection. The power button may also be used.
-Injection speed switching button (441): A button for switching the injection speed.

As a specific form, each time the injection speed switching button 441 is pressed, the low speed, medium speed, and high speed as described above may be switched in a loop shape in order or in reverse order. Not only three stages but also two-stage speed switching may be used, and a structure in which four or more stages of speed switching are performed may be used.

Although detailed illustration is omitted, the infusion pump 410 may have one or a plurality of display units (not shown). For example, you may comprise as what has a liquid crystal display (LCD) etc., and you may comprise as what has an illumination device (LED) etc. Such a display unit may be configured to display, for example, one or a plurality of information such as the speed during the injection of the vasodilator, the remaining amount, the injection amount, and the pressure. The display part comprised as a 7-segment LED character display part may be sufficient.

In this 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 a stand (the syringe side is directed downward during injection, and the syringe side is directed upward during an air bleeding operation or the like. And can be held in). On the other hand, the infusion pump 410 can also be freely rotated by a holding member 183 that is a part of the stand (the syringe side can be directed downward at the time of injection, and the syringe side can be directed upward at the time of air bleeding operation or the like. As configured). The above rotation may be a rotation around a horizontal axis as an example.

In addition, as means for holding the injection head 110 and the infusion pump 410, for example, a ceiling-suspended arm may be used. 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 naturally a DC power source such as a battery may be used. In still another aspect, the infusion pump 410 may be supplied with power from the chemical solution injection device 100 (which may be either the injection head 110 or the console 150). In this case, the AC cord 495b and the power supply circuit 495a may be omitted. In the case of passing through the injection head 110, for example, power may be supplied via the power supply line 197a shown by a broken line in FIG. 2A, and in the case of passing through the console 150, power may be supplied 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 include 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 either wired or wireless.

As an aspect in which communication is possible, for example, the infusion pump may be electrically connected so as to exchange predetermined signals, information, data, and the like with the injection head. The exchanged signal, information, data, etc. may relate to infusion start, infusion stop, and / or infusion end of the infusion pump. Further, it may relate to injection start, injection stop, and / or injection end of the injection head.

Also, the infusion pump may be electrically connected so as to exchange predetermined signals, information, data, etc. directly with the imaging device.

Referring to FIG. 2A again, the control circuit 455 may be configured to be electrically connected to the load cell 438 and to calculate the current injection pressure of the chemical liquid using the detection result. 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 pressure reaches the reference value. It is determined whether or not it has been. And when the determination is Yes, it is configured to perform one or a plurality of operations such as issuing an alarm, stopping the injection operation stop, and recording the fact in the injection history. It is also preferable.

This makes it possible to detect an injection abnormality not only with an injection head but also with an infusion pump, so that a safer inspection can be performed. The “pressure limit” may be any value as long as it is suitable for the syringe to be used. It may be input by a doctor or a medical staff, or may be automatically set from a database 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. In addition, the control circuit 455 may be configured to send a signal indicating that various physical buttons (see FIG. 5C) have been pressed to the control unit 155 on the console side. Based on the signal, the control unit 155 may be configured to perform an operation such as starting or stopping the operation of another device or displaying a warning, for example.

The control circuit 455 may also have a so-called self-check function. That is, whether a load cell or the like functions normally when there is a predetermined input from a doctor or medical staff (by pressing a predetermined physical button once in one example) or when the power is turned on. The check program (for example, it may be confirmed whether or not the resistance value of the load cell is within a predetermined reference value) is executed. When it is determined that the load cell or the like has a failure as a result of the self-check, 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. Self-checks other than for load cells will be described separately in other embodiments.

Of course, 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 console control unit 155 may be configured to cause the infusion pump to perform a self-check.

(3) Console The console 150 may be placed and used in an operation room adjacent to an examination room such as a CT imaging room. The console 150 has a part or all of a display 151 that displays a predetermined image, a touch panel 153, a control unit 155, one or a plurality of physical buttons 157, and a storage unit 159 such as a memory or a hard disk. is doing.

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

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

As an example of the present invention, the console integrally includes a control unit, a display, a touch panel, a physical button, a module that communicates with an injection head, a module that communicates with an imaging device, and the like. Is. However, in another embodiment of the present invention, such an integral configuration is not an essential matter, and the control unit, the display, and the like as described above may be configured as separate devices. Please keep in mind.

(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 trigger for the operation timing may be either a console or an imaging device. A predetermined operation of the imaging apparatus may be started or stopped according to a predetermined trigger generated by the console 150 or the like. Conversely, a predetermined operation on the chemical injection device 100 side may be started or stopped in accordance with 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 in accordance with the injection protocol set on the console side. 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 in accordance with the injection protocol set on the console side. For example, the detection value of the load cell 438 may be transmitted from the injection head side to the console side.

Note that 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 electrical signal is simply given from one to the other. For example, an electrical signal that triggers the start, stop, or both of the operation of the infusion pump may be sent from the chemical infusion device side. As an example of such connection, a part of the chemical liquid 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. As an example, as shown in FIG.
-Setting screen display section 155a,
-Injection protocol creation unit 155b,
An injection controller 155c,
A 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 an injection protocol, specifically, a GUI (graphical user interface) for setting an injection protocol on the display 151. The GUI data for setting the injection protocol may be stored in any storage device of the liquid injector, the imaging device, 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 of the display 151 by a doctor or a medical worker, and creating an injection protocol reflecting the contents. The protocol creation unit 155b, for example, based on at least one input selected from the type of the chemical solution, the injection rate of the chemical solution, the injection amount of the chemical solution, the patient's physical information, the body classification of the patient to be imaged, and the imaging site, Correspondingly, a predetermined parameter of the injection protocol is created or changed.

The injection control unit 155c may correspond to a 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. 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 a function of generating injection history data. As "injection history data", for example,
An injection work ID which is unique identification information for each injection work;
-Date and time of infusion start and end,
-Identification information of chemical injection device,
-Injection conditions of contrast medium and / or saline,
-Identification information of chemicals and imaging parts,
-Data on the vasodilator used (ATP formulation),
-Vasodilator injection conditions (infusion rate, amount, time, etc.), etc.
-Information on the combination of vasodilator and contrast agent used,
It may be at least one of the following.

These may be text data. Further, image data of a time-dependent graph in which one of the horizontal axis and the vertical axis is the elapsed time and the other is the injection rate may be used. Alternatively, one of the horizontal axis and the vertical axis may be image data of an elapsed time and the other is an injection pressure over time graph. The injection history data may be information on a medical solution obtained from an IC tag of a syringe, manually input by a doctor or medical worker, or input from an external network or the like, or information on a syringe.

The history output unit 155e may correspond to a function of transmitting injection history data to the outside. Specifically, data may be transmitted to a predetermined external device and / or a database on a network.

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

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

As shown in FIG. 2A, the chemical injection device of this embodiment has a power supply unit including an AC cord 195b and a power supply circuit 195a. In this example, the AC power source provided in the console 150 is illustrated, but naturally a DC power source such as a battery may be used.

2. Imaging Apparatus The imaging apparatus 1100 is, for example, an X-ray CT apparatus, an MRI apparatus, a PET (Positron Emission Tomography) apparatus, an ultrasonic diagnostic apparatus, an angiographic imaging apparatus, 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 1103 a (see FIG. 2A) that controls the operations of the imaging unit 1103 b and the bed 1103 in the gantry. ).

Although detailed illustration is omitted, the imaging device 1100 includes a data collection unit that collects fluoroscopic imaging data. Since the imaging device 1100 itself can use a conventionally known one, only main components will be described below. Hereinafter, a CT apparatus will be described as an example.

The gantry 1101 has a central opening through which a patient can pass, and a patient lying on the bed 1103 can move in the lateral direction inside the gantry 1101. An gantry 1101 includes an X-ray tube, a collimator, and the like, and an X-ray irradiation unit (not shown) that irradiates the patient with X-rays, and a detection unit (not shown) that detects X-rays transmitted through the patient. ) Etc. are arranged. The X-ray irradiation unit and the detection unit constitute the imaging unit 1103b, and perform scanning while rotating around the patient's body axis while maintaining their positional relationship. Data from this scan is acquired by a data collection unit (not shown), and fluoroscopic imaging data (projection data) is collected.

It should be noted that the CT apparatus may be of any type as long as it can obtain a transmission image by irradiating the patient with X-rays from a predetermined direction. In one example, for example, a multi-slice CT apparatus that can obtain cross-sectional images in three directions of a patient may be used.

Since the present invention is intended for examination of myocardial analysis, it is also preferable that the imaging apparatus be capable of examining myocardial blood flow dynamics using an X-ray CT apparatus. Examination of myocardial blood flow (perfusion) using an X-ray CT apparatus is performed as follows in one 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 a myocardial perfusion image is taken as a part of a contrast examination of the heart, not a single examination. For example, in the case of capturing a myocardial perfusion image, a scan for cardiac function analysis such as coronary artery and heart lumen wall motion may be performed separately from the scan of the myocardial perfusion image. Attempts have also been made to create a myocardial perfusion image in a shorter time while further reducing the amount of contrast medium injected into the patient and exposure by X-rays. That is, a technique for acquiring blood flow information from information such as coronary angiography CT image data and myocardial contrast CT image data obtained by a scan for acquiring myocardial images without adding a scan for acquiring blood flow information It is.

The imaging device is connected to an electrocardiograph 1150 (ECG, see FIG. 2A) so that ECG-synchronized imaging can be performed, and trigger information is obtained in synchronization with the acquired ECG data (that is, from the data). A) configured to perform imaging.

3. Hospital System As shown in FIG. 3, for example, the hospital system includes an imaging device, a chemical solution injection device, a medical record management device HIS, an imaging management device RIS, a data storage device PACS, and an image browsing device. A viewer, printer, etc. are provided. It is not always necessary to have all of these.

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

In the medical record data, the patient's weight, sex, age, etc. may be registered as personal condition data related to the whole 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 record acquired from the 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 above electronic medical record,
-Identification information of the CT device,
-Date and time of image capture start and end,
-Body segment or imaging site,
-Appropriate types consisting of types of chemicals such as contrast media for imaging work,
-It may include data such as a proper ID composed of a chemical ID suitable for the imaging operation.

(PACS)
The PACS receives and stores fluoroscopic image data to which imaging order data is added from the imaging device.

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

4). Operation (1) Protocol Setting Stage The chemical liquid injector according to the present embodiment operates as follows as an example. First, “setting of injection protocol” will be described, and then the operation of injection will be described.

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

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

As the “icon indicating that it is a myocardial analysis test”, for example, when a body classification icon is selected, it may be displayed as a lower item (imaging site). Regardless of whether the body classification icon is selected, the icon displayed on the screen before the selection may be used. The “icon” may be selected with a mouse or a trackball cursor, in addition to being selected by touching on the screen. The console 150 may be configured to recognize and display the injection protocol window 610 by pressing a physical button or switch provided on the injection head, console, or other device instead of the icon. Good. As another form, an icon for myocardial analysis examination is displayed as one of the body classification icons (head, chest, abdomen, etc.), and the injection protocol window 610 is displayed by selecting this icon. It may be.

This injection protocol window 610 is
(I) vasodilator injection condition data;
(Ii) Contrast medium injection condition data;
(Iii) dilution contrast agent injection condition data;
(Iv) physiological saline infusion condition data;
Is graphically displayed in the form of a graph.

(VD condition box)
The vasodilator injection 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. Although the display of the condition box 611 can be changed as appropriate, it may include, for example, characters “VD” indicating a vasodilator.

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

In order to realize relatively slow injection 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) The operation of the piston drive mechanism 430 of the pump 410 is controlled. For example, the motor 431 may be rotated at a constant speed.

When setting the injection protocol, when an operator touches the condition box 611 of “VD”, one or more of parameters such as “injection volume”, “injection time”, and “injection speed” can be arbitrarily modified and changed. It is also preferable that it is configured. It is good also as a structure which selects a box with a cursor etc. instead of a touch panel type.

(Contrast agent start delay time display box)
The delay time display box 613 is a box for setting a 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 passed. In other words, the contrast agent injection is started 30 seconds before the end of the vasodilator injection. In this example, a character indicating “30” seconds is displayed in the box 613. This may be displayed as a default value.

It is assumed that the timing for injecting contrast medium will vary depending on the patient and the drug used. Therefore, it is also preferable that the time display box 613 is touched by the condition so that the time can be arbitrarily modified and changed.

FIG. 7 shows an example of how the delay time is changed. In this way, when a box to be changed is touched, for example, a numeric keypad screen 621 is displayed, and a desired numerical value can be set using the numeric keypad. You may be comprised so that it can input. In this figure, the state of changing the delay time is illustrated, but the same numeric keypad is used when changing the aforementioned vasodilator injection conditions and / or when changing the injection conditions of a contrast agent or the like described later. The screen 621 may be changed.

(Contrast medium and saline injection condition box)
Next, in the injection protocol of this embodiment, injection of contrast medium, simultaneous injection of contrast medium and physiological saline, and boost injection of physiological saline are performed. The injection protocol window 610 includes these three phases as injection condition boxes 615, 616, and 617, respectively.

The second phase of this injection protocol is the injection of contrast agent. In the injection condition box 615 of FIG. 6, for 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, since the contrast medium injection is started before the completion of the vasodilator, the contrast medium and the vasodilator are injected simultaneously for 30 seconds (one example).

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

The dilution ratio “50:50” is merely 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 ratio, a predetermined graphical user interface is displayed. By operating this icon, for example, the user can change from “50:50” to another dilution ratio. It is also preferable.

This injection is carried out following the injection of the contrast medium (without holding time etc.).

The third phase of this injection protocol is injection of saline only. The injection condition box 617 is an example, and the injection rate 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 following the above simultaneous injection (without holding time etc.).

Regarding the injection condition boxes 615, 616, and 617, when the operator touches the condition box, one or more of parameters such as “injection amount”, “injection time”, and “injection speed” can be arbitrarily modified and changed. It is preferable that it is comprised.

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 with a horizontal width corresponding to the injection time of each phase. The boxes 615, 616, and 617 are preferably displayed in different colors because they are easily visible. For example, a box 615 associated with a contrast agent may be a first color (eg, green) and a box 617 associated with saline may be a second color (eg, blue). Further, the box 616 related to the co-injection may be represented by an intermediate color between them, or a part of the box may be represented by the first color and the remaining part by the second color.

In the graph of the infusion protocol window 610, as described above, the horizontal axis is time, but the start point “0:00” of the elapsed time is the start time of vasodilator injection (that is, the start point of the first phase). 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, for example, it is also preferable that the scan start timing by the imaging device is displayed in the same screen. The “scan start timing” may be set as one information included in the injection protocol. That is, the chemical injection device 100 stores information on the scan start timing as an injection protocol, and after the injection starts, the chemical injection device 100 transmits a trigger signal to the imaging device 1100 at the scan start timing. Based on this, the imaging device 1100 may be configured to start imaging. Note that the imaging apparatus 1100 may perform electrocardiogram synchronous imaging with reference to a measurement result of an electrocardiograph.

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

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

First, in step S1 of the flow of FIG. 10, a doctor or a medical worker prepares a syringe to be used and attaches it to the injection head 110 and the infusion pump 410. And an extension tube is connected to each syringe 110,410. As shown in FIG. 2A, for example, contrast agent and saline are injected from the patient's right hand via extension tube 230, while vasodilator is injected from the patient's left hand via extension tube 235, but not limited thereto. Such a connection mode may be used.

If necessary, a route for injecting another drug may be provided. An example of this is a drug that lowers the heart rate. Specifically, it is a drug such as a beta blocker having an action of lowering the heart rate by selectively blocking the β1 receptor present in the heart. In addition, this may be injected through a route additionally connected to a part of the tube 230, for example. In addition, the injection is not performed using the apparatus, but a doctor or the like manually operates the syringe. It may be injected. The beta blocker injection path is, for example, provided with a stopcock (three-way stopcock in one example) for switching the injection path on the tube 230. With this stopcock, (i) a state in which a beta blocker can be injected, and (ii) ) It may be configured to be switchable between a state in which a contrast medium or the like can be injected.

Returning to the flow of FIG. 10, the injection protocol is set in step S2. In the infusion protocol setting (step S2), a doctor or a medical worker 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.

The system according to the present embodiment is configured such that a default injection protocol is presented when a predetermined icon or the like is selected via the display-like GUI of the console 150. Therefore, it is not necessary to input numerical values for the injection amount and injection speed of each phase (aside from the case where fine adjustment of numerical values is performed), and can be set very easily.

Even if it is necessary to make fine adjustments to the conditions of the proposed infusion protocol, the doctor or health care worker touches boxes 611, 613, 615-617 (see FIG. 6) to change the conditions. Changes can be made with an 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 finally confirm the set injection protocol. Therefore, it is possible to eliminate an artificial mistake such as setting an injection condition by mistake.

Next, in step S3, the doctor or medical worker inputs a predetermined injection start to the system. Specifically, it may be by pressing a physical button on the injection head, touching a predetermined icon on the console display, or a combination thereof. In step S4, using this input as a trigger, a series of injection operations according to the injection protocol set by the chemical injection device 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 injection device 100 may give an electrical signal as a trigger to the infusion pump 410, and the piston drive mechanism 430 may start automatic injection accordingly. The infusion conditions (infusion rate, infusion volume, or both of them) of the infusion pump 410 may be set by the console 150 or the like and sent to the infusion pump. May be. That is, it may be set in advance by, for example, pressing 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 a constant speed. Compared with the case of performing manual injection, safe injection can be performed under more appropriate conditions.

When it is 30 seconds before the injection of the vasodilator in the first phase ends (an example), the drug solution injector 100 then operates the piston drive mechanism 130 on the contrast medium side of the injection head 110 as the second phase. . Thereby, the contrast agent is injected from the syringe 200C at a predetermined rate. Whether or not it is 30 seconds before the end of the injection of the vasodilator (one example) is determined by, for example, the chemical injection device 100 based on information of a timer (elapsed time measurement unit) in the device. Also good.

Next, the chemical liquid injector 100 operates both piston drive mechanisms 130 of the injection head 110 as the third phase after the second phase is completed. Thereby, a contrast agent and physiological saline are pushed out simultaneously from syringe 200C and syringe 200S. These chemicals are merged and mixed in the middle of the extension tube 230 and injected as a diluted contrast agent.

Thereafter, after the third phase is completed, the chemical injection device 100 operates the physiological saline side piston drive mechanism 130 of the injection head 110 as the fourth phase. Thereby, the physiological saline is infused from the syringe 200S at a constant rate.

In the chemical 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 “status display” in step S5.

In this image, the state in which the medicine is injected from the syringe is displayed as a still image or as a moving image (as an animation). The amount of drug injected, the remaining amount, or both may be displayed as text as a numerical value. Further, the elapsed time from the injection, the remaining time, or both may be displayed as a numerical value as text. FIG. 8 shows an example in which “30” sec is displayed in real time as an elapsed time after the start of injection as an example. Alternatively, the remaining time until the start of contrast medium injection may be displayed. For example, a display such as “XX seconds until start of contrast medium injection” may appear. As one mode of display, blink display (flashing display) may be employed. Further, as an example, an alarm (message display, generation of sound or sound, etc. may be used) is generated at a predetermined time until the start of contrast medium injection. Good. Such a configuration has an advantage that a safe examination can be promoted by a doctor or a medical worker because it alerts an X-ray exposure in CT imaging or the like.

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

(CT imaging)
According to the set injection protocol, in this system, imaging is automatically performed in conjunction with the imaging device at a predetermined timing (step S6). That is, a signal serving as a trigger is transmitted from the chemical 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 chemical solution injection is terminated (step S7).

Thereafter, in step S8, the chemical solution injector 100 creates injection history data. As described above, the injection history data includes not only the injection volume, injection time, injection speed, injection time, etc. of contrast medium and physiological saline, but also the injection volume, 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”.

In step S9, save it. The data is stored in a storage area in any device belonging to the chemical injection device 100 or a database connected via a network or the like.

(Function and effect)
According to the system of the present embodiment configured as described above, the operation of the injection head (that is, injection of contrast medium and physiological saline) and the operation of the infusion pump (that is, injection of vasodilator) are set in advance. It can be executed automatically according to the protocol. Therefore, it is possible to inject vasodilators, contrast agents, physiological saline, etc. at the desired speed, amount, and timing, and the good effects of vasodilators on the function of the heart and good imaging results with contrast agents. Obtainable. In particular, if a predetermined amount or more of a vasodilator is injected, there is a risk that an excessive burden is applied to the heart. Therefore, a dedicated injection device (infusion solution) different from the injection device for contrast medium injection as in this embodiment is used. According to the configuration in which the injection is performed by the pump), the inspection can be made safer.

The first phase is a vasodilator injection phase, and the second phase (which may partially overlap) is set as a contrast agent injection phase. Accordingly, it is possible to obtain a contrast-enhanced fluoroscopic image while applying a load to the myocardium with the vasodilator, which is preferable for myocardial analysis.

Furthermore, according to the injection protocol of this embodiment, in which the third phase is a simultaneous injection phase of contrast medium and physiological saline, and the fourth phase is a physiological saline boosting phase, the left heart and the right heart of the heart Is a preferable protocol for myocardial analysis.

Regarding the setting of such an injection protocol including a plurality of phases, according to the system of the present embodiment, numerical values are not input for the injection speed and the injection time of each phase. A protocol setting GUI (610) is provided. In this GUI, a predetermined default value is presented as each phase. The doctor or medical staff may confirm the contents and correct the numerical values as necessary to make the final injection protocol. In particular, the conditions of each phase are displayed in boxes 611, 615, 616, 617, etc. and shown in the form of a graph, so that the contents can be checked and corrected very intuitively. Therefore, it is possible to greatly expect reduction of injection condition setting errors and the like.

In addition, since it is possible to visually recognize that the vasodilator is currently being injected from the graphical image as shown in FIG. 8, it is possible to check the injection status even at a console remote 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) FIG. 1 shows a configuration in which one two-cylinder injection head 110 and one one-cylinder infusion pump 410 are used, but a multi-cylinder in which three injection driving mechanisms are provided in one injection head. An infusion head of the formula may be used.
(A2) Further, 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-tube injection heads are used. It may be a thing.
(A3) Referring to FIG. 2A, the console control unit 155 and the display 151 are not necessarily configured integrally. If the arithmetic unit corresponding to the control unit 155 and a display for displaying a GUI or the like are provided as the chemical injection device 100 as a whole, for example, the operational effect as in the above embodiment in which an injection protocol can be easily set through the GUI. Is because it can be obtained similarly. The example in which the control unit 155 of the console gives an instruction to the infusion pump 410 to control its operation (at least the start of injection and the stop of injection) has been described, but as another form, the control unit 145 of the injection head 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 in FIG. 2A. In the figure, the two are directly connected to each other, but of course, they are indirectly connected with other circuits intervening as long as electrical signals can be exchanged or data can be transmitted or received. Also 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 console display. As an example of this, a head display provided integrally with the casing of the injection head or installed in the vicinity thereof may be used. The head display may or may not be a touch panel type.
(A5) Regarding the infusion pump, it is not necessarily limited to a vasodilator, and other drugs may be automatically injected.
(A6) Regarding the operation of the infusion pump, for example, the control circuit or the control unit of the console calculates the actual injection rate of the chemical solution, 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. It is also preferable that an error guidance is issued when the upper limit value is exceeded or below the upper limit value. With such a configuration, damage to blood vessels and occurrence of misdiagnosis can be prevented.
(A7) In order to inject another drug in addition to the vasodilator, a second infusion pump may be further provided in the system. This drug may be a beta blocker having an action such as lowering the heart rate. Also in this case, the technical matter of the pump described above as an example of an infusion pump for injecting a 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, it has 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 at a constant rate. Exemplified what is injected. However, in this intermediate phase, the so-called “cross injection” (or “trapezoidal cross injection”), in which the injection rate of the contrast agent decreases linearly and the injection rate of the saline increases linearly. Such injection conditions may be set.

5. Other embodiment (infusion pump)
The infusion pump which concerns on another form is demonstrated with reference to FIG. 11, FIG.

The infusion pump A410 in FIG. 12 is the same as that in the above embodiment in that it includes 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, the mode of the display unit for displaying various information, and the like are different.

In the following description, overlapping description of the parts common to the above-described embodiment will be omitted, and different parts will be mainly described. In addition, in FIGS. 11 to 14, an alphabetic character “A” is added at the beginning of the reference numeral, such as “A410”, but the numerals are the same as or corresponding to those in the embodiment described above. ing. For convenience of explanation, in the following, there may be a mixture of an alphabetic character such as “A430” and “430” and a designated one. However, the configuration and operation of the infusion pump of the above embodiment may be adopted in place of the matters described below without departing from the spirit of the present invention.

The infusion pump A410 is for injecting a chemical 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 casing, and a control circuit 455 (see FIG. 11) is arranged in the casing. Of the piston drive mechanism A430, the motor 431 and the transmission mechanism 432 are also arranged in the housing. On the other hand, the presser member A433 protrudes to the outside of the housing. The presser member is a member also called “ram”. A member that abuts on the piston member is provided at the front end of the presser member, and a pair of claws that can be opened and closed elastically are attached to the member.

Two support bars A481 extend forward from the front end of the housing. In this example, the two support bars A481 are arranged in 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 part A420a that 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 at a predetermined depth from the upper surface thereof downward (downward in FIG. 12). A syringe adapter A423 is detachably attached to the receiving groove A421. More specifically, as a method of holding the syringe by the syringe adapter, a method disclosed in Japanese Patent Application Laid-Open No. 2010-213977 (Applicant: Nemoto Kyorindo Co., Ltd.) can be used. The syringe adapter A423 is detachably attached to the receiving groove A421 while holding the periphery of the flange portion of the syringe.

The specification of the piston drive mechanism is not particularly limited. As an example, the piston drive mechanism can inject a chemical solution at a pressure of at least 10 PSI, and preferably can inject a chemical solution at a pressure of at least 20 PSI. There may be.

The following buttons are arranged on the casing of the infusion pump A410. Note that these are not all essential and one or several may be omitted:
-Start button (infusion 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 injection, and the stop button A447 is a button for stopping. 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 an auto return, that is, a button for automatically moving the presser member to a predetermined retracted position. For example, the auto return operation may not be executed only by pressing the auto return button once, but only when the auto return button is pressed for a long time. The long pressing 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. The presser member moves only while these buttons are 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 in a range of 1.0 ml / sec to 3.0 ml / sec. “Low speed” is an example, and may be a speed within a range of 0.1 ml / sec to 1.0 ml / sec.

Also, the following are arranged as display units or display devices. All of these are not essential, and one or some of them may be omitted: a power display unit (power emission unit, power LED), a status display unit, a set speed display unit, a time display unit, and a battery remaining amount display unit. , Speed unit display unit, pressure over display unit, syringe sensor display unit (syringe sensor light emitting unit, syringe sensor LED), clamp sensor display unit (clamp sensor light emitting unit, clamp sensor LED). The specific contents of the display unit will be described later with reference to other drawings.

All the buttons and the display unit as described above are electrically connected to the control circuit 455 (see FIG. 11) of the apparatus. The control circuit detects that the button has been pressed and operates the device in a predetermined manner accordingly. The control circuit is configured as described above when a predetermined condition is satisfied (for example, when a value to be detected reaches a predetermined reference value or when a predetermined button is pressed, but not limited thereto). Switch on / off the lighting of the display. Further, lighting / extinguishing of a light source (for example, one or a plurality of LEDs) is controlled according to a preset pattern.

Infusion pump A410 has clamp sensor A477 in this example. The clamp sensor A477 is used to determine whether or not the presser member A433 is in contact with a piston member (not shown) (including a state in which the sensor reacts but is not in complete contact). Although various sensors can be used as the clamp sensor A477, for example, a contact type sensor (switch) that performs detection by abutting against an object may be used. In addition, 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. For example, a Hall element, a photoelectric sensor, a CCD sensor, a capacitive 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 disposed on the front surface of the presser member as shown in FIG. More specifically, it arrange | positions so that it may protrude from the front surface of a 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, it may be a contact-type sensor that performs detection by contacting an object. In addition, 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. For example, a Hall element, a photoelectric sensor, a CCD sensor, a capacitive 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). Syringe sensor A478 is arrange | positioned in a part in syringe holding | maintenance part 420a. More specifically, it arrange | positions so that it may protrude from the recessed part of a syringe holding part.

In addition, although it is the structure arrange | positioned one by one in the example of a figure regarding either or both of said sensors A477 and 478, you may make it arrange | position a some sensor. In addition, the arrangement position of the sensor is not necessarily limited to the presser member or the syringe holding unit, and may be any other position.

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

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

Next, attach the syringe and injection circuit to the infusion pump. In one form, it is preferable that the syringe is in a state where air is vented.

Next, injection conditions are set. The injection conditions may be set on the console of the chemical solution injection device, transmitted from the console to the infusion pump, and set on the infusion pump side. Alternatively, it may be manually input by an 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 volume of the syringe mounted on the infusion pump is constant (that is, when the volume is a fixed value), the injection time can be calculated using the injection speed and volume set above. The infusion pump performs this calculation and sets the infusion time. Thereby, the setting of “injection speed” and “injection time” as “injection conditions” is completed.

Next, the chemical solution is injected. The chemical liquid injection is an example, and may be a total volume injection that injects all the chemical liquid in the syringe. Specific examples of conditions for starting the injection will be described later.

Next, remove the injection circuit and syringe. Then turn off the infusion pump.

2. Operation Control Using Clamp Sensor When the syringe is attached to the infusion pump A410, the operator advances the presser member A433 after setting the syringe on the syringe holding part A420a. For example, this operation is performed by pressing a forward button. The presser member A433 is advanced until its front end surface comes into contact with the rear end surface of the piston member of the syringe, and when it reaches this position, the pair of claws of the presser A433 holds the piston rear end surface. In this state, the piston rear end surface comes into contact with the clamp sensor A477. According to the electrical signal from the clamp sensor A477, the infusion pump A410 (specifically, the control circuit 455) determines that the syringe is properly attached.

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

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

Control may be performed so that the presser member A433 is not advanced instead of or together with the alarm. Specifically, even if the start button A446 is pressed, the control circuit 455 does not operate the piston drive mechanism 430 in a state where it is not determined that the syringe is properly attached by the clamp sensor A477.

According to such a configuration, it is possible to prevent the presser member A433 from moving forward and improperly injecting a chemical solution even when the syringe is not properly attached.

3. Operation Control Using Syringe Sensor When the syringe is set in the syringe holding part 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 holding part A420a according to this electrical signal from the syringe sensor A478.

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

Next, in the set state, even if the operator presses any of “medium speed forward”, “medium speed reverse”, and “auto return”, the piston drive mechanism 430 is not operated.

Such a configuration provides the following advantages. That is, in this example, infusion pump A410 inject | pours the chemical | medical agent (for example, chemical | medical agent etc. which control heart rate etc.) with a comparatively large influence with respect to a patient's physical function. Therefore, it is preferable that at least a predetermined amount or more of injection is not performed. Therefore, according to the configuration in which at least “medium speed advance” is prohibited as described above, it is possible to prevent injection of a predetermined amount or more due to an erroneous operation by the operator. On the other hand, since “medium-speed reverse” and “auto-return” are prohibited, it is possible to prevent blood from being drawn into the drug tube.

Note that “medium speed forward”, “medium speed reverse”, and “auto return” are not necessarily prohibited. 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 is configured to perform the following operation. Specifically, the infusion pump A410 prohibits manual operation by the operator (for example, advancement, retraction, or both of the presser member by pressing a button) when the syringe is set. May be. In other words, the infusion pump A410 is configured to allow only automatic injection according to the programmed chemical solution conditions.

According to such a configuration, since injection under conditions other than the programmed chemical solution conditions cannot be executed, injection due to human error can be further prevented.

4). Operation Control Utilizing Combination of Syringe Sensor and Clamp Sensor Results Operation control as shown in the following table may be performed using the detection results of the two sensors described above. Here, “◯” in the table indicates that the operation can be performed when the button is pressed, and “X” indicates that the operation cannot be performed even when the button is pressed.

○: Operation possible ×: Operation not possible

From the viewpoint of more safely injecting the chemical 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 in the state where the syringe sensor is OFF, the chemical liquid injection is not started even when the start button is pressed, and at least in the state where the clamp sensor is OFF, the chemical liquid injection is not started even when the start button is pressed.

It is preferable in terms of safe chemical injection to prevent the piston drive mechanism from operating 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 when the chemical solution injection is started. However, when the detection result of at least one of the clamp sensor and the syringe sensor changes during the chemical solution injection (for example, when the syringe is detached). May be performed).

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

Injection operation display part A471 includes a plurality of segments that emit light by way of 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 emit a plurality of segments in a predetermined pattern according to the operation of the pump. For example, display in a pattern as shown in FIG. 15 may be performed. During the forward movement, only the front half side of the plurality of segments of the injection movement 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 turned on in order and displayed as if they are rotating.

In this example, the alarm indicator A 472 includes “PRS”, “Syringe”, and “RAM” indicators (light emitting units).

“PRS” means pressure. In this example, a display schematically showing a tube is provided as an example. The infusion pump A410 detects the pressure during the injection of the chemical solution, compares the detected pressure with a predetermined limit value, and determines whether or not the detected pressure has reached (or exceeded) the limit value. When the detected pressure reaches (or exceeds) the limit value, the infusion pump lights or flashes the “PRS” indicator. Thereby, it is possible to notify the operator that the pressure limit is exceeded.

“Syringe” indicates the mounting of the syringe. In this example, a display schematically showing a syringe is provided as an example. Infusion pump A410 determines whether the syringe is attached based on the detection result of syringe sensor A478. When an injection operation is to be performed with the syringe not attached (ie, advancement of the presser member), the infusion pump lights 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. Infusion pump A410 determines whether or not the presser member correctly holds the piston rear end surface based on the detection result of clamp sensor A477. If an infusion operation is attempted (ie, advancement of the presser member) while not being held correctly, the infusion pump lights or flashes the “RAM” indicator.

The injection rate display part A473 displays the set injection rate. Injection time display part A475 displays the time until the injection is completed. The remaining battery level display A474 displays the remaining battery level.

5. Alarm display (warning display)
Based on the detection results of various sensors, it may be configured such that it is determined in which part an error has occurred, and this is notified to the operator by an alarm display as shown in FIG.

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

FIG. 16 (b) shows a mounting abnormality of the syringe, and an alarm display is displayed at the location of the syringe (“Syringe”). In addition, you may be comprised so that the said display may disappear by mounting | wearing with a syringe. Alternatively, the display may be turned off by pressing a stop switch or any other button.

FIG. 16 (c) shows a clamp abnormality, and an alarm display is displayed at the location of the syringe ("RAM"). Note that the display may disappear when it is detected that the syringe is clamped. Alternatively, the display may be turned off by pressing a stop switch or any other button.

6). Specific Description of State Transition FIG. 17 is an example of the 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. Naturally, 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 long pressing the power switch. A configuration in which an initialization operation (described below) is automatically performed when the power is turned on may be employed. Examples of the initialization operation include a self-check for confirming the operation of one or more electrical elements in the apparatus. As a specific example, the configuration may be such that the SUM of data in a storage medium (not shown) inside the pump is checked, and an abnormality is determined if the SUM does not match. If it is not determined to be abnormal, initialization is completed and the piston drive mechanism is operable. When it is determined that there is an abnormality, a configuration may be adopted in which a predetermined alarm is issued or the operation is 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 apparatus is OFF, the state transitions to the low speed forward state.
-Release the button,
-Press another button,
-Advance limit is ON,
-Syringe sensor input is switched,
-Transition to stop when there is at least one of the pressure reaches a predetermined limit value (10PSI, 15PSI in one example). In addition, as described above, the transition may be made to stop depending on the detection result of the clamp sensor or the syringe sensor.

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

FIG. 19 is an example of state transition relating to auto return.
When the auto return button is pressed while a limit switch (rear end limit, not shown) in the apparatus is OFF, auto return is performed. The condition for transition from auto-wait waiting to auto-return may be a long press of a button.
-Press another button,
-The rear end limit is ON.
-Syringe sensor input is switched,
-Clamp sensor input is switched,
If there is at least one of these, transition to stop.

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

(Appendix 1)
This application discloses the following invention:
1. A: an infusion pump (410);
B: Chemical solution injection device (100);
A chemical injection system comprising:
The infusion pump has a piston drive mechanism (430) that moves a piston member of a syringe (200V) filled with a medicine for myocardial analysis test,
The chemical injection device is
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);
A control unit (155),
The controller (155) is connected to the display (151).
It is configured to display a setting screen (GUI) for setting an injection protocol including an injection operation condition of the injection head and an injection operation condition of the infusion pump.
Chemical injection system.

2. Furthermore, it has a memory | storage part (159) which memorize | stores the said injection | pouring protocol.

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

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

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

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

A system according to another aspect includes:
A: an infusion pump (410);
B: Chemical solution injection device (100);
A chemical injection system comprising:
The infusion pump has a drive mechanism (430) for injecting a drug for myocardial analysis testing toward a patient,
The chemical injection device is
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 controller (145, 155, or both)
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 serving as a trigger for at least one of starting and stopping the operation to the infusion pump.

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

10. The chemical injection device includes a console (150), and the console and the display are provided on the console.

11. Further, another infusion pump for injecting another drug (for example, a beta blocker) different from the drug for the myocardial analysis test toward the patient is also provided.

(Appendix 2)
This application also discloses the following invention:
A1. The computer is on the predetermined display,
Displaying a setting screen (GUI) for setting an injection protocol including an injection operation condition of the injection head and an injection operation condition of the infusion pump;
How the system works.

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

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

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

A5. The method of 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 in which a computer displays a graphical image on a display indicating that a liquid medicine for myocardial analysis is being injected during the liquid medicine injection.

A7. In storage media such as memory,
-As the first phase, vasodilator injection conditions,
-Contrast injection conditions as the second phase,
Infusion protocol data including at least (including the case of simple numerical data),
When there is a predetermined input 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 conditions for simultaneous injection of contrast medium and physiological saline, and conditions for physiological saline injection.

(Appendix 3)
This application discloses the following invention:
B1. A: an infusion pump (A410);
B: Chemical solution 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 thereto;
In addition,
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 a 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 so, the piston drive is not operated.

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 receives an input for starting the 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 both the detection results of the first and second sensors are OFF.

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

B6-1. Furthermore, the infusion pump is
First pressure detection means using a motor current and / or second pressure detection means using a pressure sensor are provided.

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

B7. An infusion pump included in the above system.

1 Imaging System 100 Chemical Solution Injection Device (Contrast Medium Injection Device)
110 Injection head (injector head)
111 Housing 121, 122 Adapter 120a Syringe holding part (recessed part)
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 unit 180 Stand 195a Power supply 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 (concave)
422 Holding member 431 Motor 432 Transmission mechanism 433 Presser member 438 Load cell 440 Operation unit 455 Control circuit 495a Power supply circuit 495b AC code 610 Injection protocol window 611, 613, 615 to 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 (11)

1. An infusion pump,
   A chemical injection device;
   A chemical injection system comprising:
   The infusion pump has a drive mechanism for injecting a drug for myocardial analysis testing toward a patient,
   The chemical injection device is
   An injection head having at least a piston drive mechanism for moving a piston member of a syringe filled with a contrast agent;
   Display,
   A control unit,
   The control unit is connected to the display.
   It is configured to display a setting screen for setting an injection protocol including an injection operation condition of the injection head and an injection operation condition of the infusion pump.
   Chemical injection system.
2. further,
   A storage unit for storing the injection protocol;
   The chemical injection system according to claim 1.
3. The injection head also has another piston drive mechanism that moves the piston member of a syringe filled with diluent or saline.
   The chemical injection system according to claim 1 or 2.
4. The injection protocol setting screen is:
   The first phase includes a vasodilator injection phase,
   Including the contrast agent injection phase as the second phase,
   The chemical injection system according to claim 3.
5. The injection protocol setting screen further includes:
   The third phase includes the simultaneous injection phase of contrast medium and physiological saline,
   Including a boosting phase of saline as the fourth phase,
   The chemical injection system according to claim 4.
6. The control unit is connected to the display.
   Configured to display a graphical image indicating that a vasodilator is being injected;
   The chemical solution injection system according to any one of claims 1 to 5.
7. An infusion pump,
   A chemical injection device;
   A chemical injection system comprising:
   The infusion pump has a drive mechanism for injecting a drug for myocardial analysis testing toward a patient,
   The chemical injection device is
   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 controller 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.
   Chemical injection system.
8. The chemical injection system according to claim 7, wherein the control unit sends an electrical signal serving as a trigger for at least one of start and stop of the operation to the infusion pump.
9. Furthermore, an imaging device is provided,
   The control unit is also connected to the imaging device.
   The chemical solution injection system according to any one of claims 1 to 8.
10. The chemical injection device includes a console,
    The chemical injection system according to any one of claims 1 to 6, wherein the console is provided with the control unit and the display.
11. further,
    It also includes another infusion pump for injecting another drug other than the drug for myocardial analysis testing toward the patient.
    The chemical solution injection system according to any one of claims 1 to 10.
    

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