JP2015213633A - Injection protocol setting device, chemical injection device and medical system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an injection protocol setting device or the like capable of setting a more suitable injection protocol to a patient.SOLUTION: A chemical injection protocol setting device includes: (a1) means for preparing data on a plurality of recommended injection protocols for acquiring an estimation time density curve in actual inspection corresponding to a time density curve obtained by performing test injection; (a2) means for receiving an input for selecting one of the plurality of recommended injection protocols by an operator; (a3) means for displaying GUI including an adjustment item about at least one of (i) biological information on a patient, (ii) an operation condition of an imaging device, and (iii) an operation condition of the chemical injection device in a display to adjust the selected injection protocol; (a4) means for receiving an input of the adjustment item by the operator; and (a5) means for changing the injection protocol in accordance with the inputted adjustment item.

Description

  The present invention relates to an apparatus and the like for setting an injection protocol when injecting a contrast medium or the like into a patient, and in particular, an injection protocol setting apparatus, a drug solution injection apparatus, and an apparatus that can set a more preferable injection protocol for a patient It relates to medical systems.

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

  In general, injection of a chemical solution into a patient is automatically performed using a chemical solution injection device. The chemical liquid injector includes, for example, an injection head on which a syringe filled with a chemical liquid is detachably mounted, and a console that controls the operation of the injection head. The syringe has a cylinder and a piston inserted in the cylinder so as to be movable in the axial direction, and the liquid medicine is filled in the cylinder. The injection head includes a piston drive mechanism for pushing the piston of the syringe attached to the injection head into the cylinder. After connecting the injection needle to the tip of the cylinder via an extension tube and puncturing the patient's blood vessel, the piston drive mechanism pushes the piston into the cylinder, so that the drug solution in the syringe is injected into the patient .

  In imaging using a contrast agent (CT scan in one example), an injection protocol is set so that a good contrast effect can be obtained. The CT image is preferably captured at the timing when the contrast agent that has flowed on the patient's bloodstream reaches the imaging region after the injection of the contrast agent. Therefore, in the conventional diagnostic imaging apparatus, in order to measure the arrival time of the contrast agent at the imaging site, a test injection may be performed and a monitoring scan of the imaging site may be performed prior to the main scan.

  In addition, based on a time density curve (TDC: Time Density Curve) obtained by a monitoring scan of test injection, a method by Fleichmann et al. That mathematically estimates a time density curve (TDC) in a real test is also proposed ( Non-patent document 1). In addition to the method by Fleishmann et al., A method called “addition method (simple linear addition model)” has also been proposed.

Dominik Fleischmann and Karl Hittmair: "Mathematical Analysis of Arterial Enhancement and Optimization of Bolus Geometry for CT Angiography Using the Discrete Fourier Transform", Journal of Computer Assisted Tomography 23 (3): 474-484,1999

  Estimating the TDC of the production test by mathematical analysis in this way, and further calculating the desired infusion protocol on the basis of the computer and automatically creating and presenting one or more infusion protocols is This is advantageous in that it eliminates the need for an injection protocol parameter setting by a person. However, because the patient's biological characteristics affect the contrast effect in a complicated manner, even if a contrast medium is injected under the same conditions, the obtained CT value varies greatly between patients, and a stable contrast effect may not be obtained. is there. On the other hand, since the injection of contrast medium may have side effects on the patient's body, it should be minimized.

  One aspect of the present invention has been made in view of the above points, and an object thereof is to provide an injection protocol setting device, a drug solution injection device, and a system that can set a more preferable injection protocol for a patient. There is in point to do.

One aspect of the present invention is as follows:
A method of setting an injection protocol for injecting at least a contrast agent into a patient comprising:
a1: A plurality of times for obtaining an estimated time concentration curve (hereinafter referred to as “main injection estimated TDC”) in the actual inspection corresponding to a time concentration curve (hereinafter referred to as “test injection TDC”) obtained by performing the test injection. Preparing the recommended injection protocol data for
a2: receiving an input by the operator to select one of the plurality of recommended injection protocols;
a3: to adjust the selected injection protocol,
(I) patient biometric information,
(Ii) information about contrast agents,
(Ii) operating conditions of the imaging device, and
(Iii) operating conditions of the chemical injection device,
A graphical user interface (hereinafter referred to as GUI) including adjustment items related to at least one of
a4: receiving an input of the adjustment item by the operator;
a5: then changing the injection protocol according to the input adjustment item;
An injection protocol setting method.

(Explanation of terms)
“Chemical solution” refers to, for example, a contrast agent, physiological saline, or a mixture thereof.
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.), and 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).
Specific examples of the physiological saline of “physiological saline” include physiological saline containing 180 mg of sodium chloride in 20 ml of physiological saline (for example, viscosity of 0.9595 mPa · s at 20 ° C., specific gravity of 1.004 to 1.04). 006) and the like.

The “infusion protocol” indicates what kind of chemical solution is to be infused at what amount, at what rate, and at an infusion time.
“Variable injection” refers to injecting a drug solution using an injection protocol including at least a part of a phase in which the injection rate increases or decreases with time.
“Variable constant” refers to the value obtained by dividing the terminal injection rate by the start rate in a phase in which the injection rate increases or decreases with time.

“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.

The “terminal” refers to a computer system that performs data processing, connected to a network or used stand-alone, and includes a desktop computer, a laptop computer, a portable computer, a tablet computer, or the like.

The “control unit” includes a CPU, a memory, and the like, and performs arithmetic processing. The “controller”, “processor”, “controller unit (control unit)”, “controller circuit (control circuit)”, “controller” It can also be called “module (control module)”, “processor unit”, “processor unit”, “processor module”, and the like. 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, the computer program stored in the memory is read, then data is received from the input device or the storage device according to the instructions of the computer program, and the data is calculated and processed. The data is output to a storage device such as a memory or an output device such as a display.

The “computer program” may 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.

As the “storage medium”, for example, a nonvolatile memory card (flash memory), a hard disk, an optical disk, a magneto-optical disk, for example, a CD, a DVD, or the like can be used. As the storage medium, various media such as a magnetic recording medium and an optical recording medium can be used.

“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 the operator 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.

  Note that the various components (devices, apparatuses, units, modules, and the like) referred to in this specification do not have to be individually independent, and a plurality of components are formed as a single member. One component is made up of multiple members, one component is a part of another component, and one component is a part of another component , Etc.

  The various constituent elements may be formed so as to realize their functions, and may be realized by hardware or realized by a computer program. For example, a certain component can be realized as dedicated hardware that exhibits a predetermined function, a setting device in which the predetermined function is realized by a computer program, a combination thereof, or the like.

“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.

The “icon” is configured to be (i) one that displays predetermined information and can be selected by the operator, and (ii) only displays predetermined information 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.

(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 an imaging apparatus such as a CT scanner, an MRI apparatus, a PET apparatus, an ultrasonic diagnostic apparatus, or an angiographic imaging apparatus.

  The chemical solution injection device may have two injection modes of test injection and main injection as injection modes of the chemical solution. “Main injection” is an injection of a contrast agent for taking a CT image of a patient for the purpose of diagnosis. The “test injection” is an injection for determining at least one parameter of the injection conditions in the main injection by injecting a smaller amount of contrast medium than the main injection prior to the main injection.

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.

  As a method for determining the administration conditions, not only body weight but also a body surface area as disclosed in Japanese Patent Application Laid-Open No. 2012-200430 or a body surface area as disclosed in Japanese Patent Application Laid-Open No. 2012-200430 is used. It may be one that uses lean body weight as disclosed in Japanese Patent No. 5227189.

  In addition, for example, in the weight category such as “Large”, “Medium”, and “Small”, the body surface area and / or the blood volume category, an optimal calculation formula is used for each segment so that only the iodine amount contributing to the contrast effect is injected. May be. A table for each section can also be used.

  Blood volume calculation The following formula can be used to calculate body weight:

  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 an operator, read from an IC tag of a syringe, or information in an external server (such as an electronic medical record of a hospital system) ).

The “injection head” includes a syringe holding unit that holds the syringe and a piston drive mechanism that moves the piston of the syringe forward and / or backward. The syringe mounting method mainly includes (i) a so-called side loading type in which the syringe holding portion is formed as a semi-cylindrical concave portion on the upper surface of the head and the syringe is set therein; and (ii) the syringe holding portion is There is a so-called front loading type in which the base end portion of the syringe is held on the front surface of the head. One form of the present invention includes any type of injection head.

  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 (magnet sensors, Hall sensors, etc.), One or more tilt sensors, one or more rotary encoders, one or more motor current detectors, etc.

-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.

• 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.

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 is LCD (Liquid
A display unit using a crystal display (Organic Electro-Luminescence) display or the like may be used, but an LED (Light
It may be a display unit using 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 an operator of a predetermined state of the injection head may be provided in a part of the casing of the injection head. As an example of the light source, LED (Light
Emitting Diode) can be used. Such a light emitting unit has a function as a head status display unit, and can notify the operator of various situations of the injection head by changing a light emission color or a 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 holding unit 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.

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 the console are provided with a communication unit for communicating with an external device. 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.

Abnormality detection: It is preferable that one or a plurality of injection abnormalities can be detected using the various sensors as described above.
-Injection abnormalities due to malfunction of the piston drive mechanism,
-Injection abnormalities due to the syringe not being properly mounted on the injection head,
-Abnormal injection due to insufficient contrast agent remaining in the syringe to perform the injection operation,
-Abnormal injection due to the catheter or needle not being inserted into the patient normally-Abnormal injection due to kinks occurring in the middle of the drug solution path,
-An injection abnormality in which 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.

-At the time of chemical | medical solution injection | pouring, for example, when the chemical | medical solution path | route is clogged, the drive force of a piston drive mechanism will exceed a 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 it is detected by the sensor that the predetermined amount of the chemical is not normally loaded, the detection result may be transmitted to the outside from the communication unit.
-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.

(II. General Description of Imaging Device)
The imaging device may be, for example, an X-ray CT scanner or the like. Generally, an imaging unit (a 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. In the case of a CT scanner, an X-ray irradiation unit that has an X-ray tube, a collimator, etc. and irradiates the patient with X-rays, and a detection unit that detects X-rays transmitted through the patient are arranged inside the gantry. Is done. The X-ray irradiation unit and the detection unit scan while rotating around the patient's body axis while maintaining their positional relationship, and fluoroscopic imaging data (projection data) is collected by the data collection unit. The bed is configured to be movable using, for example, a motor as a drive source, and the movement operation is controlled by the operation control unit.

  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.

  ADVANTAGE OF THE INVENTION According to this invention, the injection | pouring protocol setting apparatus which can set a more suitable injection | pouring protocol with respect to a patient, a chemical | medical solution injection apparatus, a medical system, etc. can be provided.

It is a perspective view which shows the structural example of a chemical injection device. It is a perspective view which shows an injection | pouring head and the chemical | medical solution syringe with which it is mounted | worn. It is a block diagram of a chemical injection device and an imaging device. It is a block diagram which shows the structure of the injection | pouring process part implement | achieved by the program. It is a block diagram which shows typically the structure of a hospital system. It is a flowchart which shows an example of an injection | pouring protocol setting procedure. It is an example of GUI. It is an example of TDC displaying the recommended injection protocol and estimated TDC. It is a figure for demonstrating the theory which estimates this injection | pouring TDC from test injection | pouring TDC. It is a figure for demonstrating the theory which estimates this injection | pouring TDC from test injection | pouring TDC. It is an example of this injection | pouring TDC estimated by superimposition. It is a figure for demonstrating the theory which estimates this injection | pouring TDC by a transfer function method.

1. System Configuration A chemical solution injector will be described with reference to FIGS. The chemical injection device 100 according to an embodiment of the present invention includes, for example, an injection head 110 held on an upper portion of a movable stand 111, and a console 150 electrically connected to the injection head 110 via a cable 102. . In this example, two syringes 200C and 200P are detachably attached to the injection head 110 in parallel. Note that the injection head and the console may be connected in a wireless manner.

  In the following description, the syringes 200C and 200P may be simply referred to as “syringe 200” without being distinguished. An “injection head” is also called an injector or an injection head. In order to distinguish the console 150 of the chemical injection device 100 from the console of the imaging device, it may be referred to as an “injector console”. Moreover, in the following description, although it demonstrates based on one specific form represented by drawing, about a chemical | medical solution injection device, a syringe, etc., various changes other than what is demonstrated below are possible. Modifications of the present invention will be described later.

[A1. Syringe〕
Examples of the chemical solution filled in the syringes 200C and 200P (see FIG. 2) include a contrast medium and physiological saline. For example, one syringe 200C may be filled with a contrast medium, and the other syringe 200P may be filled with physiological saline.

  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. The syringe may be a prefilled type that is pre-filled with a chemical solution, or may be a suction type that sucks and uses a chemical solution in an empty syringe.

  An extension tube 230 is connected to the conduit portion 221b of each syringe 200. The extension tube 230 may be a so-called T-shaped tube or Y-shaped tube. The tube 231a extends from the conduit portion 221b of one syringe 200C to the branch portion, and the tube extends from the conduit portion 221b of the other syringe 200P to the branch portion. It may have 231b 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 the syringe 200P.

  In addition, even if the mixing device (one which produces a swirl flow inside and mixes the chemicals in one example) is used as the extension tube at the junction of the first chemical and the second chemical Good.

  As shown in FIG. 3, an IC tag 225 may be attached to a part of the cylinder member 221. 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, expiry date, chemical 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. For example, an RFID (Radio frequency identification) tag can be used as the IC tag 225. 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.

  Note that information may be written to the IC tag at the time of manufacture, or may be written when sucked with a suction device in a hospital.

[A2. Injection head)
As shown in FIG. 2, the injection head 110 has a casing that extends long in the front-rear direction as an example, and two recesses in which syringes 200 </ b> C and 200 </ b> P are placed on the top end side of the casing, 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 a predetermined syringe adapter. In FIG. 2, the cylinder flange 221 a of each syringe 200 and syringe adapters 121 and 122 that hold 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.

  The injection head 110 also has a piston drive mechanism 130 having at least a function of pushing the piston member 222 of the syringe 200, as shown in FIGS. Two systems of piston drive mechanisms 130 are provided, and each mechanism 130 operates independently. The piston drive mechanism 130 may have a function of retracting the piston member 222, for example, for sucking a chemical solution into the syringe. The two piston drive mechanisms 130 may be driven simultaneously, or may be driven at different timings.

  Although not shown in detail, the piston drive mechanism 130 is connected to a drive motor (not shown), a motion conversion mechanism (not shown) that converts the rotational output of the drive motor into a linear motion, and the motion conversion mechanism. It may have a syringe presser (ram member) for moving the piston member 222 forward and / or backward. 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 operations of the piston drive mechanism include the following: chemical injection (ram member advance) and chemical suction (ram member retract). 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 (not shown) for detecting the force with which the syringe presser presses the piston member 220. 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 a load cell (not shown), the pressure may be calculated based on a motor current of a drive motor (not shown).

  When the IC tag 225 is attached to the syringe, the injection head 110 includes a reader / writer 145 that reads information from the IC tag 225 and / or writes information to the IC tag 225, as shown in FIG. You may have. The reader / writer 145 may be provided in the recess 120a in which the syringe 200 is mounted. Note that the reader / writer 145 may have only a function of reading information from the IC tag 225.

  As shown in FIG. 3, the injection head 110 may have a control unit 144 for controlling operations of the piston drive mechanism 130 and the reader / writer 145. In addition, for example, a storage unit 146 that temporarily stores information read from the IC tag 225 may be included. The control unit 144 can be configured as a control circuit having a processor, a memory, and the like.

  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.

[A3. console〕
For example, the console 150 may be used by being placed in an operation room adjacent to the examination room. The console 150 includes a display 151 that displays a predetermined image, an operation panel 159 provided on the front surface of the casing, a control circuit (detailed below) disposed in the casing, and the like. The operation panel 159 is a portion where one or a plurality of physical buttons are arranged, and is operated by an operator. The display 151 may be a touch panel display or a simple display. The console 150 may include a speaker or the like (not shown) for outputting sound and / or sound.

  In the block diagram of FIG. 3, the console 150 is connected to a control unit 153 that controls the operation of each connected unit, an injection processing unit 155, a storage unit 154 that stores various data, and a predetermined external device. It is drawn as having an interface to do. The console 150 may have an input device 157 (not shown in FIG. 1) such as a hand unit operated by the operator.

The injection processing unit 155 is a part that controls 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,
-History generation unit 155d, and
-History output unit 155e,
including.

  The setting screen display unit 155a may correspond to a function for displaying information for setting the injection protocol, specifically, a GUI for setting the injection protocol on the display 151. The GUI 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.

  For example, the protocol creation unit 155b may correspond to a function of accepting an input operation to the touch panel of the display 151 by the operator and creating an injection protocol reflecting the contents. The conditions input by the operator in this way are, for example, at least 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, the imaging region, and the like. There may be one.

  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 history generation unit 155d may correspond to a function of generating injection history data. The “injection history data” includes, for example, an injection operation ID that is unique identification information for each injection operation, injection start and end dates and times, identification information of the chemical injection device, and identification of the chemical solution and the imaging region that are the injection conditions described above. It may be information. 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 elapsed time and the other is injection rate may be used. The injection history data may be information on a drug solution or information on a syringe acquired from an IC tag of a syringe, manually input by an operator, or input from an external network or the like.

  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 network. Information on the liquid medicine obtained from the IC tag of the syringe or manually input by the operator or input from an external network or the like is transmitted from the liquid injector to the medical information system in the hospital. A system configuration in which a system having an accounting processing function performs accounting processing based on the information is also possible.

  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 predetermined storage means (for example, the storage unit 154) in the console.

  The storage unit 154 may store, for example, an image 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. Note that such information regarding the injection protocol may be input from an external device connected via the interface terminal 158. The console 150 may have a slot (not shown) and may be input through an external storage medium inserted therein.

[A4. Imaging device]
The imaging apparatus 300 is, for example, an X-ray CT scanner, an MRI apparatus, or an angiography apparatus, and as shown in FIG. 3, an imaging unit 303b that captures a fluoroscopic image of a patient, a bed 304 on which the patient is placed, and their It may have a control part 303a which controls operation.

  The imaging unit 303b includes an X-ray irradiation unit that is disposed in the gantry and has an X-ray tube, a collimator, and the like and irradiates the patient with X-rays, and an X-ray detector that detects X-rays transmitted through the patient. It may have a detecting part to have. The X-ray irradiation unit and the detection unit are configured to perform scanning while rotating around the patient's body axis while maintaining their positional relationship.

[A5. Hospital system)
As an example, as shown in FIG. 5, the hospital system includes an imaging device, a chemical injection device, a medical record management device HIS, an imaging management device RIS, a data storage device PACS, an image viewing device image viewer, A printer is provided.

(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 names,
-It may include data such as medical chart data relating to a patient's disease.

  In the medical record data, patient weight, sex, age, serum creatinine value, etc. may be registered as personal condition data related to the overall treatment.

(RIS)
The RIS manages imaging order data for imaging fluoroscopic image data from a patient with unique identification information. This imaging order data is created based on an electronic medical record acquired from the HIS. The imaging order data is, for example,
An 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 aforementioned electronic medical record,
-CT scanner identification information,
-Date and time of imaging start and end,
-Body segment or imaging site,
-Appropriate type consisting of chemicals such as contrast media corresponding to the imaging work,
-You may include data, such as appropriate ID which consists of chemical | medical solution ID suitable for imaging work.

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

[A5. Example of general operation)
The chemical injection device of this embodiment may operate as follows as an example:

  First, the operator attaches the syringes 200 </ b> P and 200 </ b> C to the injection head 110 with the power of the chemical solution injection device 100 turned on. After attaching the syringes 200P and 200C, for example, the operator connects the extension tube to the syringes 200P and 200C via the extension tube 230, and inserts an injection needle (not shown) provided at the distal end of the extension tube to the patient. Puncture.

Thereafter, as an example, when the operator operates a predetermined button of the console 150, one or more screens for setting the injection protocol are displayed on the display 151. In this screen, at least one of the following parameters may be entered, selected or changed:
-Body segment to be imaged-Site to be imaged (referred to as imaging site)
-Information such as patient weight-Type of medicinal solution to be injected, etc. Images for selecting these parameters may be displayed sequentially or collectively. The input, selection, or change of the parameters as described above may be automatically performed according to the function of the apparatus, or may be performed by the operation of the operator.

  When the parameter input is completed, the operator presses a predetermined button (for example, a confirmation button) on the screen. When creating an injection protocol, for example, (i) select one of several basic patterns prepared in advance according to the image for creating the injection protocol displayed on the screen, and confirm or need its contents. (Ii) by creating a desired injection protocol by plotting several reference points in the injection graph displayed on the screen.

  The method (ii) will be described later with reference to other drawings. To plot the reference point on the injection graph, you can create a reference point by directly touching any position (or any grid point in the graph) in the graph, or A method of creating a reference point through an operation on a predetermined pop-up screen can be adopted. Using a known digital phantom, it is also possible to create an injection pattern of a chemical solution while predicting a time concentration curve (TDC). For example, various conditions can be determined with reference to a TDC curve of a digital phantom.

  It is also possible to create an injection pattern of a drug solution while predicting the concentration of the contrast agent using a method for estimating the concentration change of the contrast agent using pharmacokinetic analysis. To perform pharmacokinetic analysis, when the patient and contrast medium injection conditions (for example, height, weight, sex, cardiac output, contrast medium concentration, injection speed, injection volume, etc.) are changed This can be implemented using simulation software or the like that can estimate changes in the temporal contrast curve of the aorta (which may be the right heart, left heart, artery, pulmonary circulation, systemic circulation, etc.). A CT value (HU) of 1 mgI / ml may be set. The injection condition to be changed may be the amount of iodine per body weight, the amount of iodine per body weight per time, or the like. Papers on pharmacokinetic models of contrast intensity include “Estimation of Contrast Agent Concentration Change in Aorta Using Pharmacokinetic Analysis: Rapid Intravenous Contrast Imaging Using MDCT”, Isao Yamaguchi et al., 2007, and the like.

  Various conditions in the simulation software may be input and output through two-way data communication with PACS, HIS, RIS, imaging device, workstation, and the like. The imaging device may acquire a complex injection protocol, the imaging device may set the injection protocol, or change the speed and / or amount while viewing the CT value.

  When the injection protocol is created, after a predetermined injection start button is operated by the operator, the piston drive mechanism 130 is controlled based on the injection protocol, and the medical solution is injected into the patient.

2. Example of Procedure for Creating Injection Protocol In the chemical injection device 100 of the present embodiment, for example, the following processing can be performed. Hereinafter, description will be given with reference to the flowchart of FIG.

  First, as shown in the flowchart of FIG. 6, the operator selects an imaging region of the patient (step S1). As a specific example, for example, the abdomen is selected from the body sections such as the chest, abdomen, and lower limbs. A graphical user interface (GUI) as shown in FIG. 7A is displayed on the display 151 of the console 150, and a part (here, the abdomen 561b) of the sections 561a to 561c of the human body image 561 is displayed via the touch panel or You may select with the cursor on a screen.

  The controller 153 of the injector console 150 receives such an input, and then reads the injection protocol data for the test injection from the storage unit 154. For example, the injection protocol data for the test injection may be registered in advance for each imaging region. As another mode, when the control unit 153 accepts the input of the site selection, a GUI (that is, a test injection condition setting screen) for inputting an injection protocol condition for the test injection is displayed on the display 151. May be.

  As a specific example of the test injection, a contrast medium having a concentration of 350 mgI / ml may be used, and the injection condition may be 2 seconds at an injection speed (constant speed) of 5 ml / sec. If necessary, a boost injection condition of physiological saline is added. The condition in this case may be, for example, 20 ml injection at the same speed as the contrast medium.

  The piston drive mechanism is operated according to the set test injection conditions, and test injection is performed (step S2). At this time, the imaging apparatus 300 performs a monitoring scan and creates data of a concentration time curve (also referred to as “test injection TDC”) of the test injection. The data format is not particularly limited, and may be numerical data, image data, or the like. For example, the test injection TDC may be displayed on a display of a console (not shown) of the imaging apparatus. Alternatively, the test injection TDC may be displayed on a predetermined terminal that is stored in a predetermined server via the network and connected to the network.

  In the case where the imaging device and the chemical liquid injector can communicate with each other, the imaging device may transmit data of the test injection TDC to the chemical injector. Data may be transmitted directly from the imaging device to the chemical solution injector, or may be transmitted via another device. Alternatively, the test injection TDC data may be temporarily stored in a server or the like in an arbitrary system, and the chemical solution injection device may read the data.

  As another aspect, the operator reads the data of the test injection TDC displayed on the predetermined display, or prints out the test injection TDC, and the operator sends the test injection TDC to the chemical injection device based on the data. It is good also as a structure by which data is input into a chemical injection device by inputting data manually.

  As another aspect, for example, when the image data of the test injection TDC displayed on the predetermined display of the imaging apparatus is captured by a portable terminal with an imaging function, the terminal performs image recognition processing, and numerical data is obtained. It can also be configured to extract it and display it on a portable terminal, or to transmit the data to a chemical injection device. As the image recognition processing by the terminal, for example, a plurality of points on a TDC curve are automatically extracted, and data of the X coordinate and the Y coordinate of each extracted point is converted into a numerical value, whereby time and CT value (HU ) And correlation data may be acquired. Such a function may be realized as software.

  Through the steps so far (steps S1 to S3), data of the test injection TDC, which is a result of the test injection, is acquired by the chemical injection device 100.

  Thereafter, the chemical injection device 100 uses the data of the test injection TDC to create an estimated time concentration curve (also referred to as “main injection estimated TDC”) in the main scan (step S4). As a method for estimating the TDC of the main scan, a “transfer function method”, an “addition method (simple linear addition model)”, or the like can be used.

  The “transfer function method” is a method of estimating the TDC in the main injection by Fourier-transforming the imaging protocol of the test injection and the TDC obtained therefrom, thereby calculating the transfer function. The transfer function can be expressed by the following equation. Here, pt (t) is the contrast profile of the test injection, dt (t) is the test injection TDC, PT (f) is the Fourier transform of pt (t), and DT (f) is the Fourier transform of dt (t). .

  The “addition method” is a method of estimating the main injection TDC by simply adding the TDC of the test injection (see the following formula). For example, assume that the test injection is defined as a 2-second injection at 3 ml / sec as shown in FIG. On the other hand, this injection is defined as a 3 ml / sec, 10 second injection as shown in FIG. 8B. In this case, if the test injection is added five times at time interval 0, the TDC of the main injection can be estimated. In the example of FIG. 8C, the broken line TDC has shifted the test injection TDC. The solid line TDC is the main injection estimated TDC. In the following equation, D (t) is the estimated value (HU) of the CT value of the actual injection at time t, d (t) is the measured CT value (HU) of the test injection at time t, T is the estimated injection time (sec) of the actual injection, Δt is the injection time (sec) of the test injection, and N is the number of additions (T / Δt).

  The TDC estimation for this injection can be performed on any computer in the system. For example, a chemical solution injection device, an imaging device, or another computer may be used. The estimated TDC is not limited to one, and a plurality of estimated TDCs may be created.

  Examples of obtaining several main injection estimation TDCs by the addition method include those exemplified in Japanese Patent No. 4086309 (see FIGS. 19A to 19C, for example). According to the technique of the same document (see FIG. 20 etc. of the same document), it is also possible to calculate “a plurality of injection protocols” together with a plurality of main injection estimation TDCs. Specifically, (i) for each of a plurality of injection functions in which the injection rate is set to a constant value equal to the test injection rate and the injection time is different from the test injection time, a time concentration curve is calculated based on the test time concentration curve. (Ii) Then, a maximum concentration value (h) that can ensure a required concentration maintenance time (T) in the estimated time concentration curve is obtained, and the maximum concentration value (h) and the required concentration enhancement value (H) The injection rate v is determined based on the ratio. In this way, a plurality of appropriate injection protocols that can maintain the concentration enhancement value (H) over the concentration maintenance time (T) can be created by the computer. In one embodiment of the present invention, this technique may be used, whereby a plurality of main injection guess TDCs and injection protocols can be prepared. However, data of a plurality of recommended injection protocols may be created and / or acquired by other methods besides the method of this document.

  In one form of this invention, the system etc. which an operator can handle easily the data of the some recommended injection | pouring protocol prepared in this way are provided. For example, when the number of recommended injection protocol data prepared is too large, more specifically, when, for example, 15 or more injection protocol data are displayed on the display, the operator selects any of the injection protocols. You may be wondering if you should choose a protocol. On the other hand, it may be necessary to adjust the injection protocol thus obtained in consideration of the patient's biological information and the like. Therefore, according to one aspect of the present invention, there is provided a chemical solution injection device and the like that can easily select any one of the plurality of recommended injection protocols and can easily change (adjust) the conditions for the injection protocol.

For example, the injector console 150 of this embodiment may display a plurality of injection protocol candidates and the corresponding main injection estimation TDC as a GUI on the display 151 of the console 150 as shown in FIG. 7B. Here, in the example of the GUI in FIG. 7B, three (one example) selected from a plurality of injection protocols are displayed on the protocol display unit 531. Specifically:
-Injection protocol 1: 2.3 ml / sec, 69 ml, (time 30 sec)
-Injection protocol 2: 3.0 ml / sec, 90 ml (time 30 sec)
-Injection protocol 3: 3.5 ml / sec, 150 ml, (time 30 sec)

  The operator selects a desired one from these conditions (step S6), and the console 150 receives this input by the operator. It is also preferable that the estimated TDC corresponding to the selected injection protocol is displayed on the estimated TDC display unit 521. That is, the console 150 may be configured to display the estimated TDC corresponding to the selected injection protocol in the graph of the estimated TDC display unit 521 after receiving the input, thereby allowing the operator to It is possible to easily confirm visually what kind of TDC is the injection protocol that can be obtained.

  In the example of FIG. 7B, the information of the “required concentration value” (200HU in one example) necessary for the contrast and the “maintenance time” (time t1 to t2) at which it is maintained is displayed in the graph of the main injection estimated TDC. The Normally, in contrast agent injection, when the injection time is constant, the TDC peak time becomes earlier as the injection speed increases, and the TDC peak time appears later as the speed decreases.

  In this manner, with the injection protocol candidates and the estimated TDCs corresponding thereto displayed, the operator can adjust the injection protocol as necessary (step S7). The adjustment can be performed from various viewpoints, and may be as follows. Hereinafter, it demonstrates in order.

(1) Contrast Agent Concentration If there is no condition for the injection rate desired by the operator among the candidates for the injection protocol, the injection rate may be changed by changing the type of contrast agent, for example. For example, when the contrast medium having a concentration of 300 mgI / ml is changed to one having 350 mgI / ml, the amount of contrast medium to be injected is about 0.85 times (300 ÷ 350). The injection rate is also reduced accordingly. Such a change in infusion rate is advantageous, for example, when the infusion rate is too high and there is a risk of damaging the patient's blood vessel if infused under those conditions.

  An icon for changing the concentration of the contrast medium may be displayed on the GUI as shown in FIG. 7B so that the concentration of the contrast medium can be easily changed. Specifically, the currently assumed contrast medium concentration is displayed (for example, a numerical value such as “300”), and when it is selected, other contrast medium concentration options are displayed in a manner such as a pull-down menu. (240, 350, 370, etc.) may be displayed.

  As another aspect, when the syringe of the injection head is replaced with another one (for example, changing from a 300 mg I / ml concentration to a 350 mg I / ml concentration), the injection head reads the tag information of the syringe, The read concentration information may be automatically set, and the injection rate or the like may be recalculated based on the concentration information.

  Instead of replacing the contrast agent syringe, the concentration of the contrast agent may be adjusted by so-called “dilution injection”. Specifically, the two piston drive mechanisms are operated simultaneously, and the contrast medium and the physiological saline are injected while mixing, thereby injecting a lower concentration contrast medium. In the GUI on the display, an icon for determining whether or not to perform dilution injection and what mixing ratio may be displayed may be displayed.

(2) Tube voltage of the imaging device The tube voltage does not change the time for the contrast agent to reach the target site in TDC or the time to reach the maximum CT, and does not affect the horizontal axis (time axis) of TDC. Don't give. However, it is known that the CT value on the vertical axis shifts higher in TDC as the tube voltage becomes lower. For example, 100 kV has a higher CT value in the aorta and liver parenchyma, for example, compared with the tube voltage of 120 kV. The effect will be improved. More specifically, using a commonly used tube voltage of 120 kV, the amount of contrast agent used to obtain the same TDC as the TDC at 120 kV is 62% at 80 kV, 84% at 100 kV, and 135 kV. It is explained that it is about 113%. Further, it is explained that the relative value of the CT value with 120 kV as a reference is 1.61 at 80 kV, 1.23 at 100 kV, and about 0.88 at 135 kV. Therefore, for example, when the tube voltage value at the time of test injection is different from the tube voltage value at the main injection, it is preferable that the operator can change the tube voltage value.

  Specifically, at 120 kV and 100 kV, the CT value is 1.23 times as described above. By the way, as described above, in the method of Japanese Patent No. 4086309, information such as “required density value” (200 HU in one example) necessary for contrast and “maintenance time” (30 seconds in one example) for maintaining it is input. Based on this, multiple injection protocols were sought. Changing the tube voltage means changing the CT value (HU value). Therefore, when changing the tube voltage in this way, the "required concentration value" is input again and recalculated. The injection protocol may be re-determined.

(3) Patient biological information (3-1) Renal function Depending on the renal function of the patient, it may be better not to inject contrast medium. Therefore, information indicating the patient's renal function may be displayed on the GUI of the display. As information indicating the renal function, glomerular filtration rate (estimated glomerular filtration rate estimated GFR (eGFR)) may be used.

The eGFR value can be calculated by the following formula:
eGFR = 194 × (creatinine [mg / dL]) − ^1.094 × (age [age]) ^−0.287
(Women x0.739)

  For example, the console 150 may be configured to access electronic medical record information on a network and read an eGFR value from the outside. Alternatively, the electronic medical record information on the network may be accessed to read the patient's creatinine value, and the eGFR value may be calculated, for example, by performing the calculation according to the above formula.

  The console 150 may display such information on the display 151. In addition, when there is data of a predetermined reference value and the read or calculated eGFR value is compared with the reference value, and the eGFR value exceeds the predetermined reference value (that is, the renal function of the patient is contrast-enhanced) It is also preferable that at least one of a process of issuing a warning, a process of prohibiting setting of an injection protocol, and a process of prohibiting contrast medium injection is performed when it is low enough to be unsuitable for agent injection.

When the eGFR value is less than a first reference value or a reference range (in one example, 30 (ml / min / 1.73 m ² ) indicating that the predetermined reference value is a level that is not suitable for performing contrast medium injection ) And a second reference value or reference range (for example, 30 or more and less than 45) indicating a level that can be implemented by diluting the contrast agent may be set. The amount may be adjusted by decreasing the amount according to the level of the eGFR value. Alternatively, the speed may be lowered instead of adjusting the amount.

(3-2) Cardiac function Heart rate and cardiac output are also factors that affect the contrast effect. Therefore, the chemical injection device of this embodiment may display information indicating the patient's cardiac function on the GUI of the display 151.

  For example, when a fluoroscopic image of a patient with chronic heart failure is taken, the CT value tends to be lower than that of a normal patient. As a result, an intended image may not be acquired even if the same amount of contrast medium as that of a normal patient is injected. Therefore, in this case, a better image can be acquired by determining the amount of contrast medium in consideration of such symptoms of the patient.

  In this case, for example, the console 150 may be configured to access the electronic medical record information on the network and read information related to the cardiac function of the patient from the outside. The console 150 may display such information on the display 151. The console 150 may be configured to determine whether the patient has heart failure and, in the case of heart failure, display a warning to prompt the operator to set a higher contrast effect (CT value) injection protocol. Good. In addition, for example, a warning for increasing the injection rate and / or the injection amount may be displayed on the GUI. An icon or the like for changing the injection rate and / or the injection amount is preferably displayed on the GUI, so that the operator can reset the injection protocol on the GUI.

However, when the amount of contrast medium is determined in consideration of the patient's symptoms as described above, the amount of contrast medium to be injected is increased as compared with a normal case, and the physical burden on the patient is increased. Therefore, the console 150 displays the amount of contrast medium calculated together with the warning text on the display 151, for example, “This case requires XX ml or more of the contrast medium. Do you want to continue?” It is preferable to call attention. Displaying the contrast medium amount in this way is not limited to taking into account the patient's symptoms, but when calculating the contrast medium amount from the maximum CT value and the tube voltage value of the X-ray tube in the test injection (details will be described later). You may apply.

(Such as cardiac output)
If a contrast medium is injected into a patient with higher cardiac output than usual, such as a patient with valvular disease, the contrast medium concentration in the blood decreases while the contrast medium reaches the target imaging site, and a desired image is obtained. It may not be possible. Even in such a case, it is preferable to inject the contrast medium so that a larger amount of iodine than usual is administered.

  Therefore, in order to obtain the desired image even for patients with more cardiac output than usual, the chemical injection device measures the cardiac output of the patient prior to determining the injection conditions of the chemical A cardiac output meter that measures the patient's cardiac output may further be provided. As an example, the console 150 of the chemical injection device 100 can be configured to read data from the cardiac output meter and use the data to correct the contrast agent injection conditions.

  For example, by correcting the injection amount of the contrast medium by the console 150, the injection speed of the contrast medium is changed accordingly. More specifically, in the correction of the contrast agent injection amount in the main injection taking into account the measured value of the patient's cardiac output, if the measured cardiac output is higher than normal, the cardiac output The required iodine amount I is set to a large value according to the measured value of the amount. Conversely, when the measured cardiac output is lower than normal, the required iodine amount I is set to a small value according to the measured value of the cardiac output.

  The value of the iodine amount I necessary for the above calculation may be set manually by the operator according to the measured value of the cardiac output. For this purpose, an icon for changing the iodine amount I is displayed on the GUI. May be. Alternatively, if the cardiac output meter is connected to the chemical injection device so that data can be transmitted to the chemical injection device, a console calculation unit is required based on the data transmitted from the cardiac output meter. It can also be configured to increase or decrease the value of the correct iodine amount I.

(Patient age information, etc.)
For example, in elderly patients, injecting a contrast agent at a high injection rate may damage the blood vessels. Therefore, in such a case, it may be preferable that the contrast medium is injected at a limited injection speed.

  Therefore, according to one aspect of the present invention, the console of the chemical injection device may be configured to access electronic medical record information on a network, read patient age information, and display the information on a display.

In particular, for example, the console determines whether or not the patient's age exceeds a predetermined reference age, and if the patient's age exceeds the reference age, the liquid medicine injection at a rate equal to or higher than a predetermined value is prohibited. It may be configured as follows. As an example,
-Display a warning to that effect if the patient's age exceeds the specified reference age;
-It is determined whether or not an injection protocol with a speed higher than a predetermined value is set, and if it is higher than a predetermined value, a warning to that effect is displayed or an injection protocol at such a speed is prohibited. It may be configured as follows.

In summary, the injection protocol creation device according to one aspect of the present invention can be expressed as follows:
An apparatus for creating an injection protocol for the main injection,
a1: Data of a plurality of recommended injection protocols for obtaining an estimated time concentration curve (“main injection estimated TDC”) in a production test corresponding to a time concentration curve (“test injection TDC”) obtained by performing a test injection Means (153, 155) for preparing
a2: means (153, 155) for receiving an input by the operator for selecting one of the plurality of recommended injection protocols;
a3: In order to adjust the selected injection protocol, adjustment items relating to at least one of (i) patient biological information, (ii) operating conditions of the imaging device, and (iii) operating conditions of the drug solution injector Means (153, 155) for displaying a graphical user interface (hereinafter referred to as GUI) on the display;
a4: means (153, 155) for receiving an input of the adjustment item by the operator;
a5: means (155) for changing the injection protocol in accordance with the input adjustment item thereafter;
An infusion protocol setting device (153, 155).

  The injection protocol setting device is an example, and is a computer having a1: recommended injection protocol data preparation unit, a2: selection input reception unit, a3: GUI display unit, a4: adjustment item input reception unit, a5: injection protocol change unit It can be configured as. Each unit may be a function realized by a computer program. In the above example, the aspect in which the “injection protocol setting device” is provided in the injector console has been described. In another aspect of the present invention, the “injection protocol setting device” is an arbitrary computer that constitutes the imaging device, It can be configured as any computer (other than the injector console) constituting the chemical liquid injector, or as another computer or terminal.

  According to the injection protocol setting device of the present embodiment configured as described above, (i) patient biometric information and (ii) imaging displayed as GUI after data of a plurality of recommended injection protocols are prepared. The change can be made by inputting an adjustment item relating to at least one of the operation condition of the apparatus and (iii) the operation condition of the chemical liquid injector. Therefore, it is possible to set a more suitable injection protocol for the patient.

(Appendix)
This specification discloses the following inventions:
A1. A method of setting an injection protocol for injecting at least a contrast agent into a patient comprising:
a1: A plurality of times for obtaining an estimated time concentration curve (hereinafter referred to as “main injection estimated TDC”) in the actual inspection corresponding to a time concentration curve (hereinafter referred to as “test injection TDC”) obtained by performing the test injection. Preparing the recommended injection protocol data for
a2: receiving an input by the operator to select one of the plurality of recommended injection protocols;
a3: to adjust the selected injection protocol,
(I) Patient biometric information (eg, renal function, cardiac function, age, etc., one of them, any two combinations, or three combinations),
(Ii) information about contrast medium (for example, iodine amount, etc.),
(Iii) operating conditions (for example, tube voltage value, etc.) of the imaging device, and
(Iv) Operating conditions of the chemical liquid injector (for example, dilution injection, etc.),
A graphical user interface (hereinafter referred to as GUI) including adjustment items related to at least one of
a4: receiving an input of the adjustment item by the operator;
a5: An injection protocol setting method comprising: a step of changing the injection protocol according to the input adjustment item.

  In the step a1, the computer may perform calculations on its own to create data of a plurality of recommended injection protocols, or may read data created by other devices. The step a2 is usually necessary, but may be omitted in one embodiment of the present invention.

A2. Displaying at least two of the plurality of recommended injection protocols on the display in order of increasing or decreasing numerical value of any one of the contrast agent injection rate, the injection amount, and the injection time.
The injection protocol setting method as described above.

A2-1. When the prepared plurality of recommended injection protocols are many (for example, 15 or more), the computer has a predetermined number (for example, 2 to 10, which is easy for an operator to make a selection, preferably 2 to 6, more preferably 3-5) and having it displayed on the display.

A2-2. To select a predetermined number of protocols, the computer determines whether the numerical value is within a reference range for at least one of the infusion rate, infusion volume, and infusion time included in the recommended infusion protocol, and out of the reference range (e.g., The injection protocol has a step of not displaying on the display.

A3. Causing the display to display a main infusion estimated TDC corresponding to the selected recommended infusion protocol;
The injection protocol setting method as described above.

A4. The adjustment item is the concentration of contrast agent,
further,
Re-setting the injection protocol based on the changed contrast agent concentration when the contrast agent concentration is changed;
The injection protocol setting method as described above.

  A5. The contrast agent injection protocol setting method according to the above, wherein the GUI includes an image (for example, an icon or a box for inputting a numerical value on a screen) for changing the concentration of the contrast agent.

A6. The adjustment item is information related to the renal function or cardiac function of the patient.
The injection protocol setting method as described above.

A7. The contrast medium injection protocol setting method according to the above, wherein the GUI includes an image and / or a character indicating a patient's renal function or cardiac function.

A8. The adjustment item is information related to the tube voltage value of the imaging device.
The injection protocol setting method as described above.

A9. The contrast agent injection protocol setting method according to the above, wherein the GUI includes an image and / or characters indicating information related to a tube voltage value of the imaging apparatus.

A9-1. A method in which two or more contents selected from the following are displayed in one screen of the GUI:
-Recommended injection protocol information,
The main injection estimated TDC,
-An image for changing the concentration of the contrast agent,
-Images and / or text showing the renal or cardiac function of the patient,
An image and / or text showing information about the tube voltage value of the imaging device;

A9-2. The method further includes a step of receiving an input of an injection pattern change by an operator. Specifically, the changes may be as follows:
・ Change to “two-phase injection” or “three-phase injection” ・ Change to “variable injection” ・ Change to “simultaneous injection (dilution injection)” ・ Change to “cross injection”, etc.

B1. An apparatus for creating an injection protocol for injecting at least a contrast agent into a patient,
a1: A plurality of times for obtaining an estimated time concentration curve (hereinafter referred to as “main injection estimated TDC”) in the actual inspection corresponding to a time concentration curve (hereinafter referred to as “test injection TDC”) obtained by performing the test injection. A means of preparing recommended injection protocol data for
a2: means for receiving an input by the operator for selecting one of the plurality of recommended injection protocols;
a3: In order to adjust the selected injection protocol, (i) biological information of the patient, (ii) information on the contrast agent, (iii) operating conditions of the imaging device, and (iv) operating conditions of the liquid injector Means for displaying on a display a graphical user interface (hereinafter referred to as GUI) including adjustment items related to at least one of the following:
a4: means for receiving an input of the adjustment item by the operator;
a5: means for subsequently changing the injection protocol in accordance with the input adjustment item;
An infusion protocol setting device.

C1. An imaging device for imaging a fluoroscopic image of a patient;
A liquid injector for injecting at least a contrast medium into a patient;
A medical system comprising:
A medical system in which the injection protocol setting device according to claim 10 is provided in the imaging device or the chemical solution injection device.

D1. A computer program for setting an injection protocol for setting an injection protocol for injecting at least a contrast medium into a patient,
To a computer (eg, an injector console, imaging device, or other computer device);
a1: A plurality of times for obtaining an estimated time concentration curve (hereinafter referred to as “main injection estimated TDC”) in the actual inspection corresponding to a time concentration curve (hereinafter referred to as “test injection TDC”) obtained by performing the test injection. Preparing the recommended injection protocol data for
a2: receiving an input by the operator to select one of the plurality of recommended injection protocols;
a3: In order to adjust the selected injection protocol, (i) biological information of the patient, (ii) information on the contrast agent, (iii) operating conditions of the imaging device, and (iv) operating conditions of the liquid injector Displaying on a display a graphical user interface including adjustment items relating to at least one of the following:
a4: receiving an input of the adjustment item by the operator;
a5: then changing the injection protocol according to the input adjustment item;
A computer program for setting the injection protocol.

  It should be noted that each aspect of the present invention described as the above method can of course be expressed as the present invention with categories of apparatuses, systems, and programs.

3. Example of infusion protocol creation and / or adjustment procedure B1. Injection protocol setting taking into account the tube voltage of the imaging device This procedure determines the amount of contrast agent in the main injection based on the maximum CT value of the TDC measured in the test injection, the tube voltage value of the imaging device, and the target CT value. It is to predict. Thereby, an appropriate injection protocol (particularly the amount of contrast agent) according to individual differences among patients can be easily obtained. As this procedure, for example, the one disclosed in Japanese Patent No. 5416761 can be used. In one form of the invention, the procedure may be used in combination to create and / or adjust the infusion protocol.

This procedure basically carries out the following steps:
-Test injection,
-Monitoring scan (infusion TDC creation),
-Calculation of injection volume.

(Outline of device configuration)
An imaging apparatus (X-ray CT apparatus) includes at least an input device that receives an input from an operator, a display device that displays predetermined information, a connection interface for connecting to an external device, and a main controller (control unit) that controls the operation of each unit. ) And the like. These components may be incorporated in a console that controls the operation of the imaging apparatus by way of example (hereinafter also referred to as “imaging apparatus console”).

The imaging apparatus console acquires transmission X-ray data acquired by operating the CT apparatus main body. The imaging device console then reconstructs the image based on the data and displays the fluoroscopic image on the display device. The imager console displays on the display device for the following information:
The maximum CT value (HU) of the TDC of the test injection,
-Time to reach maximum CT value after injection of contrast agent (maximum CT value arrival time, sec)
-Tube voltage value (kV), etc.

  The voltage (tube voltage) applied to the X-ray tube of the imaging device is normally 120 kV, and is adjusted by an operator or input from an external device (for example, a chemical injection device) via an interface (not shown). Correspondingly, it may be changed.

(Outline of the configuration of the chemical injection device)
The console of the chemical liquid injector may have an “injection amount calculator”. This injection amount calculation unit may be an injection amount calculation function realized by a computer program, for example.

  For example, the injection amount calculation unit sets a target in the main injection based on the maximum CT value measured in the test injection and the voltage value (tube voltage value) applied to the X-ray tube of the X-ray CT apparatus during the main injection. A contrast agent amount is calculated such that the target CT value, which is a CT value, is obtained as the maximum CT value measured by the main injection.

The method of inputting the “maximum CT value” of the test injection TDC to the console of the chemical injection device can be as follows:
The operator manually inputs the value obtained with the X-ray CT apparatus by means of test injection via an input device;
-When the chemical injection device and the X-ray CT apparatus are configured to exchange data bidirectionally, data is automatically input from the X-ray CT apparatus to the console.

  The “tube voltage value” and “target CT value” may be manually input by an operator via an input device.

  By the way, there is the following relationship between the result of the test injection and the injection conditions of the main injection. That is, if the injection time of the contrast agent is the same, there is a generally proportional relationship between the injected contrast agent amount and the increase in the maximum CT value. Therefore, using this proportional relationship, the amount of contrast medium injected in the main injection can be easily obtained from the amount of contrast medium injected in the test injection, the maximum CT value, and the target CT value.

  On the other hand, the tube voltage of the X-ray tube is such that the lower the tube voltage, the longer the wavelength of the generated X-rays, the weaker the transmission power, and the higher the contrast of the CT image. That is, there is a correlation between the tube voltage and the maximum CT value, and the maximum CT value increases when the tube voltage is lowered. Therefore, a desired maximum CT value can be obtained with a smaller amount of contrast agent by lowering the tube voltage. However, when the tube voltage is lowered, there is a tendency that the quality of the obtained CT image is lowered. Therefore, the tube voltage is set according to the purpose of imaging.

  Hereinafter, an example of a procedure for calculating the contrast medium amount of the main injection using the maximum CT value of the test injection TDC and the like will be described.

(Test injection)
First, the chemical injection device is operated to perform test injection. A test injection start signal is transmitted from the injector console to the X-ray CT apparatus at the same time as the start of the test injection or at an arbitrary timing, and the X-ray CT apparatus executes a monitoring scan after a predetermined time has elapsed from the start of the test injection.

  During the monitoring scan, the X-ray CT apparatus measures CT values at regular time intervals, for example, and displays the results on a predetermined display device, for example, as a graph, a numerical value, or an image.

  When the monitoring scan ends, for example, the X-ray CT apparatus transmits a monitoring scan end signal to the chemical liquid injector. Upon receiving the monitoring scan end signal, the injector console injects a main injection setting screen (GUI) for inputting conditions necessary for calculating the amount of contrast medium injected in the main injection by the injection amount calculation unit. Display on the display device of the instrument console.

  As described above, in order to obtain the amount of contrast medium injected in the main injection, the “maximum CT value” obtained in the test injection, the “tube voltage value” and the “target CT value” of the X-ray tube are used.

  This injection setting screen is a screen (GUI) for accepting input of these data by the operator. However, if the maximum CT value measured by the X-ray CT apparatus in the test injection can be acquired from the X-ray CT apparatus via the interface, the maximum CT value is automatically interfaced from the X-ray CT apparatus. And the input by the operator is omitted. In addition, a specific numerical value can be input as the target CT value, or the operator can select from several modes set in advance in the control unit in accordance with the imaging purpose or the like. Also good.

The “main injection setting screen” as a GUI is, for example,
A box (display) for the operator to manually enter the maximum CT value in the test injection;
It may have a box for inputting a tube voltage value of the X-ray tube, a plurality of buttons for setting a mode of main injection, and the like.

The infusion may have three modes: “standard mode”, “weight loss mode” and “expected mode”. For example, the mode may be selected by the operator appropriately touching each icon. here,
The “standard mode” is a mode for acquiring an image with a sufficiently clear detail.
The “weight reduction mode” is a mode for acquiring an image that does not need to be clear in detail and that allows an overview to be grasped.
The “prediction mode” is a mode for acquiring an image by specifically specifying the maximum CT value.

(Diagnosis of heart coronary artery)
For example, in the diagnosis of the coronary artery of the heart, the “standard mode” is set to about 350 HU as an example so as to be suitable for the diagnosis of coronary artery stenosis and plaque.
On the other hand, in the “weight reduction mode”, the maximum CT value is set to about 250 HU so as to be suitable for determination of coronary artery stenosis.

  The maximum CT value may be set in a table or the like stored in a storage device of an arbitrary device according to the imaging region and mode. When the mode is selected by the operator, the control unit of the injector console reads the data of the maximum CT value corresponding to the mode and sends it to the injection amount calculation unit.

  The tube voltage value may be selected by the operator from, for example, 80 kV, 100 kV, and 120 kV on the GUI.

  By selecting a predetermined icon on the main injection setting screen (GUI), the injector console is injected with main injection based on the “maximum CT value”, “tube voltage value”, and “target CT value”. The dosage is calculated.

  According to the procedure for setting the injection protocol as described above, the individual difference is estimated by predicting the contrast medium amount in the main injection from the maximum CT value, the tube voltage value of the X-ray tube and the target CT value measured in the test injection. It is possible to easily obtain the optimum amount of contrast medium according to the above. In addition, the tube voltage value applied to the X-ray tube is changed to a value lower than normal according to the purpose of diagnosis, and the contrast injection injected in the main injection so as to obtain the target CT value based on the changed tube voltage value. By determining the amount of the agent, an image having information necessary for diagnosis can be acquired with a smaller amount of contrast agent. Since the test injection is a process that is normally performed prior to the main injection in order to measure the time for the contrast medium to reach the imaging region, the number of processes is not increased by performing the test injection.

B2. Estimating the contrast medium injection amount of the main injection using the result of the test injection TDC This procedure predicts the contrast medium amount of the main injection using the maximum CT value of the TDC measured by the test injection. is there. Thereby, it is possible to obtain an appropriate injection protocol (particularly the amount of contrast agent) according to individual differences among patients. For example, the one disclosed in Japanese Patent No. 5394371 can be used.

  In order to realize this procedure, the chemical injection device, after the completion of the test injection, the setting screen (GUI) for the main injection, specifically, the CT value of the test injection, the target CT value, the injection amount of the test injection, A GUI for displaying and / or inputting information such as the injection amount of the main injection, the peak time, and the imaging start time may be displayed.

(Theory for injection amount estimation)
By the way, if the injection time of the contrast agent is the same, it may be approximated that there is a generally proportional relationship between the injection amount of the contrast agent and the increase in the maximum CT value.

Thus, the following proportional expression holds:
C _T : C _A = I _t : I _a
here,
C _T is increase in the maximum CT value by the test injection,
C _A is increase in the maximum CT value in accordance with the present injection,
I _t is, at the time of test injection contrast agent injection amount,
_Ia is the amount of contrast medium injected at the time of injection.

However, in practice, the imaging region has a certain CT value even when the contrast medium is not injected, and the CT value measured by the CT apparatus is the CT value before the contrast medium is injected. It is an included value. Therefore,
C _T = C _t −C ₀
C _A = C _a −C ₀
It becomes. here,
C _T is the maximum CT values obtained by CT apparatus in the test injection,
C _A is the target maximum CT value to be obtained by the CT apparatus at the maximum CT value by the main injection,
C ₀ is the CT value before injection of contrast agent.

Thus, the above proportional expression can be expressed as:
_{(C t -C 0) :( C} a -C 0) = I t: I a
The target maximum CT value C _a is the maximum CT value with which the best contrast effect can be obtained, and this value can be set in advance based on statistical data or the like.

In this way, by utilizing the proportional relationship between the contrast agent injection amount and the maximum CT, the injection amount of the contrast agent and the maximum CT value obtained by the CT apparatus at that time are known in the test injection. The injection amount of the contrast agent that can obtain the target maximum CT value Ca in the main injection can be obtained very easily.

Specifically, the injection amount calculation unit of the injector console is
The maximum CT value C _{t of} the test injection,
The target maximum CT value C _a to be obtained by the CT apparatus in the main injection,
A CT value C ₀ before contrast agent injection,
- test injection time of a contrast medium injection volume I _{t and,}
Formula: I _a = I _t × (C _a -C ₀ ) / (C _t -C ₀ )
Based on the above, the contrast medium injection amount I _a at the time of main injection is calculated.

Of the data required to calculate the contrast agent injection volume at the time of main injection, the target maximum CT at the time of main injection
It values C _a and contrast medium injection quantity I _t of the time calculated test injection is stored in a predetermined storage area as the data. In addition, as the CT value before injection of the contrast agent, an appropriate value corresponding to the imaging region can be stored in advance in a predetermined storage area as data based on statistical data. In this case, therefore, the operator, for example, may only maximum CT value C _t obtained in test injection to input to the touch panel.

For example, in the setting screen (GUI) for main injection, in addition to the maximum CT value at the time of test injection, the elapsed time from the start of test injection when the maximum CT value is reached by test injection is input as a peak time. It may be. When the peak time is input, the console may display the imaging start time of the main scan executed by the CT apparatus in response to the main injection on the setting screen. This imaging start time can be, for example, 2 seconds before the peak time of the CT value. Thereby, since imaging can be performed in a period including the peak time of the CT value, a good contrast effect can be obtained. How many seconds before the peak time of the CT value is started may be determined in advance, but can be changed by the operator as necessary.

  Generally, when the amount of contrast medium injected increases, the time to reach the maximum CT value tends to be delayed. Therefore, if the imaging timing from the start of contrast agent injection is constant, even though the contrast agent injection amount is different between the test injection and the main injection, the imaging time that the CT apparatus executes in response to the main injection is There may be a deviation from the timing of reaching the target maximum CT value. Therefore, the console may correct the peak time of the CT value obtained by the test injection based on the contrast agent injection amount in the main injection calculated by the main injection amount calculation unit. In that case, the control unit can set the imaging start time based on the corrected peak time.

  When the imaging start time is set, the console transmits the data to the CT apparatus through the interface, and the CT apparatus executes the main scan, for example, for 4 seconds from the imaging start time accordingly.

  Note that the imaging start time after the main injection can be determined in advance in consideration of the difference between the start of the injection of the contrast agent and the arrival of the maximum CT value between the test injection and the main injection. In that case, it is not necessary to input the peak time in the test injection.

  In this embodiment, the main injection is performed by the same protocol as the test injection in which the contrast medium is injected at a constant injection rate during a predetermined injection time. Here, since the injection amount of the contrast medium is different between the test injection and the main injection, in the main injection, the injection time is the same as the injection time in the test injection, but the injection speed is different from the test injection. Usually, since the amount of contrast medium injected in the main injection is larger than that in the test injection, the contrast medium is injected at a higher injection rate than in the test injection. In this embodiment, after the contrast agent is injected, a predetermined amount of physiological saline is injected at a preset injection rate.

  After confirming the main injection confirmation screen, the operator touches the main injection start button displayed on the touch panel. When the main injection start button is touched, the console controls the two piston drive mechanisms 113 so that the contrast medium and the physiological saline are injected into the patient according to the above-described protocol, thereby performing the main injection.

  For example, simultaneously with the start of the main injection, a main injection start signal is transmitted from the control unit to the CT apparatus via the interface. The CT apparatus executes a main scan after the start of the main injection after the imaging start time set by the chemical injection device based on the result of the test injection. By the main scan, a CT image of the patient at the target imaging site is captured.

  According to the injection protocol setting procedure described above, the contrast agent injection amount in the main injection is determined using the maximum CT value measured in the test injection. The maximum CT value obtained by the test injection reflects individual differences such as the patient's circulating blood volume, cardiac output, and vascular resistance. Therefore, without actually measuring these circulating blood volumes, etc. Therefore, it is possible to set the optimum injection amount of the contrast medium according to the individual difference very easily. In addition, since the test injection is a process that is normally performed prior to the main injection in order to measure the time for the contrast medium to reach the imaging region, the number of processes is not newly increased by performing the test injection.

B3. TDC analysis using the result of test injection TDC and Fourier transform (background)
In contrast agent injection, if the injection parameters set based on the injection rate and injection amount of the contrast agent are not appropriate, the difference in the density values of the images is too small to be useful for diagnosis or, conversely, the concentration value is too high. May result in an image with no contrast.

  On the other hand, the time density change (image density time change) due to the injection of the contrast agent varies greatly depending on the weight of the patient, the disease being held, and the like. For this reason, variations in density values and variations in delay time from the start of contrast agent injection until the contrast agent appears in the region of interest may increase. In this regard, if the time density curve (TDC) can be estimated with the aid of a computer, it can be expected that the amount of contrast medium to be used can be set appropriately and that it will not be excessively administered. This is thought to reduce the physical and economic burden on the patient.

Conventional studies for analyzing TDC conventionally include the method of Fleichmann et al. (See below):
Dominik Fleischmann and Karl Hittmair: "Mathematical Analysis of Arterial Enhancement and Optimization of Bolus Geometry for CT Angiography Using the Discrete Fourier Transform", Journal of Computer Assisted Tomography 23 (3): 474-484, 1999

  In this method, first, Fourier transformation is applied to the test infusion parameters and the resulting time concentration curve (TDC), and the relationship of the time concentration change to the patient infusion is derived as a “transfer function”. By using the transfer function, it is possible to estimate a time concentration curve for an arbitrary injection parameter, and conversely, by setting a time concentration curve required in CT, an optimal injection parameter for obtaining it can be obtained. It can be estimated.

  In one form of the invention, this theory can be used. Based on this theory, the injection protocol required to obtain the desired contrast result (TDC) is, for example, such that the injection rate is represented by a complex shape function that varies non-linearly over time. In this case, the fitting process may be performed on an injection protocol (two-phase injection in one example) having a shape that can be practically implemented by the chemical injection device.

(Analysis of time concentration curve using Fourier transform)
First, a test injection is performed prior to the main injection, and a test injection TDC is obtained as data. Based on the data, the arrival time of the contrast agent to the region of interest is examined, and an appropriate imaging start time of the CT scan is determined. In this embodiment,
-Test time concentration curve,
-Using the two data of the test infusion parameters, analyze the characteristics of the time concentration curve for each patient and estimate the data of the time concentration curve in the main infusion.

  The basic theory for the analysis is as follows. In other words, in this analysis, the complex system of the human body is regarded as a black box, and only the input and output are analyzed, that is, the analysis is performed using only two data of the contrast medium injection function of the device and the time density curve obtained thereby. I do.

The “contrast agent injection function (inj)” corresponds to time-series data obtained from two values of “injection speed” and “injection amount” of the test injection, and is considered as an input to the system.
The “transfer function G” is derived using the contrast agent injection function (test injection function) and the value of the time density curve (test time density curve) obtained thereby. By using the transfer function G, it is possible to estimate a time concentration curve corresponding to an arbitrary contrast medium injection function for the patient. Conversely, it is possible to estimate the contrast agent injection function for obtaining an ideal time density curve. The time density curve (enh) can be obtained by convolving and integrating the contrast agent injection function (inj) serving as an input to the system and the system function g representing the system, and can be analyzed using Fourier transform. It becomes.

(Analysis and estimation using Fourier transform)
The transfer function G is obtained by measuring in advance the test injection function Inj _test of the contrast agent and the test time concentration curve Enh _test obtained thereby and using the following equation. Once the transfer function G is determined, the time density curve can be estimated from the contrast agent injection function:
G = Enh _test / inj _test

The production time concentration curve Enh _Std obtained when the injection function Inj _std is given as an input is obtained using the following equation:
Enh _test = G ・ Inj _test

A time concentration curve (TDC) in the time domain is obtained by applying inverse Fourier transform to the Enh _test thus obtained. An _ideal injection function Inj _ideal for obtaining an _ideal time concentration curve Enh _ideal can also be calculated based on the characteristics of the Fourier transform.

As an example, when it is desired to obtain a trapezoidal TDC, an ideal injection function Inj _ideal is calculated using the Enh _ideal obtained by Fourier transforming the TDC and the transfer function G, and the Fourier transform is performed on the _ideal injection function Inj _ideal. It is also possible to derive ideal injection conditions.

  The injector console may have the following configuration: test time concentration curve generator, estimated time concentration curve generator, maximum concentration value calculator, injection rate calculator, injection protocol generator, injection protocol selection Department.

The “test time concentration curve creation unit” pays attention to a region of interest in a plurality of cross-sectional images obtained by imaging at the time of test injection, and creates data of a time concentration curve in the region of interest. The created data is stored in a predetermined storage area.

The “estimated time concentration curve creation unit” reads out the time concentration curve from the storage area, and corresponds to a plurality of contrast agent injection times (injection time candidates) assumed in the actual examination based on the test time concentration curve. Create an estimated time concentration curve. As an example, this estimated time-concentration curve is predicted to be observed in the region of interest when the contrast agent injection rate is set equal to that at the time of the test injection and the contrast agent is injected into the subject at various injection times. It is a time concentration curve. The plurality of estimated time density curves created in this way are stored in a predetermined storage area.

The “maximum density value calculation unit” reads the plurality of estimated time density curves from the storage area, and obtains the maximum density value h that can satisfy the predetermined density maintenance time T in each estimated time density curve.

  The density maintenance time T may be set by the operator. This density maintenance time T is a time during which the image density of the region of interest should be maintained at a predetermined required density value H (density enhancement value) or more during CTA imaging. The maximum density value h obtained for each estimated time density curve is stored in a predetermined storage area.

The “injection rate calculation unit” reads the maximum concentration value h obtained for each estimated time concentration curve from the storage area, and compares each maximum concentration value h with the required concentration value H. Based on the comparison result, the injection rate calculation unit calculates a contrast agent injection rate v that can achieve the required concentration value H for each estimated time concentration curve (that is, for each injection time). . The calculated plurality of contrast medium injection speeds v are associated with the respective injection times and stored in a predetermined storage area.

The “injection protocol creation unit” obtains the contrast agent injection amount (= injection speed × injection time) by reading the plurality of calculated injection speeds v from the storage area and multiplying them by the corresponding injection speeds. In this way, a plurality of contrast agent injection protocols composed of a set of contrast agent injection amount and injection speed v are created and stored in a predetermined storage area.

The “injection protocol selection unit” selects an appropriate contrast agent injection protocol from the plurality of contrast agent injection protocols stored in the storage unit 8 based on the contrast agent injection conditions set by the operator's input. This is stored in a predetermined storage area as the main injection protocol (injection protocol to be used for the actual inspection). In one example, this main injection protocol is passed by the injection controller to the control unit of the automatic injector.

4-2. Estimation of contrast medium injection parameters

  The operator inputs a test injection protocol via a predetermined input device in advance.

  The test infusion protocol includes, for example, infusion rate, infusion time and infusion volume information. For example, the speed may be 5.0 ml / sec (constant speed), the injection time may be 2.0 sec, and the injection volume may be 10 ml. Boost injection of saline is performed as necessary. In one example, 20 ml of physiological saline is injected at 5.0 ml / sec (constant speed).

  An automatic injector (specifically, a piston drive mechanism) performs a test injection according to a test injection protocol.

  The operation information of the automatic injector at this time is sent to the imaging device, and the imaging device controls the operation of the scanner based on this operation information. Thus, a scan for a test inspection is performed in accordance with the test injection of the contrast agent.

  The transmitted X-ray data collected by the CT scanner is stored in a predetermined storage area. Based on the transmitted X-ray data, image data representing a shadow image is created (step S4).

  Also, a test time density curve is created by the test time density curve creation unit based on the plurality of image data.

Next, the operator inputs the following information via a predetermined input device:
(1) Concentration enhancement value HU [ΔHU] (200HU in one example) that is desired to be obtained during the actual inspection
(2) Maintenance time T (seconds) (10 sec in one example)

  Then, the estimated time concentration curve creation unit, for example, when the injection rate is constant at a value equal to the test injection rate and the injection time is a natural number multiple of the test injection time by superimposing the test time concentration curve An estimated value of the time concentration curve to be obtained (estimated time concentration curve) is created.

  The estimated time density curve thus created is stored in a predetermined storage area.

  The estimated time concentration curve creation unit can create a plurality of estimated time concentration curves by performing the same processing as described above for a plurality of different injection times.

  The maximum density value calculation unit obtains a maximum density value that can secure the maintenance time T in a plurality of (for example, six) estimated time density curves (the first one is a test time density curve) created. The maintenance time T is a time required for imaging at the actual inspection in the CT scanner.

Next, the injection rate calculation unit obtains a ratio H / hi (where i = 1, 2, 3,...) Of the concentration enhancement value H with respect to the maximum concentration value obtained for each estimated time concentration curve. Then, by multiplying this by the test injection speed, an injection speed (= V _test · H / hi) corresponding to each injection time is obtained.

  The reason for the above calculation is that it is assumed that the injection function Inj (t) and the concentration curve Enh (t) are in a linear relationship.

  Then, the injection protocol creation unit calculates the contrast agent injection amount by multiplying the injection speed vi and the injection time ti corresponding thereto.

  In this way, six (one example) injection protocols represented by sets of contrast medium injection amount and injection speed are obtained, and data representing these injection protocols is stored in the storage unit.

  This injection protocol represents a rectangular injection function corresponding to a single phase injection in which a constant injection rate vi is maintained over the injection time ti.

  When the six injection protocols are obtained in this way, the injection protocol selection unit 741 selects one injection protocol that matches the injection conditions specified by the input from the operator as the injection protocol for the actual inspection (main injection protocol). .

  As injection conditions, for example, the contrast agent injection amount is the minimum, the contrast agent injection speed is the predetermined value or less, the contrast agent injection speed is the minimum, and other appropriate conditions depending on the parameter to be noted. Conditions can be set.

When the main injection protocol is determined in this way, the contrast medium is injected by the automatic injector in accordance with the main injection protocol, and in synchronization with this, imaging for the actual inspection is executed by the CT scanner.

  In addition, this invention is not limited to the specific aspect demonstrated above, A various change is possible in the range which does not deviate from the meaning of this invention. In addition, the mathematical formulas shown in the present specification are merely examples, and a predetermined calculation target may be derived using other mathematical formulas and theories.

In other forms of the invention, the following modifications may be made:
(M1) In the above description, the configuration screen (graphical user interface) for setting the protocol has been described on the display of the injection I console. However, the injection head has a sub-display, and the protocol is displayed there. A setting screen as described above for setting may be displayed.
(M2) Alternatively, a setting screen as described above for setting a protocol may be displayed on a display included in the imaging apparatus. That is, in this case, the imaging apparatus provides a graphical user interface, and the operator can set conditions via this interface. And it is also preferable that the data of the conditions set on the imaging device side in this way is transmitted to the chemical injection device by wire or wireless, and the setting is performed from the imaging device side.
(M3) Setting as described above for setting a protocol in any device (for example, a chemical injection device, an imaging device, a database server, or other computer system) in the system in order to realize the configuration as described above Can hold screen (graphical user interface) data.
(M4) In the above description, for example, as shown in FIG. 1, the chemical injection device in which the injection head and the console are configured separately is shown. However, a chemical injection device such as the following may be used:
-A chemical injection device in which the injection head and the console are integrated, in other words, a single device is used to set the injection protocol, display various states during chemical injection, and control the operation of the piston drive mechanism. Such as a chemical injection device.
-In the above-mentioned chemical solution injection device in which the injection head and the console are integrated as one casing, the chemical solution injection device further comprising a separate battery unit. Such a battery unit may be an AC power source, may be installed at any location in the examination room, or may be held in a part of a movable stand.
A chemical injection device in which a control unit, such as a miniaturized console (e.g. having one or more buttons and / or a display), is arranged in the vicinity of the injection head. For example, such a control unit is held on a movable stand together with an injection head. Or, for example, such a control unit is held on a ceiling-suspended arm together with an injection head. Alternatively, it is integrated with the injection head.
(M5) In the above description, the drug solution in the syringe 200P is physiological saline, but other diluents may be used.

  Although the “addition method” and the “transfer function method” are exemplified to estimate the main injection TDC, a dynamic model by Bae et al. May be used. Bae et al. Proposes to develop a model of the pharmacokinetics (PK) and kinetics of contrast agent response and find the function that causes the most uniform arterial enhancement. By such modeling and adjustment of the injection conditions as described above, an appropriate injection protocol can be set. Also, the inverse solution of a set of differential equations in a simplified partitioning model described by Bae et al. Is optimal / constant enhancement in CT imaging procedures by exponentially reducing the contrast agent flow rate. (For example, US Pat. No. 6,055,985 (Japanese Patent 4,650,855)). References relating to estimating the TDC of the actual injection using a dynamic model or the like include, for example, Japanese Patent No. 3553968 and US Pat. No. 5,687,208. An appropriate injection protocol can be set by such estimation of TDC, injection protocol setting using the same, and adjustment of injection conditions as described above.

  In addition, Jacobs' “algorithm based on optimal linear model applied to drug delivery driven by pharmacokinetic model”, Wada and Ward “mixed: computer controlled infusion pump Modeling and simulation such as “a new pharmacokinetic model” can also be used.

100 Chemical Injection Device 102 Cable 110 Injection Head 120a Recess 111 Movable Stand 130 Piston Drive Mechanism 144 Control Unit 145 Reader / Writer 146 Storage Unit 150 Console (Injection Control Unit)
151 Display (display device)
153 Control unit 154 Storage unit 155 Injection processing unit 157 Input device (hand unit)
159 Operation panel 200 Syringe 221 Cylinder member 222 Piston member 225 IC tag 230 Extension tubes 231a to 231c Tube 300 Imaging device 303a Control unit 300b Imaging unit 304 Bed

Claims (14)

A method of setting an injection protocol for injecting at least a contrast agent into a patient comprising:
a1: A plurality of times for obtaining an estimated time concentration curve (hereinafter referred to as “main injection estimated TDC”) in the actual inspection corresponding to a time concentration curve (hereinafter referred to as “test injection TDC”) obtained by performing the test injection. Preparing the recommended injection protocol data for
a2: receiving an input by the operator to select one of the plurality of recommended injection protocols;
a3: to adjust the selected injection protocol,
(I) patient biometric information,
(Ii) information about contrast agents,
(Iii) operating conditions of the imaging device, and
(Iv) Operating conditions of the chemical injection device,
A graphical user interface (hereinafter referred to as GUI) including adjustment items related to at least one of
a4: receiving an input of the adjustment item by the operator;
a5: then changing the injection protocol according to the input adjustment item;
An injection protocol setting method. Displaying at least two of the plurality of recommended injection protocols on the display in order of increasing or decreasing numerical value of any one of the contrast agent injection rate, the injection amount, and the injection time.
The injection protocol setting method according to claim 1. Causing the display to display a main infusion estimated TDC corresponding to the selected recommended infusion protocol;
The injection protocol setting method according to claim 1 or 2. The adjustment item is the concentration of contrast agent,
further,
Re-setting the injection protocol based on the changed contrast agent concentration when the contrast agent concentration is changed;
The injection protocol setting method according to any one of claims 1 to 3.   The contrast agent injection protocol setting method according to claim 4, wherein the GUI includes an image for changing a concentration of a contrast agent. The adjustment item is information related to the renal function or cardiac function of the patient.
The injection protocol setting method according to claim 1 or 2.   The contrast medium injection protocol setting method according to claim 6, wherein the GUI includes an image and / or a character indicating a patient's renal function or cardiac function. The adjustment item is information related to the tube voltage value of the imaging device.
The injection protocol setting method according to claim 1 or 2.   The contrast agent injection protocol setting method according to claim 8, wherein the GUI includes an image and / or characters indicating information related to a tube voltage value of the imaging apparatus. An apparatus for creating an injection protocol for injecting at least a contrast agent into a patient,
a1: A plurality of times for obtaining an estimated time concentration curve (hereinafter referred to as “main injection estimated TDC”) in the actual inspection corresponding to a time concentration curve (hereinafter referred to as “test injection TDC”) obtained by performing the test injection. A means of preparing recommended injection protocol data for
a2: means for receiving an input by the operator for selecting one of the plurality of recommended injection protocols;
a3: In order to adjust the selected injection protocol, (i) biological information of the patient, (ii) information on the contrast agent, (iii) operating conditions of the imaging device, and (iv) operating conditions of the liquid injector Means for displaying on a display a graphical user interface (hereinafter referred to as GUI) including adjustment items related to at least one of the following:
a4: means for receiving an input of the adjustment item by the operator;
a5: means for subsequently changing the injection protocol in accordance with the input adjustment item;
An infusion protocol setting device. A piston drive mechanism for moving the piston member of the syringe;
A control unit for controlling the operation of the piston drive mechanism;
An infusion protocol setting device of claim 10;
A chemical solution injection device. An injection head to which at least one syringe is attached;
A console operably connected to the injection head;
The piston drive mechanism is provided in the injection head;
The control unit and the injection protocol setting device are provided in the console,
The chemical | medical solution injection device of Claim 11. An imaging device for imaging a fluoroscopic image of a patient;
A liquid injector for injecting at least a contrast medium into a patient;
A medical system comprising:
A medical system in which the injection protocol setting device according to claim 10 is provided in the imaging device or the chemical solution injection device. A computer program for setting an injection protocol for setting an injection protocol for injecting at least a contrast medium into a patient,
On the computer,
a1: A plurality of times for obtaining an estimated time concentration curve (hereinafter referred to as “main injection estimated TDC”) in the actual inspection corresponding to a time concentration curve (hereinafter referred to as “test injection TDC”) obtained by performing the test injection. Preparing the recommended injection protocol data for
a2: receiving an input by the operator to select one of the plurality of recommended injection protocols;
a3: In order to adjust the selected injection protocol, (i) biological information of the patient, (ii) information on the contrast agent, (iii) operating conditions of the imaging device, and (iv) operating conditions of the liquid injector Displaying on a display a graphical user interface including adjustment items relating to at least one of the following:
a4: receiving an input of the adjustment item by the operator;
a5: then changing the injection protocol according to the input adjustment item;
A computer program for setting the injection protocol.

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