JP2020032246A - Injection protocol setup device, medical solution injector, and medical system - Google Patents

Abstract

To provide an injection protocol setup device, etc. capable of further favorably setting up an injection protocol for patients.SOLUTION: The medical solution injection protocol setup device includes: a1 means for performing test injection to prepare a plurality of recommended injection protocol data for acquiring an estimated time-density curve in real check corresponding to a time-density curve acquired by performing the test injection; a2 means for receiving an operator's input that selects one of the plurality of recommended injection protocols; a3 means for causing a display to display GUI including adjustment items relating to at least one of (i) bio-information of a patient, (ii) operation condition of an image pickup device, and (iii) an operation condition of the medical solution injector; a4 means for receiving an input of adjustment items by the operator; a5 means for changing the injection protocols according to the input adjustment items.SELECTED DRAWING: Figure 7B

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, particularly, an injection protocol setting apparatus capable of setting a more preferable injection protocol for a patient, a drug solution injection apparatus, and It relates to medical systems and the like.

  Currently, CT (Computed Tomography) scanners, MRI (Magnetic Resonance Imaging) devices, PET (Positive Emission Tomography) devices, ultrasonic diagnostic devices, angiographic imaging devices, and the like are used as medical image diagnostic devices. ing. When such an imaging device is used, a contrast medium, a physiological saline, or the like (hereinafter, these may be simply referred to as “medical solution”) may be injected into a patient.

  It is common practice to inject a drug solution into a patient automatically using a drug solution injection device. The drug solution injector includes, for example, an injection head to which a syringe filled with a drug solution is detachably mounted, and a console for controlling the operation of the injection head. The syringe has a cylinder and a piston inserted into the cylinder so as to be movable in the axial direction, and the liquid medicine is filled in the cylinder. The injection head has a piston drive mechanism for pushing a piston of a syringe mounted on the injection head into a cylinder. After connecting the injection needle to the distal end of the cylinder via an extension tube and piercing the injection needle into 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 (in one example, CT scan), an injection protocol is set so that a good contrast effect is obtained. It is desirable that the imaging of the CT image be performed at a timing after the injection of the contrast agent, when the contrast agent flowing along with the blood flow of the patient reaches the imaging site. Therefore, in the conventional image diagnostic apparatus, a test injection may be performed and a monitoring scan of the imaging site may be performed prior to the main scan in order to measure the arrival time of the contrast agent at the imaging site.

  Further, a method by Fleischmann et al., Which mathematically infers a time concentration curve (TDC) in a production test based on a time density curve (TDC) obtained by a monitoring scan of a test injection, has been proposed ( Non-patent document 1). In addition to Fleischmann's method, a method called “addition method (simple linear addition model)” has 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, further calculating the desired injection protocol by computer based on the TDC, and automatically creating and presenting one or more injection protocols are performed by the operation. This is advantageous in that the setting of the parameters of the injection protocol by the operator becomes unnecessary. However, since a patient's biological characteristics affect the contrast effect in a complicated manner, even if a contrast agent is injected under the same conditions, the obtained CT value varies widely among patients, and a stable contrast effect may not be obtained. is there. On the other hand, injection of the contrast agent may have side effects on the patient's body, and therefore, it is necessary to minimize the injection.

  An 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. Is to do.

One embodiment of the present invention is as follows:
A method of setting an injection protocol for injecting at least a contrast agent into a patient,
a1: A plurality of methods for obtaining an estimated time concentration curve (hereinafter, referred to as “main injection estimated TDC”) in a production test corresponding to a time concentration curve obtained by performing test injection (hereinafter, referred to as “test injection TDC”). Providing data for the recommended injection protocol of
a2: accepting an input by an operator to select one of the plurality of recommended infusion protocols;
a3: To adjust the selected injection protocol,
(I) biological information of the patient,
(Ii) information on the contrast agent,
(Ii) operating conditions of the imaging device, and
(Iii) operating conditions of the drug solution injector,
Causing a display to display a graphical user interface (hereinafter referred to as a GUI) including adjustment items for at least one of the following:
a4: receiving input of the adjustment item by the operator;
a5: then, changing the injection protocol according to the input adjustment item;
A method for setting an injection protocol, comprising:

(Explanation of terms)
The “medical solution” refers to, for example, a contrast agent, a 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 at 37 ° C. and a specific gravity of 1.268 to 1.296), 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 at 37 ° C. and a specific gravity of 1.335 to 1.371) and an iodine concentration of 350 mg / ml (for example, a viscosity of 10.6 mPa · s at 37 ° C. and a specific gravity of 1.392 to 1.371). 433).
As a specific example of the physiological saline of “physiological saline”, a physiological saline containing 180 mg of sodium chloride in 20 ml of physiological saline (for example, a viscosity of 0.9595 mPa · s at 20 ° C., a specific gravity of 1.004 to 1.0. 006).

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

"Connection"-In this specification, when it is said that a predetermined device is connected to another device, it may be either a wired connection or a wireless connection. In addition, a form of unidirectional or bidirectional connection so that other devices can be controlled may be referred to as “operably connected / linked”.
“Electrically connected” means that components are connected to each other so that an electric signal can be transmitted in one direction or two directions, and may be in any form of a wired connection or a wireless connection. . Further, in addition to the case where the components are 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 and is connected to a network or used stand-alone, and includes a desktop computer, a laptop computer, a portable computer, a tablet computer, and 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” Module (control module) "," processor unit "," processor unit "," processor module ", and the like. The "controller" can be comprised of a microcomputer, microcontroller, programmable logic controller, application specific integrated circuit, and other programmable circuits. In the present specification, the “control unit” may be physically one, but two or three or more control units functionally cooperate to constitute one “control unit”. It may be.

  Basic processing in the control unit is an example, first, read a computer program stored in a memory, then receive data from an input device or a storage device according to the instructions of the computer program, and after calculating and processing the data, 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 causes the computer to operate with a predetermined function. In this case, the storage medium storing the computer program forms one embodiment of the present invention. Further, the computer program may be provided via a communication network (for example, the Internet). The computer program may be a program that can be realized in combination with a program already recorded in the computer, that is, a so-called difference program.

As the “storage medium”, for example, a nonvolatile memory card (flash memory), a hard disk, an optical disk, a magneto-optical disk, and for example, a CD, a DVD, and the like can be used. Various storage 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, and the like. There may be. The movement of the operator may be recognized (in one example, non-contact) to recognize a predetermined input corresponding to the movement.

"Part (also expressed as" element "or" module ")"-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. Further, it is not necessary to provide the function in one device, and the corresponding function may be provided in two or more devices in a distributed manner. Furthermore, only one or a plurality of 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 that a computer logically has.

  Various components (devices, apparatuses, units, modules, etc.) referred to in the present specification do not need to be independent from each other, and a plurality of components are formed as one member. One component is formed of multiple members, one component is a part of another component, and one component overlaps with another component , Etc.

  The various components need only 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 performs 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) refers to, for example, visually operating an icon, an image button, a pull-down menu, or a numerical value input window on a screen by touching with a cursor or a touch panel. An interface that can be used.

The “icon” is configured such that (i) one that displays predetermined information and can be selected by an operator, and (ii) that is merely for displaying predetermined information and can be selected. It may include both of those that do not. All or some of the icons displayed on the screen can be selected by touching the respective display locations with a touch pen, an operator's finger, or the like, or by using a cursor on the screen.

(I. General Description of Chemical Injection Device)
The “medicine injection device” includes, in one embodiment, the following components: a piston drive mechanism, a control unit (control unit), and a display.
Here, these components may be provided in any device constituting the drug solution injector. That is, when the liquid injector includes an injection head, a console, and the like, (i) the injection head may be provided with a piston driving mechanism, the console may be provided with a control unit and a display, or (ii) the injection head may be provided. The control unit may be provided on both the console and the console, or (iii) the 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, and an angiographic imaging apparatus.

  The chemical liquid injector may have two injection modes of a test liquid injection and a main injection as the liquid injection modes. "Main injection" is injection of a contrast agent for capturing 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 condition in the main injection by injecting a smaller amount of the contrast agent than the main injection before the main injection.

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

  As a method for determining the administration conditions, not only the body weight, but also using the blood volume as disclosed in JP-A-2012-016377, the body surface area as disclosed in JP-A-2012-43030 Or a device using lean body mass as disclosed in Japanese Patent No. 5227189.

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

  The following formula can be used to calculate blood volume and weight:

  In order to calculate the injection amount of the contrast agent in the main injection, in one example, the weight of the patient, the required iodine amount, and the iodine concentration are input, and the computer uses the input data to execute the imaging in the main injection. The injection amount of the agent may be calculated. A part of this information may be manually input by an operator, may be read from an IC tag of a syringe, or may be information in an external server (for example, an electronic medical record of a hospital system, etc.). ).

The “injection head” has a syringe holding unit that holds the syringe, and a piston drive mechanism that moves the piston of the syringe forward and / or backward. There are mainly two types of syringe mounting methods: (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. There is a so-called front loading type formed on the front surface of the head and holding the base end of the syringe. One embodiment of the present invention includes any type of injection head.

  The liquid injector 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, and one or more motor current detectors, etc.

Pressure sensor: The pressure sensor is for detecting, for example, a pressure for pressing the piston member, and can thereby obtain an estimated pressure value of the chemical solution. The pressure sensor may be, for example, a load cell. The load cell should just be provided in the position which can detect the pressure which the ram member of the piston drive mechanism pushes the piston member. For example, when using the detection result of the load cell to obtain an estimated value of the pressure of the drug solution during the injection of the drug solution, the calculation is performed by the resistance of the injection circuit (for example, the size of the needle), the concentration of the drug solution, It may be performed in consideration of conditions and the like. In another aspect, a pressure sensor or the like that directly detects the pressure of the chemical solution may be provided.

Syringe detection sensor: The syringe detection sensor detects whether a syringe, adapter, and / or protective case is mounted, or detects what kind of syringe, adapter, and / or protective case is mounted. It is used to determine. Such a sensor may be either a contact type or a non-contact type, and examples thereof include the following: a contact sensor using physical contact, and an electric sensor for electrically detecting an object. Sensors, magnetic sensors, hall sensors, optical sensors, proximity sensors, etc.

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

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

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

  The liquid injector or injection head may further include one or more of the following: one or more head displays, one or more head status indicators, one or more Physical buttons, one or more RFID communication devices, one or more data receivers, one or more data transmitters, etc.

Display: A display for displaying predetermined information may be provided on the injection head. The display may for example be provided on a part of the housing of the injection head. Alternatively, a sub-display provided separately from the housing may be used. The display is an LCD (Liquid
A display unit using a Crystal Display (Organic Electro-Luminescence) display or the like may be used, but an LED (Light) may be used.
A display unit using Emitting Diode may be used. The contents displayed on this display are not particularly limited, but may be the following: a predetermined state display during the injection operation, a liquid injection condition to be injected, a liquid injection condition to be injected, a liquid injection condition. Injection volume, liquid pressure, injection speed, etc.

For example, a predetermined light emitting section for notifying an operator of a predetermined state of the injection head may be provided in a part of the housing of the injection head. As a light source, for example, an LED (Light
Emitting Diode) can be used. Such a light emitting section has a function as a head status display section, and can notify an operator of various states of the injection head by changing a light emission color and a light emission pattern.

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

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

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

Data transmitter: The data transmitter is for transmitting predetermined data from an injection head or the like to the outside by wire or wirelessly. As the communication protocol of the data receiver and the data transmitter, a suitable protocol may be appropriately adopted in consideration of a communication method with another device which is a communication partner. Note that a data transmitter or the like that performs communication with an external device may be provided in a console or other devices. The data that can be transmitted from the injection head to the outside by the data transmitter may be one or more of the following: the name of the used contrast agent (contrast agent identification information), the total amount of the injected contrast agent, and the like. , Contrast agent injection time, contrast agent injection pressure, contrast agent injection speed, set injection protocol, etc. In addition, one or more of the following: patient identification information (for example, patient ID), examination identification information (for example, examination ID), information about imaging time, and the like. Such information may be transmitted in combination with the information on the contrast agent described above.

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

-Abnormality detection: It is preferable that the above various sensors are used to detect one or more injection abnormalities out of the following.
-Injection abnormality due to malfunction of piston drive mechanism,
Abnormal injection due to the syringe not properly mounted on the injection head,
-Abnormal injection due to insufficient contrast agent remaining in the syringe to perform the injection operation;
-Injection abnormalities due to improper insertion of the catheter or injection needle into the patient-Injection abnormalities due to kinks in the middle of the drug solution path,
Injection anomalies, such as the pressure value of the detected chemical solution not being in a predetermined range (a predetermined range having an upper limit and a lower limit, or a predetermined upper limit, a predetermined lower limit, etc.).

-At the time of injecting a chemical solution, for example, if the chemical solution path is clogged, the driving force of the 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 the predetermined range. By observing such a change in the driving force, it can be detected whether or not the chemical solution is normally injected.
-If the sensor detects that the predetermined amount of the chemical is not properly loaded, the detection result may be transmitted from the communication unit to the outside.
-Alternatively, for example, a pressure sensor for measuring pressure may be provided in the middle of the extension tube to detect whether or not the chemical is injected at a predetermined pressure.

(II. General Description of Imaging Device)
The imaging device may be, for example, an X-ray CT scanner, and generally includes an imaging unit (for example, a gantry), a bed (couch) on which a patient is placed, and an operation control unit that controls the operations thereof. , A data collection unit that collects and processes fluoroscopic imaging data, a main controller that controls the entire operation, and the like. The main controller may be provided as a console, for example. The imaging device may also have one or more displays for displaying certain information. In the case of a CT scanner, an X-ray irradiator that has an X-ray tube, a collimator, etc. and irradiates X-rays toward a patient, and a detector that detects X-rays transmitted through the patient are arranged inside the gantry. Is done. The X-ray irradiator and the detector perform scanning while rotating around the patient's body axis while maintaining their positional relationship, and the data collection unit collects fluoroscopic imaging data (projection data). The bed is configured to be movable using, for example, a motor as a drive source, and its movement operation is controlled by an operation control unit.

  Between the imaging device and the liquid injector, between the other devices of the imaging device, between the liquid injector and other devices, various communication protocols between the devices can be used, for example, CANopen, Protocols such as HL7 and DICOM.

  According to the present invention, it is possible to provide an injection protocol setting device, a drug solution injection device, a medical system, and the like that can set a more preferable injection protocol for a patient.

It is a perspective view showing the example of composition of a medical fluid injection device. It is a perspective view which shows an injection | pouring head and the chemical | medical solution syringe attached to it. It is a block diagram of a medical-solution injection device and an imaging device. FIG. 4 is a block diagram illustrating a configuration of an injection processing unit realized by a program. It is a block diagram which shows the structure of a hospital system typically. It is a flowchart which shows an example of an injection protocol setting procedure. It is an example of a GUI. 5 is an example of a TDC displaying a recommended infusion protocol and an estimated TDC. It is a figure for explaining the theory which estimates main injection TDC from test injection TDC. It is a figure for explaining the theory which estimates main injection TDC from test injection TDC. It is an example of this injection | pouring TDC estimated by superposition. It is a figure for explaining the theory which estimates this injection TDC by a transfer function method.

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

  In the following description, the syringes 200C and 200P may be simply referred to as "syringe 200" without distinction. An "injection head" is also called an injector or an injection head or the like. The console 150 of the liquid injector 100 may be referred to as an “injector console” to distinguish it from the console of the imaging device. In the following description, the description will be made based on one specific embodiment shown in the drawings. However, various modifications other than those described below can be made for the liquid injector and the syringe. Modifications of the present invention will be described later.

[A1. Syringe〕
The liquid medicine to be filled in the syringes 200C and 200P (see FIG. 2) includes a contrast medium and a physiological saline. For example, one syringe 200C may be filled with a contrast agent, and the other syringe 200P may be filled with physiological saline.

  The syringe 200 has a hollow cylindrical cylinder member 221 and a piston member 222 slidably inserted into the cylinder member 221. The cylinder member 221 may have a cylinder flange 221a formed at the base end and a conduit portion 221b formed at the tip end. By pushing the piston member 222 into the cylinder member 221, the liquid medicine in the syringe is pushed out to the outside via the conduit part 221b. The syringe may be of a prefilled type in which a drug solution is filled in advance, or may be of a suction type in which a drug solution is sucked into an empty syringe for use.

  The extension tube 230 is connected to the conduit part 221b of each syringe 200. The extension tube 230 may be a so-called T-shaped tube or Y-shaped tube, and a tube 231a extending from the conduit portion 221b of one syringe 200C to a branch portion and a tube extending from the conduit portion 221b of the other syringe 200P to a branch portion. 231b and a tube 231c extending from the bifurcation to the patient. For example, an injection needle is connected to the distal end side (not shown) of the tube 231c. The injection needle is punctured into the blood vessel of the patient, and the liquid medicine in syringe 200C and / or syringe 200P is pushed out, whereby the liquid medicine is injected into the blood vessel.

  It should be noted that, even if a mixing device (one that generates a swirl flow inside and mixes the chemicals therein) is disposed at the junction of the first chemical and the second chemical as the extension tube, it may be used. 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 (identification information of the syringe, withstand pressure of the syringe, inner diameter of the cylinder member, stroke of the piston member, and the like), information (name (for example, product name)) of the liquid medicine filled in the syringe, Ingredient information such as iodine amount, expiration date, chemical solution volume, etc.) are stored. The IC tag may have a unique ID unique to the tag. The IC tag may have at least one information selected from a syringe size, a serial number of the syringe, and a drug standardization code. In addition, as the IC tag 225, for example, an RFID (Radio frequency identification) tag can be used. The position where the IC tag 225 is attached is, for example, the outer peripheral surface of the cylinder member 221, and more specifically, may be near the cylinder flange on the outer peripheral surface.

  The writing of information to the IC tag may be performed at the time of manufacturing, or may be performed when the information is sucked by a suction device in a hospital.

[A2. Injection head)
As shown in FIG. 2, the injection head 110 has, as an example, a casing that extends long in the front-rear direction. Two recesses on which the syringes 200C and 200P are respectively mounted are provided on the top end side of the casing. 120a are formed. The recess 120a is a portion that functions as a syringe holding unit.

  The syringe 200 may be directly mounted on the recess 120a, or may be mounted via a predetermined syringe adapter. FIG. 2 illustrates, as an example, the syringe adapters 121 and 122 that hold the cylinder flange 221a of each syringe 200 and the vicinity thereof. The shape and function of the syringe adapter are not limited to specific ones, but may be any.

  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. The piston drive mechanism 130 is provided in two systems, 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 at the same time, 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) for converting the rotational output of the drive motor into a linear motion, and connected to the motion conversion mechanism. And 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 drug solution injector can be used. Note that an actuator other than the motor may be used as a drive source.

  Typical operations of the piston drive mechanism include the following: liquid injection (advance of the ram member) and liquid suction (retraction of the ram member). In the "chemical liquid injection", the motor is operated according to a predetermined motor control signal to advance the ram member, thereby performing the chemical liquid injection according to the set injection protocol (injection condition). In the "medical solution suction", the motor is operated according to a predetermined control signal to retract the piston member, thereby sucking the chemical solution into the syringe. In addition, in the case of a prefilled syringe, it is not necessary to carry out the drug solution suction.

  Note that the piston drive mechanism 130 may include a load cell (not shown) for detecting the force of the syringe presser pressing the piston member 220. Using the detection result of the load cell, for example, an estimated value of the pressure of the chemical solution during the injection of the chemical solution can be obtained. The calculation of the estimated value is performed in consideration of the size of the needle, the concentration of the drug solution, injection conditions, and the like. Alternatively, 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 reads the information of the IC tag 225 and / or writes the 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 of the IC tag 225.

  As shown in FIG. 3, the injection head 110 may include a control unit 144 for controlling the operations of the piston drive mechanism 130 and the reader / writer 145. Further, for example, a storage unit 146 for temporarily storing information read from the IC tag 225 may be provided. 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 housing of the injection head 110. Some of these physical buttons may be configured to emit light, for example, to notify predetermined information to an operator.

[A3. console〕
The console 150 may be used, for example, by being placed in an operation room adjacent to an examination room. The console 150 has a display 151 for displaying a predetermined image, an operation panel 159 provided on the front surface of the housing, a control circuit (details described below) arranged in the housing, 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 voice.

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

The injection processing unit 155 is a part that controls creation of an injection protocol, execution of an injection, and the like. As an example, as illustrated in FIG.
A setting screen display unit 155a,
-An injection protocol generator 155b,
An injection control unit 155c,
A history generation unit 155d, and
A history output unit 155e;
including.

  The setting screen display unit 155a may correspond to a function of displaying information for setting an injection protocol, specifically, a GUI for setting an 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 computers.

  The protocol creation unit 155b may correspond to, for example, a function of receiving an input operation performed by an operator on a touch panel or the like of the display 151 and creating an injection protocol in which the content is reflected. The conditions input by the operator in this manner include, for example, at least one selected from the type of the medical solution, the injection speed of the medical solution, the injection amount of the medical solution, the body information of the patient, the body division of the patient performing the imaging, and the imaging site. It 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 driving mechanisms 130 and operate both at the same time.

  The history generation unit 155d may correspond to a function of generating injection history data. The “injection history data” includes, for example, an infusion operation ID that is unique identification information for each infusion operation, date and time of injection start and end, identification information of the liquid injector, and identification of the liquid and the imaging site that are the injection conditions described above. It may be information or the like. These may be text data. Further, one of the horizontal axis and the vertical axis may be elapsed time and the other may be image data of a time-dependent graph of the injection speed. The injection history data may be information of a drug solution or information of a syringe obtained from an IC tag of the 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, the data may be transmitted to a predetermined external device and / or network. The information of the drug solution or the information of the syringe 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 drug solution injector to the medical information system in the hospital, for example, A system configuration in which a system having an accounting processing function performs accounting based on the information is also possible.

  Note that each function of each of the units 155a to 155e may be executed by a computer using an installed program. The program may be stored in a predetermined storage unit (for example, the storage unit 154) in the console in advance.

  The storage unit 154 may store, for example, an image displayed on the display 151 and GUI data. Further, an algorithm including a calculation formula for setting the injection condition and the like, and data of the injection protocol may be stored. The injection rate may be constant or may change over time. When the contrast medium and the physiological saline are injected, information such as the order in which the liquid medicines are injected is also included in the injection protocol. Note that information on such an injection protocol may be input from an external device connected via the interface terminal 158. Also, the console 150 may have a slot (not shown) and input through an external storage medium inserted therein.

[A4. Imaging device)
The imaging device 300 is, for example, an X-ray CT scanner, an MRI device, or an angiography device. 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 And a control unit 303a for controlling the operation.

  The imaging unit 303b includes an X-ray irradiator that has an X-ray tube and a collimator and irradiates the patient with X-rays, and an X-ray detector that detects X-rays transmitted through the patient. And a detection unit. The X-ray irradiator and the detector are configured to scan while rotating around the body axis of the patient while maintaining their positional relationship.

[A5. Hospital system)
As an example, the hospital system includes, as shown in FIG. 5, an imaging device, a liquid injector, a HIS as a medical record management device, an RIS as an imaging management device, a PACS as a data storage device, an image viewer as an image browsing device, A printer and the like are provided.

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

  Further, the patient's weight, gender, age, serum creatinine value, and the like may be registered in the chart data as personal condition data related to 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,
Imaging work ID, which is unique identification information;
Work types such as CT imaging and MR imaging,
-The patient ID and chart data of the electronic chart described above;
-Identification information of the CT scanner,
The start and end date and time of the imaging,
-Body segments or imaging sites,
-An appropriate type consisting of a chemical type such as a contrast agent corresponding to the imaging operation,
-It may include data such as a proper ID composed of a chemical liquid ID suitable for the imaging operation.

(PACS)
The PACS receives and stores fluoroscopic image data to which imaging order data has been added from an imaging device.

[A5. Example of general operation)
The liquid injector according to the present 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 while the power of the liquid injector 100 is on. After mounting the syringes 200P and 200C, the operator connects the extension tubes to the syringes 200P and 200C via the extension tubes 230, for example, and attaches an injection needle (not shown) provided at the distal end of the extension tubes to the patient. Puncture.

Thereafter, as an example, when the operator operates a predetermined button on the console 150, one or more screens for setting an injection protocol are displayed on the display 151. On this screen, at least one of the following parameters may be entered, selected or changed:
-Body segment to be imaged-Site to be imaged (imaged site)
-Information such as patient's weight-Type of drug 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 by a function of the apparatus, or may be performed by an operation of an operator.

  When the input of the parameters is completed, the operator presses a predetermined button (for example, a confirmation button) on the screen. When creating an injection protocol, for example, (i) selecting one of several basic patterns prepared in advance and confirming or confirming the contents according to the image for creating the injection protocol displayed on the screen (Ii) plotting several reference points in the injection graph displayed on the screen to create an arbitrary injection protocol, and so on.

  The method (ii) will be described later with reference to other drawings. The operation for plotting the reference point on the injection graph includes a method of directly touching an arbitrary position in the graph (or an arbitrary grid point in the graph) to create the reference point, or For example, a method of creating a reference point through operation of a predetermined pop-up screen may be adopted. Using a known digital phantom, it is also possible to create a drug solution injection pattern 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 a drug solution injection pattern while predicting the contrast agent concentration using a method for estimating a change in the concentration of the contrast agent using pharmacokinetic analysis. In order to perform pharmacokinetic analysis, when the patient and the injection conditions of the contrast agent (for example, at least a part of height, weight, sex, cardiac output, contrast agent concentration, injection speed, injection amount, etc.) are changed (A right heart, a left heart, an artery, a pulmonary circulation, a systemic circulation, or the like) can be implemented using simulation software or the like that can estimate a change in a time contrast curve. Further, a CT value (HU) of 1 mgI / ml may be set. The injection conditions to be changed may be the amount of iodine per body weight or the amount of iodine per body weight per hour. In addition, as a dissertation on the pharmacokinetic model of the contrast intensity, there are “Estimation of Contrast Agent Concentration Change in Aorta Using Pharmacokinetic Analysis: Rapid Intravenous Contrast Inspection Using MDCT”, Isao Yamaguchi et al.

  Various conditions in the simulation software may be input and output by bidirectional data communication with a PACS, HIS, RIS, imaging device, workstation, or the like. The imaging device may acquire a complicated injection protocol, the imaging device may set the injection protocol, or change the speed and / or amount while watching the CT value.

  After the injection protocol is created, after a predetermined injection start button is operated by the operator, the operation of the piston drive mechanism 130 is controlled based on the injection protocol, and the liquid medicine is injected into the patient.

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

  First, as shown in the flowchart of FIG. 6, the operator selects an imaging part of a patient (step S1). As a specific example, for example, the abdomen is selected from the body divisions 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 It may be selected by a cursor on the screen.

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

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

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

  When the imaging device and the liquid injector are configured to be able to communicate with each other, the imager may transmit test injection TDC data to the liquid injector. The data may be transmitted directly from the imaging device to the liquid injector, or may be transmitted via another device. Further, the configuration may be such that the test injection TDC data is temporarily stored in a server or the like in an arbitrary system, and the chemical injection device reads 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 based on the data, the operator sends the test injection TDC to the liquid injector. A configuration is also possible in which data is input to the drug solution injector by manually inputting the data.

  As still another aspect, for example, when the image data of the test injection TDC displayed on a predetermined display of the imaging device is captured by a portable terminal with a capturing function or the like, the terminal performs image recognition processing and converts the numerical data. It is also possible to adopt a configuration in which the data is extracted and displayed on a portable terminal, or the data is transmitted to a liquid injector. As the image recognition processing by the terminal, for example, a plurality of points on a TDC curve are automatically extracted, and the X-coordinate and Y-coordinate data of each extracted point are digitized, so that the time and CT value (HU ) May be obtained. Such a function may be realized as software.

  Through the steps up to this point (Steps S1 to S3), the data of the test injection TDC, which is the result of the test injection, is acquired by the chemical injector 100.

  Thereafter, the drug solution injector 100 creates an estimated time concentration curve (also referred to as “main injection estimated TDC”) in the main scan using the data of the test injection TDC (step S4). As a method of 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 performing a Fourier transform on a contrast injection protocol of a test injection and a TDC obtained from the protocol, thereby calculating a transfer function, and estimating the TDC in the main injection. The transfer function can be represented by the following equation. Here, pt (t) is the contrast profile of the test injection, dt (t) is the TDC of the test injection, 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 equation). For example, suppose that the test injection was defined as 2 ml injection at 3 ml / sec as shown in FIG. 8A, and TDC was obtained. On the other hand, this injection is defined as 3 ml / sec, 10 second injection as shown in FIG. 8B. In this case, the TDC of the main injection can be estimated by adding the test injection five times at the time interval 0. In the example of FIG. 8C, the TDC indicated by the broken line shifts the test injection TDC. , The solid line TDC is the main injection estimation TDC. In the following equation, D (t) is the estimated CT value of the actual injection at time t (HU), d (t) is the measured CT value of the test injection at time t (HU), T is the injection time (sec) of the actual injection to be estimated, 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, it may be a liquid injector, an imaging device, or another computer. The number of estimated TDCs is not limited to one, and a plurality of estimated TDCs may be created.

  As a method for obtaining some main injection estimated TDCs by the addition method, there is a method as exemplified in, for example, Japanese Patent No. 4086309 (see FIGS. 19A to 19C). According to the method of the document (see FIG. 20 of the document), “plural injection protocols” can be calculated together with plural main injection estimation TDCs. Specifically, (i) a time concentration curve is set based on the test time concentration curve for each of a plurality of injection functions in which the injection speed is set to a constant value equal to the test injection speed and the injection time is different from the test injection time. (Ii) A maximum density value (h) which can secure a required density maintenance time (T) in the estimated time density curve is obtained, and the maximum density value (h), the required density enhancement value (H) and Is determined based on the ratio of. In this way, a plurality of suitable injection protocols can be created by the computer that can maintain the concentration enhancement value (H) over the concentration maintenance time (T). In one embodiment of the present invention, this technique may be used, and thereby a plurality of main injection estimation TDCs and injection protocols can be prepared. However, data of a plurality of recommended injection protocols may be created and / or obtained by other techniques other than the technique of this document.

  According to an embodiment of the present invention, there is provided a system or the like that allows an operator to easily handle data of a plurality of recommended injection protocols prepared as described above. For example, when the number of prepared infusion protocol data is too large, more specifically, when the data of, for example, 15 or more infusion protocols is displayed on the display, the operator selects any one of the infusion 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 determined in consideration of the patient's biological information and the like. In view of the above, an embodiment of the present invention provides a drug solution injector and the like in which any one of such a plurality of recommended injection protocols can be easily selected, and the conditions for the injection protocol can be easily changed (adjusted).

For example, the injector console 150 of the present embodiment may display a plurality of candidates for the injection protocol 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 of 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 of these conditions (step S6), and console 150 accepts this input by the operator. It is also preferable that the estimated TDC corresponding to the selected infusion protocol is displayed on the estimated TDC display section 521. That is, the console 150 may be configured to display the estimated TDC corresponding to the selected infusion protocol in the graph of the estimated TDC display unit 521 after receiving the input, whereby the operator can It is possible to easily confirm visually what kind of TDC is the obtained injection protocol.

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

  With the injection protocol candidates and the estimated TDC corresponding thereto displayed as described above, 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, description will be made in order.

(1) Concentration of Contrast Agent In the case where the condition of the injection speed desired by the operator does not exist among the candidates for the injection protocol, the injection speed may be changed by, for example, changing the type of the contrast agent. For example, when the concentration of the contrast agent is changed from 300 mgI / ml to 350 mgI / ml, the amount of the contrast agent to be injected is about 0.85 times (300、350). The injection rate is correspondingly reduced. Such a change in the infusion rate is advantageous, for example, when the infusion rate is too high and if infused under these conditions may damage the blood vessels of the patient.

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

  In another embodiment, when the syringe of the injection head is replaced with another one (for example, from 300 mgI / ml concentration to 350 mgI / ml concentration), the injection head reads the tag information of the syringe, The read concentration information may be automatically set, and the injection speed and the like may be recalculated based on the information.

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

(2) Tube Voltage of Imaging Device The tube voltage does not change the time required for the contrast agent in the TDC to reach the target site or the time required to reach the maximum CT, but has an effect on the horizontal axis (time axis) of the TDC. Do not give. However, it is known that the lower the tube voltage, the higher the CT value on the vertical axis in TDC shifts. For example, the CT value of 100 kV is higher than that of the tube voltage of 120 kV, for example, ascending CT value in the aorta and hepatic parenchyma is higher. The effect will be improved. More specifically, based on a generally used tube voltage of 120 kV, the amount of the contrast agent used to obtain the same TDC as that at 120 kV is 62% at 80 kV, 84% at 100 kV, and 135% at 135 kV. It is described as about 113%. Further, it is described that the relative value of the CT value based on 120 kV 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 the test injection is different from the tube voltage value at the time of the main injection, it is preferable that the operator can make the change.

  Specifically, at 120 kV and 100 kV, the CT value becomes 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) required for imaging and "maintenance time" (30 seconds in one example) for maintaining the density is input. Based on that, multiple injection protocols were sought. Since the change of the tube voltage means the change of the CT value (HU value), when the tube voltage is changed in this way, the "required concentration value" is input again and the calculation is performed again. The injection protocol may be re-determined.

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

The eGFR value can be calculated by the following equation:
eGFR = 194 × (creatinine [mg / dL]) − ^1.094 × (age [years]) − ^0.287
(* 0.739 for women)

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

  The console 150 may display such information on the display 151. In addition, the apparatus has data of a predetermined reference value, compares the read or calculated eGFR value with the reference value, and determines that the eGFR value exceeds the predetermined reference value (that is, the patient's renal function is poor). It is also preferable to be configured to perform at least one of a process of issuing a warning, a process of prohibiting the setting of the injection protocol, and a process of prohibiting the injection of the contrast agent when the temperature is too low to be suitable for the agent injection).

When the eGFR value is less than a first reference value or a reference range (for example, less than 30 (ml / min / 1.73 m ² )) indicating that the eGFR value is at a level unsuitable for performing contrast agent injection. ), A second reference value or a reference range (in an example, 30 or more and less than 45) indicating a level that can be implemented by diluting the contrast agent, and the like. Adjustment may be made such as by reducing the amount according to the level of the eGFR value. Alternatively, the speed may be reduced instead of adjusting the amount.

(3-2) Cardiac Function The heart rate and cardiac output are also factors that influence the contrast effect. Therefore, the liquid injector according to the present embodiment may display information indicating the cardiac function of the patient on the GUI of the display 151.

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

  In this case, the console 150 may be configured to, for example, access electronic medical record information on a network and read information on the patient's cardiac function from 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 to display a warning in the event of heart failure to prompt the operator to set a higher contrast effect (CT value) injection protocol. Good. In addition, a warning that prompts an increase in the injection speed and / or the injection amount may be displayed on the GUI, for example. An icon or the like for changing the injection speed and / or the injection amount is preferably displayed on the GUI, so that the operator can reset the injection protocol on this GUI.

However, when the amount of the contrast agent is determined in consideration of the symptoms of the patient as described above, the amount of the injected contrast agent is larger than usual, and the physical burden on the patient is increased. Then, the console 150 displays the calculated amount of the contrast agent together with a warning message on the display 151, for example, "This case requires XX ml or more of the contrast agent. Do you want to continue?" It is preferable to call attention. Displaying the amount of the contrast agent in this manner is not limited to the case where the symptoms of the patient are taken into consideration, but also the case where the amount of the contrast agent is calculated from the maximum CT value and the tube voltage value of the X-ray tube during the test injection (details will be described later). May be applied.

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

  Therefore, in order to obtain a desired image even for a patient with a larger cardiac output than usual, the liquid injector measures the patient's cardiac output prior to determining the liquid injection conditions. The device may further include a cardiac output meter for measuring the cardiac output of the patient. As an example, the console 150 of the liquid injector 100 may be configured to read data from the cardiac output meter and use the data to correct the contrast agent injection condition.

  In one example, when the injection amount of the contrast agent is corrected by the console 150, the injection speed of the contrast agent and the like are changed accordingly. More specifically, in the correction of the injection amount of the contrast medium in the main injection in consideration of the measured value of the cardiac output of the patient, if the measured cardiac output is larger than usual, The necessary value of the iodine amount I is set to be large according to the measured value of the amount. Conversely, when the measured cardiac output is lower than usual, the necessary value of the iodine amount I is set to be small according to the measured cardiac output.

  The value of the iodine amount I required for the above calculation may be manually set 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 done. Alternatively, if the cardiac output meter is connected to the liquid injector so that data can be transmitted to the liquid injector, the arithmetic unit of the console is required based on the data transmitted from the cardiac output meter. The configuration may be such that the value of the iodine amount I is increased or decreased.

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

  Therefore, in one embodiment of the present invention, the console of the liquid injector may access the electronic medical record information on the network, read the age information of the patient, and display the information on the display.

In particular, for example, the console determines whether or not the patient's age is over a predetermined reference age, and if the age is over the reference age, prohibits infusion of the drug solution at a speed equal to or higher than a predetermined value. It may be configured as follows. As an example,
Displaying a warning if the patient's age is above a certain reference age;
-Determine whether an infusion protocol with a speed higher than a predetermined value is set, and if so, display a warning to that effect or prohibit the injection protocol at such speed It may be configured as follows.

In summary, one embodiment of the injection protocol generator of the present invention can be expressed as follows:
An apparatus for creating an injection protocol for the present injection,
a1: Data of a plurality of recommended injection protocols to obtain an estimated time concentration curve in a production test (“estimated injection TDC”) corresponding to a time concentration curve obtained by performing a test injection (“test injection TDC”). 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) biological information of the patient, (ii) operating conditions of the imaging device, and (iii) operating conditions of the drug solution injection device are set. Means (153, 155) for displaying a graphical user interface (hereinafter, referred to as GUI) including the above on a display;
a4: means (153, 155) for receiving an input of the adjustment item by the operator;
a5: means (155) for subsequently changing the infusion protocol according to the input adjustment item;
An injection protocol setting device (153, 155) comprising:

  The injection protocol setting device is, for example, a1: a recommended injection protocol data preparing unit, a2: a selection input receiving unit, a3: a GUI display unit, a4: an adjustment item input receiving unit, and a5: an injection protocol changing unit. It can be configured as Each unit may be a function realized by a computer program. In the above example, the embodiment in which the “injection protocol setting device” is provided in the injector console has been described, but in another embodiment of the present invention, the “injection protocol setting device” is any computer that constitutes the imaging device. Any computer (other than the injector console) constituting the drug solution injection device, or another computer or terminal can be configured.

  According to the injection protocol setting device of the present embodiment configured as described above, after preparing data of a plurality of recommended injection protocols, (i) patient's biological information, (ii) imaging displayed as a GUI Changes can be made by inputting adjustment items relating to at least one of the operating conditions of the device and (iii) the operating conditions of the liquid injector. Therefore, it is possible to set a more suitable injection protocol for the patient.

(Appendix)
The present specification discloses the following inventions:
A1. A method of setting an injection protocol for injecting at least a contrast agent into a patient,
a1: A plurality of methods for obtaining an estimated time concentration curve (hereinafter, referred to as “main injection estimated TDC”) in a production test corresponding to a time concentration curve obtained by performing test injection (hereinafter, referred to as “test injection TDC”). Providing data for the recommended injection protocol of
a2: accepting an input by an operator to select one of the plurality of recommended infusion protocols;
a3: To adjust the selected injection protocol,
(I) patient's biological information (eg, renal function, cardiac function, age, etc., one of them, any two combinations, or three combinations);
(Ii) information on the contrast agent (for example, iodine amount, etc.),
(Iii) operating conditions (for example, tube voltage value, etc.) of the imaging device, and
(Iv) operating conditions (for example, dilution injection, etc.) of the liquid injector;
Causing a display to display a graphical user interface (hereinafter referred to as a GUI) including adjustment items for at least one of the following:
a4: receiving input of the adjustment item by the operator;
a5: Then, changing the injection protocol according to the input adjustment item.

  In the step a1, the computer may perform calculations by itself to create data of a plurality of recommended injection protocols, or may read data created by another device. Step a2 is usually required, but may be omitted in one embodiment of the present invention.

A2. At least two of the plurality of recommended injection protocol, the contrast agent injection speed, the injection amount, or having the step of displaying on the display in the order of larger or smaller numerical values of the injection time,
Infusion protocol setting method as described above.

A2-1. When the plurality of recommended infusion protocols prepared is large (for example, 15 or more), the computer is provided with a predetermined number (for example, 2 to 10, preferably 2 to 6, more preferably 2 to 6, which is easy for the operator to select). 3-5 protocols) and displaying them on a display.

A2-2. In order to select a predetermined number of protocols, the computer determines whether at least one of the infusion rate, infusion volume, and infusion time included in the recommended infusion protocol is within a reference range, and determines whether the value is outside the reference range (eg, (Not an acceptable rate) the injecting protocol does not show on the display.

A3. Displaying the present infusion estimated TDC corresponding to the selected recommended infusion protocol on the display.
Infusion protocol setting method as described above.

A4. The adjustment item is a concentration of the contrast agent,
further,
If the concentration of the contrast agent has been changed, based on the changed contrast agent concentration, the step of resetting the injection protocol,
Infusion protocol setting method as described above.

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

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

A7. The method for setting a contrast agent injection protocol as described above, wherein the GUI includes an image and / or a character indicating renal or cardiac function of the patient.

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

A9. The method of setting a contrast agent injection protocol as described above, wherein the GUI includes an image and / or a character indicating information on a tube voltage value of an imaging device.

A9-1. A method in which two or more contents selected from the following are displayed in one screen of the GUI:
Information on recommended infusion protocols,
-This injection estimated TDC,
An image for changing the concentration of the contrast agent,
Images and / or text indicating the renal or cardiac function of the patient,
Images and / or text indicating information about the tube voltage value of the imaging device.

A9-2. The method further comprises receiving an input by the operator to change the injection pattern. The changes may specifically 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, the apparatus comprising:
a1: A plurality of methods for obtaining an estimated time concentration curve (hereinafter, referred to as “main injection estimated TDC”) in a production test corresponding to a time concentration curve obtained by performing test injection (hereinafter, referred to as “test injection TDC”). Means for preparing data for recommended injection protocols for
a2: means for receiving an input by the operator for selecting one of the plurality of recommended infusion protocols;
a3: In order to adjust the selected injection protocol, (i) biological information of a patient, (ii) information on a contrast agent, (iii) operating conditions of an imaging device, and (iv) operating conditions of a liquid injector. Means for displaying on a display a graphical user interface (hereinafter referred to as a GUI) including adjustment items relating to at least one of:
a4: means for receiving input of the adjustment item by the operator;
a5: means for subsequently changing the infusion protocol according to the input adjustment item;
An infusion protocol setting device comprising:

C1. An imaging device that captures a fluoroscopic image of a patient,
A liquid injector for injecting at least a contrast agent into the patient,
A medical system comprising:
A medical system, wherein the imaging device or the liquid injector is provided with the injection protocol setting device according to claim 10.

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

  It should be noted that each aspect of the present invention described as the above method can be naturally expressed as the present invention in which devices, systems, and programs are categories.

3. Example of Procedure for Creating and / or Adjusting Infusion Protocol B1. Injection Protocol Setting Considering Imager Tube Voltage This procedure determines the amount of contrast agent in this injection based on the maximum TDC CT value, the tube voltage value of the imager, and the target CT value measured in the test injection. It is to predict. This makes it possible to easily determine an appropriate injection protocol (particularly, the amount of the contrast agent) according to the individual difference between patients. As this procedure, for example, the one disclosed in Japanese Patent No. 5416761 can be used. In one aspect of the invention, the procedures may be used together to create and / or adjust the injection protocol.

The procedure basically involves the following steps:
-Test injection,
Monitoring scans (creation of infusion TDC),
-Calculation of injection volume.

(Overview of device configuration)
The 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. For example, these components may be incorporated in a console that controls the operation of the imaging device (hereinafter, also referred to as “imaging device console”).

The imaging device console obtains transmitted X-ray data obtained by operating the CT device main body. The imaging device console then reconstructs the image based on the data and causes the display device to display a fluoroscopic image. The imaging device console causes the following information to be displayed on the display device:
The maximum CT value (HU) of the TDC of the test injection,
-Time from injection of contrast agent to reaching maximum CT value (time to reach maximum CT value, sec)
Tube voltage value (kV), etc.

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

(Overview of the configuration of the chemical injection device)
The console of the drug solution injector may include an “injection amount calculator”. The injection amount calculation unit may be, for example, an injection amount calculation function realized by a computer program.

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

The method of inputting the "maximum CT value" of the test injection TDC into the console of the liquid injector may be as follows:
The operator manually inputs via the input device the values obtained on the X-ray CT device by the test injection;
-When the liquid injector and the X-ray CT apparatus are configured to exchange data bidirectionally, data is automatically input to the console from the X-ray CT apparatus.

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

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

  On the other hand, as for the tube voltage of the X-ray tube, the lower the tube voltage, the longer the wavelength of the generated X-ray, 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 lower the tube voltage, the higher the maximum CT value. Therefore, by lowering the tube voltage, a desired maximum CT value can be obtained with a smaller amount of the contrast agent. However, when the tube voltage is reduced, the quality of the obtained CT image tends to decrease, so 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 or the like of the test injection TDC will be described.

(Test injection)
First, a test injection is performed by operating the liquid injector. At the same time as the start of the test injection or at an arbitrary timing, a test injection start signal is transmitted from the injector console to the X-ray CT apparatus, and the X-ray CT apparatus executes a monitoring scan after a lapse of a predetermined time from the start of the test injection.

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

  When the monitoring scan is completed, for example, the X-ray CT apparatus transmits a monitoring scan end signal to the drug solution injector. Upon receiving the monitoring scan end signal, the injector console injects a main injection setting screen (GUI) for inputting conditions required for the injection amount calculation unit to calculate the amount of the contrast agent to be injected in the main injection. Display on the console console display device.

  As described above, the "maximum CT value", the "tube voltage value" of the X-ray tube, and the "target CT value" obtained by the test injection are used to determine the amount of the contrast agent injected in the main injection.

  The injection setting screen is a screen (GUI) for receiving input of these data by the operator. However, if the maximum CT value measured by the X-ray CT device in the test injection is configured to be acquired from the X-ray CT device via the interface, the maximum CT value is automatically set to the interface from the X-ray CT device. , And the input by the operator is omitted. As the target CT value, a specific numerical value can be input, or the operator can select one of several modes set in the control unit in advance according to an imaging purpose or the like. Is 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 the tube voltage value of the X-ray tube, and a plurality of buttons for setting the mode of the main injection.

This injection may have three modes: a "standard mode", a "weight loss mode", and a "prediction 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 sufficient sharpness to details.
The “weight loss mode” is a mode for acquiring an image that does not need to be clear to the details and that can provide an overview.
The “prediction mode” is a mode for specifically specifying the maximum CT value to acquire an image.

(About coronary artery diagnosis)
For example, in the diagnosis of the coronary artery of the heart, the "standard mode" is set to a maximum CT value of about 350 HU in an example so as to be suitable for the diagnosis of coronary stenosis and plaque.
In the “weight loss mode”, on the other hand, the maximum CT value is set to about 250 HU so as to be suitable for determining 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 an imaging region and a 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 such that the operator can select from 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 will cause the injector console to perform the main injection based on the "maximum CT value", "tube voltage value", and "target CT value". Calculate the dosage.

  According to the injection protocol setting procedure as described above, individual differences are predicted by predicting the amount of the contrast agent 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. The optimum amount of the contrast agent according to the above can be easily obtained. In addition, the imaging voltage to be applied to the X-ray tube is changed to a value lower than usual according to the purpose of diagnosis, and the contrast is injected during 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 the contrast agent. The test injection is a process that is usually performed prior to the main injection to measure the time required for the contrast agent to reach the imaging site. Therefore, the test injection does not add any additional steps.

B2. Estimation of Contrast Injection Amount of Main Injection Using Results of Test Injection TDC This procedure predicts the amount of contrast agent in the main injection using the maximum CT value of TDC measured in the test injection. is there. As a result, an appropriate injection protocol (particularly, the amount of the contrast agent) can be determined according to the individual difference of the patient. For example, the one disclosed in Japanese Patent No. 5394371 can be used.

  In order to realize this procedure, the liquid injector sets the setting screen (GUI) for the main injection after the test 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, the peak time, and the imaging start time of the main injection may be displayed.

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

Thus, the following proportional equation 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 the increase in the maximum CT value due to this injection,
I _t is, at the time of test injection contrast agent injection amount,
_Ia is the contrast medium injection amount at the time of injection.

However, actually, the imaging site has a certain CT value even if the contrast agent is not injected, and the CT value measured by the CT device is the CT value before the contrast agent is injected. This is the value included. Therefore,
C _T = C _t -C ₀
C _A = C _a −C ₀
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 due to the main injection,
C ₀ is the CT value before the injection of the contrast agent.

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

Thus, by utilizing the proportional relationship between the injection amount of the contrast agent and the maximum CT, the injection amount of the contrast agent and the maximum CT value obtained by the CT device at the time of the test injection are known. In addition, 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
The maximum CT value of the test injection C _t ,
A target maximum CT value C _a to be obtained by the CT device in the main injection,
-CT value C ₀ before injection of contrast agent,
- 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 )
Calculating a contrast medium injection volume I _a during the main injection based on.

Of the data necessary to calculate the contrast medium injection amount 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. Further, as the CT value before the 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 the main injection, in addition to the maximum CT value at the time of the test injection, the elapsed time from the start of the test injection when the maximum CT value is reached at the test injection is input as the peak time. It may be. When the peak time is input, the console may cause the setting screen to display the imaging start time of the main scan executed by the CT apparatus in response to the main injection. This imaging start time can be, for example, two seconds before the peak time of the CT value. Thereby, imaging can be performed in a period including the peak time of the CT value, and a good contrast effect can be obtained. The number of seconds before the peak time of the CT value to start the imaging may be determined in advance, but may be changed by the operator as needed.

  In general, as the injection amount of the contrast agent increases, the time to reach the maximum CT value tends to be slow. Therefore, despite the difference in the injection amount of the contrast agent between the test injection and the main injection, if the imaging timing from the start of the injection of the contrast agent is constant, the imaging time executed by the CT device in response to the main injection is The timing may reach 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 medium injection amount or the like 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 device through the interface, and the CT device executes the main scan in response to the data, for example, for four seconds from the imaging start time.

  Note that the imaging start time after the main injection may be determined in advance in consideration of a time lag between the start of the injection of the contrast agent and the reaching 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 according to 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 agent 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. Normally, the injection amount of the contrast medium in the main injection is larger than that in the test injection, and therefore, the contrast agent is injected at a higher injection rate in the main injection than in the test injection. In the present embodiment, after the contrast medium is injected, a predetermined amount of physiological saline is injected at a preset injection speed.

  After checking 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 driving mechanisms 113 so that the contrast medium and the physiological saline are injected into the patient according to the above-described protocol, whereby the main injection is performed.

  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 performs the main scan after the start of the main injection and after the lapse of the imaging start time set by the liquid injector based on the result of the test injection. By the main scan, a CT image of a patient at a target imaging region is captured.

  According to the injection protocol setting procedure described above, the injection amount of the contrast agent 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 circulating blood volume, cardiac output and vascular resistance of the patient. The optimal injection amount of the contrast agent according to the individual difference can be set very easily. Moreover, the test injection is a process that is usually performed prior to the main injection in order to measure the time required for the contrast agent to reach the imaging site. Therefore, the test injection does not add any additional steps.

B3. TDC analysis using Fourier transform using the results of test injection TDC (background)
In contrast agent injection, if the injection parameters set based on the injection speed or injection amount of the contrast agent are not appropriate, the difference in the density value of the image is small and does not help diagnosis, or conversely, the density value is too high May cause an image without contrast.

  On the other hand, the change in time density (time change in image density) due to the injection of the contrast agent greatly varies depending on the weight of the patient, the disease being carried, and the like. For this reason, the dispersion of the density value and the dispersion of the delay time from the start of the injection of the contrast agent to the appearance of the contrast agent 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 the contrast agent to be used can be appropriately set and that excessive administration will not occur. This is thought to reduce the physical and economic burden on the patient.

Previous work in analyzing TDC has traditionally included the technique of Fleischmann 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, a Fourier transform is applied to a test injection parameter and a time density curve (TDC) based on the test injection parameter, and a relationship of a time density change with respect to the injection of the patient is derived as a “transfer function”. By using the transfer function, a time-concentration curve for an arbitrary injection parameter can be estimated. Conversely, by setting a time-concentration curve required in CT, an optimal injection parameter for obtaining the same can be obtained. It can be estimated.

  In one aspect of the present invention, this theory can be used. Based on this theory, the injection protocol needed to obtain the desired imaging result (TDC) is such that, for example, the injection speed is represented by a complex shape function that varies non-linearly with time. In this case, a fitting process may be performed for an injection protocol (two-phase injection in one example) having a shape that can be practically performed by the liquid injector.

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

  The basic theory for conducting 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, that is, the contrast agent injection function of the device and the time concentration curve obtained thereby. I do.

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

(Analysis and estimation using Fourier transform)
The transfer function G is obtained by previously measuring the test injection function Inj _test of the contrast agent and the test time density curve Enh _test obtained thereby, and using the following equation. Once the transfer function G is determined, a 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

By applying the inverse Fourier transform to the thus obtained Enh _test , a time-domain time-density curve (TDC) is obtained. According to the characteristics of the Fourier transform, an ideal injection function Inj _ideal for obtaining an _ideal time-density curve Enh _ideal can also be calculated.

As an example, when it is desired to obtain a trapezoidal TDC, an ideal injection function Inj _ideal is calculated using an Enh _ideal obtained by Fourier transforming the TDC and a transfer function G, and inverse Fourier transform is performed. Can be used 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 speed calculator, injection protocol generator, injection protocol selection. Department.

The “test time density curve creation unit” focuses on 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 density curve in the region of interest. The created data is stored in a predetermined storage area.

The “estimated time density curve creating unit” reads out the time density curve from the storage area and, based on the test time density curve, corresponds to a plurality of contrast agent injection times (injection time candidates) assumed during the actual inspection. Create an estimated time concentration curve. As an example, this estimated time-density curve is predicted to be observed in the region of interest when the contrast medium is injected into the subject at various injection times, with the injection rate of the contrast medium being equal to the test injection time. FIG. 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 a maximum density value h that can satisfy the predetermined density maintenance time T in each estimated time density curve.

  The concentration maintaining time T may be set by an operator. The density maintenance time T is a time during which the image density of the region of interest is to be maintained at a predetermined 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 speed calculator” reads the maximum density value h obtained for each estimated time density curve from the storage area, and compares each maximum density value h with the required density value H. Based on the comparison result, the injection speed calculation unit calculates the contrast agent injection speed v that can achieve the required density value H for each estimated time density curve (that is, for each injection time). . The calculated plurality of contrast agent injection speeds v are stored in a predetermined storage area in association with the respective injection times.

The “injection protocol creating unit” reads out the calculated plurality of injection speeds v from the storage area and multiplies the calculated injection speeds v by the corresponding injection speeds, thereby obtaining a contrast agent injection amount (= injection speed × injection time). In this way, a plurality of contrast agent injection protocols including a set of the contrast agent injection amount and the 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 an input of the operator. This is stored in a predetermined storage area as a main injection protocol (an injection protocol to be used for the actual inspection). In one example, this injection protocol is passed by the injection controller to the control unit of the automatic injector.

4-2. Estimation of contrast agent 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 amount may be 10 ml. A boost injection of saline is performed as needed. In one example, 20 ml of physiological saline is injected at 5.0 ml / sec (constant rate).

  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 the operation information. Thus, a scan for 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. Image data representing a shadow image is created based on the transmitted X-ray data (step S4).

  Further, a test time density curve creation unit creates a test time density curve 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] to be obtained at the time of actual inspection (200 HU in one example)
(2) Maintenance time T (second) (10 sec in one example)

  Then, as an example, the estimation time concentration curve creating unit, when the injection time is made constant by a value equal to the test injection speed and the injection time is set to a natural number multiple of the test injection time by the superposition processing of the test time concentration curve, An estimated value of the time density curve to be obtained (estimated time density 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 calculates the maximum density value that can maintain the maintenance time T in a plurality of (for example, six) created estimated time density curves (the first one is a test time density curve). The maintenance time T is a time required for imaging by the CT scanner at the time of the actual inspection.

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

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

  In this manner, six (one example) injection protocols represented by a set of the contrast medium injection amount and the 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 one-phase injection in which a constant injection speed 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). .

  Injection conditions include, for example, that the injection amount of the contrast agent is the minimum, that the injection speed of the contrast agent is equal to or lower than a predetermined value, that the injection speed of the contrast agent is the lowest, and that other appropriate Conditions can be set.

When the main injection protocol is determined in this manner, the injection of the contrast agent is performed by the automatic injector according to the main injection protocol, and in synchronization with this, imaging for the actual inspection is performed by the CT scanner.

  It should be noted that the present invention is not limited to the specific embodiments described above, and various modifications can be made without departing from the spirit of the present invention. Further, the mathematical expressions shown in the present specification are merely examples, and a predetermined calculation target may be derived using another mathematical expression or theory.

In other aspects of the invention, the following changes may be made:
(M1) In the above description, the configuration in which the setting screen (graphical user interface) for setting the protocol is displayed on the display of the injection I console has been described. However, the injection head has a sub-display, and the protocol is set there. A setting screen as described above for setting may be displayed.
(M2) Alternatively, the above-described setting screen for setting the protocol may be displayed on a display of the imaging device. That is, in this case, the imaging apparatus provides a graphical user interface, and the operator can set conditions via this interface. It is also preferable that the data of the conditions set on the imaging device side be transmitted to the chemical injection device in a wired or wireless manner, and the setting be performed from the imaging device side.
(M3) The above-described setting for setting a protocol in an arbitrary device (for example, a liquid injector, an imaging device, a database server, or another computer system) in the system to realize the above-described configuration. Screen (graphical user interface) data can be retained.
(M4) In the above, for example, as shown in FIG. 1, the chemical liquid injector in which the injection head and the console are configured separately is shown. However, the following liquid injector may be used:
A liquid injector in which an injection head and a console are integrated, in other words, a single apparatus is used for setting an injection protocol, displaying various states during liquid injection, and controlling the operation of a piston drive mechanism. A liquid injector that can be used.
-The above-mentioned liquid injector in which the injection head and the console are integrated as one housing, further comprising a separate battery unit. Such a battery unit may be an AC power supply, may be installed at any place in the examination room, or may be held by a part of a movable stand.
A liquid injector in which a control unit, such as a miniaturized console (which may for example have one or more buttons and / or a display), is arranged near the injection head; For example, such a control unit is held on a movable stand together with the injection head. Or, for example, such a control unit is held on a ceiling-suspended arm together with the injection head. Alternatively, it is integrated with the injection head.
(M5) In the above description, the drug solution in the syringe 200P was physiological saline, but another diluent may be used.

  Although the “addition method” and the “transfer function method” are used to estimate the main injection TDC, a dynamic model by Bae et al. May be used. Bae et al. Proposes to develop a model for the pharmacokinetics (PK) and kinetics of the contrast agent response and find the function that causes the most uniform arterial enhancement. With 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 of a simplified partition model described by Bae et al. Provides an optimal / constant enhancement in CT imaging procedures by exponentially decreasing the flow rate of the contrast agent. (For example, US Pat. No. 6,059,855 (Japanese Patent No. 4650855)). References relating to estimating TDC of actual injection using a kinetic model or the like include, for example, Japanese Patent No. 3553968 and US Pat. No. 5,687,208. By inferring the TDC, setting an injection protocol using the TDC, and adjusting the injection conditions as described above, an appropriate injection protocol can be set.

  Others include Jacobs' "Control Algorithm Based on Optimal Linear Model Applied to Pharmacokinetic Model-Driven Drug Delivery" and Wada and Ward's "Mixed: Computer-Controlled Infusion Pump. Modeling and simulations, such as "a new pharmacokinetic model".

Reference Signs List 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,
a1: A plurality of methods for obtaining an estimated time concentration curve (hereinafter, referred to as “main injection estimated TDC”) in a production test corresponding to a time concentration curve obtained by performing test injection (hereinafter, referred to as “test injection TDC”). Providing data for the recommended injection protocol of
a2: accepting an input by an operator to select one of the plurality of recommended infusion protocols;
a3: 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;
Causing a display to display a graphical user interface (hereinafter referred to as a GUI) including adjustment items for at least one of the following:
a4: receiving input of the adjustment item by the operator;
a5: then, changing the injection protocol according to the input adjustment item;
A method for setting an injection protocol, comprising: At least two of the plurality of recommended injection protocol, the contrast agent injection speed, the injection amount, or having the step of displaying on the display in the order of larger or smaller numerical values of the injection time,
The method for setting an injection protocol according to claim 1. Displaying the present infusion estimated TDC corresponding to the selected recommended infusion protocol on the display.
The injection protocol setting method according to claim 1 or 2. The adjustment item is a concentration of the contrast agent,
further,
If the concentration of the contrast agent has been changed, based on the changed contrast agent concentration, the step of resetting the injection protocol,
The method for setting an injection protocol according to claim 1.   The contrast agent injection protocol setting method according to claim 4, wherein the GUI includes an image for changing a concentration of the contrast agent. The adjustment item is information on the renal function or cardiac function of the patient,
The injection protocol setting method according to claim 1 or 2.   The method of setting a contrast agent injection protocol according to claim 6, wherein the GUI includes images and / or characters indicating renal function or cardiac function of the patient. The adjustment item is information on a tube voltage value of the imaging device.
The injection protocol setting method according to claim 1 or 2.   9. The contrast agent injection protocol setting method according to claim 8, wherein the GUI includes an image and / or a character indicating information on a tube voltage value of the imaging device. An apparatus for creating an injection protocol for injecting at least a contrast agent into a patient, the apparatus comprising:
a1: A plurality of methods for obtaining an estimated time concentration curve (hereinafter, referred to as “main injection estimated TDC”) in a production test corresponding to a time concentration curve obtained by performing test injection (hereinafter, referred to as “test injection TDC”). Means for preparing data for recommended injection protocols for
a2: means for receiving an input by the operator for selecting one of the plurality of recommended infusion protocols;
a3: In order to adjust the selected injection protocol, (i) biological information of a patient, (ii) information on a contrast agent, (iii) operating conditions of an imaging device, and (iv) operating conditions of a liquid injector. Means for displaying on a display a graphical user interface (hereinafter referred to as a GUI) including adjustment items relating to at least one of:
a4: means for receiving input of the adjustment item by the operator;
a5: means for subsequently changing the infusion protocol according to the input adjustment item;
An infusion protocol setting device comprising: 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 injection protocol setting device according to claim 10,
A drug solution injection device comprising: An injection head to which at least one syringe is attached;
A console operably connected to the infusion head;
The piston drive mechanism is provided on the injection head,
The controller and the injection protocol setting device are provided in the console,
The drug solution injection device according to claim 11. An imaging device that captures a fluoroscopic image of a patient,
A liquid injector for injecting at least a contrast agent into the patient,
A medical system comprising:
A medical system, wherein the imaging device or the liquid injector is provided with the injection protocol setting device according to claim 10. A computer program for setting an injection protocol for setting an injection protocol for injecting at least a contrast agent into a patient,
On the computer,
a1: A plurality of methods for obtaining an estimated time concentration curve (hereinafter, referred to as “main injection estimated TDC”) in a production test corresponding to a time concentration curve obtained by performing test injection (hereinafter, referred to as “test injection TDC”). Providing data for the recommended injection protocol of
a2: accepting an input by an operator to select one of the plurality of recommended infusion protocols;
a3: In order to adjust the selected injection protocol, (i) biological information of a patient, (ii) information on a contrast agent, (iii) operating conditions of an imaging device, and (iv) operating conditions of a liquid injector. Displaying on a display a graphical user interface including adjustment items for at least one of:
a4: receiving input of the adjustment item by the operator;
a5: then, changing the injection protocol according to the input adjustment item;
Computer program for setting the injection protocol.

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