JP6570812B2 - Blood vessel state analysis apparatus and system including the same - Google Patents

Description

  The present invention relates to a blood vessel state analysis apparatus and the like, and in particular, a blood vessel state that can analyze a blood vessel state such as a coronary artery non-invasively using image analysis and can easily evaluate the presence or absence of stenosis or myocardial ischemia. It relates to an analysis device.

  There is a demand for a technique for preventing or diagnosing coronary artery stenosis or ischemia causing heart disease in a non-invasive or minimally invasive manner. Coronary stenosis is a serious lesion leading to ischemic heart disease. As a method for diagnosing this stenosis, for example, a coronary angiography (CAG) using a catheter is known. This coronary angiography is accompanied by contrast medium injection through a catheter, but is a fluoroscopic method for observing the state of the coronary artery under fluoroscopy, and is useful for finding stenosis or occlusion of the coronary artery.

  As an index for diagnosis of organic lesions in the coronary artery, an index called FFR (Fractional Flow Reserve) is known. FFR is defined as the ratio of the maximum coronary blood flow in the presence of stenosis to the maximum coronary blood flow in the absence of stenosis and approximately corresponds to the ratio of the stenotic distal coronary pressure to the proximal stenotic pressure. Since the measurement of FFR uses a pressure sensor provided at the distal end of the catheter, a cardiac catheter examination is still necessary. For example, Patent Document 1 discloses a known technique for measuring an intravascular pressure or the like by cardiac catheter examination and obtaining FFR based on the data.

JP 2014-61268 A

  By the way, it is preferable that the blood vessel state analysis of the coronary artery can be performed by contrast imaging that does not require catheter surgery, because it is minimally invasive and can reduce the burden on the patient and save medical costs.

  One aspect of the present invention has been made in view of the above points, and the object thereof is to analyze a blood vessel state such as a coronary artery non-invasively using image analysis, and to prevent stenosis and myocardial ischemia. An object of the present invention is to provide a blood vessel state analysis device and the like that can easily evaluate the presence / absence and degree.

One aspect of the present invention is as follows:
(1) An apparatus for analyzing a vascular state of a coronary artery based on fluoroscopic data of a coronary angiography examination,
A display device and a control unit;
The control unit is
(A) For at least two coronary arteries, a measured TAG (Transluminal Attenuation Gradient) curve indicating the correlation between a plurality of positions along the direction from the origin to the distal part of each coronary artery and the contrast intensity at each position A blood vessel state analysis unit for creating
(B) a display control unit that displays at least two of the actually measured TAG curves created for each coronary artery together in one graph and displayed on the display device;
A blood vessel state analyzing apparatus.

(2) A device for analyzing a vascular state of a coronary artery based on fluoroscopic image data of a coronary angiography examination,
A display device and a control unit;
The control unit is
(A1) A measured TAG (Transluminal Attenuation Gradient) curve indicating a correlation between a plurality of positions along the direction from the origin to the distal portion of at least one coronary artery and the contrast intensity at each position; a2) A standard curve that is a TAG curve of the coronary artery when it is assumed that there is no severe stenosis is created, and (b) the measured TAG curve is compared with the standard curve, and there is a deviation that exceeds a predetermined value. In this case, the blood vessel state analysis apparatus includes a blood vessel state analysis unit that automatically determines that there is a possibility that severe stenosis exists in the coronary artery.

(3) a: a piston drive mechanism that moves the piston member of the syringe filled with the chemical solution relative to the cylinder member;
b: an apparatus for setting a chemical injection protocol, a computer apparatus having an input device, a display device, a storage unit, and a control unit;
With
The controller is
(B-1) As an injection protocol for analyzing the vascular state of the coronary artery, (i) a contrast agent is used for a predetermined time while monotonously decreasing from a first speed that is an initial speed to a second speed that is lower than the first speed. Basic injection protocol data comprising: a first phase to inject; and (ii) a second phase in which contrast agent injection is then continued for a predetermined time at a constant rate that is the same or substantially the same as the second rate. Read
(B-2) accepting an input by the operator to change and / or confirm the basic infusion protocol;
(B-3) According to the confirmed injection protocol or the injection protocol reflecting the change, the piston drive mechanism is operated to inject the chemical solution.
Configured as a system.

(Explanation of terms)
“Chemical solution” refers to, for example, a contrast agent, physiological saline, or a mixture thereof.
Specific examples of the “contrast agent” include a contrast agent having an iodine concentration of 240 mg / ml (for example, a viscosity of 3.3 Pa · s and a specific gravity of 1.268 to 1.296 at 37 ° C.), and a contrast agent having an iodine concentration of 300 mg / ml ( For example, a contrast agent having a viscosity of 6.1 mPa · s and a specific gravity of 1.335 to 1.371 at 37 ° C. and an iodine concentration of 350 mg / ml (for example, a viscosity of 10.6 mPa · s at 37 ° C. and a specific gravity of 1.392 to 1.37). 433).
Specific examples of “physiological saline” include physiological saline containing 180 mg of sodium chloride in 20 ml of physiological saline (for example, viscosity 0.9595 mPa · s at 20 ° C., specific gravity 1.004 to 1.006). is there.

The “infusion protocol” indicates what kind of chemical solution is to be infused at what amount, at what rate, and at an infusion time.
“Variable injection” refers to injecting a drug solution using an injection protocol including at least a part of a phase in which the injection rate increases or decreases with time.
“Variable constant” refers to the value obtained by dividing the terminal injection rate by the start rate in a phase in which the injection rate increases or decreases with time. For example, if the start speed of the phase is 3.0 ml / sec and the end speed is 1.5 ml / sec, the variable constant is 0.5.

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

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

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

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

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

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

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

“Part (can also be expressed as“ element ”or“ module ”or the like” ””. In this specification, for example, “(function name)” + “part” can be realized as a function realized by a computer. Is. Such “parts (elements), modules, etc.” may be provided in any device in the system. In addition, it is not always necessary to have one device, and the corresponding function may be distributed to two or more devices. Furthermore, only one or more predetermined “units” may be provided in an external server or the like via a communication network (for example, the Internet).

  Note that the various components (devices, apparatuses, units, modules, and the like) referred to in this specification do not have to be independent of each other, and a plurality of components are configured as a single member. One component is composed of multiple members, one component is a part of another component, part of one component overlaps part of another component , Etc. The various components only have to be configured to realize their functions, and may be realized by hardware or realized by a computer program. For example, a certain component can be realized as dedicated hardware that exhibits a predetermined function, a setting device in which the predetermined function is realized by a computer program, a combination thereof, or the like.

A “graphical user interface” (GUI) is defined by visually touching one or more icons, image buttons, pull-down menus, numerical input windows, etc. on the screen with a cursor or in the case of a touch panel. This means an interface that can be operated manually.

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

(I. General description of the chemical injection device)
In one embodiment, the “chemical solution injector” includes the following components: a piston drive mechanism, a control unit (control unit), a display device (display), and the like. Here, the control unit (control unit) and the display device (display) may be provided in any device constituting the chemical liquid injector. That is, when the chemical liquid injector includes an injection head, a console, and the like, (i) the injection head may include a piston drive mechanism, and the console may include a control unit and a display. And a console may be provided on both the console and (iii) a display may be provided on both the injection head and the console. Such a control unit (control unit) may be provided as a part of an imaging apparatus such as a CT scanner, an MRI apparatus, a PET apparatus, an ultrasonic diagnostic apparatus, or an angiographic imaging apparatus. In addition, the control unit (control unit) may be provided as a stand-alone terminal that is neither an imaging device nor a chemical liquid injector.

  In order to calculate the injection amount of the contrast agent, the patient's weight, the required iodine amount, and the iodine concentration are input in one example, and using these input data, the computer injects the contrast agent in the main injection. The amount may be calculated. Some of these pieces of information may be manually input by an operator, read from an IC tag of a syringe, or information in an external server (such as an electronic medical record of a hospital system) ).

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

  The chemical injection device or injection head may have one or more of the following: one or more pressure sensors, one or more syringe detection sensors (magnet sensors, Hall sensors, etc.), One or more tilt sensors, one or more rotary encoders, one or more motor current detectors, etc.

-Pressure sensor: A pressure sensor is for detecting the pressure which pushes a piston member, for example, By this, the pressure estimated value of a chemical | medical solution can be calculated | required. The pressure sensor may be a load cell, for example. The load cell should just be provided in the position which can detect the pressure which the ram member of a piston drive mechanism pushes a piston member. For example, when calculating the estimated value of the pressure of the chemical solution when injecting the chemical solution using the detection result of the load cell, the calculation is performed by calculating the resistance of the injection circuit (eg, the size of the needle), the concentration of the chemical solution, the injection It may be performed in consideration of conditions. In another aspect, a pressure sensor that directly detects the pressure of the chemical solution may be included.

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

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

Rotary encoder: A rotary encoder or the like for detecting the rotation speed and / or rotation direction of the motor of the piston drive mechanism and the feed screw may be provided.
Motor current detector: It is also possible to calculate the estimated pressure value of the chemical based on the motor current without using a load cell or the like. In this system, the motor current is monitored by the motor current detector during operation of the motor, and the estimated pressure value of the chemical solution is obtained based on the motor current.

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

Display: A display for displaying predetermined information may be provided in the injection head. The display may be provided, for example, in a part of the casing of the injection head. Or the display prepared separately from the housing | casing may be sufficient. The display may be a display unit using an LCD (Liquid Crystal Display), an organic EL (Organic Electro-Luminescence) display, or the like, but may be a display unit using an LED (Light Emitting Diode). The contents displayed on the display are not particularly limited, but may be as follows: a predetermined state display during the injecting operation, conditions for injecting the liquid to be injected, conditions for injecting the liquid to be injected, liquid chemicals to be injected Injection volume, chemical pressure, injection speed, etc.

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

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

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

Data receiver: The data receiver is for receiving data transmitted from the outside to the injection head or the like by wire or wireless. For example, the data receiver may receive the following data from the outside: arbitrary data generated by the imaging device, arbitrary data generated by the hospital system, and the like.

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

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

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

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

  According to the present invention, it is possible to provide a blood vessel state analysis apparatus and the like that can analyze a blood vessel state such as a coronary artery non-invasively using image analysis, and can easily evaluate the presence or degree of stenosis or myocardial ischemia. it can.

It is a figure showing typically composition of a medical system concerning one form of the present invention. It is a perspective view which shows the structural example of a chemical injection device. It is a perspective view which shows an injection | pouring head and the chemical | medical solution syringe with which it is mounted | worn. It is a block diagram of a chemical injection device and an imaging device. It is a block diagram which shows the structure of the injection | pouring process part implement | achieved by the program. It is a figure which shows each part of the heart. It is a figure for demonstrating an aorta and a coronary artery. FIG. 6 is a schematic diagram for explaining a relationship between a distance from a starting portion and a CT value, which is displayed by linearly coronary artery by image processing. It is a graph which shows typically two examples of a TAG curve. It is a flow of vascular state analysis concerning one form of the present invention. It is the flow of the vascular state analysis which concerns on the other form of this invention. This is an example in which three TAG curves of coronary arteries are displayed in one graph. It is a graph which shows typically some examples of a nonlinear TAG curve. It is a graph which shows typically some examples of a substantially arch-shaped TAG curve. It is a plan graph which shows an example of the injection | pouring protocol for the vascular state analysis of a coronary artery. It is a flowchart which shows simply the procedure from the setting of an injection protocol to injection execution.

1. System Configuration FIG. 1 is a diagram schematically showing a configuration of a medical system according to an embodiment of the present invention. As a medical system, for example, a CT scanner 300 that is an imaging device, a HIS 360 that is a medical chart management device, a RIS 370 that is an imaging management device, a PACS 380 that is a data storage device, a chemical injection device 100 that injects a contrast medium or the like to a patient, A blood vessel state analysis apparatus 700 that analyzes a blood vessel state, a network 350 that connects these devices, and the like are provided.

  A HIS (Hospital Information System) 360 is a computer on which a dedicated computer program is installed, and has a chart management system. The electronic medical record managed by the medical record management system includes, for example, data such as a medical record ID that is unique identification information, a patient ID for each patient, personal data such as a patient's name, medical record data related to a patient's disease, and the like. There may be. In the medical record data, the patient's weight, sex, age, and the like may be registered as personal condition data related to the overall treatment.

  An RIS (Radiology Information System) 370 manages imaging order data for imaging fluoroscopic image data of a patient with unique identification information. The imaging order data may be created based on an electronic medical record acquired from the HIS. The imaging order data includes, for example, imaging work ID that is unique identification information, work type such as CT imaging and MR imaging, patient ID and medical record data of the above-described electronic medical record, identification information of CT scanner, date and time of start and end of imaging It may include data such as a body classification or an imaging region, an appropriate type consisting of a chemical solution type such as a contrast medium corresponding to the imaging work, and an appropriate ID consisting of a chemical ID suitable for the imaging work.

A PACS (Picture Archiving and Communication Systems) 380 receives fluoroscopic image data provided with imaging order data from the imaging device and stores it in a storage device.
[A. Imaging device]
The imaging apparatus is, for example, an X-ray CT scanner, and includes an imaging unit 303b that captures a fluoroscopic image of a patient, a bed 304 on which the patient is placed, and a control unit 303a that controls the operation thereof, as shown in FIG. It may be a thing.

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

[B. Chemical injection device]
The chemical injection device 100 will be described with reference to FIGS.

  The chemical injection device 100 according to an embodiment of the present invention includes, for example, an injection head 110 held on the upper part of a movable stand 111 and a console 150 connected to the injection head 110 by a cable 102. In this example, two syringes 200C and 200P are detachably attached to the injection head 110 in parallel. Note that the injection head and the console may be connected in a wireless manner.

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

(B1. Syringe)
Examples of the chemical solution filled in the syringes 200C and 200P (see FIG. 3) include a contrast medium and physiological saline. For example, one syringe 200C may be filled with a contrast medium, and the other syringe 200P may be filled with physiological saline.

  The syringe 200 includes a hollow cylindrical cylinder member 221 and a piston member 222 that is slidably inserted into the cylinder member 221. The cylinder member 221 may have a cylinder flange 221a formed at the base end portion thereof and a conduit portion 221b formed at the tip end portion thereof. By pushing the piston member 222 into the cylinder member 221, the chemical solution in the syringe is pushed out through the conduit portion 221b. The syringe may be a prefilled type that is pre-filled with a chemical solution, or may be a suction type that sucks and uses a chemical solution in an empty syringe.

  An extension tube 230 is connected to the conduit portion 221b of each syringe 200. The extension tube 230 may be a so-called T-shaped tube or Y-shaped tube. The tube 231a extends from the conduit portion 221b of one syringe 200C to the branch portion, and the tube extends from the conduit portion 221b of the other syringe 200P to the branch portion. It may have 231b and the tube 231c extended toward a patient from a branch part. For example, an injection needle is connected to the distal end side (not shown) of the tube 231c. This injection needle is punctured into a patient's blood vessel, and the chemical solution is injected into the blood vessel by pushing out the chemical solution in the syringe 200C and / or the syringe 200P. In addition, even if the mixing device (one which produces a swirl flow inside and mixes the chemicals in one example) is used as the extension tube at the junction of the first chemical and the second chemical Good.

  As shown in FIG. 4, an IC tag 225 may be attached to a part of the cylinder member 221. The IC tag 225 includes information on the syringe (syringe identification information, syringe pressure resistance, cylinder member inner diameter, piston member stroke, etc.), information on the chemical solution filled in the syringe (name (for example, product name), Component information such as iodine amount, expiry date, chemical volume, etc.) may be stored. The IC tag may have a unique ID unique to the tag. The IC tag may have at least one information selected from a syringe size, a syringe serial number, and a drug standardization code. As the IC tag, for example, an RFID (Radio frequency identification) tag can be used. The position where the IC tag is affixed may be, for example, the outer peripheral surface of the cylinder member, and specifically, may be near the cylinder flange on the outer peripheral surface.

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

(B2. Injection head)
As shown in FIG. 3, the injection head 110 has a casing that extends long in the front-rear direction as an example, and two recesses in which syringes 200 </ b> C and 200 </ b> P are placed on the top end side of the casing, respectively. 120a is formed. The recessed part 120a is a part that functions as a syringe holding part.

  The syringe 200 may be directly attached to the recess 120a or may be attached via a predetermined syringe adapter. In FIG. 3, the cylinder flange 221a of each syringe 200 and the syringe adapters 121 and 122 holding the vicinity thereof are illustrated as an example. The shape and function of the syringe adapter are not limited to a specific one, and may be anything.

  As shown in FIGS. 3 and 4, the injection head 110 has a piston drive mechanism 130 having at least a function of pushing the piston member 222 of the syringe 200. Two systems of piston drive mechanisms 130 are provided, and each mechanism 130 operates independently. The piston drive mechanism 130 may have a function of retracting the piston member 222, for example, for sucking a chemical solution into the syringe. The two piston drive mechanisms 130 may be driven simultaneously, or may be driven at different timings.

  Although not shown in detail, the piston drive mechanism 130 is connected to a drive motor (not shown), a motion conversion mechanism (not shown) that converts the rotational output of the drive motor into a linear motion, and the motion conversion mechanism. It may have a syringe presser (ram member) for moving the piston member 222 forward and / or backward. As such a piston drive mechanism, a known mechanism generally used in a chemical liquid injector can be used. An actuator other than the motor may be used as the drive source.

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

  The piston drive mechanism 130 may have a load cell (not shown) for detecting the force with which the ram member presses the piston member 220. For example, the estimated value of the pressure of the chemical solution when the chemical solution is being injected can be obtained using the detection result of the load cell. The calculation of the estimated value is performed in consideration of the needle size, the concentration of the drug solution, the injection conditions, and the like. In addition, instead of using a load cell (not shown), the pressure may be calculated based on a motor current of a drive motor (not shown).

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

  As shown in FIG. 4, the injection head 110 may include a control unit 144 for controlling operations of the piston drive mechanism 130 and the reader / writer 145. In addition, for example, a storage unit 146 that temporarily stores information read from the IC tag 225 may be included. The control unit 144 can be configured as a control circuit having a processor, a memory, and the like.

  A plurality of physical buttons for causing the injection head 110 to perform various operations are also provided on the top and side surfaces of the casing of the injection head 110. For example, some of these physical buttons may be configured to emit light in order to notify the operator of predetermined information.

(B3. Console)
For example, the console 150 may be used by being placed in an operation room adjacent to the examination room. The console 150 includes a display device 151 that displays a predetermined image, an operation panel 159 provided on the front surface of the casing, a control circuit (detailed below) disposed in the casing, and the like. The operation panel 159 is a portion where one or a plurality of physical buttons are arranged, and is operated by an operator. The display device 151 may be a touch panel display device or a simple display device. The console 150 may include a speaker or the like (not shown) for outputting sound and / or sound.

  In the block diagram of FIG. 4, the console 150 is connected to a control unit 153 that controls the operation of each connected unit, an injection processing unit 155, a storage unit 154 that stores various data, and a predetermined external device. It is drawn as having an interface to do. The console 150 may have an input device 157 (not shown in FIG. 1) such as a hand unit operated by the operator.

  The injection processing unit 155 is a part that controls creation of an injection protocol, execution of injection, etc. As an example, as shown in FIG. 5, a setting screen display unit 155a, an injection protocol creation unit 155b, an injection control unit 155c, a history A generation unit 155d and a history output unit 155e are included.

  The setting screen display unit 155a may correspond to a function for causing the display device 151 to display information for setting an injection protocol, specifically, a GUI for setting an injection protocol. The GUI for setting the injection protocol may be stored in any storage device of the chemical solution injection device, the imaging device, or other computer.

  For example, the protocol creation unit 155b may correspond to a function of accepting an input operation to the touch panel of the display device 151 by an operator and creating an injection protocol reflecting the contents. The conditions input by the operator in this way are, for example, at least selected from the type of the chemical solution, the injection rate of the chemical solution, the injection amount of the chemical solution, the patient's physical information, the body classification of the patient to be imaged, the imaging region, and the like. There may be one.

  The injection control unit 155c may correspond to a function of controlling the operation of the piston drive mechanism 130 according to the created injection protocol. The injection control unit 155b may operate only one of the piston drive mechanisms 130 and simultaneously operate both.

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

  The history output unit 155e may correspond to a function of transmitting injection history data to the outside. Specifically, data may be transmitted to a predetermined external device and / or network. Information on the liquid medicine obtained from the IC tag of the syringe or manually input by the operator or input from an external network or the like is transmitted from the liquid injector to the medical information system in the hospital. A system configuration in which a system having an accounting processing function performs accounting processing based on the information is also possible.

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

  The storage unit 154 may store, for example, images displayed on the display device 151, GUI data, and the like. Further, an algorithm including a calculation formula for setting injection conditions, and data of injection protocol may be stored. The injection rate may be constant or may change with time. In the case of injecting contrast medium and physiological saline, information on the order of injecting these drug solutions is also included in the injection protocol. Information regarding such an injection protocol may be input from an external device connected via an interface. The console 150 may have a slot (not shown) and may be input through an external storage medium inserted therein.

(B4. Example of general operation)
As an example, the chemical liquid injector according to the present embodiment may operate as follows. Needless to say, the order of the following procedures can be changed as appropriate.

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

  Thereafter, as an example, when the operator operates a predetermined button of the console 150, one or more screens for setting the injection protocol are displayed on the display device 151. In the present embodiment, it is also preferable that a GUI for setting an injection protocol for analyzing a coronary vascular state as described later is displayed.

In this screen, at least one of the following parameters may be entered, selected or changed:
-Body segment to be imaged-Site to be imaged (referred to as imaging site)
-Information such as patient weight-Type of medicinal solution to be injected, etc. Images for selecting these parameters may be displayed sequentially or collectively. The input, selection, or change of the parameters as described above may be automatically performed according to the function of the apparatus, or may be performed by the operation of the operator.

  When setting a protocol for a coronary vascular state analysis test as in one embodiment of the present invention, for example, simply selecting a vascular state analysis test (ie, without selecting a body segment or a part) , It may be configured to be in a predetermined setting mode. Of course, it may be in the order of selecting a blood vessel state analysis test after selecting a body classification and a part selection.

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

  Regarding the method of (ii), as an operation to plot the reference point on the injection graph, a reference point is created by directly touching an arbitrary position in the graph (or an arbitrary grid point in the graph). Or a method of creating a reference point through an operation on a predetermined pop-up screen. “Reference point” refers to, for example, the position of the end of a graph-like line segment representing the injection rate.

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

[C. Blood vessel state analyzer
In the present embodiment, for example, the blood vessel state analysis apparatus 700 is configured as a terminal such as a workstation. In addition, although the blood vessel state analysis apparatus 700 may be provided in the console 150 of the chemical injection device 100, in the following description, it will be described as a stand-alone terminal as shown in FIG.

  Specifically, the blood vessel state analysis apparatus 700 may include a part or all of the following configurations: a system control unit 705 that performs overall control of the apparatus, a blood vessel state analysis unit 701, and a display control unit. 702, a display device 711 for displaying information, an input device 712 that enables various inputs from an operator, a storage unit 715 that is a storage device, and one or a plurality of interface I / Fs 720 for communication with external devices ,etc. Although not limited thereto, the system control unit 705, the blood vessel state analysis unit 701, and the display control unit 702 may be provided as one unit (this is referred to as “control unit 710”).

  The system control unit 710 is an example, and may include a processor having a CPU, a memory, a computer program, and the like. The system control unit 705 receives a predetermined input that has entered through the interface I / F 720 or the input device 712, and accordingly, for example, a blood vessel state analysis unit 701, a display control unit 702, a display device 711, and a storage unit 715. To perform a predetermined operation.

  The blood vessel state analysis unit 701 and the display control unit 702 are, by way of example, equivalent to various functions performed by the CPU according to a computer program, and may be provided as software functions, for example.

  The display device 711 may be any device that can display information, but may be a liquid crystal display (LCD), for example. The number of display devices 711 is not particularly limited, and may be one or more.

  The input device 712 may be one or more selected from a keyboard, mouse, trackball, voice input, graphical user interface, and the like. A command from a doctor or the like is input through the input device 712. In the case of a touch panel display device, the touch panel serves as the input device 712.

  Although not shown, the blood vessel state analysis apparatus 700 may have a unit (for example, a slot into which a medium is inserted) that can read data from a computer-readable medium in a contact type or a non-contact type. . The computer-readable medium may store a predetermined computer program for using a general-purpose computer as a blood vessel state analyzing apparatus according to an aspect of the present invention.

(C1. About vascular condition analysis)
First, a basic concept of TAG (Translucent Attenuation Gradient) analysis used in blood vessel state analysis according to one embodiment of the present invention will be described.

  FIG. 6 is a diagram showing each part of the heart, and FIG. 7 is a diagram for explaining the aorta and the coronary arteries. The “coronary artery” is a blood vessel that branches right and left from the base of the aorta and extends along the surface of the myocardium, and supplies oxygen-rich blood to the heart. The coronary artery has two main arteries, a left coronary artery (LCA) and a right coronary artery (RCA). The left coronary artery is further divided into two parts, a left anterior descending branch (LAD) and a left circumflex branch (LCX). These thick arteries branch off like a tree branch and gradually become thin arteries that run outside the heart and then become thin blood vessels that extend inward, thereby sending blood to the entire myocardium. In this specification, for convenience of explanation, each of the left anterior descending branch (LAD) and the left circumflex branch (LCX) is also treated as a “coronary artery”.

  Examples of diseases in these coronary arteries include arteriosclerosis. That is, when fat such as cholesterol is deposited on the inner wall of the blood vessel, a swell (plaque or the like) is formed inside the blood vessel, which causes the blood vessel to become stenotic. The thickness (inner diameter) of the main blood vessels of normal coronary arteries is usually about 3 to 4 mm. However, if the plaque becomes larger and the blood vessel lumen becomes narrower, sufficient blood cannot be sent to the myocardium. Chest pain appears (this condition is called angina). Furthermore, when the plaque is broken, a thrombus is formed, the blood vessel is clogged, and the blood flow cannot be sent to the myocardium. This condition leads to necrosis of the myocardium, which is called myocardial infarction.

(About FFR: Fractional Flow Reserve)
As a method for analyzing the vascular state of the coronary arteries, an examination using the coronary flow reserve ratio (FFR) as an index has been conventionally known. FFR is an index that estimates how much blood flow is blocked by a stenotic lesion when there is a stenotic lesion in the coronary artery. In this examination, generally, a pressure wire is inserted into a coronary artery while instilling a coronary artery dilator, and the FFR is calculated by measuring the pressure of each part. Specifically, FFR can be obtained as FFR = Pd / Pa by measuring the pressure (Pa) and the pressure at the distal part (Pd) closer to the stenotic lesion in the coronary artery. For example, when FFR is about 0.75 or less, it is determined that percutaneous coronary intervention needs to be applied.

(About TAG)
In a TAG (Transluminal Attenuation Gradient) examination used in one embodiment of the present invention, a cardiac catheter examination is unnecessary. In the TAG examination, first, a contrast agent is injected into a venous blood vessel of a patient under predetermined injection conditions.

  The injection of the contrast agent can be performed using a chemical solution injection device (see FIGS. 1 to 3 etc.) as described above. As an injection condition, in one example, it is preferable that the entire coronary artery (that is, the whole from the origin to the distal part) is dyed substantially uniformly. In order to achieve this, more specifically, It is also preferred that the injection conditions be such that the left ventricle is greater than or equal to a predetermined CT value over a predetermined time. A detailed example of the injection conditions will be described later separately.

  FIG. 8 is a diagram schematically showing a state in which the coronary artery is dyed with a contrast medium. In this figure, the bent coronary artery is linearly deformed and displayed by image processing. The left side of the figure is the starting part, and the right side is the distal part. It is assumed that there is a stenosis portion at a position a1 approximately in the middle of the coronary artery.

  FIG. 9A shows a TAG curve when there is no stenosis or when it is not severe, and FIG. 9B shows a TAG curve when there is severe stenosis. In these graphs, the horizontal axis represents the distance from the origin of the coronary artery, and the vertical axis represents the CT value (HU: Hunsfield Unit) at each position of the coronary artery (for example, at intervals of several mm). These graphs show how the CT value changes depending on the distance from the origin of the coronary artery.

  In order to create a TAG curve, for example, based on a captured image of an actual coronary artery as shown in FIG. 8, for example, CT values at the central position of the blood vessel are measured at intervals of several mm, and these are displayed on the graph. Plot to. The TAG curve may be obtained by creating an approximate curve based on these plots, and the approximate curve may be either a linear or non-linear curve.

  When there is no severe stenosis in the coronary artery, the TAG curve gradually decreases as shown in FIG. 9A (primary curve in this example). On the other hand, when there is a severe stenosis, the TAG curve is a curve that decreases steeply as shown in FIG. This is because the blood flow is inhibited and delayed due to stenosis and changes. The TAG curve has such a characteristic that its inclination changes depending on whether or not the stenosis of the coronary artery is present, and therefore, the stenosis state can be estimated based on the degree of this inclination.

(I. Data analysis example: automatic judgment)
The blood vessel state analysis apparatus 700 according to an embodiment of the present invention automatically determines whether or not there is a severe stenosis in the coronary artery based on an actual imaging result. This will be described with reference to the flowchart of FIG. Note that the order of steps in this flowchart is not particularly limited to the present invention, and the order can be changed as appropriate. Further, an example of displaying a plurality of coronary artery TAG curves on a graph instead of automatic determination will be described later as another form.

  As a premise, a contrast medium is injected into a patient under a predetermined injection condition (details will be described later), and imaging by the CT scanner 300 is performed in a state where the contrast medium has reached the coronary artery, and coronary artery imaging data is obtained. And

  In this state, the blood vessel state analysis apparatus 700 acquires imaging data obtained by imaging with the CT scanner 300 (step S1). Specifically, for example, when a predetermined input is input from the operator via the input device 712, the system control unit 710 uses it as a trigger from an external device in which imaging data is stored via the interface 720. To read data into the device. As the imaging data, data stored in the storage device of the CT scanner 300 may be read, or data stored in the PACS 380 may be read.

  Next, the blood vessel state analysis apparatus 700 measures the CT value of each part of the coronary artery based on the acquired imaging data of the coronary artery (step S2). Specifically, for example, the blood vessel state analysis unit 701 performs processing of “blood vessel position extraction”, “CT value measurement”, and “table creation”.

  In “blood vessel position extraction”, the coronary artery of interest is extracted, and the position at which the CT value is measured is determined every predetermined distance from the origin (for example, at intervals of several mm). The measurement position is preferably determined automatically by a computer, but in one embodiment, the operator may manually select the measurement position. In “CT value measurement”, the CT value (HU) at each measurement position is measured. In “table creation”, a data table of correlation data between each measurement position (that is, the distance from the start of the coronary artery) and CT value obtained as described above is created.

  Next, in step S3, “TAG curve creation”, “standard curve reading” and the like are performed. In “TAG curve creation”, based on the correlation data obtained above, an approximate curve is created using, for example, a least square method, a moving average method, etc., and a TAG curve is obtained. Thereby, a TAG curve based on actual imaging data (this is referred to as “actually measured TAG curve”) is created.

  On the other hand, in “read standard curve”, data of a TAG curve (referred to as “standard curve”) when there is no severe stenosis is read. The standard curve may be created with one or more physical characteristics such as patient age, gender, weight, etc. as parameters, or at least based on the patient's previous test data It may be a patient specific curve. Then, as shown in FIG. 9B, a graph including a standard curve and an actual measurement TAG curve is created. According to the present embodiment, since a standard curve and a TAG curve created based on actual measurement data are displayed in the graph, the doctor can determine whether or not the target coronary artery state is normal. There is an advantage that it is easy to judge. The fact that the measured TAG curve is close to the standard curve suggests that there is a high possibility that there is no severe stenosis in the coronary artery.

  In the present embodiment, a comparison determination step for supporting such a determination may further exist as step S4. In step S4, the blood vessel state analysis unit 701 automatically determines whether or not the target coronary artery is estimated to include severe stenosis. This is an example, and the blood vessel state analysis unit 701 determines the degree of deviation of the measured TAG curve from the standard curve. If the degree of deviation is greater than a predetermined reference value, it is determined that severe stenosis is estimated. Otherwise, it may be determined that severe stenosis is not estimated. As a method for viewing the “degree of divergence”, for example, a determination may be made by comparing the slopes of TAG curves (as a specific example, the coefficient a when y = ax + c).

  The result of the automatic determination performed by the blood vessel state analysis unit 701 as described above may be displayed as character information and / or image information on the display device 711 as an example. Such a display can be useful information for the diagnosis of a doctor who performs image diagnosis.

(II. Data analysis example: TAG curve display of multiple coronary arteries)
The blood vessel state analysis apparatus 700 according to another embodiment of the present invention creates and displays a graph including a plurality of coronary TAG curves based on actual imaging results. This will be described below with reference to the flowchart of FIG. Note that the order of steps in this flowchart is not particularly limited to the present invention, and the order can be changed as appropriate.

  First, in step S <b> 11, the blood vessel state analysis apparatus 700 acquires imaging data obtained by imaging with the CT scanner 300. Since this step can be basically performed in the same manner as step S1 in FIG. 10, duplicate description is omitted.

  Next, in step S12, CT value analysis is performed for a plurality of coronary arteries. In one example, the right coronary artery (RCA), the left anterior descending branch (LAD), and the left swirl branch (LCX) may all be targeted. Alternatively, only two selected from the right coronary artery (RCA), the left anterior descending branch (LAD), and the left turning branch (LCX) may be targeted. For each coronary artery, processing of “blood vessel position extraction”, “CT value measurement”, and “table creation” is performed in the same manner as in step S2 of FIG.

  Next, in step S13, an actual measurement TAG curve is created for two or three coronary arteries. In step S14, the display control unit 702 (see FIG. 1) causes the display device 711 to display an image of a graph on which measured TAG curves of a plurality of coronary arteries as illustrated in FIG. 12 are displayed.

  According to the above-described form, as illustrated in FIG. 12, the measured TAG curves of the respective coronary arteries are displayed in one graph, so that the doctor compares the TAG curves of the respective coronary arteries. However, it becomes easier to diagnose which coronary artery may have a stenosis and how much the stenosis is. For example, when the slope of the TAG curve of the left anterior descending branch (LAD) is steeper than the TAG curve of the right coronary artery (RCA) or the left swirl branch (LCX), the stenosis occurs in the left anterior descending branch (LAD). Can be guessed.

  In order to perform a method for diagnosing the presence or absence of stenosis by comparing the measured TAG curves of coronary arteries, it is not always necessary to display the TAG curves of all three coronary arteries. It is good also as a structure which displays only a TAG curve.

In addition to the above, another form of the present invention may be as follows:
(A1) In the above embodiment, the TAG curve is linear, but it may be a non-linear, curved TAG curve. For example, the actually measured TAG curve in FIG. 13A is bent near the site a1 where the stenosis is present (that is, the slope of decrease after a1 is steep), and this is the stenosis. It is suggested. Further, for example, in the actually measured TAG curve of FIG. 13B, the CT value drops significantly in the vicinity of the portion a1 where the constriction is present, and thereafter, it is a crank-like curve that decreases relatively gradually. Further, for example, in the actually measured TAG curve of FIG. 13C, the CT value partially decreases in the vicinity of the portion a1 where the stenosis portion is present, and after passing this portion, the CT value slightly increases and then decreases relatively gradually. It becomes the curve of the shape that becomes.

(A2) In any of the above TAG curves, the CT value in the vicinity of the origin of the coronary artery is the highest, and the CT value tends to gradually decrease toward the distal side. Depending on the injection conditions of the agent (that is, depending on the concentration distribution of the contrast agent in the coronary artery), a TAG curve having a tendency as shown in FIG. 14 may be assumed. In this example, the CT of the intermediate portion is higher than that of the origin and the distal portion of the coronary artery, and the curve is generally arched as a whole.

  Even in such a case, the measured TAG curve and the reference curve are displayed (FIG. 14 (a)), or the TAG curves of two or three coronary arteries are displayed as in the above-described embodiment. It may be displayed (FIG. 14B).

(C2. Example of procedure for creating injection protocol)
In the coronary vascular state analysis test as described above, the contrast agent injection condition is also important. That is, in one form, it is preferable to set an injection protocol so that the coronary artery is uniformly dyed from the origin to the distal part. For this purpose, for example, the injection conditions may be such that the left ventricle is equal to or higher than a predetermined CT value over a predetermined time. In one form of the present invention, an infusion protocol for coronary vascular state analysis testing as shown in FIG. 13 is used. FIG. 13 is a graph showing the relationship between the injection speed (vertical axis) and the injection time (horizontal axis) of the chemical solution.

As shown in FIG. 13, in this injection protocol, contrast agent and saline are injected under the following conditions:
(I) the first phase (from the time _{t 0} to time _{t 1):}
Inject only contrast agent. The injection rate monotonously decreases linearly or non-linearly from rate Vc ₀ to rate Vc ₁ . The speed Vc ₀ may be, for example, 5.0 ± 1.0 ml / sec, and the speed Vc ₁ may be, for example, 3.0 ± 0.5 ml / sec. As a preferred example, the speed Vc ₀ is 5.0 ml / sec and the speed Vc ₁ is 3.0 ml / sec. “Monotonically decreasing” includes not only a mode in which the injection rate increases / decreases linearly but also a mode in which the injection rate is curved or stepped but increases / decreases substantially linearly.

(Ii) Second phase (from time t ₁ to time t ₂ ):
Subsequently, only the contrast medium is injected. Identical or substantially identical infusion rate and velocity Vc _1, or may be a speed of about speed Vc ₁ ± 0.5ml / sec. “Substantially the same” includes a case where the difference between one speed and the other speed is, for example, within 10%.

In the infusion protocol of FIG. 15, time t ₀ may be, for example, a 0 second point. Or, if performed following a predetermined chemical liquid injector, the time t ₀ may be any point on the time axis. The length of the first phase depends on the amount of contrast medium to be injected, etc.
The amount of the contrast agent may be about 30 to 50 ml, preferably 40 ml ± 5 ml, and the length may be injected. The length of the second phase also depends on the amount of contrast medium to be injected, but as an example, it may be about 15-30 ml, preferably 20 ml ± 5 ml, and the length can be injected.

(Iii) _(t 3 from the time _{t 2} time) Phase 3:
Inject only saline. Identical or substantially identical infusion rate and velocity Vc _1, or may be a speed of about speed Vc ₁ ± 0.5ml / sec. The amount of physiological saline to be injected is an example, and may be in the range of 10 to 30 ml.

  With such an injection protocol, the contrast medium is injected from the vein, so that the left ventricle of the patient's heart can be dyed to a predetermined CT value or more over a predetermined period of time, and thus extends from the proximal end of the aorta. Each coronary artery can be dyed uniformly throughout its length. As a result, the TAG analysis can be performed satisfactorily.

  Next, an example is shown about the setting procedure of the injection | pouring protocol in the chemical injection device 100 of this embodiment comprised as mentioned above. Note that the order of procedures in the following description can be changed as appropriate without departing from the spirit of the present invention. Also, not all procedures (steps) described below are essential to the present invention.

  First, as shown in FIG. 16, in step S <b> 21, as an example, the control unit 153 of the drug solution injector 100 receives input of patient information and the like. These pieces of information may be input by an operator, for example, or may be input to the control unit 153 through a network or the like. The patient information may be at least one selected from various parameters such as height, weight, and sex. You may receive input, such as a body division and an imaging region, as needed. In order to accept such an input, in one embodiment of the present invention, it is also preferable that the chemical liquid injector has a graphical user interface (GUI).

  Next, in step S22, for example, basic pattern information for setting the injection protocol as described above is displayed on the display device 151 of the chemical liquid injector 100. Specifically, the control unit 153 may read such basic pattern information from the storage unit 154, for example.

  As an example, a graph as shown in FIG. 15 may be displayed on the display device 151 as a GUI. The displayed graph includes line segment images b-1 to b-3 corresponding to each phase, and one end part or both end parts of the line segment image are configured to be selectable by touching, for example. It is also preferable that the position can be changed.

  However, the “basic pattern information” does not necessarily have to be a graphical image, and may simply be displayed as character information. That is, the injection conditions of each phase may be simply displayed as text data as all or part of the injection speed, injection amount, and injection time.

Next, in step S23, the operator inputs a parameter change and / or an injection pattern shape change via the touch panel (an example). Here, the input that can be performed by the operator may be as follows:
- time _{t 0,} the time _{t 1,} to change at least one of the equal time _{t 2.
-Change} at least one of speed V _c0 , speed V _c1, etc.
-Move or deform the line segments representing each speed up and down and / or left and right, thereby changing the infusion rate and / or infusion time.
-When the displayed basic pattern may be left as it is (when there is no need to change it), an input for injecting with the content of the basic pattern is accepted.

  Next, in step S24, an injection protocol reflecting the contents is created in response to the user input made in step S23.

  In step S25, for example, using a predetermined input from the operator as a trigger, the chemical solution is injected according to the injection protocol created in step S24. Note that, for example, a predetermined operation for discharging bubbles in the chemical solution may be performed before the injection of the chemical solution is started. Since these can be implemented according to a conventionally known procedure, description thereof is omitted in this specification.

  According to the configuration as described above, the data of the basic injection protocol for blood vessel state analysis is registered in the system, and the data can be read out and changed as necessary to facilitate the injection protocol for blood vessel state analysis. Since the entire coronary artery can be uniformly dyed, it is useful for the vascular state analysis test of the coronary artery.

  As GUI, it is good also as a mode which displays injection speed, injection volume, etc. by text data for every phase, but in the case of the graph mode as shown in FIG. 15, the injection plan can be understood intuitively, or it is wrong. It is also effective in preventing setting of the injection conditions. As an example, the display color in the graph may be different between the phase of contrast medium injection and the phase of physiological saline injection, so that the operator can understand the conditions more intuitively.

While several forms of the invention have been described above, other forms of the invention may be modified as follows:
(1) A setting screen (GUI: Graphical User Interface) for setting an injection protocol is displayed on an arbitrary display device in the system, and at least one of setting and changing injection conditions can be performed through the GUI. Although the structure displayed on the display of the injector console has been described, the injection head may have a sub display device, and the setting screen as described above for setting the protocol may be displayed there. .
(2) The injection protocol data set on the imaging device side is transmitted to the chemical solution injection device in a wired or wireless manner, and the setting is performed from the imaging device side.
(3) Data on a setting screen (GUI: Graphical User Interface) as described above for setting an injection protocol in any device (for example, a chemical injection device, an imaging device, a database server, or other computer device) in the system. Is stored.
(4) In the above description, for example, as shown in FIG. 1, the chemical injection device in which the injection head and the console are configured separately is shown. However, a chemical injection device such as the following may be used:
-A chemical injection device in which the injection head and the console are integrated, in other words, a single device is used to set the injection protocol, display various states during chemical injection, and control the operation of the piston drive mechanism. Such as a chemical injection device.
-In the above-mentioned chemical solution injection device in which the injection head and the console are integrated as one casing, the chemical solution injection device further comprising a separate battery unit. Such a battery unit may be an AC power source, may be installed at any location in the examination room, or may be held in a part of a movable stand.
A chemical injection device in which a control unit (eg, having one or more buttons and / or a display device) such as a miniaturized console is arranged in the vicinity of the injection head. For example, such a control unit is held on a movable stand together with an injection head. Or, for example, such a control unit is held on a ceiling-suspended arm together with an injection head. Alternatively, it is integrated with the injection head.

(Appendix) This application discloses the following inventions:
1. A device for analyzing coronary artery vascular condition based on fluoroscopic image data of coronary angiography,
A display device and a control unit;
The control unit is
(A) For at least two coronary arteries, a correlation between a plurality of positions along the direction from the origin to the distal part of each coronary artery and the contrast intensity (in one example, CT value [HU]) at each position A blood vessel state analysis unit that creates a measured TAG (Translucent Attenuation Gradient) curve indicating
(B) a display control unit that displays at least two of the actually measured TAG curves created for each coronary artery together in one graph and displayed on the display device;
A blood vessel state analyzing apparatus.

  In this configuration, by measuring actual TAG curves of a plurality of coronary arteries, the presence or absence of stenosis or the like is determined by comparing one predetermined coronary artery TAG curve with the remaining other curves. The “display device” and the “control unit” may be included in any device in the system, and include both cases where one device is provided with both and cases where both are not provided.

2. The blood vessel state analysis unit
As the measured TAG curve, a curve of two or all of the right coronary artery (RCA), the left anterior descending branch (LAD), and the left circumflex branch (LCA) is created.
2. The blood vessel state analysis apparatus according to 1 above.

3. The control unit is
Storing the measured TAG curve data in a storage device together with identification information for identifying a patient of the examination;
3. The blood vessel state analysis apparatus according to 1 or 2 above.

  According to such a configuration, since the data is stored in the storage device together with the patient identification information, for example, when the blood vessel state analysis test is performed again on the same patient, the data is read and used for condition setting It is preferable in that it can be compared with the previous result.

4). 4. The blood vessel state analysis device according to 3 above, wherein the storage device is a storage device provided inside the blood vessel state analysis device or an external storage device connected to the device.

5. 5. The blood vessel state analysis device according to any one of 1 to 4, wherein the actual measurement TAG curve is a linear or nonlinear approximate curve.

6). The blood vessel state analysis apparatus according to any one of 1 to 5 above;
An imaging device for imaging a fluoroscopic image of a patient;
A liquid injector for injecting at least a contrast medium into a patient;
A system comprising:

  The invention relating to the system or apparatus in this specification is expressed as a method invention such as an operation method of the system or apparatus, and also as a computer program invention (or medium invention) for causing a computer to perform such a method. It is possible.

A1. A device for analyzing coronary artery vascular condition based on fluoroscopic image data of coronary angiography,
A display device and a control unit;
The control unit is
(A1) A measured TAG (Transluminal Attenuation Gradient) curve indicating a correlation between a plurality of positions along the direction from the origin to the distal portion of at least one coronary artery and the contrast intensity at each position; a2) A standard curve that is a TAG curve of the coronary artery when it is assumed that there is no severe stenosis is created, and (b) the measured TAG curve is compared with the standard curve, and there is a deviation that exceeds a predetermined value. In this case, the blood vessel state analysis apparatus includes a blood vessel state analysis unit that automatically determines that there is a possibility that severe stenosis exists in the coronary artery.

A2. The measured TAG curve is a linear approximation curve,
The blood vessel state analysis unit according to A1, wherein the blood vessel state analysis unit determines the deviation greater than or equal to the predetermined based on a slope of a TAG curve.

A3. The blood vessel state analysis unit according to A1, wherein the blood vessel state analysis unit determines the deviation more than the predetermined based on a shape of a TAG curve.

A4. further,
A display control unit for displaying the measured TAG curve on the display device and automatically displaying that there is a possibility that severe stenosis exists in the coronary artery; The blood vessel state analysis apparatus according to any one of A1 to A3.

A5. The control unit is
Storing at least the measured TAG curve data in a storage device together with identification data for identifying a patient of the examination;
The blood vessel state analyzing apparatus according to any one of A1 to A4.

A6. The blood vessel state analyzing apparatus according to any one of A1 to A5;
An imaging device for imaging a fluoroscopic image of a patient;
A liquid injector for injecting at least a contrast medium into a patient;
A system comprising:

B1. a: a piston drive mechanism (130) for moving the piston member of the syringe filled with the chemical solution relative to the cylinder member;
b: an apparatus (150) for setting a protocol for injecting medicinal liquid, the computer apparatus (150) having an input device, a display device (151), a storage unit and a control unit (153,144);
With
The controller is
(B-1) As an injection protocol for analyzing the vascular state of the coronary artery, (i) a contrast agent is used for a predetermined time while monotonously decreasing from a first speed that is an initial speed to a second speed that is lower than the first speed. Basic injection protocol data comprising: a first phase to inject; and (ii) a second phase in which contrast agent injection is then continued for a predetermined time at a constant rate that is the same or substantially the same as the second rate. Read
(B-2) accepting an input by the operator to change and / or confirm the basic infusion protocol;
(B-3) According to the confirmed injection protocol or the injection protocol reflecting the change, the piston drive mechanism is operated to inject the chemical solution.
Configured as a system.

B2. A plurality of piston drive mechanisms (130);
The basic injection protocol for coronary vascular condition analysis further includes (iii) a third phase of boosting saline after the second phase,
The system according to B1 above.

B3. further,
A graphical user interface (GUI) for an operator to review and / or modify the basic infusion protocol for coronary vascular condition analysis on the display device;
The system according to B1 or B2.

B4. The graphical user interface (GUI) is
Text data indicating at least one of the first phase contrast agent injection rate, injection volume, and injection time;
Text data indicating at least one of a second phase contrast agent injection rate, injection volume, and injection time;
The system according to B3, comprising:

B5. The graphical user interface (GUI) is
A line segment indicating the injection rate in the first phase;
A line segment indicating the injection rate with the contrast agent of the second phase;
The system according to B3, comprising:

B6. The computer device is
As the injector console of a chemical injection device comprising an injection head and an injector console connected thereto, or
It is configured as the scanner console of an imaging apparatus including an imaging unit that captures a fluoroscopic image of a patient and a scanner console connected thereto.
The system according to any one of B1 to B5.

DESCRIPTION OF SYMBOLS 100 Chemical injection device 102 Cable 110 Injection head 120a Recess 121, 122 Syringe adapter 111 Movable stand 130 Piston drive mechanism 144 Control part 145 Reader / writer 146 Storage part 150 Console (injector console)
151 Display device (display)
153 Control unit 154 Storage unit 155 Injection processing unit 157 Input device 159 Operation panel 200 Syringe 221 Cylinder member 222 Piston member 225 IC tag 230 Extension tube 231a to 231c Tube 300 CT scanner (imaging device)
303a Control unit 300b Imaging unit 304 Bed 350 Network 360 HIS
370 RIS
380 PACS
700 Blood vessel state analyzer (terminal)
701 Blood vessel state analysis unit 702 Display control unit 705 System control unit 710 Control unit 711 Display device 712 Input device 720 Interface

Claims (12)

A device for analyzing coronary artery vascular condition based on fluoroscopic image data of coronary angiography,
A display device and a control unit;
The control unit is
(A) For at least two coronary arteries, a measured TAG (Transluminal Attenuation Gradient) curve indicating the correlation between a plurality of positions along the direction from the origin to the distal part of each coronary artery and the contrast intensity at each position A blood vessel state analysis unit for creating
(B) a display control unit that displays at least two of the actually measured TAG curves created for each coronary artery together in one graph and displayed on the display device;
With
The blood vessel state analysis unit
As the measured TAG curve, a curve of two or all of the right coronary artery (RCA), the left anterior descending branch (LAD), and the left circumflex branch (LCA) is created.
Blood vessel state analysis device. The control unit is
Storing the measured TAG curve data in a storage device together with identification information for identifying a patient of the examination;
The blood vessel state analysis apparatus according to claim 1.   The blood vessel state analysis device according to claim 2, wherein the storage device is a storage device provided inside the blood vessel state analysis device or an external storage device connected to the device.   The blood vessel state analysis device according to any one of claims 1 to 3, wherein the measured TAG curve is a linear or nonlinear approximate curve. The blood vessel state analysis device according to any one of claims 1 to 4,
An imaging device for imaging a fluoroscopic image of a patient;
A liquid injector for injecting at least a contrast medium into a patient;
A system comprising: A system comprising a blood vessel state analysis device and a drug solution injection device for injecting at least a contrast medium into a patient,
A: The blood vessel state analysis apparatus
An apparatus for performing vascular state analysis of a coronary artery based on fluoroscopic image data of a coronary angiography test, comprising a display device and a control unit,
The control unit is
(A) For at least two coronary arteries, a measured TAG (Transluminal Attenuation Gradient) curve indicating the correlation between a plurality of positions along the direction from the origin to the distal part of each coronary artery and the contrast intensity at each position A blood vessel state analysis unit for creating
(B) a display control unit that displays at least two of the actually measured TAG curves created for each coronary artery together in one graph and displayed on the display device;
With
The blood vessel state analysis unit
As the measured TAG curve, a curve of two or all of the right coronary artery (RCA), the left anterior descending branch (LAD), and the left circumflex branch (LCA) is created,
B: The chemical injection device is
a: a piston drive mechanism for moving the piston member of the syringe filled with the chemical solution relative to the cylinder member;
b: an apparatus for setting a chemical injection protocol, a computer apparatus having an input device, a display, a storage unit, and a control unit;
With
The controller is
(B-1) As an injection protocol for analyzing the vascular state of the coronary artery, (i) a contrast agent is used for a predetermined time while monotonously decreasing from a first speed that is an initial speed to a second speed that is lower than the first speed. Read basic infusion protocol data including at least the first phase to infuse,
(B-2) accepting an input by the operator to change and / or confirm the basic infusion protocol;
(B-3) According to the confirmed injection protocol or the injection protocol reflecting the change, the piston drive mechanism is operated to inject the chemical solution.
Configured as a system.   The injection protocol further includes, after the first phase, (ii) a second phase of continuing contrast agent injection for a predetermined time at a constant rate that is the same or substantially the same as the second rate. The system according to claim 6. A plurality of piston drive mechanisms;
The basic injection protocol for coronary vascular condition analysis further includes (iii) a third phase of boosting saline after the second phase,
The system according to claim 7. further,
A graphical user interface for an operator to confirm and / or modify the basic infusion protocol for coronary vascular condition analysis on the display;
The system according to any one of claims 6 to 8. The injection protocol further includes, after the first phase, (ii) a second phase in which the contrast agent is continuously injected for a predetermined time at a constant speed that is the same or substantially the same as the second speed. And
further,
A graphical user interface for an operator to confirm and / or modify the basic infusion protocol for coronary vascular condition analysis on the display;
The graphical user interface is:
Text data indicating at least one of the first phase contrast agent injection rate, injection volume, and injection time;
Text data indicating at least one of a second phase contrast agent injection rate, injection volume, and injection time;
The system of claim 6 comprising: The injection protocol further includes, after the first phase, (ii) a second phase in which the contrast agent is continuously injected for a predetermined time at a constant speed that is the same or substantially the same as the second speed. And
further,
A graphical user interface for an operator to confirm and / or modify the basic infusion protocol for coronary vascular condition analysis on the display;
The graphical user interface is:
A line segment indicating the injection rate in the first phase;
A line segment indicating the injection rate with the contrast agent of the second phase;
The system of claim 6 comprising: The computer device is
As the injector console of a chemical injection device comprising an injection head and an injector console connected thereto, or
It is configured as the scanner console of an imaging apparatus including an imaging unit that captures a fluoroscopic image of a patient and a scanner console connected thereto.
The system according to any one of claims 6 to 11.

Images