WO2024203754A1 - 断層画像生成装置及び断層画像生成システム - Google Patents

断層画像生成装置及び断層画像生成システム Download PDF

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Publication number
WO2024203754A1
WO2024203754A1 PCT/JP2024/011113 JP2024011113W WO2024203754A1 WO 2024203754 A1 WO2024203754 A1 WO 2024203754A1 JP 2024011113 W JP2024011113 W JP 2024011113W WO 2024203754 A1 WO2024203754 A1 WO 2024203754A1
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Prior art keywords
tomographic image
optical
ultrasonic
light
signal
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PCT/JP2024/011113
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English (en)
French (fr)
Japanese (ja)
Inventor
亮 上原
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Terumo Corp
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Terumo Corp
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Priority to CN202480021911.4A priority Critical patent/CN121001661A/zh
Priority to JP2025510662A priority patent/JPWO2024203754A1/ja
Priority to EP24779873.9A priority patent/EP4674358A1/en
Publication of WO2024203754A1 publication Critical patent/WO2024203754A1/ja
Priority to US19/340,806 priority patent/US20260020842A1/en
Anticipated expiration legal-status Critical
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062—Arrangements for scanning
    • A61B5/0066—Optical coherence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0033—Features or image-related aspects of imaging apparatus, e.g. for MRI, optical tomography or impedance tomography apparatus; Arrangements of imaging apparatus in a room
    • A61B5/0035—Features or image-related aspects of imaging apparatus, e.g. for MRI, optical tomography or impedance tomography apparatus; Arrangements of imaging apparatus in a room adapted for acquisition of images from more than one imaging mode, e.g. combining MRI and optical tomography
    • A—HUMAN NECESSITIES
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    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
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    • A61B8/0883—Clinical applications for diagnosis of the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0891—Clinical applications for diagnosis of blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A—HUMAN NECESSITIES
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    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/4472—Wireless probes
    • A—HUMAN NECESSITIES
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    • A61B8/46—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
    • A61B8/461—Displaying means of special interest
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    • A61B8/5207—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of raw data to produce diagnostic data, e.g. for generating an image
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    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A61B8/085—Clinical applications involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4433—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device involving a docking unit

Definitions

  • the present invention relates to a tomographic image generating device and a tomographic image generating system.
  • Intravascular treatments such as percutaneous coronary intervention (PCI) are being performed as minimally invasive treatments for ischemic heart diseases, such as angina pectoris or myocardial infarction.
  • Intravascular imaging diagnostic devices such as an intravascular ultrasound imaging device (IVUS: IntraVascular Ultrasound) using ultrasound and an optical coherence imaging diagnostic device (OCT: Optical Coherence Tomography) using near-infrared rays, are used for preoperative diagnosis or postoperative result confirmation in intravascular treatment.
  • the imaging diagnostic device includes a catheter for imaging diagnosis, a drive device for rotating a sensor unit provided in the catheter for imaging diagnosis in a circumferential direction, and a console.
  • the console includes a control device, an operation unit, a monitor screen, etc.
  • an imaging diagnostic device that combines the functions of IVUS and OCT, that is, an imaging diagnostic device that has an ultrasound transceiver unit capable of transmitting and receiving ultrasound and an optical transceiver unit capable of transmitting and receiving light, has been proposed.
  • the console of the diagnostic imaging device is the size of a person, and takes up a large amount of space in the catheterization room, which can be an obstacle to procedures.
  • the objective of this disclosure is to provide a tomographic image generating device and a tomographic image generating system that do not require a console, generate ultrasonic tomographic image data on the drive unit side, and wirelessly transmit the data to an external display device.
  • a tomographic image generating device is (1) a tomographic image generating device that drives a sensor unit of a probe to generate a tomographic image of a tubular organ, the tomographic image generating device comprising an ultrasonic signal transceiver that transmits an ultrasonic signal to the sensor unit and receives a reflected signal that is reflected by the tubular organ and output from the sensor unit, a signal processing circuit that generates ultrasonic tomographic image data of the tubular organ based on the reflected signal received by the ultrasonic signal transceiver, and a wireless communication circuit that transmits the ultrasonic tomographic image data generated by the signal processing circuit to a display device.
  • the tomographic image generating device of (1) above (2) comprises a probe connection section to which the probe is detachably connected, a light source device connection section to which an optical device is detachably connected that emits measurement light for obtaining an optical coherence tomographic image of a tubular organ, and converts interference light based on the reflected light that is reflected by the tubular organ and output from the sensor section into an electrical signal, and an optical connection section that optically connects between the optical device and the probe, and the signal processing circuit generates an optical coherence tomographic image of the tubular organ based on the electrical signal converted by the optical device, and the wireless communication circuit preferably transmits the optical coherence tomographic image data generated by the signal processing circuit to a display device.
  • the above-mentioned (1) or (2) tomographic image generating device preferably includes (3) an optical path length control device that outputs a control signal to the optical device for controlling the optical path length of the reference light for obtaining an optical coherence tomographic image of a tubular organ.
  • the light source device connection section preferably includes a control signal line connection section to which a control signal line that transmits a control signal for controlling the operation of the optical device is connected, an optical fiber connection section to which an optical fiber that transmits the measurement light and the reflected light for obtaining an optical coherence tomographic image is connected, and a detection signal line connection section to which a detection signal line that transmits the electrical signal related to the interference light is connected.
  • the light source device connection section is a single connector that connects the control signal line connection section, the optical fiber connection section, and the detection signal line connection section to the control signal line, the optical fiber, and the detection signal line.
  • the tomographic image generating device described in any one of (1) to (5) above is preferably further provided with: (6) the light source device connection section includes a power connection section to which a power line for transmitting power supplied from the optical device is connected, and the device is equipped with an internally mounted battery and a power supply circuit that, when power supplied from an external source is received, supplies the received power to the signal processing circuit, and, when power supplied from an external source is not received, supplies the power of the battery to the signal processing circuit.
  • the tomographic image generating device described in any one of (1) to (6) above preferably includes (7) a power supply circuit that supplies power from an internally mounted battery to the signal processing circuit.
  • the tomographic image generating device described in any one of (1) to (7) above preferably includes (8) a power supply circuit that receives power supplied from an external source and supplies the received power to the signal processing circuit.
  • the tomographic image generating device described in any one of (1) to (8) above preferably includes (9) a rotation drive mechanism that rotates the sensor portion of the probe, and a motor that provides power to the rotation drive mechanism.
  • the tomographic image generating device described in any one of (1) to (9) above preferably includes (10) a storage unit that stores multiple sets of ultrasonic tomographic image data corresponding to multiple locations in the longitudinal direction of the tubular organ.
  • a tomographic image generating system preferably includes a tomographic image generating device according to any one of (1) to (10), a catheter having a sensor unit that scans a tubular organ with ultrasound or light, and an optical device that transmits measurement light for obtaining an optical coherence tomographic image of the tubular organ, receives interference light based on the reflected light that is reflected by the tubular organ and output from the sensor unit, and converts the interference light into an electrical signal.
  • FIG. 1 is an explanatory diagram illustrating an example of the configuration of an image diagnostic system.
  • FIG. 2 is an explanatory diagram showing a configuration example of an imaging diagnostic system from which a catheter for imaging diagnosis and an optical device are removed.
  • FIG. 2 is an explanatory diagram showing an example of the configuration of a catheter for diagnostic imaging.
  • FIG. 1 is a block diagram showing an example of the configuration of an image diagnostic system.
  • FIG. 2 is a block diagram showing a configuration example of a signal processing circuit.
  • 1 is an explanatory diagram illustrating a cross section of a blood vessel through which a sensor portion is inserted; FIG. FIG. FIG.
  • an imaging diagnostic system using a dual-type catheter equipped with the functions of both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) will be described.
  • the dual-type catheter is provided with a mode for acquiring ultrasonic tomographic images using IVUS only, a mode for acquiring optical coherence tomographic images using OCT only, and a mode for acquiring tomographic images using both IVUS and OCT, and these modes can be switched for use.
  • ultrasonic tomographic images and optical coherence tomographic images will be referred to as IVUS images and OCT images, respectively, as appropriate.
  • IVUS images and OCT images will be collectively referred to as tomographic images.
  • FIG. 1 is an explanatory diagram showing an example of the configuration of the imaging diagnostic system 100
  • FIG. 2 is an explanatory diagram showing an example of the configuration of the imaging diagnostic system 100 with the imaging diagnostic catheter 1 and the light source device 3 removed.
  • the imaging diagnostic system 100 of this embodiment includes the imaging diagnostic catheter 1, the imaging diagnostic device 2, the light source device 3, and an external medical device 4 having a display device 41.
  • the imaging diagnostic system 100 of this embodiment is a system in which the imaging diagnostic device 2 is miniaturized by eliminating a large console equipped with an optical system and a display monitor for realizing the OCT function. Since it is difficult to miniaturize the optical system for realizing the OCT function, the light source device 3 having the optical system and the imaging diagnostic device 2 are separate, and as shown in FIG. 1 and FIG.
  • the light source device 3 can be attached and detached to the imaging diagnostic device 2 as necessary.
  • the imaging diagnostic device 2 is configured to perform wireless communication with the external medical device 4 and display IVUS images and OCT images on the display device 41 of the external medical device 4.
  • the imaging diagnostic device 2 configured in this way is a device that is mainly composed of electrical circuits that perform electrical signal processing and data processing, making it possible to reduce the size.
  • the diagnostic imaging catheter 1 has a probe 11 and a probe connector 15 arranged at the end of the probe 11.
  • the probe 11 is connected to the diagnostic imaging device 2 via the probe connector 15.
  • the side of the diagnostic imaging catheter 1 far from the probe connector 15 is described as the tip side, and the side of the probe connector 15 is referred to as the base side.
  • the probe 11 has a catheter sheath 11a, and at its tip, a guidewire insertion section 14 through which a guidewire can be inserted is provided.
  • the guidewire insertion section 14 forms a guidewire lumen, which is used to receive a guidewire inserted in advance into a blood vessel and guide the probe 11 to the affected area by the guidewire.
  • the catheter sheath 11a forms a continuous tube section from the guidewire insertion section 14 to the probe connector 15.
  • a shaft 13 is inserted inside the catheter sheath 11a, and a sensor unit 12 is connected to the tip of the shaft 13.
  • the sensor unit 12 has a housing 12c, and the tip side of the housing 12c is formed in a hemispherical shape to suppress friction and catching with the inner surface of the catheter sheath 11a.
  • an optical transceiver 12a that transmits near-infrared light into a blood vessel and receives reflected light from the inside of the blood vessel
  • an ultrasonic transceiver 12b that transmits ultrasonic waves into the blood vessel and receives reflected waves from the inside of the blood vessel are arranged.
  • the ultrasonic transceiver 12b is provided on the tip side of the probe 11
  • the optical transceiver 12a is provided on the base end side.
  • the optical transceiver 12a and the ultrasonic transceiver 12b are arranged in the housing 12c, separated by a predetermined length along the axial direction on the central axis of the shaft 13 (on the two-dot chain line in Fig. 3).
  • the optical transceiver 12a and the ultrasonic transceiver 12b are arranged such that the transmission and reception directions of the near-infrared light and the ultrasonic waves are at an angle of approximately 90 degrees to the axial direction of the shaft 13 (the radial direction of the shaft 13).
  • the optical transceiver 12a and the ultrasonic transceiver 12b are attached slightly offset from the radial direction so as not to receive the reflected waves and light from the inner surface of the catheter sheath 11a.
  • the optical transceiver 12a is disposed in a position in which the direction of irradiation of the near-infrared light is inclined toward the tip end with respect to the radial direction
  • the ultrasonic transceiver 12b is disposed in a position in which the direction of irradiation of the ultrasonic waves is inclined toward the base end with respect to the radial direction.
  • the shaft 13 has an optical fiber cable 1a (see FIG. 4) connected to the optical transmitter/receiver 12a and an electric signal cable 1b (see FIG. 4) connected to the ultrasonic transmitter/receiver 12b inserted therein.
  • the probe 11 is inserted into the blood vessel from the tip side.
  • the sensor unit 12 and shaft 13 can move forward and backward inside the catheter sheath 11a, and can also rotate in the circumferential direction.
  • the sensor unit 12 and shaft 13 rotate around the central axis of the shaft 13 as the axis of rotation.
  • FIG. 4 is a block diagram showing an example of the configuration of the image diagnostic system 100.
  • the light source device 3 is a device equipped with an optical system for obtaining an OCT image by utilizing the coherence of laser light.
  • a wavelength-swept type optical system is described, but the optical measurement method is not particularly limited.
  • a spectral domain type or other optical system may be equipped.
  • the wavelength-swept type light source device 3 includes a wavelength-swept light source 31, an optical path length variable mechanism 32, an optical coupler 33, a photoelectric conversion element 34, a demodulator 35, a power supply circuit 36, and a light source connector 37.
  • the light source device 3 houses these optical systems in an optical system housing.
  • the optical system housing is preferably sized so that it can be placed under the bed of a patient undergoing catheter treatment.
  • the light source connector 37 includes an optical terminal 37a, a control signal terminal 37b, a detection signal terminal 37c, and a power supply terminal 37d.
  • the light source connector 37 has each terminal in one connector housing.
  • the user medical professional
  • the optical fiber 3a, the control signal line 3b, the detection signal line 3c, and the power supply line 3d are bundled together to form one connection cable 30.
  • the wavelength swept light source 31 is a light source that generates laser light with a continuously changing wavelength.
  • the wavelength swept light source 31 includes, for example, a light source, a diffraction grating, and a polygon mirror. Light from the light source is split by the diffraction grating and enters the surface of the polygon mirror, and only light with a wavelength perpendicular to the polygon mirror returns along the same optical path. By rotating the polygon mirror, it is possible to perform wavelength time sweeping.
  • the wavelength time swept light is output via a light source optical coupler (not shown).
  • One end of the optical fiber 3a is connected to the wavelength swept light source 31.
  • An optical coupler 33 is provided midway through the optical fiber 3a, and the other end of the optical fiber 3a is connected to an optical terminal 37a of the light source connector 37.
  • the optical fiber 3a is coupled to the optical fiber 3e and the optical fiber 3f by the optical coupler 33.
  • the light output from the wavelength swept light source 31 is branched by the optical coupler 33, and the first branched light (hereinafter referred to as measurement light) is output to the outside from the optical terminal 37a via the optical fiber 3a.
  • the externally output measurement light is output to the imaging diagnostic device 2 and irradiated into the blood vessel through the imaging diagnostic device 2 and the probe 11.
  • the reflected light reflected in the blood vessel is input to the light source device 3 via the imaging diagnostic device 2 and the optical fiber 3a.
  • the optical path length variable mechanism 32 is a mechanism for finely adjusting the optical path length of the reference light.
  • the optical path length variable mechanism 32 is provided with an optical path length changing means for changing the optical path length corresponding to the variation in length so as to absorb the variation in the length of each of the imaging diagnostic catheters 1 and probes 11 when the imaging diagnostic catheters 1 and probes 11 are replaced.
  • the optical path length variable mechanism 32 is provided with a collimating lens, a reflecting mirror, and a one-axis stage.
  • the one-axis stage changes the optical path length by changing the position of the collimating lens or the reflecting mirror.
  • the reference light incident on the optical path length variable mechanism 32 propagates through an optical path whose length has been adjusted by the optical path length variable mechanism 32.
  • the reference light reflected by the reflecting mirror is output from the optical path length variable mechanism 32 and transmitted through the optical fiber 3f.
  • the reference light and the reflected light are combined by the optical coupler 33, and the combined interference light is incident on the photoelectric conversion element 34 via the optical fiber 3f.
  • control signal line 3b One end of the control signal line 3b is connected to the optical path length variable mechanism 32, and the other end of the control signal line 3b is connected to the control signal terminal 37b of the light source connector 37.
  • the optical path length variable mechanism 32 operates according to a control signal input via the control signal terminal 37b and the control signal line 3b.
  • the control signal is a signal output from the imaging diagnostic device 2, as described below.
  • the photoelectric conversion element 34 photoelectrically converts the interference light and outputs the photoelectrically converted signal to the demodulator 35.
  • the demodulator 35 demodulates the interference light signal.
  • One end of the detection signal line 3c is connected to the output end of the demodulator 35, and the other end of the detection signal line 3c is connected to a detection signal terminal 37c of the light source connector 37.
  • the demodulator 35 outputs a signal obtained by demodulating the interference light signal (hereinafter referred to as a detection signal) from the detection signal terminal 37c to the outside. As described below, the detection signal output to the outside is input to the imaging diagnostic device 2.
  • the power supply circuit 36 is a circuit that supplies power to drive the imaging diagnostic device 2.
  • One end of the power line 3d is connected to the power supply circuit 36, and the other end of the power line 3d is connected to a power terminal 37d of the light source connector 37.
  • the power supply circuit 36 outputs power to the outside via the power line 3d and the power terminal 37d. As described below, the power output from the light source device 3 is supplied to the imaging diagnostic device 2.
  • the imaging diagnostic device 2 includes a housing 20 (see Figures 1 and 2), a signal processing circuit 21, an MDU (Motor Drive Unit) 22, an IVUS-related circuit 23, an OCT-related circuit 24, a wireless communication circuit 25, a power supply circuit 26, a built-in battery 27, a probe connection section 28, and a light source device connection section 29.
  • the housing 20 houses the signal processing circuit 21, MDU 22, IVUS-related circuit 23, OCT-related circuit 24, wireless communication circuit 25, power supply circuit 26, built-in battery 27, probe connection section 28, and light source device connection section 29 described above.
  • the probe connection part 28 is a connector to which the probe connector 15 of the diagnostic imaging catheter 1 is detachably connected.
  • the light source device connection section 29 is a connector to which the light source connector 37 of the light source device 3 is detachably attached.
  • the light source device connection section 29 includes an optical fiber connection section 29a to which the optical fiber 3a is connected, a control signal line connection section 29b to which the control signal line 3b is connected, a detection signal line connection section 29c to which the detection signal line 3c is connected, and a power supply connection section 29d to which the power supply line 3d is connected.
  • the MDU 22 is a drive device that drives a built-in motor in response to user operation and controls the operation of the diagnostic imaging catheter 1 inserted into a blood vessel.
  • the MDU 22 includes a rotary connector 22a, an optical rotary joint (optical connection section) 22b, a rotary drive mechanism 22c, a motor control device 22d, and a linear drive device 22e.
  • the rotating connector 22a is an electrical connector that rotatably connects the electrical signal cable 1b, which is connected to the ultrasonic transmitter/receiver unit 12b, and the ultrasonic signal transmitter/receiver 23a.
  • the rotating connector 22a has a rotating electrode portion with a sliding contact and a fixed electrode portion, the fixed electrode is connected to the ultrasonic signal transmitter/receiver 23a, and the electrical signal cable 1b is connected to the rotating electrode.
  • the optical rotary joint 22b is an optical connector that connects the optical fiber cable 1a connected to the optical transmitter/receiver 12a to the optical fiber connection part 29a of the light source device connection part 29.
  • the optical rotary joint 22b has a rotating part and a fixed part, and the fixed part is connected to the optical fiber connection part 29a by an internal optical fiber cable, and the optical fiber cable 1a is connected to the rotating part.
  • the rotary drive mechanism 22c includes a motor that rotates the rotary electrode of the rotary connector 22a and the fixed part of the optical rotary joint 22b. By driving the motor of the rotary drive mechanism 22c, the sensor part 12 inserted in the probe 11 and the shaft 13 can be rotated in the circumferential direction. The rotation of the motor is controlled by the motor control device 22d.
  • the rotary drive mechanism 22c also has an encoder that detects the rotation angle of the motor, and the encoder outputs a rotation angle signal indicating the rotation angle of the motor to the motor control device 22d.
  • the motor control device 22d outputs a synchronization control signal to the rotation drive mechanism 22c and the signal processing circuit 21.
  • the rotation drive mechanism 22c rotates the motor according to the synchronization control signal output from the motor control device 22d.
  • the motor control device 22d outputs the rotation angle signal output from the rotation drive mechanism 22c to the signal processing circuit 21.
  • the linear drive device 22e is equipped with a motor that moves the sensor unit 12 and shaft 13 inserted in the probe 11 in the axial direction.
  • the operation of the linear drive device 22e is controlled by the signal processing circuit 21.
  • the MDU 22 configured in this manner can perform a pull-back operation in which the sensor unit 12 and shaft 13 inserted in the probe 11 are rotated in the circumferential direction while being pulled toward the MDU 22 at a constant speed.
  • the sensor unit 12 moves and rotates from the distal end side to the proximal end side by the pull-back operation, and continuously scans the inside of the blood vessel at a predetermined time interval, and the signal processing circuit 21 can continuously generate multiple tomographic images approximately perpendicular to the probe 11 based on the scanning results.
  • the MDU 22 having a pull-back function has been described, the MDU 22 may be configured not to have the pull-back function. In other words, the MDU 22 may be configured not to include the linear drive device 22e. If the pull-back mechanism is eliminated, the user will have to manually pull the MDU 22.
  • the IVUS-related circuit 23 includes an ultrasonic signal transceiver 23a, a detector 23b, and an A/D converter 23c.
  • the ultrasonic signal transceiver 23a emits an ultrasonic signal for generating an IVUS image.
  • the ultrasonic signal is, for example, a pulse wave.
  • the ultrasonic signal transceiver 23a transmits the ultrasonic signal to the ultrasonic transmission/reception unit 12b via the rotating connector 22a.
  • the ultrasonic signal transceiver 23a also receives a reflected wave that is irradiated into a blood vessel and reflected.
  • the reflected wave received by the ultrasonic signal transceiver 23a is detected by the detector 23b.
  • the A/D converter 23c converts the detected analog reflected signal into digital data.
  • the signal processing circuit 21 generates digital ultrasound line data (ultrasonic tomographic image data) from the reflected signal by sampling the reflected wave signal at a predetermined rate.
  • the ultrasound line data is data that indicates the reflection intensity of ultrasound in the depth direction of the blood vessel as seen from the ultrasound transmission/reception unit 12b.
  • An IVUS image P1 (see Figures 7A and 7B) that shows the transverse layers of the blood vessel can be constructed based on the generated ultrasound line data.
  • the OCT-related circuit 24 includes an optical path length control device 24a and an A/D converter 24b.
  • the optical path length control device 24a is a circuit that outputs a control signal for controlling the operation of the optical path length variable function of the light source device 3.
  • the optical path length control device 24a is connected to the control signal line connection unit 29b.
  • the optical path length control device 24a outputs a control signal to the optical path length variable mechanism 32 via the control signal line connection unit 29b, and adjusts the optical path length of the reference light.
  • the A/D converter 24b is connected to the detection signal line connection part 29c.
  • the A/D converter 24b converts the analog detection signal input via the detection signal line 3c and the detection signal line connection part 29c into digital data.
  • the signal processing circuit 21 generates digital optical line data (optical coherence tomography image data) from the detection signal by sampling the detection signal at a predetermined rate.
  • the image diagnostic device 2 can construct an OCT image P2 (see Figures 7A and 7B) showing the transverse layers of the blood vessel based on the generated optical line data.
  • the wireless communication circuit 25 includes a communication circuit that performs wireless communication with the external medical device 4.
  • the standard and protocol of the wireless communication are not particularly limited.
  • the wireless communication circuit 25 may be configured to perform direct wireless communication with the external medical device 4, or may be configured to communicate via a router.
  • the wireless communication circuit 25 can wirelessly transmit the ultrasound line data and optical line data provided from the signal processing circuit 21 to the external medical device 4.
  • the wireless communication circuit 25 may wirelessly transmit ultrasonic line data and optical line data to the external medical device 4, or may wirelessly transmit frame data of the IVUS image P1 and the OCT image P2 configured as two-dimensional frame images to the external medical device 4 as ultrasonic tomographic image data and optical coherence tomographic image data.
  • the power supply circuit 26 is a circuit that supplies power to the signal processing circuit 21 and other circuits that constitute the imaging diagnostic device 2.
  • the imaging diagnostic device 2 is equipped with a built-in battery 27, and the power supply circuit 26 supplies power from the built-in battery 27 to the signal processing circuit 21 and the like.
  • the built-in battery 27 may be a primary battery or a secondary battery.
  • the power supply circuit 26 is preferably configured to include a charging circuit for the built-in battery 27, which is a secondary battery.
  • the power supply circuit 26 is connected to the power supply connection portion 29d and can receive power supplied from the light source device 3 via the power line 3d.
  • the power supply circuit 26 supplies the power supplied from the light source device 3 to the signal processing circuit 21 and the like.
  • the power supply circuit 26 supplies the externally supplied power to the signal processing circuit 21, etc., instead of the built-in battery 27.
  • the power supply circuit 26 supplies the power of the built-in battery 27 to the signal processing circuit 21, etc.
  • FIG. 5 is a block diagram showing an example of the configuration of the signal processing circuit 21.
  • the signal processing circuit 21 is a computer, and includes a processing unit 21a, a memory unit 21b, an ultrasonic line data generating unit 21c, an optical line data generating unit 21d, and an input/output I/F 21e.
  • the processing unit 21a is configured using one or more arithmetic processing devices such as a CPU (Central Processing Unit), an MPU (Micro-Processing Unit), a GPU (Graphics Processing Unit), a GPGPU (General-purpose computing on graphics processing units), an FPGA (Field Programmable Gate Array), or a SoC FPGA.
  • the processing unit 21a is connected to each of the hardware components that make up the signal processing circuit 21 via a bus.
  • the memory unit 21b has, for example, a main memory unit and an auxiliary memory unit.
  • the main memory unit is a temporary storage area such as SRAM (Static Random Access Memory), DRAM (Dynamic Random Access Memory), or flash memory, and temporarily stores data necessary for the processing unit 21a to execute arithmetic processing.
  • the auxiliary memory unit is a storage device such as a hard disk, EEPROM (Electrically Erasable Programmable ROM), or flash memory.
  • the memory unit 21b stores a computer program P (program product) executed by the processing unit 21a and various data necessary for other processing.
  • the auxiliary memory unit may be an external storage device connected to the signal processing circuit 21.
  • the computer program P may be written to the auxiliary memory unit during the manufacturing stage of the signal processing circuit 21, or the signal processing circuit 21 may acquire the computer program P via communication from a remote server device and store it in the auxiliary memory unit.
  • the computer program P may be recorded in a readable manner on a recording medium such as a magnetic disk, optical disk, or semiconductor memory, and the reading unit may read it from the recording medium and store it in the auxiliary storage unit.
  • the ultrasound line data generating unit 21c generates digital ultrasound line data from the reflected signal by sampling the reflected signal at a predetermined rate, the reflected signal being output from the ultrasound transmitting/receiving unit 12b of the diagnostic imaging catheter 1.
  • the processing unit 21a stores the generated ultrasound line data in the memory unit 21b as IVUS tomographic image data.
  • the optical line data generator 21d generates digital optical line data from the detection signal by sampling the detection signal output from the light source device 3 at a predetermined rate.
  • the processor 21a stores the generated optical line data in the memory 21b as OCT tomographic image data.
  • the input/output I/F 21e is an interface to which the wireless communication circuit 25 is connected.
  • the processing unit 21a controls the operation of the wireless communication circuit 25 via the input/output I/F 21e, and transmits and receives various data and information.
  • the processing unit 21a of the signal processing circuit 21 reads out and executes the computer program P stored in the memory unit 21b, thereby generating ultrasonic line data in the ultrasonic line data generating unit 21c, and wirelessly transmitting the generated ultrasonic line data to the external medical device 4 via the wireless communication circuit 25.
  • the processing unit 21a also reads out and executes the computer program P stored in the memory unit 21b, thereby generating optical line data in the optical line data generating unit 21d, and wirelessly transmitting the generated optical line data to the external medical device 4 via the wireless communication circuit 25.
  • wirelessly transmitting the ultrasonic line data and the optical line data to the external medical device 4 it is possible to display IVUS tomographic images and OCT images on the external display device 41.
  • the memory unit 21b stores the generated ultrasound line data and optical line data
  • the processing unit 21a can wirelessly transmit the requested ultrasound line data and optical line data to the external medical device 4 upon request from the external medical device 4.
  • optical line data and ultrasonic line data obtained by the optical transceiver 12a and ultrasonic transceiver 12b, and the IVUS image P1 and OCT image P2 constructed from the optical line data and ultrasonic line data.
  • FIG. 6 is an explanatory diagram showing a schematic cross-section of a blood vessel through which the sensor unit 12 has been inserted
  • FIGS. 7A and 7B are explanatory diagrams of tomographic images.
  • the sensor unit 12 and shaft 13 are inserted into the blood vessel and tomographic imaging is started, the sensor unit 12 rotates in the direction indicated by the arrow, with the central axis of the shaft 13 as the center of rotation.
  • the ultrasonic transmission/reception unit 12b transmits and receives ultrasonic waves at each rotation angle.
  • Lines 1, 2, ... 512 indicate the transmission and reception direction of ultrasonic waves at each rotation angle.
  • the ultrasonic transmission/reception unit 12b intermittently transmits and receives ultrasonic waves 512 times during a 360-degree rotation (one rotation) within the blood vessel.
  • the ultrasonic transmission/reception unit 12b obtains one line of data in the transmission and reception direction by transmitting and receiving ultrasonic waves once, so that 512 pieces of ultrasonic line data extending radially from the center of rotation can be obtained during one rotation.
  • the 512 pieces of ultrasonic line data are dense near the center of rotation, but become sparse as they move away from the center of rotation. Therefore, the imaging diagnostic device 2 can generate pixels in the empty spaces of each line using a well-known interpolation process to construct a two-dimensional IVUS image P1 as shown in FIG. 7A.
  • the optical transmitter/receiver 12a also transmits and receives near-infrared light (measurement light) at each rotation angle.
  • the optical transmitter/receiver 12a also transmits and receives measurement light 512 times while rotating 360 degrees within the blood vessel, so that data on 512 optical lines extending radially from the center of rotation can be obtained during one rotation.
  • the imaging diagnostic device 2 can generate pixels in the empty spaces of each line by known interpolation processing, thereby constructing the two-dimensional OCT image P2 shown in FIG. 7A.
  • a two-dimensional tomographic image constructed from multiple ultrasound line data in this manner is called one frame of IVUS image P1.
  • a two-dimensional tomographic image constructed from multiple optical line data is called one frame of OCT image P2.
  • the sensor unit 12 scans while moving inside the blood vessel, one frame of IVUS image P1 or OCT image P2 is acquired at each position of one rotation within the movement range.
  • one frame of IVUS image P1 or OCT image P2 is acquired at each position from the tip side to the base end side of the probe 11 within the movement range, so that multiple frames of IVUS image P1 or OCT image P2 are acquired within the movement range, as shown in FIG. 7B.
  • the number of times ultrasonic waves and light are transmitted and received in one rotation is an example, and the number of times is not limited to 512. Furthermore, the number of times ultrasonic waves are transmitted and received and the number of times light is transmitted and received may be the same or different.
  • the console is eliminated, and the ultrasound line data and the optical line data can be generated by the small imaging diagnostic device 2 and wirelessly transmitted to an external display device.
  • the image diagnostic device 2 and the light source device 3 are configured separately, and the light source device 3 is configured to be detachable from the image diagnostic device 2, thereby making it possible to miniaturize the image diagnostic device 2.
  • the user can remove the light source device 3 from the image diagnostic device 2 and capture the IVUS image using the small image diagnostic device 2.
  • the user can connect the light source device 3 to the image diagnostic device 2 and capture the OCT image.
  • the light source device 3 is a large device compared to the image diagnostic device 2, the user can place the light source device 3 under the bed. Therefore, the light source device 3 does not get in the way of the procedure.
  • the connection cable 30 is composed of a single cable, and the imaging diagnostic device 2 and the light source device 3 can be connected simply by connecting one light source connector 37 to the light source device connection section 29 of the imaging diagnostic device 2. Specifically, the user can connect the imaging diagnostic device 2 and the light source device 3 with the optical fiber 3a, the control signal line 3b, the detection signal line 3c, and the power line 3d with a single connector connection.
  • the imaging diagnostic device 2 is equipped with an optical path length control device 24a that controls the operation of the light source device 3, and the operation of the light source device 3 is controlled by the imaging diagnostic device 2.
  • the imaging diagnostic device 2 can be made smaller and the configuration of the light source device 3 can be simplified.
  • the imaging diagnostic device 2 can operate using power supplied from the light source device 3.
  • the imaging diagnostic device 2 can also operate using power from the built-in battery 27.
  • the diagnostic imaging device 2 has a built-in MDU 22, and this single device can drive the probe 11 of the diagnostic imaging catheter 1 and perform image processing.
  • the diagnostic imaging device 2 stores the generated ultrasound line data and optical line data in the memory unit 21b, and can provide the ultrasound line data and optical line data stored in the memory unit 21b in response to a request from the external medical device 4.
  • the image diagnostic system 100 and image diagnostic device 2 are described as obtaining cross-sectional images of blood vessels, but they may be configured to capture cross-sectional images of tubular organs other than blood vessels.
  • an example of using a dual-type catheter equipped with both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) functions has been described, but an IVUS catheter equipped with an ultrasound transmitter/receiver 12b but not an optical transmitter/receiver 12a, or an OCT catheter equipped with an optical transmitter/receiver 12a but not an ultrasound transmitter/receiver 12b, can also be connected to the imaging diagnostic device 2 and used.
  • IVUS intravascular ultrasound
  • OCT optical coherence tomography
  • Probe connector 20 Housing 21: Signal processing circuit 22b: Optical rotary joint (optical connection section) 23: IVUS-related circuit 23a: Ultrasound signal transceiver 23b: Detector 23c: A/D converter 24: OCT-related circuit 24a: Optical path length control device 24b: A/D converter 25: Wireless communication circuit 26: Power supply circuit 27: Built-in battery 28: Probe connection section 29: Light source device connection section 29a: Optical fiber connection section 29b: Control signal line connection section 29c: Detection signal line connection section 29d: Power supply connection section 30: Connection cable 31: Wavelength sweep light source 32: Optical path length variable mechanism 33: Optical coupler 34: Photoelectric conversion element 35: Demodulator 36: Power supply circuit

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PCT/JP2024/011113 2023-03-28 2024-03-21 断層画像生成装置及び断層画像生成システム Ceased WO2024203754A1 (ja)

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EP24779873.9A EP4674358A1 (en) 2023-03-28 2024-03-21 Tomographic image generation device and tomographic image generation system
US19/340,806 US20260020842A1 (en) 2023-03-28 2025-09-25 Apparatus and system for generating a tomographic image of a luminal organ

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006189592A (ja) * 2005-01-05 2006-07-20 Olympus Corp 内視鏡装置
WO2014049641A1 (ja) * 2012-09-26 2014-04-03 テルモ株式会社 画像診断装置及び情報処理装置並びにそれらの制御方法
WO2014162368A1 (ja) 2013-04-05 2014-10-09 テルモ株式会社 画像診断装置及びプログラム
JP2022189662A (ja) * 2021-06-11 2022-12-22 上田日本無線株式会社 超音波プローブおよび無線超音波プローブ

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006189592A (ja) * 2005-01-05 2006-07-20 Olympus Corp 内視鏡装置
WO2014049641A1 (ja) * 2012-09-26 2014-04-03 テルモ株式会社 画像診断装置及び情報処理装置並びにそれらの制御方法
WO2014162368A1 (ja) 2013-04-05 2014-10-09 テルモ株式会社 画像診断装置及びプログラム
JP2022189662A (ja) * 2021-06-11 2022-12-22 上田日本無線株式会社 超音波プローブおよび無線超音波プローブ

Non-Patent Citations (1)

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Title
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