Medical image processing device, medical image processing program, and ultrasonic diagnostic device

Abstract

To accurately grasp an indwelling state of a device in a target part.SOLUTION: A medical image processing device includes an acquisition unit, an evaluation unit, and an output control unit. The acquisition unit acquires a medical image on a target part where a device is indwelled. The evaluation unit evaluates an indwelling state of the device with respect to the target part at a plurality of angles using the medical image. The output control unit outputs information based on a result of the evaluation of the indwelling state.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The embodiments disclosed in this specification and the drawings relate to a medical image processing device, a medical image processing program, and an ultrasound diagnostic device. [Background technology]

[0002] One of the representative treatments to reduce the risk of stroke due to atrial fibrillation is transcatheter left atrial appendage closure using a left atrial appendage closure device. Transcatheter left atrial appendage closure is a treatment in which a left atrial appendage closure device is placed at the entrance of the left atrial appendage using a catheter. It is necessary to check whether the left atrial appendage closure device has been placed correctly during the procedure by evaluating the degree of deformation of the left atrial appendage closure device after placement. Therefore, the left atrial appendage closure device is placed in the correct position by pulling the left atrial appendage closure device with a catheter after placement and calculating the degree of compression of the left atrial appendage closure device depicted in a standard four-section image. However, the method of pulling the left atrial appendage closure device is only a qualitative evaluation of the degree of fixation, and since measurements using standard four-section images are taken in two dimensions, there is a risk of overlooking sections with abnormal compression rates. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2020-5785 A [Patent Document 2] Special Publication No. 2023-513383 [Patent Document 3] Special Publication No. 2017-507723 Summary of the Invention [Problem to be solved by the invention]

[0004] One of the problems to be solved by the embodiments disclosed in this specification and the drawings is to accurately grasp the placement state of a device in a target site. However, the problems to be solved by the embodiments disclosed in this specification and the drawings are not limited to the above problem. Problems corresponding to the effects of each configuration shown in the embodiments described later can also be positioned as other problems. [Means for solving the problem]

[0005] A medical image processing apparatus according to an embodiment includes an acquisition unit, an evaluation unit, and an output control unit. The acquisition unit acquires medical images of a target site in which a device is placed. The evaluation unit uses the medical images to evaluate the placement state of the device relative to the target site from multiple angles. The output control unit outputs information based on the results of the evaluation of the placement state. [Brief description of the drawings]

[0006] [Figure 1] FIG. 1 is a diagram showing an example of the configuration of an ultrasonic diagnostic apparatus according to this embodiment. [Diagram 2] FIG. 2 is a schematic diagram of the left atrial appendage. [Diagram 3] FIG. 3 illustrates the placement of the left atrial appendage closure device in the left atrial appendage. [Figure 4] FIG. 4 is a side view of a left atrial appendage closure device. [Diagram 5] FIG. 5 is a plan view of a left atrial appendage closure device. [Figure 6] FIG. 6 is a diagram showing the diameter [mm] of the inlet of the left atrial appendage and the application range [mm] of the left atrial appendage closure device. [Figure 7] FIG. 7 is a diagram illustrating a processing procedure for evaluating the placement state of a left atrial appendage closure device by an ultrasound diagnostic apparatus. [Figure 8] FIG. 8 is a diagram illustrating a three-dimensional ultrasound image. [Figure 9] FIG. 9 is a diagram illustrating an example of an orthogonal cross-sectional image and an axis-parallel cross-sectional image. [Figure 10]FIG. 10 is a diagram illustrating an example of a device diameter map indicating the measured value and the appropriate value for each line segment angle. [Figure 11] FIG. 11 is a diagram illustrating an example of a device diameter graph showing the measured value and the optimum value for each line segment angle. [Figure 12] FIG. 12 is a diagram showing an example of a display screen including a superimposed image of a device diameter map and an orthogonal axial cross-sectional image. [Figure 13] FIG. 13 is a diagram showing a device diameter map indicating a determination result according to the second modification. [Figure 14] FIG. 14 is a diagram showing a device diameter map showing dimensional measurements before and after the tensile test. [Figure 15] FIG. 15 is a diagram showing a device diameter graph showing dimensional measurements before and after the tensile test. [Figure 16] FIG. 16 is a diagram illustrating an electrocardiogram and a device diameter map. [Figure 17] FIG. 17 is a diagram illustrating an example of the configuration of a medical image processing apparatus according to the sixth modification. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] Hereinafter, a medical image processing apparatus, a medical image processing program, and an ultrasound diagnostic apparatus according to the present embodiment will be described in detail with reference to the drawings.

[0008] Fig. 1 is a diagram showing an example of the configuration of an ultrasonic diagnostic device 100 according to this embodiment. As shown in Fig. 1, the ultrasonic diagnostic device 100 has an ultrasonic probe 1 and an apparatus body 2. The apparatus body 2 is a computer having a transmitting circuit 21, a receiving circuit 22, a transmission / reception control circuit 23, a signal processing circuit 24, a processing circuit 25, a storage device 26, an input device 27, a communication device 28, and a display device 29. The apparatus body 2 is an example of a medical image processing device. The ultrasonic probe 1 is detachably connected to the apparatus body 2.

[0009] The ultrasonic probe 1 is a probe responsible for transmitting and receiving ultrasonic waves. The ultrasonic probe 1 has a plurality of transducers arranged one-dimensionally or two-dimensionally. Each transducer transmits ultrasonic waves upon receiving a drive signal supplied from a transmission circuit 21. A delay time is provided to each drive signal for focusing the ultrasonic waves transmitted from the entire ultrasonic probe 1 into a beam shape. The generated ultrasonic waves are reflected by an acoustic impedance mismatch surface within the subject. Each transducer receives ultrasonic waves (reflected waves) reflected within the subject and converts them into an echo signal. The ultrasonic probe 1 may be a linear probe, a convex probe, a sector probe, a radial probe, an arc probe, a circular probe, or any other arrangement method.

[0010] The transmission circuit 21 transmits ultrasonic waves in a beam shape via the ultrasonic probe 1 under the control of the transmission / reception control circuit 23. Specifically, in order to transmit ultrasonic waves in a beam shape deflected at a given transmission beam angle, the transmission circuit 21 imparts a delay time for imparting transmission directivity to each drive signal and supplies the drive signal to each transducer. The transmission circuit 21 repeats ultrasonic transmission while changing the transmission beam angle.

[0011] The receiving circuit 22 receives, under the control of the transmission / reception control circuit 23, a receiving signal corresponding to the ultrasonic transmission transmitted by the transmitting circuit 21 via the ultrasonic probe 1. Specifically, the receiving circuit 22 provides a focusing delay time for focusing the reflected wave and a deflection delay time for providing reception directivity to each echo signal received by the ultrasonic probe 1, and performs phasing addition on these echo signals to generate a receiving signal corresponding to a receiving beam. The generation of the receiving signal is also called beamforming.

[0012] The transmission and reception control circuit 23 synchronously controls the transmission circuit 21 and the reception circuit 22 so as to perform a three-dimensional ultrasonic scan on an imaging target area within the subject's body via the ultrasonic probe 1.

[0013] The signal processing circuit 24 performs B-mode processing, color Doppler processing, and the like on the received signal from the receiving circuit 22. In the B-mode processing, the signal processing circuit 24 performs logarithmic amplification, envelope detection processing, logarithmic compression, and the like on the received signal from the receiving circuit 22, and generates B-mode information in which the signal strength is expressed by the brightness of luminance for each of a plurality of sample points. Then, the signal processing circuit 24 generates a two-dimensional or three-dimensional B-mode image in which the signal strength is expressed by a luminance value based on the B-mode information. In the Doppler processing, the signal processing circuit 24 performs frequency analysis on the received signal from the receiving circuit 22, and estimates Doppler information such as the speed, dispersion, and power of a moving body such as blood or tissue for each of a plurality of sample points. Then, the signal processing circuit 24 generates a two-dimensional or three-dimensional Doppler image in which the speed, dispersion, and power of a moving body such as blood or tissue are expressed by a color value. When there is no distinction between a B-mode image and a Doppler image, they will be called an ultrasound image. The ultrasound image is stored in the storage device 26. The signal processing circuit 24 can be realized by any processor.

[0014] The processing circuit 25 has a processor such as a CPU (Central Processing Unit) that controls the ultrasound diagnostic device 100. The processing circuit 25 executes an ultrasound diagnostic program stored in the storage device 26 to realize a function corresponding to the program. The processing circuit 25 realizes, for example, a scan control function 251, an acquisition function 252, an evaluation function 253, and an output control function 254. Each of the functions 251 to 254 is not limited to being realized by a single processing circuit. A processing circuit may be configured by combining a plurality of independent processors, and each processor may execute a control program to realize each of the functions 251 to 254. In addition, each of the functions 251 to 254 may be implemented as a module that constitutes a control program, or may be implemented as individual hardware.

[0015] By implementing the scan control function 251, the processing circuitry 25 controls the transmission and reception control circuitry 23 and the signal processing circuitry 24 to execute a three-dimensional ultrasonic scan on an imaging target area within a subject. By executing a three-dimensional ultrasonic scan, the signal processing circuitry 24 generates an ultrasonic image as described above.

[0016] By implementing the acquisition function 252, the processing circuitry 25 acquires various information. As an example, the processing circuitry 25 acquires a medical image relating to the target site where the device is placed. As the medical image, typically, a three-dimensional ultrasound image generated by the signal processing circuitry 24 is acquired. The device is a device that is placed in a target site inside the subject's body. More specifically, it is sufficient that the device enters the target site in a contracted state and is compressed by being expanded at the site. The device according to this embodiment includes a left atrial appendage closure device, a balloon, a stent, and the like.

[0017] By implementing the evaluation function 253, the processing circuitry 25 evaluates the placement state of the device relative to the target site at multiple angles using the medical images acquired by the acquisition function 252. Typically, the processing circuitry 25 evaluates the placement state at multiple angles around the axis of the device. The placement state can be evaluated based on the appropriateness of placement of the device relative to the target site, the dimensions of the device placed in the target site at a predetermined cross section, etc. As an example, the processing circuitry 25 measures the dimensions of each of multiple angles related to the device placed in the target site based on a three-dimensional ultrasound image.

[0018] By implementing the output control function 254, the processing circuitry 25 outputs various information. The output destination may be the storage device 26 or the display device 29, or may be another computer via the communication device 28. As an example, the processing circuitry 25 displays information based on the result of the evaluation of the placement state by the evaluation function 253, specifically, the dimensions of each of a plurality of angles related to the device placed in the target site, on the display device 29. Alternatively, the processing circuitry 25 may display the measured values ​​and appropriate values ​​of the dimensions of each of the plurality of angles in a map or graph.

[0019] The storage device 26 is a storage device such as a ROM, a RAM, a hard disk drive (HDD), a solid state drive (SSD), an integrated circuit storage device, etc., that stores various information. The storage device 26 may also be a drive device that reads and writes various information from and to a portable storage medium such as a CD-ROM drive, a DVD drive, or a flash memory. For example, the storage device 26 stores an ultrasound diagnostic program of the ultrasound diagnostic device 100, etc.

[0020] The input device 27 is a variety of user interfaces on a touch panel or an operation panel. An operator can input various operations and commands to the ultrasound diagnostic apparatus 100 through the input device 27. The input device 27 may be a voice recognition device that converts a voice signal collected by a microphone into an instruction signal.

[0021] The communication device 28 is a communication interface that communicates data between a PACS (Picture Archiving and Communication System) server, a HIS (Hospital Information System) server, an MWM (Modality Worklist Management) server, etc. via a LAN (Local Area Network) or the like.

[0022] The display device 29 displays various information in accordance with commands from the processing circuit 25. As the display device 29, for example, a CRT display, a liquid crystal display (LCD), a CRT (cathode ray tube) display, an organic electroluminescence display (OELD), a plasma display, or any other arbitrary display can be appropriately used. Note that a projector may be provided as the display device 29.

[0023] An example of the operation of the ultrasound diagnostic apparatus 100 according to this embodiment will be described in detail below.

[0024] The ultrasound diagnostic apparatus 100 is used for a procedure for placing a device in a target region. The procedure according to the present embodiment is not particularly limited, but is assumed to be a left atrial appendage closure procedure. The left atrial appendage closure procedure is a minimally invasive treatment for placing a left atrial appendage closure device in the left atrial appendage (LAA). Here, the left atrial appendage is an example of a "target region," and the left atrial appendage closure device is an example of a "device." The left atrial appendage closure device is not particularly limited as long as it is a device that is placed in the left atrial appendage, but is assumed to be WATCHMAN (registered trademark) manufactured by Boston Scientific Corporation or an improved version thereof.

[0025] FIG. 2 is a schematic diagram of the left atrial appendage. As shown in FIG. 2, the heart has the right atrium, right ventricle, left atrium, and left ventricle. The left atrium has a sac-shaped chamber called the left atrial appendage. When blood in the atrium stagnates due to atrial fibrillation, a blood clot (thrombus) is likely to form in the left atrial appendage. If the thrombus breaks off from the left atrial appendage, travels through an artery to reach the brain, and becomes lodged in a blood vessel in the brain, it will cause a stroke. It is possible to reduce the risk of a stroke by closing the left atrial appendage.

[0026] FIG. 3 is a diagram showing the placement of the left atrial appendage closing device 30 in the left atrial appendage. The device 30 is detachably connected to a catheter 31. The surgeon guides the device 30 to the left atrial appendage through the catheter 31 inserted from a vein in the groin. The surgeon then deploys the device 30 and presses it against the inner wall of the left atrial appendage. Once the pressurization is confirmed, the surgeon detaches the device from the catheter 31 and places the left atrial appendage closing device 30 permanently. When the left atrial appendage closing device is placed in the left atrial appendage, the left atrial appendage closing device 30 is gradually covered by the endothelium of the left atrial appendage, and eventually completely closes the left atrial appendage. By placing the left atrial appendage closing device 30 in the left atrial appendage, it is possible to prevent blood clots generated in the left atrial appendage from flowing out and to keep the device in the left atrial appendage. This can reduce the risk of stroke.

[0027] FIG. 4 is a side view of the left atrial appendage closing device 30, and FIG. 5 is a plan view of the left atrial appendage closing device. As shown in FIGS. 4 and 5, the left atrial appendage closing device has a metal skeleton that can be deployed around an axis 32, and a mesh that covers the skeleton. When the left atrial appendage closing device is placed in the left atrial appendage, the mesh is gradually endothelialized by the endothelium of the left atrial appendage. The dimension of the left atrial appendage closing device in a direction perpendicular to the axis 32 is called the device diameter. The maximum value of the device diameter is called the maximum diameter DD. The maximum diameter when the left atrial appendage closing device is deployed to its limit without being pressed by the left atrial appendage, etc. is called the device size. The device size is determined according to the inlet diameter DL of the left atrial appendage of the subject (see FIG. 3).

[0028] The inlet diameter is measured by intraoperative transesophageal echocardiography (TEE) before placement of the left atrial appendage closure device. The intraoperative TEE may be performed by the scan control function 251 of the processing circuitry 25. Specifically, the inlet diameter of the left atrial appendage may be measured on four two-dimensional scanning planes corresponding to four probe angles before placement of the left atrial appendage closure device. The probe angle refers to the angle around the axis of the ultrasound probe 1. The probe angle of 0 degrees can be set arbitrarily. The probe angle is not particularly limited, but it is recommended to set it at 45° intervals, such as 0°, 45°, 90°, and 135°.

[0029] There are multiple left atrial appendage closure devices available, each corresponding to a different device size. If the size of the left atrial appendage closure device is too large for the inlet diameter of the left atrial appendage, there is a risk that the left atrial appendage closure device will compress the coronary artery, and conversely, if the device size is too small, there is a risk that the left atrial appendage closure device will become dislodged from the left atrial appendage. Therefore, the left atrial appendage closure device to be used is determined according to the inlet diameter of the left atrial appendage measured by TEE during surgery.

[0030] Fig. 6 is a diagram showing the inlet diameter [mm] of the left atrial appendage and the range of application [mm] of the left atrial appendage closing device. The horizontal axis of the graph shown in Fig. 6 represents the inlet diameter of the left atrial appendage, and the device sizes of the left atrial appendage closing devices applicable to each inlet diameter are superimposed. For example, a left atrial appendage closing device with a device size of 31 mm is applicable to left atrial appendages with inlet diameters of 21.5 mm to 28 mm. As another example, a left atrial appendage closing device with a device size of 24 mm or 27 mm is applicable to a left atrial appendage with an inlet diameter of 20 mm.

[0031] The attachment of the left atrial appendage closure device to the left atrial appendage is confirmed by a tensile test of the left atrial appendage closure device called a tag test. The maximum diameter of the left atrial appendage closure device attached to the left atrial appendage is measured in four two-dimensional scanning planes similar to those used in intraoperative TEE before placement of the left atrial appendage closure device, and the compression ratio, which is the ratio of the device size to this measurement, is measured. If the compression ratio is between 10% and 30%, it is determined that the device has been placed normally. For example, a measurement value of 21mm to 27mm is considered to be the appropriate value for device size.

[0032] However, the method of pulling the left atrial appendage closure device is limited to a qualitative evaluation of the degree of compression, which may be inaccurate. The compression ratio is measured on four two-dimensional scanning sections, but since the measurements are taken on two-dimensional scanning planes, these sections may not be appropriate for measuring the compression ratio. In the first place, it is difficult to accurately evaluate the diameter of the left atrial appendage closure device on two-dimensional scanning planes.

[0033] An example of the operation of the process for evaluating the placement state of a left atrial appendage closing device performed by the ultrasound diagnostic apparatus 100 according to this embodiment will be described below with reference to Fig. 7. Fig. 7 is a diagram illustrating the processing procedure of the process for evaluating the placement state of a left atrial appendage closing device performed by the ultrasound diagnostic apparatus 100. It is assumed that the left atrial appendage closing device is placed in the left atrial appendage of the subject at the start of step S1 in Fig. 7. However, it does not matter whether the catheter has been removed from the left atrial appendage closing device.

[0034] First, the processing circuitry 25 acquires a three-dimensional ultrasound image by implementing the acquisition function 252 (step S1). The three-dimensional ultrasound image is assumed to be a three-dimensional B-mode image. Specifically, with the ultrasound probe 1 in contact with the chest of the subject, three-dimensional ultrasound scanning is performed under the control of the scan control function 251 with the heart, including the left atrial appendage, as the imaging target region. Based on the reception signal obtained by the reception circuitry 22 through the three-dimensional ultrasound scanning, the signal processing circuitry 24 generates a three-dimensional ultrasound image, which is a three-dimensional B-mode image. The subject's left atrial appendage and a left atrial appendage closure device placed in the left atrial appendage are depicted in the three-dimensional ultrasound image. The three-dimensional ultrasound image is stored in the storage device 26.

[0035] When step S1 is performed, the processing circuitry 25, by implementing the evaluation function 253, extracts the left atrial appendage closing device from the three-dimensional ultrasound image acquired in step S1 (step S2). Specifically, in step S2, the processing circuitry 25 performs image processing on the three-dimensional ultrasound image to extract an image region corresponding to the left atrial appendage closing device from the three-dimensional ultrasound image. The image processing may be an appropriate extraction process that utilizes empirical rules such as the brightness value of the left atrial appendage closing device in the three-dimensional ultrasound image and the shape of the left atrial appendage closing device. Furthermore, the image processing may be machine learning that utilizes a neural network that inputs the three-dimensional ultrasound image and outputs the position of the left atrial appendage closing device.

[0036] When step S2 is performed, the processing circuit 25, by implementing the evaluation function 253, calculates the orthogonal axial cross section in which the left atrial appendage closing device or the left atrial appendage inlet has the maximum diameter (step S3). Hereinafter, the processing circuit 25 will be assumed to calculate the orthogonal axial cross section in which the left atrial appendage closing device has the maximum diameter. The orthogonal axial cross section means a cross section perpendicular to the axis of the left atrial appendage closing device. Note that the orthogonal axial cross section in which the left atrial appendage inlet has the maximum diameter means a orthogonal axial cross section in which the inlet diameter of the left atrial appendage has the maximum value. In the case of the orthogonal axial cross section in which the left atrial appendage inlet has the maximum diameter, subsequent processing is possible in the same way as in the case of the orthogonal axial cross section in which the left atrial appendage closing device has the maximum diameter.

[0037] FIG. 8 is a diagram showing a schematic diagram of a three-dimensional ultrasonic image I1. As shown in FIG. 8, a left atrial appendage I11 is drawn in the three-dimensional ultrasonic image I1. A left atrial appendage closing device I12 is placed in the left atrial appendage I11. The left atrial appendage closing device I12 is extracted in step S2. The processing circuit 25 calculates an axis IA1 of the left atrial appendage closing device I12 based on the brightness value distribution, shape, and the like of the left atrial appendage closing device I12. The processing circuit 25 also measures the dimensions (device diameter) of the left atrial appendage closing device I12 at predetermined intervals along the axis IA1 to identify the maximum diameter DD. The processing circuit 25 calculates a plane perpendicular to the axis IA1 and including the maximum diameter DD as an axis-orthogonal cross section having the maximum diameter. The processing circuit 25 may also calculate other cross sections based on the axis IA1. For example, the processing circuit 25 may calculate a plane parallel to the axis IA1 and including the maximum diameter DD (axis-parallel cross section). The processing circuitry 25 performs MPR (Multi-Planar Reconstruction) processing on the three-dimensional ultrasonic image to generate an MPR cross-sectional image (orthogonal axis cross-sectional image) relating to a cross-section perpendicular to the axis and an MPR cross-sectional image (axial parallel cross-sectional image) relating to a cross-section parallel to the axis.

[0038] FIG. 9 is a diagram illustrating an orthogonal axial cross-sectional image I13 and an axial parallel cross-sectional image I14. As shown in FIG. 9, the orthogonal axial cross-sectional image I13 is a cross-sectional image perpendicular to the axis of the left atrial appendage closing device, and the left atrial appendage closing device I12 is depicted in a ring shape. In the orthogonal axial cross-sectional image I13, the change in device diameter of the left atrial appendage closing device I12 around the axis can be observed. The axial parallel cross-sectional image I14 is a cross-sectional image parallel to the axis of the left atrial appendage closing device I12. In the axial parallel cross-sectional image I14, the compression between the left atrial appendage closing device I12 and the left atrial appendage can be observed.

[0039] When step S3 is performed, the processing circuitry 25, by implementing the evaluation function 253, measures the diameter of the left atrial appendage closure device over a plurality of angles on the cross-sectional plane calculated in step S3 (step S4). In step S4, the processing circuitry 25 identifies a point on the axis of the left atrial appendage closure device on the cross-sectional plane (hereinafter, the axis point), and calculates a line segment that passes through the axis point and connects both ends of the left atrial appendage closure device for each of a plurality of angles around the axis point (hereinafter, the line segment angle). For example, the line segment angle is set to 0 degrees on the +X axis (horizontal axis) on the cross-sectional plane, and the angle increases as the line segment rotates counterclockwise. The processing circuitry 25 measures the length of the line segment as the device diameter. The measured device diameter is also called the measurement value.

[0040] When step S4 is performed, the processing circuitry 25 displays the measurement value and the appropriate value for each line segment angle by implementing the output control function 254 (step S5). In step S5, the processing circuitry 25 displays the measurement value and the appropriate value for each line segment angle in a predetermined layout on the display device 29. The measurement value and the appropriate value for each line segment angle are displayed in a layout such as a device diameter map or a device diameter graph, for example. The layout can be arbitrarily selected according to a user instruction.

[0041] Fig. 10 is a diagram illustrating a device diameter map I2 showing the measurement value I21 and the appropriate values ​​I22, I23, and I24 for each line segment angle. As shown in Fig. 10, the device diameter map I2 is a schematic map of a cross section perpendicular to the axis, in which the measurement value I21 and the appropriate values ​​I22, I23, and I24 are plotted for each line segment angle around the axis point I20.

[0042] As described above, the measurement value I21 represents the distance between both ends of the left atrial appendage closing device passing through the axis point I20. In other words, the curve drawn by the measurement value I21 represents the contour of the left atrial appendage closing device in the cross section perpendicular to the axis. As the appropriate value, an appropriate range I22, an upper appropriate value I23, and / or a lower appropriate value I24 may be drawn. The appropriate range I22 is a range between the upper appropriate value I23 and the lower appropriate value I24. If the measurement value I21 is within the appropriate range I22, it means that the left atrial appendage closing device is normally crimped. The upper appropriate value I23 and the lower appropriate value I24 are determined based on the device size. As an example, if the compression ratio of the device size is in the appropriate range of 10% to 30%, the upper appropriate value I23 is determined to be 10% of the compression ratio of the device size of the left atrial appendage closing device to be used, and the lower appropriate value I24 is determined to be 30% of the compression ratio of the device size of the left atrial appendage closing device to be used. The processing circuitry 25 may display the appropriate range I22 and other ranges (inappropriate ranges) by different colors. The processing circuitry 25 may also plot the device size I25 on the device diameter map I2. The device size I25 may be specified via the input device 27, or may be previously stored in the storage device 26 in a searchable manner.

[0043] FIG. 11 is a diagram illustrating a device diameter graph I3 showing the measurement value I31 and the appropriate values ​​I32, I33, and I34 for each line segment angle. As shown in FIG. 11, the horizontal axis of the device diameter graph I3 represents the device diameter, and the vertical axis represents the line segment angle. The device diameter graph I3 plots the measurement value I31, the appropriate values ​​I32, I33, and I34, and the device size I35 for each line segment angle around the axis center point. As the appropriate values, the appropriate range I32, the upper appropriate value I33, and / or the lower appropriate value I34 may be drawn, similar to the appropriate range I22, the upper appropriate value I23, and / or the lower appropriate value I24 of the device diameter map I2 shown in FIG. 10. Note that the device diameter graph I3 is not limited to the graph shown in FIG. 11, and may be a graph expressing the relationship between the device diameter and the line segment angle, such as a bar graph or a pie chart.

[0044] As described above, the device diameter map and the device diameter graph plot the measured values ​​and the appropriate values ​​of the device diameter (dimension) of the left atrial appendage closure device for each line segment angle. By checking such a device diameter map or device diameter graph, the user can comprehensively check the relationship between the measured values ​​and the appropriate values ​​across a plurality of line segment angles. Furthermore, the user can visually and easily check at which line segment angles the measured values ​​are within the appropriate range or not. By using the device diameter map, the user can check the relationship between the measured values ​​and the appropriate values ​​in the same coordinate system as the axial cross section. By using the device diameter graph, the user can clearly grasp the distribution of the measured values ​​and the appropriate values ​​for each line segment angle.

[0045] For line segment angles where the measurement value is not within the appropriate range, it can be estimated that the left atrial appendage closure device is not accurately crimped onto the left atrial appendage at that line segment angle, and for line segment angles where the measurement value is within the appropriate range, it can be estimated that the left atrial appendage closure device is accurately crimped onto the left atrial appendage at that line segment angle. In this way, the user can judge whether the crimping or placement of the left atrial appendage closure device onto the left atrial appendage is appropriate or inappropriate for each line segment angle. If there is a line segment angle where the left atrial appendage closure device is not accurately crimped onto the left atrial appendage, the user will determine whether it is necessary to redo the placement operation of the left atrial appendage closure device, etc. If the left atrial appendage closure device is crimped over the entire line segment angle, the user will determine, for example, that the left atrial appendage closure device has been accurately placed.

[0046] The processing circuitry 25 may display either the device diameter map or the device diameter graph, whichever is selected via the input device 27. The processing circuitry 25 may also display both the device diameter map and the device diameter graph side by side.

[0047] When step S5 is performed, the process of evaluating the placement state of the left atrial appendage closure device ends.

[0048] It should be noted that the above embodiment is merely an example, and the present embodiment is not limited to this embodiment, and various elements can be deleted, added, and / or modified without departing from the spirit of the embodiment.

[0049] (Variation 1) The processing circuitry 25 according to the first modification displays an orthogonal axial cross-sectional image perpendicular to the axis of the device in the three-dimensional ultrasonic image, and displays the measurement values ​​and optimum values ​​of the dimensions of each of a plurality of line segment angles on the orthogonal axial cross-sectional image. Specifically, the processing circuitry 25 displays the measurement values, optimum values ​​and / or device sizes of the device diameter of the left atrial appendage closure device for each line segment angle by superimposing them on the orthogonal axial cross-sectional image.

[0050] FIG. 12 is a diagram showing an example of a display screen I4 including a superimposed image I44 of a device diameter map and an orthogonal axis cross-sectional image. As shown in FIG. 12, the processing circuit 25 displays an axis parallel cross-sectional image I41, an axis parallel cross-sectional image I42, an axis parallel cross-sectional image I43, and a superimposed image I44 in parallel on the display screen I4. The axis parallel cross-sectional image I41 is generated based on a three-dimensional ultrasonic image and represents a cross section corresponding to a specified line segment angle. The axis parallel cross-sectional image I41 represents a pseudo two-dimensional scanning cross-sectional image with the specified line segment angle as the probe angle. The axis parallel cross-sectional image I42 is generated based on a three-dimensional ultrasonic image and represents a cross section corresponding to an angle orthogonal to the specified line segment angle. The axis parallel cross-sectional image I42 represents a pseudo two-dimensional scanning cross-sectional image with the angle orthogonal to the specified line segment angle as the probe angle. The axis parallel cross-sectional image I43 is an axis parallel cross-sectional image on which the device diameter map is not superimposed. The display screen I4 may further display a mark I45 indicating the cross-sectional position of the cross-sectional images I41, I42, and I43 and a mark I46 indicating the probe angle. Also, a mark indicating the cross-sectional position of each of the cross-sectional images I41, I42, and I43 may be superimposed on each of the cross-sectional images I41, I42, and I43.

[0051] 12, in the superimposed image I44, the measurement value I441, the optimum values ​​I442, I443, I444, and the device size I445 are aligned and superimposed on the axial cross-sectional image. The curves representing the measurement value I441, the optimum values ​​I442, I443, I444, and the device size I445 may be displayed with different colors or line types to improve visibility. For example, the curve representing the measurement value I441 may be displayed as a blue solid line, the curves representing the upper optimum value I443 and the lower optimum value I444 as red dotted lines, and the curve representing the device size I445 as a yellow solid line.

[0052] As shown in Modification 1, by displaying the superimposed image, the user can check the measured value and the appropriate value of the diameter of the left atrial appendage closure device on the orthogonal axial cross-sectional image. This makes it possible to judge whether the crimping or placement of the left atrial appendage closure device is appropriate or not, for example, by taking into account the positional relationship with the echo image of the left atrial appendage.

[0053] (Variation 2) The processing circuit 25 according to the second modification judges whether or not the placement of the left atrial appendage closing device in the left atrial appendage is appropriate for each of the plurality of line segment angles based on the measured values ​​and appropriate values ​​of the dimensions. Specifically, the processing circuit 25 judges that the placement is appropriate when the measured values ​​are within the appropriate range, and judges that the placement is inappropriate when the measured values ​​are not within the appropriate range. The processing circuit 25 displays the judgment result of whether or not the placement of the left atrial appendage closing device is appropriate for each of the plurality of line segment angles. The processing circuit 25 displays a display screen of the judgment result on the display device 29. As an example of the display of the judgment result, the processing circuit 25 displays the angle range in which the placement of the left atrial appendage closing device is appropriate and the angle range in which the placement is inappropriate with different visual effects. The judgment result is displayed on a device diameter map and / or a device diameter graph.

[0054] FIG. 13 is a diagram showing a device diameter map I5 showing the judgment result according to the second modification. As shown in FIG. 13, the device diameter map I5 shows the measurement value I51 and the appropriate values ​​I52, I53, and I54 for each line angle around the axis point I50. Marks I56 and I57 showing the judgment result of the appropriateness of the placement of the left atrial appendage closure device are drawn on the device diameter map I5. Specifically, the line segment angle range in which the measurement value I51 falls within the appropriate range I52 is decorated with the appropriate mark I56. More specifically, the periphery of the line segment angle range in which the measurement value I51 falls within the appropriate range I52 is bordered with the appropriate mark I56. Similarly, the line segment angle range in which the measurement value I51 falls outside the appropriate range I52 is decorated with the inappropriate mark I57. The appropriate mark I56 and the inappropriate mark I57 may be drawn with different color values ​​and / or line types to visually distinguish them from each other. For example, a thin green line surrounding the corresponding line segment angle range may be displayed as the correct mark I56, and a thick red line may be displayed as the incorrect mark I57. The marks I56 and I57 may be superimposed on the line representing the device size.

[0055] The mark showing the result of the judgment on the suitability of the placement of the left atrial appendage closure device is not limited to a line decorated with a color value and / or a line type. For example, it may be a character string showing the suitability or insuitability of the placement of the left atrial appendage closure device, or a color or hatching may be added to the whole or part of the corresponding line angle range.

[0056] (Variation 3) The processing circuit 25 according to the third modification may measure the dimensions of the left atrial appendage closing device before the tensile test based on a three-dimensional ultrasound image collected before the tensile test of the left atrial appendage closing device, and may measure the dimensions of the left atrial appendage closing device after the tensile test based on a three-dimensional ultrasound image collected after the tensile test. The three-dimensional ultrasound image collected before the tensile test depicts the left atrial appendage closing device placed in the left atrial appendage before the tensile test, and the three-dimensional ultrasound image collected after the tensile test depicts the left atrial appendage closing device placed in the left atrial appendage after the tensile test. If the crimping of the left atrial appendage closing device is weak, the left atrial appendage closing device is displaced near the entrance of the left atrial appendage due to the tensile test, and the diameter of the left atrial appendage closing device tends to increase. The processing circuit 25 displays the measured values ​​of the dimensions of the left atrial appendage closing device before the tensile test and the measured values ​​of the dimensions after the tensile test. The processing circuit 25 displays a display screen showing the measured values ​​of the dimensions before and after the tensile test on the display device 29. The measured values ​​of the dimensions before and after the tensile test may be displayed on a device diameter map or a device diameter graph.

[0057] FIG. 14 is a diagram showing a device diameter map I6 showing the measurement values ​​of dimensions before and after the tensile test. As shown in FIG. 14, the device diameter map I6 shows the measurement value I61 before the tensile test, the measurement value I62 after the tensile test, the optimum values ​​I63, I64, I65, and the device size I66 for each line angle around the axis point I60. As the optimum values, the optimum range I63, the upper optimum value I64, and the lower optimum value I65 are displayed. According to the device diameter map I6, the user can grasp the degree of deviation between the measurement value I61 before the tensile test and the measurement value I62 after the tensile test for each line angle. It is also possible to compare the measurement values ​​I61 and I62 before and after the tensile test with the optimum range I63 and the device size I66 for each line angle. This makes it possible to grasp the placement state of the left atrial appendage closure device in more detail.

[0058] FIG. 15 is a diagram showing a device diameter graph I7 showing the measurement values ​​of dimensions before and after a tensile test. As shown in FIG. 15, the device diameter graph I7 shows the measurement value I71 before the tensile test, the measurement value I72 after the tensile test, the optimum values ​​I73, I74, I75, and the device size I76 for each line angle around the axis center point. As the optimum values, the optimum range I73, the upper optimum value I74, and the lower optimum value I75 are displayed. In the device diameter graph I7, as in the device diameter map I6 shown in FIG. 14, for example, the degree of deviation between the measurement value I71 before the tensile test and the measurement value I72 after the tensile test for each line angle can be grasped.

[0059] (Variation 4) The storage device 26 according to the fourth modification stores time-series frame data of a three-dimensional ultrasound image in association with an electrocardiographic phase. The time-series frame data of a three-dimensional ultrasound image can be collected by capturing a moving image by three-dimensional ultrasound scanning. In parallel with the three-dimensional ultrasound scanning, an electrocardiogram of the subject is collected by an electrocardiograph, and the electrocardiogram is transferred from the electrocardiograph to the ultrasound diagnostic device 100. The storage device 26 stores the frame data and the electrocardiographic phase in association with each other based on the collection time. The processing circuit 25 identifies a maximum phase in which the dimensions of the left atrial appendage closing device are at a maximum value and / or a minimum phase in which the dimensions are at a minimum value from the electrocardiographic phase, and measures the dimensions of the left atrial appendage closing device based on a three-dimensional ultrasound image of a frame corresponding to the maximum phase and / or the dimensions of the left atrial appendage closing device based on a three-dimensional ultrasound image of a frame corresponding to the minimum phase. The processing circuit 25 displays the measurement value of the dimensions of the left atrial appendage closing device at the maximum phase and / or the measurement value of the dimensions of the left atrial appendage closing device at the minimum phase. These measured values ​​may be displayed on a device diameter map or a device diameter graph.

[0060] Fig. 16 is a diagram illustrating an electrocardiogram I8 and a device diameter map I9. As shown in Fig. 16, electrocardiogram I8 shows an electrocardiogram waveform for one heartbeat. The maximum phase in which the dimensions of the left atrial appendage closing device are at their maximum is estimated to be the phase θ1 immediately after the T wave (ventricular end systole) when the ventricular volume is at its approximately minimum. The minimum phase in which the dimensions of the left atrial appendage closing device are at their minimum is estimated to be the phase θ2 of the R wave (ventricular end diastole) when the ventricular volume is at its approximately maximum.

[0061] The processing circuit 25 analyzes the electrocardiogram waveform of the electrocardiogram I8 to detect a T wave, identifies the phase θ1 immediately after the T wave as the maximum phase, identifies a frame of a three-dimensional ultrasound image associated with the maximum phase θ1 (hereinafter, the maximum phase frame), and measures the device diameter of the left atrial appendage closing device for each line segment angle in the orthogonal axial cross section of the maximum phase frame. The processing circuit 25 also analyzes the electrocardiogram waveform of the electrocardiogram I8 to detect a T wave, identifies the phase θ1 immediately after the T wave as the maximum phase, identifies a frame of a three-dimensional ultrasound image associated with the minimum phase θ2 (hereinafter, the minimum phase frame), and measures the device diameter of the left atrial appendage closing device for each line segment angle in the orthogonal axial cross section of the minimum phase frame.

[0062] As shown in FIG. 16, the processing circuit 25 generates a device diameter map I9 in which at least the diameter measurement value I91 at the maximum phase and the diameter measurement value I92 at the minimum phase are plotted. The device diameter map I9 is ​​displayed on the display device 29. The device diameter map I9 may further include appropriate values ​​I93, I94, and I95 and a device size I96. The appropriate range I93, the upper appropriate value I94, and the lower appropriate value I95 may be displayed as appropriate values. According to the device diameter map I9, it is possible to grasp the measurement value of the device diameter for each line segment angle at the maximum phase and the minimum phase, and to compare the measurement value with the appropriate value. By checking the measurement value at multiple phases in this way, it is possible to reduce or prevent overlooking a phase in which the measurement value does not take the appropriate value.

[0063] (Variation 5) The storage device 26 according to the fifth modification stores time-series frame data of a three-dimensional ultrasound image. The time-series frame data of the three-dimensional ultrasound image can be collected by taking a moving image in three-dimensional ultrasound scanning under the control of the transmission / reception control circuit 23. The processing circuit 25 measures the dimensions of the left atrial appendage closing device for each of the time-series frame data, and identifies the maximum frame in which the dimensions of the left atrial appendage closing device are maximum and / or the minimum frame in which the dimensions are minimum, based on the measurement values ​​of the dimensions of the left atrial appendage closing device for each of the time-series frame data. The processing circuit 25 displays the measurement values ​​of the device dimensions in the maximum frame and / or the measurement values ​​of the device dimensions in the minimum frame. The measurement values ​​of the device dimensions in the maximum frame and / or the measurement values ​​of the device dimensions in the minimum frame may be displayed on a device diameter map, as in FIG. 16. Note that the device diameter may be displayed on a device diameter graph instead of the device diameter map.

[0064] According to the fifth modification, it is possible to grasp the measurement value of the device diameter for each line segment angle in the maximum frame and the minimum frame, and to compare the measurement value with an appropriate value. By checking the measurement values ​​in multiple frames in this way, it is possible to reduce or prevent overlooking frames in which the measurement value is not appropriate.

[0065] (Variation 6) The medical image processing device 2 according to some of the above embodiments is a device main body provided in the ultrasound diagnostic device 100. However, the present embodiment is not limited to this. The medical image processing device according to the sixth modification is a computer independent of the ultrasound diagnostic device.

[0066] Fig. 17 is a diagram showing a configuration example of a medical image processing device 500 according to Modification 6. As shown in Fig. 17, the medical image processing device 500 is a computer having a processing circuit 51, a storage device 53, an input device 55, a communication device 57, and a display device 59. Data communication between the processing circuit 51, the storage device 53, the input device 55, the communication device 57, and the display device 59 is performed via a bus.

[0067] The processing circuitry 51 has a processor such as a CPU that controls the medical image processing device 500. The processing circuitry 51 executes a medical image processing program stored in the storage device 53 to realize a function corresponding to the program. The processing circuitry 51 realizes, for example, an acquisition function 511, an evaluation function 512, and an output control function 513. Each of the functions 511 to 513 is not limited to being realized by a single processing circuit. A processing circuit may be configured by combining a plurality of independent processors, and each processor may execute a program to realize each of the functions 511 to 513. In addition, each of the functions 511 to 513 may be implemented as a module that constitutes a program, or may be implemented as individual hardware.

[0068] The acquisition function 511, the evaluation function 512, and the output control function 513 correspond to the acquisition function 252, the evaluation function 253, and the output control function 254, respectively. The medical image acquired by the acquisition function 511 is a three-dimensional medical image collected by a medical image diagnostic device. The medical image diagnostic device according to the sixth modification may be an ultrasound diagnostic device, an X-ray computed tomography device, an X-ray diagnostic device, a magnetic resonance imaging device, a nuclear medicine diagnostic device, or any other modality.

[0069] (Variation 7) In some of the above embodiments, the processing circuit 25 evaluates the placement state of the left atrial appendage closing device relative to the left atrial appendage at multiple angles using a three-dimensional medical image. However, this embodiment is not limited to this. The placement state of the left atrial appendage closing device relative to the left atrial appendage may be evaluated at multiple angles using a two-dimensional medical image according to the seventh modification. As an example, the processing circuit 25 may collect two-dimensional ultrasound images intersecting the axis of the left atrial appendage closing device, and measure the diameter of the left atrial appendage closing device for each of multiple line segment angles using the two-dimensional ultrasound images. Alternatively, the processing circuit 25 may measure the device diameter of the left atrial appendage closing device at multiple probe angles corresponding to the multiple ultrasound scanning planes using multiple axis-parallel cross-sectional images corresponding to the multiple ultrasound scanning planes.

[0070] (Summary) According to some of the above-mentioned embodiments, in the medical image processing apparatus, the processing circuit acquires medical images of a target site in which a device is placed. The processing circuit evaluates the placement state of the device relative to the target site at a plurality of angles using the medical images. The processing circuit outputs information based on the result of the evaluation of the placement state.

[0071] According to the above configuration, the placement state is evaluated from multiple angles, making it possible to grasp the placement state after accurately grasping the shape of the device, and it is expected that overlooking cross sections that make a crucial contribution to the evaluation of the placement state will be reduced.

[0072] According to at least one of the embodiments described above, the placement state of the device in the target site can be accurately grasped.

[0073] The term "processor" used in the above description means a circuit such as a CPU, a GPU, an application specific integrated circuit (ASIC), a programmable logic device (e.g., a simple programmable logic device (SPLD), a complex programmable logic device (CPLD), and a field programmable gate array (FPGA)). The processor realizes a function by reading and executing a program stored in a memory circuit. Instead of storing a program in a memory circuit, the program may be directly built into the circuit of the processor. In this case, the processor realizes a function by reading and executing a program built into the circuit. On the other hand, when the processor is, for example, an ASIC, instead of storing the program in a memory circuit, the function is directly built into the circuit of the processor as a logic circuit. Note that each processor in this embodiment is not limited to being configured as a single circuit for each processor, but may be configured as a single processor by combining multiple independent circuits. Furthermore, the multiple components in FIG. 1 and FIG. 17 may be integrated into a single processor to realize the function.

[0074] Although some embodiments have been described, these embodiments are presented as examples and are not intended to limit the scope of the invention. These embodiments can be implemented in various other forms, and various omissions, substitutions, modifications, and combinations of embodiments can be made without departing from the spirit of the invention. These embodiments and their modifications are included in the scope of the invention and its equivalents as described in the claims, as well as in the scope and spirit of the invention. [Explanation of symbols]

[0075] 1 Ultrasound probe 2. Device body (medical image processing device) 21 Transmitting circuit 22 Receiving circuit 23 Transmission / reception control circuit 24 Signal Processing Circuit 25 Processing circuit 26 Storage device 27 Input Devices 28 Communication Equipment 29 Display equipment 100 Ultrasound diagnostic equipment 251 Scanning control function 252 Acquisition Function 253 Rating Function 254 Output control function

Claims

1. an acquisition unit that acquires medical images relating to a target site in which the device is placed; an evaluation unit that evaluates a placement state of the device relative to the target site at a plurality of angles using the medical images; an output control unit that outputs information based on a result of the evaluation of the placement state; A medical image processing device comprising:

2. The acquisition unit acquires, as the medical image, a three-dimensional medical image collected by a medical image diagnostic device, The evaluation unit evaluates the placement state at the multiple angles around the axis of the device.

2. The medical image processing apparatus according to claim 1.

3. The evaluation unit measures dimensions of each of the plurality of angles related to the device placed in the target site based on the three-dimensional medical image, the output control unit displays the measurement values ​​of the dimensions of each of the plurality of angles on a display device.

3. The medical image processing apparatus according to claim 2.

4. The medical image processing apparatus according to claim 3 , wherein the output control unit displays the measured values ​​and appropriate values ​​of the dimensions for each of the plurality of angles in the form of a map or a graph.

5. The output control unit is Displaying a cross-sectional image of the three-dimensional medical image perpendicular to an axis of the device; displaying the measurement values ​​and appropriate values ​​of the dimensions for each of the plurality of angles on the cross-sectional image; 5. The medical image processing apparatus according to claim 4.

6. the evaluation unit determines whether or not the device is placed in the target site based on the measurement values ​​and appropriate values ​​of the dimensions for each of the plurality of angles; The output control unit displays a judgment result of whether the device is placed in the dimension for each of the plurality of angles.

5. The medical image processing apparatus according to claim 4.

7. The medical image processing apparatus according to claim 6 , wherein the output control unit displays an angle range in which placement of the device is appropriate and an angle range in which placement of the device is inappropriate in different colors.

8. The evaluation unit measures the dimensions of the device before a tensile test based on the three-dimensional medical image collected before the tensile test of the device, and measures the dimensions of the device after a tensile test based on the three-dimensional medical image collected after the tensile test; The output control unit displays the measurement values ​​of the dimensions of the device before and after the tensile test. The medical image processing device according to claim 3.

9. A storage unit that stores time-series frame data of the three-dimensional medical image in association with an electrocardiographic phase, the evaluation unit identifies a maximum phase in which the dimension of the device is at a maximum value and / or a minimum phase in which the dimension is at a minimum value from the electrocardiographic phases, and measures the dimension of the device based on the three-dimensional medical image of a frame corresponding to the maximum phase and / or the dimension of the device based on the three-dimensional medical image of a frame corresponding to the minimum phase; The output control unit displays the measurement value of the dimension of the device at the maximum time phase and / or the measurement value of the dimension of the device at the minimum time phase. The medical image processing device according to claim 3.

10. A storage unit that stores time-series frame data of the three-dimensional medical image, the evaluation unit measures the dimension of the device for each of the time-series frame data, and identifies a maximum frame in which the dimension of the device has a maximum value and / or a minimum frame in which the dimension of the device has a minimum value based on the measured value of the dimension of the device for each of the time-series frame data; The output control unit displays the measurement value of the dimension of the device in the maximum frame and / or the measurement value of the dimension of the device in the minimum frame. The medical image processing device according to claim 3.

11. 3. The medical image processing apparatus according to claim 2, wherein the medical image diagnostic apparatus is an ultrasonic diagnostic apparatus, an X-ray computed tomography apparatus, a magnetic resonance numerical simulation apparatus, or a nuclear medicine diagnostic apparatus.

12. the target site is the left atrial appendage; the device is a left atrial appendage closure device; 2. The medical image processing apparatus according to claim 1.

13. On the computer, A function for acquiring medical images of the target site where the device is placed; a function of evaluating the placement state of the device relative to the target site at multiple angles using the medical images; and a function of outputting information based on the result of the evaluation of the placement state; A medical image processing program that makes this possible.

14. an image generating unit that generates a medical image of a target site in which a device is placed, based on an echo signal from an ultrasound probe that transmits and receives ultrasound to a subject in which the device is placed; an evaluation unit that evaluates a placement state of the device relative to the target site at a plurality of angles using the medical images; an output control unit that outputs information based on a result of the evaluation of the placement state; An ultrasound diagnostic device comprising:

Images