Image diagnostic device

Abstract

To provide an image diagnostic device capable of reducing a work load on a medical expert and an operator required for checking how a medical instrument inserted into a living body lumen is used.SOLUTION: A control part 300 of an image diagnostic device 10 executes a first notification operation for notifying that an imaging unit 145 is moving backward while the imaging unit is moving backward when executing first display control, and executes a second notification operation for notifying that the imaging unit is advancing while the imaging unit is advancing when executing second display control. The control part starts a reciprocating operation mode from a state that the imaging unit is arranged at an advance limit position De in a sheath 110.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] The present disclosure relates to diagnostic imaging devices. [Background technology]

[0002] 2. Description of the Related Art Diagnostic imaging catheters that use ultrasound or light to obtain cross-sectional images are known as devices for obtaining diagnostic images of lesions, such as stenoses, that have occurred in a body lumen.

[0003] A typical diagnostic imaging catheter includes an imaging shaft with an imaging unit at its tip for acquiring tomographic images, a sheath into which the imaging shaft is inserted, and a hub disposed on the base end side of the sheath. When the diagnostic imaging catheter is used, a driving device is used that generates a driving force for moving the imaging shaft back and forth along the axial direction of the sheath (see Patent Document 1 below).

[0004] The operation of the diagnostic imaging catheter and the driving device is controlled by a control unit that includes a CPU, etc. The control unit moves the imaging unit together with the imaging shaft back and forth along the axial direction of the sheath. While moving the imaging shaft back and forth, the control unit causes the imaging unit to emit inspection waves such as ultrasound and light, thereby acquiring tomographic images of a biological lumen such as a blood vessel over a predetermined range in the axial direction of the sheath. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Special table number 2015-515918 Summary of the Invention [Problem to be solved by the invention]

[0006] By checking the tomographic images acquired by the diagnostic imaging catheter, the surgeon can confirm the state of the biological lumen (e.g., the state of diseased areas such as stenosis and occlusion). By interpreting the acoustic shadows displayed on the tomographic images, the surgeon can obtain not only the state of the biological lumen but also various other information. One such piece of information is information about the usage state of a medical instrument such as a guidewire inserted into the biological lumen together with the diagnostic imaging catheter (e.g., the position, direction, and posture of the tip of the medical instrument).

[0007] When passing a guidewire through a lesion formed in a blood vessel, the surgeon adjusts the position and direction of the tip of the guidewire and the attitude (curvature) of the guidewire so that the tip of the guidewire faces the target site of the lesion. When adjusting the position of the guidewire, the surgeon needs to understand the usage state of the guidewire inside the lumen of the living body.

[0008] The surgeon obtains a tomographic image in cooperation with an operator who assists in the operation of the diagnostic imaging catheter. The surgeon further confirms the position of the distal tip of the guidewire projected on the tomographic image and the position of the shaft of the guidewire projected on the tomographic image. In general, the distal tip of the guidewire and the shaft of the guidewire are made of materials with different acoustic impedances. Therefore, the distal tip of the guidewire and the shaft of the guidewire are displayed with different brightness on the tomographic image. The surgeon needs to understand the usage state of the guidewire by interpreting the positions of the distal tip of the guidewire and the shaft of the guidewire on the tomographic image.

[0009] Therefore, the present disclosure provides an imaging diagnostic device that can easily grasp the usage state of a medical instrument inserted into a body lumen and reduce the workload of a surgeon and an operator. [Means for solving the problem]

[0010] According to one aspect of the present invention, there is provided an imaging diagnostic apparatus comprising: a sheath that can be inserted into a biological lumen; an imaging catheter that can move back and forth along the axial direction of the sheath and has an imaging unit at its tip for acquiring a tomographic image of the biological lumen; and a hub that is disposed on the proximal end side of the sheath; a drive device that can be connected to the hub of the imaging diagnostic catheter and drives the imaging shaft to move back and forth; and a control unit that controls the operation of the drive device and the imaging unit, wherein the control unit implements a reciprocating operation mode in which the imaging unit is moved backward one or more times and forward one or more times between an advance limit position and a retreat limit position in the axial direction, and the control unit controls the imaging unit in the reciprocating operation mode. a first display control for displaying on a display device a first tomographic image acquired while the imaging unit is retracting in synchronization with the retraction of the imaging unit, and a second display control for displaying on a display device a second tomographic image acquired while the imaging unit is advancing in synchronization with the advancing of the imaging unit, and when implementing the first display control, the control unit implements a first notification operation for notifying that the imaging unit is retracting while the imaging unit is retracting, and when implementing the second display control, implements a second notification operation for notifying that the imaging unit is advancing while the imaging unit is advancing, and the control unit starts the reciprocating operation mode from a state in which the imaging unit is disposed at the forward limit position in the sheath. Effect of the Invention

[0011] According to the present disclosure, the usage state of a medical instrument inserted into a biological lumen can be easily confirmed, thereby reducing the workload of a surgeon and an operator. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a diagram showing an imaging diagnostic apparatus according to an embodiment. [Diagram 2] 1 is a cross-sectional view of a distal end of a catheter for diagnostic imaging according to an embodiment. [Diagram 3]4 is a flowchart showing an example of operation and a procedure for using the diagnostic imaging device according to the embodiment. [Figure 4] 1 is a cross-sectional view showing an example of use of a catheter for diagnostic imaging according to an embodiment. [Diagram 5] FIG. 1 is a perspective view showing an example of use of a diagnostic imaging catheter according to an embodiment. [Figure 6] FIG. 2 is a cross-sectional view for explaining a reciprocating operation mode of the diagnostic imaging catheter according to the embodiment. [Figure 7] FIG. 2 is a cross-sectional view for explaining a reciprocating operation mode of the diagnostic imaging catheter according to the embodiment. [Figure 8] FIG. 2 is a cross-sectional view for explaining a reciprocating operation mode of the diagnostic imaging catheter according to the embodiment. [Figure 9] FIG. 2 is a cross-sectional view for explaining a reciprocating operation mode of the diagnostic imaging catheter according to the embodiment. [Figure 10] FIG. 4 is a diagram showing an example of a tomographic image displayed on a display device. [Figure 11] FIG. 4 is a diagram showing an example of a tomographic image displayed on a display device. [Figure 12] FIG. 4 is a diagram showing an example of a tomographic image displayed on a display device. [Figure 13] FIG. 4 is a diagram showing an example of a tomographic image displayed on a display device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Hereinafter, an embodiment will be described with reference to the attached drawings. The following description does not limit the technical scope or the meaning of terms described in the claims. The dimensional ratios in the drawings are exaggerated for the convenience of explanation and may differ from the actual ratios. In this specification, the range "X to Y" means "X or more, Y or less."

[0014] FIG. 1 is a diagram showing an imaging diagnostic device 10 according to an embodiment, FIG. 2 is a diagram illustrating an imaging diagnostic catheter 100 according to an embodiment, FIG. 3 is a diagram showing a flowchart of a control method according to an embodiment, FIGS. 4 to 9 are diagrams illustrating examples of use of the imaging diagnostic device 10 and the imaging diagnostic catheter 100, and FIGS. 10 to 13 are diagrams showing examples of each tomographic image displayed on a display device 400.

[0015] <Imaging diagnostic equipment> As shown in FIG. 1, the diagnostic imaging device 10 includes a diagnostic imaging catheter 100 , a driving device 200 , a control unit 300 , and a display device 400 .

[0016] The diagnostic imaging catheter 100 is configured as an intravascular ultrasound examination catheter that acquires tomographic images (diagnostic images) by ultrasonic waves.

[0017] The driving device 200 is a device that moves the imaging shaft 140 and the imaging unit 145 included in the diagnostic imaging catheter 100 along the axial direction of the sheath 110 when acquiring a tomographic image of a blood vessel (corresponding to a body lumen).

[0018] The control unit 300 comprehensively controls the operation of each unit of the diagnostic imaging device 10. The objects controlled by the control unit 300 include the operation control of the drive unit 200, the operation control of the imaging unit 145 included in the diagnostic imaging catheter 100, and the operation control of the display device 400. The control unit 300 may include, for example, a known microcomputer equipped with a CPU, RAM, ROM, etc. The communication method between the control unit 300 and other devices is not particularly limited, and may be, for example, wired communication or wireless communication.

[0019] The display device 400 is configured as a known monitor equipped with a display 401 capable of outputting voice and music and displaying still and moving images. The display device 400 displays each of the tomographic images 501, 502, 511, and 512 acquired by the diagnostic imaging catheter 100 based on an operation command transmitted from the control unit 300 (see Figs. 12 and 13). The display device 400 may be configured, for example, as a plurality of display devices capable of displaying each of the tomographic images 501, 502, 511, and 512.

[0020] The diagnostic imaging device 10 has a device configuration in which a drive unit 200, a control unit 300, and a display unit 400 are integrally combined as a unit. However, the diagnostic imaging device 10 only needs to have at least the diagnostic imaging catheter 100, the drive unit 200, and the control unit 300. For example, the display unit 400 may be configured by another device (e.g., a portable terminal device, etc.) that is not incorporated in the diagnostic imaging device 10.

[0021] <Catheter for diagnostic imaging> As shown in Figures 1 and 2, the diagnostic imaging catheter 100 comprises a sheath 110 that can be inserted into a living body, an imaging shaft 140 that can move back and forth along the axial direction of the sheath 110 and has an imaging unit 145 at its tip for obtaining tomographic images of a blood vessel B, and a hub 160 that is disposed on the base end side of the sheath 110.

[0022] In the description of the specification, the side of the diagnostic imaging catheter 100 that is inserted into the blood vessel B is referred to as the distal end side, and the side of the diagnostic imaging catheter 100 where the hub 160 is disposed is referred to as the proximal end side. The extension direction of the sheath 110 is referred to as the axial direction. The axial direction of the sheath 110 is indicated by the arrow X1-X2 in FIG. 2.

[0023] 1 and 2, the lumen 110a of the sheath 110 extends to the base end of the sheath 110. The lumen 110a of the sheath 110 communicates with an internal space (not shown) of the hub 160. The imaging shaft 140 inserted into the lumen 110a of the sheath 110 is electrically connected to the driving device 200 by connecting a connection portion (not shown) provided at the base end of the hub 160 to the driving device 200.

[0024] The lumen 110 a of the sheath 110 communicates with a port 162 of the hub 160 through the internal space of the hub 160 .

[0025] The priming liquid can be supplied into the lumen 110a of the sheath 110 via a port 162 of the hub 160. An injection device H (see FIG. 1) for injecting the priming liquid when performing the priming process is connected to the port 162 of the hub 160. The injection device H can be composed of, for example, a syringe for supplying the priming liquid, and a connector and a tube for connecting the syringe and the port 162 of the hub 160.

[0026] 2, an observation window 119 is formed in the sheath 110. The observation window 119 is configured to be able to transmit ultrasonic waves emitted from a signal transmitting / receiving unit 145a of the imaging unit 145 arranged in the lumen 110a of the sheath 110. Being able to transmit ultrasonic waves means that the refractive index is low (transmittance is high) to the extent that the image quality of the diagnostic image acquired using the diagnostic imaging catheter 100 is not significantly impaired.

[0027] The length of the observation window 119 along the axial direction can be formed to be, for example, the same as the distance between the forward limit position De of the imaging unit 145 and the backward limit position Pe of the imaging unit 145. The forward limit position De is a position when the imaging unit 145 is advanced to the most forward position in the axial direction of the sheath 110 by the driving device 200. The forward limit position De is, for example, a position where the imaging unit 145 overlaps with the base end of the reinforcing member 117 arranged in the sheath 110 in the axial direction. The imaging unit 145 can advance to a position where the tip portion 146 of the imaging unit 145 (the tip portion of the housing 145b) abuts against the reinforcing member 117. The backward limit position Pe is a position when the imaging unit 145 is advanced to the most backward position in the axial direction of the sheath 110 by the driving device 200. The backward limit position Pe can be determined, for example, according to the length of the sheath 110 of the diagnostic imaging catheter 100 and the product specifications of the driving device 200.

[0028] 2, a guidewire insertion portion 114 is disposed at the distal end of the sheath 110, juxtaposed to a lumen 110a of the sheath 110. The guidewire insertion portion 114 is provided with a guidewire lumen 114a through which a guidewire W1 used for guiding the diagnostic imaging catheter 100 to a desired position in a blood vessel B can be inserted.

[0029] 2, a reinforcing member 117 for supporting and reinforcing the guidewire insertion portion 114 is provided at the distal end of the sheath 110. A communication passage 117a is formed in the reinforcing member 117, which communicates with the inside of the lumen 110a of the sheath 110 located on the proximal end side of the reinforcing member 117. A communication hole 116 is formed at the distal end of the reinforcing member 117, which communicates between the communication passage 117a and the outside of the lumen 110a of the sheath 110.

[0030] The communication hole 116 is provided for discharging a priming liquid (ultrasound transmission liquid) filled in the lumen 110a of the sheath 110. When a tomographic image is acquired using the diagnostic imaging catheter 100, the lumen 110a of the sheath 110 is filled with the priming liquid. When the lumen 110a of the sheath 110 is sufficiently filled with the priming liquid, the communication hole 116 discharges the excess priming liquid to the outside of the lumen 110a of the sheath 110. For example, physiological saline can be used as the priming liquid.

[0031] When the sheath 110 is inserted into the blood vessel B with the lumen 110a of the sheath 110 filled with the priming liquid, the priming liquid is interposed between the signal transmitting / receiving unit 145a and the inner wall of the blood vessel B. When ultrasonic waves are emitted from the signal transmitting / receiving unit 145a in this state, the ultrasonic waves are transmitted well to the inner wall of the blood vessel B via the priming liquid, and are further reflected back from the inner wall of the blood vessel B.

[0032] As shown in FIG. 1, the diagnostic imaging catheter 100 includes an inner shaft 130 and an outer tube 120 into which the inner shaft 130 can be inserted. The inner shaft 130, the imaging shaft 140, and the hub 160 are connected to each other so that they can move forward and backward in the axial direction as one body. When the driving device 200 is operated to push the hub 160 toward the distal end, the inner shaft 130 connected to the hub 160 is pushed into the outer tube 120, and the imaging shaft 140 and the imaging unit 145 advance toward the distal end in the lumen 110a of the sheath 110. When the driving device 200 is operated to pull the hub 160 toward the proximal end, the inner shaft 130 is drawn out from the outer tube 120 toward the proximal end. At this time, the imaging shaft 140 and the imaging unit 145 retreat toward the proximal end in the lumen 110a of the sheath 110.

[0033] 2, the imaging shaft 140 has a long tubular body 141 and a signal line 142 inserted inside the tubular body 141. The tubular body 141 can be formed, for example, of a multi-layer coil wound in different directions around the axis. The coil can be formed, for example, of stainless steel or Ni-Ti (nickel-titanium) alloy.

[0034] The imaging unit 145 has a signal transmitting / receiving unit 145a for transmitting and receiving ultrasonic waves, and a housing 145b in which the signal transmitting / receiving unit 145a is disposed. The signal transmitting / receiving unit 145a is configured with an ultrasonic transducer that generates ultrasonic waves by generating a piezoelectric effect when a voltage is applied. The signal line 142 is connected to the signal transmitting / receiving unit 145a and the driving device 200, and enables communication of electric signals between the two. The signal line 142 can be configured with, for example, a twisted pair cable or a coaxial cable.

[0035] When using the diagnostic imaging catheter 100, the surgeon connects the hub 160 to the drive device 200. By connecting the hub 160 to the drive device 200, the surgeon is able to supply a driving force from the drive device 200 to the imaging shaft 140 and the imaging unit 145. The imaging shaft 140 and the imaging unit 145 are caused by the drive force supplied from the drive device 200 to move forward and backward along the axial direction of the sheath 110 while rotating (radial scanning), thereby capturing images of the blood vessel B in a 360-degree direction.

[0036] <Drive unit> The driving device 200 has a first motor 200a which is a power source for rotating the imaging shaft 140, and a second motor 200b which is a power source for moving the imaging shaft 140 in the axial direction. The rotational motion output by the second motor 200b is converted into axial motion by a linear motion conversion mechanism 200c connected to the second motor 200b. The linear motion conversion mechanism 200c can be configured, for example, by a ball screw or a rack and pinion mechanism.

[0037] Next, a description will be given of an example of use of the diagnostic imaging apparatus 10 and a control method of the control unit 300. In the following, the "reciprocating operation mode" in which the control unit 300 controls the operation will be mainly described.

[0038] FIG. 3 shows a flow chart of the use and control procedures of the diagnostic imaging apparatus 10.

[0039] A surgeon or an operator assisting the operation of the image diagnostic apparatus 10 performs various settings related to the reciprocating operation mode when using the image diagnostic apparatus 10 (step S11). The surgeon or operator can perform the above settings using, for example, a controller attached to the image diagnostic apparatus 10, an input device for inputting instructions, an external device, or the like. The timing at which the surgeon or operator performs the above settings is not particularly limited. For example, the surgeon or operator may perform the setting of the reciprocating operation mode before starting a procedure using the image diagnostic apparatus 10, or may perform the setting of the reciprocating operation mode while performing a procedure using the image diagnostic apparatus 10.

[0040] The reciprocating operation mode is an operation mode in which the imaging unit 145 is moved backward one or more times and forward one or more times between an advance limit position De and a retreat limit position Pe in the axial direction of the sheath 110.

[0041] The setting items for the reciprocating operation mode include, for example, the forward limit position De and the backward limit position Pe (round trip distance), the initial position of the imaging unit 145 when starting the reciprocating operation, the number of round trips, the moving speed of the imaging unit 145, and the stopping time at the forward limit position De and the backward limit position Pe.

[0042] The forward limit position De can be set to, for example, the most distal position within the movable range of the imaging shaft 140 (the position where the distal end 146 of the imaging unit 145 contacts the reinforcing member 117). The backward limit position can be set to, for example, the most proximal position within the movable range of the imaging shaft 140 (the position where the inner shaft 130 is pulled out most from the outer tube 120). However, the forward limit position De and the backward limit position Pe in the reciprocating operation mode can be set to any position within the movable range of the imaging shaft 140. In other words, the forward limit position De does not have to be the most distal position within the movable range determined by the product specifications of the driving device 200 and the axial length of the sheath 110. Similarly, the backward limit position Pe does not have to be the most proximal position within the movable range determined by the product specifications of the driving device 200 and the axial length of the sheath 110.

[0043] The distance between the forward limit position De and the backward limit position Pe (the reciprocating distance of the imaging unit 145) can be set to, for example, 1.5 mm to 10 mm. When moving the imaging unit 145 over the above reciprocating distance, the control unit 300 controls the operating distance of the driving device 200 (the axial distance driven by the linear motion conversion mechanism 200c) within a range of 5 mm to 100 mm.

[0044] In a general guidewire, the tip and shaft are made of different materials (for example, different metal materials). Therefore, on a tomographic image acquired by the imaging diagnostic catheter 100, the acoustic shadow of the tip and the acoustic shadow of the shaft are displayed with different brightness. As described later, in a procedure using the imaging diagnostic device 10, an operator visually distinguishes the tip of the guidewire from the shaft of the guidewire on a tomographic image. The tip is generally disposed within a range of 5 mm from the tip side of the guidewire. Therefore, by setting the reciprocating distance of the imaging unit 145 to 5 mm to 10 mm as described above, an operator can confirm the tip W2c of the guidewire W2 and the shaft W2s located on the base end side of the tip W2c on a tomographic image when the imaging diagnostic device 10 is operated in the reciprocating operation mode.

[0045] The initial position can be set to any position within a movable range of the imaging unit 145. However, as described later, in order to make it easier to confirm the distal tip W2c of the guidewire W2 and the shaft W2s located on the proximal side of the distal tip W2c on a tomographic image when the reciprocating operation mode is performed, it is preferable to set the initial position to, for example, the forward limit position De.

[0046] The number of reciprocations can be set, for example, from 1 to 3 times. The number of reciprocations is not particularly limited as long as it is at least 1 time. However, if the number of reciprocations is set excessively high, there is a possibility that the smooth progress of the procedure will be hindered. Therefore, it is preferable to set the number of reciprocations within the above range.

[0047] The moving speed of the imaging unit 145 can be set to, for example, 0.1 mm / s to 10 mm / s. If the moving speed of the imaging unit 145 is too fast, it becomes difficult for the surgeon to check the tomographic image. On the other hand, if the moving speed of the imaging unit 145 is too slow, it becomes stressful for the surgeon. Taking these points into consideration, it is preferable to set the moving speed within the above range.

[0048] The stop time at the forward limit position De and the backward limit position Pe is, for example, 0.5 to 3 seconds. The stop time is the time from when the imaging unit 145 reaches the forward limit position De or the backward limit position Pe until the control unit 300 transmits an operation command to the driving device 200 and the imaging unit 145 actually resumes movement. If the imaging unit 145 stops for too long, it will be stressful for the surgeon. In consideration of this point, it is preferable to set the stop time within the above range.

[0049] In the reciprocating operation mode, the control unit 300 performs a first display control for displaying on the display device 400 a first tomographic image 511 (see FIG. 11) acquired while the imaging unit 145 is moving backward in synchronization with the moving backward of the imaging unit 145, and a second display control for displaying on the display device 400 a second tomographic image 512 (see FIG. 13) acquired while the imaging unit 145 is moving forward in synchronization with the moving forward of the imaging unit 145. The above "display in synchronization" means that the tomographic image acquired while the imaging unit 145 is moving is live displayed on the display device 400 in conjunction with the movement of the imaging unit 145.

[0050] When setting the reciprocating operation mode, the surgeon or operator can set the display contents of the display device 400. For example, the surgeon or operator can set the control unit 300 to transmit an operation command to the display device 400 so that the control unit 300 displays only one of the first tomographic image 511 and the second tomographic image 512. In other words, when implementing the reciprocating operation mode, the control unit 300 can control the display of the tomographic image so that only one of the first tomographic image 511 and the second tomographic image 512 is displayed while causing the imaging unit 145 to perform a reciprocating operation.

[0051] In this embodiment, the control unit 300 transmits an operation command to cause the display device 400 to display a tomographic image 501 (see FIG. 10) when the imaging unit 145 reaches the forward limit position De and a tomographic image 502 (see FIG. 12) when the imaging unit 145 reaches the backward limit position Pe. However, the surgeon or operator may set the operation so as to omit displaying the above-mentioned tomographic images 501 and 502.

[0052] When the control unit 300 performs the first display control (when the control unit 300 causes the display device 400 to display the first tomographic image 511), the control unit 300 can cause the image diagnostic device 10 to perform a first notification operation for notifying the operator that the imaging unit 145 is retracting while the imaging unit 145 is retracting, as shown in FIG. 11, for example, as the first notification operation. The image 511a is not particularly limited as long as the operator can visually confirm that the imaging unit 145 is retracting, and can be configured with the characters "Proximal", for example. The first notification operation is not limited to a form in which an image is displayed on the display device 400, and may be, for example, an operation in which a part of the color of the display device 400 is changed, or a sound or voice is generated from the display device 400.

[0053] When the control unit 300 performs the second display control (when the second tomographic image 512 is displayed on the display device 400), the control unit 300 can cause the image diagnostic device 10 to perform a second notification operation for notifying the user that the imaging unit 145 is moving forward while the imaging unit 145 is moving forward. For example, as shown in FIG. 13, the control unit 300 can cause the display device 400 to display an image 512a indicating that the imaging unit 145 is moving forward as the second notification operation. The image 512a is not particularly limited as long as the operator can visually confirm that the imaging unit 145 is moving forward, but can be configured with the characters "Distal", for example. The second notification operation is not limited to a form in which an image is displayed on the display device 400, and may be, for example, an operation in which a part of the display device 400 is changed in color or the display device 400 generates a sound or voice.

[0054] 10, when the imaging unit 145 is located at the forward limit position De, the control unit 300 can cause the display device 400 to display an image 501a notifying that the imaging unit 145 is located at the forward limit position De. The image 501a can be configured with the characters "Distal end", for example. The above-mentioned notification operation is not limited to a form in which an image is displayed on the display device 400, and may be, for example, an operation in which a color of a part of the display device 400 is changed, or a sound or voice is generated from the display device 400.

[0055] 12, when the imaging unit 145 is located at the rearmost position Pe, the control unit 300 can cause the display device 400 to display an image 502a notifying that the imaging unit 145 is located at the rearmost position Pe. The image 502a can be configured with the words "Proximal end", for example. The above-mentioned notification operation is not limited to a form in which an image is displayed on the display device 400, and may be, for example, an operation in which a part of the display device 400 is changed in color, or the display device 400 generates a sound or voice.

[0056] After the initial settings of the reciprocating operation mode are performed, the control unit 300 moves the imaging unit 145 to an initial position for the reciprocating operation (step S12). After moving the imaging unit 145 to the initial position, the control unit 300 starts the reciprocating operation of the imaging unit 145. While performing the reciprocating operation, the control unit 300 acquires each of the tomographic images 501, 502, 511, and 512 shown in FIGS. 10 to 13. The control unit 300 causes the display device 400 to display each of the tomographic images 501, 502, 511, and 512 and each of the images 501a, 502a, 511a, and 512a according to the contents of the initial settings (step S13).

[0057] An example of a procedure using the diagnostic imaging device 10 will be described with reference to Figures 4 to 9. Figures 4 and 5 show a state in which an attempt is made to pass the diagnostic imaging catheter 100 through a lesion (CTO lesion) S formed in a blood vessel B, and then the catheter 100 attempts to pass through the lesion S from another site.

[0058] In the example shown in FIG. 5, the surgeon uses the guidewire W1 to pass the diagnostic imaging catheter 100 through the lesion S, and then inserts another guidewire W2 into the blood vessel B. Because the distal tip W2c of the guidewire W2 is pointing toward the wrong target site F1, the surgeon performs an operation to adjust the direction and position of the distal tip W2c of the guidewire W2 to the target site T1 through which the surgeon wishes to pass. To perform this operation, the surgeon needs to understand the usage state of the guidewire W2 (the direction and position of the distal tip, the attitude of the guidewire W2, etc.). At this time, the surgeon can confirm the usage state of the guidewire W2 based on the tomographic images 501 and 502 acquired when the diagnostic imaging device 10 performs the reciprocating operation mode.

[0059] Fig. 6 shows a state in which the imaging unit 145 starts a reciprocating operation mode. The imaging unit 145 is disposed at an advance limit position De. Fig. 10 shows a schematic diagram of a tomographic image 501 acquired by the imaging unit 145 at the position shown in Fig. 6. The symbol S shown in Fig. 10 indicates a lesion, the symbol Lo indicates the adventitia of a blood vessel B, the symbol Lm indicates the tunica media of a blood vessel B, the symbol Li indicates the intima of a blood vessel B, and the symbol Ba indicates the lumen of a blood vessel B.

[0060] By visually checking the cross-sectional image 501 shown in FIG. 10, the surgeon can understand the position of the distal tip W2c of the guidewire W2 on the orthogonal cross section (a cross section intersecting the axial direction of the sheath 110).

[0061] Fig. 7 shows a state in which the imaging unit 145 is moving backward in the reciprocating operation mode. Fig. 11 shows a first tomographic image 511 acquired when the imaging unit 145 is moving backward.

[0062] By retracting, the imaging unit 145 moves to a position where it overlaps with the shaft W2s of the guidewire W2 in the axial direction. Therefore, the first tomographic image 511 in FIG. 11 shows an acoustic shadow of the shaft W2s of the guidewire W2. By visually checking the first tomographic image 511 in FIG. 11, the surgeon can grasp the direction and posture of the guidewire W2 from the distal tip W2c side of the guidewire W2 to the shaft W2s side (from the distal end side to the proximal end side of the guidewire W2). In addition, when the first tomographic image 511 in FIG. 11 is displayed on the display device 400, the image 511a is also displayed on the display device 400. Therefore, the surgeon can easily grasp that the imaging unit 145 is retracting. The arrow and the symbol W2c shown in FIG. 11 are examples added to make it easier to understand the change in the position of the guidewire W2 from the distal tip W2c to the shaft W2s of the guidewire W2.

[0063] The control unit 300 sets the forward limit position De as an initial position and starts the reciprocating motion of the imaging unit 145 from the forward limit position De toward the base end side. The surgeon can visually observe the difference over time between the acoustic shadow of the distal tip W2c of the guidewire W2 displayed on the tomographic image 501 acquired at the forward limit position De and the acoustic shadow of the shaft W2s of the guidewire W2 displayed on the first tomographic image 511 acquired at a position retreated from the forward limit position De. Therefore, the surgeon can easily grasp the difference between the position of the distal tip W2c of the guidewire W2 and the position of the shaft W2s of the guidewire W2 on the axially orthogonal cross section.

[0064] Fig. 8 shows the state when the imaging unit 145 has moved to the retract limit position Pe. Fig. 12 shows a tomographic image 502 acquired by the imaging unit 145 at the position shown in Fig. 8. By visually checking the tomographic image shown in Fig. 12, the surgeon can grasp the position of the portion of the shaft W2s of the guidewire W2 that is farther away from the distal tip W2c toward the base end on the cross section perpendicular to the axial direction.

[0065] When the imaging unit 145 moves to the retreat limit position Pe, the control unit 300 stops the movement of the imaging unit 145 for 0.5 to 3 seconds. Therefore, by confirming that the same tomographic image 502 is displayed on the display device 400 for a predetermined time, the surgeon can easily understand that the imaging unit 145 is in a state immediately before it starts to advance. The arrow and the symbol W2s shown in FIG. 12 are examples added to make it easier to understand the change in the axial position of the shaft W2s of the guidewire W2.

[0066] Fig. 9 shows the state in which the imaging unit 145 is moving forward. Fig. 13 shows a second tomographic image 512 acquired while the imaging unit 145 is moving forward.

[0067] The imaging unit 145 moves forward to a position where it overlaps with the distal tip W2c of the guidewire W2 in the axial direction. Therefore, the acoustic shadow of the distal tip W2c of the guidewire W2 is displayed in the second tomographic image 512 shown in FIG. 13. The surgeon can grasp the direction and posture of the guidewire W2 from the shaft W2s side of the guidewire W2 to the distal tip W2c side (from the base end side to the distal end side of the guidewire W2) by visually checking the second tomographic image 512 in FIG. 13. In addition, when the second tomographic image 512 in FIG. 13 is displayed on the display device 400, the image 512a is displayed, so that the surgeon can easily grasp that the imaging unit 145 is moving forward. The arrows shown in FIG. 13 are examples added to easily indicate the change in the position of the guidewire W2 from the shaft W2s to the distal tip W2c of the guidewire W2.

[0068] By visually checking the first tomographic image 511 and the second tomographic image 512 acquired in the reciprocating operation mode, the surgeon can obtain information on the usage state, such as the direction, position, and posture of the distal tip W2c of the guidewire W2 and the direction, position, and posture of the shaft W2s of the guidewire W2, as shown in Fig. 5. When the surgeon can confirm that the guidewire W2 is in the state shown in Fig. 5, the surgeon rotates the guidewire W2 clockwise as shown by the arrow R, for example by lifting the guidewire W2 by hand operation, in order to pass the guidewire W2 toward the desired target site T1. By operating the guidewire W2 in this way, the surgeon can appropriately adjust the position, direction, and posture of the distal end of the guidewire W2.

[0069] The effects of the diagnostic imaging apparatus 10 and the control method according to this embodiment will be described.

[0070] The diagnostic imaging device 10 includes a catheter 100 for diagnostic imaging, which includes a sheath 110 that can be inserted into a blood vessel B, an imaging shaft 140 that can move forward and backward along the axial direction of the sheath 110 and has an imaging unit 145 at its tip for acquiring a tomographic image of the blood vessel B, and a hub 160 that is disposed on the base end side of the sheath 110, a drive device 200 that can be connected to the hub 160 of the catheter 100 for diagnostic imaging and drives the forward and backward movement of the imaging shaft 140, and a control unit 300 that controls the operation of the drive device 200 and the imaging unit 145. The control unit 300 implements a reciprocating operation mode in which the imaging unit 145 is moved backward one or more times and forward one or more times between an advance limit position De and a retreat limit position Pe in the axial direction. In the reciprocating operation mode, the control unit 300 performs a first display control for displaying on the display device 400 a first tomographic image 511 acquired while the imaging unit 145 is moving backward in synchronization with the moving backward of the imaging unit 145, and a second display control for displaying on the display device 400 a second tomographic image 512 acquired while the imaging unit 145 is moving forward in synchronization with the moving forward of the imaging unit 145. When performing the first display control, the control unit 300 performs a first notification operation for notifying that the imaging unit 145 is moving backward while the imaging unit 145 is moving backward, and when performing the second display control, the control unit 300 performs a second notification operation for notifying that the imaging unit 145 is moving forward while the imaging unit 145 is moving forward.

[0071] According to the imaging diagnostic device 10, the reciprocating motion of the imaging diagnostic catheter 100 is controlled by the control unit 300. Therefore, when the imaging diagnostic catheter 100 is reciprocated, the surgeon and the operator do not need to give instructions from the surgeon side to the operator side or talk to each other. Therefore, the imaging diagnostic device 10 can reduce the workload of the surgeon and the operator when performing the reciprocating motion. The control unit 300 performs the first notification operation and the second notification operation. Therefore, while the reciprocating motion mode is being performed, the surgeon can easily know whether the imaging unit 145 is moving backward or forward. Since the operator does not need to inform the surgeon whether the imaging unit 145 is moving backward or forward, the workload when performing the reciprocating motion mode is reduced.

[0072] As a first notification operation, the control unit 300 causes the display device 400 to display an image 511a indicating that the imaging unit 145 is moving backward. As a second notification operation, the control unit 300 causes the display device 400 to display an image 512a indicating that the imaging unit 145 is moving forward. Therefore, by visually checking the display content of the display device 400, the surgeon can easily know whether the imaging unit 145 is moving backward or forward while the reciprocating operation mode is being performed.

[0073] The control unit 300 starts the reciprocating operation mode from a state in which the imaging unit 145 is disposed at the forward limit position De in the sheath 110. Therefore, the surgeon can visually observe over time the difference between the acoustic shadow of the distal tip W2c of the guidewire W2 displayed on the tomographic image 501 acquired at the forward limit position De and the acoustic shadow of the shaft W2s of the guidewire W2 displayed on the first tomographic image 511 acquired at a position retreated from the forward limit position De, and can easily grasp the difference between the position of the distal tip W2c of the guidewire W2 and the position of the shaft W2s of the guidewire W2.

[0074] The forward movement limit position De and the backward movement limit position Pe can be set within any range along the axial direction of the sheath 110. Therefore, the surgeon or operator can appropriately set the reciprocating distance depending on the structure, type, and product specifications of the medical instrument (guidewire) to be observed.

[0075] The diagnostic imaging catheter 100 is a catheter for intravascular ultrasound examination. Therefore, the surgeon can easily grasp the usage state of the guidewire W2 based on the difference between the acoustic shadow of the distal tip W2c and the acoustic shadow of the shaft W2s of the guidewire W2 inserted into a biological lumen such as a blood vessel B, based on each of the tomographic images 511 and 512.

[0076] In the reciprocating operation mode, when the imaging unit 145 reaches the forward limit position De or the backward limit position Pe, the control unit 300 stops the movement of the imaging unit 145 for 0.5 to 3 seconds. Therefore, the surgeon can easily know that the imaging unit 145 has reached the forward limit position De or the backward limit position Pe by visually checking the tomographic image.

[0077] The control method is a method for controlling the operation of an imaging diagnostic catheter 100 that includes a sheath 110 that can be inserted into a blood vessel B, an imaging shaft 140 that can move back and forth along the axial direction of the sheath 110 and has an imaging unit 145 at its tip for acquiring tomographic images within the blood vessel B, and a hub 160 that is arranged on the base end side of the sheath 110. The control method includes implementing a reciprocating operation mode in which the imaging unit 145 is moved backward one or more times and forward one or more times between a forward limit position De and a backward limit position Pe in the axial direction, and implementing, in the reciprocating operation mode, a first display control for causing the display device 400 to display a first tomographic image 511 acquired while the imaging unit 145 is moving backward in synchronization with the backward movement of the imaging unit 145, and a second display control for causing the display device 400 to display a second tomographic image 512 acquired while the imaging unit 145 is moving forward in synchronization with the forward movement of the imaging unit 145. When implementing the first display control, a first notification operation for notifying that the imaging unit 145 is moving backward is implemented while the imaging unit 145 is moving backward, and when implementing the second display control, a second notification operation for notifying that the imaging unit 145 is moving forward is implemented while the imaging unit 145 is moving forward.

[0078] According to the control method, the surgeon and the operator do not need to give instructions from the surgeon side to the operator side or talk to each other when performing the reciprocating motion of the diagnostic imaging catheter 100. Therefore, the workload of the surgeon and the operator when performing the reciprocating motion can be reduced. The surgeon can easily know whether the imaging unit 145 is moving backward or forward while the reciprocating motion mode is being performed. Since the operator does not need to inform the surgeon whether the imaging unit 145 is moving backward or forward, the workload when performing the reciprocating motion mode is reduced.

[0079] The diagnostic imaging device 10 includes a catheter 100 for diagnostic imaging, which includes a sheath 110 that can be inserted into a blood vessel B, an imaging shaft 140 that can move forward and backward along the axial direction of the sheath 110 and has an imaging unit 145 at its tip for acquiring a tomographic image of the blood vessel B, and a hub 160 that is disposed on the base end side of the sheath 110, a drive device 200 that can be connected to the hub 160 of the catheter 100 for diagnostic imaging and drives the forward and backward movement of the imaging shaft 140, and a control unit 300 that controls the operation of the drive device 200 and the imaging unit 145. The control unit 300 implements a reciprocating operation mode in which the imaging unit 145 is moved backward one or more times and forward one or more times between an advance limit position De and a retreat limit position Pe in the axial direction. The control unit 300 may be configured to perform only one of a first display control for causing the display device 400 to display a first tomographic image 511 acquired while the imaging unit 145 is retracting in synchronization with the retraction of the imaging unit 145, and a second display control for causing the display device 400 to display a second tomographic image 512 acquired while the imaging unit 145 is advancing in synchronization with the advancement of the imaging unit 145, in the reciprocating operation mode. Even in this configuration, the surgeon and the operator can easily check the usage state of the guidewire W inserted into the blood vessel B in a procedure using the imaging diagnostic device 10.

[0080] The control method is a control method for controlling the operation of an imaging diagnostic catheter 100 including a sheath 110 that can be inserted into a blood vessel B, an imaging shaft 140 that can move forward and backward along the axial direction of the sheath 110 and has an imaging unit 145 at its tip for acquiring a tomographic image inside the blood vessel B, and a hub 160 disposed on the base end side of the sheath 110. The control method may be configured to perform a reciprocating operation mode in which the imaging unit 145 is retracted one or more times and advanced one or more times between an advance limit position De and a retreat limit position Pe in the axial direction, and to perform only one of a first display control for displaying a first tomographic image 511 acquired while the imaging unit 145 is retracting on the display device 400 in synchronization with the retreat of the imaging unit 145 in the reciprocating operation mode, and a second display control for displaying a second tomographic image 512 acquired while the imaging unit 145 is advancing on the display device 400 in synchronization with the advance of the imaging unit 145. Even when controlled in this manner, the surgeon or operator can easily check the usage state of the guidewire W inserted into the blood vessel B during a procedure using the diagnostic imaging device 10.

[0081] The imaging diagnostic device and operation method according to the present disclosure have been described above through embodiments, but the imaging diagnostic device and control method according to the present disclosure are not limited to the contents disclosed in the specification and may be modified as appropriate based on the description of the claims.

[0082] For example, in the embodiment, an example has been described in which the diagnostic imaging catheter according to the present disclosure is applied to a catheter for intravascular ultrasound examination, but the diagnostic imaging catheter according to the present disclosure may also be applied to a diagnostic imaging catheter that acquires images using light such as optical coherence tomography (OCT), or may be applied to a dual-type diagnostic imaging catheter that can use both ultrasound diagnosis and optical coherence tomography diagnosis.

[0083] The biological lumen that is the target of the procedure using the diagnostic imaging catheter may be other than a blood vessel, and may be, for example, a bile duct, a trachea, an esophagus, a urethra, an ear and nose cavity, or the like.

[0084] The specific procedure using the diagnostic imaging catheter is not limited. For example, when inserting a guidewire into a side branch of a blood vessel, the diagnostic imaging device and control method according to the present disclosure may be used to check the usage state of the guidewire. The medical device whose usage state is grasped by the diagnostic imaging catheter is not limited to the guidewire.

[0085] The specific configurations of the imaging diagnostic catheter, the drive unit, the display device, and the imaging diagnostic device are not limited to those described in the specification. The materials of the components, the arrangement of the components, the omission of additional components, the addition of additional components, etc. may be changed as desired. [Explanation of symbols]

[0086] 10 Diagnostic imaging devices; 100 Diagnostic imaging catheter, 110 sheath, 110a sheath lumen, 114 Guide wire insertion portion, 114a guidewire lumen, 119 Observation window, 140 imaging shaft, 141 Tube body, 142 signal line, 145 Imaging unit, 145a signal transmitter / receiver; 145b Housing, 146 Tip of imaging unit, 160 hub, 200 Drive unit, 300 control section, 400 display devices, 401 display, 511 First tomographic image, 512 Second tomographic image, B. Blood vessels (biological lumen), De forward limit position, Pe Retraction limit position, T1 target site, S: lesion; W1 guidewire, W2 Guidewire, W2c Guidewire Tip, W2s Guidewire shaft.

Claims

1. a catheter for diagnostic imaging, the catheter comprising: a sheath that can be inserted into a body lumen; an imaging shaft that can move back and forth along the axial direction of the sheath and has an imaging unit at its tip for acquiring a tomographic image of the body lumen; and a hub that is disposed on the base end side of the sheath; a driving device that is connectable to the hub of the diagnostic imaging catheter and drives the imaging shaft to move forward and backward; a control unit that controls the operation of the driving device and the imaging unit, the control unit implements a reciprocating operation mode in which the imaging unit is moved backward one or more times and forward one or more times between a forward limit position and a backward limit position in the axial direction, the control unit, in the reciprocating operation mode, performs a first display control for causing a display device to display a first tomographic image acquired while the imaging unit is moving backward in synchronization with the moving backward of the imaging unit, and a second display control for causing a display device to display a second tomographic image acquired while the imaging unit is moving forward in synchronization with the moving forward of the imaging unit; when the control unit performs the first display control, the control unit performs a first notification operation for notifying the user that the imaging unit is moving backward while the imaging unit is moving backward, and when the control unit performs the second display control, the control unit performs a second notification operation for notifying the user that the imaging unit is moving forward while the imaging unit is moving forward; The control unit starts the reciprocating operation mode from a state in which the imaging unit is disposed at the forward limit position within the sheath.

2. The control unit causes the display device to display an image indicating that the imaging unit is moving backward as the first notification action, The image diagnostic device according to claim 1 , wherein the control unit causes the display device to display, as the second notification action, an image indicating that the imaging unit is moving forward.

3. The image diagnostic device according to claim 1 or 2, wherein the first notification action and the second notification action include an action of generating a sound or a voice.

4. The diagnostic imaging device according to claim 1 , wherein the first notification action and the second notification action include an action of changing a color of a part of the display device.

5. 5. The diagnostic imaging device according to claim 1, wherein the moving speed of the imaging unit can be set to a range of 0.1 mm / s to 10 mm / s.

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