JP5576665B2 - In-vivo diagnostic apparatus and control method thereof - Google Patents

Description

  The present invention relates to an in-vivo diagnostic apparatus that is used by being inserted into a body cavity such as a blood vessel and a blood vessel and a control method thereof.

  In order to examine an affected part in a body cavity such as a blood vessel and a vascular vessel, an ultrasonic catheter that transmits and receives ultrasonic waves in the affected part is used. As an example, an ultrasonic catheter has a sheath inserted into a body cavity, and a drive shaft that has a transducer unit at the tip for transmitting and receiving ultrasonic waves and capable of axial rotation and axial movement within the sheath. doing.

  When using an ultrasonic catheter, first, physiological saline is primed in the sheath, and the transducer unit is disposed in the most distal side in advance in the sheath and the sheath is carried deeper than the affected part. Thereafter, while leaving the sheath, only the transducer unit is retracted from the distal end of the sheath and passed through the affected part. By retracting only the transducer unit (pull back), the transducer unit moves from the deep part through the affected part, so that ultrasonic observation can be continuously performed before and after the affected part, and blood vessels and veins can be observed. A tomographic image having a shape such as a tube can be created.

  However, when the transducer unit is retracted in the sheath at the time of measurement, the volume of the region to be filled with physiological saline in the catheter increases, so that blood is drawn into the sheath. When blood is drawn into the sheath and reaches the vibrator unit, the attenuation of the ultrasonic wave becomes larger than in the case where the vibrator unit is covered with physiological saline, and the measured image deteriorates.

  By the way, in patent document 1, in order to prevent that a living tissue and an ultrasonic transducer (vibrator) are in direct contact and the living tissue is destroyed at the time of measurement and accurate diagnosis cannot be performed, ultrasonic conversion is performed. An ultrasonic diagnostic imaging apparatus including a transmission medium supply device is described so that a transmission medium such as physiological saline can be supplied into an inner needle in which a vessel exists.

  However, in the ultrasonic diagnostic imaging apparatus described in Patent Document 1, since the diagnosis is performed with the ultrasonic transducer exposed to the living body, inflow of blood into the sheath is not considered.

  In addition, minute bubbles that do not affect the living body may be present in the sheath, but if bubbles adhere to the transducer unit during measurement, the ultrasonic waves will not propagate and are measured by the transducer unit. The signal becomes weak and the image cannot be acquired.

  Thus, as a technique for removing bubbles, for example, Patent Document 2 describes a technique for removing bubbles by moving the probe at a high speed when bubbles are attached to the probe (vibrator).

  However, the ultrasonic inspection apparatus described in Patent Document 2 is not premised on use in a living body, and in an ultrasonic catheter that has a restriction such as the presence of a vibrator unit in a sheath, the vibrator unit is moved at high speed. It is difficult.

JP-A-8-154936 JP-A-6-331604

  The present invention has been made to solve the above-described problems, and provides an in-vivo diagnostic apparatus and a control method thereof that can automatically suppress adhesion of blood and bubbles to a transducer unit and obtain a good image. The purpose is to provide.

The in-vivo diagnostic device of the present invention that achieves the above object has a sheath inserted into the living body and a signal transmitting / receiving member for transmitting and receiving signals at the tip, and is capable of axial rotation and axial movement within the sheath. An in-vivo diagnostic device for connecting to an in-vivo insertion probe having a shaft and transmitting / receiving signals to / from the signal transmitting / receiving member to acquire in-vivo information and to move the drive shaft within the sheath An axial movement device for moving the drive shaft in an axial direction, medium supply means for supplying a transmission medium into the in-vivo insertion probe, controlling the medium supply means, and from the signal transmitting / receiving member A control unit that automatically adjusts the supply amount of the transmission medium in accordance with a signal waveform or an axial movement amount of the drive shaft. The control unit controls the medium supply unit to supply the transmission medium at a flow rate equal to or higher than the volume increase rate of the medium region in the in-vivo insertion probe accompanying the axial movement of the drive shaft toward the proximal end side. .

In addition, the control method of the in-vivo diagnostic device of the present invention that achieves the above-described object has a sheath for insertion into the living body and a signal transmitting / receiving member for transmitting and receiving signals at the tip, and the shaft rotation and shaft in the sheath Connected to an in-vivo insertion probe having a drive shaft capable of moving in a direction, and transmits / receives a signal to / from the signal transmitting / receiving member to acquire in-vivo information and move the drive shaft in the sheath A control method for an in-vivo diagnostic device for the in-vivo diagnostic device, wherein the in-vivo diagnostic device transmits a signal into the in-vivo insertion probe according to a signal waveform from the signal transmitting / receiving member or an axial movement amount of the drive shaft. The supply amount of the transmission medium from the medium supply means for supplying is automatically adjusted by the control unit. When driving the axial movement device, the volume increase rate of the medium region in the biological insertion probe accompanying the axial movement of the drive shaft toward the proximal end is calculated by the control unit or stored in the control unit. The control unit transmits a command signal to the medium supply means so as to supply the transmission medium at a flow rate equal to or higher than the volume increase rate.

The in-vivo diagnostic device of the present invention configured as described above is provided with a control unit that adjusts the supply amount of the transmission medium in accordance with the signal from the signal transmitting / receiving member or the axial movement amount of the drive shaft. It is possible to automatically discriminate and suppress the adhesion of blood and bubbles to the child unit and acquire a good image. Further, the medium supply means may be configured so that the control unit supplies the transmission medium at a flow rate equal to or higher than the volume increase rate of the medium region in the in-vivo insertion probe accompanying the axial movement of the drive shaft toward the proximal end side. Because of the control, blood does not flow into the sheath, and it is possible to obtain a good image by suppressing the adhesion of blood to the transducer unit.

  If the control unit controls the medium supply unit to supply the transmission medium when the amplitude of the signal waveform from the signal transmission / reception member is smaller than a preset threshold value, It is possible to discriminate the attachment of bubbles and automatically remove the bubbles from the signal transmission / reception member by the transmission medium, and a good image can be acquired.

  If the medium supply means is formed integrally with the axial movement device, the device is reduced in space and workability is improved.

  If the medium supply means is provided in an axial movement unit that is connected to the in-vivo insertion probe and moves in the axial direction, a port of the in-vivo insertion probe to which a transmission medium is supplied in communication with the medium supply means Even in the configuration in which the direction moving device moves in the axial direction, the distance between the medium supply unit and the port of the in-vivo insertion probe does not change, and the axial direction moving device can operate satisfactorily.

  By providing power transmission means for mechanically transmitting power from the axial movement device to the medium supply means, the medium supply means can be driven in synchronization with the axial movement device.

The control method of the in-vivo diagnostic device of the present invention configured as described above is for automatically adjusting the supply amount of the transmission medium from the medium supply means according to the signal from the signal transmitting / receiving member or the axial movement amount of the drive shaft. Therefore, it is possible to automatically determine and suppress the adhesion of blood or bubbles to the vibrator unit and acquire a good image. Further, when driving the axial movement device, the controller calculates or increases the volume increase rate of the medium region in the living body insertion probe accompanying the axial movement of the drive shaft toward the proximal end side. Since the command signal is transmitted from the control unit to the medium supply means so as to supply the transmission medium at a flow rate equal to or higher than the volume increase rate from the control unit, blood does not flow into the sheath, and the vibrator A good image can be obtained by suppressing the adhesion of blood to the unit.

  The amplitude of the signal waveform transmitted from the signal transmission / reception member to the control unit is compared with a threshold value set in advance by the control unit, and when the value is lower than the threshold value, the control unit supplies the transmission medium. If the command signal is transmitted to the medium supply means, it is possible to determine the adhesion of bubbles to the signal transmission / reception member, and to automatically remove the bubbles from the signal transmission / reception member by the transmission medium, thereby obtaining a good image. .

It is a top view which shows the in-vivo diagnostic apparatus which concerns on 1st Embodiment. It is a top view which shows an ultrasonic catheter. It is longitudinal direction sectional drawing which shows the front-end | tip part of an ultrasonic catheter. It is a top view which shows the ultrasonic catheter at the time of pulling back a vibrator unit. It is a longitudinal direction sectional view showing a hub of an ultrasonic catheter. FIG. 3 is a longitudinal sectional view showing a unit connector and a relay connector of an ultrasonic catheter. It is a top view which shows at the time of pulling back a scanner apparatus in the in-vivo diagnostic apparatus which concerns on 1st Embodiment. It is longitudinal direction sectional drawing which shows the volume change in an outer tube | pipe at the time of pulling back. It is a flowchart which shows the procedure of the control processing of the in-vivo diagnostic apparatus in the case of pullback. It is a flowchart which shows the procedure of a flushing process. It is a top view which shows the in-vivo diagnostic apparatus which concerns on 2nd Embodiment. It is a top view which shows at the time of pulling back a scanner apparatus in the in-vivo diagnostic apparatus which concerns on 2nd Embodiment. It is a top view which shows the in-vivo diagnostic apparatus which concerns on 3rd Embodiment. It is a schematic plan view which shows the power transmission means of the in-vivo diagnostic apparatus which concerns on 3rd Embodiment.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

<First Embodiment>
As shown in FIG. 1, the in-vivo diagnostic apparatus according to the first embodiment includes an ultrasonic catheter 1 (in-vivo insertion probe) for observing the inside of a body cavity and an ultrasonic catheter connected to the ultrasonic catheter. And an external driving device 7 for driving.

  First, the ultrasonic catheter 1 will be described in detail.

  As shown in FIG. 2, the ultrasonic catheter 1 includes a sheath 2 that is inserted into a body cavity, and an operation unit 3 that is not inserted into the body cavity and is disposed on the user's hand side for operation by the user. Composed.

  As shown in FIG. 3, the sheath 2 includes a sheath tip member 21, a sheath body 22, and a filling liquid inlet / outlet member 23. The sheath body 22 is bonded to the sheath tip member 21 and the filling liquid inlet / outlet member 23 so as to cover the sheath tip member 21 and the filling liquid inlet / outlet member 23.

  An X-ray contrast marker 24 is provided between the sheath tip member 21 and the sheath body 22 so that the tip position of the ultrasonic catheter can be confirmed under fluoroscopy when inserted into a body cavity.

  A hole 211 is formed in the sheath distal end member 21, and the guide wire 25 is inserted into the hole 211 and passes therethrough. The guide wire 25 is inserted into the body cavity in advance, and the ultrasonic catheter 1 is guided to the affected area while passing the guide wire 25 through the sheath distal end member 21.

  The filling liquid inlet / outlet member 23 and the sheath main body 22 are formed with a priming lumen 221 that is a hole for allowing a physiological saline solution filled in the sheath main body 22 to flow to the outside.

  An imaging core 4 is incorporated in the sheath 2 so as to be slidable in the axial direction of the sheath 2. The imaging core 4 includes a transducer unit 41 for transmitting and receiving ultrasonic waves toward the body cavity tissue, and a drive shaft 42 that attaches the transducer unit 41 to the tip and rotates the transducer unit 41. The transducer unit 41 includes an ultrasonic transducer 411 (signal transmission / reception member) that transmits and receives ultrasonic waves, and a housing 412 that houses the ultrasonic transducer 411.

  The sheath 2 is formed of a material having high ultrasonic permeability. A portion of the sheath 2 within the range in which the ultrasonic transducer 411 moves constitutes an acoustic window portion through which ultrasonic waves are transmitted. Ultrasound has the property of reflecting at the boundary where the acoustic impedance changes. At the time of diagnosis, that is, in a state where the ultrasonic catheter 1 is placed in the blood vessel, the periphery of the ultrasonic catheter 1 is filled with blood (body fluid). Therefore, it is necessary to configure the ultrasonic transducer 411 and the blood vessel wall to be diagnosed so that nothing other than an acoustic impedance equivalent to that of blood exists. The acoustic impedance is a material-specific constant represented by the product of the acoustic propagation speed (sound speed) in the material and the material density. Into the lumen of the sheath 2, physiological saline having substantially the same acoustic impedance as blood is injected as an ultrasonic transmission liquid. For this reason, the material constituting the sheath 2 needs to be a material having an equivalent acoustic impedance. As an example, in this embodiment, polyethylene is used as the material of the sheath 2.

  The drive shaft 42 is flexible and has a characteristic capable of transmitting the rotational power generated in the operation unit 3 (see FIG. 2) to the vibrator unit 41. For example, the right and left and the winding direction are alternately 3 It is composed of a multilayer coil-like tube body such as a layer coil. When the driving shaft 42 transmits the rotational power, the vibrator unit 41 rotates, and the affected part in the body cavity such as a blood vessel and a vascular vessel can be observed 360 degrees. The drive shaft 42 has a signal line 54 for transmitting a signal detected by the vibrator unit 41 to the operation unit 3.

  As shown in FIG. 2, the operation unit 3 includes a hub 31 having a port 311 for injecting physiological saline for bleeding air, a unit connector 32 connected to the hub 31 via an inner tube 312, an external connector The relay connector 33 is connected to the unit connector 32 via the pipe 331 and connects the sheath 2 and the operation unit 3.

  The hub 31 holds the drive shaft 42 and the inner tube 312. When the inner tube 312 is pushed into or pulled out of the unit connector 32 and the outer tube 331, the drive shaft 42 is interlocked and slides in the sheath 2 in the axial direction.

  When the inner tube 312 is pushed in the most, as shown in FIG. 2, the end of the inner tube 312 reaches the vicinity of the outer end of the outer tube 331, that is, the vicinity of the relay connector 33. In this state, the transducer unit 41 is located near the distal end of the sheath body 22 of the sheath 2.

  When the inner tube 312 is pulled out most, as shown in FIG. 4, the stopper 313 formed at the tip of the inner tube 312 is caught by the inner wall of the unit connector 32, and the portions other than the vicinity of the caught tip are exposed. In this state, the transducer unit 41 is pulled back while leaving the sheath 2. By moving the transducer unit 41 while rotating, it is possible to create tomographic images of blood vessels and vessels.

  Next, a specific structure of each part of the ultrasonic catheter 1 will be described.

  As shown in FIG. 5, the hub 31 includes a joint 50, a male connector 51, a rotor 52, a connection pipe 53, a signal line 54, a hub body 55, a seal member 56, and a kink protector 57. Have.

  The joint 50 has an opening 501 on the user's hand side of the ultrasonic catheter 1 and arranges the male connector 51 and the rotor 52 therein. The male connector 51 can be connected to the female connector 711 of the external drive device 7 (see FIG. 1) from the opening 501 side of the joint 50, whereby the external drive device 7 and the male connector 51 are mechanically and electrically connected. Connected.

  The rotor 52 holds the connection pipe 53 in a non-rotatable manner and rotates integrally with the male connector 51. The connection pipe 53 holds the drive shaft 42 at the end opposite to the rotor 52 side in order to transmit the rotation of the rotor 52 to the drive shaft 42. A signal line 54 is passed through the connection pipe 53. One end of the signal line 54 is connected to the male connector 51, and the other end is connected to the vibrator unit 41 through the drive shaft 42. The observation result in the transducer unit 41 is transmitted to the external drive device 7 through the male connector 51, subjected to appropriate processing, and displayed as an image.

  The hub body 55 is injected with physiological saline from the port 311 and introduces the physiological saline into the inner tube 312 without leaking outside. In addition, since the seal member 56 including the O-ring 58 is installed between the hub body 55 and the joint 50, physiological saline does not leak to the opening 501 side of the joint 50.

  A part of the inner tube 312 is fitted into the hub body 55, and the kink protector 57 is disposed around the inner tube 312 and the hub body 55.

  As shown in FIG. 6, the unit connector 32 includes a unit connector main body 61, a sealing member 62, a cover member 63, and a packing 64.

  In the unit connector main body 61, an outer tube 331 attached to the relay connector 33 is inserted, and an inner tube 312 extending from the hub 31 is inserted into the outer tube 331. The sealing member 62 is combined with the unit connector main body 61 to hold the packing 64, and the cover member 63 is combined with the unit connector main body 61 to hold the outer tube 331. Since the packing 64 is sealed between the unit connector main body 61 and the sealing member 62, physiological saline supplied to the port 311 of the hub 31 flows into the outer tube 331 through the inner tube 312. However, it does not leak outside the unit connector 32.

  Further, since the inner pipe 312 extending from the hub 31 is formed with a stopper 313 at the tip, even when the hub 31 is most pulled, that is, when the inner pipe 312 is most pulled out from the outer pipe 331, the stopper 313 is provided as a unit. The inner tube 312 is not pulled out from the unit connector 32 by being caught on the inner wall of the connector main body 61.

  The relay connector 33 includes an outer tube holding portion 65 and a relay connector main body 66. The outer tube holding part 65 holds the outer tube 331. Also, the proximal end of the sheath 2 is connected to the inner surface of the outer tube holding portion 65, and a drive shaft 42 that passes through the outer tube 331 and a path for introducing physiological saline into the sheath 2 are formed. ing. A plurality of tubes can be further inserted into this path to prevent buckling of the drive shaft 42 and leakage of physiological saline.

  A protective tube 67 is fixed to the inner wall of the outlet member 332 through which the drive shaft 42 of the outer tube holding portion 65 passes. The protective tube 67 extends toward the inner tube 312 extending from the hub 31 and is disposed between the drive shaft 42 and the inner tube 312. Therefore, when the inner tube 312 is pushed into the outer tube 331, the protective tube 67 is pushed into the inner tube 312 in the direction opposite to the pushing direction. When the inner tube 312 is pushed into or pulled out from the outer tube 331, the protective tube 67 is also pushed or pulled out relative to the inner tube 312 from the opposite direction. Even if a bending force is generated in the drive shaft 42, the bending force can be suppressed by the protective tube 67, and bending or the like can be prevented. The protective tube 67 is formed of a metal sparsely wound coiled body, and therefore physiological saline can flow from the gap between the coils, so that air remains in the outer tube 331. There is no.

  Next, the external drive device 7 will be described in detail.

  As shown in FIG. 1, the external drive device 7 includes a scanner device 71 incorporating an external drive source such as a motor, an axial movement device 72 that holds the scanner device 71 and moves the scanner device 71 in the axial direction, and a syringe pump. 73 (medium supply means), a signal processing device 79 (control unit), and a display unit 74 that displays an image obtained by the transducer unit 41.

  The scanner device 71 is provided with a scanner control device 76 for driving the scanner device 71, and the axial direction movement device 72 is provided with an axial direction movement control device 77 for driving and controlling the axial direction movement device 72. The syringe pump 73 is provided with a pump control device 78 for driving and controlling the syringe pump 73. The signal processing device 79 controls the scanner control device 76, the axial movement control device 77, and the pump control device 78 in an integrated manner. That is, the signal processing device 79 receives signals from the scanner control device 76, the axial movement control device 77, and the pump control device 78, and sends a command signal to the scanner control device 76, the axial movement control device 77, and the pump control device 78. Can be transmitted and these can be controlled synchronously. The signal processing device 79 is a computer such as a PC or an EWS (engineering workstation), but may be a dedicated device capable of arithmetic processing.

  Each of the scanner control device 76, the axial movement control device 77, and the pump control device 78 is configured separately from the scanner device 71, the axial movement device 72, and the syringe pump 73 in FIG. It may be configured. Alternatively, a part of the scanner control device 76, the axial movement control device 77, and the pump control device 78 may be configured inside the signal processing device 79. Further, two or more of the scanner control device 76, the axial movement control device 77, and the pump control device 78 may be configured by the same device.

  The axial movement device 72 includes a scanner gripping portion 721 that grips and fixes the scanner device 71 and a sheath support portion 722 that supports the sheath 2 so that it does not shift during pullback.

  In this embodiment, the syringe pump 73 is configured integrally with the axial movement device 72, and fixes the syringe 731 and the cylindrical syringe 731 that stores physiological saline (transmission medium) therein. A syringe fixing part 732, a plunger 733 that enters the inside of the syringe 731, a pressing part 734 that presses the plunger 733, and a drive source (not shown) such as a motor that drives the pressing part 734 are provided. By integrally configuring the syringe pump 73 and the axial movement device 72, the device is gathered in a space-saving manner, and workability is improved.

  The scanner device 71 includes a female connector 711 to which the male connector 51 of the ultrasonic catheter 1 can be connected. By this connection, signals can be transmitted to and received from the transducer unit 41, and at the same time, the drive shaft 42 is rotated. It becomes possible to make it.

  Ultrasonic scanning (scanning) in the ultrasonic catheter 1 transmits the rotational motion of the motor in the scanner device 71 to the drive shaft 42, and rotates the housing 412 fixed to the tip of the drive shaft 42, thereby rotating the housing 412. This is performed by scanning an ultrasonic wave transmitted and received by the ultrasonic transducer 411 provided in the substantially radial direction. The ultrasonic image obtained here is a transverse cross-sectional image in the blood vessel. In addition, by pulling the entire ultrasonic catheter 1 toward the proximal side and moving the imaging core 4 in the longitudinal direction, a 360 ° cross-sectional image of the surrounding tissue body in the axial direction in the blood vessel can be obtained in a scanning manner. Can do.

  Next, operations of the ultrasonic catheter 1 and the external drive device 7 when observing the inside of the body cavity of the present invention will be described.

  Before inserting the sheath 2 of the ultrasonic catheter 1 into a body cavity, a priming operation is performed to fill the ultrasonic catheter 1 with physiological saline. By performing this priming operation, air in the ultrasonic catheter 1 can be removed and air can be prevented from entering into a body cavity such as a blood vessel.

  In order to perform the priming operation, as shown in FIG. 1, the syringe 731 is installed in the syringe pump 73 and fixed by the syringe fixing portion 732. Further, the male connector 51 (see FIG. 5) of the ultrasonic catheter 1 is connected to the female connector 711 of the external drive device 7, and the unit connector main body 61 is coupled to the sheath support portion 722 of the external drive device 7. Further, the connection tube 735 allows communication between the port 311 of the hub 31 and the syringe 731.

  Next, in a state where the hub 31 is most pulled toward the user, that is, in a state where the inner tube 312 is pulled out most from the outer tube 331, the syringe pump 73 is operated by the pump control device 78 to press the plunger 733. Physiological saline solution is injected into the port 311 through the connecting tube 735 by pressing with the portion 734. The injected physiological saline solution is filled from the hub 31 into the sheath 2 in order. When the inside of the ultrasonic catheter 1 is completely filled with the physiological saline, the physiological saline is removed from the priming lumen 221 formed on the filling fluid inlet / outlet member 23 (see FIG. 3) of the sheath 2. Thereby, the filling of the physiological saline solution is confirmed.

  The operation and stop of the syringe pump 73 in priming can be easily performed by pressing an operation button provided on the pump control device 78 or the syringe pump 73, and workability is improved. Note that priming may be performed before the ultrasonic catheter 1 is connected to the external drive device 7, and the ultrasonic catheter 1 may be connected to the external drive device 7 after priming.

  Next, the hub 31 is pushed in so that the inner pipe 312 is pushed most into the outer pipe 331 (see FIG. 1). In this state, the sheath 2 is inserted into the body, and the insertion is stopped after the distal end of the sheath 2 exceeds the affected area.

  Next, as shown in FIG. 7, the axial movement device 72 is operated to move the transducer unit 41 in the axial direction while pulling the hub 31 toward the hand side, and the transducer unit 41 causes the acoustic window of the sheath 2 to move. Observe the area across the affected area.

  When the hub 31 is pulled toward the hand side, as shown in FIG. 8, the inner tube 312 is pulled out from the inside of the outer tube 331, and the volume of the region filled with physiological saline in the outer tube 331 increases. The volume increase amount A in the outer tube 331 is such that the pullback distance (retraction distance) is X, the volume per unit length corresponding to the outer diameter D of the inner tube 312 is B, the drive shaft 42 and the internal signal line 54. Assuming that the total volume per unit length is C, the volume increase amount can be expressed as A = (BC) × X. Also in the sheath 2, the volume increase E = C × X corresponding to the pullback distance X of the drive shaft 42 and the signal line 54 is increased by pulling out the drive shaft 42 and the signal line 54. Therefore, since the volume increase amount F of the region (medium region) filled with physiological saline and blood flowing from the priming lumen 221 in the ultrasonic catheter 1 is A + E, the volume increase amount F = B × X of the medium region. It is represented by

  When the volume of the medium region increases due to the pullback, blood flows into the sheath body 22 from the priming lumen 221 at the distal end of the sheath body 22 when no new physiological saline is supplied from the port 311. Since the inner diameter of the sheath body 22 is smaller than the outer diameter D of the inner tube 312, the length of blood flowing from the distal end side is longer than the pullback distance X. Therefore, the blood that has flowed in reaches the position of the transducer unit 41 and the drive shaft 42 that are pulled back within the sheath body 22 by the pullback distance X. When the vibrator unit 41 is covered with blood, the ultrasonic wave is attenuated more than when the vibrator unit 41 is covered with physiological saline, and the image displayed on the display unit 74 is deteriorated.

  Further, when the blood reaches the vibrator unit 41 and the drive shaft 42, when the scanner device 71 once pulled back is moved forward again (push forward), the viscosity of the blood becomes physiological saline. Therefore, the vibrator unit 41 is difficult to move to the tip side. As a result, the drive shaft 42 and the signal line are disconnected, or the drive shaft that cannot enter the sheath body 22 from the outer tube 331 stays in the outer tube 331, thereby protecting the drive shaft in the outer tube 331. There is a possibility that a phenomenon such as the tube 67 being wound in a toggro manner may occur. In order to prevent such a phenomenon from occurring, it is necessary to perform push-forward while rotating the drive shaft 42.

  In contrast, in the present embodiment, as shown in the flowchart of FIG. 9, physiological saline having the same volume as or larger than the volume increase amount F is supplied from the port 311 according to the volume increase amount F of the medium region by pullback. Supply.

  That is, the signal processing device 79 calculates the flow rate of the syringe pump 73 in accordance with a preset pullback speed (or a pullback speed newly input to one of the control devices) (step S101). Or you may read from the data stored in the signal processing apparatus 79 instead of calculating.

  The flow rate (volume movement amount per unit time) of the syringe pump 73 is preferably equal to or higher than the volume increase rate (change amount of the volume increase amount F per unit time) of the medium region due to pullback. Since the pullback speed is not always constant, it is desirable to calculate or read out the temporal change in the flow rate of the syringe pump 73 in accordance with the change in the pullback speed. The flow rate of the syringe pump 73 is not calculated in advance before the image measurement for ultrasonic diagnosis, but the syringe pump 73 is sequentially calculated by the signal processing device 79 from the pullback speed during the image measurement. The flow rate from 73 may be controlled.

  Next, the signal processing device 79 transmits a command signal to the scanner control device 76 to start ultrasonic measurement by the scanner device 71 (step S102), and also transmits a command signal to the axial direction movement control device 77 to Pull-back of the scanner device 71 by the direction moving device 72 is started (step S103). Note that the order of step S102 and step S103 may be interchanged.

  Thereafter, the signal processing device 79 controls the syringe pump 73 in synchronization with the pullback speed of the axial movement device 72 to adjust the flow rate of the syringe pump 73 (step S104). Accordingly, the amount of physiological saline supplied from the syringe pump 73 is always greater than or equal to the volume increase F of the medium region due to pullback, and the inflow of blood from the priming lumen 221 into the sheath body 22 is suppressed. It is possible to suppress the attenuation of the image and display a good image, and to suppress the occurrence of disconnection or the like during push forward.

  Thereafter, when the pullback by the axial movement device 72 reaches a preset designated distance or when a designated time elapses, the signal processing device 79 determines that the pullback has ended (step S105), and the axial movement device 72 and The syringe pump 73 is stopped (step S106). Thereafter, the signal processing device 79 stops ultrasonic diagnostic measurement by the scanner device 71 (step S107).

  In addition, when the ultrasonic measurement is started, the signal processing device 79 can perform the flushing process shown in FIG. 10 in parallel with the process shown in FIG.

  There are minute bubbles in the sheath 2 that do not affect the living body, and when the bubbles adhere to the transducer unit 41 (air trap) during measurement, the ultrasonic waves do not propagate and measurement is performed by the transducer unit 41. The received signal becomes weak and the image cannot be acquired. When such an air trap occurs, the syringe pump 73 is automatically operated to perform the flushing process, whereby bubbles can be removed (flushed) from the vibrator unit 41 by physiological saline.

  First, the signal processing device 79 compares the amplitude of the signal waveform measured and received by the transducer unit 41 with a preset threshold value (step S201). The threshold value is determined from an experiment or analysis performed in advance. If the measured signal is not smaller than the threshold value, it is determined that no air trap has occurred, and the process proceeds to step S205. In step S205, if the ultrasonic measurement has been completed, the process ends. If the ultrasonic measurement has not been completed, the process returns to step S201, and the process of step S201 is repeated.

  If the signal measured in step S201 is smaller than the threshold value, the signal processing device 79 determines that an air trap has occurred, transmits a command signal to the pump control device 78, and sets the syringe pump 73 in advance. Control is performed to start flushing at the flow rate (or pressure) (step S202). At this time, the flow rate corresponding to the pullback speed has already been supplied from the cylinder 731 by the process shown in FIG. A flow rate of physiological saline is supplied from the syringe pump 73 to the port 311.

  Note that the flow rate (or pressure) of the syringe pump 73 for flushing may be determined from the level of the signal measured by the transducer unit 41.

  When the signal measured by the transducer unit 41 exceeds the threshold value, it is determined that the air trap has been eliminated (step S203), and the flushing is stopped by controlling the syringe pump 73 (step S204). Even during flushing, when the ultrasonic measurement is completed (step S203), the syringe pump 73 is stopped (step S204).

  Thereafter, if the ultrasonic measurement has been completed, the process is terminated. If the ultrasonic measurement has not been completed, the process returns to step S201 (step S205).

  In the flushing process, it is not determined that the air trap has been eliminated when the signal measured by the transducer unit 41 exceeds the threshold value (step S204), but the flushing process may be performed until a predetermined time has elapsed. it can. Further, only the flushing process shown in FIG. 10 can be performed without performing the flow rate control process associated with the pullback shown in FIG.

  A certain amount of flow (pressure) is usually required for flushing to remove such bubbles. Therefore, when manually pressing a syringe without using a syringe pump, it is difficult to generate a high flow rate (high pressure) with a large-diameter syringe manually, so it is necessary to use a small-bore syringe. . However, since a small-bore syringe has a small volume of liquid that can be accommodated, it is desirable to use a large-bore syringe in combination, which complicates the apparatus.

  On the other hand, in this embodiment, since the syringe pump 73 is used, it is possible to generate a high flow rate (high pressure) with higher accuracy than in the case of manual operation using only the large-diameter syringe 731. The flushing ability can be improved and workability can also be improved.

  In this embodiment, the occurrence of an air trap is discriminated based on a threshold value and flushing is automatically performed. However, by pressing a button 781 (see FIG. 1) provided on the pump control device 78 or the syringe pump 73, It can also be set as the structure which operates the syringe pump 73 and performs flushing.

  In the present embodiment, since the syringe 731 is fixed to the syringe pump 73, as shown in FIGS. 1 and 7, the movement of the connection tube 735 in the pull back and push forward is limited to a limited range, and the connection is limited. The phenomenon that the tube 735 is caught with the scanner device 71 is less likely to occur, and the occurrence of the phenomenon that the scanner device 71 cannot be pulled back can be suppressed.

<Second Embodiment>
In the in-vivo diagnostic apparatus according to the second embodiment, as shown in FIG. 11, the syringe pump 83 of the external drive device 8 is fixed to a scanner gripping part 721 (axial movement part) that moves in the axial direction. This is different from the in-vivo diagnostic apparatus according to the first embodiment only in that it is. Moreover, the syringe pump 83 may be fixed to the scanner device 71 (axial movement unit) instead of the scanner gripping unit 721. Since other configurations are the same as those in the first embodiment, the same reference numerals as those in the first embodiment are used, and duplicate descriptions are omitted.

  In the in-vivo diagnostic apparatus according to the second embodiment, since the syringe pump 83 is fixed to the scanner gripping portion 721 that moves in the axial direction during pull back and push forward, as shown in FIGS. The pump 83 also moves. Therefore, during pull back and push forward, the distance between the port 311 of the ultrasonic catheter 1 and the syringe 731 does not change, so that the connection tube 735 is not deformed, and the phenomenon that the connection tube 735 is caught with the scanner device 71 is less likely to occur. The occurrence of the phenomenon that the scanner device 71 cannot be pulled back can be more reliably suppressed.

<Third Embodiment>
The in-vivo diagnostic apparatus according to the third embodiment shown in FIG. 13 is the first in that the syringe pump 93 of the external driving device 9 operates by obtaining a driving force directly from the driving source of the axial movement device 92. Different from the in-vivo diagnostic apparatus according to the embodiment. Note that parts having the same functions as those of the first embodiment are denoted by the same reference numerals as those of the first embodiment, and redundant description is omitted.

  In addition to the configuration according to the first embodiment, as shown in FIGS. 13 and 14, the axial direction moving device 92 and the syringe pump 93 that are integrally configured have the driving force of the axial direction moving device 92 as a syringe pump. Power transmission means 100 for transmitting to 93 is provided. The power transmission means 100 includes a ratchet mechanism, and includes an input rotating unit 110 fixed to an input shaft 921 to which a driving force of the axial movement device 92 is input, and an output rotating unit 120 that can rotate coaxially with the input shaft 921. have.

  The input rotating unit 110 is provided with a plurality of (two in the present embodiment) claws 112 urged by the spring 111 in the radially outward direction. The output rotating unit 120 has ratchet teeth 121 that mesh with the claws 112 on the inner peripheral surface. The output rotating unit 120 is fixed to a coaxial output gear 123, and the output gear 123 meshes with a rack 124 that is connected to the pressing unit 734 of the syringe pump 93.

  When the drive source of the axial movement device 92 is activated to pull back the scanner gripping portion 721, the input rotating portion 110 rotates clockwise in FIG. At this time, the claw 112 of the input rotation unit 110 meshes with the ratchet teeth 121 of the output rotation unit 120, the output gear 123 rotates together with the output rotation unit 120, and the rack 124 meshing with the output gear 123 moves to move the physiological force from the syringe pump 93. Saline is supplied. At this time, it is desirable that the power transmission means 100 is designed so that physiological saline having the same volume or more than the volume increase amount F of the medium region by pullback is supplied from the port 311.

  Further, when the scanner gripper 721 pushes forward, the input rotation unit 110 rotates counterclockwise in FIG. 13, and the input rotation unit 110 idles without the claws 112 meshing with the ratchet teeth 121. For this reason, no power is transmitted to the output rotating unit 120 and the output rotating unit 120 does not rotate, and the pressing unit 734 of the syringe pump 93 does not move backward. Therefore, the pressing part 734 does not leave the plunger 733 even after push forward, and the syringe pump 93 can be controlled again. In addition, the structure of the power transmission means 100 which transmits rotational force only to one direction is only an example, and another structure can also be applied. For example, as long as the power transmission means can mechanically transmit the power from the drive source of the axial movement device 92 to the syringe pump 93, it is not necessary to obtain the drive force directly from the drive source, and the scanner moves in the axial direction. Power may be obtained from the moving force of the grip portion 721.

  Since the in-vivo diagnostic apparatus according to the third embodiment operates the syringe pump 93 by the drive source of the axial movement device 92, the physiological saline supplied by the syringe pump 93 is mechanically fed with the pullback of the axial movement device 92. Can be synchronized. At this time, since the syringe pump 93 is controlled by the axial movement control device 77, the axial movement control device 77 also functions as a pump control device. Therefore, the pump control device 78 shown in FIG. 13 is not necessarily provided. However, by providing the pump control device 78, other processes such as the flushing described above can be performed.

  In addition, even if the pressing portion 734 is retracted, if the plunger 733 does not retract together with the pressing portion 734 (a structure in which the physiological saline that has flowed out does not return into the syringe), the rotational force is always limited to only one direction. It is not necessary to provide the power transmission means 100 for transmitting the power.

  The present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims. For example, in the above embodiment, the case where the present invention is applied to an ultrasonic catheter has been described. However, the present invention can also be applied to other diagnostic catheters. For example, the present invention can be applied to a diagnostic catheter using optical interference tomography (OCT). In OCT, measurement light is incident on a living body, and the living body can be observed based on light that has been scattered, absorbed, reflected, or refracted in the living body.

  Further, the medium supply means is not limited to the syringe pump, and a pump having another structure may be used as long as the flow rate or pressure of the medium can be controlled and the safety of the living body can be secured.

1 ultrasonic catheter (in vivo insertion probe),
2 sheath,
7, 8, 9 External drive device,
42 drive shaft,
71 scanner device,
72, 92 axial movement devices,
73, 83, 93 Syringe pump (medium supply means),
76 Scanner control device,
77 Axial movement control device,
78 pump controller,
79 Signal processing device (control unit),
100 power transmission means,
411 ultrasonic transducer (signal transmission / reception member),
731 syringe,
734 pressing part,
735 connecting tube,
F Volume increase,
X Pullback distance.

Claims (7)

A living body insertion probe having a sheath inserted into a living body and a driving shaft having a signal transmitting / receiving member for transmitting and receiving signals at a distal end and capable of axial rotation and axial movement within the sheath; An in-vivo diagnostic device for transmitting / receiving a signal to / from a signal transmitting / receiving member to acquire in-vivo information and to move the drive shaft within the sheath,
An axial movement device for moving the drive shaft in the axial direction;
Medium supply means for supplying a transmission medium into the in vivo insertion probe;
Controlling the medium supply means, we have a, and a control unit for automatically adjusting the supply amount of the transfer medium in accordance with the axial movement amount of the signal waveform or the drive shaft from the signal transmitting and receiving member,
The control unit controls the medium supply unit to supply the transmission medium at a flow rate equal to or higher than the volume increase rate of the medium region in the in-vivo insertion probe accompanying the axial movement of the drive shaft toward the proximal end side. In vivo diagnostic device. The in-vivo diagnosis according to claim 1, wherein the control unit controls the medium supply unit to supply a transmission medium when an amplitude of a signal waveform from the signal transmission / reception member is smaller than a preset threshold value. apparatus. The in-vivo diagnostic apparatus according to claim 1 , wherein the medium supply unit is formed integrally with the axial movement device. The medium supply means is connected to the in-vivo insertion probe provided on axial movement unit for axially moving, in vivo diagnostic apparatus according to claim 1 or 2. Having a power transmission means for transmitting to mechanically said medium supplying unit power from the axial direction moving device, in vivo diagnostic apparatus according to any one of claims 1 to 4.   A living body insertion probe having a sheath for insertion into a living body, and a drive shaft having a signal transmission / reception member for transmitting and receiving signals at the tip and capable of axial rotation and axial movement within the sheath; A method for controlling an in-vivo diagnostic apparatus for transmitting / receiving a signal to / from the signal transmitting / receiving member to acquire in-vivo information and to move the drive shaft within the sheath, wherein the in-vivo diagnostic apparatus includes: The control unit automatically adjusts the supply amount of the transmission medium from the medium supply means for supplying the transmission medium into the living body insertion probe in accordance with the signal waveform from the signal transmitting / receiving member or the axial movement amount of the drive shaft. And
  When driving the axial movement device, the volume increase rate of the medium region in the biological insertion probe accompanying the axial movement of the drive shaft toward the proximal end is calculated by the control unit or stored in the control unit. A method for controlling an in-vivo diagnostic apparatus that reads out from the data and transmits a command signal from the control unit to the medium supply means to supply a transmission medium at a flow rate equal to or higher than the volume increase rate. The amplitude of the signal waveform transmitted from the signal transmission / reception member to the control unit is compared with a threshold value set in advance by the control unit, and when the value is lower than the threshold value, the control unit supplies the transmission medium. The method for controlling an in- vivo diagnostic apparatus according to claim 6, wherein a command signal is transmitted to the medium supply unit .

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