WO2025062859A1 - Puncture control device - Google Patents

Abstract

Provided is a puncture control device capable of simultaneously ascertaining a cross-sectional image and the state of a puncture part when automatically performing blood vessel puncture. A puncture control device (10) comprises: an ultrasonic probe (41) that, while in contact with the surface of the skin, oscillates an ultrasonic wave and acquires a cross-sectional image of the human body on the basis of the received reflected wave; a puncture part (50) that is provided with a sharp needle tip (53); a drive unit (60) that moves the puncture part (50) relative to the ultrasonic probe (41); a control unit (70) that causes the ultrasonic probe (41) to acquire a cross-sectional image and that causes the drive unit (60) to operate; and a display unit (90) that displays the cross-sectional image. The control unit (70), on the basis of the location of the leading end of the needle tip (53) before the drive unit (60) is operated and the operation history of the drive unit (60), estimates the location of the leading end of the needle tip (53), and displays current location indicators (92, 92a to 92d) obtained by projecting the estimated location of the leading end of the needle tip (53) on a cross-sectional image (91) displayed on the display unit (90).

Description

Puncture control device

The present invention relates to a puncture control device that displays cross-sectional images of the human body obtained by an ultrasound probe in order to perform a puncture.

Vascular puncture involves inserting a needle into the human body to secure an access route to blood vessels for drug administration or intravascular treatment. When performing vascular puncture, the operator cannot see the blood vessels from the surface of the skin, so they estimate the location of the blood vessels using standard knowledge of vascular anatomy and skills such as palpation of vascular pulsation.

In recent years, there are devices that perform automatic vascular puncture. Devices that perform automatic vascular puncture use an ultrasound probe to obtain cross-sectional images of the human body, calculate the puncture target position based on this cross-sectional image, and control the drive of the needle toward the calculated puncture target position. The cross-sectional image is displayed on a display unit, allowing the operator to grasp the positional relationship between the detected tip of the needle and the blood vessel. An example of such a puncture control device is given in Patent Document 1.

International Publication No. WO 2022/195981

When performing the puncture, the operator must monitor the movement of the needle and recognize and respond if an abnormality occurs. When the operator performs the puncture manually, the operator can easily predict the needle's position and trajectory from intuitive information obtained through sight and touch, making it relatively easy to recognize abnormalities. However, when vascular puncture is performed automatically, it is difficult for the operator to intuitively grasp the condition of the needle.

In devices that automatically perform vascular puncture, it may be possible for an operator to recognize abnormalities during puncture by directly observing the cross-sectional images acquired by the ultrasound probe and the condition of the needle, but in practice it is difficult to monitor these two simultaneously. Furthermore, when the tip of the needle enters the body, if the tip is outside the imaging plane of the ultrasound probe, the position cannot be displayed in the cross-sectional image. As a result, the operator cannot grasp the trajectory of the needle tip during puncture.

The present invention has been made to solve the above-mentioned problems, and aims to provide a puncture control device that can simultaneously grasp cross-sectional images and the state of the needle tip when automatically puncturing a blood vessel.

The puncture control device (1) according to the present invention, which achieves the above object, is a puncture control device comprising an ultrasonic probe that contacts the surface of the skin to emit ultrasonic waves and obtain a cross-sectional image of the human body based on the received reflected waves, a puncture unit with a sharp needle tip, a drive unit that moves the puncture unit relative to the ultrasonic probe, a control unit that causes the ultrasonic probe to obtain the cross-sectional image and operates the drive unit, and a display unit that displays the cross-sectional image, and the control unit estimates the tip position of the needle tip based on the tip position of the needle tip before operating the drive unit and the operation history of the drive unit, and displays a current position indicator that projects the estimated tip position of the needle tip onto the cross-sectional image displayed on the display unit.

The puncture control device (1) configured as described above displays the estimated tip position of the needle on the cross-sectional image, so that when automatically puncturing a blood vessel, the operator can simultaneously grasp the cross-sectional image and the position of the needle tip, and can easily confirm whether the puncture is being performed correctly.

(2) In the puncture control device of (1) above, the control unit may detect the position of a target blood vessel from the cross-sectional image acquired by the ultrasonic probe, calculate the target position of the needle tip and the position where the needle tip passes through the imaging plane of the ultrasonic probe based on the detected position of the blood vessel, and display, on the cross-sectional image displayed on the display unit, a reach position index projected with the calculated target position of the needle tip and a pass position index indicating the position where the needle tip passes through the imaging plane of the ultrasonic probe. In this way, the puncture control device can grasp the target position and pass position of the needle tip on the cross-sectional image, allowing the operator to easily grasp whether there is any abnormality in these positions and can also be used as an indicator of whether puncture is being performed normally.

(3) In the puncture control device of (2) above, the control unit may stop the operation of the drive unit if it detects an abnormality in the positional relationship between the estimated tip position of the needle tip and the calculated target position of the needle tip while the drive unit is moving the puncture unit. This allows the puncture control device to automatically stop the puncture when there is an abnormality in the tip position of the needle tip, thereby making it possible to reduce the depth of wounds on the patient caused by failed puncture.

(4) In the puncture control device of either (2) or (3) above, the control unit may stop the operation of the drive unit if, when the needle tip is caused to pass through the imaging plane of the ultrasound probe by the drive unit, the estimated tip position of the needle tip is at least a certain distance from the calculated position where the needle tip passes through the imaging plane of the ultrasound probe. This allows the puncture control device to automatically stop the puncture if the estimated needle tip position is abnormal, based on the actual imaged position of the needle tip as it passes through the imaging plane, thereby making it possible to reduce the wound on the patient caused by a failed puncture.

(5) In any of the puncture control devices (1) to (4) above, a load detection unit that detects a load applied to the puncture unit may be provided, and the control unit may cause the load detection unit to detect the load applied to the puncture unit when the puncture unit is being moved by the drive unit, and cause the display unit to display a change in the load applied to the puncture unit in correspondence with the estimated tip position of the needle tip. This allows the puncture control device to quickly detect an abnormality when, for example, the needle tip hits a bone or the like outside the imaging range.

(6) In the puncture control device of (5) above, if the load detection unit detects a load equal to or greater than a certain level while the puncture unit is being moved by the drive unit, the control unit may stop the operation of the drive unit. This allows the puncture control device to automatically stop the puncture when there is an abnormality that can be detected by an abnormality in the load applied to the puncture unit, thereby making it possible to reduce the depth of injury to the patient caused by a failed puncture.

(7) In the puncture control device of (1) to (6) above, a backflow detection unit is provided that detects backflow blood flowing from a blood vessel into the puncture section, and the control unit may cause the backflow detection unit to detect backflow blood flowing into the puncture section while the drive unit is moving the puncture section, and cause the display unit to display whether backflow blood has been detected relative to time or the depth reached by the needle tip. This allows the puncture control device to more reliably recognize the puncture of a blood vessel by detecting backflow blood.

(8) In any of the puncture control devices (1) to (7) above, the control unit may acquire a tolerance range for the puncture unit before moving the puncture unit with the drive unit, and while moving the puncture unit with the drive unit, cause the display unit to display an error range for the estimated tip position of the needle tip based on the acquired tolerance range of the puncture unit. This allows the puncture control device to allow the operator to grasp the position of the needle tip taking the error range into account.

1 is a perspective view of a blood vessel puncture device according to an embodiment of the present invention. FIG. 2 is a side view of the vascular puncture device of the present embodiment. 2 is a partial side view of an imaging section and a puncture section of the vascular puncture device. FIG. 1 is a diagram showing the positional relationship between the bottom surface of the imaging unit and the arm of a human body. FIG. 1 is a diagram showing the configuration of a blood vessel puncture device. FIG. 2 is a flow diagram of the operation of the blood vessel puncture device up to the start of puncture. 1A is a plan view showing the initial position of the puncture part relative to the arm, as viewed from the palm side, and FIG. 1B is a plan view showing the initial position of the puncture part relative to the arm, as viewed from the palm side, when the orientation of the puncture part does not match the orientation of the blood vessel, and when the orientation of the puncture part matches the orientation of the blood vessel. FIG. 13 is a cross-sectional view showing the positional relationship between the imaging unit, the inside of the arm, and the puncture unit, illustrating the state before the tip of the puncture unit reaches the target blood vessel. 9 is an example of a screen displayed on a display unit in the state of FIG. 8. FIG. 2 is a flow diagram of the operation of the blood vessel puncture device when performing puncture. FIG. 13 is a cross-sectional view showing the positional relationship between the imaging unit and the inside of the arm and the puncture unit, and shows the state when the tip position of the puncture unit has reached the imaging surface of the imaging unit. 12 is an example of a screen displayed on a display unit in the state of FIG. 11. FIG. 13 is a cross-sectional view showing the positional relationship between the imaging unit, the inside of the arm, and the puncture unit, and showing the state when the tip position of the puncture unit has reached the target position. 14 is an example of a screen displayed on the display unit in the state of FIG. 13. 13 is an example of a screen display displayed on a display unit, in which an error range for the tip position of the needle tip is displayed on a current position indicator. 13 is an example of a screen displayed on the display unit, showing the state of reverse blood.

Below, an embodiment of the present invention will be described with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated for the sake of explanation and may differ from the actual ratios.

The puncture control device 10 according to an embodiment of the present invention is used when puncturing the arm H of a human body, acquiring a cross-sectional image of the arm H, detecting the position of the blood vessel to be punctured, and automatically puncturing that blood vessel.

As shown in Figures 1 to 3, the puncture control device 10 comprises a main body 20 that automatically punctures a blood vessel, and a support stand 30 that overlaps with the main body 20 in the Z-axis direction and is positioned below the main body 20 to support the main body 20. The Z-axis direction, which is the height direction, is the direction perpendicular to the horizontal surface when the puncture control device 10 is placed on the horizontal surface. The main body 20 comprises an upper frame 21, an imaging unit 40 that contacts the skin surface to obtain a cross-sectional image of the human body, a puncture unit 50 that performs the puncture, a drive unit 60 that moves the puncture unit 50 relative to the imaging unit 40, a control unit 70 that performs image analysis of the cross-sectional image and controls the drive unit 60, and a display unit 90 that can display the cross-sectional image. The puncture unit 50 is supported by the drive unit 60.

The imaging unit 40 is fixed to the upper frame 21, and has an ultrasound probe 41 at its lower end that generates and transmits ultrasound waves and receives reflected waves (echoes) from within the living body. As shown in FIG. 4, the ultrasound probe 41 is provided to extend in one direction (the Y-axis direction) at the center of the probe surface 42, which is the bottom surface, and spans almost the entire width of the probe surface. The imaging unit 40 has a transducer that generates ultrasound waves, and can obtain cross-sectional images of the inside of the human body by detecting the reflected waves. In this embodiment, cross-sectional images perpendicular to the axial direction of the blood vessels are obtained, so the imaging unit 40 is positioned so that its length is perpendicular to the length of the arm H. The Y-axis direction, which is the width direction, and the X-axis direction, which is the length direction, are perpendicular to each other and perpendicular to the Z-axis direction.

The main body 20 supports the imaging unit 40 so that it can move in the Z-axis direction. By moving the imaging unit 40 in the Z-axis direction to adjust the distance between the ultrasound probe 41 and the arm H, it is possible to capture images with less noise and prevent deformation of the skin and blood vessels due to excessive contact.

The upper frame 21 is formed in a generally arch-like shape that convexly faces upward when viewed from the X-axis direction. The upper frame 21 has two upper walls 22 formed on both sides in the Y-axis direction, a top surface 23 connecting the two upper walls 22, and an opening 24 in which the imaging unit 40 and the puncture unit 50 are disposed. The upper frame 21 is formed, for example, from a hard resin material. Each upper wall 22 has a main body connecting surface 25 at its lower end. A display unit 90 that displays an image captured by the imaging unit 40 is disposed on the upward-facing surface of the top surface 23.

The opening 24 is formed in a concave shape when viewed from above on the peripheral side of the upper frame 21 in the X-axis direction. That is, the top surface 23 is formed shorter on the peripheral side in the X-axis direction than the upper wall 22, thereby forming the opening 24 in the upper frame 21. The opening 24 is disposed on the peripheral side of the top surface 23. From the opening 24, the arm H, which is imaged by the imaging unit 40 and punctured by the puncture unit 50, is exposed. The imaging unit 40 is connected to the opening 24. The imaging unit 40 may be removable from the opening 24 or may not be removable. Alternatively, the imaging unit 40 may be configured separately from the main body 20.

As shown in FIG. 3, the puncture unit 50 comprises a metal inner needle 51 having a sharp needle tip 53 formed at its tip, and a flexible tubular outer tube 52 arranged to cover the outer periphery of the inner needle 51. When the outer tube 52 is placed over the outside of the inner needle 51, the needle tip 53 of the inner needle 51 protrudes from the outer tube 52. The inner needle 51 and the outer tube 52 are detachable from the puncture direction drive unit 65 of the drive unit 60.

The drive unit 60 is a drive source that is controlled by the control unit 70 to change the position and/or angle of the puncture unit 50 to automatically adjust the puncture position and perform the puncture operation. The drive unit 60 has a height direction drive unit 61 that moves the entire puncture unit 50 up and down (Z-axis direction) relative to the upper frame 21, a rotation drive unit 63 that tilts the entire puncture unit 50, a width direction drive unit 64 that moves the entire puncture unit 50 in the width direction (Y-axis direction) of the arm H, a puncture direction drive unit 65 that moves the inner needle 51 forward and backward in the puncture direction, an outer tube drive unit 66 that moves the outer tube 52 forward and backward along the inner needle 51, and a length direction drive unit 67 that moves the entire puncture unit 50 in the length direction (X-axis direction) of the arm H. The puncture unit 50 can be moved in the Z-axis direction by the height direction drive unit 61 independently of the imaging unit 40. The drive unit 60 is configured by combining a rotary drive source such as a motor, a structure that converts the rotary motion of the rotary drive source into linear motion (e.g., a feed screw mechanism), and a structure that changes the angle (e.g., a hinge), but the configuration is not limited.

The driving unit 60 has a load detection unit 75 that detects the load applied to the puncture unit 50. The load detection unit 75 can detect a load along the puncture direction of the puncture unit 50. In addition, the load detection unit 75 may be able to detect a load along a direction perpendicular to the puncture direction of the puncture unit 50.

As shown in FIG. 5, the control unit 70 is connected to the imaging unit 40 via the transmission unit 72 and the reception unit 73, and can cause the imaging unit 40 to acquire cross-sectional images and receive the acquired cross-sectional images. The control unit 70 can cause the display unit 90 to display the cross-sectional images acquired by the imaging unit 40. The control unit 70 can control the drive unit 60 to operate the imaging unit 40 and the puncture unit 50 to acquire cross-sectional images and perform puncture. The control unit 70 can also cause the load detection unit 75 to detect the load applied to the puncture unit 50. The control unit 70 has a memory circuit and an arithmetic circuit as physical components. The memory circuit can store programs and various parameters. The arithmetic circuit can perform arithmetic processing.

The control unit 70 may be disposed in the upper frame 21, or in the imaging unit 40 or the drive unit 60. Alternatively, the control unit 70 may be configured separately from the main body 20.

The control unit 70 can identify the position of the blood vessel in the image by performing image analysis on the acquired cross-sectional image. The control unit 70 can also detect the relative position of the inner needle 51 with respect to the imaging unit 40 by performing image analysis. The outer tube 52 is made of resin and therefore cannot be detected by ultrasound. However, for example, if the outer tube 52 is made of resin containing metal, it can be detected by ultrasound, and the control unit 70 can detect the relative position of the outer tube 52 with respect to the imaging unit 40. The control unit 70 can also display the cross-sectional image on the display unit 90 by performing image analysis on the acquired cross-sectional image. Furthermore, the control unit 70 can control the drive unit 60 to adjust the position and angle of the puncture unit 50, and automatically perform puncture with the inner needle 51 and outer tube 52 at the desired position and angle.

The display unit 90 is a monitor or the like capable of displaying a cross-sectional image. The display unit 90 is preferably placed near the puncture unit 50 that performs the puncture. The display unit 90 is placed, for example, on the upward-facing surface of the top surface 23 adjacent to the opening 24 in which the puncture unit 50 is placed. This allows the operator to visually check the skin of the arm H to be punctured while viewing the cross-sectional image of the blood vessel on the display unit 90. The display unit 90 may also be placed away from the main body 20 and the support base 30.

The support base 30 has a lower frame 31 and a holding portion 80 that holds the arm H. The lower frame 31 is formed in a generally arch shape that is convex downward when viewed from the X-axis direction. The lower frame 31 has two lower walls 32 formed on both sides in the Y-axis direction, and a bottom surface portion 33 that connects the two lower walls 32. The lower frame 31 is formed, for example, from a hard resin material.

The bottom surface portion 33 has a bottom surface 37 that contacts the operating table or the like, and a support surface 38 that faces upward. A holding portion 80 that holds the arm H is fixed to the support surface 38.

The main body 20 or the support base 30 may have a sensor that detects changes in the position of the fixed arm H. The main body 20 or the support base 30 may have at least one distance sensor at a position facing the fixed arm H. In this case, after the arm H is fixed, the distance sensor monitors changes in the relative distance to the arm H. If the relative distance between the distance sensor and the arm H changes by more than a certain amount, it is determined that the fixed arm H is moving, and a notification is issued, and if puncturing is in progress, the operation of the drive unit 60 can be stopped. In addition, an instruction to strengthen the fixation of the arm H, etc. can be issued. This instruction can also be selected by the operator. The distance sensor can directly detect the distance to the arm H, and can estimate the distance to the arm H by detecting color tone, brightness, temperature, etc. Multiple distance sensors may be provided, in which case the undulations of the skin can be measured as a distance and the movement can be monitored.

The main body 20 or the support base 30 may have a cushion that holds the arm H. The cushion may be soft or hard, but is preferably soft and conforms to the shape of the arm. If the cushion is soft, it may be expanded or contracted by injecting and discharging gas or liquid into it. To do this automatically, a pressure sensor can be provided in the cushion. Also, partitions can be provided inside the cushion, and a pressure sensor can be provided for each partition. This makes it possible to measure the pressure applied by the arm H in each direction. By measuring this pressure change, the movement of the arm H can be detected.

The main body 20 or the support base 30 may have an inertial sensor consisting of an inclination sensor, an acceleration sensor, or a gyro sensor. This makes it possible to measure the inclination or displacement of the puncture control device 10 after the arm H is fixed. If it is detected that the puncture control device 10 has inclined or displaced by more than a certain amount, it is determined that the puncture control device 10 has moved, and a notification can be given or the operation of the drive unit 60 can be stopped.

The main body 20 may have a camera that captures an image of the surface of the arm H. The camera captures an image of the surface of the fixed arm H, and detects feature points such as wrinkles, moles, veins, and pores. Movement of the arm H can be detected by comparing the positions of feature points in the surface image captured by the camera immediately after the arm H is fixed with the latest surface image.

The drive unit 60 may have a proximity sensor at a position facing the inner needle 51 or the outer tube 52. The proximity sensor is a sensor that can detect characteristic points such as grooves or identification marks on the inner needle 51 or the outer tube 52. The proximity sensor detects the movement of the characteristic points on the inner needle 51 or the outer tube 52, and can provide a notification or stop the operation of the drive unit 60 if it detects an abnormality in this movement.

Next, the operation of the puncture control device 10 according to this embodiment will be described. In advance, the operator places the support table 30 on a table such as an operating table, and places the patient's arm H on the holding part 80. At this time, the arm H is placed on the holding part 80 with the palm side of the wrist bent upwards. This makes it possible to prevent the skin from shifting and the puncture position from shifting during the subsequent puncture.

Then, the operator activates the puncture control device 10. As shown in FIG. 6, the control unit 70 of the puncture control device 10 acquires needle information of the puncture unit 50 (S1-1). The needle information includes type information associated with dimensions such as the outer diameter and length of the needle, needle tolerance information, and the distance from the puncture direction drive unit 65 to the needle tip 53. Needle tolerance information may be registered in advance for each needle type, or may be measured and input each time it is used. In addition, the distance from the puncture direction drive unit 65 to the needle tip 53 may be adjusted and installed to be a default value.

Next, the initial position of the puncture unit 50 is set (S1-2). As shown in FIG. 7(a), if the direction D1 in which the needle tip 53 of the puncture unit 50 extends is different from the direction D2 in which the artery 200, which is the puncture target, extends, the tip of the needle tip 53 cannot reach the puncture target position 210. For this reason, as shown in FIG. 7(b), the orientation of the puncture unit 50 is adjusted so that the direction D1 in which the needle tip 53 extends coincides with the direction D2 in which the artery 200, which is the puncture target, extends. This adjustment may be performed by the operator predicting the running direction of the blood vessel by sight or touch, or may be performed automatically by the puncture control device 10. When the puncture control device 10 performs the adjustment automatically, the control unit 70 moves the imaging unit 40 along the X-axis direction to confirm the running direction of the target blood vessel. Next, the control unit 70 adjusts the orientation of the puncture unit 50 so that it faces the same direction as the running direction of the blood vessel. The control unit 70 may also display on the display unit 90 a display for adjusting the orientation of the puncture unit 50, and the operator may adjust the orientation of the puncture unit 50 or the arm H accordingly. After adjusting the initial position of the puncture unit 50, the control unit 70 calculates the initial position of the needle tip 53 based on the needle information of the puncture unit 50.

Next, the control unit 70 acquires a cross-sectional image of the human body using the ultrasound probe 41 of the imaging unit 40 (S1-3). The control unit 70 sets a position based on the acquired cross-sectional image (S1-4). The positions to be set here are (1) the arrival projection position, which is the target position of the needle tip 53 of the puncture unit 50 projected onto the cross-sectional image, and (2) the passing position, which is the position where the needle tip 53 passes through the imaging plane of the ultrasound probe 41.

To set the position, the control unit 70 recognizes the target blood vessel from the cross-sectional image. In this embodiment, the target blood vessel is the artery 200. The control unit 70 detects the area recognized as the artery 200 in the cross-sectional image. To detect the area recognized as the artery 200 in the cross-sectional image, a large number of similar images can be prepared and machine learning or deep learning techniques can be used. In addition, the ultrasonic probe 41 can detect an area with blood flow using the Doppler method and recognize the area as the artery 200 area. When detecting the blood vessel area from the cross-sectional image, it is necessary to distinguish and detect the artery 200 and the vein 201. The artery 200 and the vein 201 can be distinguished based on the position of the arm bone 202 and the magnitude of the pulsation that appear in the cross-sectional image. In addition, when a blood flow area is detected using the Doppler method, the artery 200 and the vein 201 can also be distinguished based on the direction of the blood flow. Here, when multiple arteries 200 are detected, the operator can select any artery.

The control unit 70 calculates the arrival projection position and the passing position from the position of the artery 200 recognized in the cross-sectional image.

After the positions are set, the control unit 70 displays the arrival projection position and the passing position on the cross-sectional image of the display unit 90, and the operator judges whether each position is appropriate or not (S1-5). If the arrival projection position or the passing position is displayed on the cross-sectional image at a position far from the position intended by the operator, it is possible that the position of the artery 200 is not correctly recognized by the control unit 70, and therefore the operator adjusts the positional relationship between the imaging unit 40 and the arm H, or the operator arbitrarily specifies the arrival projection position and the passing position on the cross-sectional image (S1-6), and repeats the steps from S1-3. Note that if the operator arbitrarily specifies the arrival projection position and the passing position on the cross-sectional image, the calculation of the arrival projection position and the passing position by the control unit 70 is skipped. If the operator judges that each position is appropriate in S1-5, the control unit 70 sets the movement direction and movement amount of the puncture drive unit 62 based on each position and the initial position of the needle tip 53 so that the tip position of the needle tip 53 passes the passing position and reaches the target position. Thereafter, the control unit 70 drives the drive unit 60 to start puncturing by the puncturing unit 50 (S1-7). Note that S1-5 and S1-6 may be performed automatically by the puncturing control device 10.

Once the puncture has begun, the control unit 70 calculates each position to be displayed on the display unit 90. As shown in FIG. 8, the imaging plane W of the ultrasound probe 41 extends vertically from the surface of the arm H on which the ultrasound probe 41 abuts. The target position P1 of the needle tip 53 is set to the position where it penetrates the artery 200, and the drive unit 60 positions the puncture portion 50 so that the target position P1 and the passing position P3 are on the extension of the direction in which the needle tip 53 extends. The position where the target position P1 is projected onto the imaging plane W of the ultrasound probe 41 is P2. The position where the tip position P4 of the needle tip 53 passes through the imaging plane W of the ultrasound probe 41 is P3. The position where the tip position P4 of the needle tip 53 is projected onto the imaging plane W of the ultrasound probe 41 is P5. The target position P1, the arrival projection position P2, and the passing position P3 are set in S1-4 to S1-6. The control unit 70 can calculate position P2, where target position P1 is projected onto the imaging surface W, from target position P1 and the position of the ultrasonic probe 41. The control unit 70 can calculate and estimate tip position P4 of needle tip 53 from the initial position and orientation of needle tip 53 and the operation history of the drive unit 60. The control unit 70 can calculate position P5, where tip position P4 of needle tip 53 is projected onto the imaging surface W, from position P4 and the position of the ultrasonic probe 41.

As shown in FIG. 9, the control unit 70 displays a current position indicator 92 of the estimated needle tip 53 on a cross-sectional image 91 acquired by the ultrasound probe 41. The current position indicator 92 indicates a position P5 where the tip position P4 of the needle tip 53 is projected onto the imaging surface W. The current position indicator 92 is displayed on the display unit 90 as a point where a vertical line 92a and a horizontal line 92b intersect. The current position indicator 92 is also represented by a horizontal position indicator section 92c displayed below the cross-sectional image 91 and a vertical position indicator section 92d displayed to the right of the cross-sectional image 91. The current position indicator 92 allows the operator to grasp the current position of the needle tip 53 while viewing the cross-sectional image 91. The current position indicator 92 is updated each time the control unit 70 estimates the tip position P4 of the needle tip 53. Therefore, after the puncture of the puncture section 50 begins, the current position indicator 92 moves within the screen in accordance with the movement of the needle tip 53.

The control unit 70 also displays a passing position index 94 and a reaching position index 93 on the cross-sectional image 91. The passing position index 94 indicates the position P3 where the tip position P4 of the needle tip 53 passes through the imaging plane W. The passing position index 94 is displayed as a point on the cross-sectional image 91. The reaching position index 93 indicates the position P2 where the target position P1 is projected onto the imaging plane W. The reaching position index 93 is displayed as an intersection of a dotted vertical line 93a and a dotted horizontal line 93b on the cross-sectional image 91. The passing position index 94 and the reaching position index 93 do not change after their positions are set in S1-3, so they do not move within the screen even after the puncture unit 50 starts puncturing. The passing position index 94 and the reaching position index 93 may be displayed as either a point or an intersection of a vertical line and a horizontal line, or may be displayed using other lines or figures.

In the cross-sectional image 91, the current position indicator 92, the arrival position indicator 93, and the passing position indicator 94 are always displayed. However, in order not to impede the operator's observation of the cross-sectional image, they may be made to blink or temporarily not be displayed depending on their positional relationship.

The control unit 70 displays a load graph section 95 on the right side of the cross-sectional image 91. When the drive unit 60 is moving the puncture unit 50, the control unit 70 causes the load detection unit 75 to detect the load applied to the puncture unit 50, and displays the magnitude of the load applied to the puncture unit 50 at a position corresponding to the current position indicator 92, specifically at the same position horizontally as the current position indicator 92, thereby making it possible to represent the change in load as the puncture unit 50 punctures as a graph.

The control unit 70 may display, on the display unit 90, in addition to the cross-sectional image 91 and the load graph section 95, structural information about the blood vessel that is the puncture target outside the cross-sectional image 91.

The flow of the puncture control device 10 after the puncture unit 50 performs puncture will be described. As shown in FIG. 10, the control unit 70 drives the drive unit 60 to cause the puncture unit 50 to perform puncture (S2-1), and then causes the load detection unit 75 to measure the puncture resistance (S2-2). The control unit 70 also estimates the tip position of the needle tip 53 from the operating state of the drive unit 60 (S2-3). The control unit 70 causes the imaging unit 40 to acquire a cross-sectional image, and causes the display unit 90 to display the acquired cross-sectional image (S2-4).

The control unit 70 determines whether the blood vessel contour is appropriate from the acquired cross-sectional image (S2-5). The control unit 70 determines whether the blood vessel contour is appropriate by determining whether the position of the artery 200, which is the puncture target, has changed. As the needle tip 53 approaches the artery 200, the position of the artery 200 may move, making it impossible to puncture the artery 200 with the needle tip 53. This condition can be recognized by determining whether the blood vessel contour is appropriate. If the blood vessel contour is determined to be inappropriate, the control unit 70 stops driving the puncture unit 50 by the drive unit 60 (S2-6). If the blood vessel contour is determined to be appropriate in S2-5, proceed to the next step.

The control unit 70 determines whether the puncture resistance, which is the load applied to the puncture unit 50 detected by the load detection unit 75, is appropriate (S2-7). If the puncture is not performed properly, such as when the needle tip 53 hits a bone instead of a blood vessel, the puncture resistance will be larger than expected. Therefore, by determining whether the puncture resistance is appropriate, it is possible to determine whether the puncture is performed properly. Also, as shown in Figures 12 and 14, when the needle tip 53 penetrates the blood vessel wall, the puncture resistance temporarily increases. Therefore, it is possible to determine whether the puncture resistance is large at the position of the blood vessel wall estimated from the cross-sectional image, and if the puncture resistance is not large, to determine that the puncture resistance is abnormal. If the puncture resistance is determined to be inappropriate, the control unit 70 stops driving the puncture unit 50 by the drive unit 60 (S2-6). If the puncture resistance is determined to be appropriate in S2-7, proceed to the next step.

The control unit 70 repeats steps S2-2 to S2-7 until the needle tip 53 reaches the imaging surface W (S2-8). As shown in FIG. 11, when the tip position of the needle tip 53 reaches the imaging surface W, the captured needle tip 53 is displayed in the cross-sectional image 91 as shown in FIG. 12. In this way, it is possible to determine that the needle tip 53 has reached the imaging surface W because the needle tip 53 is captured in the cross-sectional image acquired by the imaging unit 40. When the needle tip 53 reaches the imaging surface W, the control unit 70 determines whether the tip position of the needle tip 53 is appropriate (S2-9). The control unit 70 can determine that the tip position of the needle tip is not appropriate if the difference between the position P3 where the previously calculated tip position P4 of the needle tip 53 passes through the imaging surface W and the tip position of the needle tip 53 actually appearing on the imaging surface W is equal to or greater than a certain value. In this case, the control unit 70 stops the operation of the drive unit 60 (S2-10). If the tip position of the needle tip 53 is appropriate, proceed to the next step.

The control unit 70 repeats steps S2-2 to S2-9 by driving the driving unit 60 in the initially set direction and amount of movement until the needle tip 53 reaches the target position (S2-11). Here, the tip position P4 of the needle tip 53 is calculated and estimated by the control unit 70 based on the initial position and orientation of the needle tip 53 and the operation history of the driving unit 60, as well as the tip position of the needle tip 53 appearing on the imaging surface W. As shown in FIG. 13, when the needle tip 53 reaches the target position, the control unit 70 compares the tip position P4 of the needle tip 53 estimated at that time with the target position P1, and determines whether the two are apart by a certain amount or more (S2-12). As shown in FIG. 14, when the difference between the estimated tip position P4 of the needle tip 53 indicated by the current position indicator 92 and the target position P1 indicated by the reached position indicator 93 is small, the position of the needle tip 53 is determined to be appropriate. If the estimated tip position P4 of the needle tip 53 is a certain distance or more from the target position P1, the control unit 70 determines that the needle position is not appropriate and stops the operation of the drive unit 60 (S2-10). If the needle position is appropriate, the control unit 70 determines that the puncture is complete and performs completion processing (S2-13). Thereafter, the drive unit 60 retracts the inner needle 51 while leaving the tip of the outer tube 52 inside the blood vessel, and pulls it out from the outer tube 52. Note that the operator may manually retract the inner needle 51. Also, when pulling out the inner needle 51, the tip position P4 of the needle tip 53 may be estimated and the current position indicator 92 may continue to be displayed on the cross-sectional image 91.

When blood vessel puncture by the puncture control device 10 is complete, the operator removes both or either of the inner needle 51 and the outer tube 52 from the drive unit 60. Next, the operator lifts the main body 20 and detaches it from the support base 30 to remove it. After removing the main body 20, the operator can perform the catheter procedure via the outer tube 52.

The error range of the estimated tip position of the needle tip 53 can be calculated from the tolerance information included in the needle information acquired in S1-1. As shown in FIG. 15, an error range indicator 96 indicating the calculated error range may be displayed together with the current position indicator 92 displayed on the cross-sectional image 91. The error range indicator 96 only needs to be able to indicate the error range, and may be displayed, for example, by changing the hue along the circumferential direction, or may be displayed by the size of the horizontal position indicator section 92c and the vertical position indicator section 92d.

The puncture control device 10 may have a backflow detection unit that detects backflow blood flowing from a blood vessel to the base end side of the inner needle 51. The backflow detection unit may be configured with a pressure sensor that detects the internal pressure of the inner needle 51. The control unit 70 can acquire information on the internal pressure of the inner needle 51 detected by the backflow detection unit while moving the puncture unit 50 by the drive unit 60. As shown in FIG. 16, the control unit 70 displays an estimated current position indicator 92 of the needle tip 53 on a cross-sectional image 91 acquired by the ultrasonic probe 41, while displaying a backflow graph section 97 to the right of the cross-sectional image 91. The backflow graph section 97 shows the internal pressure of the inner needle 51 detected by the backflow detection unit on the horizontal axis or the depth reached by the needle tip, and the vertical axis. When the inner needle 51 punctures a blood vessel, backflow is generated and the internal pressure of the inner needle 51 increases, as can be confirmed from the backflow graph section 97. This makes it easy to determine whether the blood vessel has been punctured, in conjunction with the current position indicator 92 of the needle tip 53 displayed on the cross-sectional image 91. The puncture control device 10 may have both the load detection unit 75 and backflow detection unit described above, and may display both the load on the puncture unit 50 and the state of backflow on the display unit 90.

As described above, in this embodiment, (1) the puncture control device 10 is a puncture control device 10 comprising an ultrasonic probe 41 that contacts the surface of the skin to emit ultrasonic waves and acquire a cross-sectional image of the human body based on the received reflected waves, a puncture section 50 with a sharp needle tip 53, a drive section 60 that moves the puncture section 50 relative to the ultrasonic probe 41, a control section 70 that causes the ultrasonic probe 41 to acquire a cross-sectional image and operates the drive section 60, and a display section 90 that displays the cross-sectional image, and the control section 70 estimates the tip position of the needle tip 53 based on the tip position of the needle tip 53 before operating the drive section 60 and the operation history of the drive section 60, and displays a current position indicator 92 projecting the estimated tip position of the needle tip 53 onto a cross-sectional image 91 displayed on the display section 90. The puncture control device 10 configured in this manner displays the estimated tip position of the needle tip 53 on the cross-sectional image 91, so that when automatically puncturing a blood vessel, the operator can simultaneously grasp the cross-sectional image 91 and the position of the needle tip 53, and can easily confirm whether the puncture is being performed correctly.

(2) In the puncture control device 10 described above in (1), the control unit 70 may detect the position of the target blood vessel from the cross-sectional image 91 acquired by the ultrasonic probe 41, calculate the target position of the needle tip 53 and the position where the needle tip 53 passes through the imaging plane of the ultrasonic probe 41 based on the detected position of the blood vessel, and display, on the cross-sectional image 91 displayed on the display unit 90, a reach position indicator 93 projecting the calculated target position of the needle tip 53 and a pass position indicator 94 indicating the position where the needle tip 53 passes through the imaging plane of the ultrasonic probe 41. In this way, the puncture control device 10 can grasp the target position and pass position of the needle tip 53 on the cross-sectional image 91, allowing the operator to easily grasp whether there is an abnormality in these positions and can also be used as an indicator of whether the puncture is being performed normally.

(3) In the puncture control device 10 of (2) above, if the control unit 70 detects an abnormality in the positional relationship between the estimated tip position of the needle tip 53 and the calculated target position of the needle tip 53 while the drive unit 60 is moving the puncture unit 50, the control unit 70 may stop the operation of the drive unit 60. This allows the puncture control device 10 to automatically stop puncture when there is an abnormality in the tip position of the needle tip 53, making it possible to reduce the depth of wounds on the patient caused by failed puncture.

(4) In the puncture control device 10 of either (2) or (3) above, the control unit 70 may stop the operation of the drive unit 60 when the estimated tip position of the needle tip 53 is a certain distance or more from the calculated position where the needle tip 53 passes through the imaging plane of the ultrasound probe 41 when the needle tip 53 passes through the imaging plane of the ultrasound probe 41 by the drive unit 60. This allows the puncture control device 10 to automatically stop the puncture if the estimated position of the needle tip 53 is abnormal, based on the actual imaged position of the needle tip 53 as it passes through the imaging plane, thereby making it possible to reduce the wound on the patient caused by a failed puncture.

(5) In any of the puncture control devices 10 described above in (1) to (4), a load detection unit 75 is provided that detects the load applied to the puncture unit 50, and the control unit 70 may cause the load detection unit 75 to detect the load applied to the puncture unit 50 while the drive unit 60 is moving the puncture unit 50, and cause the display unit 90 to display the change in the load applied to the puncture unit 50 in correspondence with the estimated tip position of the needle tip 53. This allows the puncture control device 10 to quickly detect an abnormality when, for example, the needle tip 53 hits a bone or the like outside the imaging range.

(6) In the puncture control device 10 of (5) above, if the load detection unit 75 detects a load equal to or greater than a certain level while the puncture unit 50 is being moved by the drive unit 60, the control unit 70 may stop the operation of the drive unit 60. This allows the puncture control device 10 to automatically stop puncturing when there is a detectable abnormality in the load applied to the puncture unit 50, thereby making it possible to reduce the depth of injury to the patient caused by a failed puncture.

(7) The puncture control device 10 described above in (1) to (6) may include a backflow detection unit that detects backflow blood flowing from a blood vessel into the puncture unit 50, and the control unit 70 may cause the backflow detection unit to detect backflow blood flowing into the puncture unit 50 while the drive unit 60 is moving the puncture unit 50, and cause the display unit 90 to display whether backflow blood has been detected relative to time or the depth reached by the needle tip 53. This allows the puncture control device 10 to more reliably recognize the puncture of a blood vessel by detecting backflow blood.

(8) In any of the puncture control devices 10 described above in (1) to (7), the control unit 70 may acquire the tolerance range of the puncture unit 50 before moving the puncture unit 50 with the drive unit 60, and while moving the puncture unit 50 with the drive unit 60, display the error range for the estimated tip position of the needle tip 53 on the display unit 90 based on the acquired tolerance range of the puncture unit 50. This allows the puncture control device 10 to allow the operator to grasp the position of the needle tip 53 taking the error range into account.

The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical concept of the present invention.

This application is based on Japanese Patent Application No. 2023-155463, filed on September 21, 2023, the disclosures of which are hereby incorporated by reference in their entirety.

REFERENCE SIGNS LIST 10 Puncture control device 20 Main body 30 Support base 40 Imaging unit 41 Ultrasonic probe 42 Probe surface 50 Puncture unit 51 Inner needle 52 Outer tube 53 Needle tip 60 Driving unit 70 Control unit 75 Load detection unit 90 Display unit 91 Cross-sectional image 92 Current position indicator 93 Arrival position indicator 94 Passing position indicator 95 Load graph unit 96 Error range indicator

Claims (8)

an ultrasonic probe that contacts the surface of the skin to emit ultrasonic waves and obtains cross-sectional images of the human body based on the received reflected waves;
A puncture unit having a sharp needle tip;
a drive unit that moves the puncture unit relative to the ultrasonic probe;
a control unit that causes the ultrasonic probe to acquire the cross-sectional image and operates the drive unit;
A display unit that displays the cross-sectional image;
A puncture control device comprising:
The control unit is
estimating a tip position of the needle tip based on a tip position of the needle tip before operating the driving unit and an operation history of the driving unit;
a puncture control device that displays a current position indicator obtained by projecting the estimated tip position of the needle tip onto the cross-sectional image displayed on the display unit. The control unit is
Detecting a position of a target blood vessel from the cross-sectional image acquired by the ultrasonic probe;
Calculating a target position of the needle tip and a position where the needle tip passes through an imaging plane of the ultrasonic probe based on the detected position of the blood vessel;
The puncture control device according to claim 1, further comprising: a first section for projecting a calculated target position of the needle tip onto the cross-sectional image; and a second section for projecting a calculated target position of the needle tip onto the cross-sectional image. The control unit is
The puncture control device according to claim 2, wherein if an abnormality is detected in the positional relationship between the estimated tip position of the needle tip and the calculated target position of the needle tip while the drive unit is moving the puncture unit, the operation of the drive unit is stopped. The control unit is
The puncture control device according to claim 2, wherein when the needle tip is caused to pass through the imaging surface of the ultrasonic probe by the driving unit, if the estimated tip position of the needle tip is away from the calculated position where the needle tip passes through the imaging surface of the ultrasonic probe by a certain distance or more, the operation of the driving unit is stopped. a load detection unit that detects a load applied to the puncture unit,
The control unit is
detecting a load applied to the puncture unit by the load detection unit while the puncture unit is being moved by the drive unit;
The puncture control device according to claim 1 , further comprising: a display unit that displays a change in the load applied to the puncture portion in correspondence with the estimated tip position of the needle tip. The puncture control device according to claim 5, wherein the control unit stops the operation of the drive unit if the load detection unit detects a load equal to or greater than a certain level while the drive unit is moving the puncture unit. a backflow detection unit for detecting backflow of blood flowing from a blood vessel into the puncture unit,
The control unit is
When the puncture unit is moved by the drive unit, the backflow detection unit detects backflow flowing into the puncture unit,
The puncture control device according to claim 1 , wherein the display unit displays whether backflow of blood has been detected relative to time or the depth reached by the needle tip. The control unit is
obtaining a tolerance range of the puncture unit before moving the puncture unit by the drive unit;
A puncture control device as described in any one of claims 1 to 7, wherein when the puncture part is moved by the drive unit, an error range for the estimated tip position of the needle tip is displayed on the display unit based on the acquired tolerance range of the puncture part.

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