Puncture control device

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

[0001] The present invention relates to a puncture control device that displays cross-sectional images of a human body acquired by an ultrasound probe for puncturing.

[0002] Vascular puncture involves inserting a needle into the human body to secure an access route to blood vessels for drug administration or intravascular treatment. During vascular puncture, the operator cannot see the blood vessels from the surface of the skin, so they estimate the location of the blood vessels based on standard knowledge of vascular anatomy and skills such as palpation of vascular pulsation.

[0003] In recent years, there have been devices that perform automatic vascular puncture. These devices acquire cross-sectional images of the human body using an ultrasound probe, calculate the puncture target position based on the cross-sectional images, and control the drive of the needle toward the calculated puncture target position. The cross-sectional images are 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 disclosed in Patent Document 1.

[0004] WO 2022 / 195981

[0005] When performing puncture, the operator must monitor the needle's movement and recognize and respond if an abnormality occurs. When performing 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 an abnormality. However, when performing vascular puncture automatically, it is difficult for the operator to intuitively grasp the needle's condition.

[0006] In devices that automatically perform vascular puncture, an operator may be able to recognize abnormalities during puncture by observing cross-sectional images acquired by an ultrasound probe and by directly observing the state of the needle. However, in practice, it is difficult to simultaneously monitor these two aspects. Furthermore, when the tip of the needle enters the body, if the tip is outside the imaging plane of the ultrasound probe, the cross-sectional image cannot display its position. As a result, the operator cannot grasp the trajectory of the needle tip during puncture.

[0007] The present invention has been made to solve the above-mentioned problems, and aims to provide a puncture control device that can simultaneously grasp the cross-sectional image and the state of the needle tip when automatically performing vascular puncture.

[0008] (1) The puncture control device of the present invention, which achieves the above-mentioned object, is a puncture control device comprising an ultrasonic probe that contacts the surface of the skin to emit ultrasonic waves and acquires 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 acquire the cross-sectional image and operates the drive unit, and a display unit that displays the cross-sectional image, wherein 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 projecting the estimated tip position of the needle tip onto the cross-sectional image displayed on the display unit.

[0009] The puncture control device (1) configured as described above displays the estimated tip position of the needle tip on a cross-sectional image, so that when automatically performing vascular puncture, 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.

[0010] (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 a target position of the needle tip and a position where the needle tip passes through an imaging surface 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, an arrival position index projected with the calculated target position of the needle tip and a passing position index indicating the position where the needle tip passes through the imaging surface of the ultrasonic probe. In this way, the puncture control device can grasp the target position and passing 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 also using them as an index of whether puncture is being performed normally.

[0011] (3) In the puncture control device of (2) above, if the control unit 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, the control unit may stop the operation of the drive unit. This allows the puncture control device to automatically stop 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.

[0012] (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 surface of the ultrasound probe by the drive unit, the estimated tip position of the needle tip is separated by a certain amount or more from the calculated position where the needle tip passes through the imaging surface 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 after passing through the imaging surface, thereby making it possible to reduce the depth of wounds on the patient caused by failed puncture.

[0013] (5) In any of the above (1) to (4), the puncture control device may further include a load detection unit that detects a load applied to the puncture unit, and the control unit may cause the load detection unit to detect the load applied to the puncture unit while the drive unit is moving the puncture unit, and may cause the display unit to display changes 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, such as when the needle tip hits a bone or the like outside the imaging range.

[0014] (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 drive unit is moving the puncture unit, the control unit may stop the operation of the drive unit. This allows the puncture control device to automatically stop puncture when an abnormality is detected that can be detected as an abnormality in the load on the puncture unit, thereby making it possible to reduce the depth of wounds on the patient caused by failed puncture.

[0015] (7) In the puncture control device according to (1) to (6), a backflow detection unit may be provided to detect 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 over time or with respect to 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.

[0016] (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.

[0017] 11 is a perspective view of the vascular puncture device of the present embodiment; FIG. 12 is a side view of the vascular puncture device of the present embodiment; FIG. 13 is a partial side view of the imaging unit and the puncturing unit of the vascular puncture device; FIG. 14 is a diagram showing the positional relationship between the bottom of the imaging unit and the arm of a human body; FIG. 15 is a configuration diagram of the vascular puncture device; FIG. 16 is a flow diagram of the operation of the vascular puncture device up to the start of puncturing; FIG. 17 is a plan view showing the initial position of the puncturing unit with respect to the arm, as seen from the palm side; FIG. 18(a) is a diagram showing a case where the orientation of the puncturing unit does not match the orientation of the blood vessel, and FIG. 18(b) is a diagram showing a case where the orientation of the puncturing unit matches the orientation of the blood vessel; FIG. 19 is a cross-sectional view showing the positional relationship between the imaging unit, the inside of the arm, and the puncturing unit, showing the state before the tip position of the puncturing unit reaches the target blood vessel; FIG. 19 is an example of a screen display displayed on the display unit in the state of FIG. 8; FIG. 19 is a flow diagram of the operation of the vascular puncture device when puncturing is performed; FIG. 19 is a cross-sectional view showing the positional relationship between the imaging unit, the inside of the arm, and the puncturing unit, showing the state when the tip position of the puncturing unit has reached the imaging surface of the imaging unit; FIG. 11 is an example of a screen display displayed on the display unit in the state of 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 display displayed on the display unit in the state of FIG. 13. 15 is an example of a screen display displayed on the display unit when an error range for the tip position of the needle tip is displayed on the current position indicator. 16 is an example of a screen display displayed on the display unit when the state of backflow is displayed.

[0018] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensional proportions in the drawings may be exaggerated for the sake of explanation and may differ from the actual proportions.

[0019] The puncture control device 10 according to an embodiment of the present invention is used when puncturing a human arm H, and acquires a cross-sectional image of the arm H to detect the position of the blood vessel to be punctured, and then automatically punctures that blood vessel.

[0020] As shown in Figures 1 to 3, the puncture control device 10 includes a main body 20 that automatically punctures a blood vessel, and a support base 30 that overlaps 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 includes an upper frame 21, an imaging unit 40 that contacts the skin surface to acquire cross-sectional images of the human body, a puncture unit 50 that performs 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.

[0021] The imaging unit 40 is fixed to the upper frame 21 and has an ultrasound probe 41 at its lower end. The ultrasound probe 41 generates and transmits ultrasound waves and receives reflected waves (echoes) from within the living body. As shown in FIG. 4 , the ultrasound probe 41 extends in one direction (the Y-axis direction) at the center of the probe surface 42, which is the bottom surface, and spans substantially the entire width of the probe surface 42. The imaging unit 40 has a transducer that generates ultrasound waves and detects the reflected waves to obtain cross-sectional images of the inside of the human body. 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.

[0022] 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 and adjusting 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.

[0023] The upper frame 21 is formed in a generally arch-like shape that convexes upward when viewed in 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.

[0024] Opening 24 is formed in a concave shape as viewed from above on the peripheral side of upper frame 21 in the X-axis direction. That is, opening 24 is formed in upper frame 21 by forming top surface 23 shorter on the peripheral side in the X-axis direction than upper wall 22. Opening 24 is located on the peripheral side of top surface 23. Arm H, which is imaged by imaging unit 40 and punctured by puncturing unit 50, is exposed from opening 24. Imaging unit 40 is connected to opening 24. Imaging unit 40 may be detachable from opening 24 or may not be detachable. Alternatively, imaging unit 40 may be configured separately from main body 20.

[0025] 3 , the puncture unit 50 includes a metal inner needle 51 having a sharp needle tip 53 formed at its tip, and a flexible tubular outer cylinder 52 arranged to cover the outer peripheral surface of the inner needle 51. When the outer cylinder 52 is placed over the outside of the inner needle 51, the needle tip 53 of the inner needle 51 protrudes from the outer cylinder 52. The inner needle 51 and the outer cylinder 52 are detachable from the puncture direction drive unit 65 of the drive unit 60.

[0026] The drive unit 60 is a drive source controlled by the control unit 70 to change the position and / or angle of the puncturing unit 50 to automatically adjust the puncturing position and perform the puncturing operation. The drive unit 60 includes a height direction drive unit 61 that moves the entire puncturing unit 50 up and down (in the Z-axis direction) relative to the upper frame 21, a rotation drive unit 63 that tilts the entire puncturing unit 50, a width direction drive unit 64 that moves the entire puncturing unit 50 in the width direction of the arm H (in the Y-axis direction), a puncturing direction drive unit 65 that moves the inner needle 51 forward and backward in the puncturing 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 puncturing unit 50 in the length direction of the arm H (in the X-axis direction). The height direction drive unit 61 can move the puncturing unit 50 in the Z-axis direction 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 to this.

[0027] Drive unit 60 has a load detection unit 75 that detects a load applied to puncturing unit 50. Load detection unit 75 can detect a load along the puncturing direction of puncturing unit 50. In addition, load detection unit 75 may be able to detect a load along a direction perpendicular to the puncturing direction of puncturing unit 50.

[0028] 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 display the cross-sectional images acquired by the imaging unit 40 on the display unit 90. 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 is physically configured to include a memory circuit and an arithmetic circuit. The memory circuit can store programs and various parameters. The arithmetic circuit can perform arithmetic processing.

[0029] The control unit 70 may be disposed on the upper frame 21, or may be disposed in the imaging unit 40 or the drive unit 60. Alternatively, the control unit 70 may be configured as a separate unit from the main body 20.

[0030] The control unit 70 can identify the position of the blood vessel in the image by analyzing the acquired cross-sectional image. Furthermore, the control unit 70 can detect the relative position of the inner needle 51 with respect to the imaging unit 40 by analyzing the image. Note that the outer tube 52 is made of resin and therefore cannot be detected by ultrasound. However, if the outer tube 52 is made of resin containing metal, for example, 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. Furthermore, the control unit 70 can display the cross-sectional image on the display unit 90 by analyzing the acquired cross-sectional image. Furthermore, the control unit 70 controls the drive unit 60 to adjust the position and angle of the puncture unit 50, allowing automatic puncture by the inner needle 51 and outer tube 52 at the desired position and angle.

[0031] Display unit 90 is a monitor or the like capable of displaying a cross-sectional image. Display unit 90 is preferably disposed near puncture unit 50, which performs the puncture. Display unit 90 is disposed, for example, on the upward-facing surface of top surface 23 adjacent to opening 24 in which puncture unit 50 is disposed. This allows the operator to visually check the cross-sectional image of the blood vessel on display unit 90 while visually checking the skin of arm H to be punctured. Note that display unit 90 may also be disposed away from main body 20 and support base 30.

[0032] 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-like shape that convex downward when viewed in 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 portion 33 that connects the two lower walls 32. The lower frame 31 is formed, for example, from a hard resin material.

[0033] The bottom surface portion 33 has a bottom surface 37 that contacts an operating table or the like, and an upward-facing support surface 38. A holding portion 80 that holds the arm H is fixed to the support surface 38.

[0034] 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 also have at least one distance sensor located opposite 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. In addition, if puncturing is in progress, the operation of the drive unit 60 may be stopped. In addition, an instruction to tighten the fixation of the arm H may be issued. This instruction can also be selected by the operator. The distance sensor may directly detect the distance to the arm H, or may be capable of estimating the distance to the arm H by detecting color tone, brightness, temperature, etc. Multiple distance sensors may be provided. In this case, the undulations of the skin may be measured as distance and the movement may be monitored.

[0035] 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 or discharging gas or liquid into or from the cushion. To perform this automatically, a pressure sensor may be provided in the cushion. Also, partitions may be provided inside the cushion, and a pressure sensor may 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.

[0036] The main body 20 or the support base 30 may have an inertial sensor such as an inclination sensor, an acceleration sensor, or a gyro sensor. This makes it possible to measure the tilt 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 tilted or displaced by more than a certain amount, it is determined that the puncture control device 10 has moved, and a notification can be sent or the operation of the drive unit 60 can be stopped.

[0037] The main body 20 may have a camera that captures an image of the surface of the arm H. The camera acquires an image of the surface of the fixed arm H and detects feature points such as wrinkles, moles, veins, and pores. By comparing the positions of feature points in the surface image of the arm H acquired by the camera immediately after the arm H is fixed with the latest surface image, movement of the arm H can be detected.

[0038] The drive unit 60 may have a proximity sensor located opposite 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 issue a notification or stop the operation of the drive unit 60 if it detects an abnormality in this movement.

[0039] 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 holder 80. At this time, the arm H is placed on the holder 80 with the palm side of the wrist bent upward. This makes it possible to prevent the skin from shifting and the puncture position from shifting during subsequent puncture.

[0040] The operator then activates the puncture control device 10. As shown in FIG. 6 , the control unit 70 of the puncture control device 10 acquires needle information for the puncture unit 50 (S1-1). The needle information includes product 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. The needle tolerance information may be registered in advance for each type of needle, or may be measured and input each time the needle is used. Alternatively, the distance from the puncture direction drive unit 65 to the needle tip 53 may be adjusted and installed to a predetermined value.

[0041] 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 differs 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. Therefore, 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 visual or tactile means, or it may be performed automatically by the puncture control device 10. When the puncture control device 10 performs this 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. Furthermore, control unit 70 may display on display unit 90 a display for adjusting the orientation of puncturing unit 50, and the operator may accordingly adjust the orientation of puncturing unit 50 or arm H. After adjusting the initial position of puncturing unit 50, control unit 70 calculates the initial position of needle tip 53 based on the needle information of puncturing unit 50.

[0042] 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) an arrival projection position, in which the target position of the needle tip 53 of the puncture unit 50 is projected onto the cross-sectional image, and (2) a passing position, in which the needle tip 53 passes through the imaging plane of the ultrasound probe 41.

[0043] 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 an artery 200. The control unit 70 detects a region recognized as the artery 200 in the cross-sectional image. To detect a region 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. Alternatively, the ultrasound probe 41 can detect a region with blood flow using the Doppler method and recognize the region as the artery 200. When detecting a blood vessel region from the cross-sectional image, it is necessary to distinguish between 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. Furthermore, when a region with blood flow 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, if multiple arteries 200 are detected, the operator can select any artery.

[0044] 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.

[0045] After the positions are set, the control unit 70 displays the arrival projection position and the passage position on the cross-sectional image of the display unit 90, and the operator determines whether each position is appropriate (S1-5). If the arrival projection position or the passage position on the cross-sectional image is displayed at a position far removed from the position intended by the operator, this may be due to the control unit 70 not correctly recognizing the position of the artery 200. 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 passage position on the cross-sectional image (S1-6), and then repeats steps S1-3 and S1-4. Note that if the operator arbitrarily specifies the arrival projection position and the passage position on the cross-sectional image, the control unit 70 skips the calculation of the arrival projection position and the passage position. If the operator determines that each position is appropriate in S1-5, the control unit 70 sets the movement direction and movement amount of the puncture driver 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 passage position and reaches the target position. Thereafter, control unit 70 drives drive unit 60 to start puncturing by puncturing unit 50 (S1-7). Note that steps S1-5 and S1-6 may be performed automatically by puncturing control device 10.

[0046] Once the puncture is initiated, 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 ultrasonic probe 41 extends perpendicularly from the surface of the arm H on which the ultrasonic probe 41 abuts. The target position P1 of the needle tip 53 is set at the point where it penetrates the artery 200, and the driving unit 60 positions the puncture unit 50 so that the target position P1 and the passing position P3 are on extensions of the direction in which the needle tip 53 extends. The position P2 is the position where the target position P1 is projected onto the imaging plane W of the ultrasonic probe 41. The position P3 is the position where the tip position P4 of the needle tip 53 passes through the imaging plane W of the ultrasonic probe 41. The position P5 is the position where the tip position P4 of the needle tip 53 is projected onto the imaging plane W of the ultrasonic probe 41. The target position P1, the arrival projection position P2, and the passing position P3 are set in steps S1-4 to S1-6. The control unit 70 can calculate a position P2 where the target position P1 is projected onto the imaging surface W from the target position P1 and the position of the ultrasonic probe 41. The control unit 70 can calculate and estimate the tip position P4 of the needle tip 53 from the initial position and orientation of the needle tip 53 and the operation history of the drive unit 60. The control unit 70 can calculate a position P5 where the tip position P4 of the needle tip 53 is projected onto the imaging surface W from the position P4 and the position of the ultrasonic probe 41.

[0047] As shown in FIG. 9 , 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 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 the intersection of a vertical line 92a and a horizontal line 92b. 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 unit 50 starts puncturing, the current position indicator 92 moves within the screen in accordance with the movement of the needle tip 53.

[0048] The control unit 70 also displays a passing position index 94 and an arrival 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 dot on the cross-sectional image 91. The arrival position index 93 indicates the position P2 where the target position P1 is projected onto the imaging plane W. The arrival position index 93 is displayed as the 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 arrival position index 93 do not change after their positions are set in S1-3, and therefore do not move within the screen even after the puncture unit 50 starts puncturing. The passing position index 94 and the arrival position index 93 may be displayed as either the dots or the intersections of vertical and horizontal lines, or may be displayed using other lines or shapes.

[0049] The current position indicator 92, the arrival position indicator 93, and the passing position indicator 94 are always displayed on the cross-sectional image 91. However, they may be blinked or temporarily hidden depending on their positional relationship so as not to interfere with the operator's observation of the cross-sectional image.

[0050] Control unit 70 displays a load graph section 95 to the right of cross-sectional image 91. While driving unit 60 is moving puncturing unit 50, control unit 70 causes load detection unit 75 to detect the load acting on puncturing unit 50, and displays the magnitude of the load acting on puncturing unit 50 at a position corresponding to current position indicator 92, specifically at the same position in the horizontal direction as current position indicator 92, thereby making it possible to represent, as a graph, the change in the load as puncturing unit 50 punctures.

[0051] The control unit 70 may also display, on the display unit 90 , the structural information of the blood vessel to be punctured outside the cross-sectional image 91 , in addition to the cross-sectional image 91 and the load graph section 95 .

[0052] The flow of the puncture control device 10 after puncturing by the puncturing unit 50 will be described. As shown in Figure 10, the control unit 70 drives the drive unit 60 to cause the puncturing unit 50 to perform puncturing (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 then causes the imaging unit 40 to acquire a cross-sectional image and displays the acquired cross-sectional image on the display unit 90 (S2-4).

[0053] 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 the drive unit 60 from driving the puncture unit 50 (S2-6). If the blood vessel contour is determined to be appropriate in S2-5, the process proceeds to the next step.

[0054] 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 needle tip 53 is not punctured properly, such as when it strikes a bone instead of a blood vessel, the puncture resistance will be greater than expected. Therefore, determining whether the puncture resistance is appropriate can determine whether the puncture was performed correctly. Furthermore, as shown in FIGS. 12 and 14 , the puncture resistance temporarily increases when the needle tip 53 penetrates the blood vessel wall. Therefore, the control unit 70 may determine whether the puncture resistance is increased at the position of the blood vessel wall estimated from the cross-sectional image. If the puncture resistance is not increased, the control unit 70 may determine that the puncture resistance is abnormal. If the puncture resistance is determined to be inappropriate, the control unit 70 stops the drive unit 60 from driving the puncture unit 50 (S2-6). If the puncture resistance is determined to be appropriate in S2-7, the process proceeds to the next step.

[0055] 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 imaged needle tip 53 is displayed in the cross-sectional image 91 as shown in FIG. 12. Thus, the fact that the needle tip 53 has reached the imaging surface W can be determined by the image of the needle tip 53 being captured in the cross-sectional image acquired by the imaging unit 40. Once the needle tip 53 has reached 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 53 is inappropriate if the difference between the previously calculated position P3 at which the tip position P4 of the needle tip 53 passes through the imaging surface W and the actual tip position of the needle tip 53 appearing on the imaging surface W is 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, the process proceeds to the next step.

[0056] The control unit 70 drives the drive unit 60 in the initially set direction and amount of movement, repeating steps S2-2 to S2-9 until the tip 53 reaches the target position (S2-11). The control unit 70 calculates and estimates the tip position P4 of the tip 53 based on the initial position and orientation of the tip 53, the operation history of the drive unit 60, and the tip position of the tip 53 as seen on the imaging plane W. As shown in FIG. 13 , when the tip 53 reaches the target position, the control unit 70 compares the tip position P4 of the tip 53 estimated at that time with the target position P1 and determines whether the two are separated by a certain amount or more (S2-12). As shown in FIG. 14 , if the difference between the estimated tip position P4 of the 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 tip 53 is determined to be appropriate. If the estimated tip position P4 of the needle tip 53 is more than a certain distance from the target position P1, the control unit 70 determines that the needle position is inappropriate 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, 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. Furthermore, even 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.

[0057] 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 and removes it from the support base 30. After removing the main body 20, the operator can perform the catheterization procedure via the outer tube 52.

[0058] 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 indicate the error range, and may be displayed, for example, by changing the hue along the circumferential direction, or by changing the size of a horizontal position indicator section 92c and a vertical position indicator section 92d.

[0059] The puncture control device 10 may have a backflow detection unit that detects backflow blood flowing from a blood vessel toward the proximal end 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 about the internal pressure of the inner needle 51 detected by the backflow detection unit while moving the puncture unit 50 using 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 ultrasound probe 41, while also displaying a backflow graph section 97 to the right of the cross-sectional image 91. The backflow graph section 97 shows time or needle tip depth on the horizontal axis and the internal pressure of the inner needle 51 detected by the backflow detection unit on the vertical axis. When the inner needle 51 punctures a blood vessel, backflow occurs, causing the internal pressure of the inner needle 51 to increase, as can be seen 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 the 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.

[0060] As described above, (1) the puncture control device 10 in this embodiment is a puncture control device 10 comprising an ultrasonic probe 41 that contacts the surface of the skin to emit ultrasonic waves and acquires a cross-sectional image of the human body based on the received reflected waves, a puncture unit 50 with a sharp needle tip 53, a drive unit 60 that moves the puncture unit 50 relative to the ultrasonic probe 41, a control unit 70 that causes the ultrasonic probe 41 to acquire a cross-sectional image and operates the drive unit 60, and a display unit 90 that displays the cross-sectional image, and the control unit 70 estimates the tip position of the needle tip 53 based on the tip position of the needle tip 53 before operating the drive unit 60 and the operation history of the drive unit 60, and displays a current position indicator 92 that projects the estimated tip position of the needle tip 53 onto a cross-sectional image 91 displayed on the display unit 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 performing vascular puncture, the operator can simultaneously grasp the cross-sectional image 91 and the position of the needle tip 53, and easily determine whether the puncture is being performed correctly.

[0061] (2) In the puncture control device 10 described in (1) above, the control unit 70 may detect the position of a 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, an arrival position indicator 93 projecting the calculated target position of the needle tip 53 and a passing 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 passing position of the needle tip 53 on the cross-sectional image 91, allowing the operator to easily determine whether there is any abnormality in these positions and also using them as indicators of whether the puncture is being performed normally.

[0062] (3) In the puncture control device 10 described in (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, thereby making it possible to reduce the depth of wounds on the patient caused by failed puncture.

[0063] (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 drive unit 60 causes the needle tip 53 to pass through the imaging plane of the ultrasound probe 41 and the estimated tip position of the needle tip 53 is more than a certain distance from the calculated position where the needle tip 53 passes through the imaging plane of the ultrasound probe 41. 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 depth of injury to the patient caused by a failed puncture.

[0064] (5) The puncture control device 10 of any of (1) to (4) above may include a load detection unit 75 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 display on the display unit 90 the change in the load applied to the puncture unit 50 in correspondence with the estimated distal end position of the needle tip 53. This allows the puncture control device 10 to quickly detect an abnormality, such as when the needle tip 53 hits a bone or the like outside the imaging range.

[0065] (6) In the puncture control device 10 described in (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 puncture when there is an abnormality that can be detected by an abnormality in the load on the puncture unit 50, thereby making it possible to reduce the depth of wounds on the patient caused by failed puncture.

[0066] (7) The puncture control device 10 described above in (1) to (6) may further 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 may cause the display unit 90 to display whether backflow blood has been detected over time or with respect to 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.

[0067] (8) In any of the puncture control device 10 described above in (1) to (7), the control unit 70 may acquire a tolerance range for the puncture unit 50 before moving the puncture unit 50 with the drive unit 60, and while the puncture unit 50 is being moved with the drive unit 60, may display on the display unit 90 an error range for the estimated distal end position of the needle tip 53 based on the acquired tolerance range for 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.

[0068] 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.

[0069] This application is based on Japanese Patent Application No. 2023-155463 filed on September 21, 2023, the disclosures of which are incorporated herein by reference in their entirety.

[0070] 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 Passage position indicator 95 Load graph unit 96 Error range indicator

Claims

1. 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 relatively 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, wherein 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 projecting the estimated tip position of the needle tip onto the cross-sectional image displayed on the display unit.

2. The puncture control device of claim 1, wherein the control unit detects the position of a targeted blood vessel from the cross-sectional image acquired by the ultrasonic probe, calculates a target position of the needle tip and a position where the needle tip passes through the imaging plane of the ultrasonic probe based on the detected position of the blood vessel, and displays, on the cross-sectional image displayed on the display unit, an arrival position index projecting the calculated target position of the needle tip and a passing position index indicating the position where the needle tip passes through the imaging plane of the ultrasonic probe.

3. The puncture control device according to claim 2, wherein the control unit stops 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.

4. The puncture control device according to claim 2, wherein the control unit stops the operation of the drive unit when the estimated tip position of the needle tip is away from the calculated position where the needle tip passes through the imaging plane of the ultrasound probe by the drive unit by a certain distance or more.

5. A puncture control device as described in claim 1, further comprising a load detection unit which detects a load applied to the puncture portion, wherein the control unit causes the load detection unit to detect the load applied to the puncture portion when the puncture portion is moved by the drive unit, and causes the display unit to display changes in the load applied to the puncture portion in correspondence with the estimated tip position of the needle tip.

6. The puncture control device according to claim 5, wherein the control unit stops 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.

7. A puncture control device as described in claim 1, further comprising a backflow blood detection unit that detects backflow blood flowing from a blood vessel into the puncture portion, wherein the control unit causes the backflow blood detection unit to detect backflow blood flowing into the puncture portion when the puncture portion is moved by the drive unit, and causes the display unit to display whether or not backflow blood has been detected relative to time or the depth reached by the needle tip.

8. A puncture control device as described in any one of claims 1 to 7, wherein the control unit acquires a tolerance range of the puncture part before moving the puncture part with the drive unit, and while moving the puncture part with the drive unit, causes 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 part.

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