Puncture control device

Abstract

The present invention provides a puncture control device that is capable of distinguishing the state of a cross-sectional image of a human body acquired by an ultrasonic probe. A puncture control device 10 includes an ultrasonic probe 41 that is in contact with a skin surface and emits ultrasonic waves to acquire a cross-sectional image of a human body on the basis of received reflected waves, a puncturing unit 50 that has a sharp needle tip, a drive unit 60 that moves the puncturing unit 50, and a control unit 70 that causes the ultrasonic probe 41 to acquire a cross-sectional image, and that operates the drive unit 60. The control unit 70 extracts a plurality of pieces of line information along a transmission direction of the ultrasonic waves from the cross-sectional image acquired by the ultrasonic probe 41, and distinguishes an acquisition state of the cross-sectional image on the basis of intensity distribution of the reflected waves included in the plurality of pieces of extracted line information.

Description

Puncture control device

[0001] The present invention relates to a puncture control device that determines the acquisition state of a cross-sectional image 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 surgeon cannot see the blood vessels from the surface of the skin, so they estimate the location of the blood vessels based on their knowledge of standard vascular anatomy and skills such as palpation of vascular pulsation.

[0003] In recent years, there have been devices that perform automatic vascular puncture (see, for example, Patent Document 1).

[0004] WO 2023 / 002933

[0005] A device that performs automated vascular puncture acquires cross-sectional images of the human body using an ultrasound probe, calculates the target puncture position based on these cross-sectional images, and controls the drive of the needle toward the calculated target puncture position. In order to puncture at the correct position, it is necessary to acquire clear images using the ultrasound probe.

[0006] An ultrasound probe emits ultrasound waves from the probe surface in contact with the human body and detects the reflected waves from inside the body to obtain cross-sectional images. If the probe surface is not in close contact with the surface of the human body and there is an air gap between the probe surface and the surface of the human body, the ultrasound waves will not reach the inside of the body, and cross-sectional images cannot be obtained properly. While the probe surface is either flat or convexly curved, the surface of the human body is a mixture of flat, convexly curved, and concavely curved parts, and often does not match the shape of the probe surface.

[0007] When an operator manually operates an ultrasound probe, they apply gel to the surface of the human body while viewing the acquired cross-sectional image, and then press the ultrasound probe against the surface of the human body to prevent the presence of an air gap. However, in a device that automatically acquires cross-sectional images, there is a possibility that the operator may erroneously detect the position of a blood vessel or may not be able to detect the position of a blood vessel without recognizing that the cross-sectional image has not been acquired correctly.

[0008] The present invention has been made to solve the above-mentioned problems, and has an object to provide a puncture control device that can determine the state of a cross-sectional image of a human body acquired by an ultrasound probe.

[0009] (1) A puncture control device according to the present invention that achieves the above-mentioned object is a puncture control device that includes 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, and a control unit that causes the ultrasonic probe to acquire the cross-sectional image and operates the drive unit, wherein the control unit extracts multiple pieces of line information along the transmission direction of the ultrasonic waves from the cross-sectional image acquired by the ultrasonic probe, and determines the acquisition state of the cross-sectional image based on the intensity distribution of the reflected waves contained in the extracted multiple pieces of line information.

[0010] The puncture control device (1) configured as described above can determine whether cross-sectional images are being acquired normally by the ultrasound probe, and can therefore reliably acquire information necessary for performing puncture.

[0011] (2) In the puncture control device of (1) above, the control unit may determine whether or not the puncture unit can perform puncture based on the determined acquisition state of the cross-sectional image. This allows puncture to be performed reliably.

[0012] (3) In the puncture control device of (1) or (2) above, the control unit may determine whether the intensity distribution of the reflected wave is proper or defective for each of the extracted line information, and determine that the cross-sectional image has not been acquired normally if the proportion of the line information for which the intensity distribution of the reflected wave is determined to be defective relative to the total number of extracted line information is equal to or greater than a certain value. This makes it possible to accurately determine whether the cross-sectional image is normal.

[0013] (4) In the puncture control device of (1) or (2), the control unit may determine that the cross-sectional image has not been acquired normally when the line information in which the intensity distribution of the reflected wave is determined to be poor continues for a certain period or more in a direction perpendicular to the direction along the line information. This makes it possible to accurately determine that the cross-sectional image has not been acquired normally because the ultrasound probe has not made sufficient contact with the surface of the human body.

[0014] (5) In the puncture control device of (1) or (2) above, the control unit may determine that the cross-sectional image has not been acquired normally when a certain number or more of the line information for which the intensity distribution of the reflected wave is determined to be poor are present in an area within a certain range from the center position in a direction perpendicular to the direction along the line information. This makes it possible to reliably determine whether the cross-sectional image has been acquired normally near the center of the cross-sectional image where the blood vessel is located, and to accurately estimate the position of the blood vessel.

[0015] (6) In the puncture control device of (1) or (2), the control unit may determine that the cross-sectional image has not been acquired normally when the line information, in which the intensity of the reflected wave periodically increases and decreases multiple times, exists continuously for a certain section or more in a direction perpendicular to the direction along the line information. This makes it possible to reliably determine the state of the cross-sectional image caused by multiple reflections of ultrasound waves by gel applied to the surface of the ultrasound probe, and accurately determine that the cross-sectional image has not been acquired normally.

[0016] (7) In any of the puncture control devices (1) to (6) above, the control unit may determine that the cross-sectional image has not been acquired normally when the line information, in which the intensity distribution of the reflected wave is determined to be poor over a range exceeding a certain range from the side where the ultrasound probe is located, exists continuously for a certain section or more in a direction perpendicular to the direction along the line information. This allows the puncture to proceed by treating the acquired cross-sectional image as normal even if the cross-sectional image has not been acquired normally in an area that has little effect on the puncture, and on the other hand, allows the control unit to reliably determine that the cross-sectional image has not been acquired normally in an area that has an effect on the puncture.

[0017] (8) In any of the puncture control devices (1) to (7) above, a notification unit may be provided that, when the control unit determines that the cross-sectional image has not been acquired normally, issues a notification based on the line information in which the intensity distribution of the reflected wave has been determined to be poor. This makes it possible to reliably notify the operator that the cross-sectional image has not been acquired normally.

[0018] (9) In any of the above (1) to (8) puncture control devices, a position adjustment unit may be provided that changes the position of the ultrasonic probe relative to the skin, and when the control unit determines that the cross-sectional image has not been acquired normally, the control unit may use the position adjustment unit to adjust the position of the ultrasonic probe relative to the skin based on the line information along which the intensity distribution of the reflected wave is determined to be poor. This allows the position of the ultrasonic probe to be automatically adjusted so that the cross-sectional image can be acquired normally.

[0019] 8 is a perspective view of the vascular puncture device of the present embodiment. FIG. 9 is a side view of the vascular puncture device of the present embodiment. FIG. 10 is a partial side view of the imaging unit and the puncture unit of the vascular puncture device. FIG. 11 is a diagram showing the positional relationship between the bottom of the imaging unit and the arm of a human body. FIG. 12 is a configuration diagram of the vascular puncture device. FIG. 13 is a flow diagram of the operation of the vascular puncture device up to confirmation of the puncture position. FIG. 14 is an example of a cross-sectional image acquired by the imaging unit, showing a cross-sectional image having an area that is not properly imaged in part of the image. FIG. 15 is a graph showing the reflected wave intensity distribution versus the Z-axis position in the line information in FIG. 7, where (a) is the line information A in FIG. 7 and (b) is the line information B in FIG. 7. FIG. 16 is an example of a cross-sectional image acquired by the imaging unit, showing a cross-sectional image in which a periodic pattern is observed in part of the area that is not properly imaged. FIG. 17 is a graph showing the reflected wave intensity distribution versus the Z-axis position in the line information in FIG. 15. FIG. 16 is an example of a screen display when a cross-sectional image acquired by the imaging unit is not properly acquired. FIG. 17 is a first modified example of a screen display when a cross-sectional image acquired by the imaging unit is not properly acquired. FIG. 1 is a second modified example of a screen display when a cross-sectional image obtained by the imaging unit has not been obtained normally. FIG. 2 is a configuration diagram of a blood vessel puncture device according to a modified example. FIG. 3 is a side view showing the support structure of the imaging unit in a blood vessel puncture device according to a modified example. FIG. 4 is a front view showing the support structure of the imaging unit in a blood vessel puncture device according to a modified example. FIG. 5 is a partial front view showing a state in which the imaging unit is tilted, with (a) being a front view showing a state in which the imaging unit is tilted to one side, and (b) being a front view showing a state in which the imaging unit is tilted to the other side. FIG. 6 is a flow diagram of the operation of a blood vessel puncture device according to a modified example, up to the point where the puncture position is determined.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] Opening 24 is formed in a concave shape when 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.

[0027] 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.

[0028] 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.

[0029] 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 also controls 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 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.

[0030] 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.

[0031] 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.

[0032] 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, where puncture unit 50 is disposed. This allows the surgeon 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.

[0033] 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.

[0034] 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.

[0035] Next, the operation of the puncture control device 10 according to this embodiment will be described. In advance, the surgeon 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.

[0036] Thereafter, the operator activates the puncture control device 10. As shown in Fig. 6, the control unit 70 of the puncture control device 10 acquires a cross-sectional image of the human body using the ultrasound probe 41 of the imaging unit 40 (S1).

[0037] Next, the control unit 70 extracts multiple pieces of line information along the transmission direction of the ultrasound waves from the cross-sectional image acquired by the ultrasound probe 41 (S2). The ultrasound waves transmitted from the ultrasound probe 41 travel in the Z-axis direction, which is the depth direction of the human body, and are reflected and received by the ultrasound probe 41. Therefore, as shown in FIG. 7 , line information including intensity information of the reflected waves can be extracted along the vertical direction of the acquired cross-sectional image. The control unit 70 extracts line information from multiple different positions in the Y-axis direction from the cross-sectional image and detects the intensity distribution of the reflected waves included in each piece of line information. The control unit 70 can extract line information from the cross-sectional image at regular intervals. However, the control unit 70 may also extract all of the line information from the cross-sectional image.

[0038] The control unit 70 determines whether the cross-sectional image is properly drawn based on the extracted line information (S3). The control unit 70 determines whether the intensity distribution of the reflected wave included in each extracted line information is proper or defective. From the line information at position A in the Y-axis direction in FIG. 7, the control unit 70 detects the intensity distribution of the reflected wave as shown in FIG. 8(a). Also, from the line information at position B in the Y-axis direction in FIG. 7, the control unit 70 detects the intensity distribution of the reflected wave as shown in FIG. 8(b). The image is properly acquired at position A. In this case, the intensity of the reflected wave at position A is higher than a certain threshold at most positions along the Z-axis direction. On the other hand, the image is not properly acquired at position B. In this case, the intensity of the reflected wave at position B is continuously lower than a certain threshold along the Z-axis direction. For this reason, the control unit 70 determines that the intensity distribution of the reflected waves included in the line information is poor if the area where the intensity of the reflected waves included in the line information is lower than a certain threshold continues for a certain percentage or more of the total length in the Z-axis direction, and determines that the intensity distribution of the reflected waves included in the line information is appropriate if the area where the intensity of the reflected waves is lower than a certain threshold does not continue for a certain percentage or more of the total length. The certain percentage used to determine whether the intensity distribution of the reflected waves is appropriate can be, for example, 30%. However, the certain percentage may be other percentages.

[0039] The intensity of the reflected waves included in the line information can be increased overall by increasing the gain, so determining whether an image has been acquired correctly based on whether the intensity of the reflected waves exceeds a threshold may not be accurate. For this reason, the control unit 70 may determine that the intensity distribution of the reflected waves included in the line information is poor if a region in which the intensity of the reflected waves does not change within a certain range continues for more than a certain percentage of the total length in the Z-axis direction. This makes it possible to determine whether the intensity distribution of the reflected waves is appropriate even when the intensity of the detected reflected waves is high overall.

[0040] When the ultrasonic probe 41 is in slight contact with the surface of the human body, the ultrasonic waves may reach the vicinity of the surface of the human body but not reach deep inside. For this reason, the control unit 70 may determine that the intensity distribution of the reflected waves included in the line information is poor if there is a continuous region where the intensity of the reflected waves is below a threshold in a portion below 50% in the Z-axis direction of the intensity distribution of the reflected waves included in the line information.

[0041] Ultrasound may not reach the interior of the skin due to insufficient contact of some portions of the ultrasonic probe 41 with the skin due to unevenness or the presence of an air layer within the gel. Even in this case, ultrasonic waves from peripheral portions of the ultrasonic probe 41 that are in sufficient contact with the skin surface may be able to reach deeper portions of the skin due to diffraction. In this case, the acquired line information has a poor intensity distribution within a certain range from the side where the ultrasonic probe 41 is located, and the intensity distribution beyond that range is normal. Because blood vessels are located at a certain depth from the skin surface, poor intensity distribution of the line information in areas close to the ultrasonic probe 41 has little effect on puncture. Therefore, the control unit 70 may determine that line information with poor intensity distribution within a certain range from the side where the ultrasonic probe 41 is located is normal in the intensity distribution of the reflected wave. If the blood vessel is located more than 2 mm below the skin surface and cross-sectional images are acquired up to 20 mm below the skin surface, this certain range can be set to a range less than 10% of the intensity distribution on the side where the ultrasonic probe 41 is located, for example, a range of 5% of the intensity distribution on the side where the ultrasonic probe 41 is located.

[0042] In addition, the control unit 70 may determine that the cross-sectional image has not been acquired normally if line information in which the intensity distribution of the reflected wave is judged to be poor in a range exceeding a certain range from the side where the ultrasonic probe 41 is located exists continuously for a certain section or more in a direction perpendicular to the direction along the line information.

[0043] The control unit 70 determines that the cross-sectional image has not been acquired normally if the proportion of line information determined to have a poor intensity distribution of reflected waves among the extracted line information is equal to or greater than a certain percentage. The control unit 70 determines that the cross-sectional image has been acquired normally if the proportion of line information determined to have a poor intensity distribution of reflected waves is less than a certain percentage. The certain percentage used to determine whether the cross-sectional image has been acquired normally can be, for example, 25%. However, the certain percentage may be a percentage other than this.

[0044] When a cross-sectional image cannot be acquired normally because the surface of the ultrasonic probe 41 does not match the surface shape of the human body, the intensity distribution of the reflected wave is continuously poor over a certain region along the Y-axis direction as shown in Fig. 7. Based on this, the control unit 70 can determine that a cross-sectional image has not been acquired normally when line information for which the intensity distribution of the reflected wave is determined to be poor exists continuously for a certain section or more in the direction perpendicular to the direction along the line information (Y-axis direction).

[0045] The arm H is positioned relative to the ultrasound probe 41 so that the blood vessels are imaged in the central region of the cross-sectional image. In order to accurately detect the position of the blood vessels, it is necessary that the image be properly acquired in the central region of the cross-sectional image. Therefore, the control unit 70 can determine that the cross-sectional image has not been properly acquired when a certain number or more pieces of line information for which the intensity distribution of the reflected waves is determined to be poor exist in a certain range (range R in FIG. 7 ) from the central position in the direction perpendicular to the direction along the line information (Y-axis direction).

[0046] As shown in FIG. 9 , periodic stripes may appear above an area where a cross-sectional image has not been acquired properly. This occurs due to multiple reflections of ultrasound waves from a gel applied to the surface of the ultrasound probe 41. When such stripes appear, the cross-sectional image has not been acquired properly, and this is detected. When stripes appear, at a Y-axis position C in FIG. 9 , the intensity of the reflected wave increases and decreases at equal intervals along the Z-axis, as shown in FIG. 10 . The control unit 70 can determine that a cross-sectional image has not been acquired properly when line information in which the intensity of the reflected wave periodically increases and decreases multiple times exists continuously for a certain period or more in the direction (Y-axis direction) perpendicular to the direction along the line information.

[0047] The control unit 70 determines the subsequent operation based on the determination result of S3 (S4). If it is determined in S3 that the cross-sectional image was not properly acquired, the control unit 70 determines that puncture is impossible and issues an alert on the display unit 90 as a notification means (S5). As shown in FIG. 11 , the display unit 90 has a cross-sectional image area 91 that displays the cross-sectional image and an information display area 92 that displays information such as the blood vessel position and blood vessel diameter. The alert is issued by surrounding the area in the cross-sectional image area 91 of the display unit 90 where the image was not properly acquired and displaying a message saying "Echo image not properly acquired." Furthermore, if the cause of the poor cross-sectional image can be identified, the cause of the poor cross-sectional image may be displayed together with the message in the cross-sectional image area 91 of the display unit 90. For example, in the image pattern shown in FIG. 9 , the cause of the poor cross-sectional image can be identified as air in the gel applied to the ultrasound probe 41, and this cause can be displayed on the display unit 90.

[0048] As shown in FIG. 12, the alert may be displayed by displaying a line above the area in the cross-sectional image area 91 of the display unit 90 where the image has not been properly acquired, and by displaying a message stating "Echo image not properly acquired."

[0049] As shown in FIG. 13 , the alert may be displayed in a message in the cross-sectional image area 91 of the display unit 90, indicating which part of the cross-sectional image was not properly acquired, such as “The left side of the echo image was not properly acquired.”

[0050] When the alert is notified, the surgeon adjusts the position of the arm H relative to the ultrasound probe 41, and then repeats the steps from S1.

[0051] If it is determined in S4 that the cross-sectional image has been successfully acquired, the control unit 70 determines that puncturing is possible and determines the puncture position based on the acquired cross-sectional image (S6). The puncture position is determined based on the position of the blood vessel in the cross-sectional image. The control unit 70 detects an area recognized as a blood vessel 100 in the cross-sectional image and determines the position of its center of gravity as the blood vessel position. To detect an area recognized as a blood vessel in the cross-sectional image, machine learning or deep learning techniques can be used by preparing a large number of similar images. Alternatively, the ultrasound probe 41 can detect an area with blood flow using the Doppler method and recognize that area as a blood vessel area. When detecting a blood vessel area from a cross-sectional image, it is necessary to distinguish between arteries and veins. Arteries and veins can be distinguished based on the position of the arm bones that appear in the cross-sectional image. Furthermore, if an area with blood flow is detected using the Doppler method, arteries and veins can also be distinguished based on the direction of blood flow.

[0052] In S6, once the puncture position is determined, the drive unit 60, controlled by the control unit 70, causes the tip of the inner needle 51 to reach the inside of the blood vessel together with the outer tube 52. 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 of the outer tube 52. Note that the inner needle 51 may be retracted manually by the surgeon.

[0053] When blood vessel puncture by the puncture control device 10 is complete, the surgeon removes both or either the inner needle 51 and the outer tube 52 from the drive unit 60. Next, the surgeon lifts the main body 20 and detaches and removes it from the support base 30. After removing the main body 20, the surgeon can perform the catheterization procedure via the outer tube 52.

[0054] Next, a description will be given of the puncture control device 10 having a mechanism for adjusting the position of the ultrasound probe 41 when a cross-sectional image is not normally acquired. Note that a description of configurations common to the previously described puncture control device 10 will be omitted. As shown in Fig. 14, the puncture control device 10 has a position adjustment unit 100 connected to a control unit 70, and the control unit 70 can adjust the position of the imaging unit 40 having the ultrasound probe 41 using the position adjustment unit 100.

[0055] 15 and 16 , the position adjustment unit 100 includes an X-direction driver 101, a Y-direction driver 102, and a tilt driver 103, which are provided between the main body 20 and the imaging unit 40. The X-direction driver 101 has a screw shape and connects the main body 20 and the imaging unit 40 along the X-axis direction. The imaging unit 40 can be moved in the X-axis direction by rotating the X-direction driver 101. The Y-direction driver 102 has a screw shape and connects the main body 20 and the imaging unit 40 along the Y-axis direction. The imaging unit 40 can be moved in the Y-axis direction by rotating the Y-direction driver 102. The Y-direction driver 102 is supported by the main body 20 so as to be tiltable around the X-axis direction as its central axis.

[0056] The tilt drive unit 103 is formed by two extension / contraction units 103a and 103b that connect the main body 20 and the top surface of the imaging unit 40. The extension / contraction units 103a and 103b can each independently extend or contract along the length. As shown in FIG. 17A, when one extension / contraction unit 103a contracts and the other extension / contraction unit 103b extends, the imaging unit 40 tilts to one side. The Y-direction drive unit 102 also tilts to one side relative to the main body 20 together with the imaging unit 40. As shown in FIG. 17B, when one extension / contraction unit 103a expands and the other extension / contraction unit 103b contracts, the imaging unit 40 tilts to the other side. The Y-direction drive unit 102 also tilts to the other side relative to the main body 20 together with the imaging unit 40.

[0057] As shown in FIG. 18 , the control unit 70 acquires a cross-sectional image (S2-1), extracts multiple pieces of line information from the cross-sectional image (S2-2), and determines whether the cross-sectional image is properly rendered based on the extracted line information (S2-3). Based on the determination result of S2-3, the control unit 70 determines the subsequent operation (S2-4). If the control unit 70 determines that the cross-sectional image is not properly rendered, since there is line information determined to have a poor reflected wave intensity distribution in at least a portion of the area, the control unit 70 controls the position adjustment unit 100 to adjust the position of the ultrasound probe 41 relative to the skin to resolve this (S2-5). After the position adjustment is completed, the steps from S2-1 onward are repeated. If the control unit 70 determines that the cross-sectional image is properly rendered in S2-3, the control unit 70 confirms the puncture position (S2-6).

[0058] As described above, the (1) puncture control device 10 in this embodiment includes 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, a drive unit 60 that moves the puncture unit 50, and a control unit 70 that causes the ultrasonic probe 41 to acquire the cross-sectional image and operates the drive unit 60. The control unit 70 extracts multiple pieces of line information along the ultrasonic transmission direction from the cross-sectional image acquired by the ultrasonic probe 41, and determines the acquisition status of the cross-sectional image based on the intensity distribution of the reflected waves included in the multiple extracted line information. The (1) puncture control device 10 configured in this manner can determine whether the cross-sectional image has been successfully acquired by the ultrasonic probe 41, and can therefore reliably acquire the information necessary to perform puncture.

[0059] (2) In the puncture control device 10 described in (1) above, the control unit 70 may determine whether or not puncture by the puncture unit 50 is possible based on the determined acquisition state of the cross-sectional image. This allows puncture to be performed reliably.

[0060] (3) In the puncture control device 10 described in (1) or (2) above, the control unit 70 may determine whether the intensity distribution of the reflected wave is proper or defective for each extracted line information, and determine that the cross-sectional image has not been acquired normally if the proportion of line information for which the intensity distribution of the reflected wave is determined to be defective relative to the total number of extracted line information is equal to or greater than a certain value. This allows for accurate determination of whether the cross-sectional image is normal.

[0061] (4) In the puncture control device 10 described in (1) or (2) above, the control unit 70 may determine that a cross-sectional image has not been acquired properly if line information in which the intensity distribution of the reflected wave is determined to be poor continues for a certain period or more in a direction perpendicular to the direction along the line information. This makes it possible to accurately determine that a cross-sectional image has not been acquired properly because the ultrasound probe 41 has not made sufficient contact with the surface of the human body.

[0062] (5) In the puncture control device 10 described in (1) or (2) above, the control unit 70 may determine that the cross-sectional image has not been acquired correctly if a certain number or more pieces of line information for which the intensity distribution of the reflected wave is determined to be poor are present in an area within a certain range from the center position in a direction perpendicular to the direction along the line information. This makes it possible to reliably determine whether the cross-sectional image has been acquired correctly near the center of the cross-sectional image where the blood vessel is located, and to accurately estimate the position of the blood vessel.

[0063] (6) In the puncture control device 10 described in (1) or (2) above, the control unit 70 may determine that the cross-sectional image has not been acquired correctly when line information in which the intensity of the reflected wave periodically increases and decreases multiple times is present continuously for a certain period or more in a direction perpendicular to the direction along the line information. This makes it possible to reliably determine the state of the cross-sectional image caused by multiple reflections of ultrasound waves by gel applied to the surface of the ultrasound probe 41, and accurately determine that the cross-sectional image has not been acquired correctly.

[0064] (7) In any of the puncture control devices (1) to (6) above, the control unit 70 may determine that the cross-sectional image has not been acquired normally when line information in which the intensity distribution of the reflected wave is determined to be poor over a range exceeding a certain range from the side where the ultrasound probe 41 is located exists continuously for a certain section or more in a direction perpendicular to the direction along the line information. This allows the puncture to proceed by treating the acquired cross-sectional image as normal even if the cross-sectional image has not been acquired normally for an area that has little effect on the puncture, and on the other hand, when the cross-sectional image has not been acquired normally for an area that has an effect on the puncture, it can be reliably determined that this has not been done.

[0065] (8) The puncture control device 10 of any of (1) to (7) above may have a notification means for issuing a notification based on line information for which the intensity distribution of the reflected wave is determined to be poor when the control unit 70 determines that the cross-sectional image has not been acquired normally. This allows the operator to be reliably notified that the cross-sectional image has not been acquired normally.

[0066] (9) The puncture control device 10 of any of (1) to (8) above may further include a position adjustment unit 100 that changes the position of the ultrasonic probe 41 relative to the skin, and when the control unit 70 determines that a cross-sectional image has not been acquired normally, the control unit 70 may use the position adjustment unit 100 to adjust the position of the ultrasonic probe 41 relative to the skin based on line information for which the intensity distribution of the reflected wave is determined to be poor. This allows the position of the ultrasonic probe 41 to be automatically adjusted so that a cross-sectional image can be acquired normally.

[0067] 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.

[0068] This application is based on Japanese Patent Application No. 2023-155462 filed on September 21, 2023, the disclosures of which are incorporated herein by reference in their entirety.

[0069] REFERENCE SIGNS LIST 10 Puncture control device 20 Main body 21 Upper frame 30 Support base 40 Imaging unit 41 Ultrasound probe 42 Probe surface 50 Puncture unit 51 Inner needle 52 Outer tube 53 Needle tip 60 Drive unit 61 Height direction drive unit 63 Rotation drive unit 64 Width direction drive unit 65 Puncture direction drive unit 66 Outer tube drive unit 70 Control unit 80 Holding unit 90 Display unit (notification means) 91 Cross-sectional image area 92 Information display area 100 Position adjustment unit

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; and a control unit that causes the ultrasonic probe to obtain the cross-sectional image and operates the drive unit, wherein the control unit extracts multiple pieces of line information along the transmission direction of ultrasonic waves from the cross-sectional image obtained by the ultrasonic probe, and determines the acquisition state of the cross-sectional image based on the intensity distribution of the reflected waves contained in the extracted multiple pieces of line information.

2. The puncture control device according to claim 1, wherein the control unit determines whether or not the puncture unit can perform puncture based on the determined acquisition state of the cross-sectional image.

3. A puncture control device as described in claim 1 or 2, wherein the control unit determines whether the intensity distribution of the reflected wave is proper or defective for each extracted line information, and determines that the cross-sectional image has not been acquired normally if the proportion of line information for which the intensity distribution of the reflected wave is determined to be defective relative to the total number of extracted line information is equal to or greater than a certain value.

4. A puncture control device as described in claim 1 or 2, wherein the control unit determines that the cross-sectional image has not been acquired normally when the line information in which the intensity distribution of the reflected wave is judged to be poor exists continuously for a certain section or more in a direction perpendicular to the direction along which the line information extends.

5. The puncture control device according to claim 1 or 2, wherein the control unit determines that the cross-sectional image has not been acquired normally when a certain number or more of the line information in which the intensity distribution of the reflected wave is judged to be poor exists in an area within a certain range from the central position in a direction perpendicular to the direction along the line information.

6. A puncture control device as described in claim 1 or 2, wherein the control unit determines that the cross-sectional image has not been acquired normally when the line information in which the intensity of the reflected wave periodically increases and decreases multiple times exists continuously for a certain section or more in a direction perpendicular to the direction along the line information.

7. A puncture control device as described in claim 1 or 2, wherein the control unit determines that the cross-sectional image has not been acquired normally when line information in which the intensity distribution of the reflected wave is judged to be poor in a range exceeding a certain range from the side on which the ultrasonic probe is located exists continuously for a certain section or more in a direction perpendicular to the direction along the line information.

8. A puncture control device as described in claim 1 or 2, further comprising a notification means for notifying, when the control unit determines that the cross-sectional image has not been acquired normally, based on the line information in which the intensity distribution of the reflected wave is judged to be poor.

9. A puncture control device as described in claim 1 or 2, further comprising a position adjustment unit which changes the position of the ultrasonic probe relative to the skin, wherein when the control unit determines that the cross-sectional image has not been acquired normally, the control unit adjusts the position of the ultrasonic probe relative to the skin using the position adjustment unit based on the line information in which the intensity distribution of the reflected wave is determined to be poor.

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