Blood vessel puncture device and blood vessel determination device

Abstract

To provide a blood vessel puncture device capable of determining whether or not a target blood vessel is punctured with a puncture device.SOLUTION: A blood vessel puncture device 10 includes: a puncture driving unit 21 for puncturing a living body with a puncture device 41; a blood backflow detection unit 35 for detecting characteristics of a blood backflow flowing into a base end side of the puncture device 41 from a blood vessel; and a control unit 30 for driving the puncture driving unit 21 and controlling the position of the puncture device 41 according to a result of the determination on whether or not the target blood vessel is punctured with the puncture device 41 on the basis of the characteristics of the blood backflow detected by the blood backflow detection unit 35.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a blood vessel puncture device that punctures a blood vessel with a needle and a blood vessel determination device that determines whether the punctured blood vessel is a target blood vessel. [Background technology]

[0002] Vessel puncture involves inserting an injection needle into the human body to secure an access site for drug administration or intravascular treatment. During vascular puncture, the surgeon cannot see the blood vessels from the surface of the skin, so they must estimate the location of the blood vessels using standard knowledge of the blood vessel course and skills such as palpation of vascular pulsation. However, vascular puncture often fails, causing physical and mental distress to the patient.

[0003] In recent years, technologies for visualizing blood vessel positions, such as near-infrared imaging, ultrasound echography, and optical reverberation imaging, have been used to identify the puncture position. By visualizing the blood vessel position, the surgeon can easily determine the puncture position, puncture angle, puncture depth, and the like. Also known are devices that drive a needle based on the obtained blood vessel position information to perform automatic puncture. Patent Document 1 discloses an example of an automatic puncture device. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 9,364,171 Summary of the Invention [Problem to be solved by the invention]

[0005] When inserting a needle, which is a puncture device, into a living body, there is a possibility that the needle may puncture a blood vessel other than the intended one. In an automatic puncture device, it is necessary to detect by some means whether the intended blood vessel has been punctured, and if the intended blood vessel has not been punctured, it is necessary to remove the puncture device.

[0006] The present invention has been made to solve the above-mentioned problems, and aims to provide a vascular puncture device and a vascular determination device that can determine whether a puncture device has successfully punctured a target blood vessel. [Means for solving the problem]

[0007] The vascular puncture device of the present invention, which achieves the above-mentioned object, comprises a puncture drive unit that punctures a living body with a puncture device, a backflow blood detection unit that detects the characteristics of backflow blood flowing from a blood vessel to the base end side of the puncture device, and a control unit that determines whether the puncture device has punctured a target blood vessel based on the characteristics of the backflow blood detected by the backflow blood detection unit, and drives the puncture drive unit and controls the position of the puncture device based on the determination result.

[0008] The blood vessel determination device of the present invention, which achieves the above-mentioned objective, has a backflow blood detection unit that detects the characteristics of backflow blood flowing from the blood vessel at the base end side of the puncture device that is inserted into the blood vessel, and determines whether the puncture device has inserted into the target blood vessel based on the characteristics of the backflow blood detected by the backflow blood detection unit. [Effects of the Invention]

[0009] The blood vessel puncture apparatus configured as described above can confirm whether the puncture device is being inserted into the target blood vessel based on information about the backflow of blood, and can reliably insert the puncture device into the target blood vessel.

[0010] The blood vessel determination device configured as described above can determine whether the blood vessel being punctured by the puncture device is the target blood vessel, and can therefore assist the puncture device in puncturing the target blood vessel. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 2 is a front view of the blood vessel puncture device of the present embodiment. [Figure 2] FIG. 2 is a perspective view showing the internal structure of the puncture drive unit. [Figure 3] FIG. 1 is a diagram illustrating the configuration of a blood vessel puncture device. [Figure 4] FIG. 2 is a diagram showing the skin contact surface of the probe body, illustrating its positional relationship with the arm from which cross-sectional images are acquired. [Figure 5] 1 is a flowchart of puncture using a vascular puncture device. [Figure 6] FIG. 2 is a conceptual diagram of an acquired echo image. [Figure 7] FIG. 2 is a cross-sectional view showing the positional relationship between a blood vessel and an imaging unit. [Figure 8] FIG. 10 is a diagram showing the relationship between the inner needle and the blood vessel during insertion. [Figure 9] 10 is a flowchart according to a first modified example of puncturing using a blood vessel puncture device. [Figure 10] 10 is a flowchart according to a second modified example of puncturing using a blood vessel puncture device. [Figure 11] 10 is a flowchart according to a third modified example of puncturing using a blood vessel puncture device. [Figure 12] 10 is a diagram showing the relationship between a puncture device having an outer cylinder and a blood vessel. FIG. [Figure 13] 10 is a flowchart according to a fourth modified example of puncturing using a blood vessel puncture device. [Figure 14] FIG. 2 is a front view of a guide wire driving device attached to the puncture driving unit. [Figure 15] FIG. 10 is a front view of a blood vessel puncture device according to a modified example. DETAILED DESCRIPTION OF THE INVENTION

[0012] 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.

[0013] The vascular puncture device 10 according to an embodiment of the present invention is used to puncture a human arm, acquiring a cross-sectional image of the arm to detect the position of the blood vessel, determining the puncture timing and puncture parameters, and inserting a needle into the blood vessel.

[0014] 1, the vascular puncture device 10 has a probe main body 20 having an imaging unit 22 that contacts the skin surface to acquire cross-sectional images of the human body, and a puncture drive unit 21 that holds a puncture device 41 and drives it to perform puncture. The puncture drive unit 21 has a fixing unit 21a that engages with and is fixed to the probe main body 20, and the probe main body 20 and the puncture drive unit 21 are integrated.

[0015] As shown in FIG. 2, puncture drive unit 21 has main body 40 that holds puncture device 41. Main body 40 has notification unit 23 for notifying the operator of the puncture status, etc. Notification unit 23 can be configured with a display or the like that displays information. However, notification unit 23 may also be a simpler display unit such as an LED. Notification unit 23 may also notify by voice.

[0016] The puncture device 41 has a hollow needle-shaped inner needle 60 that is inserted into a blood vessel, and a hub 62 that is provided on the proximal end side of the inner needle 60. The inner needle 60 is open at its distal end, and its proximal end communicates with the lumen of the hub 62. The hub 62 has an insertion section 62a that protrudes from the main body section 40 at its proximal end. The insertion section 62a communicates with the lumen of the hub 62, and allows a guidewire 80 to be inserted therein. The guidewire 80 inserted through the insertion section 62a can be inserted into the distal end side of the inner needle 60, passing through the lumen of the hub 62 and the inside of the inner needle 60.

[0017] The hub 62 is provided with a backflow detection unit 35 that detects backflow blood flowing from a blood vessel to the base end of the inner needle 60. The backflow detection unit 35 can detect the characteristics of backflow blood flowing through the lumen of the hub 62 from the tip end to the base end. The characteristics of backflow blood detected by the backflow detection unit 35 are one or more of the backflow blood volume, backflow blood velocity, or backflow blood color. The backflow detection unit 35 can be configured with a camera. The camera can detect the presence or absence of backflow blood and the backflow blood color. The backflow detection unit 35 may be fixed to the main body 40.

[0018] When the backflow detection unit 35 detects the backflow volume as a characteristic of backflow blood, a measuring tube with a scale branching off from the lumen of the hub 62 is provided in the hub 62, and the backflow volume can be detected by having the backflow detection unit 35, which is made up of a camera, detect the scale at which the blood flowing into the measuring tube reaches. When the backflow detection unit 35 detects the backflow velocity as a characteristic of backflow blood, the backflow detection unit 35 can be made up of a camera, and multiple cameras can be arranged along the longitudinal axis of the lumen of the hub 62 to detect the backflow velocity from the speed at which blood passes between two points. The backflow detection unit 35 may also have a flow meter in the lumen of the hub 62.

[0019] Puncture drive unit 21 has a horizontal direction drive unit 56 supported by main body unit 40, a biaxial drive unit 57 supported by horizontal direction drive unit 56, a puncture direction drive unit 54 supported by biaxial drive unit 57, a puncture direction guide unit 53 supported by puncture direction drive unit 54, and a puncture direction movement unit 52 supported by puncture direction guide unit 53 and movable along the puncture direction. FIG. 2 shows X, Y, and Z directions. The X direction corresponds to the width direction of the arm, the Y direction corresponds to the depth direction of the arm, and the Z direction corresponds to the length direction of the arm. Puncture device 41 is fixed to a holder 50 provided on puncture direction movement unit 52.

[0020] The biaxial drive unit 57 allows the orientation of the puncturing device 41 to change relative to the XZ plane. This changes the orientation of the puncturing device 41 relative to the planar direction of the skin surface, allowing the puncturing device 41 to enter straight into the blood vessel 100. The horizontal drive unit 56 allows the puncturing device 41 to move in the X direction. This allows the puncturing device 41 to move along the planar direction of the skin surface, allowing it to be positioned so that the puncturing device 41 can enter into the blood vessel 100. The biaxial drive unit 57 allows the inclination of the puncturing device 41 in the YZ plane. This allows the angle of incidence of the puncturing device 41 relative to the skin surface to be changed.

[0021] As shown in Figure 3, the vascular puncture device 10 includes an imaging unit 22 that contacts the skin surface to acquire cross-sectional images of the human body, and a control unit 30 that detects the position of the blood vessel from the cross-sectional images and drives the puncture drive unit 21 to control the position of the puncture device 41. The control unit 30 is connected to the imaging unit 22 via a transmission unit 32 and a reception unit 34, and can cause the imaging unit 22 to acquire cross-sectional images and receive the acquired cross-sectional images. The control unit 30 is connected to a backflow detection unit 35, and can acquire information about backflow blood detected by the backflow detection unit 35. The control unit 30 is also connected to a notification unit 23 provided in the main body 40, and can cause the notification unit 23 to issue a notification.

[0022] 4, the imaging unit 22 of the probe main body 20 extends in one direction at the center of the skin contact surface 20a of the probe main body 20, spanning substantially the entire width thereof. The imaging unit 22 is an echo device that has a transducer that generates ultrasound waves and obtains cross-sectional images of the inside of the human body by detecting the reflected waves. In this embodiment, to obtain cross-sectional images perpendicular to the axial direction of the blood vessels, the imaging unit 22 is disposed so that its length direction is perpendicular to the length direction of the arm H.

[0023] Next, the operation of the blood vessel puncture device 10 will be described along the flow of puncture. As shown in Figure 5, the control unit 30 acquires a cross-sectional image as shown in Figure 6 from the imaging unit 22 (S1-1). The cross-sectional image includes an image of the blood vessel 100. The horizontal direction in the cross-sectional image is the X direction, the vertical direction in the cross-sectional image is the Y direction, and the direction perpendicular to the plane of the paper of the cross-sectional image is the Z direction. The coordinates of the upper left point in this cross-sectional image are taken as the origin (0,0,0).

[0024] The control unit 30 detects the position of the blood vessel 100 in the image by analyzing the acquired cross-sectional image (S1-2). The control unit 30 detects an area recognized as the blood vessel 100 in the image and defines its center of gravity 110 as the position of the blood vessel. To detect an area recognized as a blood vessel in the image, a large number of similar images can be prepared and machine learning or deep learning techniques can be used. Alternatively, the imaging unit 22 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 bone H that appears in the cross-sectional image. Furthermore, when 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. The coordinates of the center of gravity 110 of the detected blood vessel are defined as (x, y, 0).

[0025] Next, control unit 30 determines parameters necessary for puncturing (S1-3). The parameters necessary for puncturing include the puncturing direction in the XZ plane, the puncturing position, the incident angle of puncturing device 41, the insertion depth of puncturing device 41, and the puncturing speed of puncturing device 41. As shown in Fig. 7, the puncturing direction in the XZ plane is determined such that puncturing device 41 of puncturing drive unit 21 fixed to probe main body 20 faces center of gravity position 110 because center of gravity position 110 of the blood vessel is detected from the cross-sectional image acquired by imaging unit 22.

[0026] The puncture position is set to a position directly below side surface 20b of probe main body 20. In this case, the Z-direction coordinate z of side surface 20b of probe main body 20, which is the puncture position, is half the width W of probe main body 20, and is calculated as z = W / 2. The puncture angle is the angle θ of the line from the center of gravity of the blood vessel toward the puncture position relative to a line perpendicular to the skin surface, and is calculated as θ = arctan(z / y). The puncture depth a is calculated as a = y / cos θ. These define the x-direction coordinate of the puncture position and the puncture depth a of puncture device 41.

[0027] Other parameters may also be used as the puncturing parameters, such as the puncturing start time, the puncturing completion time, the puncturing acceleration at the start of puncturing, and the puncturing acceleration at the completion of puncturing.

[0028] After determining the puncture parameters, control unit 30 operates puncture driver 21 in accordance with the puncture parameters to start puncturing (S1-4).

[0029] The control unit 30 determines whether the backflow detection unit 35 detects backflow while the puncture drive unit 21 is inserting the puncture device 41 (S1-5). If the backflow detection unit 35 does not detect backflow, the control unit 30 acquires a cross-sectional image with the imaging unit 22 (S1-6) and determines whether the positional relationship between the inner needle 60 and the blood vessel 100 is normal based on the acquired cross-sectional image (S1-7). If the acquired cross-sectional image shows that the inner needle 60 is pointing toward the blood vessel 100, as in Figures 8(a) and 8(b), it is determined that the positional relationship between the inner needle 60 and the blood vessel 100 is normal. If the inner needle 60 is not pointing toward the blood vessel 100, as in Figure 8(c), it is determined that the positional relationship between the inner needle 60 and the blood vessel 100 is not normal. This determination can be made by detecting the coordinates of the tip of the inner needle 60 and the coordinate range in which the blood vessel 100 exists in the acquired cross-sectional image through image analysis. Furthermore, the positional relationship between the inner needle 60 and the blood vessel 100 may be determined using machine learning or deep learning techniques.

[0030] If it is determined in S1-7 that the positional relationship between the inner needle 60 and the blood vessel 100 is normal, the process returns to step S1-5. If it is determined in S1-7 that the positional relationship between the inner needle 60 and the blood vessel 100 is not normal, the control unit 30 stops the insertion of the puncture device 41 and notifies the notification unit 23 to that effect (S1-8).

[0031] If the backflow detection unit 35 detects backflow blood in S1-5, the control unit 30 detects the backflow blood characteristics (S1-9). The backflow blood characteristics can be detected by the backflow detection unit 35 as described above. Once the backflow blood characteristics are detected, the control unit 30 determines whether the backflow blood characteristics are below a threshold (S1-10). The threshold for the backflow blood characteristics is determined based on the characteristics of an artery. If the backflow blood characteristic is the backflow blood volume, the backflow blood volume when an artery is punctured is greater than the backflow blood volume when a vein is punctured. Therefore, if the detected backflow blood volume is below the threshold, it can be determined that an artery has not been punctured. If the backflow blood characteristic is the backflow blood velocity, the backflow blood velocity when an artery is punctured is faster than the backflow blood velocity when a vein is punctured. Therefore, if the detected backflow blood velocity is below the threshold, it can be determined that an artery has not been punctured. If the backflow blood characteristic is the backflow blood color, the backflow blood color when an artery is punctured is close to red, and the backflow blood color when a vein is punctured is close to black. Therefore, if the magnitude of the red component of the reverse blood color detected by the reverse blood detection unit 35 is less than the threshold value, it can be determined that an artery has not been punctured.

[0032] If the characteristic of reverse blood is reverse blood color, the vascular puncture device 10 may have a sensor that acquires the color of ambient light. In this case, the control unit 30 can correct the reverse blood color acquired by the reverse blood detection unit 35 to eliminate the influence of ambient light. The control unit 30 can determine whether the corrected color is below a threshold. In this way, correcting the reverse blood color to eliminate the influence of ambient light allows for more accurate determination of the characteristics of reverse blood.

[0033] The threshold value for the backflow characteristics can be a value determined in advance based on biological information such as the age, weight, blood vessel diameter, and blood pressure of the person to be punctured. Alternatively, the threshold value for the backflow characteristics can be calculated as a predicted characteristic by obtaining the blood pressure and blood vessel diameter from the acquired cross-sectional image. Alternatively, the threshold value for the backflow characteristics can be calculated by machine learning in advance using data on the relationship between the cross-sectional image and the backflow characteristics, and the machine learning model can be applied to the acquired cross-sectional image to calculate an optimal value as the threshold.

[0034] If the characteristic of the backflow blood is less than the threshold in S1-10, it is determined that a vein other than the target blood vessel has been punctured, so the control unit 30 stops the puncturing of the puncturing device 41 and removes the puncturing device 41 (S1-11).If the characteristic of the backflow blood is greater than the threshold in S1-10, it is determined that an artery has been punctured, so the control unit 30 continues inserting the puncturing device 41 (S1-12).

[0035] If the target blood vessel to be punctured is a vein, the control unit 30 determines in S1-10 whether the characteristics of the backflow blood exceed a threshold. If the characteristics exceed the threshold, it is determined that an artery other than the target blood vessel has been punctured, and the control unit 30 stops puncturing with the puncturing device 41 and removes the puncturing device. The threshold for the characteristics of the backflow blood in S1-10 may also be determined based on the characteristics of a vein. This allows for more accurate identification of the type of blood vessel when a vein is the target blood vessel.

[0036] While the insertion of the puncture device 41 continues, the control unit 30 determines whether the insertion depth of the puncture device 41 has reached the calculated depth (S1-13). When the insertion depth of the puncture device 41 has reached the calculated depth, the control unit 30 acquires a cross-sectional image with the imaging unit 22 (S1-14) and determines whether the positional relationship between the inner needle 60 and the blood vessel 100 is normal based on the acquired cross-sectional image (S1-15). If the positional relationship between the inner needle 60 and the blood vessel 100 is not normal in S1-15, the control unit 30 performs the same abort processing as in S1-8. If the positional relationship between the inner needle 60 and the blood vessel 100 is normal, the control unit 30 stops the insertion of the puncture device 41 (S1-17) and notifies the operator of this via the notification unit 23 (S1-18). When the operator recognizes via the notification unit 23 that the insertion of the puncture device 41 has stopped, the operator inserts the guidewire 80 from the hub 62 of the puncture device 41.

[0037] In this way, the vascular puncture device 10 determines whether to continue inserting the puncture device 41 by determining the characteristics of the backflowing blood, so it can confirm whether the puncture device 41 is being inserted toward the target blood vessel, and can reliably puncture the puncture device 41 into the target blood vessel.

[0038] Next, we will explain a first modified example of puncturing using blood vessel puncturing device 10. In this example, the flow (S1-1 to S1-9) up to detecting the characteristics of backflow blood is the same as in FIG. 5, so explanation will be omitted.

[0039] In FIG. 9 , when the control unit 30 detects the characteristics of the backflow blood (S2-9), it determines whether the characteristics of the backflow blood are below a threshold (S2-10). If the characteristics of the backflow blood are below the threshold, the control unit 30 acquires a cross-sectional image with the imaging unit 22 (S2-11) and determines whether the blood vessel punctured by the puncturing device 41 is pulsating in the cross-sectional image (S2-12). Because arteries pulsate and veins do not, determining whether the blood vessel is pulsating can determine whether the blood vessel is an artery or a vein. If pulsation of the blood vessel is detected in S2-12, the control unit 30 continues inserting the puncturing device 41 (S2-14). If pulsation of the blood vessel is not detected in S2-12, the control unit 30 stops inserting the puncturing device 41 and removes the puncturing device 41 (S2-13).

[0040] If the characteristic of the backflow is greater than the threshold in S2-10, it is determined that the artery has been punctured, and the control unit 30 continues inserting the puncture device 41 (S2-14). The flow after continuing the insertion of the puncture device 41 is the same as in Fig. 5, and therefore a description thereof will be omitted.

[0041] In this way, when it is determined that the target blood vessel has not been punctured based on the characteristics of the detected backflow blood, the blood vessel puncture device 10 further determines whether the target blood vessel has been punctured by detecting the presence or absence of blood vessel pulsation, thereby enabling more accurate determination of whether the punctured blood vessel is the target blood vessel.

[0042] Next, we will explain a second modified example of puncturing using blood vessel puncturing device 10. In this example, the flow (S1-1 to S1-9) up to detecting the characteristics of backflow blood is the same as in FIG. 5, so explanation will be omitted.

[0043] In FIG. 10 , when the control unit 30 detects the characteristics of backflow blood (S3-9), it determines whether the characteristics of backflow blood are below a threshold (S3-10). If the characteristics of backflow blood are below the threshold, the control unit 30 acquires a cross-sectional image with the imaging unit 22 (S3-11) and determines the direction of blood flow in the blood vessel punctured by the puncturing device 41 in the cross-sectional image using the Doppler method (S3-12). The direction of blood flow can determine whether the blood vessel is an artery or a vein. If the direction of blood flow in S3-12 determines that the punctured blood vessel is an artery, the control unit 30 continues inserting the puncturing device 41 (S3-14). If the direction of blood flow in S3-12 determines that the punctured blood vessel is a vein, the control unit 30 stops inserting the puncturing device 41 and removes the puncturing device 41 (S3-13).

[0044] If the characteristic of the backflow is greater than the threshold in S3-10, it is determined that the artery has been punctured, and the control unit 30 continues inserting the puncture device 41 (S3-14). The flow after continuing the insertion of the puncture device 41 is the same as in Fig. 5, and therefore a description thereof will be omitted.

[0045] In this way, when the blood vessel puncture device 10 determines that the target blood vessel has not been punctured based on the characteristics of the detected backflow blood, it further detects the direction of blood flow in the blood vessel to determine whether the target blood vessel has been punctured. This allows for more accurate determination of whether the punctured blood vessel is the target blood vessel.

[0046] Next, we will explain a third modified example of puncturing using blood vessel puncturing device 10. In this example, the flow (S1-1 to S1-9) up to detecting the characteristics of backflow blood is the same as in FIG. 5, so explanation will be omitted.

[0047] 11, when the control unit 30 detects the characteristics of the backflow blood (S4-9), it determines whether the characteristics of the backflow blood are below a threshold value (S4-10). If the characteristics of the backflow blood are below the threshold value, the control unit 30 acquires a cross-sectional image with the imaging unit 22 (S4-11) and determines whether there are multiple puncturable blood vessels (S4-12). If there are no puncturable blood vessels other than the blood vessel already punctured by the puncturing device 41, the control unit 30 stops inserting the puncturing device 41 and removes the puncturing device 41 (S4-13).

[0048] If there are multiple puncturable blood vessels in S4-12, the control unit 30 selects one of the puncturable blood vessels other than the blood vessel being punctured by the puncturing device 41 as a new target blood vessel and detects the position of the target blood vessel from the cross-sectional image (S4-14). Next, the control unit 30 determines the parameters required for puncturing the new target blood vessel (S4-15). S4-14 and S4-15 can be performed in the same manner as S1-2 and S1-3. After determining the puncturing parameters, the control unit 30 starts re-puncturing the new target blood vessel with the puncturing device 41 (S4-16). Re-puncturing can be performed by removing the puncturing device 41 from the blood vessel that has already been punctured and then puncturing the blood vessel again with the puncturing device 41 based on the new puncturing parameters.

[0049] If the characteristic of the backflow is greater than the threshold in S4-10, it is determined that the artery has been punctured, and the control unit 30 continues inserting the puncture device 41 (S4-17). The flow after continuing the insertion of the puncture device 41 is the same as in Fig. 5, and therefore a description thereof will be omitted.

[0050] In this way, when it is determined that the target blood vessel has not been punctured by the puncturing device 41, the blood vessel puncturing apparatus 10 can re-puncture a blood vessel other than the target blood vessel as a new target blood vessel, thereby enabling the target blood vessel to be punctured more reliably.

[0051] Next, a fourth modified example of puncturing using the blood vessel puncture apparatus 10 will be described. In this example, the puncturing device 41 has an inner needle 60 and an outer tube 61 that covers the inner needle 60, as shown in FIG. 12(a), and the tip of the inner needle 60 protrudes from the tip of the outer tube 61. The inner needle 60 can be moved to the proximal end side of the outer tube 61 by the puncture drive unit 21 and removed. The backflow blood detection unit 35 detects backflow blood flowing between the inner needle 60 and the outer tube 61.

[0052] When the puncture device 41 having the outer tube 61 is inserted into the blood vessel 100, both the inner needle 60 and the outer tube 61 enter the blood vessel, as shown in Figure 12(b). At this time, backflow blood flows into the inner needle 60 and between the inner needle 60 and the outer tube 61.

[0053] When the puncture device 41 is further inserted, both the inner needle 60 and the outer tube 61 penetrate the blood vessel wall on the side opposite to the inserted side, as shown in Figure 12(c). At this point, the tip of the inner needle 60 and the tip of the outer tube 61 are located outside the blood vessel, so backflow of blood does not occur.

[0054] As shown in Figure 12(d), once the inner needle 60 and outer tube 61 have penetrated the blood vessel, the inner needle 60 is removed. Furthermore, as shown in Figure 12(e), by moving the placed outer tube 61 toward the proximal end, the tip of the outer tube 61 is positioned inside the blood vessel, making it possible to insert the guide wire 80.

[0055] The flow of puncture in this example will be described below. In this example, the flow (S1-1 to S1-3) up to the determination of the puncture parameters is the same as in Fig. 5, so the description will be omitted.

[0056] 13, once the puncturing device 41 starts puncturing (S5-4), the control unit 30 determines whether the backflow detection unit 35 detects first backflow while the puncturing drive unit 21 is inserting the puncturing device 41 (S5-5). The first backflow is the backflow that occurs first after the puncturing device 41 starts puncturing, and is the backflow that occurs in the state shown in FIG. 12(b). If the backflow detection unit 35 does not detect backflow, the control unit 30 acquires a cross-sectional image with the imaging unit 22 (S5-6) and determines whether the positional relationship between the inner needle 60 and the blood vessel 100 is normal based on the acquired cross-sectional image (S5-7). If the positional relationship between the inner needle 60 and the blood vessel 100 is not normal, the control unit 30 halts the insertion of the puncturing device 41 and notifies the notification unit 23 of this fact (S5-8).

[0057] In S5-5, if the backflow detection unit 35 detects the first backflow blood, the control unit 30 detects the characteristics of the first backflow blood (S5-9). This step is the same as S1-9. Once the characteristics of the backflow blood are detected, the control unit 30 determines whether the detected characteristics of the backflow blood are below a threshold (S5-10). If they are below the threshold, the control unit 30 removes the puncturing device 41 (S5-11). If the detected characteristics of the backflow blood are not below the threshold, the control unit 30 continues inserting the puncturing device 41 (S5-12). While the puncturing device 41 is still being inserted, the control unit 30 determines whether the insertion depth of the puncturing device 41 has reached the calculated depth (S5-13). Here, as shown in FIG. 12(c), the puncturing device 41 is initially inserted to a position where it penetrates the blood vessel. Therefore, once the insertion depth of the puncturing device 41 reaches the calculated depth, the control unit 30 continues inserting the puncturing device 41 (S5-14).

[0058] The control unit 30 continues inserting the puncturing device 41 until backflow is no longer detected by the backflow detection unit 35 (S5-15). When backflow is no longer detected by the puncturing device 41, the control unit 30 determines that the puncturing device 41 has penetrated the blood vessel and stops the insertion (S5-16).

[0059] Next, the control unit 30 removes the inner needle 60 from the outer tube 61 (S5-17) and causes the notification unit 23 to issue a first notification to that effect (S5-18). Subsequently, the control unit 30 starts moving the outer tube 61 toward the proximal end (S5-19). While moving the outer tube 61, the control unit 30 determines whether the backflow detection unit 35 detects second backflow (S5-20). The second backflow is backflow that occurs again after backflow has temporarily stopped, and is backflow that occurs in the state shown in Figure 12(e). Because the inner needle 60 has been removed, the second backflow is greater in volume or speed than the first backflow.

[0060] In S5-20, when the backflow detection unit 35 detects a second backflow that is greater in volume or speed than the first backflow, the control unit 30 stops the movement of the outer tube 61 (S5-21) and causes the notification unit 23 to issue a second notification to that effect (S5-22).

[0061] In this way, the blood vessel puncturing apparatus 10 having the puncturing device 41 equipped with the outer cylinder 61 can also identify the punctured blood vessel based on information about backflow blood.

[0062] As described above, the guidewire 80 is inserted into the puncture device 41. The guidewire 80 may be inserted manually by the surgeon or automatically by the guidewire driving device 70. As shown in FIG. 16 , the guidewire driving device 70 has a guidewire insertion section 72 that holds the end of a holder tube 81 that holds the guidewire 80 and into which the guidewire 80 is inserted, a guidewire driving section 71 that moves the inserted guidewire 80, and a connecting section 73 that is connected to the insertion section 62a of the hub 62 of the puncture device 41. The guidewire driving section 71 has two roller sections 71a that sandwich the guidewire 80 and can move the guidewire 80 in both directions in the longitudinal direction.

[0063] Guidewire driving device 70 is connected to hub 62 after puncture device 41 has been inserted into a blood vessel by puncture driving section 21. The operator connects guidewire driving device 70 to hub 62, but a connecting device may also be provided that moves guidewire driving device 70 and connects it to hub 62. This allows guidewire driving device 70 to be connected to puncture device 41 automatically.

[0064] In this way, by providing the guidewire driving device 70 having the guidewire driving section 71, the procedure after puncture can be automated.

[0065] Puncture driving unit 21 is not limited to the configuration of puncture driving unit 21 of this embodiment as long as it can drive puncture device 41 to perform puncture. As shown in Fig. 17, vascular puncture apparatus 10 has a puncture driving unit 91 consisting of a robot arm that can move puncture device 41 three-dimensionally, and probe main body 20. Puncture driving unit 91 can cause puncture device 41 to puncture from any position and at any angle under control based on a sensor (not shown).

[0066] After the arm H is inserted through the base 90 and fixed by the fixing part 92, a cross-sectional image is acquired by the probe main body 20, and the control part 30 determines the puncturing timing and puncturing parameters from the cross-sectional image. The puncturing driving part 91 punctures the arm H with the puncturing device 41 in accordance with the determined puncturing possibility, puncturing position or direction, and puncturing parameters, and detects backflow blood to control the puncturing.

[0067] As described above, the (1) blood vessel puncturing device 10 according to this embodiment includes a puncturing drive unit 21 that punctures the puncturing device 41 into a living body, a backflow blood detection unit 35 that detects the characteristics of backflow blood flowing from a blood vessel to the proximal end of the puncturing device 41, and a control unit 30 that determines whether the puncturing device 41 has punctured a target blood vessel based on the characteristics of the backflow blood detected by the backflow blood detection unit 35, and drives the puncturing drive unit 21 and controls the position of the puncturing device 41 based on the determination result. The blood vessel puncturing device 10 configured in this manner can confirm whether the puncturing device 41 has punctured the target blood vessel based on the backflow blood information, and can reliably puncture the target blood vessel with the puncturing device 41.

[0068] (2) In the blood vessel puncturing device 10 described above in (1), the characteristics of the backflow blood detected by the backflow detection unit 35 may be one or more of the backflow blood volume, backflow blood velocity, or backflow blood color. This allows the blood vessel puncturing device 10 to easily determine whether the punctured blood vessel is an artery or a vein.

[0069] (3) The blood vessel puncture device 10 of (1) or (2) above may further include a probe main body 20 equipped with an imaging unit 22 that acquires cross-sectional images of the human body, and when the control unit 30 determines, based on the characteristics of the backflow blood detected by the backflow blood detection unit 35, that the puncturing device 41 has not punctured the target blood vessel, the control unit 30 may determine whether or not the blood vessel punctured by the puncturing device 41 is pulsating in the cross-sectional image acquired by the imaging unit 22, and determine whether or not the target blood vessel has been punctured by the puncturing device 41 based on the presence or absence of pulsation in the blood vessel. This allows the blood vessel puncture device 10 to more accurately determine whether or not the punctured blood vessel is the target blood vessel.

[0070] (4) The blood vessel puncture device 10 of (1) or (2) above may further include a probe main body 20 equipped with an imaging unit 22 that acquires cross-sectional images of the human body, and when the control unit 30 determines, based on the characteristics of the backflow detected by the backflow detection unit 35, that the puncturing device 41 has not punctured the target blood vessel, the control unit 30 may determine the direction of blood flow in the blood vessel punctured by the puncturing device 41 in the cross-sectional image acquired by the imaging unit 22, and determine whether the puncturing device 41 has punctured the target blood vessel based on the direction of blood flow in the blood vessel. This allows the blood vessel puncture device 10 to more accurately determine whether the punctured blood vessel is the target blood vessel.

[0071] (5) In the blood vessel puncturing device 10 described in (1) above, the characteristic of backflow blood detected by the backflow blood detection unit 35 is backflow color, and the control unit 30 may compare the backflow color detected by the backflow blood detection unit 35 with a color threshold value corrected to eliminate the effects of ambient light to determine whether the puncturing device 41 has punctured the target blood vessel. This allows the blood vessel puncturing device 10 to accurately determine whether the punctured blood vessel is the target blood vessel from the detected backflow color.

[0072] (6) In the blood vessel puncturing device 10 of any of (1) to (5) above, the control unit 30 may compare the characteristics of the backflow blood detected by the backflow blood detection unit 35 with a threshold value based on the characteristics of the backflow blood from an artery to determine whether the target blood vessel has been punctured with the puncturing device 41. This allows the blood vessel puncturing device 10 to accurately determine whether the punctured blood vessel is an artery when the target blood vessel is an artery.

[0073] (7) In the blood vessel puncturing device 10 of any of (1) to (5) above, the control unit 30 may compare the characteristics of the backflow blood detected by the backflow blood detection unit 35 with a threshold value based on the characteristics of the backflow blood from a vein to determine whether the target blood vessel has been punctured with the puncturing device 41. This allows the blood vessel puncturing device 10 to accurately determine whether the punctured blood vessel is a vein when the target blood vessel is a vein.

[0074] (8) The blood vessel puncture device 10 of any of (1) to (7) above may further include a probe main body 20 equipped with an imaging unit 22 that acquires cross-sectional images of the human body, and the control unit 30 may calculate puncture parameters for the puncture device 41, assuming one blood vessel as a target blood vessel based on the cross-sectional image acquired by the imaging unit 22, insert the puncture device 41 based on the calculated puncture parameters, and, if it determines that the puncture device 41 has not punctured the target blood vessel based on the characteristics of the backflow blood detected by the backflow blood detection unit 35, calculate puncture parameters for the puncture device 41, assuming a blood vessel other than the target blood vessel as a new target blood vessel. This allows the blood vessel puncture device 10 to more reliably puncture the target blood vessel.

[0075] (9) The blood vessel puncture device 10 of any of (1) to (8) above may further include a notification unit 23 controlled by the control unit 30, and the control unit 30 may be configured to cause the notification unit 23 to notify when it determines, based on the characteristics of the backflow blood detected by the backflow blood detection unit 35, that the puncture device 41 has not punctured the target blood vessel. This allows the operator to quickly recognize any abnormality in the puncture and take appropriate measures.

[0076] (10) The blood vessel determination device has a backflow detection unit 35 that detects the characteristics of backflow blood flowing from a blood vessel to the base end side of the puncturing device 41 that is punctured into the blood vessel, and determines whether the puncturing device 41 has punctured the target blood vessel based on the characteristics of the backflow blood detected by the backflow detection unit 35. The blood vessel determination device configured in this manner can determine whether the blood vessel punctured by the puncturing device 41 is the target blood vessel, and can therefore assist the puncturing device 41 in puncturing the target blood vessel.

[0077] (11) In the blood vessel determination device of (1) above, the characteristics of the backflow blood detected by the backflow detection unit may be one or more of the backflow blood volume, backflow blood velocity, and backflow blood color, thereby enabling the blood vessel determination device to easily determine whether the punctured blood vessel is an artery or a vein.

[0078] 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 spirit of the present invention. For example, although a monitor for displaying the cross-sectional images acquired in this embodiment is not shown, the vascular puncture device 10 may be connected to a monitor so that the cross-sectional images can be viewed.

[0079] The blood vessel puncture device 10 may be configured such that the puncture drive unit 21, the backflow blood detection unit 35, and the control unit 30 are all wirelessly connected to each other, allowing them to send and receive information.

[0080] The blood vessel puncture device 10 may have a backflow detection unit 35 that detects the characteristics of backflow blood, and may be provided with a blood vessel discrimination device that determines whether the puncture device has punctured the target blood vessel based on the characteristics of backflow blood detected by the backflow detection unit. In this case, the control unit 30 can control the puncture drive unit 21 according to the determination result of the blood vessel discrimination device as to whether the puncture device has punctured the target blood vessel. [Explanation of symbols]

[0081] 10 Vascular Puncture Device 20 Probe body 21 Puncture drive unit 21a Fixed part 22 Imaging unit 23 Notification Department 30 Control Unit 32 Transmitter 34 Receiving unit 35 Backflow detection unit 40 Main body 41 Lancing Device 60 Inner needle 61 Outer cylinder 62 Hub 62a Insertion part 70 Guidewire drive device 71 Guide wire drive unit 72 Guidewire insertion site 73 Connecting part 80 Guidewire 81 Holder tube 100 blood vessels 110 Center of gravity position H wrist

Claims

1. a puncture driving unit that punctures the puncture device into a living body; a backflow detection unit that detects characteristics of backflow blood flowing from a blood vessel to a proximal end side of the puncture device; A blood vessel puncture device having a control unit that determines whether the puncture device has punctured the target blood vessel based on the characteristics of the backflow blood detected by the backflow blood detection unit, and drives the puncture drive unit and controls the position of the puncture device based on the determination result.

2. 2. The blood vessel puncture device according to claim 1, wherein the characteristics of the backflow blood detected by the backflow detection unit are one or more of the amount of backflow blood, the speed of backflow blood, and the color of backflow blood.

3. a probe body including an imaging unit for acquiring a cross-sectional image of the human body; The vascular puncture device described in claim 1, wherein when the control unit determines that the puncture device has not punctured the target blood vessel based on the characteristics of the backflow blood detected by the backflow blood detection unit, it determines whether or not the blood vessel punctured by the puncture device is pulsating in the cross-sectional image acquired by the imaging unit, and determines whether or not the puncture device has punctured the target blood vessel based on the presence or absence of pulsation in the blood vessel.

4. a probe body including an imaging unit for acquiring a cross-sectional image of the human body; The vascular puncture device of claim 1, wherein when the control unit determines that the puncture device has not punctured the target blood vessel based on the characteristics of the backflow detected by the backflow detection unit, it determines the direction of blood flow in the blood vessel that has been punctured by the puncture device in the cross-sectional image acquired by the imaging unit, and determines whether the puncture device has punctured the target blood vessel based on the direction of blood flow in the blood vessel.

5. The characteristic of the backflow blood detected by the backflow blood detection unit is backflow color, The vascular puncture device described in claim 1, wherein the control unit compares the reverse blood color detected by the reverse blood detection unit with a color threshold corrected to eliminate the effects of ambient light to determine whether the puncture device has punctured the target blood vessel.

6. The vascular puncture device described in claim 1, wherein the control unit compares the characteristics of the backflow blood detected by the backflow detection unit with a threshold value based on the characteristics of the backflow blood from the artery to determine whether the puncture device has punctured the target blood vessel.

7. The vascular puncture device described in claim 1, wherein the control unit compares the characteristics of the backflow blood detected by the backflow detection unit with a threshold value based on the characteristics of the backflow blood from a vein to determine whether the puncture device has punctured the target blood vessel.

8. a probe body including an imaging unit for acquiring a cross-sectional image of the human body; The control unit calculating puncture parameters of the puncture device for one blood vessel as a target blood vessel based on the cross-sectional image acquired by the imaging unit; inserting the puncture device based on the calculated puncture parameters; A vascular puncture device as described in claim 1, wherein if it is determined based on the characteristics of backflow blood detected by the backflow detection unit that the puncture device has not punctured the target blood vessel, the puncture parameters of the puncture device are calculated using a blood vessel other than the target blood vessel as a new target blood vessel.

9. Further, a notification unit controlled by the control unit is included. A vascular puncture device as described in any one of claims 1 to 8, wherein the control unit notifies the notification unit when it determines, based on the characteristics of the backflow blood detected by the backflow detection unit, that the puncture device has not punctured the target blood vessel.

10. a backflow detection unit for detecting characteristics of backflow blood flowing from the blood vessel at the proximal end of the puncture device that is punctured into the blood vessel; A blood vessel determination device that determines whether the puncture device has punctured a target blood vessel based on the characteristics of the backflow blood detected by the backflow detection unit.

11. The blood vessel determination device according to claim 10, wherein the characteristics of the backflow detected by the backflow detection unit are one or more of the amount of backflow, the speed of backflow, and the color of backflow.

Images