Hemostatic compression device and hemostatic compression belt

Abstract

The present disclosure provides a hemostatic compression device and a hemostatic compression belt that can be used to perform hemostasis again while checking whether or not hemostasis has been completed at a hemostasis site.　A hemostatic compression device according to the present disclosure comprises: an arm capable of holding a compression member; a switching device capable of switching between the two states, namely a fixed state in which the arm is fixed and the position of the compression member is fixed, and an allowed state in which the fixation of the arm is released and the position of the compression member is allowed to change; and a compression force changing device that changes the compression force with which a hemostasis site is compressed by the compression member.

Description

Compression tourniquet device and compression tourniquet belt

[0001] The present disclosure relates to a compression hemostasis device and a compression hemostasis belt for performing compression hemostasis.

[0002] In conventional surgery in which an instrument is inserted into a blood vessel, such as in intravascular treatment using a catheter, hemostasis is performed after the instrument is removed from the blood vessel after the surgery. Patent Document 1 listed below describes a compression hemostasis attachment that uses an ultrasonic probe to perform compression hemostasis.

[0003] Japanese Patent Application Laid-Open No. 2023-104407

[0004] After stopping the bleeding, it is necessary to check whether the bleeding has been stopped properly. The task of applying pressure to stop the bleeding can take several tens of minutes, and if the bleeding has not been stopped after checking, the area to be stopped must be compressed again. However, the above-mentioned Patent Document 1 does not specifically describe how to check whether the bleeding has been stopped properly after applying pressure to stop the bleeding.

[0005] The present disclosure has been made in consideration of such circumstances, and aims to provide a compression hemostatic device and a compression hemostatic belt that can perform hemostasis again while checking whether hemostasis at the hemostasis site has been completed.

[0006] This specification discloses a compression hemostasis device comprising an arm capable of holding a compression member, a switching device capable of switching between two states: a fixed state in which the arm is fixed and the position of the compression member is fixed, and an allowable state in which the arm is released and the position of the compression member is allowed to be changed, and a compression force changing device that changes the compression force applied by the compression member to the hemostasis area.

[0007] This specification also discloses a compression hemostatic belt comprising a belt that can be wrapped around a human body, a holding member that can hold a compression member against the belt, and a compression force changing device that changes the compression force applied to the hemostasis area by the compression member held by the holding member.

[0008] According to the compression hemostatic device and compression hemostatic belt of the present disclosure, it is possible to perform hemostasis again while checking whether hemostasis at the hemostasis location has been completed.

[0009] A perspective view showing an ultrasonic probe attached to a compression hemostasis device according to the first embodiment. A block diagram of a compression hemostasis device according to the first embodiment. A side view showing an enlarged view of the tip of an arm according to the first embodiment. A schematic view showing the state in which hemostasis is being performed according to the first embodiment. A block diagram of a compression hemostasis device according to the second embodiment. A perspective view showing a probe attached to a compression hemostasis device according to the third embodiment. A perspective view showing a compression hemostasis device and an ultrasonic device according to the fourth embodiment. A side view of the up and down mechanism etc. of a compression hemostasis belt according to the fifth embodiment. A schematic view showing the state in which hemostasis is being performed according to the fifth embodiment.

[0010] First Embodiment A first embodiment of a compression hemostasis device according to the present disclosure will now be described with reference to the drawings. Fig. 1 is a perspective view of a compression hemostasis device 10 of this embodiment, showing an ultrasonic probe 101 of an ultrasound device 100 (see Fig. 2) attached thereto. As shown in Fig. 1, the compression hemostasis device 10 of this embodiment includes a main body 21, an arm 22, a vertical movement mechanism 23, a holding member 24, and a switching device 25. As an example, the compression hemostasis device 10 of this embodiment performs hemostasis by contacting the ultrasonic probe 101 with a site on the body where hemostasis is to be performed and compressing the site with the ultrasonic probe 101 (see Fig. 4).

[0011] The main body 21 has, for example, a rectangular box shape. An arm 22 is attached to one end surface of the main body 21 (the top surface 26 in FIG. 1 ). The arm 22 includes, for example, first to third arm portions 31A, 31B, and 31C and first to fourth joint portions 32A, 32B, 32C, and 32D. Each of the first to third arm portions 31A to 31C has, for example, a round rod shape that is long in one direction. The base end of the first arm portion 31A is connected to the top surface 26 of the main body 21 via the first joint portion 32A. The first arm portion 31A is rotatably attached to the main body 21. For example, the first arm portion 31A is rotatable about a rotation axis that is perpendicular to the top surface 26, as indicated by the arrow in FIG. 1 .

[0012] The second arm 31B is rotatably attached to the tip of the first arm 31A via the second joint 32B. For example, as shown by the arrow in FIG. 1, the second arm 31B is rotatably attached starting from the tip of the first arm 31A. Similarly, the third arm 31C is rotatably attached to the tip of the second arm 31B via the third joint 32C. The vertical movement mechanism 23 is rotatably attached to the tip of the third arm 31C via the fourth joint 32D. The ultrasound probe 101 is attached to the vertical movement mechanism 23 via a holding member 24 and is attached to the tip of the arm 22. Note that the number of joints and arm portions of the arm 22 shown in FIG. 2 are merely examples. The first to fourth joints 32A to 32D may be configured to rotate about multiple axes.

[0013] The switching device 25 has first to fourth switching units 33A, 33B, 33C, and 33D. The first to fourth switching units 33A to 33D are provided in the first to fourth joint units 32A to 32D, respectively. The first switching unit 33A includes, for example, a screw threaded into the main body unit 21 and a portion of the first arm unit 31A, and a handle for turning the screw. When the handle is turned and the screw is threaded into the main body unit 21, etc., the rotational position of the first arm unit 31A relative to the main body unit 21 is fixed. When the handle is turned and the screw is loosened from the main body unit 21, etc., the first switching unit 33A allows the first arm unit 31A to rotate relative to the main body unit 21. The second to fourth switching units 33B to 33D have the same configuration as the first switching unit 33A and are provided in the second to fourth joint units 32B to 32D, respectively.

[0014] The switching device 25 can be switched between two states: a fixed state in which the position of the ultrasonic probe 101 is fixed, and an allowable state in which the position of the ultrasonic probe 101 is allowed to be changed. The fixed state is, for example, a state in which all of the screws of the first to fourth switching units 33A to 33D are tightened to fix the first to third arm units 31A to 31C, thereby fixing the position of the ultrasonic probe 101. The allowable state is, for example, a state in which the screw of at least one switching unit among the first to fourth switching units 33A to 33D is loosened to release the fixation of any of the first to third arm units 31A to 31C, thereby allowing the position of the ultrasonic probe 101 to be changed. Therefore, an operator such as a doctor or technician operating the ultrasound device 100 or the ultrasonic probe 101 can change the position or posture of the ultrasonic probe 101 by operating the switching device 25 to the allowable state. Therefore, the main body 21 of this embodiment is a flexible arm that bends when an external force is applied in the permissible state, and the position at which the ultrasonic probe 101 is held can be changed.

[0015] As shown in FIG. 2 , the main body 21 includes a control board 41, an amplifier 43, an operation unit 44, and an alarm unit 45. The control board 41, amplifier 43, operation unit 44, and alarm unit 45 can communicate with each other via a communication line 46. The communication line 46 is, for example, a communication bus or a signal line. The control board 41 is a processing board equipped with a CPU and memory, and the CPU executes a control program stored in the memory to comprehensively control the compression hemostasis device 10. The memory equipped on the control board 41 may be, for example, a RAM, a ROM, a flash memory, or the like. The control board 41 may also be configured to include other memory such as an EEPROM. The main body 21 may also be configured to include other storage devices such as an HDD or SSD.

[0016] The ultrasound device 100 also includes an ultrasound probe 101 and an ultrasound device main unit 103 connected to the ultrasound probe 101 via a cable 102. The ultrasound device main unit 103 comprehensively controls the ultrasound device 100 and processes signals received from the ultrasound probe 101 to generate an ultrasound echo image (hereinafter, sometimes simply referred to as an echo image). The ultrasound device main unit 103 also includes a display device 104 that displays the echo image and various operation switches 105. The ultrasound probe 101 may be a one-dimensional linear type or convex type, or may also include probes of other shapes such as two-dimensional or three-dimensional multidimensional probes and H-type probes. The ultrasound probe 101 and the ultrasound device 100 may also be connected wirelessly.

[0017] The display device 104 may be, for example, a color liquid crystal display, a color LED display, a color plasma display, or the like. After performing hemostasis using the hemostasis device 10, the surgeon checks whether hemostasis is complete by checking the display on the display device 104 or visually inspecting the hemostasis site. For example, the ultrasound device 100 emits ultrasound waves from the ultrasound probe 101 and receives reflected waves from the human body based on the surgeon's operation. The ultrasound device 100 processes the reflected wave signals acquired by the ultrasound probe 101 and displays an echo image on the display device 104. The ultrasound device 100 has various modes for displaying echo images, such as a B-mode that displays an echo image in grayscale and a color Doppler mode that displays a B-mode grayscale image with color blood flow superimposed on it. The surgeon uses each mode to check the blood vessel shape, blood flow status, and the like on the echo image on the display device 104 during and after hemostasis. The display device 104 may also be a monochrome display. In this case, the ultrasound device 100 does not need to be equipped with a color Doppler mode.

[0018] The compression hemostasis device 10 can also be used as an ultrasonic echo guide during surgery, such as catheter surgery. The surgeon operating the catheter guidewire recognizes the positional relationship between the tip of the guidewire and the blood vessel from the echo image obtained by pressing the ultrasonic probe 101 against the body surface of the patient. The surgeon can accurately pass the guidewire through the center of the occlusion or stenosis of the blood vessel by operating the switching device 25 to change the position and orientation of the ultrasonic probe 101 while advancing the guidewire. The surgeon can also use the compression hemostasis device 10 to compress the hemostasis site with the ultrasonic probe 101 after removing the catheter or other device from the body after surgery. The hemostasis site is, for example, the site where pressure is applied from the skin surface to a hole formed in the blood vessel wall by puncture.

[0019] 2 and 3 , the vertical movement mechanism 23 is a device that changes the compression force applied to the hemostasis site by the ultrasonic probe 101 by moving the holding member 24. The vertical movement mechanism 23 includes a base 50 and a ball screw mechanism 51. The base 50 has, for example, a thin box shape. The ball screw mechanism 51 is provided within the base 50. The ball screw mechanism 51 includes a motor 52, a screw shaft 53, and a slider 54.

[0020] The motor 52 is connected to the amplifier 43 of the main body 21 via a cable 47. The cable 47 includes, for example, a power line for supplying power to the motor 52 and a communication line for communicating with an encoder attached to the motor 52, and is disposed within the arm 22. The motor 52 is, for example, a servo motor. Note that the motor 52 is not limited to a servo motor and may be other types of motors such as a stepping motor. The amplifier 43 is, for example, a servo amplifier, and supplies power to the windings of the motor 52 via the cable 47. The control board 41 controls the amplifier 43 based on encoder information from the encoder attached to the motor 52, and changes the magnitude of the current supplied to the motor 52, thereby performing feedback control of the motor 52. The rotation speed and direction of the motor 52 are changed based on the control of the control board 41.

[0021] The screw shaft 53 is connected to the output shaft of the motor 52 and rotates in response to the rotation of the motor 52. The slider 54 is attached to a nut threaded onto the screw shaft 53 and moves in a sliding direction 55 shown in FIG. 3 in response to the rotation of the screw shaft 53. The holding member 24 is fixed to the slider 54 and moves in the sliding direction 55 as the slider 54 moves. Therefore, the control board 41 controls the rotation of the motor 52 of the ball screw mechanism 51 to move the ultrasonic probe 101 attached to the holding member 24 in the sliding direction 55. By controlling the rotation of the motor 52, the control board 41 can change the compression force applied to the hemostasis site by the ultrasonic probe 101.

[0022] In this embodiment, the ultrasonic probe 101 is used as the compression member of the present disclosure. However, the compression member of the present disclosure may be a member other than the ultrasonic probe 101. For example, it may be a member having the same shape and size as the ultrasonic probe 101. Specifically, it may be a resin member, a metal member, or a wooden member having the same shape as the ultrasonic probe 101. It may also be a member that can be sterilized at high temperatures, such as a heat-resistant resin member.

[0023] The ball screw mechanism 51 is an example of a compressive force changing device of the present disclosure. However, the compressive force changing device is not limited to the ball screw mechanism 51. As in a second embodiment described below, the compressive force changing device may be, for example, a fluid pressure cylinder 81. The compressive force changing device may also be a device that converts the rotational force of a motor into linear motion using a gear and a rack (linear gear). Therefore, the compressive force changing device of the present disclosure can employ various configurations that can change the compressive force applied to the hemostasis site by a compressing member.

[0024] 1 and 3, i.e., the direction in which the ultrasonic probe 101, which is the compression member, is moved, is one example. The direction in which the ultrasonic probe 101 is moved can be changed by changing the attitude or angle of the base 50. Therefore, although the name "up-down mechanism 23" is used for convenience of explanation, the direction in which the up-down mechanism 23 moves the ultrasonic probe 101 is not limited to a direction perpendicular to the installation surface of the compression hemostasis device 10 (up-down direction). The direction in which the ultrasonic probe 101 is moved may also be a direction forming a predetermined angle with respect to the up-down direction.

[0025] The holding member 24 has a pair of support walls 57 and a clamping portion 58. The pair of support walls 57 are attached, for example, to both sides of the slider 54 (only the front support wall 57 is shown in FIG. 3 ) and support the ultrasonic probe 101 from both sides. The clamping portion 58 spans from one of the pair of support walls 57 to the other support wall 57 and holds the ultrasonic probe 101 by pressing it against the slider 54 of the up-down mechanism 23. The holding member 24 holds the ultrasonic probe 101 so that it is parallel to the sliding direction 55 of the slider 54, for example. One side of the clamping portion 58 is rotatably attached to one of the support walls 57 via a hinge, and the other side on the opposite side is detachably fixed to the other support wall 57 by a fastener (for example, a snap lock). Therefore, the clamping portion 58 can be opened and closed relative to the pair of support walls 57, and can be switched between a closed state in which the ultrasonic probe 101 is held and an open state in which the ultrasonic probe 101 can be removed. This allows the holding member 24 to be attached in either orientation, for example, by turning the linear ultrasonic probe 101 upside down.

[0026] The above-described configuration of the holding member 24 is an example. For example, the holding member 24 may be configured to fix the ultrasonic probe 101 to the slider 54 of the up-down mechanism 23 using a ratchet-type fixture or a cable tie. Alternatively, the holding member 24 may be configured to fix the ultrasonic probe 101 to the slider 54 using a screw or a bolt. Furthermore, the holding member 24 may be configured to engage with a recess or a protrusion provided on the ultrasonic probe 101, or may be configured to insert the ultrasonic probe 101, for example.

[0027] During surgery or post-surgical hemostasis, the ultrasound device 100 and the compression hemostasis device 10, including the ultrasound probe 101, are required to be covered with a sterilized cover. That is, the parts used in a so-called clean area must be covered with a sterilized cover, and the device must be attached while maintaining a sterile state. For example, the compression hemostasis device 10 is covered with a cover (not shown) that covers the holding member 24, the lifting mechanism 23, the arm 22, and the main body 21. As shown in FIG. 3 , the ultrasound probe 101 is attached to the holding member 24 while covered with a sterilized cover 59. For example, the surgeon applies ultrasound gel over the cover 59 and presses the ultrasound probe 101 against the patient's body via the cover 59 and the gel. To avoid cluttering the drawing, FIG. 3 only illustrates the cover 59 of the ultrasound probe 101, omitting the cover that covers the compression hemostasis device 10.

[0028] Therefore, for example, the surgeon covers the compression hemostasis device 10 with a sterilized cover, and then attaches the ultrasonic probe 101, which is covered with another cover 59, to the holding member 24 for use. The holding member 24 of this embodiment is configured to clamp the ultrasonic probe 101 from the sides. Specifically, the ultrasonic probe 101 has, for example, a gripping portion 101A that the surgeon holds and an emitting portion 101B that emits ultrasonic waves. The gripping portion 101A is formed to a size that can be held by the surgeon. A cable 102 is connected to the proximal end of the gripping portion 101A. The emitting portion 101B is provided at the tip of the gripping portion 101A, and an ultrasonic emitting surface 101C that emits ultrasonic waves is provided on the tip surface (the lower surface in FIG. 3 ).

[0029] A plurality of ultrasonic vibrators (not shown) are arranged in an array inside the emitting unit 101B. The ultrasonic emitting surface 101C has, for example, a substantially rectangular shape in a plan view. The plurality of ultrasonic vibrators are arranged in a row along the longitudinal direction of the ultrasonic emitting surface 101C. The holding member 24 sandwiches the gripping portion 101A with the emitting unit 101B and the ultrasonic emitting surface 101C protruding from one side in the sliding direction 55 (the lower side in FIG. 3 ). The ultrasonic probe 101 is held by being supported from the side by the holding member 24.

[0030] This configuration allows the ultrasonic probe 101, covered with the cover 59, to be attached relatively easily to the holding member 24 and the lifting mechanism 23, which are covered with another sterilized cover. By switching the opening and closing state of the holding member 24, the ultrasonic probe 101, covered with the cover 59, is placed inside the holding member 24, and the clamping portion 58 is closed to attach the ultrasonic probe 101 to the holding member 24. This reduces the burden of the attachment process and allows attachment while maintaining a sterile state. Furthermore, by attaching the ultrasonic probe 101 to the holding member 24 so that the sliding direction 55 and the ultrasonic emitting surface 101C are perpendicular to each other, compressive force can be efficiently transmitted from the ultrasonic emitting surface 101C to the hemostasis site in accordance with the sliding movement of the slider 54. The holding member 24 may be provided with a mark or recess indicating the attachment position and direction of the ultrasonic probe 101.

[0031] 1 , the operation unit 44 has a compression button 61, a compression release button 62, a registration button 63, a movement button 64, a start button 65, an increase / decrease button 66, and a time display unit 67. The control board 41 moves the ultrasonic probe 101 in a direction to press the bleeding site based on the operation of the compression button 61. Specifically, in the state shown in FIG. 3 , when the compression button 61 is pressed, the control board 41 rotates the motor 52, moves the slider 54 downward, and moves the ultrasonic probe 101 in the sliding direction 55 toward the ultrasound emission surface 101C (hereinafter, sometimes referred to as the compression side). The control board 41 also moves the ultrasonic probe 101 in a direction away from the bleeding site based on the operation of the compression release button 62. 3, when the compression release button 62 is pressed, the control board 41 rotates the motor 52 in the opposite direction, moves the slider 54 upward, and moves the ultrasound probe 101 in the sliding direction 55 toward the base end side (hereinafter, sometimes referred to as the release side) connected to the cable 102. As shown in FIG. 1, the compression button 61 and the compression release button 62 are provided with triangular marks that indicate the direction of movement when each button is pressed when the ultrasound probe 101 is pointed downward (toward the patient).

[0032] For example, the control board 41 moves the ultrasonic probe 101 toward the compression side while the compression button 61 is pressed (while being pressed and held), and moves the ultrasonic probe 101 toward the release side while the compression release button 62 is pressed. Furthermore, the control board 41 moves the ultrasonic probe 101 toward the compression side by a predetermined distance (e.g., several millimeters) when the compression button 61 is pressed once, and moves the ultrasonic probe 101 toward the release side by the same distance when the compression release button 62 is pressed once. This allows the surgeon to release the compression by pressing the compression release button 62 a predetermined number of times, confirm that hemostasis has been completed, and if hemostasis is not complete, return the ultrasonic probe 101 to its original position by operating the compression button 61 the same number of times. The area where hemostasis is to be recompressed under the same conditions can be compressed again. The control board 41 may also notify the operator that the compression button 61 or the compression release button 62 has been pressed once via the notification unit 45. This may be used to notify the operator that the compression button 61 or the compression release button 62 has been pressed once. The control board 41 may also accept a change in the amount of movement. The control board 41 may also be configured to accept only one of the long press operation and the single press operation.

[0033] The control board 41 also stores the position of the ultrasonic probe 101 (slider 54) in the slide direction 55 based on the operation of the registration button 63. For example, when the registration button 63 is pressed, the control board 41 detects the position of the slider 54 at the time the registration button 63 is pressed based on information from an encoder attached to the motor 52, and stores the detected position information in memory. The control board 41 also moves the ultrasonic probe 101 to the position stored based on the operation of the registration button 63 based on the operation of the movement button 64. When the movement button 64 is pressed, the control board 41 moves the slider 54 to the stored slide position based on the position information stored in memory. This allows the ultrasonic probe 101 to be placed at the registered position with a simple button operation.

[0034] For example, the surgeon operates the compression button 61 to place the ultrasonic probe 101 at a predetermined compression position, and then operates the registration button 63 to register the position. After a predetermined time has passed, the surgeon operates the compression release button 62 to release the compression and check whether compression hemostasis has been completed. If hemostasis has not been completed, the surgeon can operate the movement button 64 to return the ultrasonic probe 101 to the original compression position and apply compression to the hemostasis area again under the same conditions.

[0035] The start button 65 is a button that starts measuring the compression time. The alarm unit 45 is, for example, a speaker, and is attached to the side surface of the main body 21. The control board 41 can make the alarm unit 45 emit a predetermined alarm sound. The control board 41 starts measuring the compression time based on the operation of the start button 65, and makes the alarm unit 45 emit an alarm sound based on the fact that the measured compression time has reached a preset time.

[0036] The increase / decrease buttons 66 and the time display unit 67 are a user interface for setting the set time. The increase / decrease buttons 66 include, for example, an up arrow button and a down arrow button. The time display unit 67 is a display screen that digitally displays the set time in minutes. In the example of FIG. 1 , the set time is set to 12 minutes. When the up arrow button of the increase / decrease buttons 66 is pressed once, the control board 41 increases the set time displayed on the time display unit 67 by, for example, one minute. Similarly, when the down arrow button of the increase / decrease buttons 66 is pressed once, the control board 41 decreases the set time displayed on the time display unit 67 by, for example, one minute. The control board 41 sets the time (minutes) displayed on the time display unit 67 at the time the start button 65 is operated as the set time, and issues an alarm sound from the alarm unit 45 when the set time has elapsed. This allows the user to confirm the duration of compression hemostasis by the alarm sound.

[0037] The main body 21 is also provided with a clamp 68. The clamp 68 is attached, for example, to the surface of the main body 21 that is opposite in the thickness direction to the surface on which the operation unit 44 is provided. Fig. 4 shows the compression hemostatic device 10 attached to a bed rail 73 of an operating table 72 on which a patient 71 is lying. Note that Fig. 4 does not show a sterilized cover such as the cover 59 or the ultrasonic device 100.

[0038] The bed rail 73 is, for example, a metal plate-like member attached to the side of the operating table 72 and extending in the longitudinal direction of the operating table 72. The clamp 68 includes, for example, a metal member that clamps the bed rail 73 from above and a screw member that is screwed into the metal member. The surgeon can fix the compression hemostatic device 10 to the bed rail 73 by screwing the screw member while the bed rail 73 is clamped between the metal members of the clamp 68. Therefore, the clamp 68 detachably fixes the main body 21 to the bed rail 73 by operating the screw member.

[0039] The above-described configuration of the main body 21 is merely an example. For example, the operation unit 44 may be configured without at least one of the register button 63, the move button 64, the start button 65, the increase / decrease button 66, and the time display unit 67. The control board 41 may also be configured such that the set time for issuing an alarm cannot be changed. Furthermore, the operation units, such as the compression button 61, the compression release button 62, and the registration button 63, do not have to be buttons. For example, each operation unit may be a slide switch or a rotary switch. The compression hemostasis device 10 may also be provided with a touch panel as a user interface.

[0040] The clamp 68 is not limited to the above configuration and may be a belt that is wrapped around the bed rail 73 to secure the main body 21. The main body 21 may not have the clamp 68. The compression hemostatic device 10 may be secured to a member other than the bed rail 73. The compression hemostatic device 10 may be placed on a medical cart, for example. The compression hemostatic device 10 may have legs and be self-supporting.

[0041] (Regarding Compression Hemostasis) Next, an example of a method for performing compression hemostasis using the compression hemostasis device 10 will be described. The compression hemostasis device 10 can perform compression hemostasis with the ultrasonic probe 101 in contact with the body of the patient 71. In the following explanation, as an example, using Figure 4, a case will be described in which, after catheter surgery on the thigh, the catheter is removed and hemostasis is performed at a hemostasis location 75 using the ultrasonic probe 101.

[0042] For example, before starting catheter surgery, the surgeon fixes the compression hemostasis device 10 to the bed rail 73. During catheter surgery, the surgeon uses the compression hemostasis device 10 as an ultrasonic echo guide. The surgeon changes the position of the ultrasonic probe 101 by switching the switching device 25 between the fixed state and the open state, and performs monitoring using the ultrasonic device 100. While checking the echo image, the surgeon inserts a sheath introducer, inserts a catheter guide wire, and performs treatment.

[0043] After the catheterization procedure is completed, the surgeon removes the guidewire from the patient's body 71. The surgeon applies pressure to the hemostasis site 75 with their hand while removing the sheath introducer inserted into the puncture site. The surgeon sets the switching device 25 to the allowable state, moves the ultrasonic probe 101, and while pressing the ultrasonic probe 101 against the hemostasis site 75, swaps the ultrasonic probe 101 with their hand that is stopping the bleeding. The surgeon sets the switching device 25 to the fixed state, and fixes the position of the ultrasonic probe 101. For example, the surgeon positions and fixes the ultrasonic probe 101 so that the sliding direction 55 is perpendicular to the skin surface of the hemostasis site 75. Note that the swapping of the hand and ultrasonic probe 101 and the switching of the switching device 25 may be performed by a different surgeon.

[0044] The surgeon operates the compression button 61 and the compression release button 62 while checking the echo image. By operating the compression button 61 and the compression release button 62, the surgeon can adjust the relative position of the ultrasonic probe 101 with respect to the hemostasis site 75 in the sliding direction 55, i.e., the compression position. The surgeon determines the compression position at which the ultrasonic probe 101 compresses the hemostasis site 75. For example, the surgeon sets the ultrasound device 100 to color Doppler mode, displays an echo image of the hemostasis site 75, and checks the state of the blood vessel and blood flow at the puncture site where the catheter was inserted. For example, the surgeon operates the compression button 61 to move the ultrasonic probe 101 toward the compression side until the blood vessel is compressed and blood flow is completely stopped, thereby stopping the hemostasis at the hemostasis site 75. Alternatively, the surgeon may check for blood leakage from the skin surface or blood vessel at the puncture site, and then fix the ultrasonic probe 101 at a compression position that ensures a certain level of blood flow to stop the hemostasis.

[0045] After placing the ultrasound probe 101 at the compression position, the surgeon operates the registration button 63 to register the compression position. While the surgeon is using the compression hemostasis device 10 to perform compression hemostasis at the hemostasis point 75, the surgeon can monitor the state of blood flow and the like using the ultrasound device 100. Furthermore, by performing compression hemostasis using the compression hemostasis device 10, the surgeon can perform tasks other than hemostasis. The surgeon can check the condition of the patient 71, check other medical equipment, retrieve medical instruments, and the like.

[0046] The surgeon also operates the start button 65 to start measuring the compression time in time with the start of hemostasis. The control board 41 then causes the alarm unit 45 to sound an alarm when the compression time reaches a preset time (e.g., 12 minutes) set in the time display unit 67. The alarm allows the surgeon to know that the compression time has elapsed, even while performing tasks other than hemostasis. The required compression time varies depending on factors such as the diameter of the catheter used, but may last from several minutes to several tens of minutes. Therefore, while automatic hemostasis using the compression hemostasis device 10 can ensure several tens of minutes of work time, managing the compression time is important. By sounding the alarm, the surgeon can more reliably be informed of the elapsed compression time, even while performing other tasks.

[0047] For example, after an alarm sounds, the surgeon operates the pressure release button 62 to release the pressure applied by the ultrasonic probe 101. The surgeon confirms whether hemostasis has been achieved by using an echo image in color Doppler mode on the ultrasound device 100. The surgeon confirms the blood flow at the puncture site from the blood vessel to the skin surface and the blood flow on the skin surface to confirm whether hemostasis has been achieved. Alternatively, the surgeon may remove the ultrasonic probe 101 from the hemostasis site 75 and visually confirm the completion of hemostasis. The surgeon may also confirm the completion of hemostasis by using an echo image or the like before the alarm sounds.

[0048] If the surgeon has not yet completed hemostasis, he can return the ultrasonic probe 101 to the original compression position by pressing the movement button 64. Hemostasis can be achieved by applying pressure in the same state as before the confirmation. In this way, the surgeon can perform appropriate hemostasis while performing other tasks.

[0049] The above-described method of using the compression hemostasis device 10 is merely an example. For example, if a member other than the ultrasonic probe 101 (such as a resin member having the same shape as the ultrasonic probe 101) is used as the compression member, the surgeon may apply the ultrasonic probe 101 to the side of the hemostasis site 75 while applying or releasing pressure with the member, and confirm the completion of hemostasis.

[0050] Therefore, as described above, the compression hemostasis device 10 of this embodiment can change the compression force applied to the hemostasis site 75 by the ultrasonic probe 101 by driving the up-down mechanism 23 while remaining in the fixed state switched by the switching device 25. This makes it possible to change the compression force by a constant amount without changing the position of the ultrasonic probe 101, making it easier to adjust the compression force.

[0051] Furthermore, the arm 22 is a flexible arm that bends when an external force is applied in the permissive state, thereby changing the position at which the ultrasonic probe 101 is held. In the fixed state, the switching device 25 fixes the position of the bent arm 22. This allows the arm 22 to be manually operated to press the ultrasonic probe 101 against the hemostasis site 75 in a desired position or orientation (e.g., vertical position).

[0052] Furthermore, the up-down mechanism 23 can slide the holding member 24 along the sliding direction 55, and by moving the holding member 24 in a direction toward or away from the hemostasis area 75, the compressive force of the ultrasonic probe 101 can be changed. For example, by positioning the up-down mechanism 23 so that the sliding direction 55 is perpendicular to the skin surface of the hemostasis area 75, the ultrasonic probe 101 can compress the hemostasis area 75 perpendicularly. The compressive force of the ultrasonic probe 101 can be efficiently transmitted to the hemostasis area 75.

[0053] The holding member 24 also has a clamping portion 58 that holds the ultrasonic probe 101 by clamping it from the side. The clamping portion 58 holds the ultrasonic probe 101 by clamping it from above the cover 59. This allows the ultrasonic probe 101 to be brought into contact with the human body via the sterilized cover 59. When the ultrasonic probe 101 is placed against the human body via an ultrasonically transparent member, as in the configuration of the prior art document (JP 2023-104407 A), it is difficult to keep the ultrasonic probe 101 in a clean area. Furthermore, if the ultrasonic probe 101 is covered with a sterile cover and then placed against the ultrasonically transparent member, the ultrasonic waves radiated from the ultrasonic emitting surface may be affected by passing through multiple members and the spaces between those members. In contrast, with the configuration of this embodiment, the ultrasonic probe 101 can be held from the side and pressed against the human body via the cover 59 or ultrasound testing gel. An echo image can be appropriately acquired using ultrasonic waves.

[0054] The control board 41 also controls the up / down mechanism 23 based on operations on the operation unit 44. When the compression button 61 is pressed, the control board 41 moves the holding member 24 in a direction to press the hemostasis site 75, and when the compression release button 62 is pressed, the control board 41 moves the holding member 24 in a direction away from the hemostasis site 75. This allows the surgeon to adjust the compression force by operating the compression button 61 and the compression release button 62. When the registration button 63 is pressed, the control board 41 memorizes the position of the holding member 24 in the sliding direction 55. When the movement button 64 is pressed, the control board 41 moves the holding member 24 to the memorized position. This allows the surgeon to position the ultrasound probe 101 at an appropriate position as a compression position and register that position by operating the registration button 63. After confirming that hemostasis is complete by operating the compression release button 62 to release the compression force, the surgeon can return the ultrasound probe 101 to its original registered position if further compression is required by operating the movement button 64.

[0055] The clamp 68 detachably fixes the main body 21 to a bed rail 73 attached to the operating table 72. With the main body 21 fixed to the bed rail 73 by the clamp 68, the compression hemostatic device 10 holds the arm 22 with the main body 21, and applies pressure to the hemostasis area 75 of the patient 71 lying on the operating table 72 with the ultrasonic probe 101. This allows the compression hemostatic device 10 to be used while fixed to the bed rail 73. The ultrasonic probe 101 can stably apply pressure to the hemostasis area 75. By detaching the main body 21 from the bed rail 73, the compression hemostatic device 10 can be attached to another operating table 72 and used.

[0056] Furthermore, the control board 41 starts measuring the compression time when the start button 65 is operated, and issues an alarm via the notification unit 45 when the measured compression time reaches a preset time. This allows the compression time to be measured and managed. If the worker is performing a task other than stopping bleeding, the alarm will alert the worker that the compression time has reached the preset time.

[0057] Incidentally, the relationship between the contents of the present disclosure and the terminology of the first embodiment is as follows: The up / down mechanism 23 is an example of a compression force changing device of the present disclosure. The control board 41 is an example of a control device. The compression button 61 is an example of a compression operation unit. The compression release button 62 is an example of a compression release operation unit. The registration button 63 is an example of a memory operation unit. The move button 64 is an example of a move operation unit. The start button 65 is an example of a start operation unit. The ultrasound probe 101 is an example of a compression member or a probe.

[0058] The first embodiment described above provides the following advantages. The switching device 25 of one aspect of the first embodiment can be switched by the first to fourth switching units 33A to 33D between two states: a fixed state in which the arm 22 is fixed and the position of the ultrasonic probe 101 is fixed, and an allowable state in which the arm 22 is released and the position of the ultrasonic probe 101 is allowed to be changed. The up / down mechanism 23 changes the compression force with which the ultrasonic probe 101 compresses the hemostasis site 75.

[0059] This allows a surgeon, such as a doctor or technician, to operate the switching device 25 to set it to the allowable state and position the ultrasonic probe 101 held by the arm 22 at any desired hemostasis site 75. Alternatively, the surgeon can operate the switching device 25 to set it to the fixed state and position and fix the ultrasonic probe 101 at the hemostasis site 75. The surgeon can also operate the up-down mechanism 23 to change the compression force, allowing the surgeon to compress the hemostasis site 75 with the ultrasonic probe 101. By using the compression hemostasis device 10 to stop bleeding, the surgeon can perform tasks other than hemostasis in parallel. This also relieves the surgeon from the heavy labor of hemostasis. After stopping bleeding for a predetermined compression time, the surgeon can operate the up-down mechanism 23 to reduce the compression force and check the blood flow to confirm whether hemostasis is complete. If hemostasis is not complete, the surgeon can operate the up-down mechanism 23 to increase the compression force again and compress the hemostasis site 75 with the ultrasonic probe 101 again to stop the bleeding.

[0060] Second Embodiment Next, a second embodiment of the present disclosure will be described. FIG. 5 shows a block diagram of a compression-hemostasis device 10A according to the second embodiment. In the first embodiment, a ball screw mechanism 51 was provided as the compression force change device of the present disclosure, but the configuration of the compression force change device is not limited thereto. The compression-hemostasis device 10A according to the second embodiment differs from the first embodiment in that it includes a fluid pressure cylinder 81 as the compression force change device. Furthermore, in the first embodiment, a flexible arm capable of changing its posture and orientation in response to an external force, such as a hand force, was employed as the arm of the present disclosure, but the configuration of the arm is not limited thereto. The compression-hemostasis device 10A according to the second embodiment differs from the first embodiment in that it includes a robot arm (multi-joint robot) as the arm. Furthermore, in the first embodiment, a switching device 25 was provided as the switching device of the present disclosure, which switches between a fixed state and an allowable state by manually operating first to fourth switching units 33A to 33D, but the configuration of the switching device is not limited thereto. The compression hemostasis device 10A of the second embodiment differs from the first embodiment in that it includes, as a switching device, motors 82A, 82B, 82C, and 82D provided at the joints 32A to 32D (see FIG. 1) and brake mechanisms 83A, 83B, 83C, and 83D. In the following description of the second and subsequent embodiments, the same components as those in the first embodiment are designated by the same reference numerals, and their description will be omitted as appropriate.

[0061] As shown in FIG. 5 , the main body 21A of the second embodiment has a fluid supply device 85 that supplies fluid to the fluid pressure cylinder 81. The fluid pressure cylinder 81 is, for example, an air cylinder or a hydraulic cylinder. The fluid supply device 85 is connected to the control board 41 via a communication line 46 and changes the fluid pressure (e.g., air pressure) of the fluid pressure cylinder 81 based on the control of the control board 41. The up-down mechanism 23A of the second embodiment has the fluid pressure cylinder 81, and a slider 54 is connected to the piston of the fluid pressure cylinder 81. As a result, the control board 41 controls the fluid supply device 85 in response to the operation of the compression button 61 (see FIG. 1 ) or the like (see FIG. 1 ), thereby moving the slider 54 and thereby moving the holding member 24 in the sliding direction 55 (see FIG. 3 ). As in the first embodiment, the compression force of the ultrasound probe 101 can be changed.

[0062] Furthermore, the arm 22A of the second embodiment does not include the first to fourth switching units 33A to 33D of the first embodiment in the first to fourth joint units 32A to 32D. The arm 22A has motors 82A, 82B, 82C, and 82D and brake mechanisms 83A, 83B, 83C, and 83D, respectively, in this order, in the first to fourth joint units 32A to 32D. The motors 82A to 82D are, for example, servo motors. The brake mechanisms 83A to 83D are, for example, brake coils that apply brakes to the shafts of the motor 82A, etc. Note that the brake mechanisms 83A, etc. are not limited to brake coils and may be clutch mechanisms that release the connection between the output shafts of the motors 82A to 82D and the connecting units, etc., of the first to third arm units 31A to 31C, thereby cutting off the transmission of power.

[0063] The motors 82A to 82D and the brake mechanisms 83A to 83D are connected to the amplifier 43 via cables 47 and controlled by the control board 41. For example, the motor 82A rotates the first arm 31A relative to the main body 21A. Also, for example, the motor 82D rotates the up-down mechanism 23A relative to the third arm 31C. The operation unit 44 has buttons for moving the tip of the arm 22A (the up-down mechanism 23A) up and down, left and right, and front and back. The control board 41 drives the motors 82A to 82D in response to the operation of these buttons, thereby moving the ultrasonic probe 101 in three axial directions: up and down, left and right, and front and back. The operation unit 44 also has buttons for rotating the up-down mechanism 23A around a predetermined rotation axis. The control board 41 drives the motors 82A to 82D in response to the operation of these buttons, thereby rotating the up-down mechanism 23A and changing the attitude of the ultrasonic probe 101. Furthermore, the control board 41 controls the brake mechanisms 83A to 83D to fix the position and attitude of the arm 22A and the up / down mechanism 23, and can switch between a fixed state in which the position and attitude of the ultrasonic probe 101 are fixed, and an allowable state in which the position, etc. of the ultrasonic probe 101 is allowed to be changed by operating the buttons of the operation unit 44. Note that the configuration of the arm 22C of the fourth embodiment shown in Fig. 7 can also be adopted as the configuration of the arm 22A of the second embodiment.

[0064] The brake mechanisms 83A to 83D of the second embodiment are an example of a switching device of the present disclosure, and the fluid pressure cylinder 81 is an example of a compressing force changing device.

[0065] The second embodiment described above provides the same advantages as the first embodiment. The second embodiment also provides the following advantages. The arm 22A according to one aspect of the second embodiment is a robot arm including first to third arm sections 31A to 31C and motors 82A to 82D that drive the first to third arm sections 31A to 31C and the up-down mechanism 23A relative to joint sections 32A to 32D that connect the first to third arm sections 31A to 31C. The switching device includes brake mechanisms 83A to 83D that fix the rotational positions of the motors 82A to 82D in a fixed state. This allows the position of the ultrasonic probe 101 to be changed in response to an operation on the operation unit 44 by releasing the brakes on the brake mechanisms 83A to 83D and setting them to an allowable state. Furthermore, the position of the ultrasonic probe 101 can be fixed by setting the brakes on the brake mechanisms 83A to 83D.

[0066] Third Embodiment Next, a third embodiment of the present disclosure will be described. FIG. 6 shows a perspective view of a compression hemostasis device 10B of the third embodiment. The arm 22B of the third embodiment is configured by connecting multiple units 91 in the extension direction of the arm 22B. A string 92, such as a wire, is inserted into each of the multiple units 91. The main body 21B of the third embodiment is also provided with a stiffness change device 93 that winds up the string 92. The stiffness change device 93 includes a motor or the like that winds up the string 92, and by changing the amount of winding of the string 92, the tension applied to the string 92 is changed, thereby changing the stiffness of the multiple units 91 (the stiffness of the arm 22B). The structure described in Japanese Patent Publication No. 7058847 can be used as a structure for changing the stiffness of the arm 22B.

[0067] Therefore, the flexible arm of the present disclosure may be an arm 22B whose rigidity can be changed based on the control of the control board 41 (see FIG. 2) of the main body 21B, as shown in FIG. 6 . The main body 21B controls the rigidity change device 93 to change between a fixed state in which the rigidity of the arm 22B is increased to fix the position of the ultrasonic probe 101 and an allowable state in which the rigidity of the arm 22B is decreased to allow the position to be changed. For example, the surgeon can operate the operation unit 44 (see FIG. 2 ) to decrease the tension of the string 92, thereby decreasing the rigidity of the arm 22B and freely changing the position and orientation of the ultrasonic probe 101. Furthermore, the surgeon can increase the tension of the string 92 to increase the rigidity of the arm 22B and fix the position and orientation of the ultrasonic probe 101.

[0068] Incidentally, the multiple units 91 in the third embodiment are an example of an arm of the present disclosure. The string 92 and the stiffness change device 93 are an example of a switching device. The configuration of the switching device is not limited to the above configuration, and may be, for example, a device that uses an ER fluid (electrorheological fluid) as described in Japanese Patent No. 7058847 and changes the stiffness of the arm by changing the strength of the electric field applied to the ER fluid. Alternatively, the switching device may be a device that uses an MR fluid (magnetorheological fluid) and changes the stiffness of the arm by changing the strength of the magnetic field applied to the MR fluid.

[0069] Fourth Embodiment Next, a compression hemostasis device according to a fourth embodiment of the present disclosure will be described. The compression hemostasis device according to the present disclosure may be a free-standing robot, such as a compression hemostasis device 10C shown in Fig. 7. The compression hemostasis device 10C shown in Fig. 7 is installed on a base 97 with casters 96, is configured to be movable, and can be fixed in position by fixing the casters 96 at a predetermined position. For example, the configuration of International Publication WO 2024 / 089812 can be adopted as the configuration of such a compression hemostasis device 10C.

[0070] The arm 22C of the fourth embodiment is a multi-joint robot arm, and can hold an ultrasonic probe 101 with a holding member 24 at the distal end 94 (end effector) of the arm 22C. The compression hemostasis device 10C can be used as an ultrasonic echo guide during surgery, such as catheterization. The arm 22C is, for example, a seven-axis multi-joint arm, and can move the ultrasonic probe 101 in each of the following directions: up-down (Z-axis), left-right (Y-axis), and front-back (X-axis). The compression hemostasis device 10C can also move and rotate the ultrasonic probe 101 by combining translational motion in three directions: the X-axis, Y-axis, and Z-axis directions; and rotational motion in three directions: pitching around the X-axis (Rb), rolling around the Y-axis (Ra), and yawing around the Z-axis (Rc).

[0071] The arm 22C is also provided with a motor and a brake mechanism at each joint, similar to the motors 82A-82D and brake mechanisms 83A-83D of the second embodiment. The control board 41A provided in the main body 21C is electrically connected to the motors and brake mechanisms at each joint, and moves and fixes the position of the ultrasonic probe 101 based on operations on an operation unit 44A (e.g., a touch panel). The compression hemostasis device 10C can also register the position of the ultrasonic probe 101 based on operations on a teaching button 98 provided on the distal end 94 of the arm 22C.

[0072] For example, while the teaching button 98 is being operated, the compression hemostasis device 10C releases the brake provided by the braking mechanism and applies an assist force to facilitate movement of the ultrasonic probe 101. As a preliminary preparation, the surgeon manually operates the arm 22C, brings the ultrasonic probe 101 into contact with the patient, and while checking the acquired echo image, determines the registration point to be reproduced during surgery, i.e., the position and posture at which the echo image is to be confirmed, and performs direct teaching to register this in the control board 41A.

[0073] The control board 41A of the fourth embodiment has, for example, a teaching mode and a hemostasis mode. When the teaching mode is set, the control board 41A releases the brake of the brake mechanism (see FIG. 5 ) while the teaching button 98 is pressed, placing the arm 22C in an open state and allowing changes to the position and orientation of the ultrasonic probe 101. Furthermore, when the teaching button 98 is released, the control board 41A sets the brake of the brake mechanism to place the arm 22C in a fixed state. The control board 41A registers the current position and orientation (XYZ coordinates, rotational position) of the ultrasonic probe 101 as a registration point based on operations on the operation unit 44A or other interfaces (such as a foot pedal or tablet terminal, not shown). For example, after accepting the registration of multiple registration points in order, when the play button on the operation unit 44A is operated, the control board 41A moves the ultrasonic probe 101 through the registered points in the order in which they were registered. This allows catheter surgery to be performed while sequentially moving the ultrasound probe 101 to the positions of pre-registered points to be reproduced during surgery. The control board 41A may also perform movement between registered points based on the operation of the operation unit 44A, etc.

[0074] Furthermore, when the hemostasis mode is set, the control board 41A releases the brake of the brake mechanism and switches it to an allowable state while the teaching button 98 is operated, thereby permitting changes in the position and posture of the ultrasonic probe 101. Furthermore, based on the release of the teaching button 98, the control board 41A controls the brake mechanism to set the brake, switches it to a fixed state, and fixes the arm 22C. For example, the surgeon places the ultrasonic probe 101 at the hemostasis area 75 (see FIG. 4 ) while pressing the teaching button 98, and once the ultrasonic probe 101 is placed in an appropriate position and posture relative to the hemostasis area 75, the surgeon releases the teaching button 98 to fix the ultrasonic probe 101.

[0075] After fixing the arm 22C, the control board 41A changes the compression force applied to the hemostasis site 75 by the ultrasonic probe 101 based on the operation of the operation unit 44A. For example, the base end of the arm 22C is connected to the main body 21C via an elevator device 99. The elevator device 99 includes, for example, a ball screw mechanism. By sliding the base end of the arm 22C up and down, the entire arm 22C, i.e., the ultrasonic probe 101, can be slid up and down. This allows the compression force applied by the ultrasonic probe 101 to be changed. Furthermore, similar to the hemostasis device 10 of the first embodiment, the hemostasis device 10C may include a vertical movement mechanism 23 as a compression force change device. The hemostasis device 10C may include, at the distal end 94, an elevator mechanism 23 that moves the holding member 24 in the sliding direction 55. This allows the ultrasonic probe 101 to be slid vertically relative to the hemostasis site 75 to change the compression force. The compression hemostasis device 10C can be used as an ultrasonic echo guide during surgery, and as a compression hemostasis device after surgery.

[0076] The control board 41A of the fourth embodiment is connected to the ultrasound device 100 via a communication cable 110. The control board 41A can acquire echo images acquired using the ultrasound probe 101 from the ultrasound device 100 via the communication cable 110. For example, after completing a catheterization procedure, the surgeon compresses the hemostasis site 75 (see FIG. 4 ) with the ultrasound probe 101 held by the compression hemostasis device 10C, as in the first embodiment. As described above, in the hemostasis mode, the surgeon places the ultrasound probe 101 at the hemostasis site 75 and then operates the operation unit 44A, for example, to change the compression force applied by the ultrasound probe 101. Based on an operation input to the operation unit 44A, the control board 41A controls the lifting device 99 and the up / down mechanism 23 of the tip portion 94 (an example of a compression force changing device disclosed herein) to compress the hemostasis site 75 with the ultrasound probe 101 (an example of a compression process disclosed herein). The compression-assisted hemostasis device 10C may be configured to be connected to the ultrasound device 100 via wireless communication and to acquire echo images via wireless communication, or may be configured not to be able to communicate with the ultrasound device 100 and not be able to acquire echo images.

[0077] The surgeon positions the ultrasound probe 101 in an appropriate position and posture, adjusts the compression force, and then operates the start button (not shown) on the operation unit 44A. When the start button is operated, the control board 41A starts measuring the compression time, as in the first embodiment. After a preset compression time has elapsed, the control board 41A controls the elevator device 99 and other devices to reduce the compression force applied by the ultrasound probe 101 to the hemostasis site 75. With the compression force reduced, the control board 41A acquires, for example, a color Doppler mode echo image or a video of the echo image (hereinafter, sometimes simply referred to as a video) from the ultrasound device 100 via the communication cable 110 (an example of the acquisition process of the present disclosure). Therefore, the echo image acquired by the acquisition process of the present disclosure may be a single echo image, multiple echo images, or a video of the echo images. After acquiring an echo image or the like showing blood flow in color, the control board 41A controls the lifting device 99 or the like to return the ultrasonic probe 101 to its original compression position, and the ultrasonic probe 101 compresses the hemostasis area 75 again (an example of the re-compression processing of the present disclosure).

[0078] The control board 41A determines whether hemostasis has been achieved based on the echo images and video acquired through the acquisition process. For example, the control board 41A determines whether blood is leaking from the blood vessel at the puncture site based on multiple color Doppler mode echo images and video. A method for determining whether blood is leaking from an echo image or the like may be to detect the position and movement of blood within the image using image processing or AI. If the control board 41A determines that there is no blood leakage from the puncture site, it determines that hemostasis has been achieved. For example, the control board 41A issues different notifications depending on whether hemostasis has been achieved or not (an example of the notification process of the present disclosure). The control board 41A may acquire only either echo images or video from the ultrasound device 100.

[0079] For example, if the control board 41A determines that hemostasis is not complete, it may display a message such as, "The set compression time has elapsed, but hemostasis may not be complete. Please check the echo image." Alternatively, if the control board 41A determines that hemostasis is complete, it may display a message such as, "The set compression time has elapsed. Please check the echo image to see if hemostasis is complete." This allows the surgeon to check the echo image based on the pre-determined result. Furthermore, the surgeon can check the automatically acquired echo image or video while re-compressing, and if hemostasis is complete, perform an operation to end compression. The control board 41A does not necessarily have to execute a process to determine the completion of hemostasis based on the echo image, etc. The control board 41A may execute a process to display the echo image or video acquired in the acquisition process while executing the re-compression process after a preset compression time has elapsed.

[0080] The teaching button 98 in the fourth embodiment is an example of a teaching operation unit. The teaching operation unit of the present disclosure is not limited to a button such as a push button, but may be a switch or the like. The operation unit 44A is an example of a user interface. The lifting device 99 is an example of a compression force changing device.

[0081] Similarly to the first embodiment, the compression hemostasis device 10C of the fourth embodiment can clamp and hold the ultrasonic probe 101 covered with the cover 59 using the holding member 24. Similarly to the first embodiment, the compression hemostasis device 10C includes a compression button 61 and a compression release button 62 on the operation unit 44A, allowing the surgeon to operate the operation unit 44A to control the lifting device 99 and the up / down mechanism 23 and change the compression force. Similarly to the first embodiment, the compression hemostasis device 10C includes a registration button 63 and a movement button 64 on the operation unit 44A, allowing the surgeon to operate the operation unit 44A to register the position of the ultrasonic probe 101 or move it to a registered point. Similarly to the first embodiment, the compression hemostasis device 10C includes a start button 65, an increase / decrease button 66, a time display 67, and the like on the operation unit 44A, allowing the surgeon to operate the operation unit 44A to measure the compression time and set the alarm time. The compression hemostasis device 10C may also be configured without the hemostasis mode.

[0082] Fifth Embodiment Next, a fifth embodiment of the present disclosure will be described. In the above-described embodiments, the ultrasonic probe 101, which is a compression member, is held by an arm (such as the arm 22). However, the configuration for holding the ultrasonic probe 101 is not limited to this. Fig. 8 shows a side view of the up-down mechanism 23 and other components of the compression tourniquet belt 120 of the fifth embodiment. Fig. 9 shows the state in which hemostasis is being performed by the compression tourniquet belt 120. In the following description of the compression tourniquet belt 120, components similar to those of the compression tourniquet devices (such as the compression tourniquet device 10) of the above-described embodiments will be designated by the same reference numerals, and their description will be omitted as appropriate.

[0083] As shown in Figures 8 and 9, the compression tourniquet belt 120 includes a belt 121, a plate 122, a holding member 24, a vertical movement mechanism 23, and a main body 21 (see Figure 9). The belt 121 is attached to the plate 122 and can be worn around the human body, such as the thigh. The plate 122 is, for example, a plate-shaped resin or metal member, to which the vertical movement mechanism 23 is attached and which holds the holding member 24 via the vertical movement mechanism 23. A pin 123 is provided at one end of the plate 122. A first end 121A of the belt 121 is rotatably attached to the pin 123. The material of the belt 121 is not particularly limited, but a material that ensures hygiene is preferable.

[0084] Furthermore, a through hole 125 is formed in the end of the plate 122 opposite the end where the pin 123 is provided. A second end 121B of the belt 121 opposite the first end 121A is inserted into the through hole 125, and the inserted tip of the second end 121B is fixed to the belt 121 on the first end 121A side of the through hole 125. The second end 121B may be fixed to the belt 121 on the first end 121A side of the through hole 125 using a hook-and-loop fastener, or a buckle through which the belt 121 is passed. Alternatively, the buckle through which the second end 121B is passed may be fitted into the plate 122 to be fixed.

[0085] The ultrasonic probe 101 is attached to the plate 122 via the holding member 24 and the lifting mechanism 23. Therefore, the holding member 24 holds the ultrasonic probe 101 relative to the belt 121. As in the first embodiment, the ultrasonic probe 101 moves in the sliding direction 55 in response to the driving of the lifting mechanism 23. The lifting mechanism 23 is connected to the main body 21 via a cable 47, and drives the ball screw mechanism 51 under the control of the control board 41 (see FIG. 2 ), changing the compression force with which the ultrasonic probe 101 held by the holding member 24 compresses the hemostasis site 75 (see FIG. 9 ).

[0086] As shown in FIG. 9 , the surgeon uses the compression tourniquet belt 120 by fixing the main body 21 to the bed rail 73 and wrapping the belt 121 around the thigh of the patient 71, as in the first embodiment. For example, after completing a catheterization procedure, the surgeon attaches the ultrasonic probe 101 to the compression tourniquet belt 120. The surgeon removes the catheter or the like from the puncture site and manually stops bleeding at the hemostasis site 75 while wrapping the belt 121 around the thigh, swaps the hand with the ultrasonic probe 101, and attaches the belt 121 so that the ultrasonic probe 101 is in close contact with the hemostasis site 75. The surgeon tightens and secures the belt 121, and compresses the hemostasis site 75 with the ultrasonic probe 101. As in the first embodiment, the surgeon also operates the operation unit 44 to adjust the pressure applied by the ultrasonic probe 101.

[0087] Although details are omitted, after placing the compression tourniquet belt 120, the surgeon can perform tasks other than hemostasis while managing the compression time by operating the start button 65 of the operation unit 44, as in the first embodiment. With the compression tourniquet belt 120 configured as described above, as in the compression tourniquet devices (such as the compression tourniquet device 10) of the above-described embodiments, the surgeon can perform hemostasis again while checking, using an ultrasound image or the like, whether hemostasis at the hemostasis point 75 has been completed.

[0088] The above-described configuration of the tourniquet belt 120 is merely an example. For example, the tourniquet belt 120 may be configured without the main body 21. In this case, a device equivalent to the operation unit 44 may be attached to the plate 122. For example, only the compression button 61 and the compression release button 62 may be provided on the plate 122. Furthermore, the tourniquet belt 120 may be configured with a different compression force adjusting device, such as the fluid pressure cylinder 81 of the second embodiment.

[0089] The present disclosure is not limited to the above-described embodiments and can be embodied in various forms with various modifications and improvements based on the knowledge of those skilled in the art. For example, the compression hemostasis device 10 may be configured without the operation unit 44. The compression hemostasis device 10 may be configured to drive the up / down mechanism 23 when powered on and apply a predetermined compression force (slide position). Alternatively, the compression hemostasis device 10 may be configured to only include a start button and apply a predetermined compression force in response to the operation of the start button. Furthermore, the compression time may vary depending on, for example, the diameter of the catheter used in surgery. Therefore, the control board 41 may be configured to accept the catheter diameter value or selection of the diameter via the operation unit 44 and apply compression for a time period corresponding to the accepted diameter.

[0090] Furthermore, the ultrasound device of the present disclosure is not limited to a device that captures echo images, but may also be a device that performs both echo image capture and treatment, such as high-intensity focused ultrasound (HIFU) therapy. In other words, the purpose of use of ultrasound emitted from the probe can be changed as appropriate. The compression hemostasis device 10 may also be configured without the clamp unit 68. The alarm unit 45 may issue an alarm by voice, such as "compression time has elapsed," rather than by an audible alarm. The alarm unit 45 may also issue an alarm by a lamp or other means, in addition to or instead of a voice. The compression member is not limited to the ultrasonic probe 101; it may be a member having the same shape as the ultrasonic probe 101, a member that can be attached to the holding member 24 in the same way as the ultrasonic probe 101, or another member capable of compressing the hemostasis site 75. In the above embodiments, a compression member such as the ultrasonic probe 101 is attached to a compression force changing device such as the up-down mechanism 23 via the holding member 24. However, the compression member may be attached directly to the compression force changing device without using the holding member 24. The control device of the present disclosure is not limited to the configuration of the control board 41 described above, and may be configured to include a SoC (System on a Chip) or an ASIC.

[0091] The contents of the present disclosure are not limited to the dependent relationships described in the claims. For example, this specification also discloses the technical idea of ​​changing "the compression-hemostasis device according to claim 1 or claim 2" in claim 5 to "the compression-hemostasis device according to any one of claims 1 to 4." This specification also discloses the technical idea of ​​changing "the compression-hemostasis device according to claim 5" in claim 7 to "the compression-hemostasis device according to claim 5 or claim 6." This specification also discloses the technical idea of ​​changing "the compression-hemostasis device according to claim 1 or claim 2" to "the compression-hemostasis device according to any one of claims 1 to 7" in claim 8. This specification also discloses the technical idea of ​​changing "the compression-hemostasis device according to claim 1 or claim 2" to "the compression-hemostasis device according to any one of claims 1 to 8" in claim 9. This specification also discloses the technical idea of ​​changing "the compression-hemostasis device according to claim 1 or claim 2" to "the compression-hemostasis device according to any one of claims 1 to 9" in claim 10. This specification also discloses the technical idea of ​​changing "a compression hemostasis device according to claim 1 or claim 2" in claim 11 to "a compression hemostasis device according to any one of claims 1 to 10."

[0092] 10, 10A, 10B, 10C Compression hemostasis device, 21, 21A, 21B, 21C Main body, 22, 22A, 22B, 22C Arm, 23, 23A Up and down mechanism (compression force change device), 24 Holding member, 25 Switching device, 31A to 31C First to third arm sections (arm sections), 32A to 32D First to fourth joint sections (joint sections), 41, 41A Control board (control device), 44, 44A Operation section (user interface), 45 Notification section, 55 Slide direction, 58 Clamping section, 59 Cover, 61 Compression button (compression operation section), 62 Compression release button (compression release operation section), 63 Registration button (storage operation section), 64 Movement button (movement operation section), 65 Start button (start operation section), 68 Clamp section, 71 Patient, 72 Operating table, 73 Bed rail, 75 Hemostasis location, 82A, 82B, 82C, 82D motor, 83A, 83B, 83C, 83D brake mechanism (switching device), 91 unit (arm), 92 string body (switching device), 93 rigidity change device (switching device), 98 teaching button (teaching operation unit), 99 lifting device (compression force change device), 100 ultrasound device, 101 ultrasound probe (compression member, probe), 120 compression hemostasis belt, 121 belt.

Claims

1. A compression hemostasis device comprising: an arm capable of holding a compression member; a switching device capable of switching between two states: a fixed state in which the arm is fixed and the position of the compression member is fixed; and an allowable state in which the arm is released and the position of the compression member is allowed to be changed; and a compression force changing device that changes the compression force applied by the compression member to the hemostasis area.

2. A compression hemostasis device as described in claim 1, wherein the switching device is switched to the fixed state and the compression force changing device is driven to change the compression force applied to the hemostasis area by the compression member.

3. A compression hemostasis device as described in claim 1 or claim 2, wherein the arm is a flexible arm that bends when an external force is applied in the permissive state, and the position at which it holds the compression member can be changed, and the switching device fixes the posture of the bent arm in the fixed state.

4. A compression hemostasis device as described in claim 1 or claim 2, wherein the arm is a robotic arm having a plurality of arm sections and a motor that moves the arm sections relative to joint sections that connect the plurality of arm sections, and the switching device has a brake mechanism that fixes the rotational position of the motor in the fixed state.

5. A compression hemostasis device as described in claim 1 or claim 2, further comprising a holding member provided at the tip of the arm, wherein the compression force changing device is capable of sliding the holding member along a predetermined sliding direction, and by moving the holding member in a direction pressing the hemostasis area or in a direction away from the hemostasis area, the compression force applied by the compression member to the hemostasis area is changed.

6. A compression hemostasis device as described in claim 5, wherein the compression member is a probe of an ultrasound device or a member of the same shape as the probe, the holding member has a clamping portion that clamps and holds the probe or a member of the same shape as the probe from the side, the probe or a member of the same shape as the probe is covered by a sterilized cover, and the clamping portion clamps and holds the probe or a member of the same shape as the probe from above the sterilized cover.

7. A compression hemostasis device as described in claim 5, further comprising: an operating unit; and a control device that controls the compression force change device based on an operation on the operating unit and moves the holding member in a direction to press the area where bleeding is stopped or in a direction away from the area where bleeding is stopped, wherein the operating unit has a compression operating unit, a compression release operating unit, a memory operating unit, and a movement operating unit, and the control device moves the holding member in a direction to press the area where bleeding is stopped based on an operation on the compression operating unit, moves the holding member in a direction away from the area where bleeding is stopped based on an operation on the compression release operating unit, memorizes the position of the holding member in the sliding direction based on an operation on the memory operating unit, and moves the holding member to the position memorized based on the operation on the memory operating unit based on an operation on the movement operating unit.

8. A compression hemostasis device as described in claim 1 or claim 2, further comprising a main body connected to the arm and the compression force change device, the main body having an operation unit, a control unit that controls the compression force change device based on operation on the operation unit and changes the compression force with which the compression member applies compression to the hemostasis area, and a clamp unit that detachably fixes the main body to a bed rail provided on an operating table, the main body holding the arm with the main body fixed to the bed rail by the clamp unit, and the hemostasis area of ​​a patient lying on the operating table being compressed by the compression member.

9. A compression hemostasis device as described in claim 1 or claim 2, further comprising: a control device that controls the compression force change device; a start operation unit that instructs the start of measurement of compression time; and an alarm unit that issues an alarm, wherein the control device starts measuring the compression time based on the start operation unit being operated, and issues an alarm via the alarm unit based on the compression time being measured reaching a preset time.

10. A compression hemostasis device as described in claim 1 or claim 2, wherein the compression member is a probe of an ultrasound device, and the compression hemostasis device further comprises a control device connected to the ultrasound device and acquiring from the ultrasound device an echo image acquired using the probe, the control device performing the following operations: a compression process in which the compression force changing device is controlled to compress the area to be stopped with the probe; an acquisition process in which, after starting the compression process, the compression force changing device is controlled to reduce the compression force with which the probe is used to compress the area to be stopped with the hemostasis, and the echo image is acquired from the ultrasound device in the reduced compression force state; a re-compression process in which, after acquiring the echo image by the acquisition process, the compression force changing device is controlled to re-compress the area to be stopped with the probe; and a notification process in which it is determined whether hemostasis has been completed based on the echo image acquired by the acquisition process, and if so, notifies the user that hemostasis has been completed.

11. A device further comprising a teaching operation unit, a control device having a teaching mode and a hemostasis mode, and a user interface, wherein the control device, in a state in which the teaching mode is set, controls the switching device to the permissive state to allow a change in the position of the compression member while the teaching operation unit is being operated, registers the changed position of the compression member as a registered point based on the release of the operation of the teaching operation unit, and after accepting the registration of a plurality of the registered points, moves to the plurality of registered points in order based on the operation on the user interface, A compression hemostasis device as described in claim 1 or claim 2, wherein when the hemostasis mode is set, while the teaching operation unit is being operated, the switching device is controlled to switch to the allowing state to allow the position of the compression member to be changed, and after the compression member is positioned at the hemostasis location, the switching device is controlled to switch to the fixed state based on the release of the operation of the teaching operation unit to fix the arm, and after the arm is fixed, the compression force changing device is controlled based on the operation of the user interface to change the compression force applied to the hemostasis location by the compression member.

12. A compression hemostatic belt comprising: a belt that can be wrapped around a human body; a holding member that can hold a compression member against the belt; and a compression force changing device that changes the compression force applied to the hemostasis area by the compression member held by the holding member.

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