WO2021065311A1 - Actuator and robot catheter system - Google Patents

Actuator and robot catheter system Download PDF

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Publication number
WO2021065311A1
WO2021065311A1 PCT/JP2020/033292 JP2020033292W WO2021065311A1 WO 2021065311 A1 WO2021065311 A1 WO 2021065311A1 JP 2020033292 W JP2020033292 W JP 2020033292W WO 2021065311 A1 WO2021065311 A1 WO 2021065311A1
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WO
WIPO (PCT)
Prior art keywords
gripping
unit
sheath
arm
robot
Prior art date
Application number
PCT/JP2020/033292
Other languages
French (fr)
Japanese (ja)
Inventor
弘通 谷岡
一樹 仲宗根
Original Assignee
テルモ株式会社
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Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2021065311A1 publication Critical patent/WO2021065311A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/50Supports for surgical instruments, e.g. articulated arms

Definitions

  • the present invention relates to an actuator and a robot catheter system.
  • a robot hand when treating and diagnosing a patient with a cardiovascular disease, a robot hand may be used to operate a catheter or the like.
  • the robot hand By providing a plurality of joints, the robot hand is configured so that it can rotate not only in a straight line but also in the joints with multiple degrees of freedom.
  • a cassette to which a diagnostic catheter can be attached is provided at the tip of the robot hand.
  • the cassette is equipped with a drive mechanism that can move the guide wire in the longitudinal direction and a drive mechanism that can move the diagnostic catheter and the like.
  • the diagnostic catheter is sandwiched by wheels and rollers so as to be movable in the longitudinal direction (see Patent Document 1).
  • the diagnostic catheter When the diagnostic catheter is sandwiched between a roller and a wheel and the diagnostic catheter is moved forward and backward in the longitudinal direction as in Patent Document 1, the diagnostic catheter receives the sandwiching force between the roller and the wheel. In this way, when the diagnostic catheter receives a force that contracts inward in the radial direction in the cross section intersecting the longitudinal direction, a fluid such as a contrast medium is circulated inside the catheter, or a medium such as light for diagnostic imaging is used. The function of transmitting may be impaired. For medical long bodies such as catheters, it is common to perform the procedure by moving various members into the internal space of the tubular member, and the above-mentioned problems use medical long bodies. If so, it can be applied to medical devices other than diagnostic imaging catheters.
  • the present invention has been made in view of the above problems, and an object of the present invention is to provide a novel structure capable of adjusting the gripping force for gripping a medical long body in a robot catheter system.
  • One aspect of the present invention is provided in a robot catheter system that moves a medical elongated body forward and backward in the longitudinal direction, and in a pair of gripping members that feed the medical elongated body in the longitudinal direction, a pair of the gripping members is provided. It is an actuator that adjusts the distance between the first gripping member and the second gripping member to move at least one of the first gripping member and the second gripping member with respect to the other.
  • one aspect of the present invention is a robot catheter system equipped with the above actuator.
  • FIG. 12 It is a schematic perspective view which shows the structure which adjusts the gripping force by a pair of rollers in a robot catheter system, and shows the state which partially cut a cassette.
  • the robotic catheter system according to the present embodiment is used in a percutaneous coronary intervention (PCI) used in treating a patient having a cardiovascular disease.
  • PCI percutaneous coronary intervention
  • FIG. 1 is a schematic perspective view showing the overall configuration of the robot catheter system 1 according to the present embodiment
  • FIG. 2 is a diagram showing a cassette 400, a medical device P, and the like constituting the robot catheter system 1.
  • the robot catheter system 1 is used when moving the sheath 110 forward and backward in the longitudinal direction.
  • the robot catheter system 1 includes a medical device P including a sheath 110 (corresponding to a long medical body), a bed 200, and a robot arm 300.
  • the robot catheter system 1 includes a cassette 400, a computer 600, an irradiation device 700, and an operation unit 800.
  • FIG. 3 is a diagram showing an overall configuration of an image diagnostic catheter (hereinafter referred to as an image catheter or a catheter device) as an example of a medical device attached to the robot catheter system 1.
  • FIG. 4 is a view showing the tip of the diagnostic imaging catheter 100
  • FIG. 5 is a cross-sectional view showing the proximal end side of the diagnostic imaging catheter.
  • the medical device is a dual type diagnostic imaging catheter 100 having both functions of endovascular ultrasonic diagnosis (IVUS) and optical coherence tomography (OCT).
  • IVUS endovascular ultrasonic diagnosis
  • OCT optical coherence tomography
  • the medical device that can be connected to the external device 500 is not limited to the above, and is, for example, an IVUS catheter, an OCT catheter, or a catheter used for purposes other than obtaining a diagnostic image (for example, a therapeutic catheter). You may.
  • the diagnostic imaging catheter 100 will be described with reference to FIGS. 3 to 5.
  • the diagnostic imaging catheter 100 is driven by being connected to an external device 500.
  • the diagnostic imaging catheter 100 generally includes a long sheath 110 inserted into the body cavity of a living body and an outer tube 120 provided on the proximal end side of the sheath 110.
  • the diagnostic imaging catheter 100 includes an inner shaft 130 that is inserted into the outer tube 120 so as to be movable back and forth, and a drive shaft 140 that has a signal transmission / reception unit 145 at the tip and is rotatably provided in the sheath 110.
  • the diagnostic imaging catheter 100 has a unit connector 150 provided on the proximal end side of the outer tube 120 and configured to receive the inner shaft 130, and a hub 160 provided on the proximal end side of the inner shaft 130. ing.
  • the side inserted into the body cavity of the diagnostic imaging catheter 100 is referred to as the distal end side
  • the hub 160 side provided in the diagnostic imaging catheter 100 is referred to as the proximal end side
  • the extending direction of the sheath 110 is referred to as the extending direction. It is called the axial direction.
  • the drive shaft 140 passes through the sheath 110, the outer tube 120 connected to the base end of the sheath 110, and the inner shaft 130 inserted into the outer tube 120, and extends to the inside of the hub 160. ing.
  • the hub 160, the inner shaft 130, the drive shaft 140, and the signal transmission / reception unit 145 are connected to each other so as to move forward and backward in the axial direction. Therefore, for example, when the hub 160 is pushed toward the tip end side, the inner shaft 130 connected to the hub 160 is pushed into the outer pipe 120 and the unit connector 150. Then, the drive shaft 140 and the signal transmission / reception unit 145 move inside the sheath 110 toward the tip side. For example, when the hub 160 is pulled toward the proximal end side, the inner shaft 130 is pulled out from the outer tube 120 and the unit connector 150 as shown by the arrow a1 in FIG. Further, when the hub 160 is pulled toward the proximal end side, the drive shaft 140 and the signal transmitting / receiving unit 145 move inside the sheath 110 toward the proximal end side as shown by the arrow a2 in FIG.
  • the relay connector 170 is a connector that connects the sheath 110 and the outer tube 120.
  • the drive shaft 140 includes a flexible tube body 141, and an electric signal cable 142 and an optical fiber 143 connected to a signal transmission / reception unit 145 are arranged inside the drive shaft 140.
  • the tube body 141 can be composed of, for example, a multi-layer coil having different winding directions around the axis. Examples of the constituent material of the coil include stainless steel, Ni—Ti (nickel / titanium) alloy, platinum, and iridium alloy.
  • the electric signal cable 142 is connected to an electrode terminal provided in the connector portion 165, which will be described later, as shown in FIG.
  • the electric signal cable 142 is configured to include two signal lines 142a and 142b for transmitting and receiving high frequency voltage.
  • the signal transmission / reception unit 145 has an ultrasonic wave transmission / reception unit 145a for transmitting / receiving ultrasonic waves and an optical transmission / reception unit 145b for transmitting / receiving light.
  • the ultrasonic transmission / reception unit 145a is provided with an oscillator, and has a function of transmitting ultrasonic waves based on a pulse signal into the body cavity and receiving ultrasonic waves reflected from living tissues in the body cavity.
  • the ultrasonic transmission / reception unit 145a is electrically connected to an electrode terminal (not shown) on the proximal end side of the diagnostic imaging catheter 100 via an electric signal cable 142.
  • a piezoelectric material such as ceramics or quartz can be used.
  • the light transmission / reception unit 145b continuously transmits the transmitted measurement light into the body cavity and continuously receives the reflected light from the living tissue in the body cavity.
  • the light transmission / reception unit 145b has a ball lens (optical element) provided at the tip of the optical fiber 143 and having a lens function for collecting light and a reflection function for reflecting light.
  • the signal transmission / reception unit 145 is housed inside the housing 146 as shown in FIG.
  • the base end side of the housing 146 is connected to the drive shaft 140.
  • the housing 146 is provided with an opening on the cylindrical surface of a cylindrical metal pipe so as not to obstruct the progress of ultrasonic waves transmitted and received by the ultrasonic wave transmitting and receiving unit 145a and light transmitted and received by the optical transmitting and receiving unit 145b. It has a good shape.
  • the sheath 110 includes a lumen 110a into which the drive shaft 140 is inserted so as to be movable back and forth.
  • a guide wire insertion member 114 is attached to the tip of the sheath 110 so as to be juxtaposed with the lumen 110a provided on the sheath 110 and provided with a guide wire lumen 114a through which the guide wire G can be inserted.
  • the sheath 110 and the guide wire insertion member 114 can be integrally formed by heat fusion or the like.
  • the guide wire insertion member 114 is provided with a marker 115 having X-ray contrast property.
  • the marker 115 is composed of a metal coil having high X-ray impermeable properties such as Pt and Au.
  • a communication hole 116 that communicates the inside and the outside of the lumen 110a is formed at the tip of the sheath 110.
  • a reinforcing member 117 for firmly joining and supporting the guide wire insertion member 114 is provided at the tip of the sheath 110.
  • the reinforcing member 117 is formed with a communication passage 117a that communicates the inside of the lumen 110a arranged on the proximal end side of the reinforcing member 117 with the communication hole 116.
  • the reinforcing member 117 may not be provided at the tip of the sheath 110.
  • the communication hole 116 is a priming liquid discharge hole for discharging the priming liquid.
  • a priming process is performed in which the sheath 110 is filled with a priming solution in order to reduce the attenuation of ultrasonic waves due to air in the sheath 110 and efficiently transmit and receive ultrasonic waves.
  • the priming liquid can be discharged from the communication hole 116 into the living lumen, and a gas such as air can be discharged from the inside of the sheath 110 together with the priming liquid.
  • the sheath 110, the guide wire insertion member 114, and the reinforcing member 117 are made of a flexible material, and the material is not particularly limited, and examples thereof include styrene-based, polyolefin-based, polyurethane-based, polyester-based, and polyamide-based. Examples thereof include various thermoplastic elastomers such as polyimide-based, polybutadiene-based, transpolyisoprene-based, fluororubber-based, and chlorinated polyethylene-based, and one or a combination of two or more of these (polymer alloy, polymer blend). , Laminates, etc.) can also be used.
  • a hydrophilic lubricating coating layer that exhibits lubricity when wet can be arranged on the outer surface of the sheath 110.
  • the hub 160 includes a hub body 161 having a hollow shape, a connector case 165c connected to the base end side of the hub body 161 and a port 162 communicating with the inside of the hub body 161. ..
  • the hub 160 includes protrusions 163a and 163b for determining the position (direction) of the hub 160 when connecting to the external device 500, and a connection pipe 164b for holding the drive shaft 140.
  • the hub 160 includes a bearing 164c that rotatably supports the connecting pipe 164b, and a sealing member 164a that prevents the priming liquid from leaking from between the connecting pipe 164b and the bearing 164c toward the proximal end side.
  • the hub 160 includes an electrode terminal 165a connected to the external device 500 and a connector portion 165 in which the optical connector 165b is arranged inside.
  • the inner shaft 130 is connected to the tip of the hub body 161.
  • the drive shaft 140 is pulled out from the inner shaft 130 inside the hub body 161.
  • An injection device S (see FIG. 3) for injecting the priming liquid is connected to the port 162 when performing the priming process.
  • the injection device S includes a connector S1 connected to the port 162, a tube S2 connected to the connector S1, and a three-way stopcock S3 connected to the tube S2.
  • the injection device S includes a first syringe S4 and a second syringe S5 that are connected to the three-way stopcock S3 and capable of injecting the priming liquid into the port 162.
  • the second syringe S5 is a syringe that has a larger capacity than the first syringe S4 and is used as an auxiliary when the amount of the priming liquid to be injected by the first syringe S4 is insufficient.
  • connection pipe 164b holds the drive shaft 140 in order to transmit the rotation of the electrode terminal 165a and the optical connector 165b, which are rotationally driven by the external device 500, to the drive shaft 140.
  • An electric signal cable 142 and an optical fiber 143 are inserted inside the connecting pipe 164b.
  • the connector portion 165 includes an electrode terminal 165a that is electrically connected to the electric signal cable 142 and an optical connector 165b that is connected to an optical fiber.
  • the received signal in the ultrasonic transmission / reception unit 145a is transmitted to the external device 500 via the electrode terminal 165a, subjected to predetermined processing, and displayed as an image.
  • the received signal in the optical transmission / reception unit 145b is transmitted to the external device 500 via the optical connector 165b, subjected to predetermined processing, and displayed as an image.
  • the diagnostic imaging catheter 100 is connected to and driven by an external device 500.
  • the external device 500 is connected to the connector portion 165 (see FIG. 5) provided on the base end side of the hub 160.
  • the external device 500 includes a motor 500a which is a power source for rotating the drive shaft 140 and a motor 500b which is a power source for moving the drive shaft 140 in the axial direction.
  • a motor 500a which is a power source for rotating the drive shaft 140
  • a motor 500b which is a power source for moving the drive shaft 140 in the axial direction.
  • the rotational motion of the motor 500b is converted into axial motion by the ball screw 500c connected to the motor 500b.
  • the operation of the external device 500 is controlled by the control device 501 electrically connected to the external device 500.
  • the control device 501 includes a CPU (Central Processing Unit) 501a and a memory as a main configuration.
  • the control device 501 is electrically connected to the monitor 502.
  • the control device 501 can be electrically connected to a server (not shown).
  • the bed 200 is arranged in a direction perpendicular to the ground from a pedestal placed on the ground, extends approximately along the ground, and is configured to have a flat surface capable of supporting patient Pa from children to adults. ing.
  • the bed 200 is configured such that the medical device P is attached to a cassette 400 attached to the tip of the robot arm 300 so that the medical device P can be arranged above the bed 200 when the robot arm 300 is operated.
  • the bed 200 has a table size configured according to the physique of an adult, but is equipped with a slide mechanism so that the table size can be changed in a plurality of stages according to the physique of the patient Pa. You may.
  • the robot arm 300 is configured to hold the cassette 400.
  • the robot arm 300 is a vertical articulated robot including a first axis 310, a second axis 320, a third axis 330, and a mounting portion 340 provided at the tip of the third axis 330. It is configured.
  • the first shaft 310 and the second shaft 320 are rotatably connected, and the second shaft 320 and the third shaft 330 are rotatably connected.
  • the first shaft 310, the second shaft 320, and the third shaft 330 are configured to be rotationally driven by a servomotor or the like.
  • the robot arm 300 is configured as described above so that the cassette 400 attached to the tip can be translated and rotated with 6 degrees of freedom.
  • the degree of freedom of the robot hand is not limited to 6 degrees of freedom as long as the medical device P attached to the cassette 400 can be reached by translating and rotating to a desired position.
  • the mounting portion 340 will be described in the description of the cassette 400.
  • the cassette 400 can be configured for single use and is replaceably installed at the attachment portion 340 provided at the tip of the third axis 330 of the robot arm 300 to move the guide wire G and the medical device P used for the procedure for the patient Pa. It is configured to be possible. As shown in FIG. 2, the cassette 400 includes a first drive unit 410, a second drive unit 430, and an installation unit 450.
  • the cassette 400 is configured so that the guide wire G can be moved forward and backward by the first drive unit 410 in the left-right direction shown in FIG.
  • the first drive unit 410 includes rollers 411 to 422.
  • the rollers 411 to 422 have rollers represented by odd-numbered symbols arranged on one side of the guide wire G, that is, on the upper side of the guide wire G in FIG.
  • the rollers 411 to 422 are arranged on the other side with respect to the guide wire G, that is, on the lower side with respect to the guide wire G in FIG. 2, the rollers indicated by even numbers.
  • the rollers 411 to 420 are configured such that the rollers indicated by odd-numbered or even-numbered symbols are driven rollers by a motor or the like, and the other is a driven roller.
  • the drive roller in the first drive unit 410 is configured to be rotatable by an actuator (not shown) such as a motor.
  • the second drive unit 430 is configured so that the medical device P such as the above-mentioned diagnostic imaging catheter can be moved forward and backward in the longitudinal direction.
  • the second drive unit 430 includes rollers 431 to 434, a first arm 435, a second arm 436, a rotating shaft 437, 438, 439, and an elastic member 441.
  • the mounting portion 340 of the robot arm 300 includes gears 341 and 342, gears 343 and 344, and motors 345 and 346.
  • the rollers 433 and 434 correspond to a pair of gripping members.
  • the roller 434 corresponds to the first gripping member
  • the roller 433 corresponds to the second gripping member.
  • the motor 345 corresponds to the first drive unit
  • the motor 346 corresponds to the second drive unit
  • the first arm 435 corresponds to the first installation member
  • the second arm 436 corresponds to the second installation member.
  • the elastic member 441 corresponds to an urging member.
  • the motor 345, the gears 341, 342 and the first arm 435 adjust the distance between the rollers 433 and 434 in the rollers 433 and 434 that send the medical device P including the sheath 110 in the longitudinal direction in the robot catheter system 1.
  • the motor 345, gears 341, 342 and the first arm 435 correspond to actuators.
  • rollers 431 to 434 similarly to the rollers 411 to 422, the rollers indicated by odd-numbered symbols are arranged on one side with respect to the medical device P, and on the upper side of the medical device P in FIG.
  • the rollers 431 to 434 are configured so that the rollers represented by the even-numbered reference numerals are arranged on the other side with respect to the medical device P, that is, on the lower side with respect to the medical device P in FIG.
  • the rollers 431 to 434 are configured such that the rollers indicated by odd numbers are driven rollers by a motor or the like, and the other is a driven roller.
  • the medical device P is configured to be movable back and forth in the longitudinal direction while being sandwiched by the second drive unit 430 in a direction intersecting the longitudinal direction.
  • the first arm 435 adjusts the distance between the rollers 433 and 434 and moves the roller 434 with respect to the roller 433.
  • the first arm 435 is rotatably configured by a motor 345, and a roller 434 is rotatably attached to a rotating shaft 437.
  • the first arm 435 is rotatably supported by a rotating shaft 438 in the cassette 400. With this configuration, the roller 434 can be approached and separated from the roller 433, and the relative distance between the roller 433 and the roller 434 is adjusted. That is, when the first arm 435 rotates clockwise in FIG. 6 about the rotation shaft 438, the roller 433 and the roller 434 come close to each other.
  • the first arm 435 rotates counterclockwise about the rotation shaft 438, the roller 434 is separated from the roller 433.
  • the first arm 435 is provided with a mounting portion 435a to which the elastic member 441 can be mounted.
  • the mounting portion 435a is formed in a hollow cylindrical shape so that the elastic member 441 described later can be mounted.
  • the second arm 436 can be rotated by the motor 345 and is supported by the rotating shaft 438.
  • the second arm 436 includes a mounting portion 436a to which the elastic member 441 can be mounted, similarly to the first arm 435.
  • the mounting portion 436a is configured to be insertable into the internal space of the mounting portion 435a.
  • the first arm 435 and the second arm 436 are configured to be close to each other in the rotation direction around the rotation shaft 438.
  • the operation of the first arm 435 and the second arm 436 by the motor 345, that is, the setting of the rotation angle is performed by the operation unit 800 described later.
  • the rotation shaft 439 is provided on the cassette 400 to rotatably support the roller 434, which is the drive roller in the rollers 433 and 434.
  • the elastic member 441 is provided so as to be attachable to the attachment portion 435a of the first arm 435 and the attachment portion 436a of the second arm 436.
  • the elastic member 441 is configured to use a compression spring or the like capable of urging the second arm 436 with respect to the first arm 435 in the rotation direction of the first arm 435 and the second arm 436.
  • the rollers 433 and 434 impart a constant holding force to the medical device P to prevent or suppress the slip of the medical device P.
  • the elastic member 441 acts when the rollers 433 and 434 reach the portion of the sheath 110 where the diameter changes, and only a slight stress change is required.
  • the sheath 110 is configured so that an excessive holding force is not applied.
  • the gear 341 is provided on the mounting portion 340 of the robot arm 300 in order to rotate the rotating shaft 438 on the driven side.
  • the gear 341 is derived from the motor 345 as shown in FIG. 8 and is rotatably attached to a shaft intersecting the rotation shaft 438.
  • the gear 342 is rotatably provided on the rotating shaft 438 of the cassette 400. By meshing the gear 341 and the gear 342, the rotation from the motor 345 can be converted into the rotation of the rotation shaft 438.
  • the gears 341 and 342 are configured as so-called bevel gears in the present embodiment.
  • the gear 343 is provided on the mounting portion 340 of the robot arm 300 in order to rotate the roller 433 on the drive side.
  • the gear 343 is derived from the motor 346 and is rotatably attached to a shaft that intersects the rotating shaft 439.
  • the gear 344 is rotatably provided on the rotating shaft 439 of the roller 434 in the cassette 400. By engaging the gear 343 and the gear 344, the rotation from the motor 346 can be converted into the rotation of the roller 433.
  • the gears 343 and 344 can be configured by bevel gears as described above.
  • the motor 345 applies a driving force that causes the first arm 435 to approach or separate from the second arm 436.
  • the motor 346 is provided to rotate the roller 433 around the rotation shaft 439.
  • the motor 345 and the motor 346 can be configured by a known motor.
  • the installation unit 450 is configured to install a medical device through which the first drive unit 410, the second drive unit 430, the guide wire G, and the medical device P are inserted. As shown in FIG. 2, the installation unit 450 includes a first installation unit 451, a second installation unit 452, a third installation unit 453, and a fourth installation unit 454.
  • the first installation portion 451 is configured so that the entire outer circumference shown in FIG. 2 is formed of a resin such as hard plastic.
  • the first installation portion 451 can be provided with a cover for accommodating the guide wire G and the medical device P by a hinge or the like in a state where the guide wire G and the medical device P can be inserted.
  • the second installation unit 452 includes a wall surface in which the rollers 411 to 418 constituting the first drive unit 410 are operably installed in the first installation unit 451.
  • the second installation portion 452 can be configured to be rotatable with respect to the first installation portion 451 by a motor or gear pair (not shown) with the longitudinal direction of the guide wire G (the left-right direction in FIG. 2) as the rotation axis.
  • the third installation unit 453 includes a wall surface on which rollers 419 to 422 constituting the first drive unit 410 and rollers 431 to 434 constituting the second drive unit 430 are operably installed.
  • the fourth installation unit 454 is configured as a portion to which the guide wire G to be attached to the cassette 400 and the connector C through which the medical device P is inserted can be attached.
  • the connector C installed in the fourth installation unit 454 is configured as a Y-shaped connector in the present embodiment.
  • the third installation portion is configured by a concave-convex shape or a concave-convex groove to which the connector can be attached in the present embodiment.
  • the computer 600 includes a server 650 and a client 610 as shown in FIG.
  • the client 610 includes a storage unit 620 and a control unit 630.
  • the storage unit 620 is electrically connected to the operation unit 800 and is configured to store data on the gripping force gripped by the rollers 433 and 434 with respect to the sheath 110.
  • the storage unit 620 can be configured by a ROM or the like.
  • the control unit 630 selects one of the data stored in the storage unit 620 according to the selection of the user Pb in the operation unit 800, and issues a command to operate the rollers 433 and 434.
  • the control unit 630 can be configured by a processor such as a CPU, a RAM, or the like.
  • the data stored in the storage unit 620 is configured to be updatable by communication with the server 650.
  • the server 650 is configured to be able to communicate with the control unit 630 or the storage unit 620 by a network card or the like provided on the client.
  • the irradiation device 700 is used to grasp the position of the tip of the guide wire G that has entered the living body by a marker or the like provided on the guide wire G.
  • the irradiation device 700 is provided so as to be movable in the vicinity of the bed 200, and includes a portion for irradiating radiation such as X-rays and a portion for forming an captured image by receiving the irradiated X-rays.
  • the operation unit 800 can be operated by the user Pb, and the gripping force of the medical device P by the rollers 433 and 434 can be adjusted. As shown in FIG. 10, the operation unit 800 includes a screen 810, a grip portion 820.830.840, and a pressing portion 850.
  • the operation unit 800 is configured to be able to operate each part of the robot catheter system 1.
  • the operation unit 800 is electrically connected to the robot arm 300, the cassette 400, and the irradiation device 700, and is configured to be able to operate the operation of each unit.
  • the screen 810 is configured so that the user Pb can visually recognize various operations performed by the operation unit 800.
  • the screen 810 can also be configured as a touch screen in which various operations are performed by touching the screen with a finger.
  • the user Pb selects the manufacturer name, product name, etc. of the medical device P to be used on the screen, it can be configured to display information such as the material and outer diameter of the sheath 110.
  • the grip portions 820 and 830 are configured to be operable by the fingers of the user Pb.
  • the grip portion 820 is gripped by the fingers of the left hand of the user Pb, and the grip portion 830 is configured to be grippable by the fingers of the right hand of the user Pb.
  • the grip portions 820 and 830 can be configured as sticks that can be tilted to any angle position in the circumferential direction by the pressing force from the hand of the user Pb.
  • the grip portion 840 can be configured in the same manner as the grip portions 820 and 830.
  • the guiding catheter set in the cassette 400 can be moved forward and backward by operating the grip portion 840.
  • the pressing portion 850 is configured as a button capable of urgently stopping the operation of the medical device P and / or the guide wire G in the unlikely event that the operations of the grip portions 820, 830, 840 and the like do not work.
  • the operator connects the device for injecting the priming liquid to the port 162 with the hub 160 pulled to the most proximal side, and injects the priming liquid into the lumen 110a of the sheath 110.
  • the priming liquid When the priming liquid is injected into the lumen 110a, the priming liquid is discharged to the outside of the sheath 110 through the communication passage 117a and the communication hole 116. As a result, a gas such as air can be discharged from the inside of the sheath 110 to the outside together with the priming liquid.
  • the operator connects the external device 500 to the connector portion 165 of the diagnostic imaging catheter 100 as shown in FIG. Then, the operator pushes the hub 160 until it comes into contact with the base end of the unit connector 150, and moves the signal transmission / reception unit 145 to the tip end side.
  • the operator inserts a guide wire (not shown) to the vicinity of the entrance of the coronary artery (coronary artery) of the heart of the living body. Then, the guiding catheter is inserted into the target site along the guide wire. Next, the operator pulls out the guide wire and opens the cover of the first installation portion 451 in the cassette 400. Then, the guiding catheter is attached to the Y-shaped connector C installed in the fourth installation portion 454. Next, a guide wire G different from the above is inserted through the guide wire insertion member 114 of the medical device P, and the connector C is attached to the fourth installation portion 454 of the cassette 400.
  • the guide wire G is sandwiched between the rollers 411 to 422 of the first drive unit 410.
  • the medical device P is sandwiched between the rollers 431 to 434 of the second drive unit 430. After setting the guide wire G and the medical device P, close the cover of the first installation portion 451.
  • the operator operates the operation unit 800 and inserts the guide wire G attached to the cassette 400 by the first drive unit 410 to the lesion portion.
  • the operator operates the operation unit 800 and inserts the diagnostic imaging catheter 100 to the lesion portion by the second drive unit 430 along the guide wire G.
  • the medical device P is selected by the operation unit 800 and moves back and forth at intervals of rollers 433 and 434 defined by the first arm 435 and the second arm 436.
  • the diagnostic imaging catheter 100 is moved back and forth to protrude from the tip opening of the guiding catheter. Then, while inserting the guide wire G through the guide wire lumen, the diagnostic imaging catheter 100 is further pushed along the guide wire G to be inserted into the target position in the blood vessel.
  • a known guiding catheter having a port (not shown) to which a syringe (not shown) can be connected can be used at the proximal end.
  • the blood in the blood vessel is temporarily replaced with a flash solution such as a contrast medium, and the blood in the blood vessel is temporarily replaced with the flash solution.
  • a flash solution such as a contrast medium
  • the syringe containing the flush solution is connected to the port of the guiding catheter, and the pusher of the syringe is pushed to inject the flush solution into the lumen of the guiding catheter.
  • the flush fluid passes through the lumen of the guiding catheter and is introduced into the blood vessel through its tip opening.
  • the introduced flush liquid flushes the blood around the tip of the sheath 110, and the flash liquid is filled around the tip of the sheath 110.
  • the step of replacing with the flash liquid described above can be omitted.
  • the signal transmission / reception unit 145 moves to the proximal end side while rotating together with the drive shaft 140 (pullback operation).
  • the ultrasonic transmission / reception unit 145a transmits the ultrasonic waves toward the blood vessel wall and receives the ultrasonic waves reflected by the blood vessel wall.
  • the light transmission / reception unit 145b also transmits the measurement light toward the blood vessel wall and receives the reflected light reflected by the blood vessel wall.
  • the ultrasonic wave transmitted from the ultrasonic transmission / reception unit 145a and the measurement light transmitted from the light transmission / reception unit 145b intersect, the region inspected by the ultrasonic wave in the living body and the light are inspected. Areas can be overlapped.
  • the rotation and movement operations of the drive shaft 140 are controlled by the control device 501.
  • the connector portion 165 provided in the hub 160 is rotated while being connected to the external device 500, and the drive shaft 140 is rotated in conjunction with this.
  • the signal transmission / reception unit 145 transmits ultrasonic waves and light into the body.
  • the signal corresponding to the reflected wave and the reflected light received by the signal transmitting / receiving unit 145 is sent to the control device 501 via the drive shaft 140 and the external device 500.
  • the control device 501 generates a tomographic image of the biological lumen based on the signal sent from the signal transmission / reception unit 145, and displays the generated image on the monitor 502.
  • the robot catheter system 1 for moving the sheath 110 forward and backward in the longitudinal direction includes an actuator.
  • the actuator adjusts the spacing between the rollers 433 and 434 in a pair of rollers 433 and 434 that feed the sheath 110 in the longitudinal direction, and moves the roller 434 with respect to the roller 433.
  • the actuator includes a motor 345 and a first arm 435.
  • the motor 345 generates a driving force that causes the roller 434 to approach or separate relative to the roller 433.
  • the first arm is configured to be rotatable by a motor 345, and a roller 434 can be attached to the first arm. By configuring the actuator as described above, the roller 434 can be moved closer to or further from the roller 433 to adjust the gripping force of the sheath 110 by the rollers 433 and 434.
  • the first arm 435 adjusts the relative spacing of the roller 434 to the roller 433 by rotating around the rotation shaft 438.
  • the actuator includes a second arm 436 and an elastic member 441.
  • the second arm 436 is rotatably installed on the rotating shaft 438.
  • the elastic member 441 is provided on the first arm 435 and the second arm 436, and is configured to urge the second arm 436 with respect to the first arm 435 in the rotation direction of the first arm 435 and the second arm 436. ing.
  • the present embodiment includes a robot catheter system 1 in which a motor 345 in the actuator can be installed, a robot arm 300 having a plurality of joints and capable of moving and rotating with multiple degrees of freedom, and a cassette 400. ..
  • the cassette 400 is replaceably installed in the mounting portion 340 provided at the tip of the robot arm 300, and the rollers 433, 434 and the first arm 435 are rotatably provided. With this configuration, the holding force of the sheath 110 by the rollers 433 and 434 can be adjusted so that the medical device P can be operated satisfactorily.
  • the robot catheter system 1 includes an operation unit 800, a storage unit 620 and a control unit 630 provided in the computer 600.
  • the operation unit 800 can be operated by the user Pb, and the gripping force of the rollers 433 and 434 can be adjusted.
  • the storage unit 620 is electrically connected to the operation unit 800 and stores data regarding the gripping force gripped by the rollers 433 and 434 with respect to the sheath 110.
  • the control unit 630 is configured to operate the rollers 433 and 434 by selecting any of the data stored in the storage unit 620 according to the selection of the user Pb in the operation unit 800.
  • the medical worker such as a doctor can perform the operation on the patient Pa after adjusting the holding force on the medical device P by the robot catheter system 1 without using the medical device P.
  • the computer 600 is configured to include a server 650 capable of communicating with at least one of the storage unit 620 and the control unit 630 in the present embodiment.
  • the data stored in the storage unit 620 is configured to be updatable by communication with the server 650. Therefore, the holding force of the rollers 433 and 434 can be adjusted more appropriately according to the specifications of the medical device P to be used, or the holding force can be adjusted according to the specifications of the new medical device P that has been put on the market (sold) over time. Can be adjusted.
  • FIG. 11 is a perspective view showing a modified example of FIG.
  • the present invention is not limited to this, and as shown in FIG. 11, a change in torque for moving the sheath 110 forward and backward when moving the sheath 110 forward and backward in addition to the gears 343 and 344 is detected between the rotating shaft 439 and the motor 346.
  • the detection unit 347 may be provided.
  • the frictional resistance of the medical device P with the rollers 433 and 434 can be simply considered to be uniform.
  • the surface on the tip end side of the sheath 110 is coated with a hydrophilic coating in consideration of lubricity and the like, the surface on the hand side may not be coated with a hydrophilic coating.
  • the load torque detected by the detection unit 347 becomes small when the surface of the sheath 110 shifts from non-hydrophilic to hydrophilic.
  • the rotation positions of the first arm 435 and the second arm 436 are adjusted to bring the roller 434 closer to the roller 433.
  • the frictional resistance between the rollers 433 and 434 and the sheath 110 changes, and it is effective that the long medical body such as the sheath 110 to be moved back and forth slips. Can be suppressed or prevented.
  • the medical long body constituting the medical device P attached to the cassette 400 of the robot catheter system 1 is the sheath 110 of the diagnostic imaging catheter 100 .
  • the medical long body constituting the medical device P is suitable for the object of the present invention such as a balloon catheter or a catheter for stent delivery in addition to the above. It can be applied to various catheters.
  • FIGS. 12 and 13 are diagrams showing a cassette 400a according to another embodiment of the present invention.
  • FIGS. 12 and 13 are diagrams showing a cassette 400a according to another embodiment of the present invention.
  • FIG. 12 and 13 are diagrams showing a cassette 400a according to another embodiment of the present invention.
  • FIG. 12 and 13 are diagrams showing a cassette 400a according to another embodiment of the present invention.
  • FIG. 12 and 13 are diagrams showing a cassette 400a according to another embodiment of the present invention.
  • other preferred embodiments of the present invention are shown below. That is, in the form shown below, when a hydrophilic coating is formed on the surface of the sheath 110, the sheath is formed by forming a portion in contact with the sheath having a relatively large contact area with the sheath 110 other than the roller. Slip is more strongly suppressed or prevented. Since the first drive unit 410 and the installation unit 450 constituting the cassette 400a are the same as the respective configurations indicated by the same reference numerals of the cassette 400,
  • the second drive unit 430a includes a drive belt 431a, a passive belt 431b, a drive pulley 432a, a passive pulley 433a, 433b, 433c, a support member 435b, an elastic member 436b, and a pinion gear 437a.
  • the drive belt 431a and the passive belt 431b are rotatably fixed to the cassette 400a.
  • the drive belt 431a is rotatably supported by a drive pulley 432a and a passive pulley 433a, which are drive shafts.
  • the passive belt 431b is rotatably supported by passive pulleys 433b and 433c.
  • the passive belt 431b is configured to be rotatably connected to the support member 435b. That is, the passive belt 431b is formed with a gangway through which the support member 435b is inserted near the center in the width direction of the belt.
  • the passive belt 431b is pressed against the drive belt 431a by the elastic member 436b and the movable portion 435d of the support member 435b with a constant stress that does not deform the sheath 110.
  • the support member 435b is formed in a long shape, and the movable portion 435d is provided at the end portion of the support member 435b in the longitudinal direction.
  • the elastic member 436b can be composed of a string-wound spring or the like that is inserted into the movable portion 435d of the support member 435b. With this configuration, elastic force (urging force) is applied to the passive belt 431b by the elastic member 436b.
  • the pinion gear 437a that constitutes the actuator is operated by a drive motor (not shown).
  • a bevel gear or the like as the main mechanism as described above, it is possible to transmit the rotation of the motor to the pinion gear 437a in the cassette 400a.
  • the rack 435c is provided on the support member 435b and is configured to be meshable with the teeth of the pinion gear 437a.
  • the rotation of the pinion gear 437a is converted by the rack 435c into a substantially linear approach / separation movement of the support member 435b with respect to the direction intersecting the belt surface of the passive belt 431b. That is, in the embodiment of FIGS. 12 and 13, the motor and gear similar to the motor 345 and gears 341 and 342 of FIG. 8, the pinion gear 347a, the support member 345b provided with the rack 345c, and the elastic member 346b constitute an actuator. To do.
  • the stress on the sheath 110 can be adjusted by the operation of the rack 435c and the pinion gear 437a of the support member 435b constituting the actuator.
  • the pinion gear 437a is rotated and the rack 435c of the support member 435b is displaced toward the sheath 110 side, the pressing load by the elastic member 436b increases.
  • the rack 435c of the support member 435b is displaced to the side opposite to the sheath 110, the pressing load by the elastic member 436b becomes small, so that the deformation of the sheath 110 can be suppressed.
  • the distance between the drive belt 431a and the passive belt 431b can be increased by the action of the actuator described above, and an operator such as a medical worker can easily attach / detach a long medical body such as a sheath 110. It becomes possible to do.
  • the drive pulley 432a of the drive belt 431a can operate to take a relatively large contact area with the sheath 110, and the sheath 110 can be moved back and forth in the longitudinal direction to prevent the sheath 110 from slipping. It can be strongly prevented or suppressed.
  • Robot catheter system 110 sheath (long medical body), 300 robot arm (arm), 341, 342 gears (actuators), 345 motor (first drive unit, actuator), 346 motor (second drive unit), 347 detector, 400 cassettes, 433 rollers (a pair of gripping members, a second gripping member), 434 Roller (a pair of gripping members, first gripping member), 435 1st arm (1st installation member, actuator), 436 Second arm (second installation member, actuator), 438 axis of rotation, 441 Elastic members (urging members, actuators), 600 computers, 620 Memory, 630 control unit, 650 server, 800 operation unit.

Abstract

[Problem] To provide a novel structure for a robot catheter system, the novel structure capable of adjusting the holding force for holding a medical-use long body. [Solution] An actuator, which is provided in a robot catheter system 1 for moving a sheath 110 backward and forward in the longitudinal direction, adjusts the space between a roller 433 and a roller 434 which send the sheath in the longitudinal direction, and moves one of the rollers 433, 434 towards the other.

Description

アクチュエータ及びロボットカテーテルシステムActuator and robot catheter system
 本発明は、アクチュエータ及びロボットカテーテルシステムに関する。 The present invention relates to an actuator and a robot catheter system.
 近年、心臓動脈の疾患を有する患者を治療・診断する際にロボットハンドを用いてカテーテル等の操作を行う場合がある。ロボットハンドは、複数の関節を備えることによって直進移動だけでなく、関節において多自由度に回転可能であるように構成している。ロボットハンドの先端には診断用カテーテルを取付け可能なカセットが設けられる。 In recent years, when treating and diagnosing a patient with a cardiovascular disease, a robot hand may be used to operate a catheter or the like. By providing a plurality of joints, the robot hand is configured so that it can rotate not only in a straight line but also in the joints with multiple degrees of freedom. A cassette to which a diagnostic catheter can be attached is provided at the tip of the robot hand.
 カセットには、ガイドワイヤを長手方向に移動可能な駆動機構と、診断用カテーテル等を移動可能な駆動機構と、を備えている。診断用カテーテルは、ホイールとローラーによって長手方向に移動可能に挟持される(特許文献1参照)。 The cassette is equipped with a drive mechanism that can move the guide wire in the longitudinal direction and a drive mechanism that can move the diagnostic catheter and the like. The diagnostic catheter is sandwiched by wheels and rollers so as to be movable in the longitudinal direction (see Patent Document 1).
特開2017-205546号公報JP-A-2017-205546
 特許文献1のようにローラーとホイール等によって診断用カテーテルを挟持して診断用カテーテルを長手方向に進退移動させると、診断用カテーテルはローラーとホイールによる挟持力を受ける。このように、診断用カテーテルが長手方向と交差する断面において径方向内方に収縮する力を受けると、カテーテル内部に造影剤等の流体を流通させたり、画像診断のための光等の媒体を伝送したりする機能が損なわれるおそれがある。カテーテルのような医療用長尺体は、管状部材の内部空間に様々な部材を移動させたりすることで手技を行うことが一般的であり、上記のような課題は医療用長尺体を使用するものであれば、画像診断用カテーテル以外の医療器具にも妥当しうる。 When the diagnostic catheter is sandwiched between a roller and a wheel and the diagnostic catheter is moved forward and backward in the longitudinal direction as in Patent Document 1, the diagnostic catheter receives the sandwiching force between the roller and the wheel. In this way, when the diagnostic catheter receives a force that contracts inward in the radial direction in the cross section intersecting the longitudinal direction, a fluid such as a contrast medium is circulated inside the catheter, or a medium such as light for diagnostic imaging is used. The function of transmitting may be impaired. For medical long bodies such as catheters, it is common to perform the procedure by moving various members into the internal space of the tubular member, and the above-mentioned problems use medical long bodies. If so, it can be applied to medical devices other than diagnostic imaging catheters.
 本発明は、上記課題に鑑みてなされたものであり、ロボットカテーテルシステムにおいて医療用長尺体を把持する把持力の調整が可能な新規なる構造を提供することを目的とする。 The present invention has been made in view of the above problems, and an object of the present invention is to provide a novel structure capable of adjusting the gripping force for gripping a medical long body in a robot catheter system.
 本発明の一態様は、医療用長尺体を長手方向に進退移動させるロボットカテーテルシステムに設けられ、前記医療用長尺体を前記長手方向に送る一対の把持部材において、一対の前記把持部材を構成する第1把持部材と第2把持部材との間隔を調整し、前記第1把持部材及び前記第2把持部材の少なくとも一方を他方に対して移動させるアクチュエータである。 One aspect of the present invention is provided in a robot catheter system that moves a medical elongated body forward and backward in the longitudinal direction, and in a pair of gripping members that feed the medical elongated body in the longitudinal direction, a pair of the gripping members is provided. It is an actuator that adjusts the distance between the first gripping member and the second gripping member to move at least one of the first gripping member and the second gripping member with respect to the other.
 また、本発明の一態様は、上記アクチュエータを搭載したロボットカテーテルシステムである。 Further, one aspect of the present invention is a robot catheter system equipped with the above actuator.
 上記アクチュエータ及びロボットカテーテルシステムによれば、ロボットカテーテルシステムにおいて医療用長尺体を把持する把持力の調整が可能になる。 According to the above actuator and robot catheter system, it is possible to adjust the gripping force for gripping a medical long body in the robot catheter system.
本発明の一実施形態に係るロボットカテーテルシステムを示す概略斜視図である。It is a schematic perspective view which shows the robot catheter system which concerns on one Embodiment of this invention. ロボットカテーテルシステムを構成するカセット及び医療用長尺体を示す正面図である。It is a front view which shows the cassette and the medical elongate which make up a robot catheter system. 医療用長尺体を含む医療器具について説明する概略図である。It is the schematic explaining the medical device including the medical long body. 医療器具の先端部を示す側面図である。It is a side view which shows the tip part of a medical device. 医療器具の基端側を示す断面図である。It is sectional drawing which shows the base end side of a medical device. ロボットカテーテルシステムにおいて一対のローラーによる把持力を調節する構成について示すカセット付近の拡大図である。It is an enlarged view around the cassette which shows the structure which adjusts the gripping force by a pair of rollers in a robot catheter system. ロボットカテーテルシステムにおいてカセットを構成する弾性部材の取り付けについて示す断面図である。It is sectional drawing which shows the attachment of the elastic member which constitutes a cassette in a robot catheter system. ロボットカテーテルシステムにおいて一対のローラーによる把持力を調節する構成について示し、カセットを一部切断した状態を示す概略斜視図である。It is a schematic perspective view which shows the structure which adjusts the gripping force by a pair of rollers in a robot catheter system, and shows the state which partially cut a cassette. コンピュータを示すブロック図である。It is a block diagram which shows a computer. ロボットカテーテルシステムにおける操作部を示す図である。It is a figure which shows the operation part in the robot catheter system. 図8の変形例を示す概略斜視図である。It is a schematic perspective view which shows the modification of FIG. 本発明の他の実施形態に係るカセットを示すカセット付近の拡大図である。It is an enlarged view around the cassette which shows the cassette which concerns on other embodiment of this invention. 図12に示す駆動ベルトと受動ベルトが図12に示す状態よりも離間した状態を示す図である。It is a figure which shows the state which the drive belt and the passive belt shown in FIG. 12 are separated from the state shown in FIG.
 以下、各図面を参照して、本発明の実施形態を説明する。なお、図面の寸法比率は、説明の都合上誇張されており、実際の比率とは異なる場合がある。本実施形態に係るロボットカテーテルシステムは、心臓動脈の疾患を有する患者の治療を行う際に使用される経皮的冠動脈インターベンション(Percutaneous Coronary Intervention:PCI)において利用される。 Hereinafter, embodiments of the present invention will be described with reference to each drawing. The dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios. The robotic catheter system according to the present embodiment is used in a percutaneous coronary intervention (PCI) used in treating a patient having a cardiovascular disease.
 図1は、本実施形態に係るロボットカテーテルシステム1の全体構成を示す概略斜視図であり、図2はロボットカテーテルシステム1を構成するカセット400及び医療器具P等を示す図である。 FIG. 1 is a schematic perspective view showing the overall configuration of the robot catheter system 1 according to the present embodiment, and FIG. 2 is a diagram showing a cassette 400, a medical device P, and the like constituting the robot catheter system 1.
 ロボットカテーテルシステム1は、シース110を長手方向に進退移動させる際等に使用される。図1に示すように、本実施形態に係るロボットカテーテルシステム1は、シース110(医療用長尺体に相当)を含む医療器具Pと、ベッド200と、ロボットアーム300と、を有する。ロボットカテーテルシステム1は、カセット400と、コンピュータ600と、照射装置700と、操作部800と、を有する。 The robot catheter system 1 is used when moving the sheath 110 forward and backward in the longitudinal direction. As shown in FIG. 1, the robot catheter system 1 according to the present embodiment includes a medical device P including a sheath 110 (corresponding to a long medical body), a bed 200, and a robot arm 300. The robot catheter system 1 includes a cassette 400, a computer 600, an irradiation device 700, and an operation unit 800.
 (医療器具)
 まず、ロボットカテーテルシステム1に取付けられる医療器具Pについて説明する。図3はロボットカテーテルシステム1に取付けられる医療器具の一例として画像診断用カテーテル(以下、画像カテーテル又はカテーテルデバイスと言う)の全体構成を示す図である。図4は画像診断カテーテル100の先端を示す図、図5は画像診断用カテーテルの基端側を示す断面図である。
(Medical equipment)
First, the medical device P attached to the robot catheter system 1 will be described. FIG. 3 is a diagram showing an overall configuration of an image diagnostic catheter (hereinafter referred to as an image catheter or a catheter device) as an example of a medical device attached to the robot catheter system 1. FIG. 4 is a view showing the tip of the diagnostic imaging catheter 100, and FIG. 5 is a cross-sectional view showing the proximal end side of the diagnostic imaging catheter.
 本実施形態に係る医療器具は、血管内超音波診断法(IVUS)と、光干渉断層診断法(OCT)との両方の機能を備えるデュアルタイプの画像診断カテーテル100である。ただし、外部装置500に接続可能な医療器具は上記に限定されず、例えばIVUS用カテーテル、OCT用カテーテルや、診断画像を取得する目的以外で使用されるカテーテル(例えば、治療用カテーテル等)であってもよい。 The medical device according to the present embodiment is a dual type diagnostic imaging catheter 100 having both functions of endovascular ultrasonic diagnosis (IVUS) and optical coherence tomography (OCT). However, the medical device that can be connected to the external device 500 is not limited to the above, and is, for example, an IVUS catheter, an OCT catheter, or a catheter used for purposes other than obtaining a diagnostic image (for example, a therapeutic catheter). You may.
 図3~図5を参照して、画像診断カテーテル100について説明する。 The diagnostic imaging catheter 100 will be described with reference to FIGS. 3 to 5.
 図3に示すように、画像診断カテーテル100は、外部装置500に接続されることによって駆動される。 As shown in FIG. 3, the diagnostic imaging catheter 100 is driven by being connected to an external device 500.
 図3~5に示すように、画像診断カテーテル100は、概説すると、生体の体腔内に挿入される長尺状のシース110と、シース110の基端側に設けられた外管120と、を有する。画像診断カテーテル100は、外管120内に進退移動可能に挿入される内側シャフト130と、信号を送受信する信号送受信部145を先端に有してシース110内に回転可能に設けられる駆動シャフト140と、を有する。画像診断カテーテル100は、外管120の基端側に設けられ内側シャフト130を受容するように構成されたユニットコネクタ150と、内側シャフト130の基端側に設けられたハブ160と、を有している。 As shown in FIGS. 3 to 5, the diagnostic imaging catheter 100 generally includes a long sheath 110 inserted into the body cavity of a living body and an outer tube 120 provided on the proximal end side of the sheath 110. Have. The diagnostic imaging catheter 100 includes an inner shaft 130 that is inserted into the outer tube 120 so as to be movable back and forth, and a drive shaft 140 that has a signal transmission / reception unit 145 at the tip and is rotatably provided in the sheath 110. , Have. The diagnostic imaging catheter 100 has a unit connector 150 provided on the proximal end side of the outer tube 120 and configured to receive the inner shaft 130, and a hub 160 provided on the proximal end side of the inner shaft 130. ing.
 明細書の説明においては、画像診断カテーテル100の体腔内に挿入される側を先端側と称し、画像診断カテーテル100に設けられたハブ160側を基端側と称し、シース110の延在方向を軸方向と称する。 In the description of the specification, the side inserted into the body cavity of the diagnostic imaging catheter 100 is referred to as the distal end side, the hub 160 side provided in the diagnostic imaging catheter 100 is referred to as the proximal end side, and the extending direction of the sheath 110 is referred to as the extending direction. It is called the axial direction.
 図3に示すように、駆動シャフト140は、シース110とシース110の基端に接続した外管120と外管120内に挿入される内側シャフト130とを通り、ハブ160の内部まで延在している。 As shown in FIG. 3, the drive shaft 140 passes through the sheath 110, the outer tube 120 connected to the base end of the sheath 110, and the inner shaft 130 inserted into the outer tube 120, and extends to the inside of the hub 160. ing.
 ハブ160、内側シャフト130、駆動シャフト140、及び信号送受信部145は、それぞれが一体的に軸方向に進退移動するように互いに接続されている。このため、例えば、ハブ160が先端側に向けて押される操作がなされると、ハブ160に接続された内側シャフト130は外管120内およびユニットコネクタ150内に押し込まれる。そして、駆動シャフト140および信号送受信部145がシース110の内部を先端側へ移動する。例えば、ハブ160が基端側に引かれる操作がなされると、内側シャフト130は、図3中の矢印a1で示すように外管120およびユニットコネクタ150から引き出される。また、ハブ160が基端側に引かれる操作がなされると、駆動シャフト140および信号送受信部145は、図3の矢印a2で示すように、シース110の内部を基端側へ移動する。 The hub 160, the inner shaft 130, the drive shaft 140, and the signal transmission / reception unit 145 are connected to each other so as to move forward and backward in the axial direction. Therefore, for example, when the hub 160 is pushed toward the tip end side, the inner shaft 130 connected to the hub 160 is pushed into the outer pipe 120 and the unit connector 150. Then, the drive shaft 140 and the signal transmission / reception unit 145 move inside the sheath 110 toward the tip side. For example, when the hub 160 is pulled toward the proximal end side, the inner shaft 130 is pulled out from the outer tube 120 and the unit connector 150 as shown by the arrow a1 in FIG. Further, when the hub 160 is pulled toward the proximal end side, the drive shaft 140 and the signal transmitting / receiving unit 145 move inside the sheath 110 toward the proximal end side as shown by the arrow a2 in FIG.
 図3に示すように内側シャフト130が先端側へ最も押し込まれたときには、内側シャフト130の先端部は中継コネクタ170付近まで到達する。この際、信号送受信部145は、シース110の先端付近に位置する。中継コネクタ170はシース110と外管120とを接続するコネクタである。 As shown in FIG. 3, when the inner shaft 130 is pushed most toward the tip side, the tip portion of the inner shaft 130 reaches the vicinity of the relay connector 170. At this time, the signal transmission / reception unit 145 is located near the tip of the sheath 110. The relay connector 170 is a connector that connects the sheath 110 and the outer tube 120.
 図4に示すように、駆動シャフト140は、可撓性を有する管体141を備え、その内部には信号送受信部145に接続される電気信号ケーブル142および光ファイバ143が配されている。管体141は、例えば軸まわりの巻き方向が異なる多層のコイルによって構成することができる。コイルの構成材料として、例えばステンレス、Ni-Ti(ニッケル・チタン)合金、白金、イリジウム合金などが挙げられる。電気信号ケーブル142は、本実施形態では、図4に示すように後述するコネクタ部165に設けられた電極端子に接続されている。電気信号ケーブル142は、高周波電圧を送受信するために2本の信号線142a、142bを備えるように構成している。 As shown in FIG. 4, the drive shaft 140 includes a flexible tube body 141, and an electric signal cable 142 and an optical fiber 143 connected to a signal transmission / reception unit 145 are arranged inside the drive shaft 140. The tube body 141 can be composed of, for example, a multi-layer coil having different winding directions around the axis. Examples of the constituent material of the coil include stainless steel, Ni—Ti (nickel / titanium) alloy, platinum, and iridium alloy. In the present embodiment, the electric signal cable 142 is connected to an electrode terminal provided in the connector portion 165, which will be described later, as shown in FIG. The electric signal cable 142 is configured to include two signal lines 142a and 142b for transmitting and receiving high frequency voltage.
 信号送受信部145は、図4に示すように、超音波を送受信する超音波送受信部145aと、光を送受信する光送受信部145bと、を有している。 As shown in FIG. 4, the signal transmission / reception unit 145 has an ultrasonic wave transmission / reception unit 145a for transmitting / receiving ultrasonic waves and an optical transmission / reception unit 145b for transmitting / receiving light.
 超音波送受信部145aは、振動子を備え、パルス信号に基づく超音波を体腔内に送信し、かつ、体腔内の生体組織から反射してきた超音波を受信する機能を有している。超音波送受信部145aは、電気信号ケーブル142を介して画像診断カテーテル100の基端側において電極端子(図示省略)と電気的に接続している。 The ultrasonic transmission / reception unit 145a is provided with an oscillator, and has a function of transmitting ultrasonic waves based on a pulse signal into the body cavity and receiving ultrasonic waves reflected from living tissues in the body cavity. The ultrasonic transmission / reception unit 145a is electrically connected to an electrode terminal (not shown) on the proximal end side of the diagnostic imaging catheter 100 via an electric signal cable 142.
 超音波送受信部145aが備える振動子としては、例えば、セラミックス、水晶などの圧電材を用いることができる。 As the vibrator included in the ultrasonic transmission / reception unit 145a, for example, a piezoelectric material such as ceramics or quartz can be used.
 光送受信部145bは、伝送された測定光を連続的に体腔内に送信するとともに、体腔内の生体組織からの反射光を連続的に受信する。光送受信部145bは、光ファイバ143の先端に設けられ、光を集光するレンズ機能と反射する反射機能とを備えるボールレンズ(光学素子)を有する。 The light transmission / reception unit 145b continuously transmits the transmitted measurement light into the body cavity and continuously receives the reflected light from the living tissue in the body cavity. The light transmission / reception unit 145b has a ball lens (optical element) provided at the tip of the optical fiber 143 and having a lens function for collecting light and a reflection function for reflecting light.
 信号送受信部145は、図4に示すようにハウジング146の内部に収容される。ハウジング146の基端側は駆動シャフト140に接続されている。ハウジング146は、図4に示すように円筒状の金属パイプの円筒面に超音波送受信部145aが送受信する超音波および光送受信部145bが送受信する光の進行を妨げないように開口部が設けられた形状をしている。 The signal transmission / reception unit 145 is housed inside the housing 146 as shown in FIG. The base end side of the housing 146 is connected to the drive shaft 140. As shown in FIG. 4, the housing 146 is provided with an opening on the cylindrical surface of a cylindrical metal pipe so as not to obstruct the progress of ultrasonic waves transmitted and received by the ultrasonic wave transmitting and receiving unit 145a and light transmitted and received by the optical transmitting and receiving unit 145b. It has a good shape.
 図4に示すように、シース110は、駆動シャフト140が進退移動可能に挿入されるルーメン110aを備える。シース110の先端部には、シース110に設けられたルーメン110aに並設されて、ガイドワイヤGが挿通可能なガイドワイヤルーメン114aを備えるガイドワイヤ挿通部材114が取付けられている。シース110およびガイドワイヤ挿通部材114は、熱融着等により一体的に構成することが可能である。ガイドワイヤ挿通部材114には、X線造影性を有するマーカー115が設けられている。マーカー115は、Pt、Au等のX線不透過性の高い金属コイルから構成される。 As shown in FIG. 4, the sheath 110 includes a lumen 110a into which the drive shaft 140 is inserted so as to be movable back and forth. A guide wire insertion member 114 is attached to the tip of the sheath 110 so as to be juxtaposed with the lumen 110a provided on the sheath 110 and provided with a guide wire lumen 114a through which the guide wire G can be inserted. The sheath 110 and the guide wire insertion member 114 can be integrally formed by heat fusion or the like. The guide wire insertion member 114 is provided with a marker 115 having X-ray contrast property. The marker 115 is composed of a metal coil having high X-ray impermeable properties such as Pt and Au.
 シース110の先端部には、ルーメン110aの内部と外部とを連通する連通孔116が形成されている。また、シース110の先端部には、ガイドワイヤ挿通部材114を強固に接合・支持するための補強部材117が設けられる。補強部材117には、補強部材117より基端側に配置されるルーメン110aの内部と連通孔116とを連通する連通路117aが形成されている。なお、シース110の先端部には、補強部材117が設けられていなくてもよい。 A communication hole 116 that communicates the inside and the outside of the lumen 110a is formed at the tip of the sheath 110. Further, a reinforcing member 117 for firmly joining and supporting the guide wire insertion member 114 is provided at the tip of the sheath 110. The reinforcing member 117 is formed with a communication passage 117a that communicates the inside of the lumen 110a arranged on the proximal end side of the reinforcing member 117 with the communication hole 116. The reinforcing member 117 may not be provided at the tip of the sheath 110.
 連通孔116は、プライミング液を排出するためのプライミング液排出孔である。画像診断カテーテル100を使用する際は、シース110内の空気による超音波の減衰を減らし、超音波を効率良く送受信するため、プライミング液をシース110内に充填させるプライミング処理を行う。プライミング処理を行う際に、プライミング液を連通孔116から生体管腔に放出させて、プライミング液とともに空気等の気体をシース110の内部から排出することができる。 The communication hole 116 is a priming liquid discharge hole for discharging the priming liquid. When the diagnostic imaging catheter 100 is used, a priming process is performed in which the sheath 110 is filled with a priming solution in order to reduce the attenuation of ultrasonic waves due to air in the sheath 110 and efficiently transmit and receive ultrasonic waves. When performing the priming treatment, the priming liquid can be discharged from the communication hole 116 into the living lumen, and a gas such as air can be discharged from the inside of the sheath 110 together with the priming liquid.
 シース110、ガイドワイヤ挿通部材114および補強部材117は、可撓性を有する材料で形成され、その材料は、特に限定されず、例えば、スチレン系、ポリオレフィン系、ポリウレタン系、ポリエステル系、ポリアミド系、ポリイミド系、ポリブタジエン系、トランスポリイソプレン系、フッ素ゴム系、塩素化ポリエチレン系等の各種熱可塑性エラストマー等が挙げられ、これらのうちの1種または2種以上を組合せたもの(ポリマーアロイ、ポリマーブレンド、積層体等)も用いることができる。なお、シース110の外表面には、湿潤時に潤滑性を示す親水性潤滑被覆層を配置することが可能である。 The sheath 110, the guide wire insertion member 114, and the reinforcing member 117 are made of a flexible material, and the material is not particularly limited, and examples thereof include styrene-based, polyolefin-based, polyurethane-based, polyester-based, and polyamide-based. Examples thereof include various thermoplastic elastomers such as polyimide-based, polybutadiene-based, transpolyisoprene-based, fluororubber-based, and chlorinated polyethylene-based, and one or a combination of two or more of these (polymer alloy, polymer blend). , Laminates, etc.) can also be used. A hydrophilic lubricating coating layer that exhibits lubricity when wet can be arranged on the outer surface of the sheath 110.
 図5に示すように、ハブ160は、中空形状を有するハブ本体161と、ハブ本体161の基端側に接続されるコネクタケース165cと、ハブ本体161の内部に連通するポート162と、を備える。ハブ160は、外部装置500との接続を行う際にハブ160の位置(方向)決めをするための突起163a、163bと、駆動シャフト140を保持する接続パイプ164bと、を備える。ハブ160は、接続パイプ164bを回転自在に支持する軸受164cと、接続パイプ164bと軸受164cの間から基端側に向かってプライミング液が漏れるのを防止するシール部材164aと、を備える。ハブ160は、外部装置500に接続される電極端子165aおよび光コネクタ165bが内部に配置されたコネクタ部165を備える。 As shown in FIG. 5, the hub 160 includes a hub body 161 having a hollow shape, a connector case 165c connected to the base end side of the hub body 161 and a port 162 communicating with the inside of the hub body 161. .. The hub 160 includes protrusions 163a and 163b for determining the position (direction) of the hub 160 when connecting to the external device 500, and a connection pipe 164b for holding the drive shaft 140. The hub 160 includes a bearing 164c that rotatably supports the connecting pipe 164b, and a sealing member 164a that prevents the priming liquid from leaking from between the connecting pipe 164b and the bearing 164c toward the proximal end side. The hub 160 includes an electrode terminal 165a connected to the external device 500 and a connector portion 165 in which the optical connector 165b is arranged inside.
 ハブ本体161の先端部には内側シャフト130が接続されている。駆動シャフト140は、ハブ本体161の内部において内側シャフト130から引き出されている。 The inner shaft 130 is connected to the tip of the hub body 161. The drive shaft 140 is pulled out from the inner shaft 130 inside the hub body 161.
 ポート162には、プライミング処理を行う際に、プライミング液を注入する注入デバイスS(図3参照)が接続される。注入デバイスSは、ポート162に接続されるコネクタS1と、コネクタS1に接続されるチューブS2と、チューブS2に接続される三方活栓S3と、を備える。注入デバイスSは、三方活栓S3に接続されるとともに、プライミング液をポート162に注入可能な第1シリンジS4及び第2シリンジS5を備える。第2シリンジS5は、第1シリンジS4よりも容量が大きく、第1シリンジS4が注入するプライミング液の量が不足している場合等に、補助的に使用されるシリンジである。 An injection device S (see FIG. 3) for injecting the priming liquid is connected to the port 162 when performing the priming process. The injection device S includes a connector S1 connected to the port 162, a tube S2 connected to the connector S1, and a three-way stopcock S3 connected to the tube S2. The injection device S includes a first syringe S4 and a second syringe S5 that are connected to the three-way stopcock S3 and capable of injecting the priming liquid into the port 162. The second syringe S5 is a syringe that has a larger capacity than the first syringe S4 and is used as an auxiliary when the amount of the priming liquid to be injected by the first syringe S4 is insufficient.
 接続パイプ164bは、外部装置500によって回転駆動する電極端子165aおよび光コネクタ165bの回転を駆動シャフト140に伝達するために、駆動シャフト140を保持する。接続パイプ164bの内部には電気信号ケーブル142および光ファイバ143が挿通されている。 The connection pipe 164b holds the drive shaft 140 in order to transmit the rotation of the electrode terminal 165a and the optical connector 165b, which are rotationally driven by the external device 500, to the drive shaft 140. An electric signal cable 142 and an optical fiber 143 are inserted inside the connecting pipe 164b.
 コネクタ部165は、電気信号ケーブル142と電気的に接続される電極端子165aと、光ファイバに接続される光コネクタ165bと、を備える。超音波送受信部145aにおける受信信号は、電極端子165aを介して外部装置500に送信され、所定の処理を施されて画像として表示される。光送受信部145bにおける受信信号は、光コネクタ165bを介して外部装置500に送信され、所定の処理を施されて画像として表示される。 The connector portion 165 includes an electrode terminal 165a that is electrically connected to the electric signal cable 142 and an optical connector 165b that is connected to an optical fiber. The received signal in the ultrasonic transmission / reception unit 145a is transmitted to the external device 500 via the electrode terminal 165a, subjected to predetermined processing, and displayed as an image. The received signal in the optical transmission / reception unit 145b is transmitted to the external device 500 via the optical connector 165b, subjected to predetermined processing, and displayed as an image.
 (外部装置)
 図3を参照して、画像診断カテーテル100は、外部装置500に接続されて駆動される。
(External device)
With reference to FIG. 3, the diagnostic imaging catheter 100 is connected to and driven by an external device 500.
 上述したように、外部装置500は、ハブ160の基端側に設けられたコネクタ部165(図5参照)に接続される。 As described above, the external device 500 is connected to the connector portion 165 (see FIG. 5) provided on the base end side of the hub 160.
 また、外部装置500は、図3に示すように、駆動シャフト140を回転させるための動力源であるモータ500aと、駆動シャフト140を軸方向に移動させるための動力源であるモータ500bと、を有する。モータ500bの回転運動は、モータ500bに接続したボールねじ500cによって軸方向の運動に変換される。 Further, as shown in FIG. 3, the external device 500 includes a motor 500a which is a power source for rotating the drive shaft 140 and a motor 500b which is a power source for moving the drive shaft 140 in the axial direction. Have. The rotational motion of the motor 500b is converted into axial motion by the ball screw 500c connected to the motor 500b.
 外部装置500の動作は、これに電気的に接続した制御装置501によって制御される。制御装置501は、CPU(Central Processing Unit)501aおよびメモリを主たる構成として含む。制御装置501は、モニタ502に電気的に接続している。制御装置501は、サーバ(図示省略)と電気的に接続することができる。 The operation of the external device 500 is controlled by the control device 501 electrically connected to the external device 500. The control device 501 includes a CPU (Central Processing Unit) 501a and a memory as a main configuration. The control device 501 is electrically connected to the monitor 502. The control device 501 can be electrically connected to a server (not shown).
 (ベッド)
 ベッド200は、地面に載置された台座から地面に直行する方向に配置され、およそ地面に沿って延在し、子供から成人までの患者Paを支持可能かつ平坦な面を備えるように構成している。ベッド200は、ロボットアーム300の先端に取付けられたカセット400に医療器具Pを取付け、ロボットアーム300を操作した際に医療器具Pがベッド200の上方に配置できるように構成している。ベッド200は、本実施形態において成人の体格に合わせてテーブルの大きさを構成しているが、スライド機構を搭載して患者Paの体格に合わせてテーブルの大きさを複数段階に変化可能に構成してもよい。
(bed)
The bed 200 is arranged in a direction perpendicular to the ground from a pedestal placed on the ground, extends approximately along the ground, and is configured to have a flat surface capable of supporting patient Pa from children to adults. ing. The bed 200 is configured such that the medical device P is attached to a cassette 400 attached to the tip of the robot arm 300 so that the medical device P can be arranged above the bed 200 when the robot arm 300 is operated. In the present embodiment, the bed 200 has a table size configured according to the physique of an adult, but is equipped with a slide mechanism so that the table size can be changed in a plurality of stages according to the physique of the patient Pa. You may.
 (ロボットアーム)
 ロボットアーム300は、カセット400を保持するように構成している。ロボットアーム300は、図1に示すように第1軸310と、第2軸320と、第3軸330と、第3軸330の先端に設けられる取付け部340と、を備える垂直多関節ロボットとして構成している。第1軸310と第2軸320とは回転可能に接続され、第2軸320と第3軸330とは回転可能に接続される。第1軸310、第2軸320、及び第3軸330はサーボモータ等によって回転駆動するように構成している。ロボットアーム300は、上記のように構成することによって先端に取付けたカセット400を6自由度にて並進移動及び回転移動可能に構成している。ただし、ロボットハンドの自由度はカセット400に取付けた医療器具Pを所望の位置に並進移動及び回転移動して到達できれば、ロボットの自由度は6自由度に限定されない。なお、取付け部340についてはカセット400の説明において記載する。
(Robot arm)
The robot arm 300 is configured to hold the cassette 400. As shown in FIG. 1, the robot arm 300 is a vertical articulated robot including a first axis 310, a second axis 320, a third axis 330, and a mounting portion 340 provided at the tip of the third axis 330. It is configured. The first shaft 310 and the second shaft 320 are rotatably connected, and the second shaft 320 and the third shaft 330 are rotatably connected. The first shaft 310, the second shaft 320, and the third shaft 330 are configured to be rotationally driven by a servomotor or the like. The robot arm 300 is configured as described above so that the cassette 400 attached to the tip can be translated and rotated with 6 degrees of freedom. However, the degree of freedom of the robot hand is not limited to 6 degrees of freedom as long as the medical device P attached to the cassette 400 can be reached by translating and rotating to a desired position. The mounting portion 340 will be described in the description of the cassette 400.
 (カセット)
 カセット400は単回使用として構成でき、ロボットアーム300における第3軸330の先端に設けられた取付け部340において取替え可能に設置し、患者Paに対する手技に用いられるガイドワイヤGと医療器具Pを移動可能に構成している。カセット400は、図2に示すように第1駆動部410と、第2駆動部430と、設置部450と、を備える。
(cassette)
The cassette 400 can be configured for single use and is replaceably installed at the attachment portion 340 provided at the tip of the third axis 330 of the robot arm 300 to move the guide wire G and the medical device P used for the procedure for the patient Pa. It is configured to be possible. As shown in FIG. 2, the cassette 400 includes a first drive unit 410, a second drive unit 430, and an installation unit 450.
 カセット400は、図2に示す左右方向において第1駆動部410によってガイドワイヤGを進退移動可能に構成している。第1駆動部410は、ローラー411~422を備える。ローラー411~422は、奇数の符号で示すローラーをガイドワイヤGに対して一方の側、すなわち図2においてガイドワイヤGに対して上側に配置している。ローラー411~422は、ガイドワイヤGに対して他方の側、すなわち図2においてガイドワイヤGに対して下側に偶数の符号で示すローラーを配置している。ローラー411~420は、奇数又は偶数の符号で示すローラーをモータ等によって駆動ローラーとし、他方を従動ローラーとして構成している。第1駆動部410における駆動ローラーはモータ等のアクチュエータ(図示省略)によって回転可能に構成している。 The cassette 400 is configured so that the guide wire G can be moved forward and backward by the first drive unit 410 in the left-right direction shown in FIG. The first drive unit 410 includes rollers 411 to 422. The rollers 411 to 422 have rollers represented by odd-numbered symbols arranged on one side of the guide wire G, that is, on the upper side of the guide wire G in FIG. The rollers 411 to 422 are arranged on the other side with respect to the guide wire G, that is, on the lower side with respect to the guide wire G in FIG. 2, the rollers indicated by even numbers. The rollers 411 to 420 are configured such that the rollers indicated by odd-numbered or even-numbered symbols are driven rollers by a motor or the like, and the other is a driven roller. The drive roller in the first drive unit 410 is configured to be rotatable by an actuator (not shown) such as a motor.
 第2駆動部430は、上述した画像診断カテーテル等の医療器具Pを長手方向に進退移動可能に構成している。第2駆動部430は、図6に示すようにローラー431~434と、第1アーム435と、第2アーム436と、回転軸437、438、439と、弾性部材441と、を備える。また、ロボットアーム300の取付け部340は、ギア341、342と、ギア343、344と、モータ345、346と、を備える。ここでローラー433、434は一対の把持部材に相当する。また、ローラー434は第1把持部材に相当し、ローラー433は第2把持部材に相当する。また、モータ345は第1駆動部に相当し、モータ346は第2駆動部に相当する。また、第1アーム435は第1設置部材に相当し、第2アーム436は第2設置部材に相当する。また、弾性部材441は付勢部材に相当する。また、モータ345、ギア341、342及び第1アーム435は、ロボットカテーテルシステム1においてシース110を含む医療器具Pを長手方向に送るローラー433、434においてローラー433、434の間隔を調整する。モータ345、ギア341、342及び第1アーム435はアクチュエータに相当する。 The second drive unit 430 is configured so that the medical device P such as the above-mentioned diagnostic imaging catheter can be moved forward and backward in the longitudinal direction. As shown in FIG. 6, the second drive unit 430 includes rollers 431 to 434, a first arm 435, a second arm 436, a rotating shaft 437, 438, 439, and an elastic member 441. Further, the mounting portion 340 of the robot arm 300 includes gears 341 and 342, gears 343 and 344, and motors 345 and 346. Here, the rollers 433 and 434 correspond to a pair of gripping members. Further, the roller 434 corresponds to the first gripping member, and the roller 433 corresponds to the second gripping member. Further, the motor 345 corresponds to the first drive unit, and the motor 346 corresponds to the second drive unit. Further, the first arm 435 corresponds to the first installation member, and the second arm 436 corresponds to the second installation member. Further, the elastic member 441 corresponds to an urging member. Further, the motor 345, the gears 341, 342 and the first arm 435 adjust the distance between the rollers 433 and 434 in the rollers 433 and 434 that send the medical device P including the sheath 110 in the longitudinal direction in the robot catheter system 1. The motor 345, gears 341, 342 and the first arm 435 correspond to actuators.
 ローラー431~434は、ローラー411~422と同様に奇数の符号で示すローラーを医療器具Pに対して一方の側、図2において医療器具Pの上側に配置している。ローラー431~434は、偶数の符号で示すローラーを医療器具Pに対して他方の側、すなわち図2において医療器具Pに対して下側に配置するように構成している。ローラー431~434は、奇数の符号で示すローラーをモータ等によって駆動ローラーとし、他方を従動ローラーとなるように構成している。医療器具Pは、第2駆動部430によって、長手方向と交差する方向において挟持されながら、長手方向に進退移動可能に構成している。 As for the rollers 431 to 434, similarly to the rollers 411 to 422, the rollers indicated by odd-numbered symbols are arranged on one side with respect to the medical device P, and on the upper side of the medical device P in FIG. The rollers 431 to 434 are configured so that the rollers represented by the even-numbered reference numerals are arranged on the other side with respect to the medical device P, that is, on the lower side with respect to the medical device P in FIG. The rollers 431 to 434 are configured such that the rollers indicated by odd numbers are driven rollers by a motor or the like, and the other is a driven roller. The medical device P is configured to be movable back and forth in the longitudinal direction while being sandwiched by the second drive unit 430 in a direction intersecting the longitudinal direction.
 第1アーム435は、ローラー433、434の間隔を調整し、ローラー434をローラー433に対して移動させる。第1アーム435はモータ345によって回転可能に構成され、回転軸437においてローラー434を回転可能に取付けている。第1アーム435はカセット400において回転軸438によって回転可能に支持されている。このように構成することによって、ローラー434がローラー433に接近離間可能になり、ローラー433とローラー434との相対的な間隔が調節される。すなわち、第1アーム435が回転軸438を中心に図6において時計回りに回転すれば、ローラー433とローラー434とが接近する。反対に、第1アーム435が回転軸438を中心に反時計周りに回転すれば、ローラー434がローラー433に対して離間する。第1アーム435には弾性部材441を取付け可能な取付け部435aを備える。取付け部435aは、図7に示すように後述する弾性部材441を取付けられるように中空の円筒形状に構成している。 The first arm 435 adjusts the distance between the rollers 433 and 434 and moves the roller 434 with respect to the roller 433. The first arm 435 is rotatably configured by a motor 345, and a roller 434 is rotatably attached to a rotating shaft 437. The first arm 435 is rotatably supported by a rotating shaft 438 in the cassette 400. With this configuration, the roller 434 can be approached and separated from the roller 433, and the relative distance between the roller 433 and the roller 434 is adjusted. That is, when the first arm 435 rotates clockwise in FIG. 6 about the rotation shaft 438, the roller 433 and the roller 434 come close to each other. On the contrary, when the first arm 435 rotates counterclockwise about the rotation shaft 438, the roller 434 is separated from the roller 433. The first arm 435 is provided with a mounting portion 435a to which the elastic member 441 can be mounted. As shown in FIG. 7, the mounting portion 435a is formed in a hollow cylindrical shape so that the elastic member 441 described later can be mounted.
 第2アーム436は、モータ345によって回転可能であって、回転軸438に支持される。第2アーム436は、第1アーム435と同様に弾性部材441を取付け可能な取付け部436aを備える。取付け部436aは、図7に示すように取付け部435aの内部空間に挿入可能に構成している。これにより、第1アーム435と第2アーム436は回転軸438の周りにおける回転方向において接近離間可能に構成される。モータ345による第1アーム435及び第2アーム436の操作、即ち回転角度の設定は、後述する操作部800によって行われる。 The second arm 436 can be rotated by the motor 345 and is supported by the rotating shaft 438. The second arm 436 includes a mounting portion 436a to which the elastic member 441 can be mounted, similarly to the first arm 435. As shown in FIG. 7, the mounting portion 436a is configured to be insertable into the internal space of the mounting portion 435a. As a result, the first arm 435 and the second arm 436 are configured to be close to each other in the rotation direction around the rotation shaft 438. The operation of the first arm 435 and the second arm 436 by the motor 345, that is, the setting of the rotation angle is performed by the operation unit 800 described later.
 回転軸439は、ローラー433、434において駆動ローラーにあたるローラー434を回転可能に支持するためにカセット400に設けられる。 The rotation shaft 439 is provided on the cassette 400 to rotatably support the roller 434, which is the drive roller in the rollers 433 and 434.
 弾性部材441は、第1アーム435の取付け部435aと第2アーム436の取付け部436aに取付け可能に設けられる。弾性部材441は、第1アーム435と第2アーム436の回転方向において第1アーム435に対して第2アーム436を付勢可能な圧縮ばね等を使用するように構成している。これにより、ローラー433、434によって医療器具Pに一定の挟持力が付与され、医療器具Pの滑りを防止又は抑制する。また、シース110の外径が一様でなく、変化している場合にはシース110において径が変わる部分にローラー433、434が達した時点で弾性部材441が作用し、わずかな応力変化のみでシース110に過剰な挟持力がかからないように構成している。 The elastic member 441 is provided so as to be attachable to the attachment portion 435a of the first arm 435 and the attachment portion 436a of the second arm 436. The elastic member 441 is configured to use a compression spring or the like capable of urging the second arm 436 with respect to the first arm 435 in the rotation direction of the first arm 435 and the second arm 436. As a result, the rollers 433 and 434 impart a constant holding force to the medical device P to prevent or suppress the slip of the medical device P. Further, when the outer diameter of the sheath 110 is not uniform and changes, the elastic member 441 acts when the rollers 433 and 434 reach the portion of the sheath 110 where the diameter changes, and only a slight stress change is required. The sheath 110 is configured so that an excessive holding force is not applied.
 ギア341は従動側である回転軸438を回転させるためにロボットアーム300の取付け部340に設けられる。ギア341は、図8に示すようにモータ345から導出され、回転軸438と交差する軸に回転可能に取付けられている。ギア342は、カセット400における回転軸438に回転可能に設けている。ギア341とギア342とは噛み合うことによってモータ345からの回転を回転軸438の回転に変換可能に構成している。ギア341、342は、本実施形態においていわゆるベベルギアとして構成している。 The gear 341 is provided on the mounting portion 340 of the robot arm 300 in order to rotate the rotating shaft 438 on the driven side. The gear 341 is derived from the motor 345 as shown in FIG. 8 and is rotatably attached to a shaft intersecting the rotation shaft 438. The gear 342 is rotatably provided on the rotating shaft 438 of the cassette 400. By meshing the gear 341 and the gear 342, the rotation from the motor 345 can be converted into the rotation of the rotation shaft 438. The gears 341 and 342 are configured as so-called bevel gears in the present embodiment.
 ギア343は、駆動側であるローラー433を回転させるためにロボットアーム300の取付け部340に設けられる。ギア343はモータ346から導出され、回転軸439と交差する軸に回転可能に取付けられている。ギア344は、カセット400におけるローラー434の回転軸439に回転可能に設けている。ギア343とギア344とが噛み合うことによって、モータ346からの回転をローラー433の回転に変換可能に構成している。ギア343、344は上記と同様にベベルギアによって構成することができる。 The gear 343 is provided on the mounting portion 340 of the robot arm 300 in order to rotate the roller 433 on the drive side. The gear 343 is derived from the motor 346 and is rotatably attached to a shaft that intersects the rotating shaft 439. The gear 344 is rotatably provided on the rotating shaft 439 of the roller 434 in the cassette 400. By engaging the gear 343 and the gear 344, the rotation from the motor 346 can be converted into the rotation of the roller 433. The gears 343 and 344 can be configured by bevel gears as described above.
 モータ345は、第1アーム435を第2アーム436に対して相対的に接近又は離間させる駆動力を付与する。モータ346は、回転軸439の周りにローラー433を回転させるために設けられる。モータ345、モータ346は、公知のモータによって構成できる。 The motor 345 applies a driving force that causes the first arm 435 to approach or separate from the second arm 436. The motor 346 is provided to rotate the roller 433 around the rotation shaft 439. The motor 345 and the motor 346 can be configured by a known motor.
 設置部450は、第1駆動部410、第2駆動部430及びガイドワイヤG及び医療器具Pを挿通させる医療デバイスを設置するように構成している。設置部450は、図2に示すように第1設置部451と、第2設置部452と、第3設置部453と、第4設置部454と、を備える。 The installation unit 450 is configured to install a medical device through which the first drive unit 410, the second drive unit 430, the guide wire G, and the medical device P are inserted. As shown in FIG. 2, the installation unit 450 includes a first installation unit 451, a second installation unit 452, a third installation unit 453, and a fourth installation unit 454.
 第1設置部451は、図2に示す全体の外周を硬質プラスチック等の樹脂にて形成するように構成している。第1設置部451は、ガイドワイヤGや医療器具Pを挿通可能な状態でヒンジ等によりガイドワイヤGや医療器具Pを収容するカバーを設けることができる。第2設置部452は、第1設置部451の中でも第1駆動部410を構成するローラー411~418を動作可能に設置する壁面を備える。第2設置部452は、第1設置部451に対してガイドワイヤGの長手方向(図2における左右方向)を回転軸として不図示のモータやギア対により回転可能に構成できる。 The first installation portion 451 is configured so that the entire outer circumference shown in FIG. 2 is formed of a resin such as hard plastic. The first installation portion 451 can be provided with a cover for accommodating the guide wire G and the medical device P by a hinge or the like in a state where the guide wire G and the medical device P can be inserted. The second installation unit 452 includes a wall surface in which the rollers 411 to 418 constituting the first drive unit 410 are operably installed in the first installation unit 451. The second installation portion 452 can be configured to be rotatable with respect to the first installation portion 451 by a motor or gear pair (not shown) with the longitudinal direction of the guide wire G (the left-right direction in FIG. 2) as the rotation axis.
 第3設置部453は、第1駆動部410を構成するローラー419~422及び第2駆動部430を構成するローラー431~434を動作可能に設置する壁面を備える。 The third installation unit 453 includes a wall surface on which rollers 419 to 422 constituting the first drive unit 410 and rollers 431 to 434 constituting the second drive unit 430 are operably installed.
 第4設置部454は、カセット400に取付けるガイドワイヤG及び医療器具Pを挿通するコネクタCを取付け可能な部位として構成している。第4設置部454に設置するコネクタCは、本実施形態においてY字状に形成されたコネクタとして構成している。第3設置部は、本実施形態において上記コネクタを取付け可能な凹凸形状又は凹凸状の溝によって構成している。 The fourth installation unit 454 is configured as a portion to which the guide wire G to be attached to the cassette 400 and the connector C through which the medical device P is inserted can be attached. The connector C installed in the fourth installation unit 454 is configured as a Y-shaped connector in the present embodiment. The third installation portion is configured by a concave-convex shape or a concave-convex groove to which the connector can be attached in the present embodiment.
 (コンピュータ)
 コンピュータ600は、図9に示すようにサーバ650とクライアント610とを備える。クライアント610は、記憶部620と制御部630とを備える。記憶部620は、操作部800と電気的に接続され、シース110に対してローラー433、434が把持する把持力に関するデータを記憶するように構成している。記憶部620はROM等によって構成できる。制御部630は操作部800における使用者Pbの選択に応じて記憶部620に記憶されたデータのいずれかを選択してローラー433、434を動作させる命令を行う。制御部630はCPU等のプロセッサやRAM等によって構成できる。記憶部620に記憶されるデータはサーバ650との通信によって更新可能に構成している。サーバ650は、クライアントに設けられたネットワークカード等によって制御部630又は記憶部620と通信可能に構成している。
(Computer)
The computer 600 includes a server 650 and a client 610 as shown in FIG. The client 610 includes a storage unit 620 and a control unit 630. The storage unit 620 is electrically connected to the operation unit 800 and is configured to store data on the gripping force gripped by the rollers 433 and 434 with respect to the sheath 110. The storage unit 620 can be configured by a ROM or the like. The control unit 630 selects one of the data stored in the storage unit 620 according to the selection of the user Pb in the operation unit 800, and issues a command to operate the rollers 433 and 434. The control unit 630 can be configured by a processor such as a CPU, a RAM, or the like. The data stored in the storage unit 620 is configured to be updatable by communication with the server 650. The server 650 is configured to be able to communicate with the control unit 630 or the storage unit 620 by a network card or the like provided on the client.
 (照射装置)
 照射装置700は、ガイドワイヤGに設けられたマーカー等によって生体内に進入させたガイドワイヤGの先端位置を把握するために用いられる。照射装置700は、ベッド200の付近において移動可能に設けられ、X線等の放射線を照射する部位と、照射したX線を受信することによって撮像画像を形成する部位と、を備える。
(Irradiation device)
The irradiation device 700 is used to grasp the position of the tip of the guide wire G that has entered the living body by a marker or the like provided on the guide wire G. The irradiation device 700 is provided so as to be movable in the vicinity of the bed 200, and includes a portion for irradiating radiation such as X-rays and a portion for forming an captured image by receiving the irradiated X-rays.
 (操作部)
 操作部800は、使用者Pbによって操作可能であって、ローラー433、434による医療器具Pの把持力を調整可能に構成している。操作部800は、図10に示すようにスクリーン810と、把持部820.830.840と、押下部850と、を備える。
(Operation unit)
The operation unit 800 can be operated by the user Pb, and the gripping force of the medical device P by the rollers 433 and 434 can be adjusted. As shown in FIG. 10, the operation unit 800 includes a screen 810, a grip portion 820.830.840, and a pressing portion 850.
 操作部800は、ロボットカテーテルシステム1における各部を操作可能に構成している。操作部800は、ロボットアーム300、カセット400、照射装置700と電気的に接続され、各部の動作を操作可能に構成している。スクリーン810は、操作部800による各種操作を使用者Pbに視覚的に認識可能に構成している。スクリーン810は、各種操作を画面への手指の接触によって行うタッチスクリーンとして構成することもできる。スクリーン810の使用例として、使用者Pbが画面上において使用する医療器具Pのメーカー名、製品名等を選択すると、シース110の材質や外径等の情報を表示するように構成できる。 The operation unit 800 is configured to be able to operate each part of the robot catheter system 1. The operation unit 800 is electrically connected to the robot arm 300, the cassette 400, and the irradiation device 700, and is configured to be able to operate the operation of each unit. The screen 810 is configured so that the user Pb can visually recognize various operations performed by the operation unit 800. The screen 810 can also be configured as a touch screen in which various operations are performed by touching the screen with a finger. As an example of using the screen 810, when the user Pb selects the manufacturer name, product name, etc. of the medical device P to be used on the screen, it can be configured to display information such as the material and outer diameter of the sheath 110.
 把持部820、830は、使用者Pbの手指によって操作可能に構成される。把持部820は、使用者Pbの左手の手指によって把持し、把持部830は使用者Pbの右手の手指によって把持可能に構成している。把持部820、830は、使用者Pbの手からの押圧力によって周方向においていずれかの角度位置に倒すことが可能なスティックとして構成できる。把持部820、830の操作によって医療器具Pを患者Paの生体管腔に進退移動させることができる。 The grip portions 820 and 830 are configured to be operable by the fingers of the user Pb. The grip portion 820 is gripped by the fingers of the left hand of the user Pb, and the grip portion 830 is configured to be grippable by the fingers of the right hand of the user Pb. The grip portions 820 and 830 can be configured as sticks that can be tilted to any angle position in the circumferential direction by the pressing force from the hand of the user Pb. By operating the grips 820 and 830, the medical device P can be moved back and forth into the biological lumen of the patient Pa.
 把持部840は、把持部820、830と同様に構成できる。把持部840の操作によってカセット400にセットされたガイディングカテーテルを進退移動させることができる。押下部850は、把持部820、830、840等の操作が、万が一効かなくなった場合に医療器具P及び/又はガイドワイヤGの操作を緊急停止可能なボタンとして構成している。 The grip portion 840 can be configured in the same manner as the grip portions 820 and 830. The guiding catheter set in the cassette 400 can be moved forward and backward by operating the grip portion 840. The pressing portion 850 is configured as a button capable of urgently stopping the operation of the medical device P and / or the guide wire G in the unlikely event that the operations of the grip portions 820, 830, 840 and the like do not work.
 (使用例)
 次にロボットカテーテルシステム1を用いた手技について説明する。
(Example of use)
Next, a procedure using the robot catheter system 1 will be described.
 術者はハブ160を最も基端側に引いた状態でプライミング液を注入するデバイスをポート162に接続し、プライミング液をシース110のルーメン110aに注入する。 The operator connects the device for injecting the priming liquid to the port 162 with the hub 160 pulled to the most proximal side, and injects the priming liquid into the lumen 110a of the sheath 110.
 プライミング液をルーメン110aの内部に注入すると、連通路117a及び連通孔116を介してプライミング液がシース110の外部に放出される。これにより、プライミング液とともに空気等の気体をシース110の内部から外部に排出することができる。 When the priming liquid is injected into the lumen 110a, the priming liquid is discharged to the outside of the sheath 110 through the communication passage 117a and the communication hole 116. As a result, a gas such as air can be discharged from the inside of the sheath 110 to the outside together with the priming liquid.
 プライミング処理後、術者は、図3に示すように、外部装置500を画像診断カテーテル100のコネクタ部165に接続する。そして、術者は、ハブ160をユニットコネクタ150の基端に当接するまで押し込み、信号送受信部145を先端側に移動させる。 After the priming process, the operator connects the external device 500 to the connector portion 165 of the diagnostic imaging catheter 100 as shown in FIG. Then, the operator pushes the hub 160 until it comes into contact with the base end of the unit connector 150, and moves the signal transmission / reception unit 145 to the tip end side.
 次に、術者は、不図示のガイドワイヤを生体の心臓の冠動脈(冠状動脈)入り口付近まで挿入する。そして、ガイドワイヤに沿わせてガイディングカテーテルを目的部位に挿入する。次に、術者は上記ガイドワイヤを抜去し、カセット400における第1設置部451のカバーを開く。そして、第4設置部454に設置するY字状のコネクタCにガイディングカテーテルを取り付ける。次に、上記とは別のガイドワイヤGを医療器具Pのガイドワイヤ挿通部材114に挿通させ、コネクタCをカセット400の第4設置部454に取付ける。 Next, the operator inserts a guide wire (not shown) to the vicinity of the entrance of the coronary artery (coronary artery) of the heart of the living body. Then, the guiding catheter is inserted into the target site along the guide wire. Next, the operator pulls out the guide wire and opens the cover of the first installation portion 451 in the cassette 400. Then, the guiding catheter is attached to the Y-shaped connector C installed in the fourth installation portion 454. Next, a guide wire G different from the above is inserted through the guide wire insertion member 114 of the medical device P, and the connector C is attached to the fourth installation portion 454 of the cassette 400.
 そして、ガイドワイヤGを第1駆動部410のローラー411~422に挟持させる。そして、医療器具Pを第2駆動部430のローラー431~434に挟持させる。ガイドワイヤGと医療器具Pをセットできたら、第1設置部451のカバーを閉じる。 Then, the guide wire G is sandwiched between the rollers 411 to 422 of the first drive unit 410. Then, the medical device P is sandwiched between the rollers 431 to 434 of the second drive unit 430. After setting the guide wire G and the medical device P, close the cover of the first installation portion 451.
 次に、術者は操作部800を操作して、第1駆動部410によりカセット400に装着したガイドワイヤGを病変部まで挿入する。次に、術者は操作部800を操作し、ガイドワイヤGに沿って、第2駆動部430により画像診断カテーテル100を病変部まで挿入する。医療器具Pは、操作部800により選択され、第1アーム435と第2アーム436により規定されたローラー433、434の間隔において進退移動する。 Next, the operator operates the operation unit 800 and inserts the guide wire G attached to the cassette 400 by the first drive unit 410 to the lesion portion. Next, the operator operates the operation unit 800 and inserts the diagnostic imaging catheter 100 to the lesion portion by the second drive unit 430 along the guide wire G. The medical device P is selected by the operation unit 800 and moves back and forth at intervals of rollers 433 and 434 defined by the first arm 435 and the second arm 436.
 次に、画像診断カテーテル100を進退移動させて、ガイディングカテーテルの先端開口部から突出させる。その後、ガイドワイヤルーメンにガイドワイヤGを挿通させながら、ガイドワイヤGに沿って画像診断カテーテル100をさらに押し進めて血管内の目的の位置に挿入する。なお、ガイディングカテーテルとしては、シリンジ(図示省略)を接続可能なポート(図示省略)を基端部に備える公知のガイディングカテーテルを使用することができる。 Next, the diagnostic imaging catheter 100 is moved back and forth to protrude from the tip opening of the guiding catheter. Then, while inserting the guide wire G through the guide wire lumen, the diagnostic imaging catheter 100 is further pushed along the guide wire G to be inserted into the target position in the blood vessel. As the guiding catheter, a known guiding catheter having a port (not shown) to which a syringe (not shown) can be connected can be used at the proximal end.
 次に、血管内の血液を造影剤などのフラッシュ液で血管内の血液を一時的にフラッシュ液で置換する。前述したプライミング処理と同様にフラッシュ液が入ったシリンジをガイディングカテーテルのポートに接続し、シリンジの押し子を押してフラッシュ液をガイディングカテーテルのルーメンの内部に注入する。フラッシュ液は、ガイディングカテーテルのルーメン内を通り、その先端開口部を介して血管内に導入される。導入されたフラッシュ液により、シース110の先端部の周りの血液が押し流されて、シース110の先端部の周囲にフラッシュ液が充満された状態となる。なお、IVUSのみによって断層画像を取得するモードの際は、上述のフラッシュ液で置換する工程を省略することができる。 Next, the blood in the blood vessel is temporarily replaced with a flash solution such as a contrast medium, and the blood in the blood vessel is temporarily replaced with the flash solution. Similar to the priming process described above, the syringe containing the flush solution is connected to the port of the guiding catheter, and the pusher of the syringe is pushed to inject the flush solution into the lumen of the guiding catheter. The flush fluid passes through the lumen of the guiding catheter and is introduced into the blood vessel through its tip opening. The introduced flush liquid flushes the blood around the tip of the sheath 110, and the flash liquid is filled around the tip of the sheath 110. In the mode of acquiring the tomographic image only by IVUS, the step of replacing with the flash liquid described above can be omitted.
 血管内の目的の位置で断層画像を得る際、信号送受信部145は、駆動シャフト140とともに回転しつつ基端側へと移動する(プルバック操作)。プルバック操作と同時に、超音波送受信部145aは超音波を血管壁に向けて送信するとともに、血管壁において反射された超音波を受信する。また、光送受信部145bも、同時に、測定光を血管壁に向けて送信し、血管壁において反射された反射光を受信する。なお、前述したように、超音波送受信部145aから送信される超音波と光送受信部145bから送信される測定光が交差するため、生体内において超音波によって検査される領域と、光によって検査される領域を重ねることができる。 When obtaining a tomographic image at a target position in a blood vessel, the signal transmission / reception unit 145 moves to the proximal end side while rotating together with the drive shaft 140 (pullback operation). At the same time as the pullback operation, the ultrasonic transmission / reception unit 145a transmits the ultrasonic waves toward the blood vessel wall and receives the ultrasonic waves reflected by the blood vessel wall. At the same time, the light transmission / reception unit 145b also transmits the measurement light toward the blood vessel wall and receives the reflected light reflected by the blood vessel wall. As described above, since the ultrasonic wave transmitted from the ultrasonic transmission / reception unit 145a and the measurement light transmitted from the light transmission / reception unit 145b intersect, the region inspected by the ultrasonic wave in the living body and the light are inspected. Areas can be overlapped.
 駆動シャフト140の回転および移動操作は、制御装置501によって制御される。ハブ160内に設けたコネクタ部165は、外部装置500に接続された状態で回転され、これに連動して、駆動シャフト140が回転する。 The rotation and movement operations of the drive shaft 140 are controlled by the control device 501. The connector portion 165 provided in the hub 160 is rotated while being connected to the external device 500, and the drive shaft 140 is rotated in conjunction with this.
 また、制御装置501から送られる信号に基づき、信号送受信部145は体内に超音波および光を送信する。信号送受信部145が受信した反射波および反射光に対応する信号は、駆動シャフト140および外部装置500を介して制御装置501に送られる。制御装置501は、信号送受信部145から送られてくる信号に基づき生体管腔の断層画像を生成し、生成した画像をモニタ502に表示する。 Further, based on the signal sent from the control device 501, the signal transmission / reception unit 145 transmits ultrasonic waves and light into the body. The signal corresponding to the reflected wave and the reflected light received by the signal transmitting / receiving unit 145 is sent to the control device 501 via the drive shaft 140 and the external device 500. The control device 501 generates a tomographic image of the biological lumen based on the signal sent from the signal transmission / reception unit 145, and displays the generated image on the monitor 502.
 以上説明したように本実施形態に係る、シース110を長手方向に進退移動させるロボットカテーテルシステム1はアクチュエータを備える。アクチュエータは、シース110を長手方向に送る一対のローラー433、434においてローラー433、434の間隔を調整し、ローラー434をローラー433に対して移動させる。 As described above, the robot catheter system 1 for moving the sheath 110 forward and backward in the longitudinal direction according to the present embodiment includes an actuator. The actuator adjusts the spacing between the rollers 433 and 434 in a pair of rollers 433 and 434 that feed the sheath 110 in the longitudinal direction, and moves the roller 434 with respect to the roller 433.
 アクチュエータを上記のように構成することによって、ローラー433とローラー434との間隔を調整してロボットカテーテルシステム1におけるシース110を把持する把持力の調整が可能になる。 By configuring the actuator as described above, it is possible to adjust the distance between the roller 433 and the roller 434 to adjust the gripping force for gripping the sheath 110 in the robot catheter system 1.
 また、アクチュエータは、モータ345と、第1アーム435と、を備える。モータ345はローラー434をローラー433に対して相対的に接近又は離間させる駆動力を生成する。第1アームはモータ345によって回転可能に構成され、ローラー434を取付け可能に構成している。アクチュエータを上記のように構成することによって、ローラー434をローラー433に対して接近又は離間させてローラー433、434によるシース110の把持力を調整できる。 Further, the actuator includes a motor 345 and a first arm 435. The motor 345 generates a driving force that causes the roller 434 to approach or separate relative to the roller 433. The first arm is configured to be rotatable by a motor 345, and a roller 434 can be attached to the first arm. By configuring the actuator as described above, the roller 434 can be moved closer to or further from the roller 433 to adjust the gripping force of the sheath 110 by the rollers 433 and 434.
 また、第1アーム435は、回転軸438の周りに回転することによってローラー434のローラー433に対する相対的な間隔を調整する。アクチュエータは、上記に加えて第2アーム436と、弾性部材441と、を備える。第2アーム436は回転軸438において回転可能に設置される。弾性部材441は、第1アーム435と第2アーム436に設けられ、第1アーム435と第2アーム436の回転方向において第2アーム436を第1アーム435に対して付勢するように構成している。このように構成することによって、ローラー433、434によるシース110の挟持力が低下しすぎない程度に当該挟持力を調整できる。また、シース110の外径が変化する場合には弾性部材441が作用することによってシース110の外面に挟持力が過剰に作用しないようにできる。 Also, the first arm 435 adjusts the relative spacing of the roller 434 to the roller 433 by rotating around the rotation shaft 438. In addition to the above, the actuator includes a second arm 436 and an elastic member 441. The second arm 436 is rotatably installed on the rotating shaft 438. The elastic member 441 is provided on the first arm 435 and the second arm 436, and is configured to urge the second arm 436 with respect to the first arm 435 in the rotation direction of the first arm 435 and the second arm 436. ing. With this configuration, the holding force of the sheath 110 by the rollers 433 and 434 can be adjusted to the extent that the holding force is not excessively reduced. Further, when the outer diameter of the sheath 110 changes, the elastic member 441 acts to prevent an excessive holding force from acting on the outer surface of the sheath 110.
 また、本実施形態は上記アクチュエータにおけるモータ345を設置可能であって、複数の関節を備え、多自由度で移動及び回転可能なロボットアーム300と、カセット400と、を有するロボットカテーテルシステム1を含む。カセット400は、ロボットアーム300の先端に設けられた取付け部340に取替え可能に設置され、ローラー433、434及び第1アーム435を回転可能に設けている。このように構成することによって、ローラー433、434によるシース110の挟持力を調整して医療器具Pを良好に動作させることができる。 Further, the present embodiment includes a robot catheter system 1 in which a motor 345 in the actuator can be installed, a robot arm 300 having a plurality of joints and capable of moving and rotating with multiple degrees of freedom, and a cassette 400. .. The cassette 400 is replaceably installed in the mounting portion 340 provided at the tip of the robot arm 300, and the rollers 433, 434 and the first arm 435 are rotatably provided. With this configuration, the holding force of the sheath 110 by the rollers 433 and 434 can be adjusted so that the medical device P can be operated satisfactorily.
 また、ロボットカテーテルシステム1は、操作部800と、コンピュータ600に設けられる記憶部620と制御部630と、を備える。操作部800は、使用者Pbによって操作可能であって、ローラー433、434による把持力を調整可能に構成している。記憶部620は、操作部800と電気的に接続され、シース110に対してローラー433、434が把持する把持力に関するデータを記憶する。制御部630は、操作部800における使用者Pbの選択に応じて記憶部620に記憶されたデータのいずれかを選択してローラー433、434を動作させるように構成している。これにより、医師などの医療従事者自身が医療器具Pを使用せずにロボットカテーテルシステム1によって医療器具Pに対する挟持力を調整したうえで患者Paに対する手術を実施できる。 Further, the robot catheter system 1 includes an operation unit 800, a storage unit 620 and a control unit 630 provided in the computer 600. The operation unit 800 can be operated by the user Pb, and the gripping force of the rollers 433 and 434 can be adjusted. The storage unit 620 is electrically connected to the operation unit 800 and stores data regarding the gripping force gripped by the rollers 433 and 434 with respect to the sheath 110. The control unit 630 is configured to operate the rollers 433 and 434 by selecting any of the data stored in the storage unit 620 according to the selection of the user Pb in the operation unit 800. As a result, the medical worker such as a doctor can perform the operation on the patient Pa after adjusting the holding force on the medical device P by the robot catheter system 1 without using the medical device P.
 また、コンピュータ600は本実施形態において記憶部620及び制御部630の少なくともいずれかと通信可能なサーバ650を備えるように構成している。記憶部620に記憶されるデータは、サーバ650との通信によって更新可能に構成している。そのため、使用する医療器具Pの仕様に応じてローラー433、434による挟持力をより適切に調整したり、時の経過により上市(販売)された新たな医療器具Pの仕様に対応して挟持力を調整したりできる。 Further, the computer 600 is configured to include a server 650 capable of communicating with at least one of the storage unit 620 and the control unit 630 in the present embodiment. The data stored in the storage unit 620 is configured to be updatable by communication with the server 650. Therefore, the holding force of the rollers 433 and 434 can be adjusted more appropriately according to the specifications of the medical device P to be used, or the holding force can be adjusted according to the specifications of the new medical device P that has been put on the market (sold) over time. Can be adjusted.
 なお、本発明は上述した実施形態にのみ限定されず、特許請求の範囲において種々の変更が可能である。図11は図8の変形例を示す斜視図である。上記ではローラー433を駆動させるモータ346において回転軸439とモータ346との間にギア343、344を設ける実施形態について説明した。しかし、これに限定されず、回転軸439とモータ346の間には図11に示すようにギア343、344に加えてシース110を進退移動させる際にシース110を進退移動させるトルクの変化を検出する検出部347を設けてもよい。 The present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims. FIG. 11 is a perspective view showing a modified example of FIG. In the above, the embodiment in which the gears 343 and 344 are provided between the rotating shaft 439 and the motor 346 in the motor 346 for driving the roller 433 has been described. However, the present invention is not limited to this, and as shown in FIG. 11, a change in torque for moving the sheath 110 forward and backward when moving the sheath 110 forward and backward in addition to the gears 343 and 344 is detected between the rotating shaft 439 and the motor 346. The detection unit 347 may be provided.
 ローラー433、434によって医療器具Pを挟持した状態で医療器具Pを長手方向に進退移動させる場合、医療器具Pにおけるローラー433、434との摩擦抵抗は単純に一様と考えることができる。ただし、シース110の先端側の表面には潤滑性等を考慮して親水性のコーティングが施される一方で、手元側には親水性コーティングが施されていない場合がある。 When the medical device P is moved back and forth in the longitudinal direction while the medical device P is sandwiched by the rollers 433 and 434, the frictional resistance of the medical device P with the rollers 433 and 434 can be simply considered to be uniform. However, while the surface on the tip end side of the sheath 110 is coated with a hydrophilic coating in consideration of lubricity and the like, the surface on the hand side may not be coated with a hydrophilic coating.
 これに対して検出部347を設置した場合、シース110の表面が非親水性から親水性に移行する場合には検出部347の検出する負荷トルクが小さくなる。これを受けて、第1アーム435と第2アーム436による回転位置を調整し、ローラー434をローラー433に接近させる。これにより、シース110を長手方向に移動させる際にローラー433、434とシース110との摩擦抵抗が変化し、進退移動の対象となるシース110等の医療用長尺体がスリップすることを効果的に抑制又は防止できる。 On the other hand, when the detection unit 347 is installed, the load torque detected by the detection unit 347 becomes small when the surface of the sheath 110 shifts from non-hydrophilic to hydrophilic. In response to this, the rotation positions of the first arm 435 and the second arm 436 are adjusted to bring the roller 434 closer to the roller 433. As a result, when the sheath 110 is moved in the longitudinal direction, the frictional resistance between the rollers 433 and 434 and the sheath 110 changes, and it is effective that the long medical body such as the sheath 110 to be moved back and forth slips. Can be suppressed or prevented.
 上記と反対にローラー433、434を通過するシース110の表面が親水性から非親水性に移行する場合には検出部347が検出する負荷トルクが大きくなる。これを受けて第1アーム435と第2アーム436による回転角度を調整し、ローラー434をローラー433から離間させることでシース110が変形することを抑制できる。 Contrary to the above, when the surface of the sheath 110 passing through the rollers 433 and 434 shifts from hydrophilic to non-hydrophilic, the load torque detected by the detection unit 347 becomes large. In response to this, the rotation angle of the first arm 435 and the second arm 436 is adjusted, and the roller 434 is separated from the roller 433 to prevent the sheath 110 from being deformed.
 また、ロボットカテーテルシステム1のカセット400に取付ける医療器具Pを構成する医療用長尺体は画像診断カテーテル100のシース110である実施形態について説明した。しかし、生体内に挿入可能な長尺状のものであれば、医療器具Pを構成する医療用長尺体は上記以外にもバルーンカテーテルやステントデリバリ用のカテーテル等、本発明の目的に適った各種カテーテルに適用可能である。 Further, the embodiment in which the medical long body constituting the medical device P attached to the cassette 400 of the robot catheter system 1 is the sheath 110 of the diagnostic imaging catheter 100 has been described. However, if it is a long body that can be inserted into a living body, the medical long body constituting the medical device P is suitable for the object of the present invention such as a balloon catheter or a catheter for stent delivery in addition to the above. It can be applied to various catheters.
 図12、13は本発明の他の実施形態に係るカセット400aを示す図である。次に、本発明の他の好適な実施形態を以下に示す。すなわち、以下に示す形態ではシース110の表面に親水性コーティングが形成されている場合に、シースと接触する部位をローラー以外のシース110との接触面積が比較的大きいもので構成することによってシースのスリップをより強固に抑制又は防止する。なお、カセット400aを構成する第1駆動部410と設置部450はカセット400の同一符号で示す各々の構成と同様であるため、説明を省略する。 12 and 13 are diagrams showing a cassette 400a according to another embodiment of the present invention. Next, other preferred embodiments of the present invention are shown below. That is, in the form shown below, when a hydrophilic coating is formed on the surface of the sheath 110, the sheath is formed by forming a portion in contact with the sheath having a relatively large contact area with the sheath 110 other than the roller. Slip is more strongly suppressed or prevented. Since the first drive unit 410 and the installation unit 450 constituting the cassette 400a are the same as the respective configurations indicated by the same reference numerals of the cassette 400, the description thereof will be omitted.
 第2駆動部430aは、図12、13に示すように駆動ベルト431a、受動ベルト431b、駆動プーリ432a、受動プーリ433a、433b、433c、支持部材435b、弾性部材436b、及びピニオンギア437aを備える。 As shown in FIGS. 12 and 13, the second drive unit 430a includes a drive belt 431a, a passive belt 431b, a drive pulley 432a, a passive pulley 433a, 433b, 433c, a support member 435b, an elastic member 436b, and a pinion gear 437a.
 本形態では、シースのスリップをより強固に抑制又は防止する手段として、ローラーの代わりにベルト及びプーリを用い、ベルトでシース110の軸方向と交差する方向においてシース110を把持する。具体的には、図12に示すように、駆動ベルト431aと受動ベルト431bをカセット400aに回転可能に固定する。図12において、駆動ベルト431aは駆動軸である駆動プーリ432a、受動プーリ433aによって回転可能に支持される。受動ベルト431bは受動プーリ433b、433cによって回転可能に支持される。受動ベルト431bは、支持部材435bと回転可能に連結するように構成している。すなわち、受動ベルト431bには、ベルトの幅方向中央付近において支持部材435bを挿通させる貫通路を全周に形成している。 In this embodiment, as a means for more firmly suppressing or preventing slipping of the sheath, a belt and a pulley are used instead of rollers, and the sheath 110 is gripped by the belt in a direction intersecting the axial direction of the sheath 110. Specifically, as shown in FIG. 12, the drive belt 431a and the passive belt 431b are rotatably fixed to the cassette 400a. In FIG. 12, the drive belt 431a is rotatably supported by a drive pulley 432a and a passive pulley 433a, which are drive shafts. The passive belt 431b is rotatably supported by passive pulleys 433b and 433c. The passive belt 431b is configured to be rotatably connected to the support member 435b. That is, the passive belt 431b is formed with a gangway through which the support member 435b is inserted near the center in the width direction of the belt.
 受動ベルト431bは、弾性部材436bと支持部材435bの可動部435dによりシース110を変形させない程度の一定応力で駆動ベルト431aに対して押付けられる。支持部材435bは、長尺状に構成しており、可動部435dは支持部材435bの長手方向の端部に設けている。弾性部材436bは、支持部材435bの可動部435dに挿通する弦巻ばねなどで構成できる。このように構成することによって受動ベルト431bには弾性部材436bによって弾性力(付勢力)が付与される。 The passive belt 431b is pressed against the drive belt 431a by the elastic member 436b and the movable portion 435d of the support member 435b with a constant stress that does not deform the sheath 110. The support member 435b is formed in a long shape, and the movable portion 435d is provided at the end portion of the support member 435b in the longitudinal direction. The elastic member 436b can be composed of a string-wound spring or the like that is inserted into the movable portion 435d of the support member 435b. With this configuration, elastic force (urging force) is applied to the passive belt 431b by the elastic member 436b.
 アクチュエータを構成するピニオンギア437aは駆動モータ(図示省略)により動作する。主な機構は前記したようにベベルギア等を用いることで、モータの回転をカセット400a内のピニオンギア437aに伝達することが可能となる。ラック435cは支持部材435bに設けられ、ピニオンギア437aの歯とかみ合い可能に構成している。これにより、ピニオンギア437aの回転は、ラック435cによって受動ベルト431bのベルト面に交差する方向に対する支持部材435bの略直線的な接近離間移動に変換される。すなわち、図12、13の実施形態では図8のモータ345、ギア341、342と同様のモータ及びギアと、ピニオンギア347aと、ラック345cを備える支持部材345bと、弾性部材346bとがアクチュエータを構成する。 The pinion gear 437a that constitutes the actuator is operated by a drive motor (not shown). By using a bevel gear or the like as the main mechanism as described above, it is possible to transmit the rotation of the motor to the pinion gear 437a in the cassette 400a. The rack 435c is provided on the support member 435b and is configured to be meshable with the teeth of the pinion gear 437a. As a result, the rotation of the pinion gear 437a is converted by the rack 435c into a substantially linear approach / separation movement of the support member 435b with respect to the direction intersecting the belt surface of the passive belt 431b. That is, in the embodiment of FIGS. 12 and 13, the motor and gear similar to the motor 345 and gears 341 and 342 of FIG. 8, the pinion gear 347a, the support member 345b provided with the rack 345c, and the elastic member 346b constitute an actuator. To do.
 シース110の表面の親水性コーティングの作用でカテーテルの摩擦抵抗が非常に小さい場合には、アクチュエータを構成する支持部材435bのラック435cとピニオンギア437aの動作で、シース110への応力を調整できる。ピニオンギア437aを回転させ、支持部材435bのラック435cがシース110側に変位すると、弾性部材436bによる押付け荷重が大きくなる。これにより、ベルト駆動時にシースのスリップを防止又は抑制できる。一方、支持部材435bのラック435cがシース110と反対側に変位すると、弾性部材436bによる押付け荷重が小さくなるため、シース110の変形を抑制できる。 When the frictional resistance of the catheter is very small due to the action of the hydrophilic coating on the surface of the sheath 110, the stress on the sheath 110 can be adjusted by the operation of the rack 435c and the pinion gear 437a of the support member 435b constituting the actuator. When the pinion gear 437a is rotated and the rack 435c of the support member 435b is displaced toward the sheath 110 side, the pressing load by the elastic member 436b increases. As a result, slippage of the sheath can be prevented or suppressed when the belt is driven. On the other hand, when the rack 435c of the support member 435b is displaced to the side opposite to the sheath 110, the pressing load by the elastic member 436b becomes small, so that the deformation of the sheath 110 can be suppressed.
 また、上記したアクチュエータの作用により、図13に示すように、駆動ベルト431aと受動ベルト431bとの間隔を大きくでき、医療従事者等のオペレーターはシース110等の医療用長尺体を容易に着脱することが可能となる。 Further, as shown in FIG. 13, the distance between the drive belt 431a and the passive belt 431b can be increased by the action of the actuator described above, and an operator such as a medical worker can easily attach / detach a long medical body such as a sheath 110. It becomes possible to do.
 これらの構造により、駆動ベルト431aの駆動プーリ432aが動作することでシース110との接触面積を比較的多く取ることができ、シース110を長手方向に進退移動可能な程度でシース110のスリップをより強固に防止又は抑制できる。 With these structures, the drive pulley 432a of the drive belt 431a can operate to take a relatively large contact area with the sheath 110, and the sheath 110 can be moved back and forth in the longitudinal direction to prevent the sheath 110 from slipping. It can be strongly prevented or suppressed.
 本出願は、2019年9月30日に出願された日本国特許出願2019-179014号に基づいており、その開示内容は参照により全体として引用される。 This application is based on Japanese Patent Application No. 2019-179014 filed on September 30, 2019, the disclosure of which is cited as a whole by reference.
1 ロボットカテーテルシステム、
110 シース(医療用長尺体)、
300 ロボットアーム(アーム)、
341、342 ギア(アクチュエータ)、
345 モータ(第1駆動部、アクチュエータ)、
346 モータ(第2駆動部)、
347 検出部、
400 カセット、
433 ローラー(一対の把持部材、第2把持部材)、
434 ローラー(一対の把持部材、第1把持部材)、
435 第1アーム(第1設置部材、アクチュエータ)、
436 第2アーム(第2設置部材、アクチュエータ)、
438 回転軸、
441 弾性部材(付勢部材、アクチュエータ)、
600 コンピュータ、
620 記憶部、
630 制御部、
650 サーバ、
800 操作部。
 
1 Robot catheter system,
110 sheath (long medical body),
300 robot arm (arm),
341, 342 gears (actuators),
345 motor (first drive unit, actuator),
346 motor (second drive unit),
347 detector,
400 cassettes,
433 rollers (a pair of gripping members, a second gripping member),
434 Roller (a pair of gripping members, first gripping member),
435 1st arm (1st installation member, actuator),
436 Second arm (second installation member, actuator),
438 axis of rotation,
441 Elastic members (urging members, actuators),
600 computers,
620 Memory,
630 control unit,
650 server,
800 operation unit.

Claims (7)

  1.  医療用長尺体を長手方向に進退移動させるロボットカテーテルシステムに設けられ、前記医療用長尺体を前記長手方向に送る一対の把持部材において、一対の前記把持部材を構成する第1把持部材と第2把持部材との間隔を調整し、前記第1把持部材及び前記第2把持部材の少なくとも一方を他方に対して移動させるアクチュエータ。 In a pair of gripping members that are provided in a robot catheter system that moves a medical elongated body forward and backward in the longitudinal direction and that feeds the medical elongated body in the longitudinal direction, a first gripping member that constitutes the pair of gripping members An actuator that adjusts the distance from the second gripping member and moves at least one of the first gripping member and the second gripping member with respect to the other.
  2.  前記第1把持部材を前記第2把持部材に対して相対的に接近又は離間させる駆動力を生成する第1駆動部と、
     前記第1駆動部によって回転可能に構成され、前記第1把持部材を取付け可能な第1設置部材と、を備える請求項1に記載のアクチュエータ。
    A first driving unit that generates a driving force that causes the first gripping member to approach or separate from the second gripping member.
    The actuator according to claim 1, further comprising a first installation member rotatably configured by the first drive unit and to which the first gripping member can be attached.
  3.  前記第1設置部材は、回転軸の回りに回転することによって前記第1把持部材の前記第2把持部材に対する相対的な前記間隔を調節し、
     前記回転軸に回転可能に設置される第2設置部材と、
     前記第1設置部材と前記第2設置部材とに設けられ、前記第1設置部材と前記第2設置部材の回転方向において前記第2設置部材を前記第1設置部材に対して付勢する付勢部材と、をさらに備える請求項2に記載のアクチュエータ。
    The first installation member adjusts the distance of the first grip member relative to the second grip member by rotating around a rotation axis.
    A second installation member that is rotatably installed on the rotating shaft,
    An urging provided on the first installation member and the second installation member to urge the second installation member with respect to the first installation member in the rotational direction of the first installation member and the second installation member. The actuator according to claim 2, further comprising a member.
  4.  前記第2把持部材は、回転可能なローラーを備え、
     前記ローラーを回転させる第2駆動部と、前記医療用長尺体を進退移動させる際において前記医療用長尺体を進退移動させるトルクの変化を検出する検出部と、をさらに備える請求項1~3のいずれか1項に記載のアクチュエータ。
    The second gripping member includes a rotatable roller and has a rotatable roller.
    A second drive unit for rotating the roller, and a detection unit for detecting a change in torque for moving the medical long body forward and backward when moving the medical long body forward and backward, according to claim 1 to 1. The actuator according to any one of 3.
  5.  請求項2に記載のアクチュエータにおける前記第1駆動部を設置可能であって、複数の関節を備え、多自由度で移動及び回転可能なアームと、
     前記アームの先端に取替え可能に設置され、一対の前記把持部材及び前記第1設置部材を回転可能に設けたカセットと、を有するロボットカテーテルシステム。
    An arm capable of installing the first drive unit in the actuator according to claim 2, having a plurality of joints, and being movable and rotatable with multiple degrees of freedom.
    A robot catheter system having a pair of gripping members and a cassette rotatably provided with the first mounting member, which is replaceably installed at the tip of the arm.
  6.  使用者によって操作可能であって、一対の前記把持部材による把持力を調整する操作部と、
     前記操作部と電気的に接続され、前記医療用長尺体に対応して一対の前記把持部材が把持する把持力に関するデータが記憶された記憶部と、
     前記操作部における使用者の選択に応じて前記記憶部に記憶された前記データのいずれかを選択して一対の前記把持部材を動作させる制御部と、をさらに有する請求項5に記載のロボットカテーテルシステム。
    An operation unit that can be operated by the user and adjusts the gripping force of the pair of the gripping members,
    A storage unit that is electrically connected to the operation unit and stores data on a gripping force that is gripped by the pair of gripping members corresponding to the medical elongated body.
    The robot catheter according to claim 5, further comprising a control unit that selects any of the data stored in the storage unit to operate the pair of gripping members according to the user's selection in the operation unit. system.
  7.  前記記憶部及び前記制御部の少なくともいずれかと通信可能なサーバをさらに有し、
     前記記憶部に記憶される前記データは、前記サーバとの通信によって更新可能に構成される請求項6に記載のロボットカテーテルシステム。
     
    Further having a server capable of communicating with at least one of the storage unit and the control unit,
    The robot catheter system according to claim 6, wherein the data stored in the storage unit can be updated by communicating with the server.
PCT/JP2020/033292 2019-09-30 2020-09-02 Actuator and robot catheter system WO2021065311A1 (en)

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