WO2024070899A1 - Cathéter et dispositif médical - Google Patents

Cathéter et dispositif médical Download PDF

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Publication number
WO2024070899A1
WO2024070899A1 PCT/JP2023/034351 JP2023034351W WO2024070899A1 WO 2024070899 A1 WO2024070899 A1 WO 2024070899A1 JP 2023034351 W JP2023034351 W JP 2023034351W WO 2024070899 A1 WO2024070899 A1 WO 2024070899A1
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Prior art keywords
unit
catheter
control device
drive
catheter body
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PCT/JP2023/034351
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English (en)
Japanese (ja)
Inventor
亮 上原
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テルモ株式会社
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Publication of WO2024070899A1 publication Critical patent/WO2024070899A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters

Definitions

  • This disclosure relates to catheters and medical devices.
  • Patent Document 1 discloses an ultrasound catheter that obtains images by intravascular ultrasound (IVUS: Intra Vascular Ultra Sound) as an example of this type of imaging diagnostic catheter.
  • the ultrasound catheter of Patent Document 1 is configured to be connectable to an external drive source that has a built-in motor.
  • the drive shaft and ultrasound transducer of the ultrasound catheter of Patent Document 1 are driven by an external drive source.
  • the drive shaft and ultrasonic transducer as the moving parts are driven by an external drive source, for example, by operating an operating part provided on the external drive source.
  • An operator such as a surgeon, who operates the ultrasonic catheter, can drive the drive shaft and ultrasonic transducer by, for example, holding the ultrasonic catheter with one hand and operating the external drive source with the other hand.
  • the external drive source needs to be placed in a location that is easy for the operator to operate, such as a designated position on the operating table, but it can be difficult to secure a place to place the external drive source.
  • the present disclosure aims to provide a catheter and medical device that allows the operator to easily operate the drive unit for driving the moving part, even if the drive unit is not located in a position that is easy for the operator to operate.
  • a catheter according to a first aspect of the present disclosure includes: (1) A catheter comprising: A tubular catheter body; a moving part attached to the catheter body or housed in the catheter body; The catheter body includes a connection portion connectable to a control device, the operating unit is configured to be drivable by a driving unit of the control device in a state in which the connection unit of the catheter body is connected to the control device, The catheter body is a catheter equipped with an operating unit capable of operating the driving of the movable unit by the driving unit of the control device.
  • a catheter includes: (2) The operation unit includes: a detection unit provided on a peripheral wall of the catheter body and detecting an input from an operator; The catheter according to (1) above, further comprising: a communication unit capable of transmitting detection information of the detection unit to the control device via wired or wireless communication.
  • a catheter includes: (3) The catheter according to (2) above, wherein the detection unit is configured to be able to detect contact by an operator and movement of the contact position.
  • a catheter includes: (4)
  • the catheter body is a catheter described in any one of (1) to (3) above, which is equipped with an interlock mechanism that can switch whether or not the drive unit of the control device can drive the movable unit.
  • a catheter includes: (5) The detection unit is a drive detection unit capable of detecting an input of whether or not the drive unit of the control device is to drive the movable unit; The catheter according to (2) or (3) above, further comprising an operation detection unit capable of detecting input of operation information for driving the movable unit by the drive unit of the control device.
  • a catheter includes: (6) The catheter according to (5) above, wherein the drive detection unit and the operation detection unit are provided at positions spaced apart in the longitudinal direction of the catheter body.
  • a catheter includes: (7)
  • the catheter body is the catheter described in any one of (1) to (6) above, which is provided with a display unit that displays the position of the operation unit to the outside.
  • a catheter includes: (8) The catheter according to (7) above, wherein the display portion is a tab provided on a part of the peripheral wall of the catheter body.
  • a catheter includes: (9) The catheter according to (8) above, wherein the operating portion is provided on the tab.
  • a medical device includes: (10) A catheter according to any one of (1) to (9) above; and the control device.
  • a medical device comprises: (11)
  • the control device is the medical device described in (10) above, which includes a control unit that controls the drive unit based on information input from the operation unit of the catheter body.
  • FIG. 1 illustrates a medical device according to an embodiment of the present disclosure, comprising a catheter according to an embodiment of the present disclosure.
  • FIG. 2 is a view showing the catheter of FIG. 1 alone.
  • 2B is a diagram showing the catheter alone of FIG. 1, showing a state in which the position of the probe in the longitudinal direction is different from that of FIG. 2A.
  • 2 is a longitudinal cross-sectional view of the distal end of the catheter of FIG. 1.
  • FIG. FIG. 2 is a diagram showing details of an operating portion of the sheath of the catheter of FIG. 1.
  • FIG. 2 shows details of the proximal connector of the outer tube of the catheter of FIG. 1. 1.
  • FIG. 4 is a diagram showing an example of a connection configuration in which a proximal connector of an outer tube of the catheter in FIG. 1 is mechanically and electrically connected to a control device.
  • FIG. 2 is a diagram showing a modified example of the sheath of the catheter shown in FIG. 1.
  • FIG. 2 is a diagram showing a modified example of the sheath of the catheter shown in FIG. 1.
  • FIG. 2 is a diagram showing a modified example of the sheath of the catheter shown in FIG. 1.
  • FIG. 2 is a diagram showing a modified example of the sheath of the catheter shown in FIG. 1.
  • FIG. 2 is a diagram showing a modified example of the sheath of the catheter shown in FIG. 1.
  • 12A and 12B are diagrams showing an example of use of the sheath shown in FIG. 11.
  • FIG. 2 is a diagram showing a modified example of the medical device shown in FIG. 1 .
  • FIG. 1 is a diagram showing a medical device 100 as one embodiment of a medical device according to the present disclosure.
  • the medical device 100 includes a catheter 1 as one embodiment of a catheter according to the present disclosure, and a control device 2.
  • FIG. 1 shows the state in which the catheter 1 is connected to the control device 2.
  • the longitudinal direction of the catheter 1 will be referred to as "longitudinal direction A".
  • the side of the catheter 1 in longitudinal direction A that is inserted into the living body will be referred to as the "distal side”.
  • the side of the catheter 1 in longitudinal direction A that is operated outside the living body will be referred to as the "proximal side”.
  • the direction from the proximal side to the distal side of the catheter 1 may be simply referred to as the "insertion direction A1".
  • the direction from the distal side to the proximal side of the catheter 1 may be simply referred to as the "removal direction A2".
  • the circumferential direction of the catheter 1 will be referred to as the "circumferential direction B”.
  • the catheter 1 comprises a tubular catheter body 3 and an operating unit 4.
  • the operating unit 4 may be attached to the catheter body 3 or may be housed in the catheter body 3.
  • the operating unit 4 is housed in the catheter body 3.
  • the catheter body 3 comprises a connection unit 3a that can be connected to the control device 2.
  • the operating unit 4 is configured to be drivable by the drive unit 5 of the control device 2 when the connection unit 3a of the catheter body 3 is connected to the control device 2.
  • "operation” is not limited to actions that involve movement, but includes actions that consume energy without movement, such as heat generation and light emission.
  • the catheter 1 of this embodiment is an ultrasound catheter as an imaging diagnostic catheter configured to acquire tomographic images of tubular organs such as blood vessels.
  • the catheter body 3 is composed of a sheath 20 and an outer tube 40.
  • the moving part 4 is composed of a probe 10 and an inner tube 30.
  • connection portion 3a of the catheter body 3 of this embodiment is configured by the proximal connector 43 of the outer tube 40.
  • the proximal connector 43 of the outer tube 40 is configured to be connectable to the control device 2.
  • the probe 10 and inner tube 30 as the moving part 4 in this embodiment are configured to be drivable by the drive unit 5 of the control device 2 when the proximal connector 43 of the outer tube 40 as the connection part 3a of the catheter body 3 is connected to the control device 2.
  • the probe 10 and inner tube 30 as the moving part 4 are driven by the drive unit 5 of the control device 2 to operate.
  • the drive unit 5 of the control device 2 in this embodiment can drive the probe 10 and inner tube 30 to move in the longitudinal direction A of the catheter 1 inside the sheath 20 and outer tube 40.
  • the drive unit 5 of the control device 2 in this embodiment can drive the probe 10 to rotate in the circumferential direction B of the catheter 1 inside the sheath 20 and outer tube 40.
  • the catheter body 3 further includes an operation unit 3b that can control the driving of the operating unit 4 by the drive unit 5 of the control device 2.
  • an operator such as a surgeon who operates the catheter 1 can use the operation unit 3b of the catheter body 3 to control the driving of the operating unit 4 by the drive unit 5 of the control device 2.
  • the driving of the operating unit 4 can be easily controlled without placing the drive unit 5 for driving the operating unit 4 in a position that is easy for the operator to operate.
  • the operation unit 3b of this embodiment is provided on the sheath 20 out of the sheath 20 and outer tube 40 that constitute the catheter body 3.
  • the operation unit 3b may also be provided on the outer tube 40.
  • the catheter 1 of this embodiment is an ultrasound catheter as a catheter for diagnostic imaging, but the catheter according to the present disclosure is not limited to this configuration. More specifically, the catheter 1 of this embodiment is an ultrasound catheter equipped with an ultrasound transmission/reception unit for IVUS, but the catheter according to the present disclosure may be, for example, an imaging diagnostic catheter that enables optical coherence tomography (OCT), near infrared spectroscopy (NIRS), etc. In such a case, the imaging diagnostic catheter as the catheter according to the present disclosure may be configured to include an optical transmission/reception unit instead of or in addition to the ultrasound transmission/reception unit. Furthermore, the catheter according to the present disclosure is not limited to an imaging diagnostic catheter. The catheter according to the present disclosure may be, for example, an ablation catheter, a rotablator, etc. In this embodiment, the catheter 1, which is an ultrasound catheter, will be illustrated as an example of a catheter according to the present disclosure.
  • Figures 2A and 2B are views showing the catheter 1 alone shown in Figure 1. As will be described in detail later, Figures 2A and 2B show different positions of the longitudinal direction A of the probe 10 within the sheath 20.
  • Figure 3 is a cross-sectional view showing a cross section parallel to the longitudinal direction A at the distal end of the catheter 1 (hereinafter referred to as the "distal end").
  • the catheter 1 of this embodiment includes a probe 10, a long sheath 20, an inner tube 30, and an outer tube 40. Each part of the catheter 1 of this embodiment will be described in detail below.
  • the probe 10 includes an imaging core 60, a shaft 13, and an electric signal line 14 extending inside the shaft 13.
  • the imaging core 60 of this embodiment includes an ultrasonic transmitting/receiving unit 61a and a housing 61b.
  • the imaging core 60 is fixed to the distal end of the shaft 13.
  • the ultrasound transmitting/receiving unit 61a of the imaging core 60 includes a piezoelectric element.
  • the piezoelectric element includes a flat piezoelectric body and an electrode laminated on the piezoelectric body.
  • the ultrasound transmitting/receiving unit 61a can transmit and receive ultrasound.
  • the housing 61b of the imaging core 60 supports the ultrasound transmitting/receiving unit 61a.
  • the proximal side of the housing 61b is connected to the shaft 13.
  • the housing 61b may be integrated with the shaft 13. Therefore, the housing 61b may be directly connected to the shaft 13 by adhesion or the like, or may be indirectly connected to the shaft 13 via a connector or the like.
  • the shaft 13 is inserted into the sheath 20.
  • the shaft 13 is made of a flexible tube.
  • an electric signal line 14 connected to the ultrasound transmission/reception unit 61a of the imaging core 60 is disposed inside the shaft 13.
  • the shaft 13 is made of, for example, multi-layered coils with different winding directions around the axis. More specifically, the shaft 13 of this embodiment is made of a three-layered coil. Examples of the coil material include stainless steel and Ni-Ti (nickel-titanium) alloy.
  • the shaft 13 extends through the inside of the sheath 20, the inner tube 30, and the outer tube 40. As described above, the distal end of the shaft 13 is connected to the housing 61b of the imaging core 60. The proximal end of the shaft 13 (hereinafter referred to as the "proximal end”) is held by the hub 32 (described below) that constitutes the proximal end of the inner tube 30. In other words, the shaft 13 extends in the longitudinal direction A from the distal end connected to the housing 61b of the imaging core 60 to the proximal end connected to the hub 32 of the inner tube 30.
  • the electric signal line 14 extends inside the shaft 13. As shown in FIG. 1, when the proximal connector 43 of the outer tube 40 is connected to the control device 2, the electric signal line 14 electrically connects the ultrasonic transmission/reception unit 61a of the imaging core 60 to the control device 2 (see FIG. 1).
  • a plurality of electric signal lines 14 are provided, and each electric signal line 14 is connected to an electrode of the ultrasonic transmission/reception unit 61a of the imaging core 60.
  • the plurality of electric signal lines 14 are, for example, configured as a twisted pair cable in which two electric signal lines 14 are twisted together.
  • Each electric signal line 14 can be a flexible thin wire member having an outer diameter greater than 0 mm and equal to or less than 0.1 mm.
  • Each electric signal line 14 can be configured, for example, as a conductor and a covering material formed of an insulating material that covers the conductor.
  • the sheath 20 is inserted into the lumen of a tubular organ such as a blood vessel.
  • the sheath 20 includes a main body 20a and a guidewire insertion section 20b.
  • a first hollow section is defined inside the main body 20a.
  • a second hollow section is defined in the guidewire insertion section 20b.
  • the probe 10 is accommodated in the first hollow section of the main body 20a.
  • the probe 10 can move forward and backward in the longitudinal direction A in the first hollow section.
  • a guidewire W can be inserted into the second hollow section of the guidewire insertion section 20b.
  • the tubular guidewire insertion section 20b is adjacent to the distal end of the tubular main body 20a so as to be parallel to each other.
  • the main body 20a and the guidewire insertion section 20b may be formed by joining different tubular members by heat fusion or the like.
  • the sheath 20 is made of a flexible material, and the material is not particularly limited.
  • the constituent materials include various thermoplastic elastomers such as polyethylene, styrene, polyolefin, polyurethane, polyester, polyamide, polyimide, polybutadiene, trans-polyisoprene, fluororubber, and chlorinated polyethylene, and polymer alloys, polymer blends, laminates, etc., which are combinations of one or more of these materials, can also be used.
  • the main body 20a may have a reinforcing portion at its proximal end that is reinforced with a highly rigid material.
  • the reinforcing portion may be formed, for example, by disposing a reinforcing material in which metal wires such as stainless steel are braided into a mesh shape on a flexible tubular member such as resin.
  • the tubular member may be formed, for example, from the constituent material of the sheath 20 described above.
  • the sheath 20 of this embodiment includes an operation unit 3b.
  • FIG. 4 is a diagram showing the details of the operation unit 3b of the sheath 20.
  • the operation unit 3b may be, for example, a capacitive touch sensor or a pressure sensor that is held on the outer surface of the peripheral wall of the sheath 20.
  • the operation unit 3b of this embodiment includes a detection unit 3b1 that detects input from the operator, and a communication unit 3b2 that can transmit the detection information of this detection unit 3b1 to the control device 2 by wire.
  • the detection unit 3b1 is configured to be capable of detecting the operator's contact and the movement of the contact position.
  • the detection unit 3b1 of this embodiment has a first detection area group 50a and a second detection area group 50b at different positions in the longitudinal direction A of the sheath 20.
  • the first detection area group 50a has a plurality (two in this embodiment) of detection areas 50a1 and 50a2 arranged adjacent to each other in the circumferential direction B of the sheath 20.
  • the second detection area group 50b has a plurality (two in this embodiment) of detection areas 50b1 and 50b2 arranged adjacent to each other in the circumferential direction B of the sheath 20.
  • Each of the two detection areas 50a1 and 50a2 of the first detection area group 50a can detect contact with the operator's finger. Therefore, the first detection area group 50a can detect the movement of the operator's finger in the circumferential direction B of the sheath 20 from a state in which the operator's finger is in contact with one of the detection areas 50a1 and 50a2 to a state in which the operator's finger is in contact with the other of the detection areas 50a1 and 50a2. The same is true for the second detection area group 50b. Each of the two detection areas 50b1 and 50b2 of the second detection area group 50b can detect the contact of the operator's finger.
  • the second detection area group 50b can detect the movement of the operator's finger in the circumferential direction B of the sheath 20 from a state in which the operator's finger is in contact with one of the detection areas 50b1 and 50b2 to a state in which the operator's finger is in contact with the other of the detection areas 50b1 and 50b2.
  • the detection unit 3b1 of this embodiment can detect the contact of the operator's finger and the movement of the contact position in each of the first detection area group 50a and the second detection area group 50b.
  • the detection unit 3b1 is configured to be able to detect the operator's contact and the movement of the contact position, so that the detection unit 3b1 can realize various operations that combine contact information and information on the movement of the contact position.
  • the detection unit 3b1 of this embodiment includes a first detection area group 50a and a second detection area group 50b, but is not limited to this configuration.
  • the detection unit 3b1 may include, for example, only one of the first detection area group 50a and the second detection area group 50b.
  • the detection unit 3b1 may include, for example, another detection area group in addition to the first detection area group 50a and the second detection area group 50b.
  • the detection unit 3b1 include multiple detection area groups, it is possible to increase the variety of various operations that can be input to the detection unit 3b1.
  • the first detection region group 50a in this embodiment includes two detection regions 50a1 and 50a2 arranged adjacent to each other in the circumferential direction B of the sheath 20, but is not limited to this configuration.
  • the first detection region group 50a may include three or more detection regions arranged adjacent to each other in the circumferential direction B of the sheath 20.
  • the second detection region group 50b may include three or more detection regions arranged adjacent to each other in the circumferential direction B of the sheath 20.
  • each of the first detection region group 50a and the second detection region group 50b may include a plurality of detection regions arranged adjacent to each other in the longitudinal direction A of the sheath 20, instead of or in addition to the plurality of detection regions arranged in the circumferential direction B of the sheath 20.
  • the above-mentioned detection unit 3b1 obtains movement information of the contact position of the operator's finger by providing multiple adjacent detection areas, but is not limited to this configuration.
  • the detection unit 31b1 may detect contact information and movement information based on detection strength that depends on, for example, the distance from the operator's finger, the pressing force applied by the operator, etc.
  • the communication unit 3b2 is connected to each of the detection areas 50a1, 50a2, 50b1, and 50b2 of the detection unit 3b1.
  • the communication unit 3b2 of this embodiment includes a conductor portion 51a1 connected to one detection area 50a1 of the first detection area group 50a, and a conductor portion 51a2 connected to the other detection area 50a2 of the first detection area group 50a.
  • the communication unit 3b2 of this embodiment also includes a conductor portion 51b1 connected to one detection area 50b1 of the second detection area group 50b, and a conductor portion 51b2 connected to the other detection area 50b2 of the second detection area group 50b.
  • the four conductor portions 51a1, 51a2, 51b1, and 51b2 extend in the longitudinal direction A, and their proximal ends are located at the proximal connector 43 of the outer tube 40 described later.
  • the four conductors 51a1, 51a2, 51b1, and 51b2 are configured to be electrically connected to the control device 2 by connecting the proximal connector 43 of the outer tube 40 to the control device 2.
  • contact information is transmitted to the control device 2 through the four conductors 51a1, 51a2, 51b1, and 51b2.
  • An example of a specific connection configuration for electrically connecting the four conductors 51a1, 51a2, 51b1, and 51b2 to the control device 2 will be described later (see FIG. 6).
  • the communication unit 3b2 in this embodiment is configured with four conductor parts 51a1, 51a2, 51b1, and 51b2, but is not limited to this configuration.
  • the communication unit 3b2 may be configured to be capable of wirelessly transmitting the detection information of the detection unit 3b1 to the control device 2.
  • the control device 2 may be provided with a communication unit that includes a communication interface capable of receiving information transmitted from the communication unit 3b2. This will be described in detail later (see FIG. 13).
  • the specific configuration of the detection unit 3b1 and communication unit 3b2 of the operation unit 3b is not particularly limited.
  • the detection unit 3b1 and communication unit 3b2 of the operation unit 3b may be configured, for example, by a film device in which the sensor units that become the detection areas 50a1, 50a2, 50b1, and 50b2, and the circuits that become the conductor units 51a1, 51a2, 51b1, and 51b2 are laminated by printing or the like on a flexible resin base film.
  • the detection unit 3b1 and communication unit 3b2 may be formed by wrapping and fixing this film device around the outer surface of the peripheral wall of the tube that becomes the sheath 20.
  • operation information input by the operator to the detection unit 3b1 is transmitted to the control device 2 by the communication unit 3b2. Then, the control unit 7 of the control device 2 controls the drive unit 5 based on the received operation information.
  • the inner tube 30 accommodates the proximal end of the shaft 13 and is movable within the outer tube 40 together with the shaft 13.
  • the inner tube 30 includes an inner tube body 31 and a hub 32.
  • the inner tube body 31 is inserted within the outer tube 40 so as to be movable back and forth in the longitudinal direction A.
  • the hub 32 is connected to the proximal side of the inner tube body 31.
  • the outer tube 40 is fixed to the proximal end of the sheath 20.
  • the outer tube 40 comprises an outer tube main body 41, a distal connector 42, and a proximal connector 43.
  • the outer tube main body 41 is located radially outside the inner tube main body 31, and the inner tube main body 31 moves back and forth within the outer tube main body 41 in the longitudinal direction A.
  • the distal connector 42 connects the proximal end of the main body 20a of the sheath 20 and the distal end of the outer tube main body 41.
  • the proximal connector 43 is fixed to the proximal end of the outer tube main body 41.
  • the shaft 13 and electrical signal line 14 of the probe 10 described above extend through the main body 20a of the sheath 20, through the outer tube 40 connected to the proximal side of the main body 20a, and through the inner tube 30, a portion of which is inserted into the outer tube 40.
  • the above-mentioned probe 10 and inner tube 30 are connected to each other so that they can move forward and backward integrally in the longitudinal direction A. Therefore, for example, when the inner tube 30 is pushed in the insertion direction A1, the inner tube 30 is pushed into the outer tube 40 in the insertion direction A1, as shown in FIG. 2A. When the inner tube 30 is pushed into the outer tube 40 in the insertion direction A1, the probe 10 connected to the inner tube 30 moves in the insertion direction A1 inside the main body 20a of the sheath 20. Conversely, when the inner tube 30 is pulled in the removal direction A2 (pullback operation), the inner tube 30 is pulled out from the outer tube 40 in the removal direction A2, as shown in FIG. 2B. When the inner tube 30 is pulled out from the outer tube 40 in the removal direction A2, the probe 10 connected to the inner tube 30 moves in the removal direction A2 inside the main body 20a of the sheath 20.
  • the imaging core 60 of the probe 10 is located near the distal end of the main body 20a of the sheath 20.
  • the proximal connector 43 of the outer tube 40 is configured to be mechanically and electrically connectable to the control device 2.
  • FIG. 5 is a diagram showing details of the proximal connector 43 of the outer tube 40.
  • FIG. 6 is a diagram showing an example of a connection configuration in which the proximal connector 43 of the outer tube 40 is mechanically and electrically connected to the control device 2.
  • the proximal connector 43 of the outer tube 40 has a cylindrical catheter side terminal portion 43a that holds the proximal ends of the four conductor portions 51a1, 51a2, 51b1 and 51b2 as the communication portion 3b2 on its outer surface. As shown in FIG.
  • the catheter side terminal portion 43a is configured to be clamped by the clamp portion 6a of the connection port 6 of the control device 2.
  • the clamp portion 6a has four port side terminal portions 6a1 that contact and conduct electricity with the proximal ends of the four conductor portions 51a1, 51a2, 51b1, and 51b2 held on the outer surface of the catheter side terminal portion 43a when the clamp portion 6a is clamped to the catheter side terminal portion 43a.
  • FIG. 6 shows only one conductor portion 51a1 and one port side terminal portion 6a1 that contacts and conducts electricity with the conductor portion 51a1.
  • the proximal connector 43 of the outer tube 40 is mechanically and electrically connected to the control device 2 by clamping the catheter side terminal portion 43a to the clamp portion 6a of the connection port 6.
  • proximal end of the hub 32 of the inner tube 30 is configured to be mechanically and electrically connectable to the drive unit 5 of the control device 2 when the proximal connector 43 of the outer tube 40 is mechanically and electrically connected to the connection port 6 of the control device 2.
  • the proximal end of the hub 32 of the inner tube 30 is provided with a connector portion that is mechanically and electrically connected to the drive unit 5 of the control device 2 (see FIG. 1). That is, the catheter 1 is mechanically and electrically connected to the drive unit 5 of the control device 2 by the connector portion provided on the hub 32 of the inner tube 30. More specifically, the electrical signal line 14 of the probe 10 extends from the ultrasonic transmission/reception unit 61a of the imaging core 60 to the connector portion of the hub 32 of the inner tube 30, and electrically connects the ultrasonic transmission/reception unit 61a of the imaging core 60 to the drive unit 5 of the control device 2 with the connector portion of the hub 32 mechanically connected to the drive unit 5 of the control device 2.
  • the control unit 7 of the control device 2 transmits transmission information for transmitting ultrasonic waves by the ultrasonic transmission/reception unit 61a through the drive unit 5 and the electrical signal line 14.
  • the reception information of the ultrasonic waves received by the ultrasonic transmission/reception unit 61a is transmitted to the control unit 7 of the control device 2 through the electrical signal line 14 and the drive unit 5.
  • the control unit 7 Based on the above transmitted and received information, the control unit 7 generates a tomographic image of a tubular organ such as a blood vessel, and displays it on the display unit 8.
  • control device 2 As shown in FIG. 1 , the control device 2 of this embodiment includes a drive unit 5 , a connection port 6 , a control unit 7 , and a display unit 8 .
  • the drive unit 5 includes a motor 5a, which is a power source for rotating the shaft 13 of the catheter 1 in the circumferential direction B around the central axis, and a motor 5b, which is a power source for moving the shaft 13 in the longitudinal direction A.
  • the rotational motion of the motor 5b is converted into axial motion, for example, by a ball screw connected to the motor 5b.
  • the drive unit 5 is configured to be mechanically and electrically connectable to the hub 32 of the inner tube 30 of the catheter 1 when the proximal connector 43 of the outer tube 40 of the catheter 1 is mechanically and electrically connected to the connection port 6.
  • connection port 6 is configured to be connectable to the proximal connector 43 of the outer tube 40 of the catheter 1.
  • the connection port 6 of this embodiment includes a clamp portion 6a that can clamp and mechanically hold the catheter side terminal portion 43a of the proximal connector 43.
  • the clamp portion 6a of the connection port 6 of this embodiment also includes a port side terminal portion 6a1 that contacts and conducts with the conductor portions 51a1, 51a2, 51b1, and 51b2 held on the outer surface of the catheter side terminal portion 43a when the clamp portion 6a of the connection port 6 of this embodiment clamps the catheter side terminal portion 43a of the proximal connector 43.
  • the connection port 6 of this embodiment is configured to be mechanically and electrically connectable to the proximal connector 43 of the outer tube 40 of the catheter 1.
  • the control unit 7 controls the operation of the ultrasonic transmission/reception unit 61a of the catheter 1 and each unit of the control device 2. Specifically, the control unit 7 processes various information input from the drive unit 5 and the connection port 6. The control unit 7 also controls the operation of the drive unit 5 and the display unit 8. Furthermore, the control unit 7 controls the ultrasonic transmission/reception unit 61a of the imaging core 60 of the catheter 1 via the drive unit 5.
  • control unit 7 can control the ultrasound transmitter/receiver unit 61a of the imaging core 60 of the catheter 1 via the drive unit 5 and the electrical signal line 14 of the catheter 1. That is, the control unit 7 can control the ultrasound transmission operation by the ultrasound transmitter/receiver unit 61a. Furthermore, reception information of the ultrasound received by the ultrasound transmitter/receiver unit 61a is input to the control unit 7 via the electrical signal line 14 and the drive unit 5. The control unit 7 can generate a tomographic image of a tubular organ such as a blood vessel based on the transmission and reception information of the ultrasound from the ultrasound transmitter/receiver unit 61a, and display it on the display unit 8.
  • the control unit 7 also receives operation information input to the operation unit 3b of the catheter 1 via the connection port 6.
  • the control unit 7 can control the driving of the drive unit 5 based on the input operation information. For example, when operation information for rotating the shaft 13 by the drive unit 5 is input to the operation unit 3b, the control unit 7 controls the driving of the motor 5a of the drive unit 5 to rotate the shaft 13. For example, when operation information for moving the shaft 13 in the longitudinal direction A by the drive unit 5 is input to the operation unit 3b, the control unit 7 controls the driving of the motor 5b of the drive unit 5 to move the shaft 13 in the longitudinal direction A.
  • control unit 7 may simultaneously execute, for example, the control of the rotation of the shaft 13 by the motor 5a of the drive unit 5 and the control of the forward and backward movement of the shaft 13 in the longitudinal direction A by the motor 5b of the drive unit 5 based on the operation information input to the operation unit 3b of the catheter 1.
  • the control unit 7 includes at least one processor, at least one programmable circuit, at least one dedicated circuit, or any combination of these.
  • the processor is a general-purpose processor such as a CPU or GPU, or a dedicated processor specialized for specific processing.
  • CPU is an abbreviation for central processing unit.
  • GPU is an abbreviation for graphics processing unit.
  • An example of a programmable circuit is an FPGA.
  • FPGA is an abbreviation for field-programmable gate array.
  • An example of a dedicated circuit is an ASIC.
  • ASIC is an abbreviation for application specific integrated circuit.
  • the display unit 8 is, for example, a display.
  • the display is, for example, an LCD or an organic EL display.
  • LCD is an abbreviation for liquid crystal display.
  • EL is an abbreviation for electroluminescent.
  • the display unit 8 can output image data generated by the control unit 7.
  • the display unit 8 is configured as one unit with the control device 2, but this configuration is not limited to this.
  • the display unit 8 may be a separate device capable of communicating with the control device 2.
  • the control device 2 of this embodiment includes the drive unit 5, connection port 6, control unit 7, and display unit 8 described above, but is not limited to this configuration.
  • the control device 2 may include a storage unit such as a semiconductor memory, a magnetic memory, or an optical memory.
  • the storage unit functions as, for example, a main storage unit, an auxiliary storage unit, or a cache memory.
  • the storage unit may store data used for the operation of the ultrasound transmission/reception unit 61a of the catheter 1 and data used for the operation of each unit of the control device 2.
  • the catheter 1 of this embodiment includes the sheath 20 and outer tube 40 as the catheter body 3.
  • the catheter 1 of this embodiment also includes the probe 10 and inner tube 30 as the moving part 4.
  • the probe 10 and inner tube 30 of this embodiment are housed in the catheter body 3 and can move in the longitudinal direction A relative to the catheter body 3.
  • the moving part 4 may be attached to the catheter body 3, for example, by being fixed to the distal end of the catheter body 3.
  • the catheter 1 of this embodiment also includes a proximal connector 43 of the outer tube 40 as the connection part 3a of the catheter body 3.
  • the probe 10 and the inner tube 30 as the moving part 4 of this embodiment are configured to be drivable by the driving part 5 of the control device 2 when the proximal connector 43 of the outer tube 40 is connected to the control device 2.
  • the catheter 1 of this embodiment is equipped with a detection unit 3b1 provided on the peripheral wall of the sheath 20 as the operation unit 3b of the catheter body 3, and a communication unit 3b2 extending across the sheath 20 and the outer tube 40.
  • the control unit 7 of the control device 2 in this embodiment controls the drive unit 5 based on information input from the operation unit 3b of the catheter body 3.
  • the movement of the probe 10 and inner tube 30 as the moving unit 4 in the longitudinal direction A by the drive unit 5 is controlled.
  • the rotation of the probe 10 as the moving unit 4 in the circumferential direction B by the drive unit 5 is controlled.
  • Figs. 7 to 9 show a configuration in which the sheath 20 as the catheter body 3 is provided with a display unit 3c that displays the position of the operation unit 3b to the outside.
  • Fig. 7 shows an example in which the sheath 20 is provided with a different color portion 3c1 as the display unit 3c.
  • the different color portion 3c1 refers to a portion that is configured with a color different from the surroundings.
  • the different color portion 3c1 shown in Fig. 7 indicates the position of the detection unit 3b1 of the operation unit 3b. In other words, the different color portion 3c1 shown in Fig. 7 is provided only in the area in the longitudinal direction A where the detection unit 3b1 of the operation unit 3b is provided.
  • Figures 8 and 9 show an example in which the sheath 20 has a tab 3c2 provided on a part of the peripheral wall of the sheath 20 as the display unit 3c.
  • the tab 3c2 protrudes radially outward from the peripheral wall of the sheath 20 as the catheter body 3.
  • the tab 3c2 shown in Figure 8 indicates the position of the detection unit 3b1 of the operation unit 3b. In other words, the tab 3c2 shown in Figure 8 is provided only in the area in the longitudinal direction A where the detection unit 3b1 of the operation unit 3b is provided.
  • the operating unit 3b is provided on the peripheral wall of the sheath 20.
  • the operating unit 3b is provided on the tab 3c2.
  • the detection unit 3b1 of the operating unit 3b is provided on the tab 3c2.
  • the sheath 20 as the catheter body 3 shown in FIG. 10 includes an interlock mechanism 3d.
  • the interlock mechanism 3d is configured to be able to switch whether or not the driving of the operating unit 4 by the driving unit 5 (see FIG. 1) of the control device 2 can be performed.
  • the interlock mechanism 3d by operating the interlock mechanism 3d, it is possible to switch between a state in which the probe 10 and the inner tube 30 (see FIG. 1, etc.) as the operating unit 4 can be driven by the driving unit 5 by operating the operating unit 3b (hereinafter referred to as a "driving permitted state") and a state in which the probe 10 and the inner tube 30 (see FIG. 1, etc.) as the operating unit 4 cannot be driven by the driving unit 5 even if the operating unit 3b is operated (hereinafter referred to as a "driving prohibited state").
  • the interlock mechanism 3d shown in FIG. 10 includes a physical switch 3d1.
  • the interlock mechanism 3d may be configured to activate the operation unit 3b by, for example, pressing the switch 3d1.
  • the interlock mechanism 3d may be configured to switch the operation unit 3b from a state in which it does not accept input from the operator to a state in which it accepts input from the operator by pressing the switch 3d1. Therefore, when an operator such as a surgeon inputs operation information from the operation unit 3b, for example, the operator operates the switch 3d1 of the interlock mechanism 3d with one hand to switch from a drive prohibited state to a drive permitted state, and inputs operation information from the operation unit 3b with the other hand. In this way, by providing the sheath 20 as the catheter main body 3 with the interlock mechanism 3d, it is possible to prevent the operation unit 4 from operating unintentionally due to unintentional contact with the operation unit 3b by the operator.
  • the switch 3d1 serving as the interlock operation part of the interlock mechanism 3d is arranged at a position away from the operation part 3b. This can prevent the operator from accidentally touching both the switch 3d1 and the operation part 3b, causing the operation part 4 to operate unintentionally. More specifically, as shown in FIG. 10, it is preferable that the switch 3d1 serving as the interlock operation part of the interlock mechanism 3d is arranged at a position away from the operation part 3b in the longitudinal direction A. This can prevent the operator from touching both the switch 3d1 of the interlock mechanism 3d and the operation part 3b simultaneously with one hand. This can further prevent the operation part 4 from operating unintentionally.
  • the sheath 20 as the catheter body 3 shown in FIG. 10 has a tab 3c2 as the display unit 3c that displays the position of the control unit 3b. Furthermore, in addition to the tab 3c2, the sheath 20 as the catheter body 3 shown in FIG. 10 has a tab 3e1 as the display unit 3e that displays the position of the switch 3d1.
  • the detection unit 203b1 shown in FIG. 11 and FIG. 12 includes a drive detection unit 71 and an operation detection unit 72.
  • the drive detection unit 71 is configured to be capable of detecting an input of whether or not to drive the operation unit 4 (see FIG. 1, etc.) by the drive unit 5 of the control device 2.
  • the operation detection unit 72 is configured to be capable of detecting an input of operation information for driving the operation unit 4 by the drive unit 5 of the control device 2.
  • the configuration of the operation detection unit 72 is the same as that of the detection unit 3b1 described above (see FIG. 4, FIG. 7 to FIG. 9), so a description thereof will be omitted here.
  • the drive detection unit 71 can detect, for example, contact with the operator's living body. Like the operation detection unit 72, the drive detection unit 71 may be a capacitive touch sensor, a pressure sensor, or the like. Information detected by the drive detection unit 71 is transmitted to the control unit 7 (see FIG. 1) of the control device 2 through a conductor unit 73 as a wired communication unit 203b2 connected to the drive detection unit 71. The operator can switch between a drive prohibited state and a drive permitted state by operating the drive detection unit 71. Specifically, when the drive detection unit 71 does not detect the operator's input, the control unit 7 does not drive the drive unit 5 even if the operation detection unit 72 detects the operator's input.
  • the control unit 7 drives the drive unit 5 based on the operation information input to the operation detection unit 72.
  • the detector 203b1 of the operation unit 203b of the catheter main body 3 is equipped with a drive detector 71 in addition to the operation detector 72, so that the operation unit 4 (see FIG. 1, etc.) can be prevented from being unintentionally operated due to the operator unintentionally touching the operation detector 72, etc.
  • the drive detection unit 71 and the operation detection unit 72 are preferably provided at positions spaced apart in the longitudinal direction of the sheath 20 as the catheter main body 3 (the same direction as the longitudinal direction A of the catheter 1). This prevents the operator from touching both the drive detection unit 71 and the operation detection unit 72 simultaneously with one hand.
  • the drive detection unit 71 is disposed distal to the operation detection unit 72. Therefore, as shown in Fig. 12, when an operator such as a surgeon inputs operation information from the operation detection unit 72, the operator grasps the sheath 20 with one hand (left hand X1 in Fig. 12) so as to come into contact with the drive detection unit 71 located distal to the operation detection unit 72, and switches from a drive prohibited state to a drive permitted state. In this state, the operator operates the operation detection unit 72 located proximal to the drive detection unit 71 with the other hand (right hand X2 in Fig. 12). In this way, the drive of the operating unit 4 by the drive unit 5 of the control device 2 can be controlled.
  • the medical device 100 shown in FIG. 13 includes a catheter 1 in which an operation unit 3b includes a wireless communication unit 3b2, and a control device 2 including a communication unit 9 capable of communicating with the wireless communication unit 3b2. While FIGS. 1 to 12 show an example in which the operation unit 3b includes a wired communication unit 3b2, FIG. 13 shows an example in which the operation unit 3b includes a wireless communication unit 3b2. As shown in FIG. 13, the communication unit 3b2 of the operation unit 3b of the catheter body 3 of the catheter 1 is only required to transmit the detection information of the detection unit 3b1 to the control device 2, and this configuration may be wired or wireless.
  • the wireless communication unit 3b2 of the catheter 1 and the communication unit 9 of the control device 2 each include at least one communication interface.
  • the communication interface is, for example, an interface compatible with a mobile communication standard such as LTE, 4G standard, or 5G standard, an interface compatible with short-range wireless communication such as Bluetooth (registered trademark), an interface compatible with a wireless LAN communication standard such as IEEE802.11, or an interface compatible with a wired LAN communication standard such as Ethernet (registered trademark).
  • LTE is an abbreviation for Long Term Evolution.
  • 4G is an abbreviation for 4th generation.
  • 5G is an abbreviation for 5th generation.
  • IEEE is an abbreviation for Institute of Electrical and Electronics Engineers.
  • the catheter body 3 is composed of the sheath 20 and the outer tube 40, but the catheter body 3 is not limited to this configuration.
  • the catheter body 3 is not particularly limited as long as it is configured to include a connection part 3a that can be connected to the control device 2 and an operation part 3b that can operate the drive of the operating part 4 by the drive part 5 of the control device 2.
  • the operating part 4 is composed of the probe 10 and the inner tube 30, but the operating part 4 is not limited to the probe 10 and the inner tube 30.
  • the operating part 4 is not particularly limited as long as it is configured to be driven by the drive part 5 of the control device 2 when the connection part 3a of the catheter body 3 is connected to the control device 2.
  • This disclosure relates to catheters and medical devices.
  • Catheter 2 Control device 3: Catheter body 3a: Connection section 3b, 203b: Operation section 3b1, 203b1: Detection section 3b2, 203b2: Communication section 3c: Display section 3c1: Different color section 3c2: Tab 3d: Interlock mechanism 3d1: Switch 3e: Display section 3e1: Tab 4: Operation section 5: Drive section 5a, 5b: Motor 6: Connection port 6a: Clamp section 6a1: Port side terminal section 7: Control section 9: Communication section 10: Probe 13: Shaft 14: Electric signal line 20: Sheath 20a: Body section 20b: Guide wire insertion section 30: Inner tube 31: Inner tube body 32: Hub 40: Outer tube 41: Outer tube body 42: Distal side connector 43: Proximal side connector (an example of a connection section) 43a: Catheter terminal portion 50a: First detection area group (an example of the detection portion of the operation portion) 50b: Second detection area group (an example of the detection unit of the operation unit)

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Abstract

Un cathéter selon la présente invention comprend : un corps de cathéter tubulaire ; et une partie de travail fixée au corps de cathéter ou logée dans celui-ci. Le corps de cathéter est pourvu d'une partie de liaison pouvant être reliée à un dispositif de commande. La partie de travail est conçue pour être entraînée par une unité d'entraînement du dispositif de commande tandis que la partie de liaison du corps de cathéter est reliée au dispositif de commande. Le corps de cathéter est également pourvu d'une unité d'actionnement apte à permettre l'entraînement de la partie de travail entraînée par l'unité d'entraînement du dispositif de commande.
PCT/JP2023/034351 2022-09-28 2023-09-21 Cathéter et dispositif médical WO2024070899A1 (fr)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005279177A (ja) * 2004-03-31 2005-10-13 Terumo Corp 血管内カテーテルおよびカテーテル装置
JP2009240711A (ja) * 2008-03-31 2009-10-22 Terumo Corp 生体内挿入用プローブ装置
WO2011027821A1 (fr) * 2009-09-04 2011-03-10 テルモ株式会社 Cathéter
JP2018121831A (ja) * 2017-01-31 2018-08-09 テルモ株式会社 カテーテル
JP2020124521A (ja) * 2016-05-19 2020-08-20 シーエスエー メディカル， インコーポレイテッド カテーテル延在制御
JP2021115364A (ja) * 2020-01-29 2021-08-10 テルモ株式会社 バルーンカテーテル
JP2022522719A (ja) * 2019-02-28 2022-04-20 エンキャプソン・ベー・フェー エコー源性構造を有するシースアセンブリ

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005279177A (ja) * 2004-03-31 2005-10-13 Terumo Corp 血管内カテーテルおよびカテーテル装置
JP2009240711A (ja) * 2008-03-31 2009-10-22 Terumo Corp 生体内挿入用プローブ装置
WO2011027821A1 (fr) * 2009-09-04 2011-03-10 テルモ株式会社 Cathéter
JP2020124521A (ja) * 2016-05-19 2020-08-20 シーエスエー メディカル， インコーポレイテッド カテーテル延在制御
JP2018121831A (ja) * 2017-01-31 2018-08-09 テルモ株式会社 カテーテル
JP2022522719A (ja) * 2019-02-28 2022-04-20 エンキャプソン・ベー・フェー エコー源性構造を有するシースアセンブリ
JP2021115364A (ja) * 2020-01-29 2021-08-10 テルモ株式会社 バルーンカテーテル

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