JP6247160B2 - Medical device - Google Patents

Description

  The present invention relates to a medical device, and more particularly to a medical device that is inserted into a lumen such as a blood vessel or a vascular vessel and acquires an image from the lumen.

  When diagnosing an affected part in a body lumen such as a blood vessel or a vascular vessel, an ultrasonic catheter that transmits and receives ultrasonic waves in the affected part is used. The ultrasound catheter has an imaging core including a transducer unit for transmitting and receiving ultrasound and a drive shaft that rotates the transducer unit, and a sheath that incorporates the imaging core and is inserted into a lumen. ing. The imaging core is movable in the axial direction within the sheath.

  When an ultrasonic catheter is used, an introducer sheath for accessing the inside of the lumen is usually placed, and the guiding catheter is inserted into the lumen through the introducer sheath. Thereafter, the guide wire is inserted to the target position through the guiding catheter, and the ultrasonic catheter is inserted from the affected part to the deep part so as to be along the guide wire. Then, from the state in which the imaging core is disposed on the distal end side in the sheath, only the imaging core is retracted while leaving the sheath, and the affected part is passed. By retreating only the imaging core, the transducer unit moves from the deep part through the affected part, so it is possible to observe ultrasonic images continuously acquired before and after the affected part, and shapes such as blood vessels and vessels 3D data can be created.

  In order to enable the imaging core to move in the axial direction within the sheath, for example, an ultrasonic catheter described in Patent Document 1 includes an outer tube and an inner tube that is slidably inserted into the outer tube in the axial direction. The imaging core inside the sheath is axially arranged with respect to the sheath by changing the overall length of the catheter body by arranging a nested structure capable of extending and contracting in the axial direction on the proximal end side of the sheath. It is moved.

JP 2007-268133 A

  When inserted into a blood vessel, the ultrasonic catheter described in Patent Document 1 is rarely caught by a complicatedly curved blood vessel, a stenotic blood vessel, a stent embedded in the blood vessel, and the like. It may be difficult to pull it out from. In such a case, the force transmitted to the distal end of the catheter is removed by removing the imaging core from the sheath and inserting a medical device having a higher rigidity than the imaging core, for example, a guide wire (hereinafter abbreviated as appropriate). Techniques to increase and release the trapped part are being performed. However, the drive shaft is usually structured so as not to fall out of the catheter. For this reason, for example, after the operator cuts the part pulled out from the outer tube of the inner tube and opens the driving shaft accommodated in the inner tube, the driving shaft is pulled out from the sheath. I can't. However, since the drive shaft is accommodated inside the inner tube, it is very complicated to cut only the inner tube, and it takes time, which increases the burden on the living body.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a highly safe medical device in which a drive shaft can be easily pulled out from a sheath.

  A medical device that achieves the above object, a sheath that is inserted into a living body lumen, a drive shaft that is inserted into the sheath and transmits mechanical drive force, and moves while holding the drive shaft. Accordingly, a hub that moves the drive shaft in the axial direction of the sheath, an outer tube that is provided on the proximal end side of the sheath and that has an insertion portion into which the inner tube is inserted at the proximal end portion, A first locking part that is movable in the outer tube with movement and has a larger outer diameter at the distal end, and a second locking that is deformable by being positioned closer to the base end side than the first locking part And the insertion portion has a passage opening that can receive the inner tube, and the passage opening is formed from outer diameters of the first locking portion and the second locking portion. Has a small diameter and the deformation of the second locking portion causes the inner tube to 2 is allowed to pass through the portion where the locking portion is disposed, the inner tube is proximal to the first locking portion, and the second locking portion is locked by the passage port. In this state, an easy-to-expose portion for exposing the drive shaft to a portion located in the outer tube is provided.

  In the medical device configured as described above, the inner tube is located in the outer tube in a state where the inner tube is on the proximal end side with respect to the first locking portion and the second locking portion is locked by the passage port. Since it has an easily exposed portion for exposing the drive shaft to the site, the inner tube can be deformed as necessary while maintaining the easily exposed portion in the outer tube in a normal use state. The easily-exposed portion can be exposed to the outside by passing the portion where the second locking portion is disposed from the passage port to the base end side. Thus, the drive shaft exposed from the easily exposed portion can be pulled out from the inner tube, and the drive shaft can be easily pulled out from the sheath. A wire or the like is inserted into the sheath from which the drive shaft is pulled out, and the sheath is removed from the living body lumen. The pulling-out operation can be easily performed, and safety can be improved.

  If the easy-exposed part is a part where the rigidity is partially formed in the inner tube, the easy-exposing part is easily positioned when the easy-exposed part is exposed to the outside from the outer pipe. The exposed portion can be deformed and easily folded or separated, and the drive shaft can be easily pulled out from the easily exposed portion.

  If the easily exposed portion is formed between the first locking portion and the second locking portion, the second locking portion passes by moving the inner tube from the outer tube toward the proximal end. When locked to the mouth, the pulling force does not act on the easily exposed portion, and unexpected breakage of the easily exposed portion can be suppressed to increase safety.

  If the easily exposed portion is positioned on the proximal end side with respect to the insertion portion so that the inside of the inner tube is visible from the outside, the position of the member disposed inside the inner tube is taken into consideration. Meanwhile, the drive shaft can be pulled out from the easily exposed portion.

  If the medical device further includes a protective tube disposed inside the inner tube and accommodating the drive shaft, the position of the protective tube disposed inside the inner tube is observed from the easily exposed portion. On the other hand, the drive shaft can be pulled out from the easily exposed portion in a state where the easily exposed portion is disposed at a desired position with respect to the drive shaft and the protective tube.

  If the second locking portion is provided as a separate member on the inner tube, it becomes easy to deform the second locking portion, and further, the inner tube can be deformed while the second locking portion is deformed. It becomes easy to make it the structure which drops from.

  If the easily exposed portion is a notch formed in the inner tube, the bending force is applied to the easily exposed portion when the easily exposed portion is positioned on the proximal side of the outer tube and exposed to the outside. It is possible to easily bend or separate by applying a pulling force.

It is a top view which shows the medical device which concerns on one Embodiment of this invention. It is a top view which shows an intraluminal diagnostic system. It is longitudinal direction sectional drawing which shows the front-end | tip part of a medical device. 1 is a longitudinal sectional view showing a hub of a medical device. It is a top view which shows the medical device of the state which made the vibrator | oscillator unit pull back. It is longitudinal direction sectional drawing which shows the unit connector and relay connector of a medical device. It is longitudinal direction sectional drawing which shows the unit connector of a medical device. It is a longitudinal direction sectional view showing the state where the vibrator unit in the sheath is pulled back and the second locking portion is brought into contact with the passage opening. It is a longitudinal direction sectional view showing the state where the vibrator unit in the sheath was pulled back and the first suppressing portion was brought into contact with the passage port. It is longitudinal direction sectional drawing which shows a state at the time of cut | disconnecting an inner pipe | tube in an easily exposed part. It is a longitudinal direction sectional view showing the state at the time of pulling out the imaging core from the sheath. It is a top view which shows the state which pulled out the imaging core from the sheath. It is a longitudinal cross-sectional view which shows the state which penetrated the wire to the sheath which pulled out the imaging core. It is longitudinal direction sectional drawing which shows the other usage example of the medical device which concerns on one Embodiment of this invention. It is longitudinal direction sectional drawing which shows the modification of a medical device. It is longitudinal direction sectional drawing which shows the other modification of a medical device. It is longitudinal direction sectional drawing which shows the other modification of a medical device. It is longitudinal direction sectional drawing which shows the other modification of a medical device.

  Embodiments of the present invention will be described below with reference to the drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and may differ from an actual ratio.

  As shown in FIGS. 1 and 2, the medical device 1 according to the present embodiment is an ultrasonic catheter that accommodates an imaging core 4 for ultrasonic diagnosis and is inserted into a lumen. The medical device 1 is connected to an external drive device 7 that holds the medical device 1 and drives the imaging core 4, and is used mainly for diagnosing the inside of a blood vessel. In this specification, the side to be inserted into the lumen of the living body is referred to as “tip” or “tip side”, and the proximal side for operation is referred to as “base end” or “base end side”.

  The medical device 1 includes a sheath 2 that is inserted into a lumen, an imaging core 4 that transmits and receives ultrasonic waves toward the intraluminal tissue, and the imaging core 4 that penetrates and is located on the proximal side of the sheath 2. And an operation unit 3.

  As shown in FIG. 3, the sheath 2 includes a sheath distal end portion 21, a sheath tube 22, and a filling liquid inlet / outlet member 23.

  The sheath distal end portion 21 is provided with a cylindrical sheath distal end member 27 in which a guide wire lumen 211 is formed, and an X-ray contrast marker 24 provided at a portion slightly proximal to the distal end portion. The guide wire 25 is inserted into the lumen in advance, and the medical device 1 is guided to the affected area while passing the guide wire 25 through the guide wire lumen 211. The X-ray contrast marker 24 is provided so that the tip position of the medical device 1 can be confirmed under fluoroscopy when inserted into the lumen.

  The filling liquid inlet / outlet member 23 communicates with the lumen 26 in the sheath tube 22 and is a priming port 231 that is a flow path of air and physiological saline when replacing the air in the sheath tube 22 with physiological saline. Is formed.

  An imaging core 4 is incorporated in the sheath 2 so as to be slidable in the axial direction of the sheath 2. The imaging core 4 includes a transducer unit 41 for transmitting and receiving ultrasonic waves toward the intraluminal tissue, and a drive shaft 42 that attaches and rotates the transducer unit 41 to the distal end. The transducer unit 41 includes an ultrasonic transducer 411 that transmits and receives ultrasonic waves, and a housing 412 that houses the ultrasonic transducer 411.

  The sheath tube 22 is made of a material with high ultrasonic transmission. A portion of the sheath tube 22 within a range where the ultrasonic transducer 411 moves constitutes an acoustic window portion through which ultrasonic waves are transmitted. The sheath tip 21 and the sheath tube 22 are each formed of a flexible material, and the material is not particularly limited. For example, the styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, and polyimide-based materials. , Polybutadiene-based, trans-polyisoprene-based, fluororubber-based, chlorinated polyethylene-based thermoplastic elastomers, etc., one or a combination of two or more of these (polymer alloys, polymer blends, laminates) Body, etc.) can be used.

  The drive shaft 42 is flexible and has a characteristic capable of transmitting the rotational power generated in the operation unit 3 (see FIG. 1) to the vibrator unit 41. For example, the right and left and the winding direction are alternately 3 It is composed of a multilayer coil-like tube body such as a layer coil. When the driving shaft 42 transmits the rotational power, the transducer unit 41 rotates and the affected part in the lumen such as blood vessels and vascular vessels can be observed 360 degrees. The drive shaft 42 has a signal line 54 for transmitting a signal detected by the vibrator unit 41 to the operation unit 3.

  As shown in FIG. 4, the operation unit 3 includes a hub 31 having a port 311 for injecting a physiological saline solution for bleeding air, an inner tube 34 connected to the distal end side of the hub 31, and an inner tube 34 inserted therein. It has a possible outer tube 32, a relay connector 33 that connects the outer tube 32 to the sheath 2, and a protective tube 67. The outer tube 32 is connected to the tubular outer tube main body 321 whose distal end is connected to the relay connector 33 and the base end of the outer tube main body 321, and a passage port 69 into which the inner tube 34 can be inserted is formed. And a unit connector 37 (insertion portion). The unit connector 37 is a part connected to a holding portion 73 (see FIG. 2) of the external drive device 7 to be described later.

  The hub 31 holds the drive shaft 42 and the inner tube 34. When the inner tube 34 is pushed into or pulled out from the outer tube 32, the drive shaft 42 is interlocked and slides in the sheath 2 in the axial direction.

  The hub 31 of the operation unit 3 includes a joint 50, a male connector 51, a rotor 52, a connection pipe 53, a signal line 54, a hub body 55, a seal member 56, and a kink protector 57.

  The joint 50 has an opening 501 on the user hand side of the medical device 1, and the male connector 51 and the rotor 52 are disposed inside. The male connector 51 can be connected to the female connector 711 (see FIG. 2) of the external drive device 7 from the opening 501 side of the joint 50, whereby the external drive device 7 and the male connector 51 are mechanically and electrically connected. Connected.

  The rotor 52 holds the connection pipe 53 in a non-rotatable manner and rotates integrally with the male connector 51. The connection pipe 53 holds the drive shaft 42 at the end opposite to the rotor 52 side in order to transmit the rotation of the rotor 52 to the drive shaft 42. A signal line 54 is passed through the connection pipe 53. One end of the signal line 54 is connected to the male connector 51, and the other end passes through the drive shaft 42 and is connected to the vibrator unit 41. The observation result in the transducer unit 41 is transmitted to the external drive device 7 through the male connector 51, and subjected to appropriate processing and displayed as an image.

  The hub main body 55 has the inner tube 34 bonded and fixed thereto. A physiological saline solution is injected from the port 311 and the physiological saline solution is introduced into the inner tube 34 without leaking to the outside. The hub main body 55 and the seal member 56 are bonded and fixed. Further, since the seal member 56 including the O-ring 58 is installed between the hub main body 55 and the joint 50, the physiological saline is supplied to the joint 50. No leakage to the opening 501 side.

  In the hub body 55, the base end portion of the inner tube 34 is inserted such that the outer peripheral surface of the inner tube 34 is fitted to the inner peripheral surface 551 inside. A kink protector 57 is disposed around the inner tube 34 and the hub body 55.

  As shown in FIGS. 6 and 7, the inner tube 34 has an inner tube main body 340 formed with a constant outer diameter and an inner diameter, and a first engagement formed at the distal end portion with an outer diameter larger than that of the inner tube main body 340. 341, a second locking portion 342 having a larger outer diameter than the inner tube main body 340 on the proximal side of the first locking portion 341, the first locking portion 341, and the second locking portion And an easy-to-expose portion 343 which is an opening formed between the two portions 342. The easily exposed portion 343 in the present embodiment is a notched portion cut into the inner tube main body 340 in a V shape. The easily exposed portion 343 is a part of the inner tube 34 that is partially weak in rigidity, and also a part that allows the inside to be observed from the outside.

  The first locking portion 341 is formed integrally with the inner tube main body 340, has an outer diameter larger than the inner diameter of the passage port 69 formed in the unit connector 37, and cannot pass through the passage port 69. is there. The first locking portion 341 may be formed as a separate member from the inner tube main body 340. Further, the first locking portion 341 does not necessarily have a protruding shape that exists over the entire circumference of the inner tube main body 340.

  The second locking portion 342 is formed integrally with the inner tube 34 and has an outer diameter larger than the inner diameter of the passage port 69 formed in the unit connector 37. Further, at least the base end side of the second locking portion 342 is formed with a gradual change in outer diameter so that the outer diameter gradually increases from the inner tube main body 340 toward the distal end. For this reason, the first locking portion 341 is locked to the passage port 69 by moving in the proximal direction, but is deformed by applying a stronger force, as shown in FIGS. It can pass through the passage port 69. Further, the second locking portion 342 does not necessarily have a protruding shape that exists over the entire circumference of the inner tube main body 340.

  The second locking portion 342 may be formed as a separate member from the inner tube main body 340. By adjusting at least one of the outer diameter, shape, and material of the second locking portion 342, the second locking portion 342 can be set so that it can be locked to the passage port 69 and can be deformed to pass through the passage port 69. For example, the second locking portion 342 can be easily deformed by forming the second locking portion 342 with a material softer than the inner tube main body 340. The second locking portion 342 is preferably not damaged by the hydraulic pressure during priming, but the second locking portion 342 is not damaged if a force that resists the generated force derived from the hydraulic pressure is applied from the outside. Therefore, it is not always necessary to give priority to preventing damage.

  The unit connector 37 includes a unit connector main body 61, a sealing member 62, a cover member 63, and a packing 64, as shown in FIGS.

  The unit connector main body 61 is inserted so that the proximal end portion of the outer tube 32 is fitted to the inner peripheral surface 611 inside, and the inner tube 34 extending from the hub 31 is inserted into the outer tube 32. The unit connector main body 61 and the outer tube 32 are bonded and fixed. A passage port 69 into which the inner tube 34 is inserted is formed at the base end portion of the unit connector body 61. The sealing member 62 is combined with the unit connector main body 61 to hold the packing 64, and the cover member 63 is combined with the unit connector main body 61 to hold the outer tube 32. Since the packing 64 is sealed between the unit connector main body 61 and the sealing member 62, the physiological saline supplied to the port 311 of the hub 31 flows into the outer tube 32 through the inner tube 34. However, it does not leak outside the unit connector 37.

  The outer tube main body 321 is a tubular body having a constant inner diameter and outer diameter, and has a proximal end connected to the unit connector 37 and a distal end connected to the relay connector 33. The inner tube 34 is inserted into the outer tube main body 321 so as to be movable in the axial direction.

  When the inner tube 34 is pushed most into the outer tube 32, as shown in FIG. 1, the inner tube 34 reaches the sheath side end near the sheath side end of the outer tube 32, that is, near the relay connector 33. . In this state, the transducer unit 41 is located near the distal end of the sheath tube 22 of the sheath 2.

Further, when the inner tube 34 is pulled out most in normal use, that is, when a pullback operation is performed, the outer diameter of the second locking portion 342 formed on the inner tube 34 is set to the passage port 69 as shown in FIG. Therefore, the second locking portion 342 is caught on the inner wall of the unit connector 37, and the inner tube 34 does not fall out of the unit connector 37. Then, the portion other than the vicinity of the distal end where the inner tube 34 is caught is exposed on the proximal end side with respect to the unit connector 37. At this time, since the easily exposed portion 343 is located on the tip side of the second locking portion 342, it is located in the outer tube 32 and is not exposed to the outside. For this reason, bending force does not act on the easily exposed part 343, and a deformation | transformation does not arise. In this state, the transducer unit 41 is pulled back while leaving the sheath 2. By moving the transducer unit 41 while rotating, it is possible to create tomographic images of blood vessels and vessels.

  As shown in FIG. 6, the relay connector 33 includes an outer tube holding portion 65 and a kink protector 66. A part of the outer tube 32 is inserted into the outer tube holding portion 65 so that the outer peripheral surface of the distal end portion of the outer tube 32 is fitted to the inner peripheral surface 651 inside. The outer tube holding portion 65 and the outer tube 32 are bonded and fixed. In addition, the proximal end of the sheath tube 22 is connected to the inner peripheral surface 651 of the outer tube holding portion 65, and a path for introducing the drive shaft 42 and physiological saline that have passed through the outer tube 32 into the sheath 2. Is formed. The sheath tube 22 has a single layer structure in FIG. 6, but may have a multilayer structure.

  A spacer tube 68 through which the drive shaft 42 passes is disposed inside the distal end portion of the outer tube 32 fitted to the outer tube holding portion 65, and a protective tube 67 is fixed to the inner wall of the spacer tube 68. The protective tube 67 extends toward the inner tube 34 extending from the hub 31 and is disposed between the drive shaft 42 and the inner tube 34. Therefore, when the inner tube 34 is pushed into the outer tube 32, the protective tube 67 is pushed into the inner tube 34 in the direction opposite to the pushing direction. When the inner tube 34 is pushed into or pulled out from the outer tube 32, the protective tube 67 is also pushed into or pulled out relative to the inner tube 34 from the opposite direction. Even if a bending force is generated in the drive shaft 42, the bending force can be suppressed by the protective tube 67, and bending or the like can be prevented. The protective tube 67 is formed of a metal sparsely wound coiled body. For this reason, physiological saline can flow from the gap between the coils, so that air may remain in the outer tube 32. Absent.

  The constituent materials of the outer tube 32, the inner tube 34, the spacer tube 68, the hub 31, the unit connector main body 61 and the outer tube holding portion 65 are not particularly limited. For example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, Poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate, polyethylene naphthalate, butadiene-styrene copolymer, polyamide (for example, nylon 6, Various resins such as nylon 6,6, nylon 6,10, nylon 12) may be mentioned. In addition, the constituent material of these members is suitably selected according to the function requested | required, Therefore, each can be formed with a different constituent material.

  The medical device 1 described above is connected to and driven by an external drive device 7 as shown in FIG. The external drive device 7 includes a drive unit 71 that incorporates an external drive source such as a motor on the base 75 and rotationally drives the drive shaft 42, and a movement that grips the drive unit 71 and moves it in the axial direction by the motor or the like. Means 72 and a holding part 73 for holding a part of the medical device 1 in a fixed position are provided. The external drive device 7 is connected to a control unit 79 that controls the drive unit 71 and the moving means 72, and an image obtained by the vibrator unit 41 is displayed on a display unit 78 connected to the control unit 79. .

  The moving means 72 is a feed mechanism that can grip and fix the drive unit 71 and moves the gripped drive unit 71 back and forth along the groove rail 76 on the base 75.

  The drive unit 71 includes a drive female connector 711 to which the drive male connector 51 of the medical device 1 can be connected, and a joint connection unit 712 that can be connected to the joint 50 of the medical device 1. The signal can be transmitted to and received from the vibrator unit 41, and at the same time, the drive shaft 42 can be rotated.

  Ultrasonic scanning (scanning) in the medical device 1 transmits the rotational motion of the motor in the drive unit 71 to the drive shaft 42, and rotates the housing 412 fixed to the tip of the drive shaft 42. This is performed by scanning an ultrasonic wave transmitted and received by the ultrasonic transducer 411 provided in a substantially radial direction. In addition, by pulling the entire medical device 1 toward the proximal end and moving the ultrasonic transducer 411 in the longitudinal direction, a 360 ° cross-sectional image of the surrounding tissue body in the axial direction in the blood vessel can be scanned to an arbitrary position. Can get to.

  Next, the operation | movement at the time of observing the inside of a lumen using the medical device 1 which concerns on this embodiment is demonstrated.

  First, before the sheath 2 of the medical device 1 is inserted into the lumen, a priming operation for filling the medical device 1 with physiological saline is performed. When the air in the medical device 1 is replaced with physiological saline by performing the priming operation, the ultrasonic wave is easily transmitted to the outside of the device.

  In order to perform priming, the hub 31 is pulled from the unit connector 37 to the user's hand side so that the second locking portion 342 is engaged with the passage port 69 (see FIG. 5) and connected to the port 311 of the hub 31. A physiological saline solution is injected through, for example, a syringe or the like through a tube and a three-way stopcock (not shown). The injected physiological saline solution is filled into the sheath 2 in order from the hub 31. When the inside of the medical device 1 is completely filled with physiological saline, the physiological saline is removed from the priming port 231 formed in the filling liquid inlet / outlet member 23 (see FIG. 3) of the sheath 2. Thereby, filling of the physiological saline is confirmed. By performing this priming operation, when the air in the medical device 1 is replaced with physiological saline, the ultrasonic wave is easily transmitted to the outside of the device.

  Next, as shown in FIG. 2, the medical device 1 is connected to an external drive device 7 covered with a sterilized polyethylene bag (not shown). That is, the joint 50 (see FIG. 4) of the hub 31 of the medical device 1 is connected to the joint connection part 712 of the drive unit 71. As a result, signals can be transmitted and received between the vibrator unit 41 and the external drive device 7, and at the same time, the drive shaft 42 can be rotated. Then, when the unit connector 37 is fitted into the holding portion 73, the connection is completed.

  Next, the drive unit 71 is moved to the distal end side along the groove rail 76 on the base 75, whereby the hub 31 is pushed to the distal end side, and the inner tube 34 is pushed most into the outer tube 32 (see FIG. 1). In this state, the sheath 2 is inserted into the body, the insertion is stopped after the distal end of the sheath 2 has passed over the affected area, and the position of the sheath 2 is fixed. At this time, the drive shaft 42 is pushed to the distal end side of the sheath 2, thereby serving as a core material of the sheath 2, and the penetration of the sheath 2 into the lumen is improved. In this state, as shown in FIG. 5, by performing a pullback operation by moving the drive shaft 42 in the proximal direction while being rotated by the drive unit 71, it is possible to acquire an image along the axial direction of the lumen. .

  The pull back operation can be performed by controlling the moving means 72 connected to the rear end of the medical device 1 by the control unit 79. The acquired data is digitally processed by the control unit 79 and then displayed on the display unit 78 as image data.

  During the pull-back operation, the outer diameter of the second locking portion 342 formed on the inner tube 34 is larger than the inner diameter of the passage port 69, so that the inner tube 34 is prevented from accidentally falling off the unit connector 37. . Further, since the easy-to-expose portion 343 is located on the distal end side with respect to the second locking portion 342, it is located in the outer tube 32 and is not exposed to the outside. Does not leak. Furthermore, since the first locking portion 341 that cannot pass through the passage port 69 is formed at the tip of the inner tube 34, even if the second locking portion 342 passes through the passage port 69, the inner tube 34. Is reliably prevented from falling off from the unit connector 37, and safety is ensured.

  Then, after the pullback operation, the hub 31 is pushed again toward the distal end side to advance the imaging core 4.

  Thereafter, the medical device 1 is pulled out from the lumen. For example, when the medical device 1 is inserted into a curved lumen, the medical device 1 has a rapid exchange structure. If the guide wire 25 is bent to the side, the phenomenon that the guide wire 25 is bent and separated from the medical device 1, so-called “wire separation” may occur. If such a phenomenon occurs and the guide wire 25 is bent so that it is folded, for example, it may be difficult to move the medical device 1 along the guide wire 25. Or, for example, when the medical device 1 is used to check the stent placed in the lumen, the medical device 1 or the guide wire 25 is caught on the stent strut, and so-called “trapping” or the like occurs. Therefore, it may be difficult to pull out the medical device 1.

  In such a case, the surgeon fixes the vicinity of the outer tube 32 and moves the hub 31 in the proximal direction. As a result, first, the inner tube 34 moves in the proximal direction together with the hub 31, and as shown in FIG. 8, the second locking portion 342 provided in the inner tube 34 is connected to the distal end side of the passage port 69 of the unit connector 37. It is locked at the edge. Thereafter, when the operator pulls the hub 31 in the proximal direction with a stronger force, the second locking portion 342 having a gradual change in outer diameter receives a force from the passage port 69 as shown in FIG. It deforms and passes through the passage port 69. Along with this, the easy-to-expose portion 343 also passes through the passage port 69 and can move to the base end side from the unit connector 37 and is exposed to the outside. At this time, since the easily exposed portion 343 is open, the position of the protective tube 67 inside the inner tube 34 can be confirmed. When the protective tube 67 is formed in a coil shape or the like, the proximal end portion of the protective tube 67 may be sharp. However, the proximal end portion of the protective tube 67 is confirmed, and the easily exposed portion 343 is connected to the protective tube. By positioning the protective tube 67 further on the proximal end side than the proximal end portion of the 67, safety can be secured without exposing the protective tube 67 from the easily exposed portion 343.

  Thereafter, when the operator applies a bending force or a pulling force to the inner tube 34, stress concentrates on the easily exposed portion 343 having low rigidity, and the easily exposed portion 343 is formed as shown in FIG. The inner tube 34 is cut at the site. Thereafter, when the hub 31 is further moved to the proximal end side together with the external drive device 60, the broken proximal end portion of the inner tube 34 and the imaging core 4 are moved to the proximal end side as shown in FIG. Will move. When the hub 31 is further moved to the proximal end side, the imaging core 4 is pulled out from the sheath 2 and the outer tube 32 as shown in FIG.

  Thereafter, as shown in FIG. 13, a wire W such as a guide wire prepared separately is opened from the opening formed by breaking the easily exposed portion 343 of the inner tube 34 in the lumen where the imaging core 4 is disposed. insert. At this time, the easily exposed portion 343 is positioned further to the proximal end side than the proximal end portion of the protective tube 67, and the sharp end portion of the protective tube 67 does not protrude from the easily exposed portion 343. There is no need to insert, and the safety when inserting the wire W is high.

  After the wire W reaches the distal end portion of the sheath 2, the sheath 2 and the guide wire 25 are operated while applying a force to the inside of the sheath 2 by the wire W to return the sheath 2 and the guide wire 25 to an appropriate state. be able to. Thereby, the sheath 2 and the guide wire 25 can be pulled out from the lumen.

  As shown in FIG. 14, without separating the inner tube 34 with the easy-to-expose portion 343, the drive shaft 42 is pulled out from the easily-exposed portion 343, and the imaging shaft 4 is pulled by pulling the drive shaft 42. And it may be pulled out from the outer tube 32.

  According to the medical device 1 according to the present embodiment, the easily exposed portion 343 of the inner tube 34 is on the proximal end side with respect to the first locking portion 341, and the second locking portion 342 is formed by the passage port 69. Since it is formed so as to be positioned in the outer tube 32 in the locked state, the second locking portion is maintained as necessary while maintaining the easily exposed portion 343 in the outer tube 32 in a normal use state. By deforming 342, the easily exposed portion 343 can be exposed to the outside by allowing the portion of the inner tube 34 where the second locking portion 342 is disposed to pass from the passage port 69 to the proximal end side. As a result, the drive shaft 42 exposed from the easily exposed portion 343 can be pulled out from the inner tube 34, and the drive shaft 42 can be easily pulled out from the sheath 2. Therefore, the wire W is inserted into the sheath 2 from which the drive shaft 42 has been pulled out. Thus, the operation of pulling out the sheath 2 from the living body lumen can be easily performed, and safety can be improved.

  In particular, the operation of allowing the second locking portion 342 to pass through the passage port 69 by slightly pulling it and pulling out the imaging core 4 from the easily exposed portion 343 can be performed with an intuitive operation. In a highly urgent situation such as catching (and wrapping), easy and quick operation is possible, and safety can be improved.

  In addition, since the easily exposed portion 343 is a portion that is partially formed with low rigidity in the inner tube 34, when the easily exposed portion 343 is positioned on the proximal side of the outer tube 32 and exposed to the outside, the easily exposed portion 343 is exposed to the outside. The easily exposed portion 343 can be deformed and easily bent or separated, and the drive shaft 42 can be easily pulled out from the easily exposed portion 343.

  In addition, since the easily exposed portion 343 is formed between the first locking portion 341 and the second locking portion 342, the inner tube 34 is moved from the outer tube 32 in the proximal direction to move the second locking portion 342. Is locked to the passage port 69, no pulling force acts on the easily exposed portion 343, and unexpected damage to the easily exposed portion 343 can be suppressed to increase safety.

  Further, the easily exposed portion 343 is a member (inside the inner tube 34) in order to make the inside of the inner tube 34 visible from the outside when positioned on the base end side of the unit connector 37 (insertion portion). For example, the drive shaft 42 can be pulled out from the easily exposed portion 343 while taking into account the position of the protective tube 67).

  In addition, since the medical device 1 includes the protective tube 67 that is disposed in the inner tube 34 and accommodates the drive shaft 42 therein, the position of the protective tube 67 that is disposed inside the inner tube 34 can be easily exposed. While observing from 343, the drive shaft 42 can be pulled out from the easy-to-expose portion 343 in a state where the easily-exposed portion 343 is disposed at a desired position with respect to the protective tube 67 and the drive shaft 42.

  Further, if the second locking portion 342 is provided as a separate member in the inner tube 34, it is easy to easily deform the second locking portion 342 using a member having rigidity lower than that of the inner tube 34. It becomes.

  In addition, since the easily exposed portion 343 is a cut formed in the inner tube 34, when the easily exposed portion 343 is positioned on the proximal side with respect to the outer tube 32 and exposed to the outside, the easily exposed portion 343 By applying a bending force or a pulling force, it is possible to bend or separate while having a high stress concentration.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, in the above-described embodiment, the case where the present invention is applied to an ultrasonic catheter has been described. However, an optical probe (OCT catheter) for a diagnostic device using light such as an optical coherence tomography diagnostic device or an optical frequency domain imaging diagnostic device. ), An endoscopic system, and the like, and further, a tubular body such as a catheter that performs a mechanical drive such as a catheter used for directional coronary artery atherectomy (DCA). As long as it has, it can be applied to any medical device. Therefore, in the present embodiment, the liquid is filled in the lumen of the sheath 2 in which the imaging core 4 is accommodated, but the present invention can also be applied to a catheter that is not filled with the liquid.

  Moreover, the structure of the easily exposed part formed in an inner pipe will not be specifically limited if it is a structure which can make a deformation | transformation easy. Therefore, for example, as shown in FIG. 15, the easily exposed portion 344 may be a plurality of openings. As shown in FIG. 16, the easily exposed portion 345 may be a perforation composed of a plurality of cuts arranged in the circumferential direction.

  Further, the easy-to-expose part is a part that makes it easy to expose the drive shaft 42. For example, if it is easy to form an opening in the inner tube by bending, it does not need to be opened in the state before bending. Thus, the exposed portion may be in the form of a groove, for example.

  As shown in FIG. 17, the easy-to-expose portion 346 is located in the outer tube 32 in a state where the second locking portion 342 is locked by the passage port 69, and the second locking portion 342. It may be formed closer to the base end side. When the packing 64 is provided on the unit connector 37, it is preferable that the easily exposed portion 346 is located on the tip side of the packing 64.

  Further, as shown in FIG. 18, by removing (peeling) the second locking portion 347 from the inner tube main body 340 while deforming, the portion where the second locking portion 347 of the inner tube is disposed passes. A configuration that passes through the mouth 69 may also be adopted. Such a structure can easily realize a structure in which the second locking portion 347 is easily separated from the inner tube main body 340 by forming the second locking portion 347 by a member different from the inner tube main body 340. The two locking portions 347 may be formed integrally with the inner tube main body 340.

1 medical device,
2 sheath,
3 Operation part,
31 hub,
32 Outer pipe,
321 outer pipe body,
33 Relay connector,
34 Inner pipe,
340 inner pipe body,
341 first locking portion,
342, 347 second locking portion,
343, 344, 345, 346 Easy-to-expose part,
37 Unit connector (insertion part),
4 Imaging core,
41 vibrator unit,
42 drive shaft,
67 protective tube,
69 Passage,
7 Outer pipe,
W wire.

Claims (7)

A sheath inserted into the body lumen;
A drive shaft inserted into the sheath for transmitting mechanical drive force;
A hub that moves the drive shaft in the axial direction of the sheath by moving while holding the drive shaft;
An outer tube provided on the proximal end side of the sheath and provided with an insertion portion into which an inner tube is inserted at the proximal end portion, and movable within the outer tube as the hub moves, and an outer diameter at the distal end portion An enlarged first locking portion, and an inner tube provided with a deformable second locking portion located closer to the base end side than the first locking portion,
The insertion portion has a passage opening that can receive the inner tube, and the passage opening has a smaller diameter than outer diameters of the first engagement portion and the second engagement portion, and the second engagement portion. Allowing passage of the portion where the second locking portion of the inner pipe is disposed by deformation of the portion,
The inner tube is located on a proximal end side with respect to the first locking portion, and the drive shaft is placed at a position located in the outer tube in a state where the second locking portion is locked by the passage port. A medical device having an easily exposed portion for exposing.   The medical device according to claim 1, wherein the easily exposed portion is a portion where rigidity is partially formed in the inner tube.   The medical device according to claim 1, wherein the easily exposed portion is formed between the first locking portion and the second locking portion.   The medical device according to any one of claims 1 to 3, wherein when the easily exposed portion is positioned closer to the proximal end than the insertion portion, the inside of the inner tube is visible from the outside.   The medical device according to any one of claims 1 to 4, further comprising a protective tube that is disposed in the inner tube and accommodates the drive shaft therein.   The medical device according to claim 1, wherein the second locking portion is provided as a separate member on the inner tube.   The medical device according to claim 1, wherein the easily exposed portion is a cut formed in the inner tube.

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