JP2018042823A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device with excellent operability capable of adjusting a direction of a distal end portion of a shaft part by a hand operation.SOLUTION: A medical device 1 which is inserted into a lumen of a living body to acquire an image includes: a covering tube 8 for covering an image sheath 61 and a guide wire sheath 62; and a bending mechanism 9 performing bending operation of a distal end portion of the image sheath and a distal end portion of the guide wire sheath in a direction intersecting an axial direction. The bending mechanism includes: long bodies 911, 921 which extend from a hub part 5 to a distal end side along the axial direction and are arranged between the image sheath and the guide wire sheath and the covering tube in a cross section perpendicular to an axis; and bending operational parts 913, 923 which are arranged in the hub part and enable pushing and pulling of the long bodies along the axial direction.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a medical device.

  Conventionally, in order to obtain a diagnostic image for diagnosing a lesion when a lesion occurring in the body lumen is treated percutaneously, a tomographic image in the body lumen is obtained using ultrasound or light. Medical devices that acquire

  The following Patent Document 1 includes a drive shaft provided with an imaging unit capable of acquiring image information at the tip, a lumen through which the drive shaft is inserted, a shaft portion inserted into a living body lumen, and a shaft portion. There is disclosed a medical device having an operation unit that is connected to a proximal end side and that allows an operator to perform a predetermined operation.

Special table hei 10-500584

  When performing a treatment using the medical device, the distal end portion of the shaft portion is moved to a lesion portion to be observed in the living body lumen. For example, when the shaft portion is moved along a branched path in the living body lumen, if the orientation of the tip portion of the shaft portion can be adjusted appropriately by hand operation, the tip portion of the shaft portion is It is considered that it can be easily and smoothly moved to the vicinity.

  In addition, even when imaging a lesion formed on a meandering or bent part of a living body lumen, if the direction of the tip of the shaft part can be adjusted, the observation direction by the imaging unit is changed. Therefore, it is considered that the lesioned part can be easily accommodated within the viewing angle of the imaging unit.

  However, no medical device used for acquiring a tomographic image of a living body lumen is configured such that the orientation of the tip of the shaft portion can be adjusted by hand operation.

  The present invention has been made to solve the above-described problems, and an object thereof is to provide a medical device with excellent operability that can adjust the direction of the tip of the shaft portion by hand operation. To do.

  A medical device that achieves the above object is a medical device that is inserted into a living body lumen to acquire an image. The medical device is for a guide wire having an image sheath including an image lumen extending in an axial direction through which a drive shaft can be inserted, and a guide wire lumen that is arranged alongside the image lumen and through which the guide wire can be inserted. A sheath, a hub connected to the proximal end of the imaging sheath, a covering tube that covers the imaging sheath and the guidewire sheath, a distal end portion of the imaging sheath, and a distal end portion of the guidewire sheath A bending mechanism for bending in a direction crossing the axial direction, and the bending mechanism extends from the hub portion to the distal end side along the axial direction, An elongated body disposed between the sheath for an image and the sheath for the guide wire and the coated tube; and disposed in the hub portion, the elongated body being disposed in the axial direction Having a bending operation portion for the pushing and pulling can along.

  According to the medical device configured as described above, the user operates the bending operation portion by hand, and pushes and pulls the long body, whereby the distal end portion of the sheath for image and the distal end portion of the guide wire sheath Each sheath can be curved so that is oriented in the desired direction. Accordingly, the user can smoothly move each sheath along a branched path in the living body lumen by a hand operation, and can easily change the observation direction by the imaging unit. Is possible.

It is a top view which shows the medical device which concerns on embodiment. It is sectional drawing which follows the axial direction which shows the front-end | tip part of the medical device which concerns on embodiment. It is a top view which shows the hub of the medical device which concerns on embodiment. It is a figure which shows the bending mechanism of the medical device which concerns on embodiment, and is the top view seen from the arrow 4A direction shown in FIG. It is a figure which shows sectional drawing of each part of the medical device which concerns on embodiment, FIG. 5 (A) is sectional drawing shown to the arrow 5A-5A line shown in FIG. 1, FIG.5 (B) shows in FIG. FIG. 5C is a cross-sectional view taken along the line 5B-5B, and FIG. 5C is a cross-sectional view taken along the line 5C-5C shown in FIG. It is a top view which shows an external drive device. It is a top view which shows the medical device at the time of pulling back the vibrator unit. It is a flowchart which shows the procedure using the medical device which concerns on embodiment. It is a figure which shows typically the usage example of the medical device which concerns on embodiment. It is a figure which shows typically the usage example of the medical device which concerns on embodiment. It is a figure which shows the medical device which concerns on the modification 1, and is sectional drawing corresponding to FIG. 5 (B). It is a perspective view which shows the bending mechanism of the medical device which concerns on the modification 1. FIG. It is a figure which shows typically the usage example of the medical device which concerns on the modification 1. FIG. It is a figure which shows the medical device which concerns on the modification 2, and is sectional drawing corresponding to FIG. 5 (B).

  Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the following description does not limit the meaning of the technical scope and terms described in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios.

  As shown in FIGS. 1 and 2, the medical device 1 is an ultrasonic catheter that contains an imaging core 4 for acquiring a diagnostic image by ultrasonic waves and is inserted into a living body lumen. The medical device 1 is connected to an external driving device 7 (see FIG. 6) that holds the medical device 1 and drives the imaging core 4 and is used for diagnosing a living body lumen such as a blood vessel. The

  In the present specification, the side to be inserted into the living body lumen is referred to as “distal end” or “distal end side”, and the proximal side for operating the medical device 1 is referred to as “proximal end” or “proximal end side”. In addition, a portion indicating a certain range including the distal end and its peripheral portion is referred to as “tip portion”, and a portion indicating a certain range including the proximal end and its peripheral portion is referred to as “base end portion”. The direction in which the image lumen 25 inserted through the imaging core 4 extends is referred to as “axial direction”.

  As shown in FIG. 1, the medical device 1 includes a long shaft portion 2 inserted into a living body lumen, an operation unit 3 on which an operator performs a predetermined operation, and a tissue in the living body lumen. An imaging core 4 that transmits and receives ultrasonic waves toward the head, a hub portion 5 that is inserted through the imaging core 4 and is disposed on the proximal end side of the shaft portion 2, a predetermined bending mechanism 9 (see FIG. 4), It has.

  As shown in FIGS. 1 and 2, the shaft portion 2 includes a shaft distal end 21 and a shaft main body 22 disposed on the proximal end side of the shaft distal end 21.

  As shown in FIG. 5A, a guide wire lumen 26 into which the guide wire W is inserted is formed at the shaft tip 21.

  As shown in FIGS. 5B and 5C, the shaft main body 22 includes an image lumen 25 into which the imaging core 4 is inserted and a guide wire lumen 26 into which the guide wire W is inserted. Is formed. The guide wire lumen 26 is arranged in parallel with the image lumen 25. The medical device 1 according to the present embodiment is a so-called over-the-wire (OTW) type catheter in which a guide wire lumen 26 is formed from a shaft tip 21 to a shaft body 22.

  The guide wire W used in the medical device 1 of the present embodiment is a long body that is flexible and has a substantially constant outer diameter over its entire length. Although the cross-sectional shape of the guide wire W is not specifically limited, For example, it can form in a substantially circular shape.

  The guide wire W is configured to be observable from an angio image obtained by imaging a living body lumen by X-ray imaging from outside the body. The constituent material of the guide wire W is not particularly limited as long as it can be observed by an angio image. For example, a metal such as a stainless steel, spring steel, titanium, tungsten, tantalum, a nickel / titanium alloy or other superelastic alloy is used. be able to.

  As shown in FIGS. 5B and 5C, the shaft portion 2 includes an image sheath 61 in which the image lumen 25 is formed and a guidewire sheath 62 in which the guidewire lumen 26 is formed. It is formed by heat fusion (or adhesion). In the present embodiment, the image sheath 61 and the guide wire sheath 62 are formed with a fused portion 27 in which the adjacent wall portions of the sheaths 61 and 62 are thermally fused. Further, in the shaft portion 2, at a predetermined position on the proximal end side with respect to the shaft distal end 21 shown in FIG. 5 (A), as shown in FIGS. 5 (B) and 5 (C), an image sheath 61 and a guide are provided. A covering tube 8 that covers the periphery of the wire sheath 62 is disposed.

  As shown in FIG. 2, the image sheath 61 has a distal end opening 61a, and the guide wire sheath 62 has a distal end opening 62a. A reinforcing tube 23 for firmly joining and supporting the guide wire sheath 62 is provided at the tip of the image sheath 61. The reinforcing tube 23 is a tubular body in which a communication hole 24 communicating with the tip opening 61a is formed. The reinforcing tube 23 is formed by heat-sealing (or adhering) to the image sheath 61 with a material having relatively high rigidity.

  As shown in FIG. 3, the shaft main body 22 has a shaft intermediate portion 221 in which an image lumen 25 and a guide wire lumen 26 are formed side by side on the distal end side, and branches from the shaft intermediate portion 221 toward the proximal direction. And a first shaft base end portion 222 and a second shaft base end portion 223 that are extended. The first shaft base end portion 222 has an image lumen 25 formed therein, and the second shaft base end portion 223 has a guide wire lumen 26 formed therein. The shaft main body 22 may have different outer diameters and inner diameters depending on the position in the axial direction. For example, by reducing the outer diameter and inner diameter in a tapered shape from the base end side to the tip end side without causing extreme changes in physical properties, high pushability and passability are achieved while suppressing the occurrence of kinks can do.

  Although the length in alignment with the axial direction of the shaft part 2 is not specifically limited, For example, it can be 600 mm-2000 mm. When the medical device 1 is used for a lower limb procedure, particularly a femoral artery puncture, the length along the axial direction of the shaft portion 2 is shorter than that of a medical device used for a cardiac procedure, for example, , 600 mm to 1200 mm.

  The shaft portion 2 (the respective sheaths 61 and 62 and the covering tube 8 constituting the shaft portion 2) is formed of a flexible material, and the material is not particularly limited. For example, styrene-based, polyolefin-based, polyurethane , Polyester, polyamide, polyimide, polybutadiene, transpolyisoprene, fluororubber, chlorinated polyethylene, etc., including one or more of these Can be applied (polymer alloy, polymer blend, laminate, etc.). The image sheath 61 in which the image lumen 25 is formed is preferably formed of a material having high ultrasonic transmission.

  As shown in FIGS. 5B and 5C, the sheaths 61 and 62 constituting the shaft portion 2 are covered with the covering tube 8. The covering tube 8 can be fixed to each of the sheaths 61 and 62 by heat fusion, an adhesive, or the like, for example. The covering tube 8 can arrange a gap (clearance) g1 and a second elongate member 921 in which a first elongate member 911 described later can be arranged between the image sheath 61 and the guidewire sheath 62. A gap (clearance) g2 is formed. Since the long members 911 and 921 are arranged in the gaps g1 and g2 formed around the sheaths 61 and 62 by the covered tube 8, the outer diameter of the shaft portion 2 is reduced by the long members 911 and 921. It is possible to suppress the increase.

  It should be noted that the shape of the cross section perpendicular to the axis of the covering tube 8, the shape of the cross section perpendicular to the axis of the shaft portion 2 covered with the covering tube 8, the shape and size of the gaps g1, g2, etc. are limited to those shown in the figure. However, it can be changed as appropriate.

  As shown in FIG. 6, the operation unit 3 is configured such that the base end portion can be connected to an external drive device 7 in order to operate the imaging core 4. As shown in FIG. 1, the operation unit 3 includes an outer tube 31 coupled to the tube 8, an inner tube 32 disposed inside the outer tube 31, and a unit connector coupled to a proximal end portion of the outer tube 31. 33 and an operation base end portion 34 connected to the base end portion of the inner tube 32. The outer tube 31 and the inner tube 32 have a double tube structure for performing a pullback operation.

  The outer tube 31 has a distal end portion connected to a first hub 51 described later, and a proximal end portion connected to the unit connector 33. The outer tube 31 has kink resistance and is formed in a substantially linear shape. As a result, the outer tube 31 secures a path through which the inner tube 32 moves in the axial direction.

  The inner tube 32 is disposed in the inner cavity of the outer tube 31 and is configured to be movable back and forth in the axial direction relative to the outer tube 31. The lumen of the inner tube 32 communicates with the image lumen 25, and the drive shaft 42 of the imaging core 4 is inserted therethrough. A stopper 321 is disposed at the tip of the inner tube 32. The stopper 321 is configured to be engageable with the inner wall of the unit connector 33. The proximal end portion of the inner tube 32 is connected to the operation proximal end portion 34. The surgeon can move the drive shaft 42 by operating the operation base end portion 34, and can move the inner tube 32 in the axial direction relative to the outer tube 31 as the drive shaft 42 moves. .

  When the inner tube 32 is pushed most into the distal end side, as shown in FIG. 1, the end portion on the distal end side moves inside the outer tube 31 and reaches the vicinity of the distal end of the outer tube 31. In this state, the transducer unit 41 (corresponding to the imaging unit) 41 of the imaging core 4 is positioned near the tip of the image lumen 25 as shown in FIG.

  Further, when the inner tube 32 is pulled to the most proximal side by the pullback operation, as shown in FIG. 7, a stopper 321 formed at the distal end of the inner tube 32 is caught on the inner wall of the unit connector 33, and the base of the inner tube 32 is A part of the end side is exposed. In this state, the vibrator unit 41 moves to the proximal end side relative to the shaft portion 2. As described above, the transducer unit 41 can move along the axial direction while rotating inside the image lumen 25 in order to acquire a tomographic image in the living body lumen.

  The unit connector 33 is inserted so that the proximal end portion of the outer tube 31 is fitted inside. The unit connector 33 is configured to be connectable to a holding portion 73 (see FIG. 6) of the external drive device 7.

  The operation base end portion 34 holds the drive shaft 42. Further, the operation base end portion 34 includes a port 341, a joint 342, a hub side connector 343 connected to the base end portion of the drive shaft 42, and a kink protector 344.

  The port 341 communicates with the image lumen 25. The port 341 is connected to a priming syringe or a Y connector so that a fluid such as a priming liquid can be supplied to the image lumen 25.

  The joint 342 has an opening on the base end side, and the hub-side connector 343 is disposed inside. The hub side connector 343 is configured to be connectable from a proximal end side of the joint 342 to a drive side connector 711 (see FIG. 6) included in the external drive device 7. By connecting the hub side connector 343 and the drive side connector 711, the external drive device 7 and the hub side connector 343 are mechanically and electrically connected.

  One end of a signal line 43 is connected to the hub side connector 343. As shown in FIG. 2, the signal line 43 passes through the drive shaft 42, and the other end is connected to the vibrator unit 41. The ultrasonic wave is irradiated from the transducer unit 41 by a signal transmitted from the external drive device 7 to the transducer unit 41 via the drive side connector 711, the hub side connector 343, and the signal line 43. Further, a signal detected by the transducer unit 41 by receiving the ultrasonic wave is transmitted to the external drive device 7 via the signal line 43, the hub side connector 343, and the drive side connector 711.

  The kink protector 344 is disposed around the inner tube 32 and the operation base end portion 34 and suppresses kinking of the inner tube 32.

  As shown in FIG. 2, the imaging core 4 is disposed in the image lumen 25 and is configured to be movable back and forth in the axial direction relative to the shaft portion 2. The imaging core 4 includes a transducer unit 41 that can acquire and receive image information by transmitting and receiving ultrasonic waves from within a living body lumen to a living tissue, a drive shaft 42 that attaches and rotates the transducer unit 41 to the tip, have. 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 transducer unit 41 is configured to be observable with an angio image. The constituent material of the housing 412 is not particularly limited. For example, a metal such as gold, platinum, a platinum-based alloy, or a tungsten-based alloy, or barium sulfate, bismuth oxide, or tungsten is used so as to function as an X-ray contrast unit. It preferably contains an X-ray contrast material. Further, an X-ray contrast marker may be separately provided in the vicinity of the housing 412.

  The drive shaft 42 is flexible and has a characteristic capable of transmitting the rotational power generated in the external drive device 7 to the vibrator unit 41. The drive shaft 42 is configured by a multilayer coil-shaped tube body such as a three-layer coil in which the right and left and the winding direction are alternately arranged. When the driving shaft 42 transmits the rotational power, the transducer unit 41 rotates, and a lesioned part in a living body lumen such as a blood vessel can be observed in the circumferential direction. The drive shaft 42 has a signal line 43 for transmitting a signal detected by the vibrator unit 41 to the operation unit 3.

  As shown in FIG. 3, the hub portion 5 includes a first hub portion 51 that is airtightly connected to the first shaft base end portion 222 and a second hub portion 52 that is airtightly connected to the second shaft base end portion 223. A hub body 53 connected to the first hub 51 and the second hub 52, and a kink protector 54. The first hub part 51, the second hub part 52, and the hub main body part 53 can be integrally formed, for example.

  As shown in FIGS. 1 and 3, the first hub portion 51 is connected to the distal end portion of the outer tube 31 from the proximal end side, and the first shaft proximal end portion 222 is inserted from the distal end side to perform heat fusion. Or they are bonded and airtightly connected. Therefore, the physiological saline solution injected into the tube 8 through the port 341 of the operation base end portion 34 can move to the image lumen 25 through the first hub portion 51.

  The second hub portion 52 is hermetically connected by inserting the second shaft base end portion 223 from the distal end side and heat-sealing or bonding. A guide wire lumen 526 communicating with the guide wire lumen 26 is formed inside the second hub portion 52.

  As shown in FIG. 3, the hub main body 53 covers the outer peripheral surfaces of the first shaft base end portion 222 and the second shaft base end portion 223 connected to the first hub portion 51 and the second hub portion 52, respectively. Is formed.

  Inside the hub main body 53, a portion that branches from the shaft intermediate portion 221 to the first shaft base end portion 222 and the second shaft base end portion 223 in the base end direction is disposed. For this reason, since the image sheath 61 and the guide wire sheath 62 are not joined, the first shaft base end portion 222 and the second shaft base end portion 223 having rigidity lower than that of the shaft intermediate portion 221 are the hub main body portion 53. High pushability can be demonstrated without being positioned outside.

  As shown in FIG. 1, the anti-kink protector 54 surrounds the front end portion of the hub main body portion 53 and the shaft main body portion 22 led out from the hub main body portion 53 in the front end direction, and suppresses kink of the shaft main body portion 22.

  The constituent materials of the first hub part 51, the second hub part 52, the hub main body part 53, the outer pipe 31, the inner pipe 32, the unit connector 33 and the operation base end part 34 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 And various resins such as polyamide (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12).

  Note that the configuration of the hub portion 5 is not limited to that described above. For example, a split mold that covers the outer peripheral surfaces of the base end portion of the shaft intermediate portion 221, the first shaft base end portion 222, and the second shaft base end portion 223. You may comprise by the casing of a structure.

  As shown in FIG. 6, the medical device 1 is connected to and driven by an external drive device 7. The external drive device 7 includes an external drive source such as a motor on the base 75, and a drive unit 71 that rotationally drives the drive shaft 42, and a moving unit 72 that holds the drive unit 71 and moves it in the axial direction. A holding portion 73 for holding the unit connector 33 of the medical device 1 in a fixed position and a groove rail 76 extending in the axial direction 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 drive unit 71 includes a drive-side connector 711 to which the hub-side connector 343 of the medical device 1 can be connected, and a joint connection unit 712 that can be connected to the joint 342 of the medical device 1. By connecting the joint connection portion 712 to the joint 342, signals can be transmitted to and received from the transducer unit 41, and at the same time, the drive shaft 42 can be rotated.

  The moving means 72 includes a motor or the like, and is configured to be able to move the driving unit 71 forward and backward along the groove rail 76 in the axial direction while holding the driving unit 71.

  As shown in FIGS. 6 and 7, the 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 while moving the moving means 72 in the axial direction. Then, the housing 412 fixed to the tip of the drive shaft 42 is rotated. Accordingly, the ultrasonic transducer 411 provided in the housing 412 rotates while moving in the axial direction, and ultrasonic waves transmitted and received by the ultrasonic transducer 411 can be scanned in a substantially radial direction. As a result, a 360 ° tomographic image of the surrounding tissue body extending in the axial direction in the living body lumen can be obtained in a scanning manner up to an arbitrary position.

  Next, the bending mechanism 9 of the medical device 1 will be described.

  The bending mechanism 9 is a mechanism provided for bending the distal end portion of the shaft portion 2 (the distal end portion of the image sheath 61 and the distal end portion of the guide wire sheath 62) in a direction crossing the axial direction.

  As shown in FIG. 4, the medical device 1 is provided with two bending mechanisms, a first bending mechanism 91 and a second bending mechanism 92.

  The first bending mechanism 91 includes a first long member (corresponding to a long body) 911 extending from the second hub 52 of the hub portion 5 to the distal end side along the axial direction, and a second of the hub 5. A first operation member (corresponding to a bending operation portion) 913 that is disposed on the hub 52 and that allows the first elongate member 911 to be pushed and pulled along the axial direction.

  A proximal end portion of the first elongate member 911 is disposed outside the second hub 52. The first elongate member 911 passes through the outer surface of the second hub 52 and the outer surface of the hub main body 53, further passes through the inside of the kink protector 54, and extends to the shaft intermediate portion 221 side. As shown in FIG. 3, the shaft intermediate portion 221 is covered with a covering tube 8 that surrounds the image sheath 61 and the guidewire sheath 62. As shown in FIG. 5C, the first long member 911 is formed between the sheath 61 for the image and the sheath 62 for the guide wire and the covering tube 8 on the distal end side with respect to the shaft intermediate portion 221. It arrange | positions in the clearance gap g1.

  The distal end portion of the first elongate member 911 can be disposed, for example, at a position shifted to the proximal end side by a predetermined range from the shaft distal end 21. In the present embodiment, the distal end portion of the first elongate member 911 is disposed on the proximal side from the position (position shown in FIG. 5) when the imaging core 4 is pulled back most proximally. . However, the position of the distal end portion of the first long member 911 is not particularly limited as long as the bending operation of the shaft portion 2 is possible.

  As shown in FIG. 4, the first operation member 913 is formed on the grip portion 913 a that can be gripped with fingers, the slide portion 913 b to which the first long member 911 is connected, and the second hub 52. A groove portion 913c.

  The slide part 913 b is connected to the second hub part 52 via a groove part 913 c formed in the second hub 52. The groove portion 913c is formed along the axial direction of the second hub 52, and holds the slide portion 913b slidably along the groove portion 913. A user (for example, an operator) grips the first elongated member 911 connected to the slide portion 913b by holding the grip portion 913a with fingers and moving the slide portion 913b along the axial direction. It is possible to push and pull in the direction.

  The length along the axial direction of the groove portion 913c defines a movable range along the axial direction of the slide portion 913b (a movable range of the first long member 911). The length along the axial direction of the groove portion 913c is not particularly limited. For example, the movable range of the first elongate member 911 is set to a desired size in consideration of the specifications and operability of the medical device 1. It is possible to adjust appropriately.

  The constituent materials of the grip portion 913a and the slide portion 913b of the first operation member 913 are not particularly limited, and for example, the same material as that of the second hub portion 52 can be used.

  The first elongate member 911 is preferably configured to have a higher elastic modulus than the image sheath 61, the guide wire sheath 62, and the coated tube 8, for example. When the first elongate member 911 is configured as described above, the distal end portion of the shaft portion 2 can be easily bent in conjunction with the push-pull operation of the first elongate member 911 as described later. (See FIG. 9). Further, when the first long member 911 has the elastic modulus as described above, the first long member 911 also has a function as a reinforcing body that increases the rigidity of the shaft portion 2, so that the shaft portion It is possible to suitably prevent 2 folds and the like.

  When the first elongate member 911 is configured to have a higher elastic modulus than the image sheath 61, the guide wire sheath 62, and the coated tube 8 as described above, the first elongate member 911 includes, for example, Long wire such as super-elastic alloys such as nickel-titanium alloy and copper-zinc alloy, metal materials such as stainless steel, resin materials with relatively high rigidity, etc., polyvinyl chloride, polyethylene, polypropylene, ethylene-propylene It can be configured by coating a resin material such as a copolymer.

  As shown in FIG. 4, the second bending mechanism 92 is a second long member (corresponding to a long body) 921 extending from the second hub 52 of the hub portion 5 to the distal end side along the axial direction. And a second operation member (corresponding to a bending operation portion) 923 that is disposed on the second hub 52 of the hub 5 and that allows the second long member 921 to be pushed and pulled along the axial direction. Note that the second bending mechanism 92 has substantially the same configuration as the first bending mechanism 91, and therefore, differences from the first bending mechanism 91 will be described, and a part of the description will be omitted. To do.

  As shown in FIG. 5C, the second elongate member 921 is a first elongate member 911 along a direction that intersects the direction in which the image sheath 61 and the guidewire sheath 62 are arranged side by side. Are arranged in pairs. More specifically, the second elongate member 921 has an image sheath 61, a guide wire sheath 62, and a covering tube 8 on the distal end side of the shaft intermediate portion 221 as shown in FIG. It arrange | positions in the clearance gap g2 formed between. The gap g2 is formed at a position where the image sheath 61 and the guide wire sheath 62 are separated from the gap g1 in which the first long member 911 is disposed in the axial orthogonal cross section.

  The second operating member 923 is disposed at a position that is substantially symmetric with respect to the first operating member 921 with respect to the center position of the second hub 52 in the left-right direction in plan view shown in FIG.

  The second operation member 923 includes a grip portion 923 a that can be gripped with fingers or the like, a slide portion 923 b to which the first long member 921 is connected, and a groove portion 923 c formed in the second hub 52. Each part 923a, 923b, 923c of the second operation member 923 has the same configuration as each part 913a, 913b, 913c of the first operation member 913.

  Next, with reference to FIGS. 8-10, the usage example and effect of the medical device 1 which concern on embodiment are demonstrated. In the following description, a treatment example in the case where the lesioned part formed in the blood vessel of the lower limb of the patient P is set as the observation site (observation target) is shown.

  First, as step S1, a priming process for filling the medical device 1 with physiological saline is performed. By performing the priming process, ultrasonic waves can be transmitted from the ultrasonic transducer 411, and air in the medical device 1 is removed to prevent air from entering the blood vessel.

  In order to perform the priming of the image lumen 25, as shown in FIG. 7, the operation base end 34 is most pulled from the unit connector 33 to the base end side, that is, the inner pipe 32 is most pulled out from the outer pipe 31. To the state. Thereafter, a physiological saline solution is injected using, for example, a syringe or the like via a tube (not shown) connected to the port 341 of the operation base end 34 and a three-way stopcock. The injected physiological saline passes through the first hub portion 51 from the operation base end portion 34 and is filled into the image lumen 25, and the physiological saline is removed from the distal end opening portion 61a (see FIG. 2). Thereby, the filling of the physiological saline is confirmed, and the priming process in the image lumen 25 is completed.

  In order to perform priming of the guide wire lumen 26, a physiological saline solution is injected using, for example, a syringe or the like through a tube and a three-way stopcock (not shown) connected to the second hub portion 52. The injected physiological saline passes through the second hub portion 52 and is filled into the guide wire lumen 26, and the physiological saline is removed from the distal end opening 62a (see FIG. 2). Thereby, the filling of the physiological saline is confirmed, and the priming process in the guide wire lumen 26 is completed.

  Next, as step S2, as shown in FIG. 4, the medical device 1 is connected to an external drive device 7 covered with a sterilized polyethylene bag (not shown). That is, the joint 342 of the operation base end portion 34 of the medical device 1 is connected to the joint connection portion 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 33 is fitted into the holding portion 73, the connection is completed.

  Next, as step S3, the guide wire W is inserted into the blood vessel through the guiding sheath that is percutaneously inserted into the blood vessel by the Seldinger method. Next, the proximal end portion of the guide wire W is inserted into the guide wire lumen 26 through the distal end opening 62a.

  Next, as step S4, after the guide wire W is led out from the second hub portion 52 to the proximal end side, the shaft portion 2 of the medical device 1 is pushed along the guide wire W, and the distal end portion of the shaft portion 2 is observed. Move to the vicinity of the lesion. At this time, since the first hub portion 51 and the second hub portion 52 are directed in different directions, the guide wire W can be operated without being interfered with the operation portion 3 and the external drive device 7.

  Further, since the guide wire lumen 26 is opened at the second hub portion 52, the guide wire W can be easily exchanged. For this reason, it is possible to efficiently reach the medical device 1 to the deep part of a complicated site by properly using the guide wires W having arbitrary loads and shapes. In addition, a contrast agent or a drug can be supplied to the guide wire lumen 26 via the second hub portion 52 and can be released from the distal end opening 62a into the living body.

  In this state, the operation base end 34 is moved by moving the drive unit 71 to the front end side along the groove rail 76 on the base 75 while holding the shaft 2 so as not to move (see FIG. 6). It is moved to the distal end side, and the inner tube 32 is pushed most into the outer tube 31. Thereby, as shown in FIG. 1, the transducer unit 41 moves to the distal end side of the image lumen 25.

  Further, when the shaft portion 2 is moved in the blood vessel, the direction of the distal end portion of the shaft portion 2 is changed by operating the bending mechanism 9 at a portion where the blood vessel is branched. The surgeon can move the shaft portion 2 along a desired path by aligning the direction of the distal end portion of the shaft portion 2 in an arbitrary direction of the branched portion of the blood vessel. A specific operation procedure of the bending mechanism 9 will be described later.

  Next, as step S5, an angiographic image is acquired by performing X-ray imaging from outside the body at the position (lesioned portion) where the transducer unit 41 is disposed. By confirming the angio image, the position and posture of the distal end portion of the medical device 1 can be grasped.

  Next, as step S6, a pullback operation is performed while the drive shaft 42 is rotated by the drive unit 71, whereby the ultrasonic transducer 411 is moved along the axial direction from the affected part to the proximal side while performing radial scanning. As a result, a 360 ° tomographic image of the surrounding tissue body in the axial direction in the blood vessel including the affected part can be obtained by scanning up to an arbitrary position.

  By grasping the positional relationship between the guide wire W and the transducer unit 41 from both the tomographic image and the angio image, and by matching the directions of the tomographic image and the angio image, the position of the lesioned part visible in the tomographic image can be efficiently obtained. The guide wire W can be advanced.

  9 and 10 show an operation example of the medical device 1 when acquiring a tomographic image of a lesioned part (stenosis part) N formed in the blood vessel B. FIG.

  As shown in FIG. 9, for example, when a lesion N is formed in a meandering or bent portion of the blood vessel B, if the tip of the shaft portion 2 faces in the direction along the path P1 of the blood vessel B, There is a possibility that the lesioned part N cannot be accommodated within the viewing angle range F of the transducer unit 41 of the imaging core 4. Therefore, the surgeon performs an operation of changing the orientation of the distal end portion of the shaft portion 2 so that the distal end portion of the shaft portion 2 faces the lesioned portion N side. For example, the operator operates the second operation member 92 of the second bending mechanism 92 by hand, and advances the second long member 921 toward the distal end side of the shaft portion 2. By performing this operation, the distal end portion of the first long member 911 of the first bending mechanism 91 is disposed on the proximal end side with respect to the distal end portion of the second long member 921.

  When the second elongate member 921 is moved forward relative to the first elongate member 911 as described above, the physical properties of the second elongate member 921 (for example, the difference in rigidity from the shaft portion 2). ), The distal end portion of the shaft portion 2 is curved starting from the vicinity of the distal end portion of the first long member 911. When the distal end portion of the shaft portion 2 is curved, the orientation of the distal end portion of the shaft portion 2 is changed to the side where the first long member 921 is disposed (the direction of the arrow a1) with respect to the axial direction of the shaft portion 2. The Therefore, the lesioned part N can be accommodated within the viewing angle range F of the transducer unit 41 of the imaging core 4.

  In the example shown in FIG. 9, when the lesioned part N is formed on the blood vessel wall on the side where the first long member 921 is arranged (the lower blood vessel wall in FIG. 9), the operator By moving the first elongate member 911 relatively forward with respect to the second elongate member 921, the direction of the tip end portion of the shaft portion 2 can be changed in the direction opposite to the illustrated direction (arrow a2 direction). it can.

  When releasing the curved state of the distal end portion of the shaft portion 2, the surgeon operates the bending mechanism 9 to position the distal end portion of the first long member 911 and the distal end portion of the second long member 921. Adjust the position of to the axial direction.

  Further, for example, as shown in FIG. 10, when the shaft portion 2 of the medical device 1 is disposed in the blood vessel B as indicated by a solid line with respect to the lesion N, the lesion is viewed from the transducer unit 41. A guide wire W may be disposed between the portion N and the portion N. When the guide wire W is arranged in this way, the guide wire W is reflected in the tomographic image acquired by the transducer unit 41, so that the tomographic image of the portion overlapping the guide wire W in the lesioned part N is not drawn. In such a case, the surgeon adjusts the direction of the distal end portion of the shaft portion 2 and arranges the position of the distal end portion of the shaft portion 2 at a position indicated by a two-dot chain line in the drawing, for example. By changing the position of the distal end portion of the shaft portion 2 in this way, the portion where the guide wire W overlaps in the state before the position of the distal end portion of the shaft portion 2 is changed is changed to the viewing angle of the transducer unit 41. Since it can be accommodated in the range F, a tomographic image of the narrowed portion N of the portion where the guide wire W overlaps can be acquired. The operation illustrated in FIG. 10 is preferably performed on, for example, a blood vessel (for example, a femoral artery) having a large lumen so that the direction of the distal end portion of the shaft portion 2 can be changed relatively freely. It is possible to implement.

  Further, the operator performs a treatment of penetrating the lesioned portion (stenosis portion) N in a state where the long members 911 and 921 are moved to the vicinity of the distal end portion of the shaft portion 2 in the treatment using the medical device 1. It is also possible. Since the surgeon can penetrate the lesioned part N in a state where the rigidity of the distal end part of the shaft portion 2 is increased, the lesioned part N can be easily penetrated by the distal end part of the shaft part 2.

  In addition, the surgeon moves the long members 911 and 921 in the axial direction while moving the medical device 1 in the body lumen such as the blood vessel B, so that the distal end portion of the shaft portion 2 is moved. It is possible to adjust the rigidity. For example, the rigidity of the distal end portion of the shaft portion 2 can be increased by arranging the first elongated member 911 and the second elongated member 921 so as to overlap in the axial direction in the vicinity of the distal end portion of the shaft portion 2. Further, for example, only one of the long members 911 and 921 is disposed near the distal end of the shaft portion 2, and the long members 911 and 921 are axially disposed on the proximal end side of the shaft portion 2. It is possible to adjust the rigidity of the shaft portion 2 so as to increase stepwise from the distal end side to the proximal end side.

  For example, when the surgeon moves the medical device 1 along a meandering or curved portion of the blood vessel B, the surgeon adjusts the rigidity of the distal end portion of the shaft portion 2 so that it can be flexibly deformed. It is possible to smoothly move the medical device 1 by following the above-mentioned site. On the other hand, when the lesioned part N that is the acquisition target of the tomographic image is blocking the blood vessel B, the surgeon increases the rigidity of the distal end of the shaft part 2 from the proximal side of the shaft part 2. When the pushability is improved, the distal end portion of the shaft portion 2 can be easily inserted into the lesioned portion N.

  As described above, the medical device 1 according to the present embodiment performs an operation of changing the orientation of the distal end portion of the shaft portion 2 by a hand operation when acquiring a tomographic image of the lesion portion N, thereby causing the lesion portion N to be changed. The tomographic image at the desired site can be taken more reliably, and the smooth movement in the living body lumen can be realized by appropriately adjusting the rigidity of the distal end portion of the shaft portion 2 at hand. Can do.

  After acquiring a tomographic image at a desired position in the blood vessel, in step S7, the shaft portion 2 of the medical device 1 is removed from the blood vessel while the guide wire W remains in the blood vessel. The medical device 1 is removed from the guide wire W by pulling the medical device 1 along the guide wire W toward the proximal end side.

  After the medical device 1 is removed from the blood vessel, an exchange operation for inserting another medical device along the guide wire W into the blood vessel instead of the medical device 1 can be performed.

  As described above, in the treatment method using the medical device according to the present embodiment, the distal end portion of the sheath included in the medical device for acquiring an image by being inserted into the biological lumen is curved in the biological lumen. By this, the process of adjusting the direction of the front-end | tip part of a sheath is included.

  Further, the orientation of the sheath tip is adjusted when the sheath tip reaches the branched portion of the living body lumen and / or when the sheath tip reaches the vicinity of the lesion.

  Further, the sheath has an image sheath, a guide wire sheath, and a covering tube that covers the image sheath and the guide wire sheath. This is performed by pushing and pulling a long member disposed in a gap formed between the tube and the tube by a hand operation.

  For treatment using a medical device, the distal end portion of the long member is placed at the distal end portion of the sheath, and the distal end portion of the sheath is passed through a lesioned portion (stenosis portion) formed in the body lumen. Process.

  As described above, the medical device 1 according to this embodiment is arranged side by side with the image sheath 61 including the image lumen 25 extending in the axial direction through which the drive shaft 42 can be inserted, and the image lumen 25, and the guide A guide wire sheath 62 having a guide wire lumen 26 through which the wire W can be inserted, the hub portion 5 connected to the proximal end of the image sheath 61, and the coated tube 8 covering the image sheath 61 and the guide wire sheath 62. And a bending mechanism 9 for bending the distal end portion of the image sheath 61 and the distal end portion of the guide wire sheath 62 in a direction crossing the axial direction. The bending mechanism 9 extends from the hub portion 5 to the distal end side along the axial direction, and is disposed between the image sheath 61 and the guide wire sheath 62 and the covering tube 8 in the axial orthogonal cross section. It has body 911,921 and the bending operation part 913,923 arrange | positioned at the hub part 5, and makes it possible to push and pull the elongate body 911,921 along an axial direction.

  According to the medical device 1 described above, a user (for example, an operator) operates the bending operation unit 9 by hand and pushes and pulls the long bodies 911 and 921, whereby the distal end portion of the image sheath 61 and The sheaths 61 and 62 can be bent so that the distal end portion of the guide wire sheath 62 faces a desired direction. Accordingly, the user can smoothly move the sheaths 61 and 62 along the branched path in the living body lumen by the operation at hand, and change the observation direction by the transducer unit 41. Can also be easily performed.

  Further, the long body is a first long member 911 arranged in a pair along the direction intersecting the direction in which the image sheath 61 and the guide wire sheath 62 are arranged side by side in the cross-section perpendicular to the axis. And a second elongate member 921. The bending operation section includes a first operation member 913 that enables the first elongate member 911 to be pushed and pulled, and a second operation member 923 that enables the second elongate member 921 to be pushed and pulled. ing. As a result, the first elongate member 911 and the second elongate member 921 are independently pushed and pulled to intersect the direction in which the image sheath 61 and the guidewire sheath 62 are arranged side by side. Since it becomes possible to change the direction of the distal end portion of each sheath 61, 62 in the direction (the left-right direction of the cross section shown in FIG. 5C), the operability of the medical device 1 is further improved. It will be a thing.

  Further, the first elongate member 911 and the second elongate member 921 are configured to have a higher elastic modulus than the image sheath 61, the guide wire sheath 62, and the coated tube 8. It is possible to easily bend the distal end portion of the shaft portion 2 in conjunction with the push-pull operation of the one long member 911.

(Modification 1)
With reference to FIGS. 11-13, the medical device which concerns on the modification 1 is demonstrated. In the medical device according to the first modification, the first elongated member 911 and the second elongated member 921 have different cross-sectional shapes. Each of the long members 911 and 921 is configured to be rotatable, and is configured to be fixed to the shaft portion 2 with rotation. In these respects, the medical device according to the first modification is different from the above-described embodiment. In addition, the same code | symbol is attached | subjected to the site | part which has the same function as embodiment mentioned above, and description is abbreviate | omitted.

  FIG. 11 shows a cross-sectional view of the vicinity of the tip portion of the shaft portion 2. The first elongate member 911 has an isosceles triangular cross-sectional shape, and the second elongate member 921 has an elliptical cross-sectional shape.

  For example, when the first elongate member 911 is rotated within the gap g <b> 1, the apex on the cross section of the first elongate member 911 comes into contact with the sheaths 61 and 62 and the covering tube 8. Along with this contact, friction occurs between the sheaths 61 and 62 and the covering tube 8 and the first long member 911, and the first long member 911 is fixed so as not to rotate. Similarly, when the second elongate member 912 is rotated in the gap g2, each part on the outer surface of the first elongate member 911 comes into contact with the sheaths 61 and 62 and the covering tube 8, and the first elongate member 911 The member 911 is fixed so as not to rotate.

  The first elongate member 911 and the second elongate member 921 have different cross-sectional shapes in the cross section perpendicular to the axis, and therefore the direction in which the elongate members 911 and 921 are arranged when the distal end portion of the shaft portion 2 is curved. The ease of turning to is different. In this modification, the second long member 921 side where the occupied area in the gap g2 is large is less likely to bend than the first long member 911 side. For example, when a treatment using the medical device 1 is performed, if the movement path in the living body lumen, the position of the lesioned part, and the like can be predicted in advance, the medical part can be used in consideration of the ease of bending of the shaft part 2 as described above. By adjusting the orientation of the device 1 and introducing it into the living body lumen, the procedure can be advanced more quickly and easily.

  In addition, the cross-sectional shape of the 1st elongate member 911 and the 2nd elongate member 921 is not limited to the shape shown in figure. The cross-sectional shape of each of the long members 911 and 921 is fixed and fixed by changing the degree of contact (the magnitude of friction) with respect to each of the sheaths 61 and 62 and the coated tube 8 with rotation in the gaps g1 and g2. The specific shape is not limited as long as the unlocking is possible, and may be a shape other than an ellipse or an isosceles triangle, for example, other polygons.

  Further, the cross-sectional shape of each of the long members 911 and 921 may not be formed in a constant shape along the axial direction. For example, in the vicinity of the distal end portion of the shaft portion 2, as shown in FIG. The shaft portion 2 may be formed in a shape such as a circle on the base end side.

  In FIG. 12, the 1st operation member 913 which concerns on the modification 1 is shown.

  The first operating member 913 includes a slide member 933a to which the first long member 911 is connected, a protrusion 933b attached to the slide member 933a, and a groove 933c formed in the second hub portion 52. Have.

  The first elongate member 911 is fixed to the slide member 933 by being inserted into an insertion portion (insertion hole) formed in the slide member 933. The slide member 933 is disposed in a groove portion 933 c that is partially open to the outside of the second hub portion 52. A part of the outer surface of the slide member 933 is exposed from the second hub 52 through the groove 933c. The protruding portion 933 b is disposed at a portion exposed from the second hub portion 52 in the slide member 933.

  The slide member 933 has a substantially cylindrical outer shape. The groove portion 933c has a semicircular shape formed so as to extend along the axial direction. The slide member 933 can move forward and backward along the groove 933c. The first elongate member 911 connected to the slide member 933 is pushed and pulled along the axial direction as the slide member 933 moves. Further, the slide member 933 is rotatable in the groove portion 933c. The first elongate member 911 connected to the slide member 933 rotates as the slide member 933 rotates.

  When the slide member 933 is moved along the axial direction or the slide member 933 is rotated, the slide member 933 can be easily operated by grasping the protrusion 933b with fingers. The protrusion 933b also has a function as a stopper that defines the amount of rotation of the slide member 933 in the groove 933c. Further, stoppers 934a and 934b that define the amount of movement of the slide member 933 along the axial direction may be disposed on the distal end side and the proximal end side of the groove portion 933c as shown in the drawing.

  The second operation member 923 for operating the movement and rotation of the second elongate member 913 can be configured in the same manner as the first operation member 913 described above. Note that the configuration of the first operation member 913 described in the present modification is an example, and is not limited to such a configuration.

  Next, an operation example of the medical device according to the first modification will be described with reference to FIG.

  Similarly to the case described in the above-described embodiment, for example, when the lesioned part N is formed in a meandering or bent part of the blood vessel B, the distal end of the shaft part 2 extends in the direction along the path P1 of the blood vessel B. If it is facing, there is a possibility that the lesioned part N cannot be accommodated within the viewing angle range F of the transducer unit 41 of the imaging core 4. At this time, the operator performs an operation of changing the direction of the distal end portion of the shaft portion 2 so that the distal end portion of the shaft portion 2 faces the lesioned portion N side. When performing a treatment using the medical device according to Modification 1, for example, the second long member 921 is fixed to the shaft portion 2 by rotating the second long member 921 (FIG. 11). See). When the second elongated member 921 is moved so as to be pushed toward the distal end side in a state where the second elongated member 921 is fixed to the shaft portion 2, the distal end portion of the shaft portion 2 is When the long member 921 is pushed in, it is bent in the direction indicated by the arrow a1. Therefore, the lesioned part N can be accommodated within the viewing angle range F of the transducer unit 41 of the imaging core 4.

  In addition, when performing said operation, the 1st elongate member 911 may be fixed with respect to the shaft part 2, and does not need to be fixed with respect to the shaft part 2. FIG. When the 1st elongate member 911 is being fixed with respect to the shaft part 2, since the front-end | tip part of the shaft part 2 becomes difficult to curve, it becomes possible to adjust the curve degree of the shaft part 2 accurately. . On the other hand, when the 1st elongate member 911 is not being fixed with respect to the shaft part 2, since the front-end | tip part of the shaft part 2 becomes easy to curve, it becomes possible to curve the shaft part 2 smoothly.

  Moreover, the position (position in an axial direction) which fixes the 1st elongate member 911 or the 2nd elongate member 921 with respect to the shaft part 2 is not specifically limited, For example, each elongate member in the middle of a treatment By moving 911 and 921 in the axial direction, the shaft portion 2 can be fixed to an arbitrary position in the axial direction.

  In the example shown in FIG. 13, when the lesioned part N is formed on the blood vessel wall on the side where the first long member 921 is arranged (the lower blood vessel wall in FIG. 9), the operator By fixing the long member 921 to the shaft portion 2 and moving the first long member 911 so as to be pushed toward the distal end side, the shaft portion 2 is moved in the direction opposite to the direction shown (arrow a2 direction). The direction of the tip of the can be changed.

  By pushing and pulling the first elongate member 911 in a state where the first elongate member 911 is fixed to the shaft portion 2, the shaft portion 2 can be pushed and pulled in the same manner as in the above-described embodiment (see FIG. 9). The tip can be curved. The same applies to the case where the second long member 921 is pushed and pulled while the second long member 921 is not fixed to the shaft portion 2.

  In the treatment using the medical device according to the modification, the surgeon performs a treatment of penetrating the lesioned portion (stenosis portion) N in a state where the long members 911 and 921 are fixed near the distal end portion of the shaft portion 2. It is also possible to do this. Since the surgeon can penetrate the lesioned part N in a state where the rigidity of the distal end part of the shaft part 2 is increased by the long members 911 and 921, the lesioned part N can be easily penetrated by the distal end part of the shaft part 2. Can be penetrated.

  In addition, the medical device according to the first modified example, while being moved in a living body lumen such as the blood vessel B, in the same manner as the medical device 1 according to the above-described embodiment, By moving the 921 in the axial direction, it is possible to adjust the rigidity of the tip portion of the shaft portion 2. For this reason, the smooth movement in the living body lumen can be realized by appropriately adjusting the rigidity of the distal end portion of the shaft portion 2 by a hand operation.

  As described above, in the medical device according to the first modification, the first elongate member 911 and the second elongate member 921 are different from each other in the shape of the axis orthogonal cross section at least in a part in the axial direction. Therefore, when the movement path in the living body lumen, the position of the lesioned part, and the like can be predicted in advance, the living body lumen is considered while considering the ease of bending of the shaft portion 2 according to the cross-sectional shape of each of the long members 911 and 921. By performing an operation to bend the shaft portion 2 appropriately, the procedure using the medical device can be advanced more quickly and easily.

  Each bending operation unit 913, 923 included in the medical device according to Modification 1 is configured to be able to rotate the long members 911, 921. Each of the long members 911 and 921 has an axially orthogonal cross-sectional shape at least partially in the axial direction, and the shaft portion 2 (for the image sheath 61 and the guide wire) in accordance with the rotation operation by the respective bending operation portions 913 and 923 The shape can be fixed to the sheath 62). For this reason, the direction of the front-end | tip part of the shaft part 2 is easily adjusted by pushing and pulling each long member 911 and 921 by hand operation in the state which fixed each long member 911 and 921 to the shaft part 2. be able to.

  In the first modification, each of the first long member 911 and the second long member 921 is fixed to the shaft portion 2. For example, the first long member 911 and the second long member 921 can be fixed to the shaft portion 2. Only one of the second elongated members 921 may be configured to be fixable to the shaft portion 2.

  Further, in the first modification, the difference between the ease of bending on the side where the first long member 911 is arranged in the shaft portion 2 and the ease of bending on the side where the second long member 911 is arranged is different for each length. Although the example which adjusted by changing the cross-sectional shape of the scale members 911 and 921 was demonstrated, it is also possible to adjust the ease of bending of the shaft part 2 by changing the material of each long member 911 and 921, for example. It is. For example, a long member made of a flexible nickel-titanium alloy or the like is disposed on the side of the shaft portion 2 that is relatively easy to bend, and the long member that is relatively difficult to bend in the shaft portion 2 is It can be made of hard stainless steel or the like.

(Modification 2)
With reference to FIG. 14, the medical device which concerns on the modification 2 is demonstrated. In the medical device according to the modified example 2, the long body (second long member 921) is located between the sheath 61 for the image sheath 61 and the sheath 62 for the guide wire and the covering tube 8 at least in a part in the axial direction. It is fixed in a sandwiched state. In this respect, it is different from the embodiment described above. In addition, the same code | symbol is attached | subjected to the site | part which has the same function as embodiment mentioned above, and description is abbreviate | omitted.

  FIG. 14 shows a cross-sectional view of the vicinity of the tip portion of the shaft portion 2. The first elongate member 911 is disposed in a gap g <b> 1 formed between the image sheath 61 and the guidewire sheath 62 and the covered tube 8. The first long member 911 can move back and forth in the axial direction within the gap g1. On the other hand, the second elongate member 921 is disposed in the gap g2 so as to limit the forward and backward movement in the axial direction.

  The gap g2 in which the second long member 921 is disposed is formed to have a smaller area on the axis orthogonal cross section than the gap g1 in which the first long member 911 is disposed. The second elongate member 921 is in contact with the image sheath 61, the guide wire sheath 62, and the covering tube 8 in the state of being disposed in the gap g2, and is axially disposed between these members. It is fixed so that it cannot be moved to. As described above, the second elongated member 921 can be fixed to the shaft portion 2 by adjusting the size and shape of the gap g2.

  In this modification, the area of the cross section perpendicular to the axis of the gap g2 is obtained by forming the fusion parts 81 and 82 that fuse the covering tube 8 and the sheaths 61 and 62 at the vertical position of the gap g2. The second tube 921 is fixed to the shaft portion 2 in a small size. For example, the second long member 921 is changed by changing the outer diameter or cross-sectional shape of the second long member 921. You may comprise so that it may fix to the shaft part 2. FIG. Further, for example, the second elongate member 921 may be fixed to the shaft portion 2 using an adhesive or the like.

  The second elongate member 921 does not need to be fixed to the shaft portion 2 over the entire axial direction. For example, the second long member 921 is fixed on the distal end side of the shaft portion 2 and the proximal end of the shaft portion 2 On the part side, it can be configured to be movable in the axial direction. With this configuration, the distal end portion of the shaft portion 2 can be curved by pushing and pulling the second long member 921 by a hand operation as in the first modification described above ( (See FIG. 13).

  As described above, in the medical device according to the modified example 2, the second elongate member 921 is sandwiched between the imaging sheath 61 and the guide wire sheath 62 and the coated tube 8 at least at a part in the axial direction. It is fixed in the state. For this reason, the front-end | tip part of the shaft part 2 can be easily curved by pushing and pulling the 2nd elongate member 921 by operation at hand. Further, since the second long member 921 is always fixed to the shaft portion 2, the shaft portion 2 can be moved in the living body lumen in a state where the rigidity is enhanced by the second long member 921. is there. Therefore, it is possible to suitably prevent the shaft portion 2 from being bent or kinked.

  In the second modification, the second long member 921 is fixed to the shaft portion 2. However, for example, both the first long member 911 and the second long member 921 are used. It is also possible to adopt a configuration that is fixed to the shaft portion 2.

  As mentioned above, although the medical device which concerns on this invention was demonstrated through embodiment and a modification, this invention is not limited only to each structure demonstrated, It can change suitably based on description of a claim. Is possible.

  For example, in the above-described embodiment, the diagnostic imaging catheter used in an intravascular ultrasound (IVUS) method for acquiring a diagnostic image for diagnosing a diseased site or the like in the living body according to the present invention. However, the present invention can also be applied to a diagnostic imaging catheter that acquires an image using light such as optical coherence tomography (OCT). The present invention can also be applied to a hybrid type (dual type) diagnostic imaging catheter that can be used for both the diagnostic method and the optical coherence tomography diagnostic method.

  Further, the medical device is not limited to a configuration that performs a pullback operation in which the drive shaft is moved in the axial direction to the proximal end side, and may be configured not to perform the pullback operation. In this case, the operation unit does not include a double tube structure including an outer tube and an inner tube, and the drive shaft is fixed in the axial direction at an arbitrary position of the image lumen.

  In the description of the embodiment and the modified example, the example in which the bending mechanism is provided with two long bodies (the first long member and the second long member) has been described. However, the image sheath and the guide wire are illustrated. In order to curve the distal end portion of the sheath, it is sufficient that at least one long body is provided. For example, the bending mechanism is configured to perform a bending operation with one or three or more long bodies. It is also possible to do.

  Further, the bending operation portion (first operation member, second operation member) can be provided not in the second hub portion of the hub portion but in the first hub portion. Moreover, when a medical device is provided with a some elongate body, it is also possible to provide a bending operation part in both the 1st hub part and the 2nd hub part.

  The configuration of the long body (first long member, second long member) according to Modification 1 and the long body (first long member, second long body) according to Modification 2 It is also possible to incorporate the configuration of (member) into one medical device.

1 medical device,
2 shaft part,
21 Shaft tip,
22 Shaft body,
25 Lumen for images,
26 Guidewire lumen,
31 Outer pipe,
32 Inner pipe,
4 Imaging core,
41 transducer unit (imaging unit),
42 drive shaft,
5 Hub part,
51 1st hub part,
52 second hub part,
61 Image sheath,
62 sheath for guide wire,
7 external drive,
8 coated tube,
9 bending mechanism,
91 1st bending mechanism (bending mechanism),
911 1st long member (long body),
913 1st operation member (bending operation part),
92 Second bending mechanism (bending mechanism),
921 1st long member (long body),
923 first operation member (curving operation unit),
g1 gap,
g2 gap,
B blood vessels,
N lesions,
W Guide wire.

Claims (6)

A medical device for acquiring an image by being inserted into a living body lumen,
An imaging sheath comprising an imaging lumen extending in the axial direction through which the drive shaft can be inserted;
A guide wire sheath provided with a guide wire lumen through which the guide wire can be inserted, arranged alongside the image lumen;
A hub connected to the proximal end of the imaging sheath;
A coated tube covering the image sheath and the guidewire sheath;
A bending mechanism for bending the distal end portion of the image sheath and the distal end portion of the guide wire sheath in a direction intersecting the axial direction;
The bending mechanism is
An elongated body that extends from the hub portion to the distal end side along the axial direction and is disposed between the sheath for an image and the sheath for the guide wire and the covering tube in an axial orthogonal cross section;
A medical device, comprising: a bending operation portion that is disposed on the hub portion and allows the elongated body to be pushed and pulled along the axial direction. The elongate body includes a first elongate member and a first elongate member arranged in a pair along a direction intersecting a direction in which the imaging sheath and the guide wire sheath are arranged side by side in the cross section perpendicular to the axis. 2 long members,
The said bending operation part has a 1st operation member which enables the said 1st elongate member to be able to be pushed and pulled, and a 2nd operation member which enables the said 2nd elongate member to be able to be pushed and pulled. The medical device according to 1.   The medical device according to claim 2, wherein the first elongate member and the second elongate member are different from each other in at least a part of the axial direction in the shape orthogonal to the axis. The bending operation unit is configured to be able to rotate the elongated body,
In at least a part of the long body, the shape of the cross section perpendicular to the axis is a shape that can be fixed to the image sheath and the guide wire sheath in accordance with the rotation operation by the bending operation section. The medical device according to any one of claims 1 to 3.   The said elongate body is fixed in the state pinched | interposed between the said sheath for an image, the sheath for guide wires, and the said covering tube in at least one part in the said axial direction. A medical device according to claim 1.   The medical device according to claim 1, wherein the elongated body has a higher elastic modulus than the imaging sheath, the guidewire sheath, and the coated tube.