JP2018121966A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device including flexibility at a distal side and high rigidity at a proximal side and, when being curved, capable of favorably preventing a reinforcing member from breaking through a covering part.SOLUTION: A medical device 1 includes: a sheath 21 for image including a lumen 21a for image; a sheath 22 for a guide wire including a guide wire lumen 22a in which a guide wire W can insert; a covering part 23 for connecting the sheath for image at a proximal side to the guide wire sheath; and a reinforcing member 24 to be embedded in the inside of the covering part. The reinforcing member 24 includes a first portion 241, a second portion 242, and a connecting part 25 for connecting tip ends of the first portion and the second portion to each other.SELECTED DRAWING: Figure 4

Description

  The present invention relates to a medical device.

  Conventionally, as a medical device used for acquiring a diagnostic image for diagnosing a diseased site in a living body, an intravascular ultrasonic diagnostic method (IVUS) or an optical coherence tomography diagnostic method ( There is an imaging diagnostic catheter used in an imaging diagnostic apparatus such as OCT (Optical Coherence Tomography).

  In general, a diagnostic imaging catheter is delivered to a lesion along a guide wire previously inserted into a living body lumen so that the living body lumen that is meandering or curved can be moved. For this reason, the diagnostic imaging catheter has a guide wire sheath through which a guide wire can be inserted in addition to an imaging sheath through which the imaging core can be inserted (see Patent Document 1 below). Then, while rotating the imaging core drive shaft in the imaging sheath and moving it backward toward the proximal end, the imaging core signal transmission / reception unit transmits and receives the test wave to acquire the image of the biological lumen. Yes.

  In such an imaging diagnostic catheter, from the viewpoint of operability when delivering the imaging diagnostic catheter to a lesioned part, the distal end side has flexibility to follow the guide wire, and the proximal end side has a pusher. It is required to have high rigidity in order to improve the capability (transmissibility of pushing force).

  On the other hand, in recent years, in the technique of introducing a catheter or the like into an artery, the technique of the transradial artery approach (TRI), which is considered to be less burdensome on the patient after the operation than the transfemoral artery approach (TFI), is increasing. . Since the radial artery has a smaller blood vessel diameter than the femoral artery, a catheter having a smaller outer diameter is used in the TRI system. Therefore, when the diagnostic imaging catheter has flexibility at the distal end side and high rigidity at the proximal end side, it is also required that the outer diameter of the imaging diagnostic catheter does not increase.

JP2015-119994A

  Examples of the diagnostic imaging catheter having the above-described characteristics include a diagnostic imaging catheter in which a reinforcing member is embedded in a covering portion that covers at least a part of the imaging sheath and the guide wire sheath. .

  However, in the catheter configured as described above, for example, when the diagnostic imaging catheter is bent, there is a possibility that the distal end of the reinforcing member may break through the covering portion due to the force of returning to the original shape acting on the reinforcing member. is there. Once the reinforcing member breaks through the covering portion, it becomes a disadvantageous event for the patient, for example, the operation time is extended.

  The present invention has been made in order to solve the above-described problems. It is preferable that the distal end side has flexibility, the proximal end side has high rigidity, and the reinforcing member breaks through the covering portion when bent. It is an object of the present invention to provide a medical device that can be prevented.

  A medical device that achieves the above object includes an imaging sheath including an imaging lumen through which a rotatable imaging core can be inserted, and a guide wire lumen that is arranged alongside the imaging sheath and through which a guide wire can be inserted. A sheath for guide wire, a covering portion for covering at least a part of the sheath for image and the sheath for guide wire on the proximal end side so as to connect the sheath for image and the sheath for guide wire, and the covering portion And a reinforcing member embedded in the interior of the housing. The reinforcing member includes a first portion disposed along the axial direction, a second portion disposed along the axial direction alongside the first portion, the first portion, and the first portion. And a connecting portion that connects the tips of the two parts.

  According to the medical device configured as described above, since the reinforcing member is embedded inside the covering portion that covers the image sheath and the guide wire sheath on the proximal end side, It has flexibility and high rigidity on the proximal side. On the other hand, since the tips of the first part and the second part are connected to each other by the connecting portion, the original shape that acts on the first part located on the outer side when the medical device is curved is restored. A force to be applied also acts on the second portion located on the inner side through the connection portion. Further, the image sheath and the guide wire sheath are configured to be connected to each other by a covering portion. Therefore, the force acting on the first part and the second part can be dispersed in the covering portion. For this reason, when it curves, it can prevent suitably that a 1st site | part breaks through a coating | coated part. From the above, it is possible to provide a medical device that has flexibility on the distal end side and high rigidity on the proximal end side, and can suitably prevent the reinforcing member from breaking through the covering portion when bent. .

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. 3A is a cross-sectional view taken along line 3A-3A in FIG. 1, FIG. 3B is a cross-sectional view taken along line 3B-3B in FIG. 1, and FIG. FIG. 3D is a cross-sectional view taken along line 3C-3C in FIG. 1, and FIG. 3D is a cross-sectional view taken along line 3D-3D in FIG. It is the schematic when the medical device which concerns on embodiment is seen from upper direction. It is the schematic when the medical device which concerns on embodiment of the curved state is seen from upper direction. In the medical device which concerns on a comparative example, it is the schematic which shows a mode that the 1st site | part broke through the coating | coated part. It is a top view which shows the hub of a medical device. 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 the schematic when the medical device which concerns on the modification 1 is seen from upper direction. It is the schematic when the medical device which concerns on the modification 2 is seen from upper direction.

  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. 8) 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. .

  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”. A direction in which the medical device 1 extends is referred to as an “axial direction”.

  As shown in FIG. 1, the medical device 1 includes a long shaft portion 2 inserted into a living body lumen, an imaging core 4 that transmits and receives ultrasonic waves toward a tissue in the living body lumen, and imaging. A hub 5 through which the core 4 is inserted and located on the proximal end side from the shaft portion 2 and an operation portion 3 on which an operator performs a predetermined operation are provided.

  As shown in FIGS. 1 to 5, the shaft portion 2 is arranged side by side with the image sheath 21 having an image lumen 21 a through which the imaging core 4 can be inserted, and the image sheath 21, and a guide wire W can be inserted therethrough. A guide wire sheath 22 having a guide wire lumen 22a, a covering portion 23 for connecting the image sheath 21 and the guide wire sheath 22 on the proximal end side, and a reinforcing member 24 embedded in the covering portion 23; Have

  The image sheath 21 is provided so as to extend along the axial direction. As shown in FIG. 3, the image sheath 21 can be formed in a substantially circular shape with a hollow cross section. The guide wire sheath 22 extends along the axial direction. As shown in FIG. 3, the guide wire sheath 22 can be formed in a substantially circular shape with a hollow cross section. The guide wire lumen 22 a provided in the guide wire sheath 22 is configured to have a smaller diameter than the image lumen 21 a due to a difference in outer diameter between the guide wire W and the imaging core 4.

  As shown in FIG. 1, the guide wire sheath 22 is provided so as to extend further to the distal end side than the image sheath 21. The image sheath 21 and the guide wire sheath 22 are arranged side by side up to the hub 5 toward the proximal end side, and are configured to branch inside the hub 5. The image sheath 21 and the guide wire sheath 22 are connected to each other by the covering portion 23 on the proximal end side with respect to the arrow A in FIG.

  As shown in FIG. 2, the image sheath 21 has a distal end opening 21b, and the guide wire sheath 22 has a distal end opening 22b. The image sheath 21 and the guide wire sheath 22 are fused to each other at the fused portion 29. A reinforcing tube 26 for firmly joining and supporting the guide wire sheath 22 is provided at the distal end portion of the image sheath 21. The reinforcing tube 26 is a tubular body in which a communication hole 27 communicating with the tip opening 21b is formed. The reinforcing tube 26 is formed by heat-sealing (or adhering) to the image sheath 21 with a material having relatively high rigidity.

  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 22a is formed from the distal end opening 22b to the hub 5.

  The image sheath 21 and the guide wire sheath 22 are 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, polyimide-based material. , 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.). The image sheath 21 is preferably formed of a material having high ultrasonic transmission.

  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. 1 and 3 to 5, the covering portion 23 is provided on the proximal end side of the portion indicated by the arrow A in the shaft portion 2. As shown in FIGS. 3C and 3D, the covering portion 23 is configured to cover a part of the image sheath 21 and the guide wire sheath 22. The covering section may be configured to cover the entire image sheath 21 and guidewire sheath 22.

  As shown in FIGS. 3C and 3D, the covering portion 23 includes an outer wall portion 231 that connects the outer wall surface 211 of the image sheath 21 and the outer wall surface 221 of the guide wire sheath 22 with a tangent line. Note that the shape of the outer wall portion 231 of the covering portion 23 is not particularly limited as long as the reinforcing member 24 is embedded.

  Although the material which comprises the coating | coated part 23 is not specifically limited, For example, polyethylene can be used.

  As shown in FIGS. 3C, 3 </ b> D, 4, and 5, the reinforcing member 24 is embedded inside the covering portion 23 along the axial direction. The reinforcing member 24 includes a first part 241 arranged along the axial direction, a second part 242 arranged along the axial direction along with the first part 241, the first part 241 and the first part 241. And a connecting portion 25 for connecting the tips 241a and 242a of the two parts 242 to each other. The reinforcing member 24 is provided on the proximal end side of the portion indicated by the arrow A in the shaft portion 2, similarly to the covering portion 23. That is, the covering portion 23 and the reinforcing member 24 extend from the portion indicated by the arrow A toward the base end. As shown in FIG. 4, the first part 241 and the second part 242 are arranged so as to be substantially parallel to each other. 4 and 5, the reinforcing member 24 is shown by a solid line for easy understanding.

  The first part 241 and the second part 242 are provided to extend to the inside of the hub 5 on the proximal end side, and are fixed to the hub 5 by adhesion or caulking. Further, the first part 241 and the second part 242 have a substantially circular cross section. Note that the first portion 241 and the second portion 242 do not have to have a substantially circular cross section, and may have a rectangular or elliptical shape.

  Although the material which comprises the 1st site | part 241 and the 2nd site | part 242 is not specifically limited, For example, SUS, Ni-Ti, etc. can be used.

  By providing the covering portion 23 and the reinforcing member 24 as described above, the expansion of the cross-sectional shape of the medical device 1 is suppressed, and the imaging sheath 21 and the guide wire sheath 22 are connected to each other. The rigidity on the base end side can be increased.

  As shown in FIGS. 4 and 5, the connecting portion 25 is a reinforcing wire that connects the first part 241 and the second part 242 to each other. Although the connection part 25 and the 1st site | part 241 and the fixing method of the connection part 25 and the 2nd site | part 242 are not specifically limited, For example, it is adhesion | attachment with an adhesive agent. The connecting portion 25 is provided intermittently in a region of, for example, 50 mm from the distal end 241a of the first portion 241 toward the proximal end side. In addition, in this embodiment, although the connection part 25 is provided intermittently along the axial direction, what is necessary is just to connect the front-end | tips 241a and 242a of the 1st site | part 241 and the 2nd site | part 242 at least. .

  As shown in FIG. 4, when the image sheath 21 and the guidewire sheath 22 are in a straight line state, the connecting portion 25 is in a state where the first part 241 and the second part 242 are bent (curved state). Connecting. Further, as shown in FIG. 5, when the imaging sheath 21 and the guide wire sheath 22 are in a curved state, the connection portion 25 is a first portion 241 where the imaging sheath 21 and the guide wire sheath 22 are curved. The second parts 242 are connected in a stretched state.

  For example, when the image sheath 21 and the guide wire sheath 22 are in a straight line state and the connecting portion 25 is connected in a state where the first part 241 and the second part 242 are stretched together, A situation can occur. That is, when the image sheath 21 and the guide wire sheath 22 are to be bent, the image sheath is preferably used due to the difference in the diameter of the arc on the inner side and the outer side in the bent portion. 21 and the guide wire sheath 22 may not be bent.

  On the other hand, as described above, in the present embodiment, when the image sheath 21 and the guide wire sheath 22 are in a straight line state, the connection portion 25 is a state where the first part 241 and the second part 242 are bent. Connected with. For this reason, as shown in FIG. 5, even when the diameter of the arc is different between the inner side and the outer side in the curved portion, the image sheath 21 can be suitably bent. The present invention also includes a configuration in which the connection portion 25 is connected in a state where the first portion 241 and the second portion 242 are stretched while the image sheath 21 and the guidewire sheath 22 are in a straight state. . At this time, the connecting portion 25 has a spring property so that the image sheath 21 can be suitably curved even when the diameters of the arcs are different on the inner side and the outer side in the curved portion. It is desirable. Although the material which comprises the connection part 25 is not specifically limited, In order to provide the characteristic mentioned above, especially resin and SUS are preferable.

  For example, as illustrated in FIG. 6, in the medical device 900 according to the comparative example in which the first part 241 and the second part 242 are not connected to each other by the connection unit 25, the medical device 900 is curved. The following situations can occur: In other words, the first part 241 (the upper side in FIG. 6) 241 located on the outer side in the curved part is moved to the first part 241 by the force F1 to return to a straight line as shown by the arrow in FIG. There is a possibility that the tip 241a of the pierced through the covering portion 23.

  On the other hand, as shown in FIGS. 4 and 5, according to the medical device 1 according to this embodiment, at least the tips 241 a and 242 a of the first part 241 and the second part 242 are connected to each other by the connecting portion 25. Therefore, when the medical device 1 is curved, the original shape (in the present embodiment, the linear shape) acting on the first portion (the upper side in FIGS. 4 and 5) 241 located on the outer side is provided. The force F <b> 1 trying to return to () also acts on the second portion (lower side in FIGS. 4 and 5) 242 located on the inner side via the connection portion 25. Further, the image sheath 21 and the guide wire sheath 22 are configured to be connected to each other by a covering portion 23. Further, the image sheath 21 and the guide wire sheath 22 are fused to each other at the fused portion 29. Therefore, the force F <b> 1 acting on the first part 241 and the second part 242 can be dispersed in the covering part 23 and the fusion part 29. For this reason, when it curves, it can prevent suitably that the 1st site | part 241 penetrates the coating | coated part 23. FIG.

  Hereinafter, in the axial direction of the shaft portion 2, positions where the covering portion 23, the first portion 241, the second portion 242, and the connection portion 25 are provided will be described in detail.

  As shown in FIG. 3A, only the guide wire sheath 22 exists near the tip of the shaft portion 2.

  As shown in FIG. 3B, an image sheath 21 and a guidewire sheath 22 exist in the vicinity of the region R in which the imaging core 4 moves forward and backward. The length along the axial direction of the region R in which the imaging core 4 moves forward and backward is, for example, 300 mm or less.

  As shown in FIG. 3C, at the site indicated by the arrow A (the covering portion 23, the starting point of the reinforcing member 24), the image sheath 21, the guide wire sheath 22, the covering portion 23, the first portion 241, the second portion The part 242 and the connection part 25 exist.

  As shown in FIG. 3 (D), the connection portion 25 is not provided in a portion separated from the portion indicated by the arrow A toward the proximal side by a predetermined distance, and the image sheath 21, the guide wire sheath 22, the covering portion 23, A first part 241 and a second part 242 exist.

  As shown in FIG. 2, the imaging core 4 is arranged in the image lumen 21 a 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 image information by transmitting and receiving ultrasonic waves from inside the living body lumen to a living tissue, and 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 (see FIG. 8) 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 (see FIG. 1).

  As shown in FIG. 7, the hub 5 includes a first hub portion 51 that is liquid-tight and air-tightly connected to the image sheath 21, a second hub portion 52 that is liquid-tight and air-tightly connected to the guide wire sheath 22, and A hub main body 53 that covers the first hub 51 and the second hub 52 and a first kink protector 54 are provided.

  The first hub portion 51 is connected to the operation portion 3 connected to the external drive device 7 in order to operate the imaging core 4. As shown in FIG. 1 and the like, the operation portion 3 includes an outer tube 32 connected to the first hub portion 51, a unit connector 37 connected to the proximal end portion of the outer tube 32, and an axial direction relative to the outer tube 32 And an operation base end portion 31 connected to the base end portion of the inner tube.

  The operation base end portion 31 holds the drive shaft 42 and the inner tube 34. When the operation base end portion 31 moves and the inner tube 34 is pushed into the unit connector 37 and the outer tube 32 (see FIG. 1) or pulled out (see FIG. 9), the drive shaft 42 is interlocked to move the shaft portion 2. Slide in the axial direction. A port 311 for injecting physiological saline for priming is formed in the operation base end portion 31. The port 311 communicates with the image lumen 21a.

  When the inner tube 34 is pushed in the most, as shown in FIG. 1, the end of the inner tube 34 moves inside the outer tube 32 and reaches the vicinity of the first hub portion 51. In this state, as shown in FIG. 2, the vibrator unit 41 is located near the tip of the image lumen 21a.

  When the inner pipe 34 is pulled out most, as shown in FIG. 9, the stopper 315 formed at the tip of the inner pipe 34 is caught by the inner wall of the unit connector 37, and the portions other than the vicinity of the hooked tip are exposed. In this manner, the transducer unit 41 can move along the axial direction while rotating inside the image lumen 21a in order to create a tomographic image of a blood vessel or the like.

  As shown in FIG. 1, the operation base end portion 31 includes a joint 312, a hub side connector 313 connected to the base end portion of the drive shaft 42, and a second kink protector 314.

  The joint 312 has an opening on the proximal end side, and the hub side connector 313 is disposed inside. The hub-side connector 313 can be connected to the drive-side connector 711 (see FIG. 8) of the external drive device 7 from the base end side of the joint 312. By connecting, the external drive device 7 and the hub-side connector 313 are connected. Connected mechanically and electrically.

  One end of a signal line 43 is connected to the hub side connector 313, and the signal line 43 passes through the drive shaft 42 and the other end is connected to the vibrator unit 41 as shown in FIG. Yes. 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 313, 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 313, and the drive side connector 711.

  The second kink protector 314 is disposed around the inner tube 34 and the operation base end portion 31 and suppresses kinking of the inner tube 34.

  The unit connector 37 is inserted so that the base end portion of the outer tube 32 attached to the first hub portion 51 is fitted inside, and the inner tube extending from the operation base end portion 31 is inserted into the outer tube 32. 34 is inserted. The unit connector 37 can be connected to a holding portion 73 (see FIG. 8) of the external drive device 7.

  As shown in FIGS. 1 and 7, the first hub portion 51 is connected with the distal end portion of the outer tube 32 fitted from the proximal end side, and the image sheath 21 is inserted from the distal end side for thermal fusion. It is connected airtight by wearing or bonding. Therefore, the drive shaft 42 and the physiological saline that have passed through the inner tube 34 and the outer tube 32 can move to the image lumen 21 a through the first hub portion 51.

  The second hub portion 52 is hermetically coupled by inserting the guide wire sheath 22 from the distal end side and heat-sealing or bonding. Therefore, the second hub portion 52 communicates with the guide wire lumen 22a, and the guide wire W can pass therethrough.

  As shown in FIG. 7, the hub main body 53 is formed so as to cover the outer peripheral surfaces of the imaging sheath 21 and the guide wire sheath 22 connected to the first hub portion 51 and the second hub portion 52.

  As shown in FIGS. 1 and 7, the first anti-kink protector 54 surrounds the front end portion of the hub main body portion 53 and the shaft portion 2 led out from the hub main body portion 53 in the front end direction, and suppresses kink of the shaft portion 2. To do.

  The constituent materials of the first hub portion 51, the second hub portion 52, the hub main body portion 53, the outer tube 32, the inner tube 34, the unit connector 37, and the operation base end portion 31 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 Examples thereof include various resins such as coalescence and polyamide (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12).

  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-side connector 711 to which the hub-side connector 313 of the medical device 1 can be connected, and a joint connection unit 712 that can be connected to the joint 312 of the medical device 1. Signals can be transmitted to and received from the child unit 41, and at the same time, the drive shaft 42 can be rotated.

  As shown in FIGS. 8 and 9, the ultrasonic scanning (scanning) in the medical device 1 transmits the rotational movement of the motor in the driving unit 71 to the driving shaft 42 while moving the moving unit 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 longitudinal direction, and ultrasonic waves transmitted and received by the ultrasonic transducer 411 can be scanned in a substantially radial direction. Thereby, a 360 ° cross-sectional image of the surrounding tissue body in the axial direction in the blood vessel can be obtained in a scanning manner up to an arbitrary position.

  Next, the operation | movement at the time of observing a biological tissue from inside the biological lumens, such as a blood vessel, using the medical device 1 which concerns on this embodiment is demonstrated.

  First, before inserting the shaft portion 2 of the medical device 1 into the lumen, a priming operation for filling the medical device 1 with physiological saline is performed. By performing the priming operation, ultrasonic waves can be transmitted from the ultrasonic transducer 411, and the air in the medical device 1 is removed to prevent the air from entering the lumen of a blood vessel or the like.

  In order to perform the priming, as shown in FIG. 9, the operation base end portion 31 is most pulled from the unit connector 37 to the base end side, that is, the inner tube 34 is most pulled out from the outer tube 32. A physiological saline solution is injected, for example, using a syringe or the like through a tube (not shown) connected to the port 311 of the base end portion 31 and a three-way stopcock. The injected physiological saline passes through the first hub portion 51 from the operation base end portion 31, is filled into the image lumen 21a, and the physiological saline comes out from the distal end opening portion 21b. Thereby, the air in the medical device 1 is removed, filling of the physiological saline is confirmed, and priming is completed.

  Next, as shown in FIG. 8, the medical device 1 is connected to an external drive device 7 covered with a sterilized polyethylene bag (not shown). That is, the joint 312 of the operation base end portion 31 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 37 is fitted into the holding portion 73, the connection is completed.

  Next, the guide wire W is inserted into the blood vessel via the introducer inserted into the blood vessel. Next, the proximal end portion of the guide wire W is inserted into the guide wire lumen 22a through the distal end opening portion 22b of the guide wire sheath 22.

  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 so that the distal end portion of the shaft portion 2 is more than the lesioned portion to be observed. Arrange on the back side (tip side). At this time, a contrast medium or a drug can be supplied to the guide wire lumen 22a and released from the distal end opening 22b into the living body.

  In pushing forward the shaft portion 2 of the medical device 1 along the guide wire W, in the medical device 1 according to the present embodiment, the connection portion 25 has at least the distal ends 241a and 242a of the first portion 241 and the second portion 242. Since they are connected to each other, the first portion 241 can be suitably prevented from breaking through the covering portion 23 when being bent.

  In this state, the drive base 71 is moved to the front end side along the groove rail 76 on the base 75 while holding the shaft portion 2 so as not to move (see FIG. 8), so that the operation base end portion 31 is moved to the front end. The inner tube 34 is pushed most into the outer tube 32. Thereby, as shown in FIG. 2, the imaging core 4 moves to the distal end side of the image lumen 21a.

  Next, X-ray imaging is performed from outside the body at the position (lesioned part) where the transducer unit 41 is disposed to obtain an angio image. By confirming the angio image, the position and posture of the distal end portion of the medical device 1 can be grasped.

  Next, as shown in FIG. 9, by pulling back the drive shaft 42 while being rotated by the drive unit 71, the ultrasonic transducer 411 is moved along the axial direction from the affected part to the proximal side while performing radial scanning. Let Thereby, a 360 ° tomographic image of the surrounding tissue body extending in the axial direction in the blood vessel can be obtained in a scanning manner 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.

  Then, the medical device 1 is removed from the living body lumen, and the operation of the medical device 1 is completed.

  As described above, the medical device 1 according to the present embodiment is arranged side by side with the imaging sheath 21 including the imaging lumen 21a through which the rotatable imaging core 4 can be inserted, and the imaging sheath 21, and the guide wire. One of the image sheath 21 and the guidewire sheath 22 on the proximal end side so as to connect the guidewire sheath 22 including the guidewire lumen 22a through which W can be inserted, the image sheath 21 and the guidewire sheath 22 to each other. And a reinforcing member 24 embedded in the covering portion 23. The reinforcing member 24 includes a first part 241 arranged along the axial direction, a second part 242 arranged along the axial direction along with the first part 241, the first part 241 and the first part 241. And a connecting portion 25 for connecting the tips 241a and 242a of the two parts 242 to each other. According to the medical device 1 configured as described above, the reinforcing member 24 is embedded in the covering portion 23 that covers the image sheath 21 and the guide wire sheath 22 on the proximal end side. 1 has flexibility on the distal end side and high rigidity on the proximal end side. On the other hand, since the tips 241a and 242a of the first part 241 and the second part 242 are connected by the connecting portion 25, the first part 241 located on the outer side when the medical device 1 is curved. The force F <b> 1 trying to return to the original shape acting on the second portion 242 located on the inner side also acts on the second portion 242 via the connection portion 25. Further, the image sheath 21 and the guide wire sheath 22 are configured to be connected to each other by a covering portion 23. Further, the image sheath 21 and the guide wire sheath 22 are fused and fixed to each other at the fusion portion 29. Therefore, the force F <b> 1 acting on the reinforcing member 24 can be dispersed in the covering portion 23 and the fusion portion 29. For this reason, when it curves, it can prevent suitably that the 1st site | part 241 penetrates the coating | coated part 23. FIG. As described above, the medical device 1 is provided that has flexibility on the distal end side and high rigidity on the proximal end side, and that can suitably prevent the reinforcing member 24 from breaking through the covering portion 23 when curved. be able to.

  Moreover, the 1st site | part 241 and the 2nd site | part 242 are comprised as a different body mutually. According to the medical device 1 configured as described above, the reinforcing member 24 can be suitably prevented from breaking through the covering portion 23 when it is curved.

  Moreover, the 1st site | part 241 and the 2nd site | part 242 are provided in parallel with each other, and the connection part 25 has the reinforcement line which connects the front-end | tips 241a and 242a of the 1st site | part 241 and the 2nd site | part 242. . According to the medical device 1 configured in this manner, the reinforcing member 24 can be more reliably prevented from breaking through the covering portion 23 when it is curved.

  Further, when the image sheath 21 and the guide wire sheath 22 are in a straight line state, the connection portion 25 connects the distal ends 241a and 242a of the first portion 241 and the second portion 242 in a bent state, and When the sheath 21 and the guide wire sheath 22 are in a curved state, the connecting portion 25 connects in a state where the tips 241a and 242a of the first part 241 and the second part 242 are stretched. According to the medical device 1 configured in this way, the image sheath 21 can be suitably curved.

<Modification 1>
Next, the configuration of the medical device 100 according to the first modification will be described with reference to FIG. The medical device 100 according to Modification 1 is different from the medical device 1 according to the above-described embodiment in the configuration of the reinforcing member 124. FIG. 10 is a schematic diagram when the medical device 100 according to the first modification is viewed from above, and corresponds to FIG. 4 of the medical device 1 according to the embodiment.

  A medical device 100 according to Modification 1 includes a long shaft portion 120 that is inserted into a living body lumen, an imaging core 4 that transmits and receives ultrasound toward a tissue in the living body lumen, and the imaging core 4. Is inserted, and the hub 5 is located on the proximal end side of the shaft portion 2, and the operation portion 3 on which the operator performs a predetermined operation. Since the configurations of the imaging core 4, the hub 5, and the operation unit 3 are the same as those of the medical device 1 according to the above-described embodiment, the description thereof is omitted.

  As shown in FIG. 10, the shaft portion 120 includes an image sheath 21, a guide wire sheath 22, a covering portion 23, and a reinforcing member 124 embedded in the covering portion 23. Since the configurations of the image sheath 21, the guide wire sheath 22, and the covering portion 23 are the same as those of the medical device 1 according to the above-described embodiment, the description thereof is omitted.

  The reinforcing member 124 is embedded in the inside of the covering portion 23 along the axial direction. As shown in FIG. 10, the reinforcing member 124 includes a first portion 131 disposed along the axial direction, a second portion 132 disposed along the axial direction along with the first portion 131, and And a connection part 125 that connects the tips 131a and 132a of the first part 131 and the second part 132 to each other. As shown in FIG. 10, the first portion 131 and the second portion 132 are configured to be curved so as to approach each other at the tips 131a and 132a. In the modification 1, the 1st site | part 131 and the 2nd site | part 132 are formed as a different body.

  The connection part 125 is formed by directly connecting the tips 131 a and 132 a of the first part 131 and the second part 132.

  As described above, according to the medical device 100 according to the first modification, the distal ends 131a and 132a of the first part 131 and the second part 132 are connected to each other by the connecting portion 125, and thus the medical device 100 is curved. When this occurs, the force F1 to return to the original shape acting on the first part 131 located on the outer side acts on the second part 132 located on the inner side via the connecting portion 125. . Further, the image sheath 21 and the guide wire sheath 22 are configured to be connected to each other by a covering portion 23. Therefore, the force F <b> 1 acting on the first part 131 and the second part 132 can be dispersed in the covering portion 23. For this reason, when it curves, it can prevent suitably that the 1st site | part 131 penetrates the coating | coated part 23. FIG.

<Modification 2>
Next, the configuration of the medical device 200 according to Modification 2 will be described with reference to FIG. The medical device 200 according to the modified example 2 is different from the medical device 1 according to the embodiment described above in the configuration of the reinforcing member 224. FIG. 11 is a schematic view of the medical device 200 according to the second modification when viewed from above, and corresponds to FIG. 4 of the medical device 1 according to the embodiment.

  A medical device 200 according to Modification 2 includes a long shaft portion 220 that is inserted into a living body lumen, an imaging core 4 that transmits and receives ultrasonic waves toward a tissue in the living body lumen, and the imaging core 4. Is inserted, and the hub 5 is located on the proximal end side of the shaft portion 2, and the operation portion 3 on which the operator performs a predetermined operation. Since the configurations of the imaging core 4, the hub 5, and the operation unit 3 are the same as those of the medical device 1 according to the above-described embodiment, the description thereof is omitted.

  As shown in FIG. 11, the shaft portion 220 includes an image sheath 21, a guide wire sheath 22, a covering portion 23, and a reinforcing member 224 embedded in the covering portion 23. Since the configurations of the image sheath 21, the guide wire sheath 22, and the covering portion 23 are the same as those of the medical device 1 according to the above-described embodiment, the description thereof is omitted.

  The reinforcing member 224 is embedded in the covering portion 23 along the axial direction. As shown in FIG. 11, the reinforcing member 224 includes a first part 331 arranged along the axial direction, a second part 332 arranged along the axial direction along with the first part 331, and A connection portion 225 that connects the tips of the first portion 331 and the second portion 332 to each other. As shown in FIG. 11, the first part 331 and the second part 332 are configured to be curved so as to approach each other at the tip. The 1st site | part 331, the 2nd site | part 332, and the connection part 225 are comprised integrally.

  As described above, according to the medical device 200 according to the modified example 2, since the distal ends of the first part 331 and the second part 332 are connected by the connecting portion 225, when the medical device 200 is curved. A force F <b> 1 for returning to the original shape acting on the first part 331 located on the outer side acts also on the second part 332 located on the inner side via the connection portion 225. Further, the image sheath 21 and the guide wire sheath 22 are configured to be connected to each other by a covering portion 23. Therefore, the force F1 acting on the first part 331 and the second part 332 can be dispersed in the covering portion 23. For this reason, when it curves, it can prevent suitably that the 1st site | part 331 breaks through the coating | coated part 23. FIG.

  As mentioned above, although the medical device 1,100,200 which concerns on this invention through embodiment and the modification was demonstrated, this invention is not limited only to each structure demonstrated, Based on description of a claim It can be changed as appropriate.

  For example, in the above-described embodiment, the first part 241 and the second part 242 are fixed to the hub 5 by fusion or caulking at the proximal end, but the first part and the second part 242 are fixed. The part may not be fixed to the hub 5 at the proximal end. At this time, the first part and the second part are arranged so as to be movable back and forth along the axial direction in accordance with the curvature of the medical device. According to the medical device configured as described above, the first part and the second part move forward and backward along the axial direction as the medical device is bent, and thus the medical device is preferably bent. be able to.

  Further, in the above-described embodiment, the reinforcing member 24 is composed of two parts, the first part 241 and the second part 242, but may be composed of three or more parts.

  In the above-described embodiment, the diagnostic imaging catheter used in an intravascular ultrasound (IVUS) method for obtaining 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.

1, 100, 200 medical device,
2, 120, 220 shaft,
21 Image sheath,
21a Lumen for images,
22 sheath for guide wire,
22a guide wire lumen,
23 covering part,
24, 124, 224 reinforcing members,
131, 241, 331 first part,
132, 242, 332 second part,
25, 125, 225 connections,
4 Imaging core,
W Guide wire.

Claims (7)

An imaging sheath comprising an imaging lumen through which a rotatable imaging core can be inserted;
A guide wire sheath provided with a guide wire lumen through which the guide wire can be inserted;
A covering portion that covers at least a part of the sheath for image and the sheath for guide wire on the proximal end side so as to connect the sheath for image and the sheath for guide wire;
A reinforcing member embedded in the covering portion,
The reinforcing member includes a first portion disposed along the axial direction, a second portion disposed along the axial direction alongside the first portion, the first portion, and the first portion. A medical device comprising: a connecting portion that connects tips of two parts.   The medical device according to claim 1, wherein the first part and the second part are configured as separate bodies. The first part and the second part are provided in parallel to each other,
The medical device according to claim 2, wherein the connection portion includes a reinforcing wire that connects tips of the first part and the second part. In the straight state of the sheath for image and the sheath for guide wire, the connection portion connects the distal ends of the first part and the second part in a bent state,
4. The medical use according to claim 3, wherein the connection portion connects the distal ends of the first part and the second part in a state where the imaging sheath and the guide wire sheath are in a curved state. device. The first part and the second part are configured to approach each other at the tip,
The medical device according to claim 2, wherein the connection portion is formed by directly connecting tips of the first part and the second part.   The medical device according to claim 1, wherein the first part, the second part, and the connection portion are integrally formed.   The medical device according to claim 1, wherein the reinforcing member is disposed so as to be movable back and forth along the axial direction.