JP2018121701A - Medical device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical device capable of excellently acquiring an image in a living organism and suppressing undesirable flexion of a tubular part.SOLUTION: A medical device 1 which is inserted in an organism lumen and for acquiring image information has: a long sheath body 21; an ultrasonic vibrator 411 housed in a distal part of the sheath body 21; a holding part 412 holding the ultrasonic vibrator 411; a drive shaft 42 transmitting a mechanical drive force to the holding part 412; a distal side tube 22 which is arranged sideways of the distal part of the sheath body 21 and is provided with a first guide wire lumen 221; and a reinforcement part 24 arranged inside the distal part of the sheath body 21. The reinforcement part 24 is arranged nearer on the side adjacent to the distal side tube 22, and a part positioned nearer the distal side than a near part of the reinforcement part 24 and an ultrasonic vibrator 411 of the holding part 412 has a range overlapping in an axial direction of the sheath body 21.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a medical device that can be inserted into a living body lumen to acquire image information.

  Conventionally, a medical device having an imaging function has been used in the treatment of a completely occluded lesion in a body lumen such as a blood vessel. Examples of the medical device having an imaging function include an intravascular ultrasonic diagnostic apparatus (IVUS: Intra Vessel Ultra Sound). For example, Patent Document 1 describes an ultrasonic catheter which is an intravascular ultrasonic diagnostic apparatus in which an ultrasonic transducer is rotatably disposed by a drive shaft in a long sheath.

  The ultrasonic catheter is preferably a rapid exchange type having a guide wire lumen at the distal portion in order to improve pushability and operability of the guide wire. Further, a distal tube having a guide wire lumen is not provided around the most distal position where the ultrasonic transducer of the sheath can be arranged so that a portion having the guide wire lumen does not interfere with imaging. . A reinforcing tip for reinforcing the sheath is disposed inside the sheath on the distal side of the ultrasonic transducer.

JP 2003-126092 A

  A certain gap is secured in the axial direction between the ultrasonic transducer and the reinforcing tip in the sheath so that the reinforcing tip does not interfere with imaging by the ultrasonic transducer. For this reason, the part where the clearance gap between the sheaths is secured has low bending rigidity. Therefore, when the sheath is abutted against a lesioned part or the like by pushing the ultrasonic catheter, the portion where the gap of the sheath is secured is excessively bent and kinks are likely to occur. When kinks occur in the sheath, the operability is lowered and the imaging is also affected.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a medical device that can acquire an image in a living body and can suppress undesirable bending of a sheath.

  A medical device that achieves the above-described object is a medical device that is inserted into a living body lumen to acquire image information, and has a long sheath body that can be inserted into the living body lumen, and a distal portion of the sheath body An image acquisition unit that is stored in the image acquisition unit, a holding unit that holds the image acquisition unit, and is inserted into the sheath body and connected to the holding unit, and transmits a mechanical driving force to the holding unit. A drive shaft, a distal tube disposed on the side of the distal portion of the sheath body and having a guide wire lumen provided therein, and a reinforcing portion disposed in the distal portion of the sheath body The reinforcing portion is disposed in the sheath body so as to be biased toward the side adjacent to the distal tube, and the proximal end of the reinforcing portion is the distal tube. Located proximal to the proximal end of the The proximal portion and the site located at the distal side of the image acquisition unit of the holding portion of the serial reinforcing portion has a range overlapping in the axial direction of the sheath body.

  Since the medical device configured as described above has a range in which the proximal portion of the reinforcing portion and the distal portion of the holding portion overlap in the axial direction, the sheath body between the distal tube and the holding portion is reinforced by the reinforcing portion. Thus, undesirable bending of the sheath body can be suppressed. In addition, since the reinforcing part is arranged biased to the side adjacent to the distal tube inside the sheath body and the reinforcing part does not overlap the image acquiring part, the reinforcing part does not interfere with imaging by the image acquiring part, Can get images well.

  The reinforcing portion is formed integrally with a proximal portion of the distal tube, and extends from a side of the distal tube adjacent to the sheath body to the proximal side to thereby extend the inside of the sheath body. You may get in. Thereby, a reinforcement part can be easily comprised using a distal side tube. Moreover, since the reinforcement part is formed integrally with the distal tube, the strength of the sheath body can be effectively increased by the reinforcement part, and undesirable bending of the sheath body can be suppressed.

  The medical device further includes a proximal tube disposed on a side of the distal portion of the sheath body and proximal to the distal tube and having a guide wire lumen provided therein. Also good. Thereby, the site | part which is easy to bend between the distal side tube and proximal side tube of a sheath main body is appropriately reinforced by a reinforcement part, and the undesirable bending of a sheath main body can be suppressed.

  The reinforcing part may be heat-sealed to the sheath body. Thereby, the intensity | strength of a sheath main body can be effectively raised with a reinforcement part, and the undesired bending of a sheath main body can be suppressed.

  The reinforcing part may have an enlarged part whose inner diameter expands toward the proximal side. As a result, the holding part easily overlaps the reinforcing part, and the reinforcing part is less likely to interfere with the operation of the image acquiring part, so that an image can be acquired satisfactorily.

  The reinforcing portion may have a concave shape on the side toward the axial center of the sheath body. As a result, the holding part easily overlaps the reinforcing part, and the reinforcing part is less likely to interfere with the operation of the image acquiring part, so that an image can be acquired satisfactorily.

It is a top view which shows the medical device which concerns on embodiment. It is sectional drawing which shows the distal part of a medical device. It is sectional drawing which shows the distal part of a medical device, (A) is sectional drawing which follows the AA line of FIG. 2, (B) is sectional drawing which follows the BB line of FIG. It is sectional drawing which shows the distal part of the modification of a medical device, (A) is sectional drawing which follows the AA line of FIG. 2, (B) is sectional drawing which follows the BB line of FIG. It is a top view which shows an external drive device. It is a top view which shows the medical device of the state which moved the vibrator | oscillator unit to the proximal side. It is sectional drawing for demonstrating operation | movement of the medical device inserted in the blood vessel. It is sectional drawing which shows the distal part of the other modification of a medical device. It is sectional drawing which follows the CC line of FIG.

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

  The medical device 1 according to the embodiment has an imaging function, is inserted into a blood vessel percutaneously, and is used for observing a completely occluded lesion. In this specification, the side of the device that is inserted into the blood vessel is referred to as the “distal side”, and the proximal side that is operated is referred to as the “proximal side”. In addition, the lesion part in a blood vessel is not limited to a completely occluded lesion. In addition, the obstruction (or stenosis) in the blood vessel is a thrombus, a plaque, a calcified lesion, and the like, but is not limited thereto, and any object that can exist in a living body lumen can be applicable.

  As shown in FIGS. 1 to 3, the medical device 1 includes a sheath 2 that is inserted into a lumen, an imaging core 4 that transmits and receives ultrasonic waves toward the intraluminal tissue, and a sheath through which the imaging core 4 penetrates. 2 and an operation unit 3 located on the base end side.

  The sheath 2 includes a sheath body 21, a distal side tube 22 and a proximal side tube 23 that are fixed to a side surface of the sheath body 21, and a reinforcing portion 24.

  The sheath body 21 is a long tube body, and an imaging core lumen 26 is formed. The imaging core 4 is arranged in the imaging core lumen 26 so as to be slidable in the axial direction of the sheath 2. The imaging core 4 includes a transducer unit 41 for transmitting and receiving ultrasonic waves from the lumen toward the living tissue, and a drive shaft 42 that attaches and rotates the transducer unit 41 to the tip. The transducer unit 41 includes an ultrasonic transducer 411 (image acquisition unit) that transmits and receives ultrasonic waves, and a holding unit 412 that is a housing that houses and holds the ultrasonic transducer 411. At least a part of the holding portion 412 is located on the distal side of the ultrasonic transducer 411. Two notches 211 into which a part of the distal tube 22 enters are formed at the distal end of the sheath body 21. By providing the notch 211, the distal tube 22 can be easily positioned with respect to the sheath body 21 during manufacturing.

  The distal tube 22 is a tube fixed to the side surface of the distal portion of the sheath body 21. The distal tube 22 is fixed to the sheath body 21 by heat fusion or an adhesive. A first guide wire lumen 221 is formed in the distal tube 22 as a passage for passing the guide wire 100. The proximal tube 23 is a tubular body that is fixed on the side surface of the distal portion of the sheath body 21 at a position proximal to the distal tube 22 and away from the distal tube 22. The proximal tube 23 is fixed to the sheath body 21 by heat fusion or an adhesive. A second guide wire lumen 231 is formed in the proximal tube 23 as a passage for passing the guide wire 100. Between the distal tube 22 and the proximal tube 23, an intermediate portion 213 where a guide wire lumen is not formed is provided. The intermediate part 213 is a part where the transducer unit 41 can acquire an image all around 360 degrees without interference with the distal tube 22 and the proximal tube 23.

  The reinforcing portion 24 protrudes proximally from a part in the circumferential direction of the proximal end portion of the distal tube 22. The reinforcing portion 24 is formed integrally with the distal tube 22. It is preferable that the distal side tube 22 and the reinforcement part 24 are formed by being cut out from one tube. Accordingly, the reinforcing portion 24 has a concave curved surface 242 formed on the side toward the axial center of the distal tube 22 and a convex curved surface 241 formed on the opposite side thereof. The distal tube 22 enters the two notches 211 of the sheath body 21 from the distal side. For this reason, most of the distal tube 22 is disposed outside the sheath body 21, but the reinforcing portion 24 is disposed in the imaging core lumen 26 inside the sheath body 21. A part of the distal tube 22 is disposed in the lumen 26 for the imaging core. The concave curved surface 242 faces outward in the radial direction of the sheath main body 21 in the sheath main body 21, and the convex curved surface 241 faces radially inward of the sheath main body 21. The portions of the distal tube 22 and the reinforcing portion 24 that are in contact with the sheath body 21 are heat-sealed to the sheath body 21 and fixed. When the distal tube 22, the reinforcing portion 24, and the sheath body 21 are heat-sealed, a cored bar may be inserted between the inner peripheral surface of the sheath body 21 and the concave curved surface 242. The cored bar can be pulled out after heat sealing. Note that the cored bar need not be used. Note that the distal tube 22, the reinforcing portion 24, and the sheath body 21 may be fixed by, for example, an adhesive instead of heat fusion. The proximal end of the reinforcing portion 24 does not reach the position where the proximal tube 23 of the sheath body 21 is fixed, and is located in the middle of the intermediate portion 213. A portion of the reinforcing portion 24 on the proximal side has a range that overlaps in the axial direction of the sheath body 21 with the holding portion 412 of the transducer unit 41 in a state of being pushed most distally into the imaging core lumen 26. Can do. For this reason, the convex curved surface 241 of the reinforcing portion 24 can contact the holding portion 412. The reinforcing portion 24 does not have a range that overlaps the ultrasonic transducer 411 of the transducer unit 41 in the state of being pushed most distally into the imaging core lumen 26 in the axial direction of the sheath body 21. For this reason, the reinforcement part 24 does not interfere with image acquisition by the ultrasonic transducer 411.

  In addition, as for the reinforcement part 24 of the distal side tube 22, the concave curved surface 243 is formed in the side which goes to the axial center of the sheath main body 21, and the convex curved surface 244 is formed in the other side like the modification shown in FIG. May be.

  The constituent material of the sheath main body 21, the distal tube 22 and the proximal tube 23 is preferably flexible. For example, styrene, polyolefin, polyurethane, polyester, polyamide, polyimide, polybutadiene Various types of thermoplastic elastomers such as poly, isoprene, fluoro rubber, chlorinated polyethylene, etc., and combinations of one or more of these (polymer alloys, polymer blends, laminates, etc.) ).

  The drive shaft 42 is flexible and has a characteristic capable of transmitting the rotational power generated in the operation unit 3 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 the affected part in the blood vessel can be observed in the circumferential direction. The drive shaft 42 has a signal line 44 for transmitting a signal detected by the vibrator unit 41 to the operation unit 3.

  The operation unit 3 includes an outer tube 32 connected to the proximal portion of the sheath 2 via the relay connector 33, a unit connector 37 connected to the proximal portion of the outer tube 32, and an axial direction with respect to the outer tube 32. And a hub 31 connected to a proximal portion of the inner tube 34.

  The hub 31 holds the drive shaft 42 and the inner tube 34. When the hub 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. 6), the drive shaft 42 is interlocked to move inside the sheath 2. Slide in the axial direction. The hub 31 is formed with a port 311 for injecting a physiological saline solution for air bleeding. The port 311 communicates with the imaging core lumen 26. The unit connector 37 is held by a holding portion 73 (see FIG. 5) formed in the external drive device 7.

  When the inner tube 34 is pushed in most, as shown in FIGS. 1 and 2, the inner tube 34 reaches near the distal end of the outer tube 32, that is, near the relay connector 33. In this state, the transducer unit 41 is located at the intermediate portion 213 of the sheath 2. In this state, the proximal portion of the reinforcing portion 24 and the holding portion 412 have a range where they overlap in the axial direction of the sheath body 21.

  When the inner tube 34 is pulled out the most, as shown in FIG. 6, the stopper 315 formed at the tip of the inner tube 34 is caught on the inner wall of the unit connector 37. Except for the distal portion where the inner tube 34 is caught, it is exposed to the outside. In this state, the transducer unit 41 is pulled back in the proximal direction while leaving the sheath 2. By moving the transducer unit 41 while rotating, a tomographic image of a blood vessel, a lesioned part, or the like can be created by the single transducer unit 41.

  As shown in FIGS. 2 and 5, the hub 31 of the operation unit 3 includes a joint 312 and a hub-side connector 313 connected to the proximal portion of the drive shaft 42. One end of a signal line 44 is connected to the hub side connector 313. The signal line 44 passes through the drive shaft 42 and has an end connected to the vibrator unit 41. The transducer unit 41 emits ultrasonic waves by a signal transmitted from the external drive device 7 to the transducer unit 41 via the drive side connector 711 and the hub side connector 313. Further, the observation result in the transducer unit 41 is transmitted to the external drive device 7 via the hub side connector 313 and the drive side connector 711, and subjected to appropriate processing and displayed as an image.

  The above-described medical device 1 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 rotationally drives the drive shaft 42, a linear movement unit 72 that moves the drive unit 71 in the axial direction, and a part of the medical device 1 in a fixed manner on the base 75. And holding part 73 for holding. The drive unit 71 incorporates an external drive source such as a motor and rotationally drives the drive shaft 42. The linear movement unit 72 incorporates an external drive source such as a motor, and grips the drive unit 71 and moves it in the axial direction. The holding unit 73 holds the unit connector 37 of the medical device 1 in a fixed manner. The external drive device 7 is connected to a control unit 79 that controls the drive unit 71 and the linear movement unit 72. An image obtained by the transducer unit 41 is displayed on a display unit 78 connected to the control unit 79.

  The linear moving unit 72 can hold and fix the drive unit 71 and includes a feed mechanism that 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. By connecting the hub side connector 313 to the drive side connector 711 and connecting the joint 312 to the joint connection portion 712, signals can be transmitted and received between the external drive device 7 and the vibrator unit 41, and at the same time, the drive shaft 42 Can be rotated.

  When performing ultrasonic scanning (scanning) with the medical device 1, the rotational motion of the motor in the drive unit 71 can be transmitted to the drive shaft 42, and the holding unit 412 fixed to the tip of the drive shaft 42 can be rotated. . Further, the transducer unit 41 fixed to the distal portion of the drive shaft 42 can be moved in the axial direction by sliding the drive shaft 42 in the axial direction within the sheath 2 by the linear moving portion 72. Thereby, the ultrasonic waves transmitted and received by the transducer unit 41 provided in the holding unit 412 can be scanned in the substantially radial direction and the axial direction. For this reason, a 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, a method for observing a lesion L that is a completely occluded lesion of a blood vessel using the medical device 1 according to the present embodiment will be described.

  First, before inserting the sheath 2 of the medical device 1 into the blood vessel, a priming operation is performed to fill the medical device 1 with physiological saline. By performing the priming operation, ultrasonic waves can be transmitted from the transducer unit 41, and the air in the medical device 1 is removed to prevent the air from entering the body such as a blood vessel.

  In order to perform priming, a physiological saline solution is injected using a syringe or the like through a tube (not shown) connected to the port 311 of the hub 31 and a three-way stopcock. The injected physiological saline is filled into the sheath 2 in order from the hub 31. By performing this priming operation, it is possible to remove air in the medical device 1 and prevent air from entering the blood vessel.

  Next, as shown in FIG. 5, 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 hub 31 of the medical device 1 is connected to the joint connection portion 712 of the drive unit 71, and the hub side connector 313 is connected to the drive side connector 711. Thereby, signals can be transmitted and received between the external drive device 7 and the vibrator unit 41, 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, by moving the drive unit 71 distally along the groove rail 76 on the base 75, the hub 31 is pushed distally, and the inner tube 34 is pushed most into the outer tube 32. (See FIG. 1).

  Next, the guide wire 100 is inserted into the blood vessel, and the tip thereof is abutted against the lesioned part L. Next, the proximal end portion of the guide wire 100 is inserted into the first guide wire lumen 221 and the second guide wire lumen 231 of the medical device 1. Then, as shown in FIG. 7, the sheath 2 is inserted into the blood vessel along the guide wire 100 and abuts against the lesioned part L.

  When the sheath 2 hits the lesioned part L, the sheath 2 receives a force to bend from the lesioned part L. At this time, as shown in FIG. 2, the reinforcing portion 24 of the distal tube 22 has a range that overlaps with the holding portion 412 positioned inside the intermediate portion 213 in the axial direction. For this reason, the reinforcement part 24 exists between the distal side tube 22 in which the 1st guidewire lumen 221 is formed, and the vibrator unit 41, and there exists a site | part which becomes only the intermediate part 213 with low rigidity along an axial direction. Without it, the intermediate part 213 becomes difficult to bend. Thereby, excessive bending (for example, kink) in the intermediate portion 213 of the sheath 2 can be suppressed, and the operability is improved and the influence on image acquisition can be reduced.

  Next, a pull back operation is performed while rotating the drive shaft 42 by the drive unit 71 while holding the sheath 2 so as not to move. Thereby, the transducer unit 41 moves along the axial direction toward the proximal side while performing radial scanning. For this reason, the image of the biological tissue containing the lesioned part L can be acquired. The transducer unit 41 can acquire an image over the entire circumference of 360 degrees in a state of being located inside the intermediate portion 213.

  Thereafter, the medical device 1 and the guide wire 100 are removed from the living body. Thereby, the procedure by the medical device 1 is completed.

  As described above, the medical device 1 according to the present embodiment is a medical device 1 that is inserted into a living body lumen to acquire image information, and has a long sheath body 21 that can be inserted into the living body lumen. An ultrasonic transducer 411 (image acquisition unit) that is accommodated in the distal portion of the sheath body 21 and acquires image information, a holding unit 412 that holds the ultrasonic transducer 411, and the sheath body 21 are inserted into the sheath body 21. A drive shaft 42 that is connected to the holding portion 412 and transmits a mechanical driving force to the holding portion 412 and a first guide wire lumen 221 that is disposed on the side of the distal portion of the sheath body 21 are provided inside. A distal tube 22 and a reinforcing portion 24 disposed inside the distal portion of the sheath body 21, the reinforcing portion 24 being inside the sheath body 21 and adjacent to the distal tube 22. Placed sideways The proximal end of the reinforcing portion 24 is located closer to the proximal side than the proximal end of the distal tube 22, and the ultrasonic transducer of the proximal portion of the reinforcing portion 24 and the holding portion 412. A portion located more distal than 411 has a range that overlaps in the axial direction of the sheath body 21.

  Since the medical device 1 configured as described above has a range in which the proximal portion of the reinforcing portion 24 and the distal portion of the holding portion 412 overlap in the axial direction, the sheath body between the distal tube 22 and the holding portion 412 21 is reinforced by the reinforcing portion 24, and undesirable bending of the sheath body 21 can be suppressed. Further, since the reinforcing portion 24 is arranged to be biased to the side adjacent to the distal tube 22 inside the sheath body 21 and the reinforcing portion 24 does not overlap the ultrasonic transducer 411, the reinforcing portion 24 becomes the ultrasonic transducer 411. Therefore, it is possible to obtain an image in a living body without interfering with the image pickup. In addition, the ultrasonic transducer 411 can be pushed distally until the holding unit 412 that holds the ultrasonic transducer 411 overlaps with the proximal portion of the reinforcing unit 24, and the range in which an image can be acquired can be expanded. In addition, since the sheath body 21 between the distal tube 22 and the holding portion 412 is reinforced by the reinforcing portion 24, the change in physical properties (bending rigidity, etc.) in the axial direction becomes gentle, and the appropriate flexibility of the sheath 2 is achieved. Sex can be obtained. Moreover, since the reinforcement part 24 is biased and arrange | positioned at the side adjacent to the distal side tube 22 inside the sheath main body 21, it is not arrange | positioned perimeter but the sheath main body 21 can be reduced in diameter.

  The reinforcing portion 24 is formed integrally with the proximal portion of the distal tube 22 and extends from the side adjacent to the sheath body 21 of the distal tube 22 to the proximal side, 21 inside. Thereby, the reinforcement part 24 can be easily comprised using the distal side tube 22. FIG. Moreover, since the reinforcement part 24 is integrally formed with the distal side tube 22, the strength of the sheath body 21 can be effectively increased by the reinforcement part 24, and undesirable bending of the sheath body 21 can be suppressed. Further, since the reinforcing portion 24 is formed integrally with the distal tube 22, changes in physical properties (bending rigidity, etc.) in the axial direction of the sheath 2 become gentle, and appropriate flexibility of the sheath 2 is obtained. Can do. Moreover, since the reinforcement part 24 is integrally formed with the distal side tube 22, the structure can be simplified and the distal part of the medical device 1 can be reduced in diameter.

  In addition, the medical device 1 further includes a proximal tube 23 that is disposed on the side of the distal portion of the sheath body 21 and more proximally than the distal tube 22 and has a guide wire lumen provided therein. Have. Thereby, the site | part which is easy to bend between the distal side tube 22 and the proximal side tube 23 of the sheath main body 21 is appropriately reinforced by the reinforcement part 24, and the undesirable bending of the sheath main body 21 can be suppressed.

  Further, the reinforcing portion 24 may be heat-sealed to the sheath body 21. Thereby, the intensity | strength of the sheath main body 21 can be effectively raised with the reinforcement part 24, and the undesired bending of the sheath main body 21 can be suppressed.

  Further, the reinforcing portion 24 may have a concave shape on the side toward the axial center of the sheath body 21 as in the modification shown in FIG. Accordingly, the holding unit 412 easily overlaps with the reinforcing unit 24, and the reinforcing unit 24 hardly interferes with the operation of the ultrasonic transducer 411. Therefore, an image can be acquired favorably.

  Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, in the above-described embodiment, the case where the present invention is applied to an intravascular ultrasonic diagnostic apparatus (IVUS) is described. However, an optical coherence tomography (OCT) or optical frequency domain imaging diagnosis is used. The present invention can also be applied to an apparatus that acquires an image using light such as an apparatus (OFDI: Optical Frequency Domain Imaging).

  Moreover, although the medical device 1 which concerns on embodiment mentioned above has the distal side tube 22 and the proximal side tube 23 as a tube in which a guide wire lumen is formed, it does not have the proximal side tube 23. May be.

  8 and 9, the reinforcing portion 51 may be a separate structure from the distal tube 6 in which the first guide wire lumen 61 is formed. In addition, the same code | symbol is attached | subjected to the site | part which has a function similar to the above-mentioned embodiment, and description is abbreviate | omitted. The reinforcing portion 51 is provided in the reinforcing structure 5 disposed at the distal portion of the imaging core lumen 26 inside the sheath body 21. The reinforcing structure 5 includes a reinforcing tube 52 that fits into the sheath body 21 and a reinforcing portion 51 that protrudes from a part in the circumferential direction of the proximal end portion of the reinforcing tube 52. The reinforcing tube 52 is fitted into the sheath body 21 and is firmly fixed. The reinforcing tube 52 also functions as a priming port that is a hole for allowing a physiological saline solution filled in the sheath body 21 to flow outside. The reinforcing portion 51 has a concave curved surface 53 formed on the side toward the axial center of the sheath body 21 and a convex curved surface 54 formed on the opposite side. The radius of curvature of the concave curved surface 53 is larger than the inner diameter of the reinforcing tube 52. The reinforcing part 51 has an enlarged part 55 whose inner diameter expands in a tapered shape from the reinforcing tube 52 side toward the proximal side. The outer peripheral surface of the reinforcing tube 52 is heat-sealed or bonded to the sheath body 21 and the distal tube 6. The convex curved surface 54 of the reinforcing portion 51 is thermally fused or bonded to the sheath body 21. The proximal end portion of the reinforcing portion 51 does not reach the position where the proximal tube 23 of the sheath main body 21 is fixed, and is located in the middle of the intermediate portion 213. A portion of the reinforcing portion 51 on the proximal side has a range that overlaps in the axial direction of the sheath body 21 with the holding portion 412 of the transducer unit 41 in the state of being pushed most distally into the imaging core lumen 26. Can do. For this reason, the concave curved surface 53 of the reinforcing portion 51 can smoothly come into contact with the holding portion 412 located on the distal side of the ultrasonic transducer 411. The reinforcing portion 51 does not have a range that overlaps the ultrasonic transducer 411 of the transducer unit 41 in the state of being pushed most distally into the imaging core lumen 26 in the axial direction of the sheath body 21. For this reason, the reinforcement part 51 does not interfere with image acquisition by the ultrasonic transducer 411.

  As described above, the reinforcing portion 51 has the enlarged portion 55 whose inner diameter increases toward the proximal side. Accordingly, the holding unit 412 easily overlaps with the reinforcing unit 51, and the reinforcing unit 51 does not easily interfere with the operation of the ultrasonic transducer 411. Therefore, an image can be acquired favorably. In addition, the change in physical properties (such as bending rigidity) in the axial direction of the reinforcing portion 51 becomes gentle, and appropriate flexibility of the sheath 2 can be obtained.

  Further, the reinforcing portion 51 has a concave shape on the side toward the axial center of the sheath body 21. Accordingly, the holding unit 412 easily overlaps with the reinforcing unit 51, and the reinforcing unit 51 does not easily interfere with the operation of the ultrasonic transducer 411. Therefore, an image can be acquired favorably.

DESCRIPTION OF SYMBOLS 1 Medical device 21 Sheath main body 213 Intermediate | middle part 22, 6 Distal side tube 221, 61 1st guide wire lumen 24, 51 Reinforcement part 23 Proximal side tube 231 2nd guide wire lumen 26 Lumen for imaging core 4 Imaging core 41 Vibration Child unit 411 Ultrasonic transducer (image acquisition unit)
412 Holding part 42 Drive shaft 55 Enlarged part L Lesion part

Claims (6)

A medical device for acquiring image information inserted into a biological lumen,
A long sheath body that can be inserted into a body lumen;
An image acquisition unit that is stored in a distal portion of the sheath body and acquires image information;
A holding unit for holding the image acquisition unit;
A drive shaft that is inserted into the sheath body and connected to the holding portion, and transmits a mechanical driving force to the holding portion;
A distal tube disposed laterally of the distal portion of the sheath body and having a guidewire lumen disposed therein;
A reinforcing portion disposed inside the distal portion of the sheath body,
The reinforcing portion is disposed inside the sheath body so as to be biased toward a side adjacent to the distal tube, and a proximal end portion of the reinforcing portion is located on a proximal side of the distal tube. Located proximal to the end,
The medical device which has the range which the site | part located in the distal side rather than the said image acquisition part of the proximal part of the said reinforcement part and the said holding | maintenance part overlaps in the axial direction of the said sheath main body.   The reinforcing portion is formed integrally with a proximal portion of the distal tube, and extends from a side of the distal tube adjacent to the sheath body to the proximal side to thereby extend the inside of the sheath body. The medical device of claim 1, wherein the medical device is embedded.   3. The tube according to claim 1, further comprising a proximal tube disposed on a side of a distal portion of the sheath body and proximal to the distal tube and having a guide wire lumen provided therein. Medical devices.   The medical device according to claim 1, wherein the reinforcing portion is heat-sealed to the sheath body.   The medical device according to any one of claims 1 to 4, wherein the reinforcing portion has an enlarged portion whose inner diameter expands toward the proximal side.   The medical device according to any one of claims 1 to 5, wherein the reinforcing portion has a concave shape on a side toward the axis of the sheath body.

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