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WO2017149974A1 - Dispositif médical - Google Patents

Dispositif médical Download PDF

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Publication number
WO2017149974A1
WO2017149974A1 PCT/JP2017/001603 JP2017001603W WO2017149974A1 WO 2017149974 A1 WO2017149974 A1 WO 2017149974A1 JP 2017001603 W JP2017001603 W JP 2017001603W WO 2017149974 A1 WO2017149974 A1 WO 2017149974A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft portion
wall
end side
hub
medical device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2017/001603
Other languages
English (en)
Japanese (ja)
Inventor
泰徳 山下
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP2018502566A priority Critical patent/JP6823043B2/ja
Publication of WO2017149974A1 publication Critical patent/WO2017149974A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes

Definitions

  • the present invention relates to a medical device having an imaging function.
  • IVUS Intra Vascular Ultra Sound
  • an ultrasonic detector (probe) including an ultrasonic transducer is rotatably disposed in a long tubular body (see Patent Document 1).
  • the tube body is formed with an observation portion lumen for rotatably storing the probe, and a guide wire lumen into which a guide wire for guiding a diagnostic imaging device to a target position can be inserted.
  • a guide wire previously inserted to the vicinity of the target position in the blood vessel is inserted into the guide wire lumen, and the probe is placed at the target position by moving the tube body along the guide wire.
  • the probe is placed at the target position by moving the tube body along the guide wire.
  • the ultrasonic echo generated is processed by amplification, detection, etc. Based on the intensity of the blood vessel, a cross-sectional image of the blood vessel can be drawn.
  • an object of the present invention is to provide a medical device that suppresses an increase in the size of the outer shape of the device and improves the rigidity of the device on the proximal end side.
  • a medical device that achieves the above object includes a first shaft portion including an observation portion lumen into which an observation portion that acquires image information in a living body is inserted, and a guide wire lumen into which a guide wire can be inserted.
  • a second shaft portion provided adjacent to the first shaft portion, a connecting wall formed between the first shaft portion and the second shaft portion at least on the proximal end side of the first shaft portion, and at least a connecting wall And a reinforcing member embedded in the connecting wall on the base end side.
  • the connecting wall has an outer wall portion that connects arcuate outer wall surfaces provided on the first shaft portion and the second shaft portion by a tangent line at least on the distal end side.
  • the medical device according to the present invention is configured such that the outer wall portion of the connecting wall at least on the distal end side of the connecting wall connects the arcuate outer wall surfaces of the first shaft portion and the second shaft portion with a tangent line. is doing. Therefore, the outward extension of the connecting wall on the distal end side can be suppressed, and an increase in the outer shape on the distal end side of the shaft portion can be suppressed.
  • the connecting wall is provided at least on the proximal end side of the first shaft portion, and a reinforcing member is embedded on the proximal end side of the connecting wall. Therefore, the rigidity on the proximal end side of the shaft portion can be improved, and the rigidity on the proximal side of the medical device can be improved.
  • FIG. 4A is along line 4A-4A in FIG. 1
  • FIG. 4B is along line 4B-4B in FIG. 1
  • FIG. 4C is along line 4C-4C in FIG.
  • FIG. 4D is a sectional view taken along the line 4D-4D in FIG. 1
  • FIG. 4E is a sectional view taken along the line 4E-4E in FIG.
  • FIG. 10A and FIG. 10B are cross-sectional views showing modifications of FIG.
  • the medical device 1 is an ultrasonic catheter that is inserted into a living body lumen with an imaging core 4 for ultrasonic diagnosis housed therein.
  • the medical device 1 is connected to an external driving device 7 (see FIG. 2) that holds the medical device 1 and drives the imaging core 4, and is used mainly for diagnosing the inside of a blood vessel.
  • the side to be inserted into the lumen of the living body is referred to as “tip” or “tip side”
  • the proximal side for operation is referred to as “base end” or “base end side”.
  • the medical device 1 includes a long shaft portion 2 that is inserted into a lumen, and an imaging core 4 (corresponding to an observation portion) that transmits and receives ultrasonic waves toward the lumen tissue.
  • a hub 5 that penetrates the imaging core 4 and is located on the proximal side of the shaft portion 2 and an operation portion 3 that operates the imaging core 4 are provided.
  • the shaft portion 2 extends from the proximal end side to the distal end side, and has a long first shaft portion 21 through which the imaging core 4 is slidably inserted.
  • a long second shaft portion 22 extending from the first shaft portion 21 to the distal end side than the first shaft portion 21 and inserting the guide wire W, and a connecting wall 23 formed between the first shaft portion 21 and the second shaft portion 22.
  • a reinforcing member 24 embedded in the connecting wall 23.
  • the first shaft portion 21 is formed with an image lumen 211 (corresponding to the observation portion lumen) through which the imaging core 4 can be inserted, and the cross section has a substantially hollow cylindrical shape. Is formed.
  • the second shaft portion 22 is formed with a guide wire lumen 221 through which the guide wire W is inserted, and the cross section is formed in a substantially hollow cylindrical shape like the first shaft portion 21. Due to the difference in size between the guide wire W and the imaging core 4, the guide wire lumen 221 has a smaller cross section than the image lumen 211.
  • the second shaft portion 22 is arranged so that the guide wire lumen 221 is not adjacent to the inner lumen (coaxial) of the image lumen 211 but is adjacent to the image lumen 211 separately.
  • the first shaft portion 21 is disposed adjacent to the first shaft portion 21.
  • the first shaft portion 21 and the second shaft portion 22 are arranged side by side from the distal end to the distal end side of the hub 5, and are configured to branch inside the hub 5.
  • outer wall surfaces 212 and 222 are formed in a substantially circular shape at a relatively distal end side position shown in FIG.
  • the first shaft portion 21 and the second shaft portion 22 have outer wall surfaces 213 and 223 that are separated from each other in a cross section in which the connection wall 23 is formed in a substantially circular shape. Has been.
  • the outer diameter and / or inner diameter of the first shaft portion 21 and the second shaft portion 22 may be different depending on the position in the longitudinal 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 and not causing an extreme change in physical properties, high pushability and passability are achieved while suppressing the occurrence of kinks. be able to.
  • the imaging core 4 is disposed so as to be slidable in the axial (longitudinal) direction of the shaft portion 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 the transducer unit 41 to the tip and rotates the transducer unit 41.
  • 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 vibrator unit 41 can be observed from an angio image obtained by photographing a blood vessel by X-ray photography from outside the body.
  • the material of the housing 412 is not limited, for example, a metal such as gold, platinum, a platinum alloy, and a tungsten alloy, or an X-ray such as barium sulfate, bismuth oxide, and tungsten so as to function as an X-ray contrast unit. It preferably contains an impermeable material. Further, an X-ray contrast marker may be separately provided in the vicinity of the housing 412.
  • the connecting wall 23 is provided in the vicinity of the rear end of the range in which the imaging core 4 moves back and forth in the axial direction in the shaft portion 2.
  • the connecting wall 23 is formed to the near side of the front end of the first shaft portion 21 and the second shaft portion 22 in the longitudinal direction of the shaft portion 2, and as shown in FIG.
  • the shaft portion 22 is configured to cover at least a part of the outer wall surface.
  • the connecting wall 23 is configured to have substantially the same shape when symmetrically reversed in FIG. However, as long as the shaft portion 2 can be bent or curved without being biased in a specific direction, the cross-sectional shape is not necessarily symmetrical.
  • the first shaft portion 21 has a substantially arc-shaped outer wall surface 213, and the second shaft portion 22 has a substantially arc-shaped outer wall surface 223.
  • the cross sections of the first shaft portion 21 and the second shaft portion 22 are illustrated as perfect circles, but are not limited thereto, and may be, for example, oval.
  • the connecting wall 23 has a substantially straight cross section in which the arcuate outer wall surface 213 and the arcuate outer wall surface 223 are connected by a tangent line in the cross section of FIG.
  • the outer wall surface 231 has a shape (corresponding to the outer wall portion). This prevents the outer shape of the shaft portion 2 from becoming excessively large.
  • FIG. 4E which shows a relatively proximal cross section of the connecting wall 23
  • the outer wall surface 232 (corresponding to the protruding outer wall portion) of the connecting wall 23 is not linear and protrudes outward. It is configured with a curved shape.
  • the shape of the outer wall surface of the connecting wall 23 is not limited to this as long as the outer shape on the distal end side of the shaft portion 2 can be reduced and the rigidity on the hand side can be improved.
  • the reinforcing member 24 is embedded in the connection wall 23 on the base end side from the position where the imaging core 4 is most retracted.
  • the reinforcing member 24 is provided so as not to protrude between the outer wall surface 231 of the connecting wall 23, the inner wall surface 214 of the first shaft portion 21, and the inner wall surface 224 of the second shaft portion 22.
  • the reinforcing member 24 is provided in pairs on both sides across a line CL connecting the centers of the first shaft portion 21 and the second shaft portion 22 shown in FIG.
  • the reinforcing member 24 contributes to the improvement of the rigidity of the shaft portion 2, particularly on the proximal end side, like the connecting wall 23.
  • the reinforcing member 24 is configured in a substantially circular shape by taking a cross-sectional shape as an example.
  • the material of the first shaft portion 21 and the second shaft portion 22 in the shaft portion 2 is made of a material having high ultrasonic permeability.
  • the first shaft portion 21 and the second shaft portion 22 are formed of a flexible material, and the material is not particularly limited.
  • styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polyimide-based Various types of thermoplastic elastomers such as polybutadiene, trans polyisoprene, fluororubber, chlorinated polyethylene, etc., one or a combination of two or more of these (polymer alloys, polymer blends, laminates, etc.) ) Can be used.
  • the material of the reinforcing member 24 is not particularly limited, and examples thereof include a stainless steel wire and a Ni—Ti alloy.
  • a filling liquid inlet / outlet member 215 is provided at the tip of the second shaft portion 22.
  • the filling liquid inlet / outlet member 215 is provided in order to flow physiological saline or the like filled in the image lumen 211 to the outside, and therefore, a priming port 216 that is a hole is formed.
  • the first shaft part 21 and the second shaft part 22 are added to the first shaft part 21 and the second shaft part 22 as shown in FIG.
  • a connecting wall 23 is formed between the two shaft portions 22. Due to the connecting wall 23, the outer wall surface of the shaft portion 2 protrudes outward from the points 4A and 4B.
  • the first shaft portion 21, the second shaft portion 22, and the connecting wall 23 are disposed at a point 4D located on the base end side of the points 4A, 4B, and 4C of the shaft portion 2.
  • a reinforcing member 24 is embedded in the connection wall 23.
  • the outer shapes of the outer wall surfaces 213 and 223 are similar to the point 4D as shown in FIG.
  • the outer wall surface 232 of the connecting wall 23 is configured to project outward from the outer wall surface 231 of the point 4D.
  • the reinforcing member 24 is configured such that the reinforcing member 24 itself is thicker than the point 4D shown in FIG. 4D in accordance with the position of the outer wall surface of the connecting wall 23 as shown in FIG.
  • the distal end side of the shaft portion 2 such as the point 4A to the point 4D maintains a small diameter as in the case where there is no reinforcing member or the like, and can be inserted into various biological lumens. be able to.
  • the proximal end side of the shaft portion 2 such as the point 4E can increase the rigidity of the proximal side by the connecting wall 23 or the reinforcing member 24 as the distance from the proximal end increases, thereby improving the operability of the medical device 1. Can do.
  • 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.
  • a characteristic capable of transmitting the rotational power generated in the operation unit 3 to the vibrator unit 41 For example, as shown in FIG. It is composed of a multilayer coil-like tube body such as a layer coil.
  • the driving shaft 42 transmits the rotational power
  • the vibrator unit 41 rotates and the affected part in the lumen such as a blood vessel and 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.
  • the hub 5 includes a first hub portion 51 that is airtightly connected to the first shaft portion 21, a second hub portion 52 that is airtightly connected to the second shaft portion 22, and a first hub portion.
  • a hub casing 53 that covers 51 and the second hub portion 52 and a first anti-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.
  • the operation unit 3 includes an outer tube 32 coupled to the first hub unit 51, a unit connector 37 coupled to the proximal end portion of the outer tube 32, and an axial direction with respect 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.
  • the drive shaft 42 is interlocked with the shaft. Slide in the axial direction in the part 2.
  • 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 211.
  • the transducer unit 41 is located near the tip of the image lumen 211 as shown in FIG.
  • the transducer unit 41 can create a tomographic image of a blood vessel or the like by moving along the axial direction while rotating.
  • 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 base end side, and the hub side connector 313 is disposed inside.
  • the hub-side connector 313 can be connected to the drive female connector 711 (see FIG. 2) 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. Are mechanically and electrically connected.
  • 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 driving device 7 to the transducer unit 41 via the female connector for driving 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 through the signal line 43, the hub side connector 313, and the drive female connector 711.
  • the second kink resistant 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. 2) of the external drive device 7.
  • the first hub portion 51 is connected by fitting the distal end portion of the outer tube 32 from the proximal end side, and the first shaft portion 21 is inserted from the distal end side to perform heat fusion. It is connected airtight by wearing or bonding. Accordingly, 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 211 through the first hub portion 51.
  • a first connecting convex portion 511 protruding in a ring shape is formed in order to connect to the hub casing 53.
  • the second hub portion 52 is connected in an airtight manner by inserting the second shaft portion 22 from the front end side and heat-sealing or bonding. Therefore, the second hub portion 52 communicates with the guide wire lumen 221 so that the guide wire W can pass therethrough.
  • a second connecting convex portion 521 that protrudes in a ring shape is formed in order to connect to the hub casing 53.
  • the hub casing 53 includes two first casings 531 configured in a split structure so as to sandwich the outer peripheral surfaces of the shaft portion 2, the first hub portion 51, and the second hub portion 52 from both sides. And a second casing 532.
  • the first casing 531 and the second casing 532 are formed in a symmetrical shape with the shaft portion 2, the first hub portion 51 and the second hub portion 52 interposed therebetween.
  • the first casing 531 and the second casing 532 include a front end side fitting portion 533 into which the shaft portion 2 is fitted, a first hub fitting portion 534 into which the first hub portion 51 is fitted, and a second hub portion 52.
  • the second hub fitting portion 535 is formed.
  • the first hub fitting portion 534 is formed with a first connection concave portion 536 into which the first connection convex portion 511 formed on the outer peripheral surface of the first hub portion 51 can be fitted.
  • the second hub fitting portion 535 is formed with a second coupling recess 537 into which the second coupling projection 521 formed on the outer peripheral surface of the second hub portion 52 can be fitted.
  • the first casing 531 and the second casing 532 are caught by overlapping the outer peripheral surfaces of the shaft portion 2, the first hub portion 51, and the second hub portion 52 from both sides.
  • a connecting hook 538 and a connecting step 539 are formed.
  • the connecting hook 538 is once bent and then hooked to the connecting step 539, so that the first casing 531 and the second casing 532 are connected.
  • the first casing 531 and the second casing 532 may be joined by an adhesive or heat fusion without using a mechanical structure such as the connecting hook 538 and the connecting step 539.
  • the first casing 531 and the second casing 532 are provided with a fixing portion 541 that fixes the proximal end of the reinforcing member 24 embedded in the connecting wall 23 of the shaft portion 2. ing.
  • the fixing portion 541 is joined to the reinforcing member 24 with an adhesive or the like, but the manner of joining is not limited to the adhesive. Further, the shape or the like of the fixing portion 541 is not limited to that shown in FIG. 8 as long as the displacement of the reinforcing member 24 in the longitudinal direction can be prevented.
  • the first connecting convex portion 511 of the first hub portion 51 is fitted into the first connecting concave portion 536
  • the second connecting convex portion 521 of the second hub portion 52 is fitted into the second connecting concave portion 537.
  • the first hub portion 51 and the second hub portion 52 are fixed to the hub casing 53 so as not to drop off.
  • the first hub portion 51 and the hub casing 53 are joined by an adhesive or heat fusion without using a mechanical structure such as the first connecting convex portion 511 and the first connecting concave portion 536. Also good.
  • the second hub portion 52 and the hub casing 53 are also joined by an adhesive or heat fusion without using a mechanical structure such as the second connection convex portion 521 and the second connection concave portion 537. Also good.
  • the shaft portion 2 has a portion connected to the outer tube 32 positioned inside the hub casing 53.
  • of the central axis Y 1 of the first hub portion 51 with respect to the axis X is set to the axis X of the base end portion of the shaft portion 2 as a reference line.
  • the inclination of the central axis Y2 is larger than
  • of the first hub portion 51 is excessively increased, uneven rotation of the image is likely to occur due to friction between the drive shaft 42 and the first shaft portion 21. Further, when pulling back the imaging core 4, disconnection and image unevenness due to jumping that disturbs the movement of the imaging core 4 are likely to occur. Therefore, the inclination
  • the drive shaft 42 that should be arranged so as not to bend in the hub is bent in the hub 5 in this embodiment.
  • the drive shaft 42 is configured to be able to transmit a driving force while being bent in the blood vessel, so that the drive shaft 42 can be bent in the hub 5. Since the first shaft portion 21 in which the image lumen 211 that accommodates the drive shaft 42 is formed extends while being bent in the hub casing 53 and is connected to the first hub portion 51, the hub casing. The position of the drive shaft 42 that rotates within 53 can be appropriately maintained.
  • the second shaft portion 22 in which the guide wire lumen 221 for accommodating the guide wire W is formed is connected to the second hub portion 52 in the hub casing 53, the guide is guided in the hub casing 53.
  • the position of the wire W can be appropriately maintained, and the guide wire W can be favorably operated.
  • the first kink protector 54 surrounds the front end portion of the hub casing 53 and the shaft portion 2 led out from the hub casing 53 in the front end direction, and suppresses kink of the shaft portion 2.
  • the constituent materials of the first hub portion 51, the second hub portion 52, the hub casing 53, the outer tube 32, the inner tube 34, the unit connector 37, and the operation base end portion 31 are not particularly limited.
  • polyvinyl chloride Polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, polyester such as polyethylene naphthalate, butadiene-styrene copolymer
  • acrylic resin acrylonitrile-butadiene-styrene copolymer
  • polyethylene terephthalate polyester
  • polyester such as 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 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 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 capable of gripping and fixing the drive unit 71 and moving the gripped drive unit 71 back and forth along the groove rail 76 on the base 75.
  • the drive unit 71 includes a drive female connector 711 to which the 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 transducer unit 41, and at the same time, the drive shaft 42 can be rotated.
  • 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 means 72 in the axial direction.
  • 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.
  • a priming operation for filling the medical device 1 with physiological saline is performed before inserting the shaft portion 2 of the medical device 1 into the lumen.
  • 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.
  • the operation base end portion 31 is most pulled to the base end side from the unit connector 37, that is, the inner tube 34 is most pulled out from the outer tube 32.
  • Saline is infused using, for example, a syringe or the like through an instrument including a tube (not shown) connected to the port 311 of the proximal end portion 31 and a three-way stopcock.
  • the injected physiological saline is filled into the image lumen 211 from the operation base end portion 31 through the first hub portion 51, and the physiological saline comes out from the priming port 216 of the filling fluid inlet / outlet member 215. Thereby, the air in the medical device 1 is removed, filling of the physiological saline is confirmed, and priming is completed.
  • the medical device 1 is connected to an external drive device 7 covered with a sterilized polyethylene bag or the like (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.
  • 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.
  • the guide wire W is inserted into the living body lumen, and the tip portion is made to reach the vicinity of the target position to be observed.
  • the proximal end portion of the guide wire W is inserted from the distal end opening of the guide wire lumen 221 of the medical device 1, the shaft portion 2 is moved along the guide wire W, and the ultrasonic transducer 411 is observed. It arranges on the back side (tip side) from the affected part.
  • the ultrasonic transducer 411 is scanned radially.
  • An image of living tissue including the affected part can be acquired along the axial direction of the lumen by moving the base part to the proximal end side from the affected part.
  • the pull back operation can be performed by operating the moving means 72 connected to the rear end of the medical device 1 by the control unit 79.
  • the acquired data is digitally processed by the control unit 79 and then displayed on the display unit 78 as image data.
  • the outer wall surface 231 at least on the distal end side of the connecting wall 23 is the arc-shaped outer wall surface 213 of the first shaft portion 21 and the arc-shaped outer wall surface 223 of the second shaft portion 22.
  • the connecting wall 23 is provided at least on the base end side of the first shaft portion 21, and the reinforcing member 24 is embedded on the base end side of the connecting wall 23. Therefore, the rigidity on the proximal end side of the shaft portion 2 can be improved, and the rigidity on the proximal side of the medical device 1 can be improved.
  • the connecting walls 23 are provided in pairs on both sides across the line CL connecting the centers of the first shaft portion 21 and the second shaft portion 22, and the reinforcing members 24 are provided in the paired connecting walls 23, respectively. It is configured to be able to. Therefore, the rigidity of the shaft portion 2 that is symmetric in the cross section of FIG. 4D and the like can be improved evenly on the left and right, and the medical device 1 can be satisfactorily introduced into the living body.
  • the reinforcing member 24 is provided so as not to protrude between the outer wall surface 231 of the connection wall 23, the inner wall surface 214 of the first shaft portion 21, and the inner wall surface 224 of the second shaft portion 22. Thereby, it is possible to suppress an increase in the outer shape of the shaft portion 2 and to suppress a decrease in the cross section of the guide wire lumen 221 and the image lumen 211.
  • the connecting wall 23 is configured such that the outer wall surface 232 of the connecting wall 23 on the proximal end side projects outward from the outer wall surface 231 on the distal end side.
  • the lumen of the body tends to have a smaller cross section as the distal portion of the device is introduced into the peripheral region. Therefore, by configuring as described above, it is possible to more effectively improve the rigidity on the base end side while suppressing an increase in the size on the front end side for forming an image.
  • the reinforcing member 24 is configured such that the cross section increases from the distal end side to the proximal end side in accordance with the positions of the outer wall surfaces 231 and 232. . Therefore, it is possible to prevent the reinforcing member 24 from protruding from the connecting wall 23 and an excessively large cross section of the shaft portion 2 or a small cross section of the guide wire lumen 221 or the image lumen 211 from the distal end side to the proximal end side. Stiffness can be increased gradually.
  • the imaging core 4 can acquire a cross-sectional image at a desired position in the living body by being capable of moving back and forth in the longitudinal direction of the first shaft portion 21.
  • 10 (A) and 10 (B) are cross-sectional views showing a modification of the shaft portion at the position shown in FIG. 4 (D).
  • the present invention is not limited to this.
  • the medical device has a reinforcing member 24a having a substantially triangular cross section as shown in FIG. It may be configured. Further, as shown in FIG. 10B, the medical device does not have an acute corner like the apex of the triangle of FIG. 10A in the cross section, and is adjacent to the image lumen 211 and the guide wire lumen 221. You may comprise so that the surface may have the reinforcement member 24b provided with a shape like a circular arc.
  • the embodiment has been described in which two reinforcing members 24 are provided on both sides with a line CL connecting the centers of the first shaft portion 21 and the second shaft portion 22 as a boundary.
  • the present invention is not limited to this, and two or more reinforcing members may be provided as long as they do not protrude from the outer shape of the shaft portion 2 on the distal end side and do not protrude from the guide wire lumen 221 and the image lumen 211.
  • the embodiment has been described in which the reinforcing member 24 is provided from the base end side of the shaft portion 2 to the base end side from the position where the imaging core 4 is most retracted at the time of image acquisition.
  • the present invention is not limited to this, and the reinforcing member 24 may be provided from the proximal end side of the shaft portion 2 to the distal end side from the position where the imaging core 4 is most retracted.
  • the imaging core 4 is movable in the longitudinal direction in the image lumen 211 of the first shaft portion 21 .
  • the present invention is not limited to this, and the imaging core may not be moved in the longitudinal direction but may be rotated in the circumferential direction to acquire a cross-sectional image.
  • the medical device 1 acquires a cross-sectional image using intravascular ultrasound diagnosis (IVUS) has been described.
  • IVUS intravascular ultrasound diagnosis
  • the present invention is not limited to this, and devices such as an optical coherence tomography diagnostic device (OCT: Optical Coherence Tomography) and an optical frequency domain imaging diagnostic device (OFDI: Optical Frequency Domain Imaging) are used to acquire cross-sectional images. It is also possible to apply.
  • OCT optical coherence tomography diagnostic device
  • OFDI optical frequency domain imaging diagnostic device
  • 1 medical device 2 shaft part, 21 1st shaft part, 211 Lumen for images, 212, 213, 222, 223 outer wall surface, 214, 224 inner wall surface, 22 Second shaft portion, 221 guide wire lumen, 23 connecting wall, 231 outer wall surface (outer wall), 232 the wall surface (protruding outer wall), 24, 24a, 24b reinforcing members, 3 Operation part, 4 Imaging core, 41 vibrator unit, 42 drive shaft, 5 Hub, 51 1st hub part, 52 second hub part, 53 Hub casing, 541 Wall, CL line connecting the center of the first shaft portion and the second shaft portion, W Guide wire.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Physics & Mathematics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

La présente invention a pour but de fournir un dispositif médical qui améliore la rigidité du dispositif sur son côté extrémité de base, tout en supprimant une augmentation de la taille de la forme extérieure du dispositif. Pour atteindre ce but, l'invention porte sur un dispositif médical (1) équipé d'une section arbre (2) qui présente : une première partie arbre (21) équipée d'une lumière d'imagerie (211) dans laquelle un noyau d'imagerie (4), destiné à l'acquisition d'informations d'image dans un organisme vivant, est inséré ; une seconde partie arbre (22), disposée de façon à être adjacente à la première partie arbre et équipée d'une lumière de fil-guide (221) dans laquelle un fil-guide (W) peut être inséré ; une paroi de liaison (23) formée entre les première et seconde parties arbre sur au moins le côté extrémité de base de la première partie arbre ; un élément de renfort (24) incorporé dans la paroi de liaison le long d'au moins le côté extrémité de base de la paroi de liaison. La paroi de liaison présente une surface de paroi externe (231) reliant de manière tangentielle les surfaces de parois externes arquées des première et seconde parties arbre le long d'au moins le côté extrémité de pointe de ces dernières.
PCT/JP2017/001603 2016-02-29 2017-01-18 Dispositif médical Ceased WO2017149974A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2018502566A JP6823043B2 (ja) 2016-02-29 2017-01-18 医療用デバイス

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016038230 2016-02-29
JP2016-038230 2016-02-29

Publications (1)

Publication Number Publication Date
WO2017149974A1 true WO2017149974A1 (fr) 2017-09-08

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Family Applications (1)

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PCT/JP2017/001603 Ceased WO2017149974A1 (fr) 2016-02-29 2017-01-18 Dispositif médical

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JP (1) JP6823043B2 (fr)
WO (1) WO2017149974A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020075278A1 (fr) * 2018-10-11 2020-04-16 朝日インテック株式会社 Tube multi-lumière à usage médical et son procédé de production
JP2024037226A (ja) * 2022-09-07 2024-03-19 朝日インテック株式会社 カテーテル

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JP2004097286A (ja) * 2002-09-05 2004-04-02 Terumo Corp カテーテル
JP2007520281A (ja) * 2004-01-29 2007-07-26 イコス コーポレイション 小血管用超音波カテーテル
JP2011072401A (ja) * 2009-09-29 2011-04-14 Fujifilm Corp 光プローブ及び内視鏡装置
US20130331706A1 (en) * 2012-06-12 2013-12-12 Volcano Corporation Devices, Systems, and Methods for Forward Looking Imaging

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004097286A (ja) * 2002-09-05 2004-04-02 Terumo Corp カテーテル
JP2007520281A (ja) * 2004-01-29 2007-07-26 イコス コーポレイション 小血管用超音波カテーテル
JP2011072401A (ja) * 2009-09-29 2011-04-14 Fujifilm Corp 光プローブ及び内視鏡装置
US20130331706A1 (en) * 2012-06-12 2013-12-12 Volcano Corporation Devices, Systems, and Methods for Forward Looking Imaging

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020075278A1 (fr) * 2018-10-11 2020-04-16 朝日インテック株式会社 Tube multi-lumière à usage médical et son procédé de production
JPWO2020075278A1 (ja) * 2018-10-11 2021-09-02 朝日インテック株式会社 医療用のマルチルーメンチューブ、および、その製造方法
JP7049475B2 (ja) 2018-10-11 2022-04-06 朝日インテック株式会社 医療用のマルチルーメンチューブ、および、その製造方法
US12186495B2 (en) 2018-10-11 2025-01-07 Asahi Intecc Co., Ltd. Medical multi-lumen tube and method for producing the same
JP2024037226A (ja) * 2022-09-07 2024-03-19 朝日インテック株式会社 カテーテル
JP7762635B2 (ja) 2022-09-07 2025-10-30 朝日インテック株式会社 カテーテル

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JPWO2017149974A1 (ja) 2019-01-10

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