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WO2014073420A1 - Catheter - Google Patents

Catheter Download PDF

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Publication number
WO2014073420A1
WO2014073420A1 PCT/JP2013/079270 JP2013079270W WO2014073420A1 WO 2014073420 A1 WO2014073420 A1 WO 2014073420A1 JP 2013079270 W JP2013079270 W JP 2013079270W WO 2014073420 A1 WO2014073420 A1 WO 2014073420A1
Authority
WO
WIPO (PCT)
Prior art keywords
imaging unit
balloon
catheter
main body
inner tube
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/JP2013/079270
Other languages
French (fr)
Japanese (ja)
Inventor
泰佳 中野
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
Publication of WO2014073420A1 publication Critical patent/WO2014073420A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G02—OPTICS
    • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B23/00—Telescopes, e.g. binoculars; Periscopes; Instruments for viewing the inside of hollow bodies; Viewfinders; Optical aiming or sighting devices
    • G02B23/24—Instruments or systems for viewing the inside of hollow bodies, e.g. fibrescopes
    • G02B23/2476—Non-optical details, e.g. housings, mountings, supports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/233—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the nose, i.e. nasoscopes, e.g. testing of patency of Eustachian tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00096—Optical elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00163—Optical arrangements
    • A61B1/00174—Optical arrangements characterised by the viewing angles
    • A61B1/00179—Optical arrangements characterised by the viewing angles for off-axis viewing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/24—Surgical instruments, devices or methods for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible

Definitions

  • the present invention relates to a catheter having at least a balloon.
  • Patent Document 1 discloses an endoscope system including an endoscope and a balloon catheter.
  • the balloon is provided at the distal end portion of the catheter.
  • the lens portion of the endoscope is disposed on the proximal end side of the balloon. Yes.
  • the imaging device is also required to have a function of searching for a target site such as a natural mouth at the tip of the device.
  • the observation window is arranged at the proximal end portion of the balloon as in Patent Document 1
  • the balloon becomes an obstacle, and the visual field formation of the target portion such as the natural mouth cannot be performed clearly. There's a problem.
  • the present invention has been invented to solve the above-described problems, and can visually recognize the positional relationship between the balloon and the stenosis, and can clearly form a front visual field through which the catheter enters. It is an object to provide a catheter that can be used.
  • a catheter according to the present invention that achieves the above-described object includes an expandable expansion body, a long and hollow main body portion to which the expansion body is attached at the distal end, and a forward and backward movement along the longitudinal direction of the main body portion inside the main body portion.
  • An imaging unit that is movably disposed.
  • the main body has an observation window for observing the direction in which the imaging unit is directed, and the imaging unit is capable of moving back and forth at least from the base end side to the distal end side beyond the expansion body. It is a feature.
  • FIG. 4 is a cross-sectional view showing an inner tube constituting the main body at the position of line 4-4 in FIG.
  • FIGS. 5A to 5D are views showing a state where the balloon is viewed from the observation window.
  • FIG. 1 is a diagram showing a schematic configuration of an expansion system including a catheter according to Embodiment 1 of the present invention
  • FIG. 2 is a cross-sectional view showing a state where an imaging unit constituting the catheter is arranged at a distal end portion
  • FIG. 5 is a cross-sectional view showing a state in which the imaging unit constituting the lens is disposed at the proximal end portion of the balloon or the insertion portion of the balloon in the inner tube constituting the main body portion.
  • 4 is a cross-sectional view showing the inner tube constituting the main body at the position of line 4-4 in FIG.
  • the dilation system 10 of the first embodiment used for dilatation of the sinus natural mouth constricted by sinusitis has a catheter 100 that can be inserted into the natural mouth.
  • the expansion system 10 includes a pressure supply unit 200, a light source 300, and a display unit 400 connected to the catheter 100.
  • the pressure supply means 200 communicates with the outer tube 121 constituting the main body 120 which is a component of the catheter 100, and a liquid such as physiological saline or a contrast agent or a gas such as helium is passed through the outer tube 121 to the distal end of the outer tube 121. It supplies to the balloon 110 which comprises the catheter 100 connected. The balloon 110 is expanded by supplying a liquid or gas to be filled into the balloon 110 and contracted by suction.
  • the pressure supply means 200 is, for example, an indeflator, a syringe, or a pump, but is not limited thereto.
  • the light source 300 generates light emitted from the irradiation unit 142 that is a component of the catheter 100 provided at the distal end of the imaging unit 141 that is a component of the catheter 100.
  • the light generated by the light source 300 is guided to the irradiation unit 142 by the optical fiber 143 that is a component of the catheter 100 disposed inside the catheter.
  • the display unit 400 displays video information or image information acquired by the imaging unit 141 attached to the distal end portion of the camera catheter 140 that is a constituent element of the catheter 100.
  • the display means 400 is, for example, a monitor part of a PC (personal computer).
  • the catheter 100 includes an expandable balloon (expanded body) 110, a long main body 120 to which the balloon 110 is attached to a distal end portion, and a longitudinal direction of the main body 120 within the main body 120. And an imaging unit 141 arranged so as to be movable forward and backward.
  • the imaging unit 141 can move at least from the proximal end portion 126 of the balloon 110 to the distal end portion 130 of the balloon 110.
  • the imaging unit 141 is attached to the distal end of the camera catheter 140.
  • the balloon 110 is configured to be transparent in this embodiment so that the positional relationship between the balloon 110 and the narrowed natural mouth can be confirmed from the inside of the balloon 110 when expanded.
  • the balloon 110 is made of various resin materials. More specifically, polytetramethylene adipamide (nylon 46), polycaprolactam (nylon 6), polyhexamethylene adipamide (nylon 66), polyhexamethylene sebamide (nylon 610), polyhexamethylene dodeca Homopolymers such as imide (nylon 612), polyundecanolactam (nylon 11), polydodecanolactam (nylon 12), caprolactam / lauryl lactam copolymer (nylon 6/12), caprolactam / aminoundecanoic acid copolymer Polymer (nylon 6/11), caprolactam / ⁇ -aminononanoic acid copolymer (nylon 6/9), caprolactam / hexamethylene diammonium adip
  • polyalkylene A nylon elastomer that is a block copolymer having a soft segment of glycol, polyether, aliphatic polyester, or the like can be used. Among these, it is preferable to have high pressure resistance so as not to rupture when expanded.
  • it may be formed of polyamide, polyethylene terephthalate, high-density polyethylene, or the like.
  • the main body 120 has an outer tube 121 and an inner tube 122.
  • the outer tube 121 is a hollow tube, and the balloon 110 is attached to the outer periphery of the tip so as to communicate with the balloon 110.
  • the outer tube 121 is made of a metal having rigidity such as stainless steel, but is not limited thereto. It may be made of an elastic metal such as a nickel titanium alloy, or may have a structure in which flexibility is increased by processing grooves or the like in stainless steel, or a hard resin material may be used.
  • the base end portion 126 of the balloon 110 in the outer tube 121 is formed as an observation window 123 (corresponding to an observation window) with a transparent material such as polypropylene.
  • the type of the observation window is not limited as long as it is transparent, and it may be made of a flexible material such as silicone as well as a hard member such as glass.
  • the inner tube 122 is a hollow member capable of moving a medical instrument such as a camera catheter 140 with the imaging unit 141 attached to the tip thereof in the longitudinal direction.
  • the inner tube 122 is inserted through the inside of the balloon 110 attached to the tip of the outer tube 121 as shown in FIG. 2, and is joined to the balloon 110 by fusion or the like at the tip of the balloon 110.
  • the base end portion 126 of the balloon 110 in the inner tube 122 is made of a transparent material such as polypropylene so that the imaging unit 141 disposed inside the inner tube 122 can visually recognize the balloon 110. Equivalent to a window).
  • the insertion portion 127 of the balloon 110 in the inner tube 122 is formed as an observation window 125 (corresponding to another observation window).
  • protrusions 131 to 134 are formed on the inner surface of the inner tube 122 so that the imaging unit 141 can be arranged and held at a fixed position.
  • the protrusions 131 to 134 incline the imaging unit 141 attached to the distal end of the camera catheter 140 from the axis of the inner tube 122 toward the imaging target.
  • the protrusions 131 to 134 the protrusions 131 and 132 are provided at the proximal end 126 of the balloon 110 in the inner tube 122, and the protrusions 133 and 134 (corresponding to other protrusions) are inserted into the balloon 110 in the inner tube 122.
  • the protrusions 131 to 134 are arranged in pairs on the inner surface of the inner tube 122 in the circumferential direction, for example, at intervals of 180 degrees.
  • the protrusions 131 to 134 are not located at the same position in the longitudinal direction as shown in FIGS. 2 and 3, but are separated by a predetermined distance so that the tip of the imaging unit 141 can be held in an inclined state with respect to the axis of the inner tube 122.
  • the arrangement interval and the number of the protrusions 131 to 134 are not limited to the above, and for example, four positions may be provided every 90 degrees.
  • the outer tube 121 and the inner tube 122 are provided with observation windows 123, 124, and 125, and the protrusions 131 to 134 are formed on the inner surface of the inner tube 122, so that the imaging unit 141 is inclined. Is held in a state where As a result, if the imaging unit 141 is held in an inclined state by the protrusions 131 and 132 at the positions of the observation windows 123 and 124 (see the solid line-shaped imaging unit in FIG. 3), the imaging unit 141 is a balloon in the inner tube 122.
  • the outer surface of the balloon 110 located outside the inner tube 122 and the outer tube 121 can be observed from the base end portion 126 of 110. Therefore, if the narrowed natural mouth is located in the vicinity of the balloon 110, the positional relationship between the balloon 110 and the constricted portion can be confirmed and the position can be adjusted.
  • the imaging unit 141 may be the balloon 110 in the inner tube 122.
  • the state of contact between the balloon 110 and the narrowed natural mouth can be observed from the insertion portion 127 of the lens. Therefore, it can be confirmed that the balloon 110 is arranged so that the natural mouth can be expanded, and that the natural mouth is surely expanded by the balloon 110.
  • the shape of the protrusions 131 to 134 is desirably formed so as to match the side shape of the imaging unit 141.
  • the outer surface of the camera catheter 140 to which the imaging unit 141 is attached is formed in a cylindrical shape so that it can be easily inserted into the inner tube 122 or the like.
  • the protrusions 131 to 134 may form a concave curved surface at the part of the camera catheter 140 that contacts the imaging unit 141.
  • the imaging unit 141 can be directed in a desired direction while being stably held by the protrusions 131 to 134.
  • the imaging unit 141 is also disposed at the tip 130 of the balloon 110 as shown in FIG. Therefore, when the camera catheter 140 is pushed from the longitudinal direction proximal end side to the distal end side or from the distal end side to the proximal end side with a force of a certain level or more, the protrusions 131 to 134 are deformed so as to be crushed radially outward. The hardness of the protrusions 131 to 134 is adjusted so that 140 can move in the longitudinal direction.
  • a hub 161 is connected to the base end of the main body 120.
  • a holder 163 is attached to the hub 161, and an elastic member 162 is disposed between the hub 161 and the holder 163.
  • the hub 161 has a lumen 164, a recess 165, and a male screw 166.
  • the holder 163 has a female screw 167 and a protrusion 168.
  • the lumen 164 communicates with the outer tube 121 on the distal end side, and communicates with the pressure supply means 200 on the proximal end side.
  • the liquid or gas that expands the balloon 110 passes through the lumen 164 and the outer tube 121 and is supplied to the balloon 110, and passes through the outer tube 121 and the lumen 164 from the balloon 110 and is discharged to the pressure supply means 200.
  • Base ends of the outer tube 121 and the inner tube 122 are sealed with the hub 161 in a liquid-tight or air-tight manner.
  • the recess 165 is formed on the proximal end side of the hub 161.
  • the elastic member 162 is formed in an annular shape and is inserted into the recess 165 of the hub 161.
  • a camera catheter 140 or the like disposed inside the inner tube 122 can be inserted into the elastic member 162.
  • the female screw 167 provided on the holder 163 is tightened by the male screw 166 provided on the hub 161. Thereby, the protrusion 168 presses the elastic member 162 disposed between the hub 161 and the holder 163 in the longitudinal direction.
  • the male screw 166 and the female screw 167 are operated so as to loosen the tightening of the hub 161 and the holder 163, the amount of expansion of the elastic member 162 in the radial direction is reduced by the amount of the pressure on the elastic member 162 by the protrusion 168 weakening. Decrease (shrink). Therefore, the holding force of the camera catheter 140 by the elastic member 162 is weakened, and the fixation of the camera catheter 140 is released.
  • the hub 161 and the holder 163 are made of a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer.
  • the elastic member 162 is made of, for example, silicone rubber or latex rubber.
  • the camera catheter 140 is disposed inside the inner tube 122 through the hub 161, the elastic member 162, and the holder 163.
  • the camera catheter 140 has an imaging unit 141 attached to the tip.
  • the imaging unit 141 includes an irradiation unit 142, a lens 144, an imaging device 145, a cable 146, and an optical fiber 143.
  • the irradiation unit 142 supplies light supplied from the light source 300 through the optical fiber 143 toward the imaging target.
  • the image sensor 145 detects visible light from the lens 144 and acquires an image.
  • the image sensor 145 is, for example, a CCD image sensor or a CMOS image sensor, but is not limited thereto.
  • the cable 146 transmits the image information or video information acquired by the imaging unit 141 to the display unit 400.
  • image information acquired at the distal end may be imaged by a CCD image sensor or a CMOS image sensor on the proximal end side using an image fiber.
  • FIG. 5A to 5D are views showing a state where a balloon is observed from the observation window
  • FIG. 6 is a view showing a state where the catheter according to the first embodiment enters the nasal cavity
  • 7 is a view showing a state in which the catheter is aligned with a narrowed natural mouth in the nasal cavity
  • FIG. 8 is a view showing a state in which the narrowed natural mouth in the nasal cavity is expanded by the catheter
  • FIG. It is a figure which shows the state which extracted from the nasal cavity.
  • contraction process which shrink
  • recovery process which collect
  • the imaging unit 141 is disposed at the distal end portion 130 of the balloon 110 in the inner tube 122 at the time of starting the procedure, and the position in the longitudinal direction is fixed by the hub 161, the elastic member 162, and the holder 163.
  • the operator advances the catheter 100 inserted into the nasal cavity N into the natural mouth E as shown in FIG.
  • the state of the imaging range can be visually recognized.
  • the video or image acquired by the imaging unit 141 is displayed on the display unit 400.
  • the surgeon advances the catheter 100 to the natural mouth E while confirming the image and the like, and inserts and arranges the balloon 110 into the natural mouth E as shown in FIG.
  • the visual recognition process is performed at a stage where the catheter 100 can be approached to the vicinity of the narrowed natural mouth E.
  • the operator loosens the tightening by the hub 161 and the holder 163 in the visual recognition process, and makes the camera catheter 140 movable in the longitudinal direction.
  • the surgeon pulls the imaging unit 141 toward the proximal end while checking the display unit 400 and moves it to the observation windows 123 and 124 or the observation window 125.
  • the imaging unit 141 passes through the projections 131 and 132 or the projections 133 and 134, the surgeon uses resistance on the hand side that the imaging unit 141 deforms the projections 131 and 132 or the projections 133 and 134. Therefore, the position of the imaging unit 141 can be recognized tactilely.
  • the operator may recognize the position of the imaging unit 141 by providing a scale on the proximal end side of the camera catheter 140.
  • the imaging unit 141 When the camera catheter 140 is moved and the imaging unit 141 is positioned at the protrusions 131 and 132, the imaging unit 141 is disposed at the proximal end 126 of the balloon 110 in the inner tube 122. In addition, when the imaging unit 141 is positioned at the protrusions 133 and 134, the imaging unit 141 is disposed in the insertion portion 127 of the balloon 110 in the inner tube 122.
  • the imaging unit 141 is rotated in the circumferential direction so that the imaging unit 141 is aligned with the observation windows 123 and 124 or the observation window 125. If the imaging unit 141 is directed toward the observation windows 123 and 124, as shown in FIG. 5A, a video or an image from the proximal end side to the distal end side of the balloon 110 can be acquired. The position of the balloon 110 and the natural mouth E can be adjusted.
  • the imaging unit 141 is directed to the observation window 125, it is possible to acquire a video or image directed radially outward from the inner tube 122, and whether the balloon 110 is arranged so that the narrowed natural mouth E can be expanded. Can be confirmed.
  • the observation window 125 is formed in the center in the longitudinal direction in the insertion portion 127 of the balloon 110, the center of the balloon 110 cannot be disposed in the vicinity of the narrowed natural mouth E as shown in FIG.
  • the position of the balloon 110 is adjusted while confirming the positional relationship between the balloon 110 and the narrowed natural mouth E by the display means 400.
  • the balloon 110 is expanded by the pressure supply means 200 in the expansion process.
  • the narrowed natural mouth E is expanded so that the pus accumulated on the back side of the natural mouth E can be removed.
  • the balloon 110 is deflated in the contraction process as shown in FIG. 5C, the catheter 100 is removed from the nasal cavity N as shown in FIG. 9 in the recovery process, and a separate suction tube is connected to the sinus cavity.
  • Recovery may be performed by inserting the camera catheter 140 into the inside, or the camera catheter 140 may be removed from the inner tube 122 of the balloon 110 and used as a suction lumen.
  • a suction pump or the like (not shown) is connected to the proximal end portion of the inner tube, and suction is performed.
  • a medical instrument equipped with an imaging unit In the expansion of a narrowed natural mouth, which is performed in the treatment of sinusitis, a medical instrument equipped with an imaging unit is inserted into a living body, and the natural mouth is expanded by a balloon or the like.
  • a medical instrument When a medical instrument is advanced to a natural mouth, it is necessary to attach an imaging unit to the tip of the medical instrument and grasp the medical instrument entry position.
  • the imaging unit captures the front of the medical instrument, the natural mouth cannot be accurately expanded by the balloon unless the positional relationship between the balloon and the natural mouth can be grasped.
  • the catheter 100 has a distal end portion that extends from the proximal end portion 126 of the balloon 110 beyond the balloon 110 along the longitudinal direction of the main body portion 120 inside the inner tube 122 constituting the main body portion 120.
  • An imaging unit 141 that can move forward and backward up to 130 is arranged.
  • the outer tube 121 and the inner tube 122 constituting the main body 120 have observation windows 123 and 124 for observing the direction in which the imaging unit 141 is directed.
  • the imaging unit 141 is disposed at the distal end portion 130 of the balloon 110 in the inner tube 122 that constitutes the main body unit 120, the front of the catheter 100 in the entry direction can be grasped.
  • the imaging unit 141 is disposed at the proximal end 126 of the balloon 110 in the inner tube 122 constituting the main body 120, the outer surface of the balloon 110 can be observed from the position through the observation windows 123 and 124. The positional relationship with the natural mouth E can be grasped. Therefore, since both the positional relationship between the balloon 110 and the natural mouth E and the forward direction in which the catheter 100 is advanced can be grasped, a procedure for expanding the natural mouth E can be performed accurately and quickly.
  • the catheter 100 includes the expandable balloon 110, the long and hollow main body 120 to which the balloon 110 is attached at the tip, and the main body 120 within the main body 120.
  • an imaging unit 141 arranged to be movable back and forth from the proximal end 126 of the balloon 110 to the distal end 130 beyond the balloon 110 along the longitudinal direction, and an outer tube 121 and an inner tube constituting the main body 120
  • Reference numeral 122 has observation windows 123 and 124 for observing the direction in which the imaging unit 141 is directed.
  • the imaging unit 141 forward and backward from the proximal end portion 126 of the balloon 110 to the distal end portion 130 beyond the balloon 110, the positional relationship between the balloon 110 and the natural mouth E is changed at the proximal end portion 126 through the observation windows 123 and 124.
  • the distal end portion 130 can observe the state in front of the approach direction in which the catheter 100 is advanced, and a procedure such as expanding the natural mouth E can be quickly performed.
  • the inner tube 122 constituting the main body 120 has protrusions 131 and 132 that hold the imaging unit 141 tilted toward the observation windows 123 and 124 at the proximal end 126 that is proximal to the balloon 110.
  • the observation windows 123 and 124 are provided in the proximal end portion 126 which is the proximal end side of the balloon 110 in the inner tube 122 constituting the main body portion 120.
  • the imaging unit 141 tilted toward the observation windows 123 and 124 by the projections 131 and 132, even on a camera with a relatively narrow viewing angle, the surface of the balloon 110 can be seen from the base end side of the balloon 110. The state can be confirmed, and the position of the balloon 110 and the natural mouth E can be adjusted.
  • the balloon 110 is transparent, and the inner tube 122 constituting the main body 120 has an insertion portion 127 through which the balloon 110 is inserted, and an observation window 125 for observing the direction in which the imaging unit 141 is directed at the insertion portion 127. ,have. Furthermore, the inner tube 122 has projections 133 and 134 that hold the imaging unit 141 tilted toward the observation window 125 in the insertion portion 127.
  • the imaging unit 141 tilted toward the observation window 125 by the projections 133 and 134, the situation of the living body located outside the balloon 110 can be visually recognized even with a camera with a narrow viewing angle. it can. Therefore, if the natural mouth E is located in the vicinity of the balloon 110, it can be confirmed whether the balloon 110 is disposed at a position where the narrowed natural mouth E can be expanded.
  • the protrusions 131 and 132 or the protrusions 133 and 134 are provided in pairs inside the inner tube 122 and are spaced apart in the longitudinal direction. Therefore, when the imaging unit 141 is tilted from the longitudinal direction, the imaging unit 141 can be pressed from two directions as well as from one direction to be held more firmly. Therefore, even when the distance between the imaging unit 141 and the inner wall of the inner tube 122 is relatively large, imaging can be performed while the imaging unit 141 is tilted in a desired direction and held more firmly.
  • the projecting parts 131 and 132 and the projecting parts 133 and 134 are formed in a concave curved surface at the contact portion with the imaging unit 141 in the camera catheter 140.
  • the camera catheter 140 to which the imaging unit 141 is attached is often formed with a cylindrical outer surface so that it can be easily inserted into the inner tube 122 or the like. Therefore, by forming the contact portions of the projections 131 to 134 with the imaging unit 141 into a concave curved surface, the projection unit 131 can be oriented in a desired direction while holding the imaging unit 141 more stably.
  • FIG. 10 is an enlarged cross-sectional view showing the vicinity of the balloon of the catheter according to the second embodiment.
  • the protrusions 131 to 134 are provided on the inner surface of the inner tube 122 constituting the main body 120, and the imaging unit 141 is held in an inclined state.
  • the imaging unit 141 is oriented as follows. May be.
  • symbol is attached
  • the protrusions 131 to 134 are provided on the inner surface of the inner tube 122 constituting the main body 120, but also the protrusions 131 and 133 on the outer surface of the distal end portion of the camera catheter 140 to which the imaging unit 141 is attached.
  • An engaging portion 147 is provided for engaging with.
  • the engaging portion 147 is provided at a part of the outer periphery of the side surface at the distal end portion of the camera catheter 140.
  • the engaging portion 147 is a protrusion.
  • 131 or the protrusion 133 is provided at a position to be engaged.
  • the engaging portion 147 may be provided with one or a plurality of protrusions having a fan-shaped cross section on the outer periphery of the distal end portion of the camera catheter 140 so as to contact the protrusions 131 and 133 on the outer periphery of the distal end portion of the camera catheter 140.
  • one or a plurality of protrusions having a polygonal cross section may be provided in the same part.
  • the engaging portion 147 on the outer periphery of the distal end portion of the camera catheter 140 to which the imaging unit 141 is attached, the protruding portion 131 or the protruding portion 133 and the engaging portion 147 are engaged in the longitudinal direction.
  • the holding position is difficult to shift in the longitudinal direction. Therefore, it is possible to more accurately grasp the positional relationship between the balloon 110 and the narrowed natural mouth E from the observation windows 123 and 124 or the observation window 125 by holding the imaging unit 141 more accurately at a desired position.
  • the catheter 100a according to the second embodiment is engaged with the protrusion 131 or the protrusion 133 of the inner tube 122 constituting the main body 120 at the distal end portion of the camera catheter 140 to which the imaging unit 141 is attached.
  • a portion 147 is provided. Therefore, the engaging portion 147 makes the holding position of the imaging unit 141 by the protrusions 131 and 132 or the protrusions 133 and 134 more difficult to shift in the longitudinal direction. Therefore, the positional relationship between the balloon 110 and the narrowed natural mouth E can be better understood from the observation windows 123 and 124 or the observation window 125.
  • Embodiment 1 the embodiment has been described in which the protrusions 131 to 134 are provided as a pair and spaced apart in the longitudinal direction, but the present invention is not limited to this. If the imaging unit 141 can be fixed, as shown in FIG. 11, the projection 132 is not provided, the projection 131 is provided at the proximal end 126 of the balloon 110 in the inner tube 122, the projection 134 is not provided, and the projection 133 is provided. You may make it provide in the insertion part 127 of the balloon 110. FIG.
  • protrusions are provided at the two locations of the proximal end portion 126 of the balloon and the insertion portion 127 of the balloon in the inner tube 122, any one may be provided.
  • a protruding portion 148 that protrudes radially outward due to the tilted reaction may be formed in a portion closer to the proximal end than the imaging unit 141, as shown in FIG. .
  • the imaging unit 141 is disposed on the protrusions 131 and 132, and in the vicinity of the protruding portion 148 when tilted toward the observation window 128, a protruding hole is provided. 135 may be provided.
  • the main body may be a single tube 137 instead of a double tube, and a tube 138 for expanding the balloon 110 may be connected to the balloon 110 separately from the main body 120.
  • the balloon 110 and the like can be imaged from the observation window 128 by tilting the imaging unit 141 disposed inside the single tube 137 while ensuring expansion of the balloon 110.
  • the projecting hole is formed inside the balloon 110 in the longitudinal direction of the single tube 137, a portion of the projecting hole is prevented so that the fluid filled in the balloon 110 does not leak from the projecting hole to the inner lumen of the inner tube 122.
  • a film-like soft member such as polyethylene, the airtightness of the balloon 110 can be secured, and the movable range of the protruding portion 148 of the imaging unit 141 can be expanded.
  • the imaging unit 141 is inclined even when the imaging unit 141 is substantially parallel to the axis of the main body 120. Can be imaged.
  • observation windows 123 to 125 are provided in the main body 120, and the projections may not be provided.
  • the observation is not performed directly from the observation windows 123 and 124 by the imaging unit 141, but is shown in FIG.
  • the image may be observed indirectly through an optical element 139 such as a lens, a mirror, or a prism.
  • an optical element 149 such as a mirror is attached to the imaging unit 141, and the balloon 110 is interposed via the optical element 149 in a state where the imaging unit 141 is disposed at the distal end portion 130 of the balloon 110 in the inner tube 122 as shown in FIG. May be observed.
  • the engaging unit 147 is a protrusion on the outer periphery of the distal end when the imaging unit 141 is tilted toward the observation windows 123 and 124 or the observation window 125.
  • the embodiment provided at the position where it abuts on 131 or the protrusion 133 has been described.
  • the protrusion is formed on the entire inner surface of the inner end 122 of the balloon 110 and the insertion portion 127 in the inner tube 122.
  • the joint portion may be provided all around the distal end portion of the imaging unit 141.
  • the embodiment has been described in which the protrusions 131 to 134 are formed in a concave curved surface as shown in FIG. 4 so that the contact portion with the imaging unit 141 is formed so as to match the outer surface of the imaging unit 141.
  • the shape may not match the shape of the outer surface of the imaging unit 141, for example, as a convex shape.
  • mucus such as runny nose from the living body may adhere to the observation window 123 of the outer tube 121. Therefore, water is supplied to the observation window 123 separately from the catheter 100, or a brush or the like is attached to the distal end portion. Thus, a catheter having a function of cleaning the observation window 123 may be disposed to clean the observation window 123.
  • the object to be imaged by the imaging unit 141 is not limited to the vicinity of the sinuses.
  • the inner wall or branching portion of a blood vessel, an artificial blood vessel, or a trachea may be observed, or plaque formed on the blood vessel wall may be observed to determine whether the color is stable or unstable.
  • CTO chronic total occlusion
  • the position of the microchannel, the position of the stent strut, the state of the heart valve, the insertion state of the coil into the aneurysm the drug when the drug is applied to the balloon surface It is also possible to observe a situation where the action acts on the in vivo tissue.
  • the balloon 110 has a function of expanding the stenosis, but various characteristics other than the above can be imparted.
  • the surface of the balloon may be subjected to a process of cutting a stenotic tissue (calcified lesions such as calcified lesions, plaques, blood clots, etc.).
  • the ablation treatment may be performed by using the balloon 110 as a hot balloon. In this case, it is possible to confirm the treatment unit that has performed the ablation treatment by the imaging unit 141.
  • non-compliant balloons and semi-compliant balloons are used for the balloon material, or a plurality of balloons are used, for example, as a guide for blood flow disruption or instrument insertion.
  • a stent / filter or the like disposed in the stenosis portion by expansion may be adhered to the balloon surface, and the balloon may be deflated and recovered.

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Abstract

Provided is a catheter such that positioning at a stenosis can be performed while observing a balloon, and such that the formation of a field of view in the anterior direction of catheter ingress can be performed in a clear manner. The catheter has: an expanding body (110) that can expand; an elongated, hollow main body (120) to the tip of which the expanding body is attached; and an imaging unit (141) disposed in a manner able to advance and retreat along the lengthwise direction of the main body within the main body. The imaging unit can advance and retreat at least from the base end side (126) of the expanding body to the tip end side (130) beyond the expanding body, and the main body has observation windows (123, 124) for observing the direction in which the imaging unit is oriented.

Description

カテーテルcatheter

　本発明は、少なくともバルーンを有するカテーテルに関する。 The present invention relates to a catheter having at least a balloon.

　鼻腔に隣接する骨内空洞である副鼻腔で生じる副鼻腔炎では、鼻腔と副鼻腔とを結ぶ自然口と呼ばれる部位が狭窄しているため、バルーンを有するカテーテルを用いて狭窄部を拡張する手技が行われている。当該手技ではバルーンが狭窄部に位置していることを確認する必要があるため、手技の際に硬性鏡等を用いてバルーンと狭窄部との位置関係を確認している。硬性鏡等の撮像素子がカテーテルと別体である場合、術者は両手を用いて操作をしなければならないため、撮像素子は小型化され、カテーテルに搭載された状態で使用できることが望ましい。特許文献１には、内視鏡とバルーンカテーテルを備えた内視鏡システムが開示されている。特許文献１においてバルーンはカテーテルの先端部に設けられている。 In sinusitis that occurs in the paranasal sinus that is the intraosseous cavity adjacent to the nasal cavity, the part called the natural mouth that connects the nasal cavity and the sinus cavity is narrowed, so a technique to expand the stenosis using a catheter with a balloon Has been done. In this procedure, since it is necessary to confirm that the balloon is located in the stenosis, the positional relationship between the balloon and the stenosis is confirmed using a rigid endoscope or the like during the procedure. When an imaging device such as a rigid endoscope is separate from the catheter, the operator must operate with both hands, so it is desirable that the imaging device be miniaturized and used while mounted on the catheter. Patent Document 1 discloses an endoscope system including an endoscope and a balloon catheter. In Patent Document 1, the balloon is provided at the distal end portion of the catheter.

特開２００７－２６０２７７号公報JP 2007-260277 A

　特許文献１の内視鏡システムでは、カテーテルの先端部に設けられたバルーンと狭窄部との位置関係を確認することはできるが、内視鏡のレンズ部分はバルーンの基端側に配置されている。撮像素子にはバルーンと狭窄部との位置関係の確認以外に、デバイスの先端部において自然口等の目的部位を探す機能をも要求される。これに対し、特許文献１のように観察窓がバルーンの基端部位に配置されていたのでは、バルーンが障害物となり、自然口等の目的部位の視野形成を鮮明に行うことができない、といった問題がある。 In the endoscope system of Patent Document 1, although the positional relationship between the balloon provided at the distal end portion of the catheter and the narrowed portion can be confirmed, the lens portion of the endoscope is disposed on the proximal end side of the balloon. Yes. In addition to confirming the positional relationship between the balloon and the stenosis, the imaging device is also required to have a function of searching for a target site such as a natural mouth at the tip of the device. On the other hand, when the observation window is arranged at the proximal end portion of the balloon as in Patent Document 1, the balloon becomes an obstacle, and the visual field formation of the target portion such as the natural mouth cannot be performed clearly. There's a problem.

　そこで本発明は、上記問題点を解決するために発明されたものであり、バルーンと狭窄部との位置関係を視認することができ、かつ、カテーテルの進入させる前方の視野形成をも鮮明に行うことができるカテーテルを提供することを目的とする。 Accordingly, the present invention has been invented to solve the above-described problems, and can visually recognize the positional relationship between the balloon and the stenosis, and can clearly form a front visual field through which the catheter enters. It is an object to provide a catheter that can be used.

　上記目的を達成する本発明に係るカテーテルは、拡張可能な拡張体と、拡張体が先端に取り付けられる長尺状かつ中空の本体部と、本体部の内部において本体部の長手方向に沿って進退移動可能に配置された撮像部と、を有している。本発明において本体部は、撮像部が向けられた方向を観察する観察窓を有し、撮像部は、少なくとも拡張体よりも基端側から拡張体を超える先端側まで進退移動可能であることを特徴としている。 A catheter according to the present invention that achieves the above-described object includes an expandable expansion body, a long and hollow main body portion to which the expansion body is attached at the distal end, and a forward and backward movement along the longitudinal direction of the main body portion inside the main body portion. An imaging unit that is movably disposed. In the present invention, the main body has an observation window for observing the direction in which the imaging unit is directed, and the imaging unit is capable of moving back and forth at least from the base end side to the distal end side beyond the expansion body. It is a feature.

本発明の実施形態１に係るカテーテルを含む拡張システムの概略構成を示す図である。It is a figure which shows schematic structure of the expansion system containing the catheter which concerns on Embodiment 1 of this invention. 同カテーテルを構成する撮像部を先端部に配置した状態を示す断面図である。It is sectional drawing which shows the state which has arrange | positioned the imaging part which comprises the catheter to the front-end | tip part. 同カテーテルを構成する撮像部を、本体部を構成する内管においてバルーンの基端部またはバルーンの挿通部分に配置した状態を示す断面図である。It is sectional drawing which shows the state which has arrange | positioned the imaging part which comprises the catheter to the proximal end part of a balloon, or the insertion part of a balloon in the inner tube which comprises a main-body part. 図２の４－４線の位置における本体部を構成する内管を示す断面図である。FIG. 4 is a cross-sectional view showing an inner tube constituting the main body at the position of line 4-4 in FIG. 図５（ａ）～（ｄ）は観察窓からバルーンを見た様子を示す図である。FIGS. 5A to 5D are views showing a state where the balloon is viewed from the observation window. 同カテーテルを鼻腔内に進入させる様子を示す図である。It is a figure which shows a mode that the same catheter is approached in a nasal cavity. 同カテーテルを鼻腔内の狭窄した自然口に位置合わせした状態を示す図である。It is a figure which shows the state which aligned the catheter to the natural mouth narrowed in the nasal cavity. 同カテーテルによって鼻腔内の自然口を拡張させる様子を示す図である。It is a figure which shows a mode that the natural mouth in a nasal cavity is expanded with the same catheter. 同カテーテルを鼻腔内から抜去した状態を示す図である。It is a figure which shows the state which extracted the same catheter from the nasal cavity. 本発明の実施形態２に係るカテーテルの突起部を示す拡大断面図である。It is an expanded sectional view showing the projection part of the catheter concerning Embodiment 2 of the present invention. 本発明の変形例に係るカテーテルを示す拡大断面図である。It is an expanded sectional view showing a catheter concerning a modification of the present invention. 本発明の変形例に係るカテーテルを示す拡大断面図である。It is an expanded sectional view showing a catheter concerning a modification of the present invention. 本発明の変形例に係るカテーテルを示す拡大断面図である。It is an expanded sectional view showing a catheter concerning a modification of the present invention. 本発明の変形例に係るカテーテルを示す拡大断面図である。It is an expanded sectional view showing a catheter concerning a modification of the present invention. 本発明の変形例に係るカテーテルを示す拡大断面図である。It is an expanded sectional view showing a catheter concerning a modification of the present invention.

　以下、添付した図面を参照しながら、本発明の実施形態を説明する。なお、以下の記載は特許請求の範囲に記載される技術的範囲や用語の意義を限定するものではない。また、図面の寸法比率は説明の都合上誇張されており、実際の比率とは異なる場合がある。 Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the following description does not limit the technical scope and terms used in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios.

　（実施形態１）
　図１は本発明の実施形態１に係るカテーテルを含む拡張システムの概略構成を示す図、図２は同カテーテルを構成する撮像部を先端部に配置した状態を示す断面図、図３は同カテーテルを構成する撮像部を、本体部を構成する内管においてバルーンの基端部またはバルーンの挿通部分に配置した状態を示す断面図である。図４は図２の４－４線の位置における本体部を構成する内管を示す断面図である。 (Embodiment 1)
FIG. 1 is a diagram showing a schematic configuration of an expansion system including a catheter according to Embodiment 1 of the present invention, FIG. 2 is a cross-sectional view showing a state where an imaging unit constituting the catheter is arranged at a distal end portion, and FIG. 5 is a cross-sectional view showing a state in which the imaging unit constituting the lens is disposed at the proximal end portion of the balloon or the insertion portion of the balloon in the inner tube constituting the main body portion. 4 is a cross-sectional view showing the inner tube constituting the main body at the position of line 4-4 in FIG.

　図１～図４を参照して概説すれば、副鼻腔炎によって狭窄した副鼻腔自然口の拡張に用いられる実施形態１の拡張システム１０は、自然口に挿入可能なカテーテル１００を有する。また、拡張システム１０は、カテーテル１００に接続した、圧力供給手段２００、光源３００、及び表示手段４００を有する。 1 to 4, the dilation system 10 of the first embodiment used for dilatation of the sinus natural mouth constricted by sinusitis has a catheter 100 that can be inserted into the natural mouth. The expansion system 10 includes a pressure supply unit 200, a light source 300, and a display unit 400 connected to the catheter 100.

　圧力供給手段２００はカテーテル１００の構成要素である本体部１２０を構成する外管１２１と連通し、生理食塩水や造影剤等の液体やヘリウム等の気体を外管１２１を通じて外管１２１の先端に接続された、カテーテル１００を構成するバルーン１１０に供給する。バルーン１１０は、バルーン１１０へ充填する液体又は気体の供給によって拡張し、吸引によって収縮する。圧力供給手段２００は、例えはインデフレーター、シリンジ、又はポンプであるが、これに限定されない。 The pressure supply means 200 communicates with the outer tube 121 constituting the main body 120 which is a component of the catheter 100, and a liquid such as physiological saline or a contrast agent or a gas such as helium is passed through the outer tube 121 to the distal end of the outer tube 121. It supplies to the balloon 110 which comprises the catheter 100 connected. The balloon 110 is expanded by supplying a liquid or gas to be filled into the balloon 110 and contracted by suction. The pressure supply means 200 is, for example, an indeflator, a syringe, or a pump, but is not limited thereto.

　光源３００は、カテーテル１００の構成要素である撮像部１４１の先端に設けられたカテーテル１００の構成要素である照射部１４２から出射される光を発生させる。光源３００で発生した光は、カテーテル内部に配置されたカテーテル１００の構成要素である光ファイバ１４３によって照射部１４２まで導かれる。 The light source 300 generates light emitted from the irradiation unit 142 that is a component of the catheter 100 provided at the distal end of the imaging unit 141 that is a component of the catheter 100. The light generated by the light source 300 is guided to the irradiation unit 142 by the optical fiber 143 that is a component of the catheter 100 disposed inside the catheter.

　表示手段４００は、カテーテル１００の構成要素であるカメラカテーテル１４０の先端部に取り付けられた撮像部１４１によって取得された映像情報または画像情報を表示する。表示手段４００は、例えばＰＣ（パーソナルコンピュータ）のモニター部分である。 The display unit 400 displays video information or image information acquired by the imaging unit 141 attached to the distal end portion of the camera catheter 140 that is a constituent element of the catheter 100. The display means 400 is, for example, a monitor part of a PC (personal computer).

　次にカテーテル１００の構造について詳細に説明する。 Next, the structure of the catheter 100 will be described in detail.

　実施形態１に係るカテーテル１００は、拡張可能なバルーン（拡張体）１１０と、バルーン１１０が先端部に取り付けられる長尺状の本体部１２０と、本体部１２０の内部において本体部１２０の長手方向に沿って進退移動可能に配置された撮像部１４１と、を有する。撮像部１４１は、少なくともバルーン１１０の基端部１２６からバルーン１１０の先端部１３０まで移動が可能である。また、撮像部１４１は、カメラカテーテル１４０の先端に取り付けられている。 The catheter 100 according to the first embodiment includes an expandable balloon (expanded body) 110, a long main body 120 to which the balloon 110 is attached to a distal end portion, and a longitudinal direction of the main body 120 within the main body 120. And an imaging unit 141 arranged so as to be movable forward and backward. The imaging unit 141 can move at least from the proximal end portion 126 of the balloon 110 to the distal end portion 130 of the balloon 110. The imaging unit 141 is attached to the distal end of the camera catheter 140.

　バルーン１１０は、拡張させた際にバルーン１１０の内部からバルーン１１０と狭窄した自然口との位置関係を確認できるように、本実施形態では透明に構成されている。バルーン１１０は各種樹脂材料によって形成される。より具体的には、ポリテトラメチレンアジパミド（ナイロン４６）、ポリカプロラクタム（ナイロン６）、ポリヘキサメチレンアジパミド（ナイロン６６）、ポリヘキサメチレンセバカミド（ナイロン６１０）、ポリヘキサメチレンドデカミド（ナイロン６１２）、ポリウンデカノラクタム（ナイロン１１）、ポリドデカノラクタム（ナイロン１２）、等の単独重合体、カプロラクタム／ラウリルラクタム共重合体（ナイロン６／１２）、カプロラクタム／アミノウンデカン酸共重合体（ナイロン６／１１）、カプロラクタム／ω－アミノノナン酸共重合体（ナイロン６／９）、カプロラクタム／ヘキサメチレンジアンモニウムアジペート共重合体（ナイロン６／６６）、アジピン酸とメタキシレンジアミンとの共重合体、又はヘキサメチレンジアミンとｍ，ｐ－フタル酸との共重合体等のポリアミド樹脂、直鎖状低密度ポリエチレン（ＬＬＤＰＥ）、低密度ポリエチレン（ＬＤＰＥ）、高密度ポリエチレン（ＨＤＰＥ）等のポリエチレン樹脂やポリプロピレン樹脂等のポリアルキレン樹脂、エチレン－プロピレン共重合体、エチレン－酢酸ビニル共重合体、並びにこれらの架橋物及び部分架橋物（例えば、架橋型エチレン－酢酸ビニル共重合体）等のポリオレフィン、エポキシ樹脂、ウレタン樹脂、ジアリルフタレート樹脂（アリル樹脂）、ポリカーボネート樹脂、フッ素樹脂、アミノ樹脂（ユリア樹脂、メラミン樹脂、ベンゾグアナミン樹脂）、ポリエステル樹脂（例えば、ポリエチレンテレフタレート）、スチロール樹脂、アクリル樹脂、ポリアセタール樹脂、酢酸ビニル樹脂、フェノール樹脂、塩化ビニル樹脂、シリコーン樹脂（ケイ素樹脂）、ポリアリーレンサルファイド（例えば、ポリフェニレンサルファイド）、シリコーンゴム、ラテックスゴム、ナイロン６、ナイロン６６、ナイロン１１、ナイロン１２等をハードセグメントとし、ポリアルキレングリコール、ポリエーテル、又は脂肪族ポリエステル等をソフトセグメントとするブロック共重合体であるナイロンエラストマー等を採用することができる。この中でも膨張させた際に破裂しないよう高耐圧性であることが好ましく、例えばポリアミド、ポリエチレンテレフタレート、高密度ポリエチレン等によって形成されるとよい。 The balloon 110 is configured to be transparent in this embodiment so that the positional relationship between the balloon 110 and the narrowed natural mouth can be confirmed from the inside of the balloon 110 when expanded. The balloon 110 is made of various resin materials. More specifically, polytetramethylene adipamide (nylon 46), polycaprolactam (nylon 6), polyhexamethylene adipamide (nylon 66), polyhexamethylene sebamide (nylon 610), polyhexamethylene dodeca Homopolymers such as imide (nylon 612), polyundecanolactam (nylon 11), polydodecanolactam (nylon 12), caprolactam / lauryl lactam copolymer (nylon 6/12), caprolactam / aminoundecanoic acid copolymer Polymer (nylon 6/11), caprolactam / ω-aminononanoic acid copolymer (nylon 6/9), caprolactam / hexamethylene diammonium adipate copolymer (nylon 6/66), adipic acid and metaxylenediamine Copolymer or hexamethyle Polyamide resins such as copolymers of diamine and m, p-phthalic acid, polyethylene resins such as linear low density polyethylene (LLDPE), low density polyethylene (LDPE), high density polyethylene (HDPE), and polypropylene resins Polyolefins, epoxy resins, urethane resins such as polyalkylene resins, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, and cross-linked and partially cross-linked products thereof (for example, cross-linked ethylene-vinyl acetate copolymers) , Diallyl phthalate resin (allyl resin), polycarbonate resin, fluororesin, amino resin (urea resin, melamine resin, benzoguanamine resin), polyester resin (for example, polyethylene terephthalate), styrene resin, acrylic resin, polyacetal resin, vinyl acetate resin , Phenol resin, vinyl chloride resin, silicone resin (silicon resin), polyarylene sulfide (for example, polyphenylene sulfide), silicone rubber, latex rubber, nylon 6, nylon 66, nylon 11, nylon 12, etc. as hard segments, polyalkylene A nylon elastomer that is a block copolymer having a soft segment of glycol, polyether, aliphatic polyester, or the like can be used. Among these, it is preferable to have high pressure resistance so as not to rupture when expanded. For example, it may be formed of polyamide, polyethylene terephthalate, high-density polyethylene, or the like.

　本体部１２０は外管１２１と内管１２２とを有する。 The main body 120 has an outer tube 121 and an inner tube 122.

　外管１２１は中空状の管体であり、バルーン１１０と連通するようにバルーン１１０が先端部外周に取り付けられている。外管１２１は、例えばステンレス鋼のような剛性を有する金属によって構成されるが、これに限定されない。ニッケルチタン合金のように弾性を有する金属で構成されてもよいし、ステンレス鋼に溝等の加工を施すことで柔軟性を高めた構成でもよく、硬質の樹脂材料を用いてもよい。また、外管１２１におけるバルーン１１０の基端部１２６は、ポリプロピレン等の透明な材料によって観察窓１２３（観察窓に相当）として形成されている。観察窓は透明であれば種類は限定されず、ガラスなど硬い部材だけでなくシリコーン等の柔軟性を有する素材で構成されてもよい。 The outer tube 121 is a hollow tube, and the balloon 110 is attached to the outer periphery of the tip so as to communicate with the balloon 110. The outer tube 121 is made of a metal having rigidity such as stainless steel, but is not limited thereto. It may be made of an elastic metal such as a nickel titanium alloy, or may have a structure in which flexibility is increased by processing grooves or the like in stainless steel, or a hard resin material may be used. Further, the base end portion 126 of the balloon 110 in the outer tube 121 is formed as an observation window 123 (corresponding to an observation window) with a transparent material such as polypropylene. The type of the observation window is not limited as long as it is transparent, and it may be made of a flexible material such as silicone as well as a hard member such as glass.

　内管１２２は、撮像部１４１が先端に取り付けられたカメラカテーテル１４０等の医療器具を長手方向に進退移動可能な中空状の部材である。内管１２２は、図２に示すように外管１２１の先端に取り付けられたバルーン１１０の内部を挿通し、バルーン１１０の先端で融着等によってバルーン１１０に接合されている。内管１２２は、内管１２２の内部に配置される撮像部１４１がバルーン１１０を視認できるように、内管１２２におけるバルーン１１０の基端部１２６がポリプロピレン等の透明な材料によって観察窓１２４（観察窓に相当）として形成されている。また、内管１２２におけるバルーン１１０の挿通部分１２７は、観察窓１２５（他の観察窓に相当）として形成されている。 The inner tube 122 is a hollow member capable of moving a medical instrument such as a camera catheter 140 with the imaging unit 141 attached to the tip thereof in the longitudinal direction. The inner tube 122 is inserted through the inside of the balloon 110 attached to the tip of the outer tube 121 as shown in FIG. 2, and is joined to the balloon 110 by fusion or the like at the tip of the balloon 110. In the inner tube 122, the base end portion 126 of the balloon 110 in the inner tube 122 is made of a transparent material such as polypropylene so that the imaging unit 141 disposed inside the inner tube 122 can visually recognize the balloon 110. Equivalent to a window). In addition, the insertion portion 127 of the balloon 110 in the inner tube 122 is formed as an observation window 125 (corresponding to another observation window).

　また、内管１２２の内表面には撮像部１４１を一定の位置に配置して保持できるように、突起部１３１～１３４が形成されている。 Also, protrusions 131 to 134 are formed on the inner surface of the inner tube 122 so that the imaging unit 141 can be arranged and held at a fixed position.

　突起部１３１～１３４は、カメラカテーテル１４０の先端に取り付けられた撮像部１４１を内管１２２の軸線から撮像対象に向けて傾斜させる。突起部１３１～１３４は、突起部１３１、１３２が内管１２２におけるバルーン１１０の基端部１２６に設けられ、突起部１３３、１３４（他の突起部に相当）が内管１２２におけるバルーン１１０の挿通部分１２７に設けられる。突起部１３１～１３４は、内管１２２の内表面において周方向に例えば１８０度間隔で対になって配置される。また、突起部１３１～１３４は、撮像部１４１の先端が内管１２２の軸線に傾斜した状態を保持できるように、図２、図３に示すように長手方向において同一位置でなく、所定距離離間して設けられる。突起部１３１～１３４の配置間隔や個数は上記に限定されず、例えば９０度毎に４箇所設けてもよい。 The protrusions 131 to 134 incline the imaging unit 141 attached to the distal end of the camera catheter 140 from the axis of the inner tube 122 toward the imaging target. In the protrusions 131 to 134, the protrusions 131 and 132 are provided at the proximal end 126 of the balloon 110 in the inner tube 122, and the protrusions 133 and 134 (corresponding to other protrusions) are inserted into the balloon 110 in the inner tube 122. Provided in portion 127. The protrusions 131 to 134 are arranged in pairs on the inner surface of the inner tube 122 in the circumferential direction, for example, at intervals of 180 degrees. Further, the protrusions 131 to 134 are not located at the same position in the longitudinal direction as shown in FIGS. 2 and 3, but are separated by a predetermined distance so that the tip of the imaging unit 141 can be held in an inclined state with respect to the axis of the inner tube 122. Provided. The arrangement interval and the number of the protrusions 131 to 134 are not limited to the above, and for example, four positions may be provided every 90 degrees.

　このように外管１２１及び内管１２２には観察窓１２３、１２４、１２５が設けられ、内管１２２の内表面に突起部１３１～１３４が形成されることによって、撮像部１４１は、向きが傾けられた状態で保持される。これにより、撮像部１４１が観察窓１２３、１２４の位置で突起部１３１、１３２によって傾いた状態で保持されれば（図３における実線形状の撮像部参照）、撮像部１４１は内管１２２におけるバルーン１１０の基端部１２６から内管１２２及び外管１２１の外側に位置するバルーン１１０の外表面を観察することができる。よって、狭窄した自然口がバルーン１１０の近傍に位置すれば、バルーン１１０と狭窄部との位置関係を確認し、位置調整等を行うことができる。 In this way, the outer tube 121 and the inner tube 122 are provided with observation windows 123, 124, and 125, and the protrusions 131 to 134 are formed on the inner surface of the inner tube 122, so that the imaging unit 141 is inclined. Is held in a state where As a result, if the imaging unit 141 is held in an inclined state by the protrusions 131 and 132 at the positions of the observation windows 123 and 124 (see the solid line-shaped imaging unit in FIG. 3), the imaging unit 141 is a balloon in the inner tube 122. The outer surface of the balloon 110 located outside the inner tube 122 and the outer tube 121 can be observed from the base end portion 126 of 110. Therefore, if the narrowed natural mouth is located in the vicinity of the balloon 110, the positional relationship between the balloon 110 and the constricted portion can be confirmed and the position can be adjusted.

　また、撮像部１４１が観察窓１２５の位置で突起部１３３、１３４によって傾いた状態で保持されれば（図３における二点鎖線形状の撮像部参照）、撮像部１４１は内管１２２におけるバルーン１１０の挿通部分１２７からバルーン１１０と狭窄した自然口との接触の様子等を観察することができる。よって、バルーン１１０が自然口を拡張できるように配置されていること、及び自然口がバルーン１１０によって確実に拡張されたことを確認することができる。 If the imaging unit 141 is held at the position of the observation window 125 while being tilted by the projections 133 and 134 (see the imaging unit having a two-dot chain line shape in FIG. 3), the imaging unit 141 may be the balloon 110 in the inner tube 122. The state of contact between the balloon 110 and the narrowed natural mouth can be observed from the insertion portion 127 of the lens. Therefore, it can be confirmed that the balloon 110 is arranged so that the natural mouth can be expanded, and that the natural mouth is surely expanded by the balloon 110.

　突起部１３１～１３４の形状は、撮像部１４１の側面形状に合致するように形成されることが望ましい。撮像部１４１が取り付けられたカメラカテーテル１４０は、内管１２２等に挿入し易いように、外側面は円筒状に形成される場合が多い。そのため、突起部１３１～１３４は、カメラカテーテル１４０における撮像部１４１と接触する部分を凹状の曲面に形成してもよい。これによって、撮像部１４１を突起部１３１～１３４に安定して保持した状態で所望の方向へ向けることができる。 The shape of the protrusions 131 to 134 is desirably formed so as to match the side shape of the imaging unit 141. In many cases, the outer surface of the camera catheter 140 to which the imaging unit 141 is attached is formed in a cylindrical shape so that it can be easily inserted into the inner tube 122 or the like. For this reason, the protrusions 131 to 134 may form a concave curved surface at the part of the camera catheter 140 that contacts the imaging unit 141. Thus, the imaging unit 141 can be directed in a desired direction while being stably held by the protrusions 131 to 134.

　なお、撮像部１４１は、図２に示すようにバルーン１１０の先端部１３０にも配置される。そのため、カメラカテーテル１４０を一定以上の力で長手方向基端側から先端側、または先端側から基端側に押し込めば、突起部１３１～１３４が径方向外方に潰れるように変形し、カメラカテーテル１４０が長手方向に移動できるように突起部１３１～１３４の硬さが調整されている。 Note that the imaging unit 141 is also disposed at the tip 130 of the balloon 110 as shown in FIG. Therefore, when the camera catheter 140 is pushed from the longitudinal direction proximal end side to the distal end side or from the distal end side to the proximal end side with a force of a certain level or more, the protrusions 131 to 134 are deformed so as to be crushed radially outward. The hardness of the protrusions 131 to 134 is adjusted so that 140 can move in the longitudinal direction.

　本体部１２０の基端部には、ハブ１６１が接続されている。ハブ１６１にはホルダ１６３が取り付けられ、ハブ１６１とホルダ１６３の間には弾性部材１６２が配置される。 A hub 161 is connected to the base end of the main body 120. A holder 163 is attached to the hub 161, and an elastic member 162 is disposed between the hub 161 and the holder 163.

　ハブ１６１はルーメン１６４と、凹部１６５と、雄ねじ１６６と、を有する。また、ホルダ１６３は雌ねじ１６７と、突出部１６８と、を有する。 The hub 161 has a lumen 164, a recess 165, and a male screw 166. The holder 163 has a female screw 167 and a protrusion 168.

　ルーメン１６４は、先端側において外管１２１に連通し、基端側において圧力供給手段２００と連通している。バルーン１１０を拡張させる液体または気体は、ルーメン１６４及び外管１２１を通過してバルーン１１０へ供給され、また、バルーン１１０から外管１２１及びルーメン１６４を通過して圧力供給手段２００に排出される。外管１２１及び内管１２２の基端部はハブ１６１と液密または気密にシールされている。 The lumen 164 communicates with the outer tube 121 on the distal end side, and communicates with the pressure supply means 200 on the proximal end side. The liquid or gas that expands the balloon 110 passes through the lumen 164 and the outer tube 121 and is supplied to the balloon 110, and passes through the outer tube 121 and the lumen 164 from the balloon 110 and is discharged to the pressure supply means 200. Base ends of the outer tube 121 and the inner tube 122 are sealed with the hub 161 in a liquid-tight or air-tight manner.

　凹部１６５は、ハブ１６１の基端側に形成される。弾性部材１６２は、環状に形成され、ハブ１６１の凹部１６５に挿入される。弾性部材１６２には、内管１２２の内部に配置されるカメラカテーテル１４０等を挿通可能である。 The recess 165 is formed on the proximal end side of the hub 161. The elastic member 162 is formed in an annular shape and is inserted into the recess 165 of the hub 161. A camera catheter 140 or the like disposed inside the inner tube 122 can be inserted into the elastic member 162.

　ホルダ１６３に設けられた雌ねじ１６７は、ハブ１６１に設けられた雄ねじ１６６によって締めこまれる。それにより、突出部１６８は、ハブ１６１とホルダ１６３との間に配置された弾性部材１６２を長手方向において押圧する。 The female screw 167 provided on the holder 163 is tightened by the male screw 166 provided on the hub 161. Thereby, the protrusion 168 presses the elastic member 162 disposed between the hub 161 and the holder 163 in the longitudinal direction.

　次にハブ１６１、弾性部材１６２、及びホルダ１６３によるカメラカテーテル１４０の固定及び固定の解除について説明する。雄ねじ１６６と雌ねじ１６７を操作することにより、ハブ１６１とホルダ１６３とを締め付けると、ホルダ１６３の突出部１６８が弾性部材１６２を押圧する。これによって弾性部材１６２は、長手軸方向に圧縮させられる分、径方向に拡張するように変形する。弾性部材１６２の変形によって、弾性部材１６２を挿通するカメラカテーテル１４０は径方向に締め付けられ、固定される。 Next, fixing and releasing of the camera catheter 140 by the hub 161, the elastic member 162, and the holder 163 will be described. When the hub 161 and the holder 163 are tightened by operating the male screw 166 and the female screw 167, the protruding portion 168 of the holder 163 presses the elastic member 162. As a result, the elastic member 162 is deformed so as to expand in the radial direction by being compressed in the longitudinal axis direction. Due to the deformation of the elastic member 162, the camera catheter 140 inserted through the elastic member 162 is clamped and fixed in the radial direction.

　逆に、雄ねじ１６６と雌ねじ１６７によって、ハブ１６１とホルダ１６３との締め付けを緩めるように操作すると、突出部１６８による弾性部材１６２への押圧が弱まる分、弾性部材１６２の径方向への拡張量が減少する（収縮する）。そのため、弾性部材１６２によるカメラカテーテル１４０の保持力が弱まり、カメラカテーテル１４０の固定が解除される。 On the other hand, if the male screw 166 and the female screw 167 are operated so as to loosen the tightening of the hub 161 and the holder 163, the amount of expansion of the elastic member 162 in the radial direction is reduced by the amount of the pressure on the elastic member 162 by the protrusion 168 weakening. Decrease (shrink). Therefore, the holding force of the camera catheter 140 by the elastic member 162 is weakened, and the fixation of the camera catheter 140 is released.

　ハブ１６１及びホルダ１６３は、例えばポリカーボネート、ポリアミド、ポリサルホン、ポリアリレート、メタクリレート－ブチレン－スチレン共重合体等の熱可塑性樹脂によって形成される。また、弾性部材１６２は、例えばシリコーンゴム、ラテックスゴム等によって形成される。 The hub 161 and the holder 163 are made of a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer. The elastic member 162 is made of, for example, silicone rubber or latex rubber.

　カメラカテーテル１４０は、ハブ１６１、弾性部材１６２、及びホルダ１６３を通じて内管１２２の内部に配置される。カメラカテーテル１４０は、先端部に撮像部１４１が取り付けられている。 The camera catheter 140 is disposed inside the inner tube 122 through the hub 161, the elastic member 162, and the holder 163. The camera catheter 140 has an imaging unit 141 attached to the tip.

　撮像部１４１は、照射部１４２と、レンズ１４４と、撮像素子１４５と、ケーブル１４６と、光ファイバ１４３と、を有する。照射部１４２は光源３００から光ファイバ１４３を通過して供給される光を撮像対象に向けて供給する。撮像素子１４５はレンズ１４４からの可視光線を検知して画像を取得する。撮像素子１４５は、例えばＣＣＤイメージセンサやＣＭＯＳイメージセンサであるが、これに限定されない。 The imaging unit 141 includes an irradiation unit 142, a lens 144, an imaging device 145, a cable 146, and an optical fiber 143. The irradiation unit 142 supplies light supplied from the light source 300 through the optical fiber 143 toward the imaging target. The image sensor 145 detects visible light from the lens 144 and acquires an image. The image sensor 145 is, for example, a CCD image sensor or a CMOS image sensor, but is not limited thereto.

　ケーブル１４６は撮像部１４１によって取得された画像情報または映像情報を表示手段４００に伝達する。なお、撮像素子１４５と、ケーブル１４６の代わりに、イメージファイバを用いて、先端で取得した画像情報等を基端側でＣＣＤイメージセンサやＣＭＯＳイメージセンサ等によりイメージングしてもよい。 The cable 146 transmits the image information or video information acquired by the imaging unit 141 to the display unit 400. In addition, instead of the image sensor 145 and the cable 146, image information acquired at the distal end may be imaged by a CCD image sensor or a CMOS image sensor on the proximal end side using an image fiber.

　次にカテーテル１００の使用について、副鼻腔炎によって狭窄した自然口の拡張を例に挙げて説明する。図５（ａ）～（ｄ）は観察窓からバルーンを観察した様子を示す図、図６は実施形態１に係るカテーテルを鼻腔内に進入させる様子を示す図である。また、図７は同カテーテルを鼻腔内の狭窄した自然口に位置合わせした状態を示す図、図８は同カテーテルによって鼻腔内の狭窄した自然口を拡張させる様子を示す図、図９は同カテーテルを鼻腔内から抜去した状態を示す図である。 Next, the use of the catheter 100 will be described taking as an example the expansion of a natural mouth constricted by sinusitis. 5A to 5D are views showing a state where a balloon is observed from the observation window, and FIG. 6 is a view showing a state where the catheter according to the first embodiment enters the nasal cavity. 7 is a view showing a state in which the catheter is aligned with a narrowed natural mouth in the nasal cavity, FIG. 8 is a view showing a state in which the narrowed natural mouth in the nasal cavity is expanded by the catheter, and FIG. It is a figure which shows the state which extracted from the nasal cavity.

　本実施形態では、（１）カテーテルの先端部を本体部の先端に配置した状態で、前方を視認しながら生体内の目的部位へバルーンを配置する配置工程と、（２）配置工程後、カテーテルを基端側に牽引し、狭窄した自然口に対するバルーンの位置を視認する視認工程と、（３）視認工程において確認した自然口に対するバルーンの位置に基づいて、バルーンを目的の位置へ調整する調整工程と、（４）本体部の位置を固定しつつバルーンを拡張させる拡張工程と、を有する。また、本実施形態においては（５）拡張工程後、バルーンの外形を視認しながらバルーンを収縮させる収縮工程と、（６）収縮工程後、カテーテルを回収する回収工程と、を有している。なお、撮像部１４１は、手技を始める時点では、内管１２２におけるバルーン１１０の先端部１３０に配置されており、ハブ１６１、弾性部材１６２、及びホルダ１６３によって長手方向における位置が固定されている。 In the present embodiment, (1) an arrangement step of arranging a balloon at a target site in a living body while viewing the front in a state where the distal end portion of the catheter is arranged at the distal end of the main body portion; and (2) after the arrangement step, the catheter A visual recognition step of pulling the proximal end to visually recognize the position of the balloon relative to the narrowed natural mouth, and (3) an adjustment for adjusting the balloon to a target position based on the position of the balloon relative to the natural mouth confirmed in the visual recognition step. And (4) an expansion step of expanding the balloon while fixing the position of the main body. Moreover, in this embodiment, it has (5) the shrinkage | contraction process which shrink | contracts a balloon, visually recognizing the external shape of a balloon after an expansion process, and (6) The collection | recovery process which collect | recovers a catheter after a shrinkage | contraction process. The imaging unit 141 is disposed at the distal end portion 130 of the balloon 110 in the inner tube 122 at the time of starting the procedure, and the position in the longitudinal direction is fixed by the hub 161, the elastic member 162, and the holder 163.

　配置工程において、術者は図６に示すように、鼻腔Ｎに挿入したカテーテル１００を自然口Ｅへと進入させる。光源３００からの光が照射部１４２から照射されると、撮像範囲の状況を視認できるようになる。撮像部１４１によって取得された映像または画像は、表示手段４００に表示される。術者は当該画像等を確認しながらカテーテル１００を自然口Ｅへと進め、図７に示すようにバルーン１１０を自然口Ｅに挿入して配置する。 In the placement step, the operator advances the catheter 100 inserted into the nasal cavity N into the natural mouth E as shown in FIG. When light from the light source 300 is irradiated from the irradiation unit 142, the state of the imaging range can be visually recognized. The video or image acquired by the imaging unit 141 is displayed on the display unit 400. The surgeon advances the catheter 100 to the natural mouth E while confirming the image and the like, and inserts and arranges the balloon 110 into the natural mouth E as shown in FIG.

　視認工程は、カテーテル１００を狭窄した自然口Ｅの近傍まで進入させることができた段階で行われる。術者は、視認工程においてハブ１６１とホルダ１６３による締め付けを緩め、カメラカテーテル１４０を長手方向に移動可能な状態にする。この状態で術者は表示手段４００を確認しながら、撮像部１４１を基端側に牽引し、観察窓１２３、１２４または観察窓１２５まで移動させる。撮像部１４１が突起部１３１、１３２または突起部１３３、１３４を通過する際、術者は撮像部１４１が突起部１３１、１３２または突起部１３３、１３４を変形させていることを手元側において抵抗として感じるため、撮像部１４１の位置を触覚的にも認識することができる。これ以外にも、カメラカテーテル１４０の基端側にも目盛りを付与することで、撮像部１４１の位置を術者に認識させてもよい。 The visual recognition process is performed at a stage where the catheter 100 can be approached to the vicinity of the narrowed natural mouth E. The operator loosens the tightening by the hub 161 and the holder 163 in the visual recognition process, and makes the camera catheter 140 movable in the longitudinal direction. In this state, the surgeon pulls the imaging unit 141 toward the proximal end while checking the display unit 400 and moves it to the observation windows 123 and 124 or the observation window 125. When the imaging unit 141 passes through the projections 131 and 132 or the projections 133 and 134, the surgeon uses resistance on the hand side that the imaging unit 141 deforms the projections 131 and 132 or the projections 133 and 134. Therefore, the position of the imaging unit 141 can be recognized tactilely. In addition to this, the operator may recognize the position of the imaging unit 141 by providing a scale on the proximal end side of the camera catheter 140.

　カメラカテーテル１４０を移動させて、撮像部１４１を突起部１３１、１３２に位置させると、撮像部１４１は内管１２２におけるバルーン１１０の基端部１２６に配置される。また、撮像部１４１を突起部１３３、１３４に位置させると、撮像部１４１は内管１２２におけるバルーン１１０の挿通部分１２７に配置される。 When the camera catheter 140 is moved and the imaging unit 141 is positioned at the protrusions 131 and 132, the imaging unit 141 is disposed at the proximal end 126 of the balloon 110 in the inner tube 122. In addition, when the imaging unit 141 is positioned at the protrusions 133 and 134, the imaging unit 141 is disposed in the insertion portion 127 of the balloon 110 in the inner tube 122.

　そこから撮像部１４１を周方向に回転させて、撮像部１４１が観察窓１２３、１２４又は観察窓１２５に向けられるように位置合わせする。撮像部１４１が観察窓１２３、１２４に向けられれば、図５（ａ）に示すように、バルーン１１０の基端側から先端側に向けての映像又は画像を取得でき、当該画像等に基づいてバルーン１１０と自然口Ｅとの位置調整を行うことができる。 From there, the imaging unit 141 is rotated in the circumferential direction so that the imaging unit 141 is aligned with the observation windows 123 and 124 or the observation window 125. If the imaging unit 141 is directed toward the observation windows 123 and 124, as shown in FIG. 5A, a video or an image from the proximal end side to the distal end side of the balloon 110 can be acquired. The position of the balloon 110 and the natural mouth E can be adjusted.

　撮像部１４１が観察窓１２５に向けられれば、内管１２２から径方向外方に向けての映像又は画像を取得でき、バルーン１１０が、狭窄した自然口Ｅを拡張できるように配置されているかを確認することができる。観察窓１２５が例えばバルーン１１０の挿通部分１２７において長手方向における中央に形成された場合、図５（ｄ）に示すように、バルーン１１０の中央が狭窄した自然口Ｅの近傍に配置できていないことを確認することによって、位置調整を行う必要があると認識できる。 If the imaging unit 141 is directed to the observation window 125, it is possible to acquire a video or image directed radially outward from the inner tube 122, and whether the balloon 110 is arranged so that the narrowed natural mouth E can be expanded. Can be confirmed. For example, when the observation window 125 is formed in the center in the longitudinal direction in the insertion portion 127 of the balloon 110, the center of the balloon 110 cannot be disposed in the vicinity of the narrowed natural mouth E as shown in FIG. By confirming the above, it can be recognized that position adjustment is necessary.

　調整工程では、表示手段４００によってバルーン１１０と狭窄した自然口Ｅとの位置関係を確認しながらバルーン１１０の位置を調整する。 In the adjustment step, the position of the balloon 110 is adjusted while confirming the positional relationship between the balloon 110 and the narrowed natural mouth E by the display means 400.

　バルーン１１０を所望の位置に配置できたことが確認できたら、拡張工程において圧力供給手段２００によってバルーン１１０を拡張させる。これにより、図５（ｂ）、図８に示すように、バルーン１１０の拡張に伴って、狭窄した自然口Ｅが拡張され、自然口Ｅよりも奥側に溜まっていた膿を摘出できるようになる。膿の摘出の際には、収縮工程において図５（ｃ）に示すようにバルーン１１０を収縮させ、回収工程において図９に示すようにカテーテル１００を鼻腔Ｎから抜去し、別途吸引管を副鼻腔内に挿入することにより回収を行ってもよいし、バルーン１１０の内管１２２からカメラカテーテル１４０を抜去し、当該内管を吸引ルーメンとして使用してもよい。この場合、内管の基端部には図示しない吸引用のポンプ等が接続され、吸引が行われる。 When it is confirmed that the balloon 110 can be arranged at a desired position, the balloon 110 is expanded by the pressure supply means 200 in the expansion process. As a result, as shown in FIGS. 5B and 8, as the balloon 110 is expanded, the narrowed natural mouth E is expanded so that the pus accumulated on the back side of the natural mouth E can be removed. Become. When removing pus, the balloon 110 is deflated in the contraction process as shown in FIG. 5C, the catheter 100 is removed from the nasal cavity N as shown in FIG. 9 in the recovery process, and a separate suction tube is connected to the sinus cavity. Recovery may be performed by inserting the camera catheter 140 into the inside, or the camera catheter 140 may be removed from the inner tube 122 of the balloon 110 and used as a suction lumen. In this case, a suction pump or the like (not shown) is connected to the proximal end portion of the inner tube, and suction is performed.

　副鼻腔炎の治療の際に行われるような狭窄した自然口の拡張においては、撮像部を備えた医療器具を生体内に進入させ、バルーン等によって自然口を拡張している。医療器具を自然口まで進入させる際には、医療器具の先端に撮像部を取り付けて医療器具の進入位置を把握する必要がある。しかし、撮像部が医療器具の進む前方を撮像しても、バルーンと自然口との位置関係が把握できなければ、バルーンによって自然口を的確に拡張させることができない。 In the expansion of a narrowed natural mouth, which is performed in the treatment of sinusitis, a medical instrument equipped with an imaging unit is inserted into a living body, and the natural mouth is expanded by a balloon or the like. When a medical instrument is advanced to a natural mouth, it is necessary to attach an imaging unit to the tip of the medical instrument and grasp the medical instrument entry position. However, even if the imaging unit captures the front of the medical instrument, the natural mouth cannot be accurately expanded by the balloon unless the positional relationship between the balloon and the natural mouth can be grasped.

　これに対し、本実施形態に係るカテーテル１００は、本体部１２０を構成する内管１２２の内部に本体部１２０の長手方向に沿って、少なくともバルーン１１０の基端部１２６からバルーン１１０を超える先端部１３０まで進退移動可能な撮像部１４１が配置される。また、本体部１２０を構成する外管１２１及び内管１２２は、撮像部１４１の向けられた方向を観察するための観察窓１２３，１２４を有している。 On the other hand, the catheter 100 according to the present embodiment has a distal end portion that extends from the proximal end portion 126 of the balloon 110 beyond the balloon 110 along the longitudinal direction of the main body portion 120 inside the inner tube 122 constituting the main body portion 120. An imaging unit 141 that can move forward and backward up to 130 is arranged. In addition, the outer tube 121 and the inner tube 122 constituting the main body 120 have observation windows 123 and 124 for observing the direction in which the imaging unit 141 is directed.

　そのため、撮像部１４１を本体部１２０を構成する内管１２２において、バルーン１１０の先端部１３０に配置すれば、カテーテル１００の進入方向前方を把握することができる。また、撮像部１４１を本体部１２０を構成する内管１２２において、バルーン１１０の基端部１２６に配置すれば、観察窓１２３、１２４を通じて当該位置からバルーン１１０の外表面が観察でき、バルーン１１０と自然口Ｅとの位置関係を把握することができる。よって、バルーン１１０と自然口Ｅとの位置関係と、カテーテル１００を進入させる進入方向前方と、を共に把握できることによって、自然口Ｅを拡張させる手技等を的確かつ迅速に行うことができる。 Therefore, if the imaging unit 141 is disposed at the distal end portion 130 of the balloon 110 in the inner tube 122 that constitutes the main body unit 120, the front of the catheter 100 in the entry direction can be grasped. In addition, if the imaging unit 141 is disposed at the proximal end 126 of the balloon 110 in the inner tube 122 constituting the main body 120, the outer surface of the balloon 110 can be observed from the position through the observation windows 123 and 124. The positional relationship with the natural mouth E can be grasped. Therefore, since both the positional relationship between the balloon 110 and the natural mouth E and the forward direction in which the catheter 100 is advanced can be grasped, a procedure for expanding the natural mouth E can be performed accurately and quickly.

　以上説明したように、実施形態１に係るカテーテル１００は、拡張可能なバルーン１１０と、バルーン１１０が先端に取り付けられる長尺状かつ中空の本体部１２０と、本体部１２０の内部において本体部１２０の長手方向に沿って少なくともバルーン１１０の基端部１２６からバルーン１１０を超える先端部１３０まで進退移動可能に配置される撮像部１４１と、を有し、本体部１２０を構成する外管１２１及び内管１２２は撮像部１４１の向けられた方向を観察するための観察窓１２３、１２４を有している。 As described above, the catheter 100 according to the first embodiment includes the expandable balloon 110, the long and hollow main body 120 to which the balloon 110 is attached at the tip, and the main body 120 within the main body 120. And an imaging unit 141 arranged to be movable back and forth from the proximal end 126 of the balloon 110 to the distal end 130 beyond the balloon 110 along the longitudinal direction, and an outer tube 121 and an inner tube constituting the main body 120 Reference numeral 122 has observation windows 123 and 124 for observing the direction in which the imaging unit 141 is directed.

　そのため、撮像部１４１をバルーン１１０の基端部１２６からバルーン１１０を超える先端部１３０まで進退移動させることによって、基端部１２６では観察窓１２３、１２４を通じてバルーン１１０と自然口Ｅとの位置関係を把握し、さらに先端部１３０ではカテーテル１００を進入させる進入方向前方の様子を観察することができ、自然口Ｅを拡張させる等の手技を迅速に行うことができる。 Therefore, by moving the imaging unit 141 forward and backward from the proximal end portion 126 of the balloon 110 to the distal end portion 130 beyond the balloon 110, the positional relationship between the balloon 110 and the natural mouth E is changed at the proximal end portion 126 through the observation windows 123 and 124. In addition, the distal end portion 130 can observe the state in front of the approach direction in which the catheter 100 is advanced, and a procedure such as expanding the natural mouth E can be quickly performed.

　また、本体部１２０を構成する内管１２２は、バルーン１１０よりも基端側である基端部１２６において撮像部１４１を観察窓１２３、１２４に向けて傾けて保持する突起部１３１、１３２を有し、観察窓１２３、１２４は本体部１２０を構成する内管１２２においてバルーン１１０よりも基端側である基端部１２６に設けられている。 In addition, the inner tube 122 constituting the main body 120 has protrusions 131 and 132 that hold the imaging unit 141 tilted toward the observation windows 123 and 124 at the proximal end 126 that is proximal to the balloon 110. The observation windows 123 and 124 are provided in the proximal end portion 126 which is the proximal end side of the balloon 110 in the inner tube 122 constituting the main body portion 120.

　そのため、撮像部１４１を突起部１３１、１３２によって観察窓１２３、１２４に向けて傾けて保持することによって、比較的視野角の狭いカメラであってもバルーン１１０の基端側からバルーン１１０の表面の状態を確認でき、バルーン１１０と自然口Ｅとの位置調整を行うことができる。 Therefore, by holding the imaging unit 141 tilted toward the observation windows 123 and 124 by the projections 131 and 132, even on a camera with a relatively narrow viewing angle, the surface of the balloon 110 can be seen from the base end side of the balloon 110. The state can be confirmed, and the position of the balloon 110 and the natural mouth E can be adjusted.

　また、バルーン１１０は透明であり、本体部１２０を構成する内管１２２はバルーン１１０を挿通する挿通部分１２７と、挿通部分１２７において撮像部１４１が向けられた方向を観察するための観察窓１２５と、を有している。さらに、内管１２２は挿通部分１２７において撮像部１４１を観察窓１２５に向けて傾けて保持する突起部１３３、１３４を有している。 The balloon 110 is transparent, and the inner tube 122 constituting the main body 120 has an insertion portion 127 through which the balloon 110 is inserted, and an observation window 125 for observing the direction in which the imaging unit 141 is directed at the insertion portion 127. ,have. Furthermore, the inner tube 122 has projections 133 and 134 that hold the imaging unit 141 tilted toward the observation window 125 in the insertion portion 127.

　そのため、撮像部１４１を突起部１３３、１３４によって観察窓１２５に向けて傾けて保持することにより、視野角の狭いカメラであってもバルーン１１０の外方に位置する生体の状況を視認することができる。よって、バルーン１１０の近傍に自然口Ｅが位置すれば、バルーン１１０が狭窄した自然口Ｅを拡張できる位置に配置されているかを確認することができる。 Therefore, by holding the imaging unit 141 tilted toward the observation window 125 by the projections 133 and 134, the situation of the living body located outside the balloon 110 can be visually recognized even with a camera with a narrow viewing angle. it can. Therefore, if the natural mouth E is located in the vicinity of the balloon 110, it can be confirmed whether the balloon 110 is disposed at a position where the narrowed natural mouth E can be expanded.

　また、突起部１３１、１３２または突起部１３３、１３４は、内管１２２の内部において対になって設けられ、長手方向に離間して配置されている。そのため、撮像部１４１を長手方向から傾けた際に１方向からだけでなく、２方向から撮像部１４１を押さえつけて、より強固に保持することができる。よって、撮像部１４１と内管１２２の内壁との距離が比較的大きい場合でも、撮像部１４１を所望の方向に傾けてさらに強固に保持しつつ撮像を行うことができる。 Further, the protrusions 131 and 132 or the protrusions 133 and 134 are provided in pairs inside the inner tube 122 and are spaced apart in the longitudinal direction. Therefore, when the imaging unit 141 is tilted from the longitudinal direction, the imaging unit 141 can be pressed from two directions as well as from one direction to be held more firmly. Therefore, even when the distance between the imaging unit 141 and the inner wall of the inner tube 122 is relatively large, imaging can be performed while the imaging unit 141 is tilted in a desired direction and held more firmly.

　また、突起部１３１、１３２及び突起部１３３、１３４は、カメラカテーテル１４０における撮像部１４１との接触部位が凹状の曲面に形成されている。撮像部１４１が取り付けられたカメラカテーテル１４０は、内管１２２等に挿入し易いように外側面が円筒状に形成されることが多い。そのため、突起部１３１～１３４における撮像部１４１との接触部位を凹状の曲面に形成することによって、撮像部１４１をより安定して保持した状態で所望の方向へ方向づけることができる。 Further, the projecting parts 131 and 132 and the projecting parts 133 and 134 are formed in a concave curved surface at the contact portion with the imaging unit 141 in the camera catheter 140. The camera catheter 140 to which the imaging unit 141 is attached is often formed with a cylindrical outer surface so that it can be easily inserted into the inner tube 122 or the like. Therefore, by forming the contact portions of the projections 131 to 134 with the imaging unit 141 into a concave curved surface, the projection unit 131 can be oriented in a desired direction while holding the imaging unit 141 more stably.

　（実施形態２）
　図１０は実施形態２に係るカテーテルのバルーン付近を示す拡大断面図である。実施形態１では本体部１２０を構成する内管１２２の内表面に突起部１３１～１３４が設けられ、撮像部１４１を傾斜した状態に保持したが、撮像部１４１の方向付けは以下のように行ってもよい。なお、実施形態１と同様の構成には同一の符号を付し、説明を省略する。 (Embodiment 2)
FIG. 10 is an enlarged cross-sectional view showing the vicinity of the balloon of the catheter according to the second embodiment. In the first embodiment, the protrusions 131 to 134 are provided on the inner surface of the inner tube 122 constituting the main body 120, and the imaging unit 141 is held in an inclined state. However, the imaging unit 141 is oriented as follows. May be. In addition, the same code | symbol is attached | subjected to the structure similar to Embodiment 1, and description is abbreviate | omitted.

　実施形態２では、本体部１２０を構成する内管１２２の内表面に突起部１３１～１３４が設けられるだけでなく、撮像部１４１を取付けるカメラカテーテル１４０の先端部における外側面に突起部１３１、１３３と係合する係合部１４７が設けられている。係合部１４７は、カメラカテーテル１４０の先端部における側面外周の一部に設けられ、撮像部１４１を観察窓１２３、１２４または観察窓１２５に向けて傾けた際に、係合部１４７が突起部１３１または突起部１３３と係合する位置に設けられている。係合部１４７は、カメラカテーテル１４０の先端部外周において突起部１３１、１３３と当接するように、断面が扇形となる突起をカメラカテーテル１４０の先端部外周に１箇所または複数箇所設けてもよいし、又は断面が多角形状となる突起を同じ部位に１箇所または複数箇所設けてもよい。 In the second embodiment, not only the protrusions 131 to 134 are provided on the inner surface of the inner tube 122 constituting the main body 120, but also the protrusions 131 and 133 on the outer surface of the distal end portion of the camera catheter 140 to which the imaging unit 141 is attached. An engaging portion 147 is provided for engaging with. The engaging portion 147 is provided at a part of the outer periphery of the side surface at the distal end portion of the camera catheter 140. When the imaging portion 141 is tilted toward the observation windows 123 and 124 or the observation window 125, the engaging portion 147 is a protrusion. 131 or the protrusion 133 is provided at a position to be engaged. The engaging portion 147 may be provided with one or a plurality of protrusions having a fan-shaped cross section on the outer periphery of the distal end portion of the camera catheter 140 so as to contact the protrusions 131 and 133 on the outer periphery of the distal end portion of the camera catheter 140. Alternatively, one or a plurality of protrusions having a polygonal cross section may be provided in the same part.

　このように撮像部１４１を取り付けるカメラカテーテル１４０の先端部外周に係合部１４７が設けられることによって、突起部１３１または突起部１３３と係合部１４７が長手方向において係合し、撮像部１４１の保持位置が長手方向にずれにくくなる。そのため、撮像部１４１を所望の位置にさらに正確に保持して観察窓１２３、１２４または観察窓１２５からバルーン１１０と狭窄した自然口Ｅとの位置関係等をより正確に把握することができる。 Thus, by providing the engaging portion 147 on the outer periphery of the distal end portion of the camera catheter 140 to which the imaging unit 141 is attached, the protruding portion 131 or the protruding portion 133 and the engaging portion 147 are engaged in the longitudinal direction. The holding position is difficult to shift in the longitudinal direction. Therefore, it is possible to more accurately grasp the positional relationship between the balloon 110 and the narrowed natural mouth E from the observation windows 123 and 124 or the observation window 125 by holding the imaging unit 141 more accurately at a desired position.

　以上説明したように、実施形態２に係るカテーテル１００ａは、撮像部１４１を取り付けるカメラカテーテル１４０の先端部に本体部１２０を構成する内管１２２の突起部１３１または突起部１３３と係合する係合部１４７を設けている。そのため、係合部１４７によって、突起部１３１、１３２または突起部１３３、１３４による撮像部１４１の保持位置は長手方向にさらにズレにくくなる。よって、観察窓１２３、１２４または観察窓１２５からバルーン１１０と狭窄した自然口Ｅとの位置関係等をより良好に把握することができる。 As described above, the catheter 100a according to the second embodiment is engaged with the protrusion 131 or the protrusion 133 of the inner tube 122 constituting the main body 120 at the distal end portion of the camera catheter 140 to which the imaging unit 141 is attached. A portion 147 is provided. Therefore, the engaging portion 147 makes the holding position of the imaging unit 141 by the protrusions 131 and 132 or the protrusions 133 and 134 more difficult to shift in the longitudinal direction. Therefore, the positional relationship between the balloon 110 and the narrowed natural mouth E can be better understood from the observation windows 123 and 124 or the observation window 125.

　なお、本発明は上述した実施形態にのみ限定されるものでなく。特許請求の範囲において種々の改変が可能である。図１１～１５は本発明の変形例に係るカテーテルを示す拡大断面図である。 Note that the present invention is not limited to the above-described embodiment. Various modifications can be made within the scope of the claims. 11 to 15 are enlarged sectional views showing catheters according to modifications of the present invention.

　実施形態１において、突起部１３１～１３４は対になって長手方向に離間して設けられる実施形態について記載したが、これに限定されない。撮像部１４１を固定できれば、図１１に示すように、突起部１３２を設けず、突起部１３１を内管１２２におけるバルーン１１０の基端部１２６に設け、突起部１３４を設けず、突起部１３３をバルーン１１０の挿通部分１２７に設けるようにしてもよい。 In Embodiment 1, the embodiment has been described in which the protrusions 131 to 134 are provided as a pair and spaced apart in the longitudinal direction, but the present invention is not limited to this. If the imaging unit 141 can be fixed, as shown in FIG. 11, the projection 132 is not provided, the projection 131 is provided at the proximal end 126 of the balloon 110 in the inner tube 122, the projection 134 is not provided, and the projection 133 is provided. You may make it provide in the insertion part 127 of the balloon 110. FIG.

　また、突起部は内管１２２におけるバルーンの基端部１２６及びバルーンの挿通部分１２７の２箇所に設けたが、いずれか１箇所であってもよい。 In addition, although the protrusions are provided at the two locations of the proximal end portion 126 of the balloon and the insertion portion 127 of the balloon in the inner tube 122, any one may be provided.

　また、撮像部１４１を傾けた場合、撮像部１４１よりも基端側の部分には図１２に示すように、傾けた反動によって径方向外方に張り出した張り出し部分１４８が形成されることがある。撮像部１４１を所定の方向に円滑に傾けるために、管の中でも撮像部１４１を突起部１３１、１３２に配置し、観察窓１２８に向けて傾けた際の張り出し部分１４８の近傍には、突出孔１３５を設けてもよい。その場合には、本体部を二重管ではなく、例えば単管１３７とし、バルーン１１０を拡張させる管１３８を本体部１２０とは別にバルーン１１０に接続してもよい。これにより、バルーン１１０の拡張を確保しつつ、単管１３７の内部に配置された撮像部１４１を所望の方向に傾けて、観察窓１２８からバルーン１１０等を撮像することができる。なお、突出孔を単管１３７の長手方向においてバルーン１１０の内部に形成する場合、バルーン１１０に充填される流体等が突出孔から内管１２２の内部ルーメンに漏れ出さないように、突出孔の部分にはポリエチレン等のフィルム状の柔らかい部材を設けることによって、バルーン１１０の気密性を確保するとともに撮像部１４１の張り出し部分１４８の可動範囲を拡大することができる。 In addition, when the imaging unit 141 is tilted, a protruding portion 148 that protrudes radially outward due to the tilted reaction may be formed in a portion closer to the proximal end than the imaging unit 141, as shown in FIG. . In order to smoothly tilt the imaging unit 141 in a predetermined direction, among the tubes, the imaging unit 141 is disposed on the protrusions 131 and 132, and in the vicinity of the protruding portion 148 when tilted toward the observation window 128, a protruding hole is provided. 135 may be provided. In that case, the main body may be a single tube 137 instead of a double tube, and a tube 138 for expanding the balloon 110 may be connected to the balloon 110 separately from the main body 120. Accordingly, the balloon 110 and the like can be imaged from the observation window 128 by tilting the imaging unit 141 disposed inside the single tube 137 while ensuring expansion of the balloon 110. In the case where the projecting hole is formed inside the balloon 110 in the longitudinal direction of the single tube 137, a portion of the projecting hole is prevented so that the fluid filled in the balloon 110 does not leak from the projecting hole to the inner lumen of the inner tube 122. By providing a film-like soft member such as polyethylene, the airtightness of the balloon 110 can be secured, and the movable range of the protruding portion 148 of the imaging unit 141 can be expanded.

　また、撮像部１４１に斜視鏡や広角カメラ、または角度を調節できる機構が設けられたカメラが適用される場合には、撮像部１４１が本体部１２０の軸線と略平行の姿勢においても斜め方向を撮像できる。そのような場合には、図１３に示すように本体部１２０に観察窓１２３～１２５を設け、突起部は設けなくてもよい。 Further, in the case where a perspective mirror, a wide-angle camera, or a camera with a mechanism capable of adjusting the angle is applied to the imaging unit 141, the imaging unit 141 is inclined even when the imaging unit 141 is substantially parallel to the axis of the main body 120. Can be imaged. In such a case, as shown in FIG. 13, observation windows 123 to 125 are provided in the main body 120, and the projections may not be provided.

　また、本体部１２０を構成する内管１２２において、バルーン１１０の基端部１２６からバルーン１１０を観察する場合には、撮像部１４１によって観察窓１２３、１２４から直接見るのではなく、図１４に示すようにレンズ、ミラー、又はプリズムのような光学素子１３９を介して間接的に観察してもよい。 Further, in the case of observing the balloon 110 from the proximal end portion 126 of the balloon 110 in the inner tube 122 constituting the main body portion 120, the observation is not performed directly from the observation windows 123 and 124 by the imaging unit 141, but is shown in FIG. Thus, the image may be observed indirectly through an optical element 139 such as a lens, a mirror, or a prism.

　また、撮像部１４１にはミラー等の光学素子１４９を取り付け、図１５に示すように撮像部１４１を内管１２２におけるバルーン１１０の先端部１３０に配置した状態において、光学素子１４９を介してバルーン１１０を観察してもよい。 Further, an optical element 149 such as a mirror is attached to the imaging unit 141, and the balloon 110 is interposed via the optical element 149 in a state where the imaging unit 141 is disposed at the distal end portion 130 of the balloon 110 in the inner tube 122 as shown in FIG. May be observed.

　また、撮像部１４１が視野角の比較的狭いカメラである場合、係合部１４７は撮像部１４１を観察窓１２３、１２４、または観察窓１２５に向けて傾けた際における、先端部外周における突起部１３１または突起部１３３と当接する位置に設ける実施形態について説明した。しかし、斜視鏡や広角カメラのように撮像部１４１を傾ける必要がない場合には、突起部を内管１２２におけるバルーン１１０の基端部１２６及び挿通部分１２７における内表面全周に形成し、係合部を撮像部１４１の先端部外周に全周設けてもよい。 Further, when the imaging unit 141 is a camera with a relatively narrow viewing angle, the engaging unit 147 is a protrusion on the outer periphery of the distal end when the imaging unit 141 is tilted toward the observation windows 123 and 124 or the observation window 125. The embodiment provided at the position where it abuts on 131 or the protrusion 133 has been described. However, when it is not necessary to incline the imaging unit 141 as in the case of a perspective mirror or a wide-angle camera, the protrusion is formed on the entire inner surface of the inner end 122 of the balloon 110 and the insertion portion 127 in the inner tube 122. The joint portion may be provided all around the distal end portion of the imaging unit 141.

　また、突起部１３１～１３４は、撮像部１４１の外側面に合致するように、撮像部１４１との接触部分が図４に示すように凹状の曲面に形成される実施形態について記載したが、撮像部１４１を保持できれば、形状は例えば凸形状のように撮像部１４１の外側面の形状と合致しなくてもよい。 In addition, the embodiment has been described in which the protrusions 131 to 134 are formed in a concave curved surface as shown in FIG. 4 so that the contact portion with the imaging unit 141 is formed so as to match the outer surface of the imaging unit 141. As long as the portion 141 can be held, the shape may not match the shape of the outer surface of the imaging unit 141, for example, as a convex shape.

　また、外管１２１の観察窓１２３には、生体から鼻水等の粘液が付着するおそれがあるため、カテーテル１００とは別に観察窓１２３に送水を行ったり、先端部にブラシ等を取り付けたりすることによって観察窓１２３の洗浄を行う機能を有するカテーテルを配置して観察窓１２３を洗浄するようにしてもよい。 In addition, mucus such as runny nose from the living body may adhere to the observation window 123 of the outer tube 121. Therefore, water is supplied to the observation window 123 separately from the catheter 100, or a brush or the like is attached to the distal end portion. Thus, a catheter having a function of cleaning the observation window 123 may be disposed to clean the observation window 123.

　また、上記実施形態に係る撮像部１４１により撮像する対象は、副鼻腔の近傍に限定されない。上記以外にも、血管や人工血管または気管等の内壁や分岐部を観察したり、血管壁に形成されたプラークを観察して色などによる安定・不安定の判別を行ったりしてもよい。さらに、上記以外にも慢性完全閉塞（ＣＴＯ）の場合のマイクロチャネルの位置、ステントストラットの位置、心臓弁の状態、瘤へのコイルの挿入状況、バルーン表面に薬剤を塗布している場合の薬剤が生体内組織へ作用する状況等を観察したりしてもよい。 Further, the object to be imaged by the imaging unit 141 according to the above embodiment is not limited to the vicinity of the sinuses. In addition to the above, the inner wall or branching portion of a blood vessel, an artificial blood vessel, or a trachea may be observed, or plaque formed on the blood vessel wall may be observed to determine whether the color is stable or unstable. In addition to the above, in the case of chronic total occlusion (CTO), the position of the microchannel, the position of the stent strut, the state of the heart valve, the insertion state of the coil into the aneurysm, the drug when the drug is applied to the balloon surface It is also possible to observe a situation where the action acts on the in vivo tissue.

　また、上記実施形態ではバルーン１１０が狭窄部を拡張させる機能を有すると説明したが、上記以外にも種々の特性を付与することができる。例えば、バルーンの表面に狭窄部の組織（血管で言えば石灰化病変、プラークや血栓等）を削る加工を施してもよい。この場合、撮像部１４１で狭窄部組織が削られている様子を確認することができる。また、バルーン１１０をホットバルーンにすることにより、アブレーション治療を行っても良い。この場合、撮像部１４１でアブレーション処置を行った処置部を確認することができる。また、バルーンの材料についてノンコンプライアントバルーン・セミコンプライアントバルーンを採用したり、バルーンを複数用いて例えば血流途絶や器具挿入時のガイドとして用いたり、表面に粘着性を有するバルーンを採用してバルーン拡張により狭窄部に配置されたステント・フィルタなどをバルーン表面に接着させ、バルーンを収縮させて回収したりしてもよい。 In the above embodiment, it has been described that the balloon 110 has a function of expanding the stenosis, but various characteristics other than the above can be imparted. For example, the surface of the balloon may be subjected to a process of cutting a stenotic tissue (calcified lesions such as calcified lesions, plaques, blood clots, etc.). In this case, it can be confirmed that the stenosis tissue is being removed by the imaging unit 141. Further, the ablation treatment may be performed by using the balloon 110 as a hot balloon. In this case, it is possible to confirm the treatment unit that has performed the ablation treatment by the imaging unit 141. Also, non-compliant balloons and semi-compliant balloons are used for the balloon material, or a plurality of balloons are used, for example, as a guide for blood flow disruption or instrument insertion. A stent / filter or the like disposed in the stenosis portion by expansion may be adhered to the balloon surface, and the balloon may be deflated and recovered.

　本出願は、２０１２年１１月８日に出願された日本特許出願番号２０１２－２４６４８９号に基づいており、その開示内容は参照され、全体として組み入れられている。 This application is based on Japanese Patent Application No. 2012-246489 filed on November 8, 2012, the disclosure of which is referenced and incorporated as a whole.

１０　拡張システム、
１００、１００ａ　カテーテル、
１１０　バルーン（拡張体）
１２０　本体部、
１２１　外管、
１２２　内管、
１２３、１２４、１２８　観察窓、
１２５　観察窓（他の観察窓）、
１２６　内管の長手方向におけるバルーンの基端部、
１２７　内管の長手方向におけるバルーン挿通部分、
１３０　内管の長手方向におけるバルーンの先端部
１３１、１３２　突起部、
１３３、１３４　突起部（他の突起部）、
１３５　突出孔、
１３７　単管、
１３８　バルーンを拡張させるための管、
１３９、１４９　光学素子、
１４０　カメラカテーテル、
１４１　撮像部、
１４２　照射部、
１４３　光ファイバ、
１４４　レンズ、
１４５　撮像素子、
１４６　ケーブル、
１４７　係合部、
１４８　張り出し部分、
１６１　ハブ、
１６２　弾性部材、
１６３　ホルダ、
１６４　ルーメン、
１６５　凹部、
１６６　雄ねじ
１６７　雌ねじ、
１６８　突出部、
２００　圧力供給手段、
３００　光源、
４００　表示手段、
Ｅ　自然口、
Ｎ　鼻腔。 10 expansion system,
100, 100a catheter,
110 Balloon (expanded body)
120 body,
121 outer pipe,
122 inner pipe,
123, 124, 128 Observation window,
125 observation window (other observation windows),
126 proximal end of the balloon in the longitudinal direction of the inner tube,
127 Balloon insertion portion in the longitudinal direction of the inner tube,
130 Protruding portions 131, 132 of the balloon in the longitudinal direction of the inner tube,
133, 134 Protrusion (other protrusion),
135 protruding holes,
137 single tube,
138 A tube for expanding the balloon,
139, 149 optical elements,
140 camera catheter,
141 imaging unit,
142 irradiation unit,
143 optical fiber,
144 lenses,
145 image sensor,
146 cable,
147 engaging portion,
148 Overhang part,
161 hub,
162 elastic member,
163 holder,
164 lumens,
165 recess,
166 male thread 167 female thread,
168 protrusion,
200 pressure supply means,
300 light sources,
400 display means,
E Natural mouth,
N Nasal cavity.

Claims (6)

　拡張可能な拡張体と、
　前記拡張体が先端に取り付けられる長尺状かつ中空の本体部と、
　前記本体部の内部において前記本体部の長手方向に沿って進退移動可能に配置された撮像部と、を有し、
　前記撮像部は、少なくとも前記拡張体よりも基端側から前記拡張体を超える先端側まで進退移動可能であり、
　前記本体部は、前記撮像部が向けられた方向を観察する観察窓を有するカテーテル。 An extensible extension, and
A long and hollow main body to which the expansion body is attached to the tip; and
An imaging unit arranged to be movable back and forth along the longitudinal direction of the main body within the main body,
The imaging unit is capable of moving back and forth at least from the base end side to the distal end side beyond the expansion body than the expansion body,
The catheter having an observation window for observing a direction in which the imaging unit is directed. 　前記本体部は、前記拡張体よりも前記基端側において前記観察窓に向けて前記撮像部を傾けて保持する突起部と、を有し、
　前記観察窓は、前記本体部において前記拡張体よりも前記基端側に設けられる請求項１に記載のカテーテル。 The main body has a protrusion that tilts and holds the imaging unit toward the observation window on the base end side of the expansion body,
The catheter according to claim 1, wherein the observation window is provided on the base end side of the expansion body in the main body portion. 　前記拡張体は透明であり、
　前記本体部は前記拡張体を挿通する挿通部分と、
　前記挿通部分において前記撮像部が向けられた方向を観察するための他の観察窓と、
　前記挿通部分において前記他の観察窓に向けて前記撮像部を傾けて保持する他の突起部と、
をさらに有する請求項２に記載のカテーテル。 The extension is transparent;
The body portion is inserted through the expansion body, and
Another observation window for observing the direction in which the imaging unit is directed in the insertion portion;
Other protrusions that tilt and hold the imaging unit toward the other observation window in the insertion portion;
The catheter according to claim 2, further comprising: 　前記突起部は、対になり、長手方向に離間して配置される請求項２に記載のカテーテル。 The catheter according to claim 2, wherein the protrusions are paired and are spaced apart in the longitudinal direction. 　前記突起部は、前記撮像部との接触部位が凹状の曲面に形成される請求項２に記載のカテーテル。 The catheter according to claim 2, wherein the protruding portion is formed in a concave curved surface at a contact portion with the imaging unit. 　前記撮像部は、前記突起部と係合する係合部を有する請求項２に記載のカテーテル。 The catheter according to claim 2, wherein the imaging unit has an engaging portion that engages with the protruding portion.
PCT/JP2013/079270 2012-11-08 2013-10-29 Catheter Ceased WO2014073420A1 (en)

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JP2012246489A JP2016010419A (en) 2012-11-08 2012-11-08 catheter

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112138266A (en) * 2020-09-03 2020-12-29 威海世创医疗科技有限公司 Cervical balloon dilatation catheter with visual control function

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH01135901U (en) * 1988-03-11 1989-09-18
JP2008142346A (en) * 2006-12-11 2008-06-26 Olympus Corp Fluorescence endoscope

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH01135901U (en) * 1988-03-11 1989-09-18
JP2008142346A (en) * 2006-12-11 2008-06-26 Olympus Corp Fluorescence endoscope

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112138266A (en) * 2020-09-03 2020-12-29 威海世创医疗科技有限公司 Cervical balloon dilatation catheter with visual control function

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