WO2015056662A1 - アブレーションシステム及びアブレーションデバイス - Google Patents

アブレーションシステム及びアブレーションデバイス Download PDF

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Publication number
WO2015056662A1
WO2015056662A1 PCT/JP2014/077296 JP2014077296W WO2015056662A1 WO 2015056662 A1 WO2015056662 A1 WO 2015056662A1 JP 2014077296 W JP2014077296 W JP 2014077296W WO 2015056662 A1 WO2015056662 A1 WO 2015056662A1
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WIPO (PCT)
Prior art keywords
balloon
shaft
fluid
light guide
ablation device
Prior art date
Application number
PCT/JP2014/077296
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English (en)
French (fr)
Japanese (ja)
Inventor
宮川　克也
祐紀 西村
夏美 島崎
Original Assignee
ニプロ株式会社
宮川　克也
祐紀 西村
夏美 島崎
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
Priority claimed from JP2013214549A external-priority patent/JP6183134B2/ja
Priority claimed from JP2014104476A external-priority patent/JP6439274B2/ja
Priority claimed from JP2014104452A external-priority patent/JP6354323B2/ja
Application filed by ニプロ株式会社, 宮川　克也, 祐紀 西村, 夏美 島崎 filed Critical ニプロ株式会社
Priority to CN201480056430.3A priority Critical patent/CN105636540B/zh
Priority to CN201910849575.3A priority patent/CN110420057B/zh
Priority to ES14853946T priority patent/ES2739848T3/es
Priority to EP14853946.3A priority patent/EP3058888B1/en
Priority to EP18169873.9A priority patent/EP3378430B1/en
Priority to US15/028,090 priority patent/US10631930B1/en
Publication of WO2015056662A1 publication Critical patent/WO2015056662A1/ja
Priority to US16/818,299 priority patent/US10925672B2/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
    • A61B2018/00285—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434—Neural system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505—Urinary tract
    • A61B2018/00511—Kidney
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00744—Fluid flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00821—Temperature measured by a thermocouple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2255—Optical elements at the distal end of probe tips
    • A61B2018/2261—Optical elements at the distal end of probe tips with scattering, diffusion or dispersion of light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2255—Optical elements at the distal end of probe tips
    • A61B2018/2272—Optical elements at the distal end of probe tips with reflective or refractive surfaces for deflecting the beam

Definitions

  • the present invention relates to an ablation system and an ablation device for performing ablation on a tissue around a lumen of a living body.
  • renal artery sympathetic nerve ablation As one of renal artery sympathetic nerve ablation, a balloon catheter with electrodes is inserted into the left and right renal arteries, the electrodes are heated and heated from the lumen side of the renal arteries, and the heat is transferred to the adventitia of the renal arteries. There is a technique to reach and cauterize nerves.
  • the pulse laser is guided to the renal artery using a catheter, and the pulse laser is focused on the outer membrane of the renal artery by a condensing lens, thereby generating multiphoton absorption at the focal position.
  • Devices for performing ablation on the outer membrane at a position have been proposed (Patent Documents 1 and 2).
  • the devices described in Patent Documents 1 and 2 have a problem that the structure of the catheter becomes complicated because a condensing lens or the like is disposed in the catheter.
  • the focal position of the pulse laser depends on the thickness of the blood vessel wall and the position of the catheter in the blood vessel, there is a problem that it is difficult to accurately position the focal position of the pulse laser at a desired position.
  • there are individual differences in the thickness of the blood vessel wall so it is necessary to measure the thickness of the blood vessel wall of the individual to be ablated in advance and adjust the focal position of the condenser lens to the thickness of the blood vessel wall.
  • the catheter is positioned out of the center of the blood vessel, there may be a problem that the focal position of the pulse laser is not uniform in the thickness direction of the blood vessel wall in the circumferential direction of the blood vessel.
  • the present invention has been made in view of the above-described circumstances, and an object of the present invention is to heat a deep tissue around the lumen of a living body and suppress thermal damage to the lumen lumen. It is to provide an ablation system or an ablation device capable of performing the above.
  • Another object of the present invention is to provide an ablation device in which a reflector is hardly damaged even when the output of a laser beam is increased.
  • the ablation system according to the present invention is provided with an elastically inflatable balloon on the distal end side of the shaft, and a first lumen for allowing fluid to flow into the balloon, for allowing fluid to flow out from the balloon.
  • An ablation device in which a light guide material for guiding laser light into the balloon is provided along the shaft, laser light generating means for irradiating the light guide material with laser light, and the first Fluid return means for returning fluid to the internal space of the balloon through the lumen and the second lumen.
  • the ablation device includes a reflective material that reflects laser light emitted from the light guide material in the balloon in a second direction intersecting a first direction in which the light guide material is extended, and at least The reflective material can move in the balloon along the first direction, and can rotate about the first direction as an axis.
  • the balloon In the ablation device inserted into the lumen of the living body, the balloon is inflated at a desired position, and the fluid is returned to the internal space of the balloon through the first lumen and the second lumen by the fluid return means.
  • the laser light emitted from the laser light generating means is guided into the balloon by the light guide material and reflected in the second direction by the reflective material. Thereby, the laser beam is irradiated to the tissue around the lumen.
  • the reflecting material is moved in the balloon along the first direction and rotated about the first direction as an axis, the tissue around the lumen is uniformly irradiated with laser light.
  • the balloon is in contact with the inner surface of the lumen, and the heating of the inner surface by the laser light is suppressed by being cooled by the fluid circulating in the balloon.
  • the reflective material is integrally provided on a distal end side of the light guide material, the light guide material is movable along the first direction with respect to the shaft, and the first It may be rotatable about one direction as an axis.
  • the reflective material is rotated around the first direction while being moved in the balloon along the first direction.
  • the laser light generating means may irradiate the light guide material with laser light having a waveform that changes continuously and periodically.
  • the present invention provides a shaft, a balloon that is provided on the distal end side of the shaft and is elastically inflatable, and a first lumen that is provided along the shaft and allows fluid to flow into the balloon. And a second lumen for allowing fluid to flow out of the balloon, a light guide material provided along the shaft for guiding laser light into the balloon, and A reflecting material that reflects laser light emitted from the light guide material in a balloon in a second direction intersecting the first direction in which the light guide material is extended, and at least the reflective material is
  • the ablation device may be regarded as an ablation device that is movable in the balloon along the first direction and is rotatable about the first direction as an axis.
  • the reflective material is integrally provided on the tip side of the light guide material, the light guide material is movable along the first direction with respect to the shaft, and It may be rotatable about one direction as an axis.
  • An ablation device includes a main shaft having a fluid lumen through which a fluid circulates, a balloon that is provided on a distal end side of the main shaft and is inflatable by the fluid that circulates through the fluid lumen, and a guide A wire lumen through which a wire can be inserted; a sub-shaft inserted into the main shaft and extending into the balloon; and provided along the sub-shaft to guide laser light into the balloon A light guide material; and a reflective material that reflects the laser light emitted from the light guide material in the balloon in a direction intersecting the axial direction.
  • the sub shaft is movable in the axial direction with respect to the main shaft, and is rotatable around the axial direction.
  • the light guide material and the reflective material are movable and rotatable along with the sub shaft.
  • the guide wire inserted into the lumen of the living body is inserted through the wire lumen of the ablation device, and the main shaft is inserted along the guide wire to a desired position in the lumen.
  • fluid is flowed into the balloon and inflated.
  • the fluid flowing into the balloon is appropriately refluxed.
  • the laser light applied to the light guide material is guided into the balloon and reflected by the reflective material in a direction intersecting the axial direction. Thereby, the laser beam is irradiated to the tissue around the lumen.
  • the subshaft is moved in the balloon along the axial direction and rotated around the axial direction, the light guide material and the reflective material move and rotate along the outer periphery of the subshaft, and around the lumen.
  • the tissue is uniformly irradiated with laser light. At this time, even if the guide wire is inserted through the wire lumen of the sub shaft, the laser light is not blocked by the guide wire.
  • the balloon is in contact with the inner surface of the lumen, and the heating of the inner surface by the laser beam is cooled by the fluid circulating in the balloon.
  • the reflective material may be provided integrally on the tip side of the light guide material.
  • the subshaft may be inserted through the fluid lumen.
  • a connector having a port through which a fluid flows is connected to the base end side of the main shaft, and the port is connected to the fluid lumen so as to be able to flow the fluid.
  • the optical material may be rotatable about the axial direction with respect to the connector.
  • the present invention includes the ablation device, laser light generation means for irradiating the light guide material with laser light, and fluid return means for returning fluid to the internal space of the balloon through the fluid lumen. It may be viewed as an ablation system.
  • An ablation device is provided along a shaft, a balloon that is provided on the distal end side of the shaft and is elastically inflatable, and is provided along the shaft so as to distribute fluid to the balloon.
  • the fluid lumen is provided along the shaft, and the light guide material guides the laser light into the balloon.
  • the light guide material extends the laser light emitted from the light guide material in the balloon.
  • a reflecting material that reflects in a second direction that intersects the first direction.
  • the reflective material is disposed to face the first direction with respect to the tip of the light guide material.
  • the ablation device inserted into the lumen of the living body, fluid is circulated at a desired position, and the balloon is inflated.
  • Laser light is guided into the balloon by the light guide material and reflected in the second direction by the reflective material.
  • the laser beam is irradiated to the tissue around the lumen.
  • the balloon is in contact with the inner surface of the lumen, and heating of the inner surface by the laser light is suppressed by being cooled by the fluid in the balloon. Since the reflective material is disposed to face the tip of the light guide material, the reflective material is not easily damaged by the laser light.
  • the reflecting material is disposed in a flow path of fluid flowing through the balloon.
  • the reflecting material has a metal layer on the surface.
  • the reflector is movable in the balloon along the first direction, and is rotatable around the axis of the shaft along the first direction.
  • the rotation around the axis of the shaft includes rotation of the reflecting material at a position spaced from the axis of the shaft and rotation of the reflecting material on the axis of the shaft.
  • a light guide tube is provided along the shaft that is movable in the balloon along the first direction and is rotatable about the axis of the shaft along the first direction.
  • the light guide material and the reflective material are disposed in the internal space of the light guide tube.
  • the light guide tube has an opening that allows an external fluid to contact the reflective surface of the reflective material.
  • the present invention includes the ablation device, laser light generation means for irradiating the light guide material with laser light, and fluid return means for returning fluid to the internal space of the balloon through the fluid lumen. It may be viewed as an ablation system.
  • An ablation device is provided along a shaft, a tip end side of the shaft, is elastically inflatable, and is formed along the shaft, and allows fluid to flow into the balloon.
  • a light guide material for reflecting or diffusing laser light emitted from the light guide material in the balloon in a direction intersecting the first direction in which the light guide material is extended, and provided in the balloon And has a reflection layer for reflecting or blocking the laser beam reflected or diffused by the diffusion member on the inner surface side of the diffusion member, and the laser A tubular member having a transmission window that transmits light to the outside of the reflective layer.
  • the balloon In the ablation device inserted into the lumen of the living body, the balloon is inflated at a desired position, and the fluid is refluxed to the internal space of the balloon through the first lumen and the second lumen.
  • the laser light applied to the light guide material is guided into the balloon, and reflected or diffused in the direction intersecting the first direction by the diffusion member.
  • the reflected or diffused laser light is reflected by the reflective layer of the tubular member.
  • the reflected or diffused laser light travels from the transmission window of the tubular member toward the outside of the tubular member, that is, the tissue around the lumen.
  • the balloon is in contact with the inner surface of the lumen, and the heating of the inner surface by the laser light is suppressed by being cooled by the fluid circulating in the balloon.
  • the tubular member may be movable in a direction in which at least one of a position in the circumferential direction having the first direction of the transmission window as an axis and a position in the first direction is displaced.
  • the laser beam is uniformly irradiated to the tissue around the lumen.
  • the diffusion member and the tubular member may be provided integrally with the light guide material.
  • the movement of the tubular member can be controlled by operating the proximal end side of the light guide material.
  • the transmission window may have a spiral shape extending in the first direction.
  • the laser light is uniformly applied to the tissue around the lumen.
  • a plurality of the transmission windows may be provided at different positions with respect to the first direction.
  • the laser light is uniformly applied to the tissue around the lumen.
  • the plurality of transmission windows may be arranged at different positions with respect to the circumferential direction with the first direction as an axis.
  • the laser beam traveling in the circumferential direction since the direction of the laser beam traveling in the circumferential direction is different, the laser beam is not concentrated at a specific position in the first direction. Thereby, the heating to the inner surface of the lumen can be suppressed.
  • the plurality of transmission windows may be such that each transmission range partially overlaps in the first direction.
  • the present invention it is possible to heat a deep tissue around the lumen of a living body and suppress thermal damage to the lumen lumen.
  • FIG. 1 is a diagram illustrating a configuration of an ablation system 10 including an ablation device 11 in a state in which a balloon 21 according to the first embodiment is in a contracted posture.
  • FIG. 2 is a partial cross section of the ablation device 11.
  • FIG. 3 is a cross-sectional view showing the ablation device 11 in the state where the renal artery 40 is ablated.
  • FIG. 4 is a partial cross-sectional view of the vicinity of the balloon 71 of the ablation device 61 according to the second embodiment.
  • FIG. 5 is a partial sectional view of the vicinity of the connector portion 73 of the ablation device 61.
  • FIG. 6 is a diagram illustrating a configuration of an ablation system 110 including the ablation device 111 in a state where the balloon 121 according to the third embodiment is in a contracted posture.
  • FIG. 7 is a partial cross section of the ablation device 111.
  • FIG. 8 is a cross-sectional view showing the ablation device 111 in a state where the renal artery 40 is ablated.
  • FIG. 9A is a partial cross-sectional view of the vicinity of the balloon 171 of the ablation device 161 according to the fourth embodiment
  • FIG. 9B is a cross-sectional view showing a BB cut surface in FIG. 9A.
  • FIG. 9C is an enlarged cross-sectional view showing the vicinity of C in FIG. FIG.
  • FIG. 10 is a partial cross-sectional view near the connector portion 173 of the ablation device 161.
  • FIG. 1 is a diagram illustrating a configuration of an ablation system 210 including an ablation device 211 in a state in which a balloon 221 according to a fifth embodiment is in a contracted posture.
  • FIG. 12 is a partial cross section of the ablation device 211.
  • FIG. 13 is a side view of the tubular member 234.
  • FIG. 14 is a cross-sectional view showing the ablation device 211 in a state in which the renal artery 40 is ablated.
  • FIG. 15 is a side view of a tubular member 234 according to a modification of the fifth embodiment.
  • the ablation system 10 includes an ablation device 11, a laser light generation unit 12, a fluid reflux unit 13, a drive mechanism 14, and a control unit 15.
  • the ablation device 11 has a shaft 22 provided with a balloon 21 on the distal end side.
  • the shaft 22 is a member that is long in the axial direction 101.
  • the shaft 22 is a tubular body that can be elastically bent so as to be bent with respect to the axial direction 101.
  • the direction in which the shaft 22 in the uncurved state extends is referred to as the axial direction 101 in this specification.
  • the axial direction 101 corresponds to the first direction.
  • the in-tube 27 and the optical fiber 29 are inserted through the shaft 22.
  • the outer diameter and inner diameter of the shaft 22 are not necessarily constant with respect to the axial direction 101, but from the viewpoint of operability, it is preferable that the rigidity on the base end side is higher than the tip end side.
  • the shaft 22 can be made of a known material used for a balloon catheter, such as synthetic resin or stainless steel, and is not necessarily composed of only one type of material, and a plurality of parts made of other materials are assembled. It may be configured.
  • the proximal end side refers to the rear side (right side in FIG. 1) with respect to the direction in which the ablation device 11 is inserted into the blood vessel.
  • the distal end side refers to the front side (left side in FIG. 1) with respect to the direction in which the ablation device 11 is inserted into the blood vessel.
  • the balloon 21 is provided on the tip side of the shaft 22.
  • the balloon 21 expands elastically when fluid (liquid, gas) flows into the internal space and contracts when fluid flows out of the internal space. 1 and 2, the balloon 21 in a deflated state is shown.
  • the internal space of the balloon 21 is in communication with the internal space of the shaft 22 and the internal space of the in-side tube 27.
  • the balloon 21 expands in a radial direction orthogonal to the axial direction 101 so that the center of the axial direction 101 becomes the maximum diameter.
  • the internal space of the in-side tube 27 corresponds to the first lumen
  • the internal space of the shaft 22 corresponds to the second lumen.
  • An out port 28 is provided on the proximal end side of the shaft 22.
  • the out port 28 is continuous with the internal space of the shaft 22.
  • the fluid recirculated to the balloon 21 flows out from the out port 28 through the internal space of the shaft 22.
  • a hub 23 is provided at the base end of the shaft 22.
  • An optical fiber 29 is inserted through the hub 23.
  • the hub 23 is provided with an in-port 26 separately from the insertion port of the optical fiber 29.
  • the in port 26 is continuous with the internal space of the in side tube 27. Through the inner space of the in-side tube 27, the fluid recirculated to the balloon 21 flows from the in-port 26.
  • a guide wire tube 24 is provided outside the shaft 22.
  • the guide wire tube 24 is sufficiently shorter than the length of the shaft 22 in the axial direction 101.
  • the guide wire tube 24 is not necessarily provided outside the shaft 22.
  • the guide wire tube 24 may be inserted into the inner space of the shaft 22 if a monorail type is adopted.
  • the in-side tube 27 inserted into the shaft 22 has a distal end leading to the internal space of the balloon 21 and a proximal end connected to the in-port 26.
  • the distal end of the in-side tube 27 is connected to the distal tip 25 provided on the distal end side of the balloon 21.
  • openings 30 and 31 that penetrate the peripheral wall of the in-side tube 27 are provided.
  • the openings 30 and 31 are for fluid flowing through the inner space of the in-side tube 27 to flow into the balloon 21, and are arranged at different positions with respect to the circumferential direction of the axial direction 101.
  • the tip 25 is provided with a marker made of a contrast medium.
  • the contrast agent include barium sulfate, bismuth oxide, and bismuth subcarbonate.
  • the optical fiber 29 is inserted from the hub 23 into the in-side tube 27 and extends to the inside of the balloon 21.
  • the optical fiber 29 propagates the laser light generated by the laser light generation means 12 and applied to the proximal end of the optical fiber 29 to the distal end side.
  • an optical fiber having a refractive index that totally reflects at the wavelength of the laser light is appropriately adopted. Specific examples include a single mode fiber, a polarization maintaining fiber, a multimode fiber, and a bundle fiber for image transmission. .
  • the optical fiber 29 corresponds to a light guide material.
  • the distal end surface 32 of the optical fiber 29 is a flat surface inclined at an angle of 45 degrees with respect to the axial direction 101.
  • a reflective material 33 is laminated on the distal end surface 32.
  • a material that totally reflects the laser beam propagating through the optical fiber 29 is used as the reflecting material 33.
  • quartz glass or the like is employed, but the material is not particularly limited.
  • the optical fiber 29 and the reflector 33 can rotate about the axial direction 101 as a unit with respect to the in-side tube 27 and can slide in the axial direction 101.
  • the rotation and sliding of the optical fiber 29 and the reflector 33 are controlled by directly or indirectly operating the proximal end side of the optical fiber 29 extended from the hub 23. Specifically, the optical fiber 29 is rotated and slid by applying a driving force from the driving mechanism 14 to the proximal end side of the optical fiber 29.
  • a temperature sensor may be provided on the outer wall of the in-side tube 27 in the balloon 21.
  • a known sensor such as a thermocouple can be used as long as it can be installed inside the balloon 21.
  • the temperature of the fluid in the balloon 21 can be monitored by guiding the cable extended from the temperature sensor to the outside.
  • a third lumen may be provided on the shaft 22 and an imaging member such as an endoscope, IVUS, or OCT may be inserted.
  • the laser light generation means 12 is, for example, one in which light from an excitation source is given to a laser medium, and is oscillated and output by reflection of an optical resonator.
  • the laser beam output from the laser beam generating means 12 is preferably a continuous wave, and the wavelength of the laser beam is preferably in the range of 400 to 2000 nm. In particular, when the wavelength of the laser beam is in the range of 800 to 1500 nm (915 nm, 980 nm, 1470 nm), a local temperature increase can be confirmed, and the intima of the renal artery can be appropriately heated.
  • the laser light generating means 12 is connected to the base end of the optical fiber 29, and the laser light output from the laser light generating means 12 is irradiated on the base end face of the optical fiber 29.
  • the fluid reflux means 13 a known device having a roller pump or a syringe pump can be used.
  • the fluid return means 13 is connected to the in port 26 and the out port 28 of the ablation device 11 through a flow path such as a tube.
  • the fluid recirculation means 13 has a tank for storing fluid, and supplies the fluid from the tank to the in port 26 at a desired flow rate and pressure by the driving force of the pump. Further, the fluid flowing out from the out port 28 may be returned to the tank or discarded as a waste liquid.
  • reflux means 13 may be provided with the cooling device for cooling the fluid in a tank.
  • the fluid is not particularly limited, but for the purpose of ablation of the renal artery, a mixed solution of physiological saline and contrast medium is preferable.
  • the drive mechanism 14 applies a driving force for rotating and sliding the proximal end side of the optical fiber 29 with respect to the axial direction 101, and a mechanism in which a motor, a slider, or the like is combined may be employed.
  • the drive mechanism 14 is not essential, and the optical fiber 29 may be rotated and slid with respect to the axial direction 101 by the operator handling the proximal end side of the optical fiber 29.
  • the control means 15 generates, for example, laser light from the laser light generation means 12 at a predetermined light intensity and time based on a pre-programmed protocol, controls the flow rate and pressure of the fluid reflux means 13, and is driven. The drive amount and timing of the mechanism 14 are controlled.
  • the control means 15 includes an arithmetic device for performing these operation controls.
  • the ablation device 11 is connected to a laser beam generation unit 12, a fluid reflux unit 13, and a drive mechanism 14. Further, the laser light generating means 12, the fluid reflux means 13, and the drive mechanism 14 are connected to the control means 15.
  • the control means 15 is preset with a program suitable for performing ablation on the renal artery 40.
  • the ablation device 11 is inserted into the renal artery 40 from the distal end side.
  • a guide wire is inserted in advance and reaches the target portion while performing imaging under fluoroscopy.
  • Such insertion of the guide wire is performed by a known method disclosed in, for example, Japanese Patent Application Laid-Open Nos. 2006-326226 and 2006-230442.
  • the ablation device 11 When the ablation device 11 is inserted into the renal artery 40, no fluid is pressed into the balloon 21, and the balloon 21 is in a deflated state. A guide wire is inserted into the guide wire tube 24 from the tip of the ablation device 11 in this state. Then, the ablation device 11 is inserted into the renal artery 40 along the guide wire. The insertion position of the ablation device 11 in the renal artery 40 is grasped by, for example, confirming a marker placed on the distal tip 25 under the X-ray.
  • the fluid return means 13 is driven by the control means 15, and fluid is transferred from the fluid return means 13 through the in-side tube 27 to the balloon 21. And the balloon 21 is expanded. Further, the fluid is recirculated from the balloon 21 through the shaft 22 to the fluid recirculation means 13 from the out port 28.
  • the fluid recirculation to the balloon 21 indicated by an arrow 51 in FIG. 3 is managed so as to have a desired flow velocity and pressure by controlling the fluid recirculation unit 13 by the control unit 15.
  • the fluid stored in the fluid return means 13 is managed at a temperature suitable for cooling the intima of the renal artery 40.
  • the laser light generation means 12 and the drive mechanism 14 are driven by the control means 15, and the laser light 42 generated from the laser light generation means 12 is propagated into the balloon 21 through the optical fiber 29, and the axis line is formed by the reflector 33. Reflected in a direction intersecting the direction 101.
  • the reflected laser light 42 passes through the in-side tube 27 and the balloon 21, is irradiated onto the blood vessel wall of the renal artery 40, passes through the blood vessel wall, and reaches the nerve 41.
  • the nerve 41 irradiated with the laser beam 42 (shown by a two-dot chain line for convenience in FIG. 3) is ablated.
  • the intensity and irradiation time of the laser light 42 are managed by the control means 15.
  • the optical fiber 29 propagating the laser light 42 is slid while being rotated with respect to the axial direction 101. Since the optical fiber 29 is rotated and the reflecting material 33 is also rotated, the direction of the laser light 42 reflected by the reflecting material 33 is displaced in the circumferential direction of the axial direction 101 (arrow 52). Thereby, it is possible to uniformly ablate the nerve 41 existing in the circumferential direction of the renal artery 40. Further, since the optical fiber 29 is slid and the reflecting material 33 is also slid, the laser light 42 reflected by the reflecting material 33 is displaced in the axial direction 101 (arrow 53). Thereby, it is possible to uniformly ablate the nerve 41 existing in the direction in which the renal artery 40 extends (the same direction as the axial direction 101).
  • the rotation and slide pattern of the optical fiber 29 can be arbitrarily set by programming in the control means 15. Therefore, for example, when the optical fiber 29 is slid while being rotated, the nerve 41 of the renal artery 40 can be irradiated with the laser beam 42 spirally. In addition, when the rotation or slide of the optical fiber 29 is temporarily stopped, the laser light 42 is irradiated from the laser light generating means 12 so that the nerve 41 of the renal artery 40 is irradiated with the laser light 42 in a spot shape. it can. In other words, the timing and order of irradiating the laser beam 42 to the nerves 41 existing all around the predetermined range in the direction in which the renal artery 40 extends can be arbitrarily set.
  • the laser beam 42 reflected by the reflecting material 33 is also irradiated to the tissue on the intima side of the renal artery 40 before reaching the nerve 41 of the renal artery 40.
  • the inflated balloon 21 is in contact with the intima of the renal artery 40, and fluid is circulated in the balloon 21. Due to the cooling effect of the fluid, heating of the intima side of the renal artery 40 is suppressed. Therefore, it is preferable that the slide range of the optical fiber 29 is a range in which the balloon 21 is in contact with the intima of the renal artery 40.
  • the nerve 41 of the renal artery 40 can be ablated, and heating to the intima of the renal artery 40 can be suppressed to suppress thermal damage to the intima.
  • the ablation device 11 since the reflecting material 33 is integrally provided on the distal end side of the optical fiber 29 and the optical fiber 29 can move and rotate along the axial direction 101 with respect to the shaft 22, the ablation device 11 has a simple configuration. Realized. Further, the movement and rotation of the reflector 33 can be operated via the optical fiber 29 on the proximal end side of the shaft 22.
  • the reflecting material 33 is integrally provided at the tip of the optical fiber 29, but a member that transmits laser light such as a lens is provided between the tip of the optical fiber 29 and the reflecting material 33. It may be. Further, the tip of the optical fiber 29 and the reflecting material 33 are arranged through a space, and the optical fiber 29 and the reflecting material 33 are connected so that the movement and rotation of the optical fiber 29 are transmitted to the reflecting material 33. It may be. Further, the optical fiber 29 and the reflecting material 33 are completely independent, and the reflecting material 33 is fixed to, for example, the in-side tube 27 and is configured to be interlocked with the rotation and movement of the in-side tube 27. Also good.
  • the optical fiber 29 is inserted through the in-side tube 27.
  • the insertion path of the optical fiber 29 is not limited as long as the tip side reaches the balloon 21. Therefore, for example, it may be inserted into the internal space of the shaft 22 or may be inserted into the balloon 21 from the outside of the shaft 22.
  • the ablation device 61 constitutes a part of an ablation system having a laser light generation unit 12, a fluid reflux unit 13, a drive mechanism 14, and a control unit 15.
  • the ablation device 61 has a main shaft 72 provided with a balloon 71 on the distal end side.
  • the main shaft 72 is a member that is long in the axial direction 101.
  • the main shaft 72 is a tubular body that can be elastically bent so as to bend with respect to the axial direction 101.
  • the direction in which the main shaft 72 in the uncurved state extends is referred to as the axial direction 101 in this specification.
  • the main shaft 72 In the main shaft 72, an in-side tube 77, an optical fiber 79, a sub shaft 74, and a guide wire shaft 84 are inserted.
  • the outer diameter and inner diameter of the main shaft 72 are not necessarily constant with respect to the axial direction 101, but from the viewpoint of operability, it is preferable that the rigidity on the proximal side is higher than the distal side.
  • the main shaft 72 can be made of a known material used for a balloon catheter, such as synthetic resin or stainless steel, and is not necessarily composed of only one type of material, and a plurality of parts made of other materials are assembled. And may be configured.
  • the proximal side refers to the rear side (right side in FIG. 4) with respect to the direction in which the ablation device 61 is inserted into the blood vessel.
  • the distal side refers to the front side (left side in FIG. 4) with respect to the direction in which the ablation device 61 is inserted into the blood vessel.
  • a balloon 71 is provided on the front end side of the main shaft 72.
  • the balloon 71 expands elastically when fluid (liquid, gas) flows into the internal space and contracts when fluid flows out of the internal space.
  • FIG. 4 shows the balloon 71 in an expanded state.
  • the internal space of the balloon 71 communicates with the internal space of the main shaft 72 and the internal space of the in-side tube 77.
  • the balloon 71 expands in the radial direction orthogonal to the axial direction 101 so that the center of the axial direction 101 becomes the maximum diameter.
  • a fluid having a flow rate sufficient to maintain the pressure of the fluid that maintains the inflation of the balloon 71 flows into the balloon 71 and flows out from the balloon 71 through the internal space of the main shaft 72, whereby the fluid recirculates in the balloon 71. Is done.
  • the material of the balloon 71 and the method for fixing the balloon 71 and the main shaft 72 known materials and methods used in balloon catheters can be used.
  • the internal space of the in-side tube 77 and the space between the main shaft 72 and the in-side tube 77 correspond to the fluid lumen.
  • the in-side tube 77 inserted into the main shaft 72 has a distal end side reaching the internal space of the balloon 71 and a proximal end side connected to the in-port 76 of the connector portion 73.
  • the distal end of the in-side tube 77 is connected to a distal tip 75 provided on the distal end side of the balloon 71.
  • openings 80 and 81 that penetrate the peripheral wall of the in-side tube 77 are provided.
  • the openings 80 and 81 are for allowing the fluid flowing through the inner space of the in-side tube 77 to flow into the balloon 71, and are arranged at different positions with respect to the circumferential direction of the axial direction 101.
  • the tip chip 75 is provided with a marker made of a contrast medium.
  • the contrast agent include barium sulfate, bismuth oxide, and bismuth subcarbonate.
  • a sub shaft 74 is inserted into the in-side tube 77.
  • the sub shaft 74 extends from the outside of the connector portion 73 to the inside of the balloon 71.
  • the sub-shaft 74 is a member that is long in the axial direction 101, is elastically bent so as to bend with respect to the axial direction 101, and is not connected to the tip chip 75, so that the rotation around the axial direction 101 can be rotated by the connector portion. It is a tubular body that can transmit from the 73 side to the tip side.
  • the sub shaft 74 is a tubular body made of, for example, a stainless coil.
  • a guide wire shaft 84 is inserted into the internal space of the sub shaft 74.
  • the guide wire shaft 84 is connected to the tip end 75.
  • a hole 85 is formed in the distal tip 75 along the axial direction 101 so that the internal space of the guide wire shaft 84 is continued to the outside.
  • the distal end of the guide wire shaft 84 reaches the distal end of the distal end tip 75 through the hole 85.
  • As the material of the guide wire shaft 84 a known material can be adopted.
  • the internal space of the guide wire shaft 84 corresponds to a wire lumen.
  • the optical fiber 79 is bonded to the outer periphery of the sub shaft 74 from the outside of the connector portion 73 and extends in the axial direction 101 to reach the inside of the balloon 71.
  • the optical fiber 79 propagates the laser light generated by the laser light generation means 12 and applied to the proximal end of the optical fiber 79 to the distal end side.
  • an optical fiber having a refractive index that totally reflects at the wavelength of the laser light is appropriately adopted. Specific examples include a single mode fiber, a polarization maintaining fiber, a multimode fiber, and a bundle fiber for image transmission. .
  • the optical fiber 79 corresponds to the light guide material.
  • the front end surface 82 of the optical fiber 79 is an angle of 45 degrees with respect to the axial direction 101 and is a flat surface inclined so that the outer surface faces the sub shaft 74 side.
  • a reflective material 83 is laminated on the distal end surface 82.
  • a material that totally reflects the laser beam propagating through the optical fiber 79 is used as the reflecting material 83.
  • quartz glass or the like is adopted, but the material is not particularly limited.
  • the optical fiber 79 and the reflector 83 can rotate about the axial direction 101 integrally with the sub shaft 74 and can slide in the axial direction 101.
  • the rotation and sliding of the optical fiber 79 and the reflector 83 are controlled by directly or indirectly operating the proximal end side of the sub shaft 74 extending from the connector portion 73. Specifically, when the driving force from the driving mechanism 14 is applied to the base end side of the sub shaft 74, the optical fiber 79 and the reflecting material 83 rotate and slide along the outer periphery of the sub shaft 74 together with the sub shaft 74. Is done.
  • a temperature sensor may be provided on the outer wall of the in-side tube 77 in the balloon 71.
  • a known sensor such as a thermocouple can be used as long as it can be installed inside the balloon 71.
  • the temperature of the fluid in the balloon 71 can be monitored by guiding the cable extended from the temperature sensor to the outside.
  • a connector portion 73 is provided on the proximal end side of the main shaft 72.
  • the connector part 73 is a part that the practitioner has when operating the ablation device 61.
  • the connector part 73 is provided with an out port 78.
  • the out port 78 is continuous with the space between the main shaft 72 and the in-side tube 77. Through this space, the fluid returned to the balloon 71 flows out from the out port 78.
  • the connector portion 73 is provided with an in port 76.
  • the in port 76 is continuous with the space between the in side tube 77 and the sub shaft 74. Through this space, the fluid returned to the balloon 71 flows from the in port 76.
  • the in port 76 and the out port 78 are liquid-tightly separated by O-rings 86 and 87, respectively. Further, the in port 76 and the out port 78 are connected to the fluid recirculation means 13 shown in FIG.
  • the sub shaft 74 and the optical fiber 79 are extended from the base end of the connector part 73 to the outside.
  • the sub shaft 74 and the optical fiber 79 can move along the axial direction 101 with respect to the connector portion 73 and can rotate around the axial direction 101.
  • the periphery of the sub shaft 74 and the optical fiber 79 is secured by an O-ring 88.
  • the optical fiber 79 is connected to the laser light generating means 12 shown in FIG. 1, and the sub shaft 74 is connected to the drive mechanism 14 shown in FIG.
  • the usage method of the ablation device 61 described above is the same as the usage method of the ablation device 11, and is used as the ablation system 10 shown in FIG. 1 as an example of the usage method.
  • the ablation device 61 is inserted into the renal artery 40 from the distal end side.
  • a guide wire is inserted into the renal artery 40 in advance and reaches the target portion, and the guide wire is inserted into the guide wire shaft 84 of the ablation device 61, and along the guide wire, the main wire of the ablation device 61 is inserted.
  • the shaft 72 is inserted into the renal artery 40.
  • the ablation device 61 when the ablation device 61 is inserted to the target portion of the renal artery 40, the fluid is returned to the balloon 71 and the balloon 71 is expanded. Subsequently, the laser light is propagated into the balloon 71 through the optical fiber 79, and reflected by the reflecting material 73 in a direction intersecting the axial direction 101 and outside the main shaft 72. The reflected laser light passes through the in-side tube 77 and the balloon 71, is irradiated onto the blood vessel wall of the renal artery 40, passes through the blood vessel wall, and reaches the nerve.
  • the optical fiber 79 moves and rotates along the outer periphery of the sub shaft 74, the laser light reflected to the outside of the main shaft 72 is blocked by the guide wire inserted into the sub shaft 74 and the guide wire shaft 84. There is no. Therefore, when the renal artery 40 is irradiated with laser light, that is, when ablation is performed, the guide wire does not need to be drawn from the guide wire shaft 84.
  • the optical fiber 79 is fixed to the outer periphery of the sub shaft 74 and the reflector 83 reflects the laser light to the outside of the main shaft 72 in the direction intersecting the axial direction 101, The reflected laser light is not blocked by the inserted guide wire shaft 84 or the guide wire inserted through the guide wire shaft 84. Thereby, ablation can be performed with the guide wire inserted through the ablation device 61. Further, since the guide wire shaft 84 extends from the distal end to the proximal end of the main shaft 72, it is easy to insert the guide wire into the ablation device 61 again after the guide wire is removed from the ablation device 61. .
  • the ablation device 61 can be realized with a simple configuration. Is done.
  • the sub shaft 74 can be operated in the connector portion 73 to move and rotate the reflecting material 83.
  • the reflecting material 83 is integrally provided at the tip of the optical fiber 79.
  • a member such as a lens that transmits laser light is provided between the tip of the optical fiber 79 and the reflecting material 83. It may be done.
  • the tip of the optical fiber 79 and the reflecting material 83 are arranged through a space, and the optical fiber 79 and the reflecting material 83 are arranged so that the optical fiber 79 and the reflecting material 33 move and rotate together with the sub shaft 74. Each may be bonded to the sub shaft 74.
  • the guide wire may be configured to be inserted through the sub shaft 74 without the guide wire shaft 84 being provided.
  • the ablation system 110 includes an ablation device 111, a laser light generation unit 112, a fluid reflux unit 113, a drive mechanism 114, and a control unit 115.
  • the ablation device 111 has a shaft 122 provided with a balloon 121 on the distal end side.
  • the shaft 122 is a member that is long in the axial direction 101.
  • the shaft 122 is a tubular body that can be elastically bent so as to be bent with respect to the axial direction 101.
  • a direction in which the shaft 122 in an uncurved state extends is referred to as an axial direction 101 in this specification.
  • the axial direction 101 corresponds to the first direction.
  • the in-side tube 127 and the light guide tube 134 are inserted through the shaft 122.
  • the outer diameter and the inner diameter of the shaft 122 are not necessarily constant with respect to the axial direction 101, but from the viewpoint of operability, it is preferable that the rigidity on the proximal side is higher than the distal side.
  • the shaft 122 can be made of a known material used for a balloon catheter, such as synthetic resin or stainless steel, and is not necessarily composed of only one type of material, and a plurality of parts made of other materials are assembled. It may be configured.
  • the proximal end side refers to the rear side (right side in FIG. 6) with respect to the direction in which the ablation device 111 is inserted into the blood vessel.
  • the distal end side refers to the front side (left side in FIG. 6) with respect to the direction in which the ablation device 111 is inserted into the blood vessel.
  • a balloon 121 is provided on the tip side of the shaft 122.
  • the balloon 121 expands elastically when fluid (liquid, gas) flows into the internal space and contracts when fluid flows out of the internal space. 6 and 7, the balloon 121 in a deflated state is shown.
  • the internal space of the balloon 121 is in communication with the internal space of the shaft 122 and the internal space of the in-side tube 127, respectively.
  • the balloon 121 expands in the radial direction orthogonal to the axial direction 101 so that the center of the axial direction 101 becomes the maximum diameter.
  • the internal space of the in-side tube 127 and the internal space of the shaft 122 correspond to a fluid lumen.
  • An out port 128 is provided on the base end side of the shaft 122.
  • the out port 128 is continuous with the internal space of the shaft 122.
  • the fluid recirculated to the balloon 121 flows out from the out port 128 through the internal space of the shaft 122.
  • a hub 123 is provided at the base end of the shaft 122.
  • An optical fiber 129 is inserted through the hub 123.
  • the hub 123 is provided with an in-port 126 separately from the insertion port for the optical fiber 129.
  • the in port 126 is continuous with the internal space of the in side tube 127. Through the inner space of the in-side tube 127, the fluid recirculated to the balloon 121 flows from the in-port 126.
  • a guide wire tube 124 is provided outside the shaft 122.
  • the guide wire tube 124 is sufficiently shorter than the length of the shaft 122 in the axial direction 101.
  • the guide wire tube 124 is not necessarily provided outside the shaft 122.
  • the guide wire tube 124 may be inserted into the internal space of the shaft 122.
  • the in-side tube 127 inserted into the shaft 122 has a distal end side reaching the internal space of the balloon 121 and a proximal end side connected to the in-port 126.
  • the distal end of the in-side tube 127 is connected to the distal end tip 125 provided on the distal end side of the balloon 121.
  • openings 130 and 131 that penetrate the peripheral wall of the in-side tube 127 are provided in the vicinity of the distal end tip 125 of the in-side tube 127.
  • the openings 130 and 131 are for the fluid flowing through the inner space of the in-side tube 127 to flow into the balloon 121, and are arranged at different positions with respect to the circumferential direction of the axial direction 101.
  • the tip chip 125 is provided with a marker made of a contrast medium.
  • the contrast agent include barium sulfate, bismuth oxide, and bismuth subcarbonate.
  • the light guide tube 134 is a tube body that can be elastically bent so as to be curved with respect to the axial direction 101.
  • the light guide tube 134 inserted into the in-side tube 127 has a distal end side that reaches the vicinity of the openings 130 and 131 of the in-side tube 127, and a proximal end side that extends to the outside through the hub 123.
  • An opening 135 is formed on the side wall near the tip of the light guide tube 134 and serving as the internal space of the balloon 121. Through the opening 135, the internal space of the light guide tube 134 is communicated with the outside.
  • the optical fiber 129 is inserted from the hub 123 into the light guide tube 134 and extends to the opening 135.
  • the inner diameter of the inner space of the light guide tube 134 is equal to the outer diameter of the optical fiber 129. Therefore, the axis of the optical fiber 129 and the axis of the light guide tube 134 are substantially matched.
  • the front end surface 132 of the optical fiber 129 is orthogonal to the axis.
  • the optical fiber 129 is generated by the laser light generation means 112 and propagates the laser light applied to the proximal end of the optical fiber 129 to the distal end side.
  • an optical fiber having a refractive index that totally reflects at the wavelength of the laser light is appropriately adopted. Specific examples include a single mode fiber, a polarization maintaining fiber, a multimode fiber, and a bundle fiber for image transmission. .
  • the optical fiber 129 corresponds to a light guide material.
  • the reflecting material 133 is disposed in the inner space of the light guide tube 134 so as to face the distal end surface 132 of the optical fiber 129 in the axial direction 101.
  • the reflecting surface 136 facing the tip surface 132 in the reflecting material 133 is a flat surface inclined at an angle of 45 degrees with respect to the axis of the optical fiber 129.
  • the distal end surface 132 and the reflecting surface 136 are exposed to the outside of the light guide tube 134 through the opening 135 of the light guide tube 134.
  • the reflecting material 133 is a cylindrical body made of an optical fiber, a resin, or the like, and the outer diameter thereof is equal to the inner diameter of the inner space of the light guide tube 134.
  • a metal layer is laminated on the surface of the reflective material 133 including the reflective surface 136.
  • the metal layer is formed, for example, by plating or sputtering on the surface of the reflective material 133 by mixing nickel, gold, aluminum, chromium, or the like alone or mixed.
  • the optical fiber 129 and the reflective material 133 are integrated with the light guide tube 134 around the axis (axial direction 101) while maintaining the positional relationship between the distal end surface 132 and the reflective surface 136, that is, the separation distance and the angle of the reflective surface 136. And can be slid in the axial direction 101.
  • the rotation and sliding of the optical fiber 129 and the reflecting member 133 are controlled by directly or indirectly operating the proximal end side of the light guide tube 134 extended from the hub 123. Specifically, the light guide tube 134 is rotated and slid by applying a driving force from the drive mechanism 114 to the proximal end side of the light guide tube 134.
  • a temperature sensor may be provided on the outer wall of the in-side tube 127 in the balloon 121 or the like.
  • a known sensor such as a thermocouple can be used as long as it can be installed inside the balloon 121.
  • the temperature of the fluid in the balloon 121 can be monitored by guiding the cable extended from the temperature sensor to the outside.
  • a third lumen may be provided on the shaft 122, and an imaging member such as an endoscope, IVUS, or OCT may be inserted.
  • the laser light generation means 112 a known laser light generation device can be used.
  • the laser light generating means 112 is, for example, a device in which light from an excitation source is given to a laser medium, and is oscillated and output by reflection of an optical resonator.
  • the laser beam output from the laser beam generator 112 is preferably a continuous wave, and the wavelength of the laser beam is preferably in the range of 400 to 2000 nm. In particular, when the wavelength of the laser beam is in the range of 800 to 1500 nm (915 nm, 980 nm, 1470 nm), a local temperature increase can be confirmed, and the intima of the renal artery can be appropriately heated.
  • the laser light generation means 112 is connected to the base end of the optical fiber 129, and the laser light output from the laser light generation means 112 is irradiated on the base end face of the optical fiber 129.
  • the fluid reflux means 113 a known device having a roller pump or a syringe pump can be used.
  • the fluid return means 113 is connected to the in port 126 and the out port 128 of the ablation device 111 via a flow path such as a tube.
  • the fluid recirculation means 113 has a tank for storing the fluid, and supplies the fluid from the tank to the in port 126 with a desired flow rate and pressure by the driving force of the pump. Further, the fluid flowing out from the out port 128 may be returned to the tank or discarded as a waste liquid.
  • reflux means 113 may be provided with the cooling device for cooling the fluid in a tank.
  • the fluid is not particularly limited, but for the purpose of ablation of the renal artery, a mixed solution of physiological saline and contrast medium is preferable.
  • the driving mechanism 114 applies a driving force for rotating and sliding the proximal end side of the light guide tube 134 with respect to the axial direction 101, and a mechanism in which a motor, a slider, or the like is combined may be employed.
  • the drive mechanism 114 is not essential, and the light guide tube 134 may be rotated and slid with respect to the axial direction 101 by the operator handling the proximal end side of the light guide tube 134.
  • control means 115 generates laser light from the laser light generation means 112 at a predetermined light intensity and time based on a pre-programmed protocol, controls the flow rate and pressure of the fluid return means 113, and is driven. The drive amount and timing of the mechanism 114 are controlled.
  • the control means 115 includes an arithmetic unit for performing these operation controls.
  • the ablation device 111 is connected to the laser light generation means 112, the fluid reflux means 113, and the drive mechanism 114. Further, the laser light generating means 112, the fluid reflux means 113, and the drive mechanism 114 are connected to the control means 115. In the control means 115, a program suitable for performing ablation on the renal artery 40 is set in advance.
  • the ablation device 111 is inserted into the renal artery 40 from the distal end side.
  • a guide wire is inserted in advance and reaches the target portion while performing imaging under fluoroscopy.
  • Such insertion of the guide wire is performed by a known method disclosed in, for example, Japanese Patent Application Laid-Open Nos. 2006-326226 and 2006-230442.
  • the ablation device 111 When the ablation device 111 is inserted into the renal artery 40, no fluid is pressed into the balloon 121, and the balloon 121 is in a deflated state. From the tip of the ablation device 111 in this state, a guide wire is inserted into the guide wire tube 124. The ablation device 111 is then inserted into the renal artery 40 along the guide wire. The insertion position of the ablation device 111 in the renal artery 40 is grasped by, for example, confirming a marker placed on the distal tip 125 under the X-ray.
  • the fluid return means 113 is driven by the control means 115, and physiological saline or the like is passed from the fluid return means 113 through the in-side tube 127. Is flowed into the balloon 121 and the balloon 121 expands. Further, the fluid is recirculated from the balloon 121 to the fluid recirculation means 113 from the out port 128 through the shaft 122.
  • the return of the fluid to the balloon 21 indicated by the arrow 151 is managed so as to have a desired flow velocity and pressure by controlling the fluid return means 113 by the control means 115. Further, the fluid stored in the fluid return means 113 is managed at a temperature suitable for cooling the intima of the renal artery 40.
  • the laser light generation means 112 and the drive mechanism 114 are driven by the control means 115, the laser light 42 generated from the laser light generation means 112 is propagated into the balloon 121 through the optical fiber 129, and the distal end surface 132 is emitted.
  • the laser beam 42 thus reflected is reflected by the reflecting surface 136 of the reflecting material 133 in a direction intersecting the axial direction 101 (in the present embodiment, a direction orthogonal to the second direction).
  • the reflected laser light 42 passes through the in-side tube 127 and the balloon 121, is irradiated onto the blood vessel wall of the renal artery 40, passes through the blood vessel wall, and reaches the nerve 41.
  • the nerve 41 irradiated with the laser light 42 (shown by a two-dot chain line for convenience in FIG. 8) is ablated.
  • the intensity and irradiation time of the laser light 42 are managed by the control means 115.
  • the drive mechanism 114 is driven by the control means 115, the light guide tube 134 is slid while being rotated with respect to the axial direction 101.
  • the optical fiber 129 and the reflector 133 are also rotated and slid, so that the direction of the laser beam 142 reflected by the reflector 133 is displaced in the circumferential direction of the axial direction 101. (Arrow 152).
  • the laser beam 42 reflected by the reflecting material 133 is displaced in the axial direction 101 (arrow 153).
  • the rotation and slide patterns of the light guide tube 134 can be arbitrarily set by programming in the control means 115. Therefore, for example, the laser light 42 can be irradiated spirally on the nerve 41 of the renal artery 40 by sliding the light guide tube 134 while rotating.
  • the laser light 42 is irradiated from the laser light generating means 112 so that the nerve 41 of the renal artery 40 is irradiated with the laser light 42 in a spot shape. it can.
  • the timing and order of irradiating the laser beam 42 to the nerves 41 existing all around the predetermined range in the direction in which the renal artery 40 extends can be arbitrarily set.
  • the laser beam 42 reflected by the reflecting material 133 is also applied to the tissue on the intima side of the renal artery 40 before reaching the nerve 41 of the renal artery 40.
  • An inflated balloon 121 is in contact with the intima of the renal artery 40, and fluid is circulated in the balloon 121. Due to the cooling effect of the fluid, heating of the intima side of the renal artery 40 is suppressed. Therefore, it is preferable that the slide range of the optical fiber 129 is a range in which the balloon 121 is in contact with the intima of the renal artery 40.
  • the fluid recirculated into the balloon 121 contacts the reflecting surface 136 of the reflecting member 133 through the opening 135 of the light guide tube 134. Thereby, the reflective surface 136 is cooled by the fluid.
  • the nerve 41 of the renal artery 40 can be ablated, and heating to the intima of the renal artery 40 can be suppressed to suppress thermal damage to the intima.
  • the reflecting material 133 is disposed so as to face the front end surface 132 of the optical fiber 129, the reflecting material 133 is hardly damaged by the laser light 42.
  • the reflecting material 133 is disposed in the flow path of the fluid flowing through the balloon 121, the reflecting material 133 is cooled by the fluid, and damage due to the laser light 42 is further suppressed.
  • the reflector 133 is rotated around the axis of the shaft 122 while being moved in the balloon 121 along the axial direction 101, so that the laser beam 42 is uniformly applied to the tissue around the renal artery 40. Is done.
  • optical fiber 129 and the reflecting material 133 are disposed in the internal space of the light guide tube 134, the optical fiber 129 and the reflecting material 133 can be moved and rotated while maintaining the mutual positional relationship. .
  • the light guide tube 134 has the opening 135 that allows an external fluid to contact the reflective surface 136 of the reflective material 133, the reflective surface 136 of the reflective material 133 is cooled by the fluid.
  • the light guide tube 134 is inserted through the in-side tube 127.
  • the insertion path of the light guide tube 134 is not limited as long as the distal end side reaches the balloon 121. Therefore, for example, it may be inserted into the internal space of the shaft 122 or may be inserted into the balloon 121 from the outside of the shaft 122.
  • the ablation device 61 Similar to the ablation device 111 shown in FIG. 6, the ablation device 61 constitutes a part of an ablation system having a laser light generation unit 112, a fluid reflux unit 113, a drive mechanism 114, and a control unit 115.
  • the ablation device 161 has a main shaft 172 provided with a balloon 171 on the distal end side.
  • the main shaft 172 is a member that is long in the axial direction 101.
  • the main shaft 172 is a tubular body that can be elastically bent so as to bend with respect to the axial direction 101.
  • the direction in which the main shaft 172 in an uncurved state extends is referred to as the axial direction 101 in this specification.
  • the outer diameter and inner diameter of the main shaft 172 do not necessarily have to be constant with respect to the axial direction 101, but from the viewpoint of operability, it is preferable that the rigidity on the proximal side is higher than the distal side.
  • the main shaft 172 can be made of a known material used for balloon catheters, such as synthetic resin and stainless steel, and is not necessarily composed of only one type of material, and a plurality of parts made of other materials are assembled. And may be configured.
  • the proximal end side refers to the rear side (the right side in FIG. 9A) with respect to the direction in which the ablation device 161 is inserted into the blood vessel.
  • the distal end side refers to the front side (left side in FIG. 9A) with respect to the direction in which the ablation device 161 is inserted into the blood vessel.
  • a balloon 171 is provided on the distal end side of the main shaft 172.
  • the balloon 171 expands elastically when a fluid (liquid, gas) flows into the internal space and contracts when the fluid flows out from the internal space.
  • a fluid liquid, gas
  • FIG. 9 the balloon 171 in an expanded state is shown.
  • the internal space of the balloon 171 communicates with the internal space of the main shaft 172 and the internal space of the in-side tube 177.
  • the balloon 171 expands in the radial direction orthogonal to the axial direction 101 so that the center of the axial direction 101 becomes the maximum diameter.
  • known materials and methods used in balloon catheters can be used as the material of the balloon 171 and the method for fixing the balloon 171 and the main shaft 172.
  • the internal space of the in-side tube 177 and the space between the main shaft 172 and the in-side tube 177 correspond to the fluid lumen.
  • the in-side tube 177 inserted into the main shaft 172 has a distal end side reaching the internal space of the balloon 171 and a proximal end side connected to the in-port 176 of the connector portion 173.
  • the distal end of the in-side tube 177 is connected to a distal tip 175 provided on the distal end side of the balloon 171.
  • openings 180 and 181 penetrating the peripheral wall of the in-side tube 177 are provided.
  • the openings 180 and 181 are for fluid flowing through the inner space of the in-side tube 177 to flow into the balloon 171, and are arranged at different positions with respect to the circumferential direction of the axial direction 101.
  • the tip chip 175 is provided with a marker made of a contrast medium.
  • the contrast agent include barium sulfate, bismuth oxide, and bismuth subcarbonate.
  • the sub-shaft 174 is inserted through the in-side tube 177.
  • the sub shaft 174 extends from the outside of the connector portion 173 to the inside of the balloon 171.
  • the sub-shaft 174 is a member that is long in the axial direction 101, is elastically bent so as to be curved with respect to the axial direction 101, and is not connected to the tip chip 175. It is a tube that can transmit from the 173 side to the tip side.
  • the sub shaft 174 is a tubular body made of, for example, a stainless coil.
  • a guide wire shaft 184 is inserted into the internal space of the sub shaft 174.
  • the guide wire shaft 184 is connected to the tip end 175.
  • a hole 185 is formed in the distal tip 175 along the axial direction 101 so that the internal space of the guide wire shaft 184 continues to the outside.
  • the distal end of the guide wire shaft 184 passes through the hole 185 and reaches the distal end of the distal tip 175.
  • As the material of the guide wire shaft 184 a known material can be adopted.
  • the internal space of the guide wire shaft 184 is a wire lumen.
  • the light guide tube 189 is a tubular body that can be elastically bent so as to bend with respect to the axial direction 101.
  • the light guide tube 189 is bonded to the outer periphery of the sub-shaft 174 from the outside of the connector portion 173, extends in the axial direction 101, and reaches the inside of the balloon 171.
  • An opening 190 is formed on the side wall in the vicinity of the tip of the light guide tube 189 and at the position serving as the internal space of the balloon 171. Through the opening 190, the internal space of the light guide tube 189 communicates with the outside.
  • the optical fiber 179 is inserted from the connector portion 173 into the light guide tube 189 and extends to the opening 190.
  • the inner diameter of the inner space of the light guide tube 189 is equal to the outer diameter of the optical fiber 179. Therefore, the axis of the optical fiber 179 and the axis of the light guide tube 189 are substantially matched.
  • the front end surface 182 of the optical fiber 179 is orthogonal to the axis.
  • the optical fiber 179 is generated by the laser light generation means 112 and propagates the laser light applied to the proximal end of the optical fiber 179 to the distal end side.
  • an optical fiber having a refractive index that totally reflects at the wavelength of the laser light is appropriately adopted. Specific examples include a single mode fiber, a polarization maintaining fiber, a multimode fiber, and an image transmission bundle fiber. .
  • the optical fiber 179 corresponds to the light guide material.
  • the reflective material 183 is disposed in the inner space of the light guide tube 189 so as to face the distal end surface 182 of the optical fiber 179 in the axial direction 101.
  • the reflective surface 191 that faces the tip surface 182 in the reflective material 183 is a flat surface that is inclined at an angle of 45 degrees with respect to the axis of the optical fiber 179. It is exposed to the outside of the light guide tube 189 through the front end surface 182, the reflection surface 191, and the opening 190 of the light guide tube 189.
  • the reflecting material 183 is a cylindrical body made of an optical fiber, a resin, or the like, and the outer diameter thereof is equal to the inner diameter of the inner space of the light guide tube 189.
  • a metal layer is laminated on the surface of the reflective material 183 including the reflective surface 191.
  • the metal layer is formed, for example, by plating or sputtering on the surface of the reflective material 83 with nickel, gold, aluminum, chromium, or the like alone or mixed.
  • the optical fiber 179 and the reflective material 183 are integrated with the sub shaft 174 and the light guide tube 189 in the axial direction 101 while maintaining the positional relationship between the distal end surface 182 and the reflective surface 191, that is, in the state where the separation distance and the angle of the reflective surface 191 are maintained. It can rotate around and slide in the axial direction 101.
  • the rotation and sliding of the optical fiber 179 and the reflector 183 are controlled by directly or indirectly operating the proximal end side of the sub shaft 174 extending from the connector portion 173. Specifically, when the driving force from the driving mechanism 114 is applied to the base end side of the sub shaft 174, the sub shaft 174 is rotated and slid.
  • a temperature sensor may be provided on the outer wall of the in-side tube 177 in the balloon 171 or the like.
  • a known sensor such as a thermocouple can be used as long as it can be installed inside the balloon 171.
  • the temperature of the fluid in the balloon 171 can be monitored by guiding the cable extended from the temperature sensor to the outside.
  • a connector portion 173 is provided on the base end side of the main shaft 172.
  • the connector part 173 is a part that the practitioner has when operating the ablation device 161.
  • the connector part 173 is provided with an out port 178.
  • the out port 178 is continuous with the space between the main shaft 172 and the in-side tube 177. Through this space, the fluid returned to the balloon 171 flows out from the out port 178.
  • the connector portion 173 is provided with an in port 176.
  • the in-port 176 is continuous with the space between the in-side tube 177 and the sub shaft 174. Through this space, the fluid recirculated to the balloon 171 flows from the in port 176.
  • the in port 176 and the out port 178 are liquid-tightly separated by O-rings 186 and 187, respectively. Further, the in port 176 and the out port 178 are connected to the fluid reflux means 113 shown in FIG.
  • the subshaft 174 and the light guide tube 189 are extended from the base end of the connector portion 173 to the outside.
  • the sub shaft 174 and the light guide tube 189 can move along the axial direction 101 with respect to the connector portion 173 and can rotate around the axial direction 101.
  • the O-ring 188 ensures liquid tightness around the sub shaft 174 and the light guide tube 189.
  • the optical fiber 179 inserted in the light guide tube 189 is connected to the laser light generating means 112 shown in FIG. 6, and the sub shaft 174 is connected to the drive mechanism 114 shown in FIG. Yes.
  • the usage method of the ablation device 161 described above is the same as the usage method of the ablation device 111, and is used as the ablation system 110 shown in FIG. 6 as an example of the usage method.
  • the ablation device 161 is inserted into the renal artery 40 from the distal end side.
  • a guide wire is inserted in advance into the renal artery 40 and reaches the target portion, and the guide wire is inserted into the guide wire shaft 184 of the ablation device 161, and the main wire of the ablation device 161 is guided along the guide wire.
  • a shaft 172 is inserted into the renal artery 40.
  • the ablation device 161 when the ablation device 161 is inserted to the target portion of the renal artery 40, the fluid is returned to the balloon 171 and the balloon 171 is expanded. Subsequently, the laser light is propagated into the balloon 171 through the optical fiber 179 and emitted from the distal end surface 182, and is reflected to the outside of the main shaft 172 in a direction intersecting the axial direction 101 by the reflecting surface 191 of the reflecting material 183. Is done. The reflected laser light passes through the in-side tube 177 and the balloon 171, is irradiated onto the blood vessel wall of the renal artery 40, passes through the blood vessel wall, and reaches the nerve.
  • the light guide tube 189 moves and rotates along the outer periphery of the sub shaft 174, the laser light reflected to the outside of the main shaft 172 is blocked by the guide wire inserted into the sub shaft 174 and the guide wire shaft 184. There is nothing to do. Therefore, when the renal artery 40 is irradiated with laser light, that is, when ablation is performed, the guide wire does not need to be pulled out from the guide wire shaft 184.
  • the ablation is performed on the nerve of the renal artery and the heating to the intima of the renal artery is suppressed, thereby causing the heat damage to the intima. Can be suppressed.
  • the reflecting material 183 is disposed so as to oppose the distal end surface 182 of the optical fiber 179, the reflecting material 183 is hardly damaged by the laser beam.
  • the light guide tube 189 is fixed to the outer periphery of the sub-shaft 174, and the reflecting material 183 reflects the laser light to the outside of the main shaft 172 in the direction intersecting the axial direction 101.
  • the reflected laser beam is not blocked by the guide wire shaft 184 inserted inside or the guide wire inserted through the guide wire shaft 184.
  • ablation can be performed with the guide wire inserted through the ablation device 161.
  • the guide wire shaft 184 extends from the distal end to the proximal end of the main shaft 172, it is easy to insert the guide wire into the ablation device 161 again after removing the guide wire from the ablation device 161. .
  • the guide wire may be configured to be inserted through the sub shaft 174 without the guide wire shaft 184 being provided.
  • the ablation system 210 includes an ablation device 211, a laser light generation unit 212, a fluid reflux unit 213, a drive mechanism 214, and a control unit 215.
  • the ablation device 211 has a shaft 222 provided with a balloon 221 on the distal end side.
  • the shaft 222 is a member that is long in the axial direction 101.
  • the shaft 222 is a tubular body that can be elastically bent so as to be bent with respect to the axial direction 101.
  • the direction in which the shaft 222 in an uncurved state extends is referred to as the axial direction 101 in this specification.
  • the axial direction 101 corresponds to the first direction.
  • the in-side tube 227 and the optical fiber 229 are inserted through the shaft 222.
  • the outer diameter and inner diameter of the shaft 222 are not necessarily constant with respect to the axial direction 101, but from the viewpoint of operability, it is preferable that the rigidity on the proximal side is higher than the distal side.
  • the shaft 222 may be made of a known material used for a balloon catheter, such as synthetic resin or stainless steel, and is not necessarily composed of only one type of material, and a plurality of parts made of other materials are assembled. It may be configured.
  • the proximal end side refers to the rear side (right side in FIG. 11) with respect to the direction in which the ablation device 211 is inserted into the blood vessel.
  • the distal end side refers to the front side (left side in FIG. 11) with respect to the direction in which the ablation device 211 is inserted into the blood vessel.
  • a balloon 221 is provided on the tip side of the shaft 222.
  • the balloon 221 expands elastically when fluid (liquid, gas) flows into the internal space, and contracts when fluid flows out of the internal space. 11 and 12, the balloon 221 in a deflated state is shown.
  • the internal space of the balloon 221 is in communication with the internal space of the shaft 222 and the internal space of the in-side tube 227, respectively.
  • the balloon 221 expands in the radial direction orthogonal to the axial direction 101 so that the center of the axial direction 101 becomes the maximum diameter.
  • the internal space of the in-side tube 227 corresponds to the first lumen
  • the internal space of the shaft 222 corresponds to the second lumen.
  • An out port 228 is provided on the base end side of the shaft 222.
  • the out port 228 is continuous with the internal space of the shaft 222. Through the internal space of the shaft 222, the fluid recirculated to the balloon 221 flows out from the out port 228.
  • a hub 223 is provided at the base end of the shaft 222.
  • An optical fiber 229 is inserted through the hub 223.
  • the hub 223 is provided with an in-port 226 separately from the insertion port for the optical fiber 229.
  • the in port 226 is continuous with the internal space of the in side tube 227. Through the inner space of the in-side tube 227, the fluid recirculated to the balloon 221 flows from the in-port 226.
  • a guide wire tube 224 is provided outside the shaft 222.
  • the guide wire tube 224 is sufficiently shorter than the length of the shaft 222 in the axial direction 101.
  • the guide wire tube 224 is not necessarily provided outside the shaft 222.
  • the guide wire tube 224 may be inserted into the internal space of the shaft 222.
  • the in-side tube 227 inserted into the shaft 222 has a distal end side reaching the internal space of the balloon 221 and a proximal end side connected to the in-port 226.
  • the distal end of the in-side tube 227 is connected to the distal tip 225 provided on the distal end side of the balloon 221.
  • openings 230 and 231 penetrating the peripheral wall of the in-side tube 227 are provided.
  • the openings 230 and 231 are for allowing the fluid flowing through the inner space of the in-side tube 227 to flow into the balloon 221, and are arranged at different positions with respect to the circumferential direction of the axial direction 101.
  • the tip chip 225 is provided with a marker made of a contrast medium.
  • the contrast agent include barium sulfate, bismuth oxide, and bismuth subcarbonate.
  • the optical fiber 229 is inserted from the hub 223 into the inside tube 227 and extends to the inside of the balloon 221.
  • the optical fiber 229 transmits the laser light generated by the laser light generating means 212 and applied to the proximal end of the optical fiber 229 to the distal end side.
  • an optical fiber having a refractive index that totally reflects at the wavelength of the laser light is appropriately applied. Specific examples include a single mode fiber, a polarization maintaining fiber, a multimode fiber, and an image transmission bundle fiber. .
  • the optical fiber 229 corresponds to the light guide material.
  • a diffusion member 233 is provided inside the in-side tube 227 so as to be adjacent to the front end surface 232 of the optical fiber 229.
  • the diffusing member 233 is a cylindrical member, and the length in the axial direction 101 is shorter than the length in the axial direction 101 of the balloon 221.
  • the diffusing member 233 transmits the laser light emitted from the distal end surface 232 of the optical fiber 229 and diffuses the laser light so that the traveling direction of the laser light changes, that is, from the axial direction 101 to the direction intersecting the axial direction 101. It is.
  • the diffusion member 233 for example, quartz-based glass or the like is adopted, but the material is not particularly limited.
  • the diffusion member 233 is connected to and integrated with the optical fiber 229, and can rotate or slide together with the optical fiber 229 in the inner space of the in-side tube 227.
  • the diffusing member 233 is not limited to a member that changes the traveling direction of the laser light by refraction, but may be a member that changes the traveling direction of the laser light by reflection.
  • a tubular member 234 is provided inside the in-side tube 227 so as to surround the outside of the diffusion member 233.
  • the tubular member 234 is a circular tube-shaped member in which the distal end side and the proximal end side, that is, the distal tip 225 side and the hub 223 side are sealed, and covers the distal end surface 232 of the optical fiber 229 and the outer side of the diffusion member 233.
  • the length of the tubular member 234 in the axial direction 101 is shorter than the length of the balloon 221 in the axial direction 101.
  • the tubular member 234 is connected to and integrated with the optical fiber 229 inserted on the proximal end side, and can rotate or slide together with the optical fiber 229 in the inner space of the in-side tube 227. That is, the optical fiber 229, the diffusing member 233, and the tubular member 234 can be integrally rotated or slid in the inner space of the in-side tube 227.
  • the tubular member 234 is obtained by laminating a reflective layer 236 inside a resin layer 235 that can transmit laser light.
  • the resin layer 235 is a synthetic resin such as polyimide.
  • the reflective layer 236 is a metal or the like that reflects laser light, and is formed, for example, by applying gold plating to the inner surface side of the resin layer 235.
  • the reflective layer 236 is present on the inner surface side facing the diffusion member 233 and the sealed tip side. Note that the reflective layer 236 does not necessarily need to totally reflect the laser light, and may absorb part or all of the laser light.
  • the tubular member 234 has a transmission window 237 formed on a circular tube-shaped peripheral wall.
  • the transmission window 237 is formed by removing a part of the reflection layer 236. For example, it is formed by masking the inner surface of the resin layer 235 corresponding to the transmission window 237 when gold plating as the reflection layer 236 is performed.
  • the transmission window 237 has an elongated spiral shape extending along the axial direction 101. In the transmission window 237, the laser beam can be transmitted from the inner space side of the tubular member 234 to the outside.
  • the optical fiber 229, the diffusion member 233, and the tubular member 234 can rotate about the axial direction 101 as a unit with respect to the in-side tube 227, and can slide in the axial direction 101.
  • the rotation and sliding of the optical fiber 229, the diffusing member 233, and the tubular member 234 are controlled by directly or indirectly operating the proximal end side of the optical fiber 229 extended from the hub 223. Specifically, when the driving force from the driving mechanism 214 is applied to the proximal end side of the optical fiber 229, the optical fiber 229 is rotated and slid. Thereby, the position of the circumferential direction with respect to the axial direction 101 of the transmission window 237 of the tubular member 234 and the position of the axial direction 101 are displaced.
  • a temperature sensor may be provided on the outer wall of the in-side tube 227 in the balloon 221 or the like.
  • a known sensor such as a thermocouple can be used as long as it can be installed inside the balloon 221.
  • the temperature of the fluid in the balloon 221 can be monitored by guiding the cable extended from the temperature sensor to the outside.
  • a third lumen may be provided on the shaft 222, and an imaging member such as an endoscope, IVUS, or OCT may be inserted.
  • the laser light generating means 212 a known laser light generating device can be used.
  • the laser light generation means 212 is, for example, one in which light from an excitation source is given to a laser medium, and is oscillated and output by reflection of an optical resonator.
  • the laser beam output from the laser beam generator 212 is preferably a continuous wave, and the wavelength of the laser beam is preferably in the range of 400 to 2000 nm. In particular, when the wavelength of the laser beam is in the range of 800 to 1500 nm (915 nm, 980 nm, 1470 nm), a local temperature increase can be confirmed, and the intima of the renal artery can be appropriately heated.
  • the laser light generating means 212 is connected to the base end of the optical fiber 229, and the laser light output from the laser light generating means 212 is irradiated on the base end face of the optical fiber 229.
  • the fluid reflux means 213 a known device having a roller pump or a syringe pump can be used.
  • the fluid return means 213 is connected to the in-port 226 and the out-port 228 of the ablation device 211 via a flow path such as a tube.
  • the fluid recirculation means 213 has a tank for storing fluid, and supplies the fluid from the tank to the in port 226 at a desired flow rate and pressure by the driving force of the pump. Further, the fluid flowing out from the out port 228 may be returned to the tank or discarded as a waste liquid.
  • reflux means 213 may be provided with the cooling device for cooling the fluid in a tank.
  • the fluid is not particularly limited, but for the purpose of ablation of the renal artery, a mixed solution of physiological saline and contrast medium is preferable.
  • the driving mechanism 214 applies a driving force for rotating and sliding the proximal end side of the optical fiber 229 with respect to the axial direction 101, and a mechanism in which a motor, a slider, or the like is combined may be employed.
  • the drive mechanism 214 is not essential, and the optical fiber 229 may be rotated and slid with respect to the axial direction 101 by the operator handling the proximal end side of the optical fiber 229.
  • the control unit 215 generates, for example, laser light from the laser light generation unit 212 at a predetermined light intensity and time based on a pre-programmed protocol, controls the flow rate and pressure of the fluid reflux unit 213, and is driven. The drive amount and timing of the mechanism 214 are controlled.
  • the control means 215 includes an arithmetic device for performing these operation controls.
  • the ablation device 211 is connected to the laser light generation means 212, the fluid reflux means 213, and the drive mechanism 214. Further, the laser light generating means 212, the fluid reflux means 213, and the driving mechanism 214 are connected to the control means 215. A program suitable for performing ablation on the renal artery 40 is preset in the control means 215.
  • the ablation device 211 is inserted into the renal artery 40 from the distal end side.
  • a guide wire is inserted in advance and reaches the target portion while performing imaging under fluoroscopy.
  • Such insertion of the guide wire is performed by a known method disclosed in, for example, Japanese Patent Application Laid-Open Nos. 2006-326226 and 2006-230442.
  • the ablation device 211 When the ablation device 211 is inserted into the renal artery 40, no fluid is injected into the balloon 221, and the balloon 221 is in a deflated state. From the tip of the ablation device 211 in this state, a guide wire is inserted into the guide wire tube 224. Then, the ablation device 211 is inserted into the renal artery 40 along the guide wire. The insertion position of the ablation device 211 in the renal artery 40 is grasped by, for example, confirming a marker placed on the distal tip 225 under the X-ray.
  • the fluid return means 213 is driven by the control means 215, and fluid flows from the fluid return means 213 through the in-side tube 227 to the balloon 221. And the balloon 221 expands.
  • the fluid is returned from the outlet port 228 to the fluid return means 213 from the balloon 221 through the shaft 222.
  • the return of the fluid to the balloon 221 is managed so as to obtain a desired flow velocity and pressure by controlling the fluid return means 213 by the control means 215.
  • the fluid stored in the fluid return means 213 is managed at a temperature suitable for cooling the intima of the renal artery 40.
  • the laser light generation means 212 and the drive mechanism 214 are driven by the control means 215, and the laser light 42 generated from the laser light generation means 212 is transmitted into the balloon 221 through the optical fiber 229 and is diffused by the diffusion member 233. Diffused in a plurality of directions intersecting the axial direction 101.
  • the diffused laser light 42 is reflected in the internal space of the tubular member 234 by the reflective layer 236 of the tubular member 234.
  • the laser beam 42 that has reached the transmission window 237 of the tubular member 234 passes through the transmission window 237, further passes through the in-side tube 227 and the balloon 221, is irradiated onto the blood vessel wall of the renal artery 40, and passes through the blood vessel wall.
  • the nerve 41 is reached. Thereby, the nerve 41 is ablated by irradiating the nerve 41 with the laser beam 42 in a spiral shape by the transmission window 237 of the tubular member 234.
  • the intensity and irradiation time of the laser beam are managed by the control means 215.
  • the optical fiber 229 that transmits the laser light 42 is slid while being rotated with respect to the axial direction 101. Since the optical fiber 229 is rotated and the diffusing member 233 and the tubular member 234 are also rotated, the direction of the laser light 42 transmitted through the spiral transmission window 237 is displaced in the circumferential direction of the axial direction 101. Thereby, it is possible to uniformly ablate the nerve 41 existing in the circumferential direction of the renal artery 40. Further, since the optical fiber 229 is slid and the transmission window 237 is also slid, the laser light 42 transmitted through the transmission window 237 is displaced in the axial direction 101. Thereby, it is possible to uniformly ablate the nerve 41 existing in the direction in which the renal artery 40 extends (the same direction as the axial direction 101).
  • the rotation and slide pattern of the optical fiber 229 can be arbitrarily set by programming in the control means 215.
  • the laser light 42 is irradiated from the laser light generating means 212 to irradiate the nerve 41 of the renal artery 40 in a spot shape. it can.
  • the timing and order of irradiating the laser beam 42 to the nerves 41 existing all around the predetermined range in the direction in which the renal artery 40 extends can be arbitrarily set.
  • the laser beam 42 that has passed through the transmission window 237 is also applied to the tissue on the intima side of the renal artery 40 before reaching the nerve 41 of the renal artery 40.
  • An inflated balloon 221 is in contact with the intima of the renal artery 40, and fluid is circulated in the balloon 221. Due to the cooling effect of the fluid, heating of the intima side of the renal artery 40 is suppressed. Therefore, it is preferable that the slide range of the optical fiber 229 is a range in which the balloon 221 is in contact with the intima of the renal artery 40.
  • the nerve 41 of the renal artery 40 can be ablated, and heating to the intima of the renal artery 40 can be suppressed to suppress thermal damage to the intima.
  • the laser beam 42 is uniformly irradiated to the nerve 41 of the renal artery 40.
  • the diffusion member 233 and the tubular member 234 are integrally provided on the distal end side of the optical fiber 229, and the optical fiber 229 can move and rotate along the axial direction 101 with respect to the shaft 222. Realized with a simple configuration. Further, the movement and rotation of the diffusing member 233 and the tubular member 234 can be operated via the optical fiber 229 on the proximal end side of the shaft 222.
  • the transmission window 237 of the tubular member 234 has a spiral shape extending in the axial direction 101, but the shape of the transmission window 237 may be changed as appropriate.
  • a plurality of circular transmission windows 238 may be provided at different positions in the axial direction 101.
  • Each transmission range D1, D2, D3, D4 of each transmission window 238 partially overlaps with the transmission window 238 adjacent in the axial direction 101.
  • each transmission window 238 has a different position with respect to the circumferential direction in the axial direction 101.
  • the tubular member 234 is rotated and slid to uniformly irradiate the nerve 41 of the renal artery 40 with the laser light.
  • the laser light 42 since the direction of the laser light 42 that travels through each transmission window 238 is different from the circumferential direction of the axial direction 101, the laser light 42 does not concentrate in a specific circumferential direction of the axial direction 101. . Thereby, the heating to the inner surface of the renal artery 40 can be suppressed.
  • each transmission window 238 partially overlaps each transmission range D1, D2, D3, and D4 in the axial direction 101, so that an unirradiated portion of the laser light 42 is hardly generated in the axial direction 101 of the renal artery 40.
  • the diffusion member 233 and the tubular member 234 are integrally provided at the tip of the optical fiber 229.
  • the tubular member 234 is configured to be rotatable and slidable, and the tubular member.
  • An operation unit for operating 234 may be extended to the hub 223.
  • the tubular member 234 and the in-side tube 227 may be connected, and the tubular member 234 may be configured to interlock with the rotation and slide of the in-side tube 227.
  • the optical fiber 229 is inserted through the in-side tube 227.
  • the insertion path of the optical fiber 229 is not limited as long as the distal end side reaches the balloon 221. . Therefore, for example, it may be inserted into the internal space of the shaft 222 or may be inserted into the balloon 221 from the outside of the shaft 222.
  • the tubular member 234 is rotated and slid, but the tubular member 234 may be configured to be rotatable only or slidable only.
  • the tubular member 234 having the spiral-shaped transmission window 237 is provided to the same extent as the length of the balloon 221 in the axial direction 101, the renal artery 40 is within the range of the balloon 221 when the tubular member 234 is rotated. It is possible to uniformly irradiate the nerve 41 with the laser beam 42.
  • the transmission windows 237 and 238 are formed of the resin layer 235.
  • the transmission windows may be formed as holes that penetrate the resin layer 235 and the reflection layer 236. .

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PCT/JP2014/077296 2013-10-15 2014-10-14 アブレーションシステム及びアブレーションデバイス WO2015056662A1 (ja)

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