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WO2023047709A1 - Light irradiating medical device - Google Patents

Light irradiating medical device Download PDF

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Publication number
WO2023047709A1
WO2023047709A1 PCT/JP2022/022436 JP2022022436W WO2023047709A1 WO 2023047709 A1 WO2023047709 A1 WO 2023047709A1 JP 2022022436 W JP2022022436 W JP 2022022436W WO 2023047709 A1 WO2023047709 A1 WO 2023047709A1
Authority
WO
WIPO (PCT)
Prior art keywords
coil member
medical device
shaft
distal end
coil
Prior art date
Application number
PCT/JP2022/022436
Other languages
French (fr)
Japanese (ja)
Inventor
弘規 ▲高▼田
Original Assignee
株式会社カネカ
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社カネカ filed Critical 株式会社カネカ
Publication of WO2023047709A1 publication Critical patent/WO2023047709A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical 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
    • A61B18/22Surgical 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
    • A61B18/24Surgical 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/067Radiation therapy using light using laser light

Definitions

  • the present invention relates to a light irradiation medical device for irradiating tissues such as cancer cells with light in body lumens such as blood vessels and gastrointestinal tracts.
  • a photosensitizer is administered into the body by intravenous injection or intraperitoneal injection, and the photosensitizer is accumulated in target tissues such as cancer cells, and light of a specific wavelength is used. to excite the photosensitizer.
  • An energy transfer occurs when the excited photosensitizer returns to the ground state, generating reactive oxygen species.
  • Target tissue can be removed by attacking the target tissue with reactive oxygen species.
  • ablation using laser light a target tissue is irradiated with laser light and cauterized. An apparatus for performing such light irradiation has been proposed.
  • Patent Document 1 discloses a main body having an elongated outer shape, a coil body provided on the tip side of the main body, and a light irradiation part provided inside the coil body for irradiating light toward the outside. is disclosed. Further, an aspect is shown in which an inner coil body and a core shaft are provided inside the coil body, and a part of the core shaft and a part of the inner coil body are joined via a joining portion.
  • an object of the present invention is to provide a light irradiation medical device that is excellent in breakage resistance and operability.
  • a shaft having a longitudinally distal end and a proximal end and having a longitudinally extending lumen; an optical fiber member disposed in the lumen of the shaft; a first coil member having a lumen and disposed distal to the optical fiber member and having a wire wound in a helical shape, the first coil member being longer than the wire diameter of the wire.
  • a light irradiation medical device having a pitch, wherein the distal end of the fiber optic member and the proximal end of the first coil member abut but are not fixed.
  • the contact between the distal end portion of the optical fiber member and the proximal end portion of the first coil member causes a force directed from the distal side direction to the proximal side direction with respect to the shaft. That is, when a pushing force is applied to the shaft, the pitch of the first coil member shrinks to fulfill a cushioning function, so damage to the optical fiber member can be easily suppressed.
  • the first coil member and the optical fiber member are not fixed, a force directed from the proximal direction to the distal direction with respect to the shaft, that is, the shaft with respect to the shaft When a force is applied in the direction in which the coil member extends, the first coil member and the optical fiber member can be separated from each other, so damage to the optical fiber can be easily suppressed.
  • the first coil member has the pitch as described above, flexibility can be imparted to the distal end portion of the light irradiation medical device, and operability can be improved.
  • the optical fiber member has a light diffusing portion extending longitudinally in a predetermined section of its distal portion and emitting light radially outward of the shaft, and the proximal end of the tubular member is positioned closer to the proximal side than the distal end of the light diffusing section [3] or [4].
  • the light irradiation medical device according to [5] in which the outer peripheral surface of the tubular member is in contact with the inner peripheral surface of the shaft, and the outer peripheral surface of the light diffusing portion and the inner peripheral surface of the shaft are arranged apart from each other.
  • the distal end of the tubular member has a lid that has a larger area than the lumen of the distal end of the tubular member when the tubular member is viewed from the distal side [3]-[ 6], the light irradiation medical device according to any one of items.
  • the light irradiation medical device according to [8] or [9], wherein the wire diameter of the wire of the first coil member is smaller than the wire diameter of the wire of the second coil member.
  • the cross-sectional area of the wire in the direction perpendicular to the longitudinal direction and passing through the midpoint of the length in the longitudinal direction of the first coil member is the midpoint of the length in the longitudinal direction of the second coil member.
  • the contact between the distal end portion of the optical fiber member and the proximal end portion of the first coil member causes a force directed from the distal side direction to the proximal side direction with respect to the shaft. That is, when a pushing force is applied to the shaft, the pitch of the first coil member shrinks to fulfill a cushioning function, so damage to the optical fiber member can be easily suppressed.
  • the first coil member and the optical fiber member are not fixed, a force directed from the proximal direction to the distal direction with respect to the shaft, that is, the shaft with respect to the shaft When a force is applied in the direction in which the coil member extends, the first coil member and the optical fiber member can be separated from each other, so damage to the optical fiber can be easily suppressed.
  • the first coil member has the pitch as described above, flexibility can be imparted to the distal end portion of the light irradiation medical device, and operability can be improved.
  • FIG. 1 is a cross-sectional view (partial side view) of a light irradiation medical device according to an embodiment of the present invention
  • FIG. FIG. 2 is a cross-sectional end view of the light irradiation medical device shown in FIG. 1 taken along line II-II. 2 is a cut end view of the first coil member shown in FIG. 1.
  • FIG. 1. It is sectional drawing (partial side view) which shows the modification of the light irradiation medical device shown in FIG. 5 is a cut end view of the cylindrical member shown in FIG. 4.
  • It is sectional drawing (partial side view) which shows the modification of the light irradiation medical device shown in FIG. 7 is a cut end view of the second coil member shown in FIG. 6.
  • FIG. 2 is an enlarged cross-sectional view of the distal side of the fiber optic member shown in FIG. 1;
  • FIG. FIG. 7 is a cross-sectional view showing a modification of the optical fiber member shown in FIG. 6;
  • FIG. 7 is a cross-sectional view showing another modification of the optical fiber member shown in FIG. 6;
  • FIG. 7 is a cross-sectional view showing another modification of the optical fiber member shown in FIG. 6;
  • One embodiment of the photomedical device of the present invention includes a shaft having longitudinally distal and proximal ends and having a longitudinally extending lumen; and a first coil member disposed in the lumen of the shaft and distally of the optical fiber member and having a wire wound in a spiral shape;
  • the coil member has a pitch longer than the wire diameter of the wire, and the distal end of the optical fiber member and the proximal end of the first coil member are in contact, but are not fixed.
  • the contact between the distal end portion of the optical fiber member and the proximal end portion of the first coil member causes a force directed from the distal side direction to the proximal side direction with respect to the shaft.
  • the pitch of the first coil member shrinks to fulfill a cushioning function, so damage to the optical fiber member can be easily suppressed.
  • the distal end portion of the optical fiber member and the proximal end portion of the first coil member are not fixed, a force directed from the proximal direction to the distal direction with respect to the shaft, that is, the shaft with respect to the shaft When a force is applied in the direction in which the coil member extends, the first coil member and the optical fiber member can be separated from each other, so damage to the optical fiber can be easily suppressed.
  • the first coil member has the pitch as described above, flexibility can be imparted to the distal end portion of the light irradiation medical device, and operability can be improved.
  • a photoirradiation medical device is used in PDT and photoablation to irradiate light of a specific wavelength to the treatment area, which is the target tissue such as cancer cells, in a body lumen such as a blood vessel or digestive tract.
  • the light irradiation medical device may be delivered to the treatment site alone, or may be used together with a delivery catheter or endoscope.
  • a light irradiation medical device is placed inside the body through a forceps channel of the endoscope and delivered to a treatment site.
  • FIG. 1 is a cross-sectional view (partial side view) of a light irradiation medical device according to one embodiment of the present invention.
  • FIG. 2 is an end view of the light irradiation medical device shown in FIG. 1 taken along line II-II.
  • 3 is a cut end view of the first coil member shown in FIG. 1.
  • FIG. 4 is a cross-sectional view (partial side view) showing a modification of the light irradiation medical device shown in FIG. 5 is a cut end view of the cylindrical member shown in FIG. 4.
  • FIG. FIG. 6 is a sectional view (partial side view) showing a modification of the light irradiation medical device shown in FIG.
  • FIG. 7 is a cut end view of the second coil member shown in FIG. 6.
  • FIG. 8 is an enlarged cross-sectional view of the distal side of the optical fiber member shown in FIG. 1.
  • FIG. 9 to 11 are sectional views showing other modifications of the optical fiber member shown in FIG.
  • the light irradiation medical device 1 has a shaft 10 , an optical fiber member 20 and a first coil member 40 .
  • the light irradiation medical device may be simply referred to as the device.
  • the shaft 10 is omitted from FIGS.
  • the distal side of the device 1 refers to the distal end side of the shaft 10 in the longitudinal direction x and the treatment target side.
  • the proximal side of the device 1 refers to the proximal end side of the shaft 10 in the longitudinal direction x and the user's hand side.
  • the proximal side may be called the proximal portion
  • the distal side may be called the distal portion.
  • the inner side refers to the direction toward the central axis c extending in the longitudinal direction x of the shaft 10
  • the outer side refers to the radial direction opposite to the inner side.
  • the device 1 includes a shaft 10.
  • the shaft 10 has a longitudinal direction x, a radial direction and a circumferential direction p.
  • Shaft 10 has distal and proximal ends in longitudinal direction x and has a lumen 11 extending in longitudinal direction x.
  • the shaft 10 may have only one lumen 11 or may have a plurality of them.
  • Shaft 10 has a cylindrical shape for arranging optical fiber member 20 and first coil member 40 in lumen 11 thereof.
  • Shaft 10 preferably has a cylindrical shape with only one lumen 11 . Since the shaft 10 is inserted into the body, it is preferably flexible.
  • Shaft 10 has an inner peripheral surface 12 and an outer peripheral surface 13 .
  • the shaft 10 is a hollow body formed by arranging one or more wires in a predetermined pattern; a hollow body having at least one of its inner surface or outer surface coated with a resin; a resin tube; , such as those connected in the longitudinal direction.
  • a hollow body in which wires are arranged in a predetermined pattern includes a cylindrical body having a mesh structure formed by simply crossing or weaving wires, and a coil in which wires are wound.
  • the wire may be one or more solid wires or one or more twisted wires.
  • a resin tube can be manufactured, for example, by extrusion molding. When the shaft 10 is a resin tube, the shaft 10 can be composed of a single layer or multiple layers.
  • a portion of the shaft 10 in the longitudinal direction x or the circumferential direction p may be composed of a single layer, and the other portion may be composed of a plurality of layers.
  • the shaft 10 is made of, for example, polyolefin resin (eg, polyethylene or polypropylene), polyamide resin (eg, nylon), polyester resin (eg, PET), aromatic polyether ketone resin (eg, PEEK), polyether polyamide resin, polyurethane. It can be made of synthetic resin such as resin, polyimide resin, fluorine resin (for example, PTFE, PFA, ETFE), or metal such as stainless steel, carbon steel, nickel-titanium alloy. These may be used individually by 1 type, and may be used in combination of 2 or more types. It is preferable that at least a portion of the shaft 10 that overlaps with the light diffusion portion 21 described later is made of resin having light transmission properties. At least a portion of the shaft 10 that overlaps the light diffusing portion 21 may be made of a transparent resin.
  • polyolefin resin eg, polyethylene or polypropylene
  • polyamide resin eg, nylon
  • polyester resin eg, PET
  • aromatic polyether ketone resin e
  • a distal tip 15 may be attached to the distal end of the shaft 10 as shown in FIG. Damage to living tissue by the distal end of the shaft 10 can be avoided.
  • Examples of the shape of the distal tip 15 include a cylindrical shape, an oval cylindrical shape, a hemispherical shape, an oval spherical shape, a truncated pyramid shape, a truncated cone shape, a long truncated cone shape, a rounded truncated pyramid shape, or a combination thereof. can be done.
  • a handle 70 is connected to the proximal portion of the shaft 10 in FIG. By holding the handle 70 by the operator, the device 1 can be easily operated.
  • the handle 70 extends, for example, in the longitudinal direction x.
  • Handle 70 may be constructed from one or more members.
  • the handle 70 has a hollow portion extending in the longitudinal direction x.
  • the handle 70 may have, for example, a cylindrical shape.
  • the shaft 10 and the optical fiber member 20 are inserted through the hollow portion of the handle 70 .
  • the material of the handle 70 is not particularly limited, for example, polyolefin resins such as polypropylene (PP) and polyethylene (PE), polyester resins such as polyethylene terephthalate (PET), polycarbonate resins, ABS resins, and synthetic resins such as polyurethane resins are used. be able to.
  • polyolefin resins such as polypropylene (PP) and polyethylene (PE)
  • PET resins such as polyethylene terephthalate (PET)
  • PET polyethylene terephthalate
  • polycarbonate resins polycarbonate resins
  • ABS resins polyurethane resins
  • the device 1 has an optical fiber member 20 arranged in the lumen 11 of the shaft 10 .
  • the optical fiber member 20 is a member provided with an optical fiber, which is a transmission line for transmitting optical signals to the target tissue.
  • fiber optic member 20 is disposed within lumen 11 of shaft 10 .
  • the proximal end of fiber optic member 20 extends proximally from handle 70 .
  • the proximal end of fiber optic member 20 is connected to a light source such as a semiconductor laser.
  • the optical fiber member 20 preferably has a light diffusing portion 21 extending in the longitudinal direction x in a predetermined section of its distal portion and emitting light outward in the radial direction of the shaft 10 .
  • Fiber optic member 20 has an outer peripheral surface 23 .
  • the light diffusing portion 21 functions as a light emitting area capable of emitting light radially outward.
  • the light diffusing portion 21 is arranged to extend in the longitudinal direction x and the circumferential direction p of the shaft 10 .
  • the light diffusing portion 21 has an outer peripheral surface 23 .
  • An outer peripheral surface 23 of the light diffusion portion 21 faces the inner peripheral surface 12 side of the shaft 10 .
  • the device 1 is inserted through the endoscope to the position where the target tissue is in the body cavity. At this time, the target tissue is positioned radially outward of the outer peripheral surface 13 of the shaft 10 .
  • the light emitted from the light diffusing portion 21 passes through at least a portion of the shaft 10 that overlaps the light diffusing portion 21 , so that the light reaches the target tissue around the device 1 .
  • light is emitted from the light diffusion portion 21 at least outward in the radial direction of the shaft 10, and the light is emitted from the light diffusion portion 21 over the entire circumferential direction p of the shaft 10. It is preferable that the light is emitted outward in the radial direction of the shaft 10 . Light may be emitted further from the light diffusing portion 21 toward the distal direction of the shaft 10, that is, toward the front.
  • the light diffusing part 21 is not a diffusing member (for example, a diffuser plate or a prism) separate from the optical fiber of the optical fiber member 20, but a part forming part of the optical fiber.
  • An optical fiber has a core and a cladding.
  • the clad is arranged on the outer circumference of the core and covers a part of the radially outer side of the core.
  • the light diffusion part 21 has (i) a mode in which only the core is arranged, (ii) a mode in which the core and the clad are arranged, or (iii) a part in which only the core is arranged and the other part in which the core and the clad are arranged. is preferably configured from any of the aspects in which is arranged.
  • a covering material for protection may be arranged outside the clad in the radial direction, but it is preferable that the light diffusing portion 21 is not arranged with members other than the core and the clad.
  • the materials that make up the core and clad are not particularly limited, and glass such as plastic, quartz glass, and fluoride glass can be used.
  • the resin forming the shaft 10 contains inorganic particles such as titanium oxide, barium sulfate, and calcium carbonate, and organic particles such as crosslinked acrylic particles and crosslinked styrene particles. Light diffusing materials can be added. Light emitted from the light diffusing portion 21 is more easily diffused by the shaft 10 .
  • the light diffusion part 21 is preferably arranged on the most distal side of the optical fiber.
  • the light diffusion part 21 may be arranged on the most distal side of the optical fiber member 20 . This facilitates the formation of the light diffusing portion 21 and increases the flexibility of the distal end portion of the optical fiber.
  • the length of the light diffusion portion 21 in the longitudinal direction x may be set to 1/50 or more, 1/45 or more, or 1/30 or more of the total length of the optical fiber member 20 . By setting such a length, it becomes easy to irradiate the entire target tissue with a single irradiation.
  • the length of the light diffusion portion 21 in the longitudinal direction x may be set to 1/20 or less, 1/25 or less, or 1/30 or less of the total length of the optical fiber member 20 . By setting such a length, it is possible to prevent irradiation of non-target tissues.
  • the light diffusing portion 21 may be arranged only in a part of the shaft 10 in the circumferential direction p, but as shown in FIG. preferably. Since a wide range in the circumferential direction p can be irradiated at once, efficiency of the procedure can be improved.
  • the device 1 has a first coil member 40 disposed in the lumen 11 of the shaft 10 on the distal side of the optical fiber member 20 and around which a wire 42 is helically wound.
  • the entire first coil member 40 in the longitudinal direction x is preferably arranged in the lumen 11 of the shaft 10 .
  • the wire rod 42 has a distal end and a proximal end in its longitudinal direction.
  • the wire 42 may be composed of a single linear member from the distal end to the proximal end, or the wire 42 may be composed of a plurality of linear members connected to each other in the longitudinal direction thereof.
  • the cross-sectional shape of the wire rod 42 perpendicular to the longitudinal axis direction may be circular, oval, polygonal, or a combination thereof.
  • the oval shape includes an elliptical shape, an egg shape, and a rounded rectangular shape. The same applies to other descriptions in this specification.
  • the wire diameter (thickness) of the wire 42 constituting the first coil member 40 and the number of turns of the wire 42 are not particularly limited.
  • the axial length of the first coil member 40 may be larger or smaller than the maximum outer diameter of the first coil member 40 .
  • the first coil member 40 has a pitch P1 longer than the wire diameter of the wire rod 42 .
  • the pitch P1 is the distance between the central axes of two adjacent wire rods 42 forming the first coil member 40 in the axial direction, as shown in FIG.
  • the pitch P1 of the first coil members 40 may be constant in the axial direction, or may vary depending on the position in the axial direction.
  • the plurality of pitches P1 of the first coil member 40 only a portion of the pitches P1 may be longer than the wire diameter of the wire 42, or the entire pitch P1 may be longer than the wire diameter of the wire 42.
  • the first coil member 40 Since the contraction of the pitch P1 of 40 makes it easier to fulfill the cushioning function, it is possible to make it easier to suppress damage to the optical fiber member 20 .
  • the first coil member 40 has the pitch P1 as described above, the distal end portion of the device 1 can be made flexible, and the operability can be easily improved.
  • the first coil member 40 preferably has a pitch P1 that is 1.5 times or more the wire diameter of the wire 42, may have a pitch P1 that is 1.6 times or more, or is 1.7 times or more. may have a pitch P1 of Also, the first coil member 40 may have a pitch P1 of 3.0 times or less the wire diameter of the wire 42, or may have a pitch P1 of 2.5 times or less. All the pitches P1 present in the first coil member 40 may be within the above range, or a part of the pitches P1 may be within the above range.
  • the first coil member 40 Since the contraction of the pitch of the optical fiber member 20 facilitates the fulfillment of the cushioning function, it is possible to easily suppress the breakage of the optical fiber member 20 .
  • the first coil member 40 since the first coil member 40 has the pitch as described above, the distal end portion of the device 1 can be made flexible, and the operability can be easily improved.
  • the outer diameter of the first coil member 40 may be constant in the longitudinal axis direction x of the shaft 10, or the outer diameter of the first coil member 40 may vary depending on the position in the longitudinal axis direction x. For example, when the first coil member 40 is divided into a distal portion and a proximal portion in the longitudinal direction x, the average outer diameter of the distal portion of the first coil member 40 is It may be larger than the average outer diameter of the site.
  • the inner diameter of the first coil member 40 may be constant in the longitudinal axis direction x of the shaft 10, or the inner diameter of the first coil member 40 may vary depending on the position in the longitudinal axis direction x. For example, when the first coil member 40 is divided into a distal portion and a proximal portion in the longitudinal direction x, the average inner diameter of the distal portion of the first coil member 40 is equal to the proximal portion of the first coil member 40. It may be larger than the average inner diameter of the portion.
  • the inner diameter of the proximal end of the first coil member 40 is preferably smaller than the outer diameter of the distal end of the optical fiber member 20 .
  • the pitch of the first coil member 40 can be easily contracted when a force directed toward the proximal direction from the distal side to the shaft 10 , that is, a pushing force is applied to the shaft 10 . Therefore, the first coil member 40 can easily perform the cushion function. Therefore, damage to the optical fiber member 20 can be easily suppressed.
  • the first coil member 40 is preferably made of a material having a higher reflectance than the shaft 10. This configuration facilitates diffusion of the reflected light on the inner peripheral surface 43 of the first coil member 40 .
  • the reflectance refers to the reflectance of light emitted from the light diffusing portion 21, and the unit is %.
  • the reflectance can be measured using a reflectance measurement system OP-RF-VIS-GT50 manufactured by Ocean Photonics.
  • the first coil member 40 is preferably made of metal, such as gold, silver, platinum, palladium, tungsten, tantalum, iridium, and alloys thereof.
  • a superelastic alloy such as a Ti alloy may also be used.
  • a part of the first coil member 40 may be made of resin.
  • the first coil member 40 may have a coil member main body and a reflective layer arranged on the inner surface of the coil member main body.
  • the light from the light diffusing portion 21 can be reflected by the reflective layer regardless of the material of the coil member main body.
  • a coil body or a resin tube around which a resin wire is wound may be the coil member main body.
  • the reflective layer may be provided by applying a coating agent containing a reflective material to the inner surface of the coil member body, and the reflective material is applied to the inner surface of the coil member body by a method such as vapor deposition, sputtering, electroplating, or chemical plating. It may be arranged by adhering.
  • the reflective layer may be a metal thin film.
  • Reflective materials include, for example, aluminum, gold, silver, copper, tin, titanium dioxide, tantalum pentoxide, aluminum oxide, silicon dioxide, magnesium fluoride, or combinations thereof.
  • the distal end portion of the first coil member 40 has a lid portion 450 whose area when the first coil member 40 is viewed from the distal side is larger than the lumen of the distal end portion of the first coil member 40.
  • the lid portion 450 can be formed, for example, by heating the distal end 401 side of the first coil member 40 to deform it. As a result, the first coil member 40 whose distal end 401 side is closed as shown in FIG. 3 can be obtained.
  • a cylindrical coil having one lumen and a metal member separate from the cylindrical coil are prepared, and the metal member is heated and welded so as to close the opening on the distal side of the cylindrical coil.
  • a portion 450 can also be formed. In this way, the first coil member 40 with the distal end 401 side closed can also be obtained.
  • the distal end of the optical fiber member 20 of the device 1 and the proximal end of the first coil member 40 are in contact, but are not fixed. Since the distal end of the optical fiber member 20 and the proximal end of the first coil member 40 are in contact with each other, a force directed from the distal direction to the proximal direction with respect to the shaft 10 , i.e., the force applied to the shaft 10 When a pushing force is applied, the pitch of the first coil member 40 shrinks to fulfill a cushioning function, so damage to the optical fiber member 20 can be easily suppressed.
  • the distal end portion of the optical fiber member 20 and the proximal end portion of the first coil member 40 are not fixed, the force directed from the proximal direction to the distal direction with respect to the shaft 10, that is, the shaft 10 When a force is applied in the direction in which the shaft 10 extends, the first coil member 40 and the optical fiber member 20 can be separated from each other, so damage to the optical fiber member 20 can be easily suppressed.
  • the device 1 may have a tubular member 50 that is arranged in the lumen 11 of the shaft 10 and covers the first coil member 40 .
  • the tubular member 50 is preferably formed to extend in the longitudinal direction x of the shaft 10 .
  • a direction of the tubular member 50 that is parallel to the longitudinal axis direction x of the shaft 10 is referred to as an axial direction of the tubular member 50 .
  • the entire first coil member 40 may be covered with the tubular member 50 , or only a part of the first coil member 40 may be covered with the tubular member 50 . As a result, it is possible to increase the rigidity of the distal end portion, thereby making it easier to improve the operability.
  • the tubular member 50 has one lumen.
  • the shape of the cylindrical member 50 is not particularly limited, but may be cylindrical, elliptical, or polygonal.
  • the axial length of the tubular member 50 may be larger or smaller than the maximum outer diameter of the tubular member 50 .
  • the proximal end 502 of the tubular member 50 may be positioned closer to the proximal side than the distal end of the light diffusion portion 21 .
  • the cylindrical member 50 covers a part of the distal portion of the light diffusing portion 21 .
  • the portion of the light diffusing portion 21 that is not covered with the cylindrical member 50 and is exposed to the shaft 10 side is referred to as an exposed portion 22 .
  • the light emitted from the light diffusing portion 21 is reflected by the inner peripheral surface 53 of the cylindrical member 50 shown in FIG. It becomes easy to diffuse in various directions from the exposed portion 22 that is the portion of the diffusion portion 21 that is not covered with the cylindrical member 50 .
  • the emission intensity distribution of the exposed portion 22 is more likely to be uniform in the circumferential direction p of the shaft 10 .
  • the cylindrical member 50 covers the light diffusing portion 21 , it covers only a part of the light diffusing portion 21 , and preferably does not cover the entire light diffusing portion 21 . Thereby, the exposed portion 22 is formed in the light diffusion portion 21 . Note that the cylindrical member 50 does not have to partially cover the distal portion of the light diffusing portion 21 . In the radial direction of the shaft 10 , it is preferable that there be no separate member between the exposed portion 22 and the shaft 10 , but any member that does not block the light emitted from the exposed portion 22 may be provided.
  • the distal end of the tubular member 50 has a cap 550 that has a larger area than the lumen of the distal end of the tubular member 50 when the tubular member 50 is viewed from the distal side. You may have In this way, the distal end 501 side of the cylindrical member 50 is closed and the proximal end 502 side is open, so that the light emitted from the light diffusing portion 21 is directed to the inner peripheral surface of the cylindrical member 50. 53 and the inner end surface 56 can be reflected.
  • the inner peripheral surface 53 may be composed of only the curved surface portion, may be composed of only the flat surface portion, or may be composed of a combination of the curved surface portion and the flat surface portion.
  • the inner peripheral surface 53 preferably has a curved surface portion.
  • the inner end surface 56 may be composed of only the flat portion, may be composed of only the curved surface portion, or may be composed of a combination of the curved surface portion and the flat surface portion.
  • the distal end of the first coil member 40 and the distal end of the tubular member 50 may be fixed.
  • the first coil member 40 may be directly fixed to the cylindrical member 50, or may be indirectly fixed via another member.
  • the method of fixing the first coil member 40 and the cylindrical member 50 is not particularly limited, but for example, welding, welding, crimping such as caulking, bonding with an adhesive, engaging, connecting, binding, ligating, etc. physical fixing. or a combination thereof. Note that the distal end portion of the first coil member 40 and the distal end portion of the tubular member 50 do not have to be fixed.
  • the outer peripheral surface 54 of the tubular member 50 may be in contact with the inner peripheral surface 12 of the shaft 10 .
  • the position of the cylindrical member 50 and the optical fiber member 20 relative to the shaft 10 is less likely to shift, and the position of the exposed portion 22 is fixed, so that the irradiation position can be stabilized.
  • the outer peripheral surface 54 of the cylindrical member 50 does not have to be in contact with the inner peripheral surface 12 of the shaft 10 .
  • the outer peripheral surface 23 of the light diffusion portion 21 and the inner peripheral surface 12 of the shaft 10 may be arranged apart from each other. More preferably, the outer peripheral surface 23 of the light diffusing portion 21 is arranged apart from the inner peripheral surface 12 of the shaft 10 in the exposed portion 22 . Further, it is more preferable that the outer peripheral surface 23 of the light diffusing portion 21 is separated from the inner peripheral surface 12 of the shaft 10 over the entire lengthwise direction x.
  • the tubular member disposed in the lumen 11 of the shaft 10 and covering the first coil member 40 is the second coil member 60 having a wire rod 62 spirally wound thereon.
  • the description of the first coil member 40 can be referred to for the material forming the second coil member 60 .
  • the second coil member 60 preferably has a pitch P2 equal to or greater than the wire diameter of the wire rod 62, may have a pitch P2 that is 1.1 times or more, or has a pitch P2 that is 1.2 times or more. You may have Further, the second coil member 60 may have a pitch P2 of 3.0 times or less the wire diameter of the wire 62, or may have a pitch P2 of 2.5 times or less.
  • the pitch P2 is the interval between the central axes of two adjacent wire rods 62 forming the second coil member 60 . All the pitches P2 present in the second coil member 60 may be within the above range, or a part of the pitches P2 may be within the above range.
  • the second coil member 60 may have the same pitch as the wire diameter of the wire rod 62 .
  • Such coils are commonly referred to as tight wound coils.
  • a tightly wound coil is preferable because there is no gap between two adjacent wire rods 62 and light is less likely to leak from the second coil member 60 . It is also preferable when using the second coil member 60 as a marker.
  • the second coil member 60 is The pitch may be smaller than the wire diameter of the wire 62 .
  • the outer diameter of the second coil member 60 may be constant in the longitudinal axis direction x of the shaft 10, or the outer diameter of the second coil member 60 may vary depending on the position in the longitudinal axis direction x. For example, when the second coil member 60 is divided into a distal portion and a proximal portion in the longitudinal direction x, the average outer diameter of the distal portion of the second coil member 60 is It may be larger than the average outer diameter of the site.
  • the average pitch P1 of the first coil members 40 may be larger than the average pitch P2 of the second coil members 60 . Part of the pitch P1 of the first coil members 40 may be greater than the pitch P2 of the second coil members 60, but the entire pitch P1 of the first coil members 40 is greater than the pitch P2 of the second coil members 60. is preferred. As a result, flexibility can be easily imparted to the inner side of the device 1 in the radial direction, and operability can be easily improved.
  • the wire diameter of the wire 42 of the first coil member 40 may be smaller than the wire diameter of the wire 62 of the second coil member 60 .
  • the cross-sectional area of the wire rod 42 in the direction perpendicular to the longitudinal axis direction x and passing through the midpoint of the length in the longitudinal axis direction of the first coil member 40 is the middle of the length in the longitudinal axis direction of the second coil member 60. It may be smaller than the cross-sectional area of wire rod 62 passing through the point. As a result, flexibility can be easily imparted to the inner side of the device 1 in the radial direction, and operability can be easily improved.
  • the winding direction of the first coil member 40 and the winding direction of the second coil member 60 are preferably the same. As a result, the slippage between the first coil member 40 and the second coil member 60 is improved, so that the first coil member 40 and the second coil member 60 can easily follow the shape change of the shaft 10, and the device 1 can be operated. It can make it easier to improve the quality.
  • the winding direction of the first coil member and the winding direction of the second coil member may be different.
  • the distal end portion of the second coil member 60 has an area larger than the lumen of the distal end portion of the second coil member 60 when the second coil member 60 is viewed from the distal side. It preferably has a large lid 650 .
  • the lid portion 650 of the second coil member 60 can be formed by the same method as the lid portion 450 of the first coil member 40 . In this way, the distal end 601 side of the second coil member 60 is closed and the proximal end 602 side is open. can be reflected by the inner peripheral surface 63 and the inner end surface 66 of the .
  • the proximal end 602 of the second coil member 60 may be positioned closer to the proximal side than the distal end of the light diffusing portion 21 .
  • the second coil member 60 preferably covers a portion of the distal portion of the light diffusion section 21 .
  • the portion of the light diffusing portion 21 that is not covered with the second coil member 60 and is exposed to the shaft 10 side is referred to as an exposed portion 22 . Due to the presence of the second coil member 60, the rigidity of the distal end portion can be increased, so that the operability can be easily improved.
  • the light emitted from the light diffusing portion 21 is reflected by the inner peripheral surface 63 of the second coil member 60, so that the reflected light is diffused. It becomes easy to diffuse in various directions from the exposed portion 22 , which is the portion of the portion 21 that is not covered with the second coil member 60 . As a result, the emission intensity distribution of the exposed portion 22 is more likely to be uniform in the circumferential direction p of the shaft 10 . As a result, it is possible to reduce the number of times the target tissue such as a tumor is irradiated and the number of times the position of the exposed portion 22 is adjusted with respect to the target tissue, thereby improving the efficiency of the procedure.
  • the second coil member 60 covers the light diffusing section 21 , it covers only a part of the light diffusing section 21 , and preferably does not cover the entire light diffusing section 21 . Thereby, the exposed portion 22 is formed in the light diffusion portion 21 . In addition, the second coil member 60 may not partially cover the distal portion of the light diffusion section 21 . In the radial direction of the shaft 10 , it is preferable that there be no separate member between the exposed portion 22 and the shaft 10 , but any member that does not block the light emitted from the exposed portion 22 may be provided.
  • the optical fiber member 20 has a core 25 extending in the longitudinal direction x, and the optical fiber member 20 has a first clad 26 disposed around the core 25. It has a first section 31 where In the first section 31, the light is likely to be totally reflected at the boundary between the core 25 and the first clad 26. Therefore, in the first section 31, the light is confined within the core 25 and propagated to the distal side of the optical fiber member 20. be.
  • one core 25 is arranged in one first clad 26 in the first section 31 .
  • the optical fiber can be rephrased as a single-core optical fiber.
  • the first clad 26 may be positioned radially outwardly of the optical fiber member 20 in the first section 31 . That is, the first section 31 does not need to be provided with other members such as a covering material.
  • the first section 31 of the optical fiber member 20 may be provided with a coating material around the outer periphery of the first clad 26 . It is possible to protect the outside of the first section 31 , and it is also possible to suppress light leakage and emission to the outside in the first section 31 .
  • the coating material may be a coating layer arranged on the outer peripheral surface of the first clad 26 or a sheath enclosing the first clad 26 .
  • the covering material can be made of a resin such as an ultraviolet curable resin.
  • the optical fiber member 20 has a second clad 27 disposed on the outer periphery of the core 25 and having a larger surface roughness of the outer peripheral surface than the first clad 26 in the light diffusion part 21. 32.
  • the second section 32 is positioned more distally than the first section 31 .
  • part of the light is confined within the core 25 and propagated distally of the optical fiber member 20, and the remaining light is transmitted to the second section. It leaks out from the second clad 27 and is injected radially outward. It is preferable that the first section 31 does not emit light radially outward, or that the amount of light leakage is smaller than that of the second section 32 .
  • one core 25 is preferably arranged in one second clad 27 .
  • the first section 31 and the second section 32 may consist of one optical fiber.
  • the first clad 26 of the first section 31 and the second clad 27 of the second section 32 may be integrally formed.
  • the optical fiber for the first section 31 and the optical fiber for the second section 32 may be spliced in the longitudinal axis direction x.
  • the first clad 26 of the first section 31 and the second clad 27 of the second section 32 may be separately formed and then joined together.
  • the second cladding 27 is located on the outermost side of the optical fiber member 20 in the radial direction. That is, in the second section 32, it is preferable that no member (for example, a covering material) other than the core 25 and the second clad 27 is arranged. With this configuration, light can be emitted outward in the radial direction of the shaft 10 from the second section 32 .
  • the surface roughness of the outer peripheral surface of the second clad 27 in the second section 32 is greater than the surface roughness of the outer peripheral surface of the first clad 26 in the first section 31 .
  • the surface roughness is the arithmetic mean roughness Ra between the reference lengths of the roughness curve in the longitudinal axis direction of the outer peripheral surface of the optical fiber member 20 .
  • the reference length may be set according to the magnification of the laser microscope used, and is, for example, 200 ⁇ m.
  • the above arithmetic mean roughness Ra corresponds to the arithmetic mean roughness Ra specified in JIS B 0601 (2001) and is measured according to JIS B 0633 (2001).
  • a measuring machine specified in JIS B 0651 (2001) for example, a laser microscope VK-X3000 manufactured by Keyence Corporation is used.
  • the average value of the surface roughness of the outer peripheral surface of the second clad 27 in the second section 32 is preferably larger than the average value of the surface roughness of the outer peripheral surface of the first clad 26 in the first section 31 .
  • the average value of the surface roughness is the average value of the surface roughness values of 10 or more measurement points set so as to be aligned in the longitudinal axis direction x in the section to be measured (for example, the first section 31). .
  • the surface roughness of the outer peripheral surface of the second clad 27 in the proximal portion 324 is The average value is preferably smaller than the average surface roughness of the outer peripheral surface of the second clad 27 in the distal portion 323 .
  • the proximal portion 324 enhances the effect of confining light within the core 25 more than the distal portion 323, while the distal portion 323 facilitates the radially outward emission of light from the second clad 27. Therefore, the emission intensity distribution of the second section 32 is easily uniformed in the longitudinal direction x.
  • the second section 32 is preferably shorter than the first section 31 in the longitudinal direction x. It becomes easier to form the light diffusing portion 21, and the flexibility of the distal end portion of the optical fiber 20 can also be increased.
  • the length of the second section 32 in the longitudinal direction x can be set to 1/20 or less, 1/25 or less, or 1/30 or less of the length of the first section 31 .
  • the length of the second section 32 in the longitudinal axis direction x may be set to 1/50 or more, 1/45 or more, or 1/30 or more of the length of the first section 31. good.
  • the average thickness of the second clad 27 in the second section 32 is preferably smaller than the average thickness of the first clad 26 in the first section 31.
  • the clad thickness can be measured using a laser microscope VK-X3000 manufactured by Keyence Corporation.
  • the optical fiber member 20 when the optical fiber member 20 has the first section 31 , the optical fiber member 20 has no cladding in the light diffusing portion 21 and is located distally of the first section 31 . may have a third section 33 located at . Since there is no clad in the third section 33, the light from the core 25 is emitted radially outward.
  • no clad exists in at least a part of the core 25 in the circumferential direction, and more preferably, no clad exists in the entire circumferential direction of the core 25.
  • the core 25 is positioned radially outermost in the optical fiber member 20.
  • the outer diameter of the core 25 in the third section 33 may be a constant value, or the outer diameter of the core 25 may be a different value depending on the position in the longitudinal direction x.
  • the distal end of the third section 33 is preferably at the same position as the distal end of the core 25 in the longitudinal direction x.
  • the formation of the third section 33 is facilitated, and the flexibility at the distal end of the optical fiber member 20 can also be increased.
  • the surface roughness of the outer peripheral surface of the core 25 in the third section 33 is preferably larger than the surface roughness of the outer peripheral surface of the first clad 26 in the first section 31 . Light is likely to be confined within the core 25 in the first section 31 , and light is likely to be emitted radially outward from the core 25 in the third section 33 .
  • At least one of the second section 32 and the third section 33 is preferably arranged in the light diffusion section 21, and both the second section 32 and the third section 33 may be arranged.
  • the light diffusing portion 21 has a second section 32 and a third section 33 arranged in order from the proximal side to the distal side. With this configuration, the light emission intensity distribution of the light diffusing portion 21 can be easily uniformed in the longitudinal direction x.
  • the first section 31, the second section 32, and the third section 33 are adjacent to each other in the longitudinal direction x. More specifically, the first section 31 and the second section 32 are adjacent to each other, and the second section 32 and the third section 33 are preferably adjacent to each other.
  • the third section 33 is shorter than the second section 32 in the longitudinal axis direction x as shown in FIG. With this configuration, it becomes easier to uniform the emission intensity distribution of the entire exposed portion 22 in the longitudinal direction x. A mode in which the second section 32 is shorter than the third section 33 in the longitudinal direction x is also allowed.
  • the length of the third section 33 in the longitudinal direction x is preferably 20% or less of the total length of the second section 32 and the third section 33, and is preferably 18% or less. More preferably, the size is 15% or less. In addition, the length of the third section 33 in the longitudinal direction x may be 5% or more, 8% or more, or 10% or more of the total length of the second section 32 and the third section 33. . This configuration makes it easier to uniformize the emission intensity distribution of the exposed portion 22 in the longitudinal direction x.
  • the average value of the surface roughness of the outer peripheral surface of the second clad 27 in the second section 32 is preferably smaller than the average value of the surface roughness of the outer peripheral surface of the core 25 in the third section 33 . This configuration makes it easier to uniformize the emission intensity distribution in the longitudinal axis direction x in each of the second section 32 and the third section 33 .
  • the optical fiber member 20 may have only the second section 32 in the light diffusing portion 21 . That is, the optical fiber member 20 does not have to have the third section 33 in the light diffusing portion 21 . Even with the configuration having only the second section 32, the emission intensity distribution of the exposed portion 22 in the longitudinal axis direction x can be made uniform. Since the core 25 is not exposed, it also has the effect of preventing damage to the optical fiber member 20 due to bending of the device 1 during the procedure.
  • the distal end of the second section 32 may be at the same position as the distal end of the core 25 in the longitudinal direction x. preferable.
  • the optical fiber member 20 may have only the third section 33 in the light diffusing portion 21 . That is, the optical fiber member 20 does not have to have the second section 32 in the light diffusing portion 21 . Even with the configuration having only the third section 33, the emission intensity distribution of the exposed portion 22 in the longitudinal axis direction x can be made uniform.
  • the second section 32 and the third section 33 can be formed by removing the clad by etching or polishing.
  • the outer peripheral surface of the second clad 27 and the outer peripheral surface of the core 25 of the third section 33 may be uneven.
  • the unevenness can be formed by mechanically or chemically roughening the surface of the core 25 of the second clad 27 or the third section 33 . Examples of methods for roughening the surface include etching, blasting, a method using a scribe, a wire brush, or sandpaper.
  • the light diffusing portion 21 should emit the first light beam for treatment.
  • the first light beam is preferably laser light with a wavelength suitable for phototherapy such as PDT and PIT for irradiating internal tissue.
  • a second targeting beam may be emitted.
  • the second light beam is a light beam emitted to grasp the treatment site before the first light beam is emitted, and preferably has a lower radiant energy than the first light beam.
  • the optical fiber member 20 preferably has a reflector 200 on its distal end face.
  • the reflector 200 is, for example, a mirror arranged so that the reflecting surface faces the proximal side. With this configuration, light can be reflected not only by the inner peripheral surface of the second coil member 60 but also by the reflector 200, so that the reflected light can be easily diffused in various directions.
  • the surface of the reflector 200 is preferably made of aluminum, gold, silver, copper, tin, titanium dioxide, tantalum pentoxide, aluminum oxide, silicon dioxide, or magnesium fluoride.
  • the shape of the reflector 200 is not particularly limited, it can be shaped like a plate, a cylinder, or a polygonal column, for example.
  • Light irradiation medical device 10 Shaft 11: Lumen 20: Optical fiber member 21: Light diffusion part 22: Exposed part 25: Core 26: First clad 27: Second clad 200: Reflective material 31: First section 32: Second section 323: Distal section 324: Proximal section 33: Third section 40: First coil member 42: Wire rod 50: Tubular member 60: Second coil member 62: Wire rod 70: Handle x: Longitudinal axis direction p: circumferential direction

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Abstract

The present invention relates to a light irradiating medical device (1) comprising: a shaft (10) having a distal end and a proximal end in the longitudinal direction (x), and having a lumen (11) extending in the longitudinal direction (x); an optical fiber member (20) disposed in the lumen (11) of the shaft (10); a first coil member (40) disposed in the lumen (11) of the shaft (10) and located further toward the distal end than the optical fiber member (20), the first coil member (40) including a helically wound wire (42). The first coil member (40) has a pitch (P1) longer than the wire diameter of the wire (42). The distal end of the optical fiber member (20) and the proximal end of the first coil member (40) are in abutment with each other but are not fixed to each other.

Description

光照射医療装置Light irradiation medical device
 本発明は、血管や消化管等の体内管腔において、がん細胞等の組織に光を照射するための光照射医療装置に関するものである。 The present invention relates to a light irradiation medical device for irradiating tissues such as cancer cells with light in body lumens such as blood vessels and gastrointestinal tracts.
 光線力学的療法(Photodynamic Therapy:PDT)では、光増感剤を静脈注射や腹腔内投与で体内に投与し、がん細胞等の対象組織に光増感剤を集積させ、特定の波長の光を照射することにより光増感剤を励起させる。励起された光増感剤が基底状態に戻るときにエネルギー転換が生じ、活性酸素種を発生させる。活性酸素種が対象組織を攻撃することにより、対象組織を除去することができる。レーザー光を用いたアブレーションでは、対象組織にレーザー光を照射し、焼灼することが行われる。このような光照射を行うための装置が提案されている。 In photodynamic therapy (PDT), a photosensitizer is administered into the body by intravenous injection or intraperitoneal injection, and the photosensitizer is accumulated in target tissues such as cancer cells, and light of a specific wavelength is used. to excite the photosensitizer. An energy transfer occurs when the excited photosensitizer returns to the ground state, generating reactive oxygen species. Target tissue can be removed by attacking the target tissue with reactive oxygen species. In ablation using laser light, a target tissue is irradiated with laser light and cauterized. An apparatus for performing such light irradiation has been proposed.
 特許文献1には、長尺状の外形を有する本体部と、本体部の先端側に設けられたコイル体と、コイル体の内側に設けられ、外部に向けて光を照射する光照射部と、を備える光照射デバイスが開示されている。また、コイル体の内側に、内側コイル体とコアシャフトが設けられ、コアシャフトの一部と内側コイル体の一部とが接合部を介して接合されている態様が示されている。 Patent Document 1 discloses a main body having an elongated outer shape, a coil body provided on the tip side of the main body, and a light irradiation part provided inside the coil body for irradiating light toward the outside. is disclosed. Further, an aspect is shown in which an inner coil body and a core shaft are provided inside the coil body, and a part of the core shaft and a part of the inner coil body are joined via a joining portion.
特開2021-90503号公報Japanese Patent Application Laid-Open No. 2021-90503
 特許文献1に記載されている光照射デバイスにおいては、内側コイルのピッチが密である。このため、内側コイルは遠位側方向から近位側方向に向かう力を加えた際には縮むことができない。また、接合部によって固定されているものであるから、遠位側方向から近位側方向に向かう力を加えた際には内側コイルは伸びることができない。このように、内側コイルのピッチが密であることにより柔軟性に欠けることで、特許文献1に開示されている光照射デバイスは、光ファイバーや他の部材への負荷が大きくなり、破損しやすいものであった。また、柔軟性に欠けることから操作性も欠けるものであった。そこで、本発明は、耐破損性や操作性に優れる光照射医療装置を提供することを目的とする。 In the light irradiation device described in Patent Document 1, the pitch of the inner coils is dense. For this reason, the inner coil cannot contract when a force directed from the distal direction to the proximal direction is applied. Further, since it is fixed by the joint, the inner coil cannot be stretched when a force directed from the distal direction to the proximal direction is applied. In this way, the lack of flexibility due to the tight pitch of the inner coil causes the light irradiation device disclosed in Patent Document 1 to increase the load on the optical fiber and other members, and is easily damaged. Met. In addition, it lacks flexibility and therefore lacks operability. Accordingly, an object of the present invention is to provide a light irradiation medical device that is excellent in breakage resistance and operability.
 上記目的を達成し得た本発明の光照射医療装置の一実施態様は下記の通りである。
 [1]長手軸方向に遠位端と近位端を有し、かつ長手軸方向に延在している内腔を有するシャフトと、シャフトの内腔に配置されている光ファイバー部材と、シャフトの内腔であって光ファイバー部材よりも遠位側に配置されており、線材がらせん状に巻回されている第1コイル部材と、を有し、第1コイル部材は線材の線径よりも長いピッチを有しており、光ファイバー部材の遠位端部と第1コイル部材の近位端部は当接しているが、固定されていない光照射医療装置。
 上記光照射医療装置によれば、光ファイバー部材の遠位端部と第1コイル部材の近位端部が当接していることにより、シャフトに対して遠位側方向から近位側方向に向かう力、即ちシャフトに対して押し込む力が加わった場合には、第1コイル部材のピッチが収縮することによってクッション機能を果たすため、光ファイバー部材の破損を抑制しやすくすることができる。また、光ファイバー部材の遠位端部と第1コイル部材の近位端部が固定されていないことにより、シャフトに対して近位側方向から遠位側方向に向かう力、即ちシャフトに対してシャフトが伸びる方向に力が加わった場合には、第1コイル部材と光ファイバー部材とが離れることができるため、光ファイバーの破損を抑制しやすくすることができる。また、第1コイル部材が上記のようなピッチを有していることで、光照射医療装置の遠位端部に柔軟性を持たせることができ、操作性を向上させることができる。
 [2]第1コイル部材の近位端部の内径は、光ファイバー部材の遠位端部の外径よりも小さい[1]に記載の光照射医療装置。
 [3]シャフトの内腔に配置されており、第1コイル部材を覆っている筒部材を有している[1]または[2]に記載の光照射医療装置。
 [4]第1コイル部材の遠位端部と筒部材の遠位端部とが固定されている[3]に記載の光照射医療装置。
 [5]光ファイバー部材はその遠位部の所定区間に長手軸方向に延在しておりシャフトの径方向の外方に向かって光を射出する光拡散部を有し、筒部材の近位端は光拡散部の遠位端よりも近位側に位置している[3]または[4]に記載の光照射医療装置。
 [6]筒部材の外周面がシャフトの内周面と接しており、光拡散部の外周面とシャフトの内周面とが離れて配置されている[5]に記載の光照射医療装置。
 [7]筒部材の遠位端部は、筒部材を遠位側から見た時の面積が筒部材の遠位端部の内腔よりも大きい蓋部を有している[3]~[6]のいずれか一項に記載の光照射医療装置。
 [8]筒部材は線材がらせん状に巻回されている第2コイル部材である[3]~[7]のいずれか一項に記載の光照射医療装置。
 [9]第1コイル部材のピッチの平均は、第2コイル部材のピッチの平均よりも大きい[8]に記載の光照射医療装置。
 [10]第1コイル部材の線材の線径は、第2コイル部材の線材の線径よりも小さい[8]または[9]に記載の光照射医療装置。
 [11]長手軸方向に垂直な方向であって、第1コイル部材の長手軸方向における長さの中点を通る線材の断面積は、第2コイル部材の長手軸方向における長さの中点を通る線材の断面積よりも小さい[8]~[10]のいずれか一項に記載の光照射医療装置。
 [12]第1コイル部材の巻き方向と第2コイル部材の巻き方向とが同じ方向である[8]~[11]のいずれか一項に記載の光照射医療装置。
 [13]第2コイル部材の遠位端部は、第2コイル部材を遠位側から見た時の面積が第2コイル部材の遠位端部の内腔よりも大きい蓋部を有している[8]~[12]のいずれか一項に記載の光照射医療装置。
 [14]光ファイバー部材は、その遠位端面に反射材を有している[1]~[13]のいずれか一項に記載の光照射医療装置。
 [15]第1コイル部材は線材の線径の1.5倍以上のピッチを有している[1]~[14]のいずれか一項に記載の光照射医療装置。
 [16]第1コイル部材の遠位端部は、第1コイル部材を遠位側から見た時の面積が第1コイル部材の遠位端部の内腔よりも大きい蓋部を有している[1]~[15]のいずれか一項に記載の光照射医療装置。
One embodiment of the photoirradiation medical device of the present invention that can achieve the above objects is as follows.
[1] a shaft having a longitudinally distal end and a proximal end and having a longitudinally extending lumen; an optical fiber member disposed in the lumen of the shaft; a first coil member having a lumen and disposed distal to the optical fiber member and having a wire wound in a helical shape, the first coil member being longer than the wire diameter of the wire. A light irradiation medical device having a pitch, wherein the distal end of the fiber optic member and the proximal end of the first coil member abut but are not fixed.
According to the above light irradiation medical device, the contact between the distal end portion of the optical fiber member and the proximal end portion of the first coil member causes a force directed from the distal side direction to the proximal side direction with respect to the shaft. That is, when a pushing force is applied to the shaft, the pitch of the first coil member shrinks to fulfill a cushioning function, so damage to the optical fiber member can be easily suppressed. In addition, since the distal end portion of the optical fiber member and the proximal end portion of the first coil member are not fixed, a force directed from the proximal direction to the distal direction with respect to the shaft, that is, the shaft with respect to the shaft When a force is applied in the direction in which the coil member extends, the first coil member and the optical fiber member can be separated from each other, so damage to the optical fiber can be easily suppressed. In addition, since the first coil member has the pitch as described above, flexibility can be imparted to the distal end portion of the light irradiation medical device, and operability can be improved.
[2] The light irradiation medical device according to [1], wherein the inner diameter of the proximal end of the first coil member is smaller than the outer diameter of the distal end of the optical fiber member.
[3] The light irradiation medical device according to [1] or [2], which is arranged in the lumen of the shaft and has a tubular member covering the first coil member.
[4] The light irradiation medical device according to [3], in which the distal end of the first coil member and the distal end of the cylindrical member are fixed.
[5] The optical fiber member has a light diffusing portion extending longitudinally in a predetermined section of its distal portion and emitting light radially outward of the shaft, and the proximal end of the tubular member is positioned closer to the proximal side than the distal end of the light diffusing section [3] or [4].
[6] The light irradiation medical device according to [5], in which the outer peripheral surface of the tubular member is in contact with the inner peripheral surface of the shaft, and the outer peripheral surface of the light diffusing portion and the inner peripheral surface of the shaft are arranged apart from each other.
[7] The distal end of the tubular member has a lid that has a larger area than the lumen of the distal end of the tubular member when the tubular member is viewed from the distal side [3]-[ 6], the light irradiation medical device according to any one of items.
[8] The light irradiation medical device according to any one of [3] to [7], wherein the cylindrical member is a second coil member in which a wire is helically wound.
[9] The light irradiation medical device according to [8], wherein the average pitch of the first coil members is larger than the average pitch of the second coil members.
[10] The light irradiation medical device according to [8] or [9], wherein the wire diameter of the wire of the first coil member is smaller than the wire diameter of the wire of the second coil member.
[11] The cross-sectional area of the wire in the direction perpendicular to the longitudinal direction and passing through the midpoint of the length in the longitudinal direction of the first coil member is the midpoint of the length in the longitudinal direction of the second coil member. The light irradiation medical device according to any one of [8] to [10], which is smaller than the cross-sectional area of the wire passing through.
[12] The light irradiation medical device according to any one of [8] to [11], wherein the winding direction of the first coil member and the winding direction of the second coil member are the same.
[13] The distal end portion of the second coil member has a lid portion whose area when the second coil member is viewed from the distal side is larger than the lumen of the distal end portion of the second coil member. The light irradiation medical device according to any one of [8] to [12].
[14] The light irradiation medical device according to any one of [1] to [13], wherein the optical fiber member has a reflector on its distal end surface.
[15] The light irradiation medical device according to any one of [1] to [14], wherein the first coil member has a pitch of 1.5 times or more the wire diameter of the wire.
[16] The distal end of the first coil member has a lid that has a larger area than the lumen of the distal end of the first coil member when the first coil member is viewed from the distal side. The light irradiation medical device according to any one of [1] to [15].
 上記光照射医療装置によれば、光ファイバー部材の遠位端部と第1コイル部材の近位端部が当接していることにより、シャフトに対して遠位側方向から近位側方向に向かう力、即ちシャフトに対して押し込む力が加わった場合には、第1コイル部材のピッチが収縮することによってクッション機能を果たすため、光ファイバー部材の破損を抑制しやすくすることができる。また、光ファイバー部材の遠位端部と第1コイル部材の近位端部が固定されていないことにより、シャフトに対して近位側方向から遠位側方向に向かう力、即ちシャフトに対してシャフトが伸びる方向に力が加わった場合には、第1コイル部材と光ファイバー部材とが離れることができるため、光ファイバーの破損を抑制しやすくすることができる。また、第1コイル部材が上記のようなピッチを有していることで、光照射医療装置の遠位端部に柔軟性を持たせることができ、操作性を向上させることができる。 According to the above light irradiation medical device, the contact between the distal end portion of the optical fiber member and the proximal end portion of the first coil member causes a force directed from the distal side direction to the proximal side direction with respect to the shaft. That is, when a pushing force is applied to the shaft, the pitch of the first coil member shrinks to fulfill a cushioning function, so damage to the optical fiber member can be easily suppressed. In addition, since the distal end portion of the optical fiber member and the proximal end portion of the first coil member are not fixed, a force directed from the proximal direction to the distal direction with respect to the shaft, that is, the shaft with respect to the shaft When a force is applied in the direction in which the coil member extends, the first coil member and the optical fiber member can be separated from each other, so damage to the optical fiber can be easily suppressed. In addition, since the first coil member has the pitch as described above, flexibility can be imparted to the distal end portion of the light irradiation medical device, and operability can be improved.
本発明の一実施形態に係る光照射医療装置の断面図(一部側面図)である。1 is a cross-sectional view (partial side view) of a light irradiation medical device according to an embodiment of the present invention; FIG. 図1に示した光照射医療装置のII-II線における切断部端面図である。FIG. 2 is a cross-sectional end view of the light irradiation medical device shown in FIG. 1 taken along line II-II. 図1に示した第1コイル部材の切断部端面図である。2 is a cut end view of the first coil member shown in FIG. 1. FIG. 図1に示した光照射医療装置の変形例を示す断面図(一部側面図)である。1. It is sectional drawing (partial side view) which shows the modification of the light irradiation medical device shown in FIG. 図4に示した筒部材の切断部端面図である。5 is a cut end view of the cylindrical member shown in FIG. 4. FIG. 図1に示した光照射医療装置の変形例を示す断面図(一部側面図)である。1. It is sectional drawing (partial side view) which shows the modification of the light irradiation medical device shown in FIG. 図6に示した第2コイル部材の切断部端面図である。7 is a cut end view of the second coil member shown in FIG. 6. FIG. 図1に示した光ファイバー部材の遠位側を拡大した断面図である。2 is an enlarged cross-sectional view of the distal side of the fiber optic member shown in FIG. 1; FIG. 図6に示した光ファイバー部材の変形例を示す断面図である。FIG. 7 is a cross-sectional view showing a modification of the optical fiber member shown in FIG. 6; 図6に示した光ファイバー部材の他の変形例を示す断面図である。FIG. 7 is a cross-sectional view showing another modification of the optical fiber member shown in FIG. 6; 図6に示した光ファイバー部材の他の変形例を示す断面図である。FIG. 7 is a cross-sectional view showing another modification of the optical fiber member shown in FIG. 6;
 以下、本発明に関して、図面を参照しつつ具体的に説明するが、本発明はもとより図示例に限定されることはなく、前・後記の趣旨に適合し得る範囲で適当に変更を加えて実施することも可能であり、それらはいずれも本発明の技術的範囲に包含される。各図において、便宜上、ハッチングや符号等を省略する場合もあるが、かかる場合、明細書や他の図を参照するものとする。また、図面における種々部品の寸法は、本発明の特徴を理解に資することを優先しているため、実際の寸法とは異なる場合がある。 Hereinafter, the present invention will be described in detail with reference to the drawings, but the present invention is not limited to the illustrated examples, and can be implemented with appropriate modifications within the scope that can conform to the gist of the above and later descriptions. All of them are included in the technical scope of the present invention. In each drawing, hatching, symbols, etc. may be omitted for the sake of convenience. In such cases, the specification and other drawings shall be referred to. In addition, the dimensions of various parts in the drawings may differ from the actual dimensions, since priority is given to aid understanding of the features of the present invention.
 本発明の光照射医療装置の一実施態様は、長手軸方向に遠位端と近位端を有し、かつ長手軸方向に延在している内腔を有するシャフトと、シャフトの内腔に配置されている光ファイバー部材と、シャフトの内腔であって光ファイバー部材よりも遠位側に配置されており、線材がらせん状に巻回されている第1コイル部材と、を有し、第1コイル部材は線材の線径よりも長いピッチを有しており、光ファイバー部材の遠位端部と第1コイル部材の近位端部は当接しているが、固定されていない点に要旨を有する。上記光照射医療装置によれば、光ファイバー部材の遠位端部と第1コイル部材の近位端部が当接していることにより、シャフトに対して遠位側方向から近位側方向に向かう力、即ちシャフトに対して押し込む力が加わった場合には、第1コイル部材のピッチが収縮することによってクッション機能を果たすため、光ファイバー部材の破損を抑制しやすくすることができる。また、光ファイバー部材の遠位端部と第1コイル部材の近位端部が固定されていないことにより、シャフトに対して近位側方向から遠位側方向に向かう力、即ちシャフトに対してシャフトが伸びる方向に力が加わった場合には、第1コイル部材と光ファイバー部材とが離れることができるため、光ファイバーの破損を抑制しやすくすることができる。また、第1コイル部材が上記のようなピッチを有していることで、光照射医療装置の遠位端部に柔軟性を持たせることができ、操作性を向上させることができる。 One embodiment of the photomedical device of the present invention includes a shaft having longitudinally distal and proximal ends and having a longitudinally extending lumen; and a first coil member disposed in the lumen of the shaft and distally of the optical fiber member and having a wire wound in a spiral shape; The coil member has a pitch longer than the wire diameter of the wire, and the distal end of the optical fiber member and the proximal end of the first coil member are in contact, but are not fixed. . According to the above light irradiation medical device, the contact between the distal end portion of the optical fiber member and the proximal end portion of the first coil member causes a force directed from the distal side direction to the proximal side direction with respect to the shaft. That is, when a pushing force is applied to the shaft, the pitch of the first coil member shrinks to fulfill a cushioning function, so damage to the optical fiber member can be easily suppressed. In addition, since the distal end portion of the optical fiber member and the proximal end portion of the first coil member are not fixed, a force directed from the proximal direction to the distal direction with respect to the shaft, that is, the shaft with respect to the shaft When a force is applied in the direction in which the coil member extends, the first coil member and the optical fiber member can be separated from each other, so damage to the optical fiber can be easily suppressed. In addition, since the first coil member has the pitch as described above, flexibility can be imparted to the distal end portion of the light irradiation medical device, and operability can be improved.
 光照射医療装置は、PDTや光アブレーションにおいて血管や消化管等の体内管腔で、がん細胞等の対象組織である処置部に対して特定の波長の光を照射するために用いられる。光照射医療装置は、単独で処置部まで送達されるものであってもよく、送達用のカテーテルや内視鏡と共に用いられてもよい。内視鏡を用いた治療では、内視鏡の鉗子チャンネルを通じて光照射医療装置が体内に配置され、処置部まで送達される。 A photoirradiation medical device is used in PDT and photoablation to irradiate light of a specific wavelength to the treatment area, which is the target tissue such as cancer cells, in a body lumen such as a blood vessel or digestive tract. The light irradiation medical device may be delivered to the treatment site alone, or may be used together with a delivery catheter or endoscope. In treatment using an endoscope, a light irradiation medical device is placed inside the body through a forceps channel of the endoscope and delivered to a treatment site.
 図1~図11を参照しながら、装置の基本構成について説明する。図1は、本発明の一実施形態に係る光照射医療装置の断面図(一部側面図)である。図2は、図1に示した光照射医療装置のII-II線における切断部端面図である。図3は、図1に示した第1コイル部材の切断部端面図である。図4は、図1に示した光照射医療装置の変形例を示す断面図(一部側面図)である。図5は、図4に示した筒部材の切断部端面図である。図6は、図1に示した光照射医療装置の変形例を示す断面図(一部側面図)である。図7は、図6に示した第2コイル部材の切断部端面図である。図8は図1に示した光ファイバー部材の遠位側を拡大した断面図である。図9~図11は図6に示した光ファイバー部材の他の変形例を示す断面図である。光照射医療装置1は、シャフト10と光ファイバー部材20と第1コイル部材40を有している。以下では光照射医療装置を単に装置と称することがある。光ファイバー部材20と第1コイル部材40の位置関係を理解しやすくするために、図8~図11ではシャフト10を省略している。 The basic configuration of the device will be described with reference to FIGS. 1 to 11. FIG. FIG. 1 is a cross-sectional view (partial side view) of a light irradiation medical device according to one embodiment of the present invention. FIG. 2 is an end view of the light irradiation medical device shown in FIG. 1 taken along line II-II. 3 is a cut end view of the first coil member shown in FIG. 1. FIG. FIG. 4 is a cross-sectional view (partial side view) showing a modification of the light irradiation medical device shown in FIG. 5 is a cut end view of the cylindrical member shown in FIG. 4. FIG. FIG. 6 is a sectional view (partial side view) showing a modification of the light irradiation medical device shown in FIG. 7 is a cut end view of the second coil member shown in FIG. 6. FIG. 8 is an enlarged cross-sectional view of the distal side of the optical fiber member shown in FIG. 1. FIG. 9 to 11 are sectional views showing other modifications of the optical fiber member shown in FIG. The light irradiation medical device 1 has a shaft 10 , an optical fiber member 20 and a first coil member 40 . In the following, the light irradiation medical device may be simply referred to as the device. In order to facilitate understanding of the positional relationship between the optical fiber member 20 and the first coil member 40, the shaft 10 is omitted from FIGS.
 本明細書において、装置1の遠位側とは、シャフト10の長手軸方向xの遠位端側であって処置対象側を指す。装置1の近位側とは、シャフト10の長手軸方向xの近位端側であって使用者の手元側を指す。各部材をシャフト10の長手軸方向xにおいて二等分割したときの近位側を近位部、遠位側を遠位部と称することがある。装置1の径方向において、内方はシャフト10の長手軸方向xに延びる中心軸cに向かう方向を指し、外方は内方とは反対の放射方向を指す。 In this specification, the distal side of the device 1 refers to the distal end side of the shaft 10 in the longitudinal direction x and the treatment target side. The proximal side of the device 1 refers to the proximal end side of the shaft 10 in the longitudinal direction x and the user's hand side. When each member is divided into two halves in the longitudinal direction x of the shaft 10, the proximal side may be called the proximal portion, and the distal side may be called the distal portion. In the radial direction of the device 1, the inner side refers to the direction toward the central axis c extending in the longitudinal direction x of the shaft 10, and the outer side refers to the radial direction opposite to the inner side.
 上記装置1は、シャフト10を備える。シャフト10は長手軸方向xと径方向と周方向pを有している。シャフト10は、長手軸方向xに遠位端と近位端を有し、かつ長手軸方向xに延在している内腔11を有する。シャフト10は、内腔11を1つのみ有していてもよく、複数有していてもよい。シャフト10はその内腔11に光ファイバー部材20および第1コイル部材40を配置するために筒形状を有している。シャフト10は、内腔11を1つのみ有する筒形状を有していることが好ましい。シャフト10は体内に挿入されるため、好ましくは可撓性を有している。シャフト10は内周面12と外周面13を有している。 The device 1 includes a shaft 10. The shaft 10 has a longitudinal direction x, a radial direction and a circumferential direction p. Shaft 10 has distal and proximal ends in longitudinal direction x and has a lumen 11 extending in longitudinal direction x. The shaft 10 may have only one lumen 11 or may have a plurality of them. Shaft 10 has a cylindrical shape for arranging optical fiber member 20 and first coil member 40 in lumen 11 thereof. Shaft 10 preferably has a cylindrical shape with only one lumen 11 . Since the shaft 10 is inserted into the body, it is preferably flexible. Shaft 10 has an inner peripheral surface 12 and an outer peripheral surface 13 .
 シャフト10は、一または複数の線材を所定のパターンで配置することで形成された中空体;上記中空体の内側表面または外側表面の少なくともいずれか一方に樹脂をコーティングしたもの;樹脂チューブ;またはこれらを組み合わせたもの、例えばこれらを長手軸方向に接続したものが挙げられる。線材が所定のパターンで配置された中空体としては、線材が単に交差される、または編み込まれることによって網目構造を有する筒状体や、線材が巻回されたコイルが示される。線材は、一または複数の単線であってもよく、一または複数の撚線であってもよい。樹脂チューブは、例えば押出成形によって製造することができる。シャフト10が樹脂チューブである場合、シャフト10は単層または複数層から構成することができる。シャフト10は長手軸方向xまたは周方向pの一部が単層から構成されており、他部が複数層から構成されていてもよい。 The shaft 10 is a hollow body formed by arranging one or more wires in a predetermined pattern; a hollow body having at least one of its inner surface or outer surface coated with a resin; a resin tube; , such as those connected in the longitudinal direction. A hollow body in which wires are arranged in a predetermined pattern includes a cylindrical body having a mesh structure formed by simply crossing or weaving wires, and a coil in which wires are wound. The wire may be one or more solid wires or one or more twisted wires. A resin tube can be manufactured, for example, by extrusion molding. When the shaft 10 is a resin tube, the shaft 10 can be composed of a single layer or multiple layers. A portion of the shaft 10 in the longitudinal direction x or the circumferential direction p may be composed of a single layer, and the other portion may be composed of a plurality of layers.
 シャフト10は、例えば、ポリオレフィン樹脂(例えば、ポリエチレンやポリプロピレン)、ポリアミド樹脂(例えば、ナイロン)、ポリエステル樹脂(例えば、PET)、芳香族ポリエーテルケトン樹脂(例えば、PEEK)、ポリエーテルポリアミド樹脂、ポリウレタン樹脂、ポリイミド樹脂、フッ素樹脂(例えば、PTFE、PFA、ETFE)等の合成樹脂や、ステンレス鋼、炭素鋼、ニッケルチタン合金等の金属から構成することができる。これらは一種のみを単独で用いてもよく、二種以上を組み合わせて用いてもよい。シャフト10のうち少なくとも後述する光拡散部21と重なる部分は、光透過性を有する樹脂から構成されていることが好ましい。シャフト10のうち少なくとも光拡散部21と重なる部分は、透明樹脂から構成されていてもよい。 The shaft 10 is made of, for example, polyolefin resin (eg, polyethylene or polypropylene), polyamide resin (eg, nylon), polyester resin (eg, PET), aromatic polyether ketone resin (eg, PEEK), polyether polyamide resin, polyurethane. It can be made of synthetic resin such as resin, polyimide resin, fluorine resin (for example, PTFE, PFA, ETFE), or metal such as stainless steel, carbon steel, nickel-titanium alloy. These may be used individually by 1 type, and may be used in combination of 2 or more types. It is preferable that at least a portion of the shaft 10 that overlaps with the light diffusion portion 21 described later is made of resin having light transmission properties. At least a portion of the shaft 10 that overlaps the light diffusing portion 21 may be made of a transparent resin.
 図1に示すようにシャフト10の遠位端には先端チップ15が取り付けられていてもよい。シャフト10の遠位端部による生体組織の損傷を回避することができる。先端チップ15の形状としては、例えば円柱形状、長円柱形状、半球形状、長円球形状、角錐台形状、円錐台形状、長円錐台形状、角丸錐台形状、またはこれらの組み合わせを挙げることができる。 A distal tip 15 may be attached to the distal end of the shaft 10 as shown in FIG. Damage to living tissue by the distal end of the shaft 10 can be avoided. Examples of the shape of the distal tip 15 include a cylindrical shape, an oval cylindrical shape, a hemispherical shape, an oval spherical shape, a truncated pyramid shape, a truncated cone shape, a long truncated cone shape, a rounded truncated pyramid shape, or a combination thereof. can be done.
 図1では、シャフト10の近位部にハンドル70が接続されている。術者がハンドル70を把持することで、装置1の操作が行いやすくなる。ハンドル70は、例えば長手軸方向xに延在している。ハンドル70は、一または複数の部材から構成することができる。図1では、ハンドル70は長手軸方向xに延在している中空部を有している。ハンドル70は例えば筒形状を有していてもよい。図1ではハンドル70の中空部にシャフト10と光ファイバー部材20が挿通されている。 A handle 70 is connected to the proximal portion of the shaft 10 in FIG. By holding the handle 70 by the operator, the device 1 can be easily operated. The handle 70 extends, for example, in the longitudinal direction x. Handle 70 may be constructed from one or more members. In FIG. 1, the handle 70 has a hollow portion extending in the longitudinal direction x. The handle 70 may have, for example, a cylindrical shape. In FIG. 1, the shaft 10 and the optical fiber member 20 are inserted through the hollow portion of the handle 70 .
 ハンドル70の構成材料は特に限定されないが、例えばポリプロピレン(PP)、ポリエチレン(PE)等のポリオレフィン樹脂、ポリエチレンテレフタレート(PET)等のポリエステル樹脂、ポリカーボネート樹脂、ABS樹脂、ポリウレタン樹脂等の合成樹脂を用いることができる。 Although the material of the handle 70 is not particularly limited, for example, polyolefin resins such as polypropylene (PP) and polyethylene (PE), polyester resins such as polyethylene terephthalate (PET), polycarbonate resins, ABS resins, and synthetic resins such as polyurethane resins are used. be able to.
 上記装置1は、シャフト10の内腔11に配置されている光ファイバー部材20を有する。光ファイバー部材20は、対象組織まで光信号を送信する伝送路である光ファイバーを備える部材である。図1に示すように光ファイバー部材20は、シャフト10の内腔11に配置されている。図1では光ファイバー部材20の近位端部はハンドル70から近位側に向かって延出している。光ファイバー部材20の近位端部は半導体レーザー等の光源に接続される。 The device 1 has an optical fiber member 20 arranged in the lumen 11 of the shaft 10 . The optical fiber member 20 is a member provided with an optical fiber, which is a transmission line for transmitting optical signals to the target tissue. As shown in FIG. 1, fiber optic member 20 is disposed within lumen 11 of shaft 10 . In FIG. 1, the proximal end of fiber optic member 20 extends proximally from handle 70 . The proximal end of fiber optic member 20 is connected to a light source such as a semiconductor laser.
 光ファイバー部材20はその遠位部の所定区間に長手軸方向xに延在しておりシャフト10の径方向の外方に向かって光を射出する光拡散部21を有していることが好ましい。光ファイバー部材20は外周面23を有している。光拡散部21は径方向の外方に向かって発光することができる発光エリアとして機能する。光拡散部21は、シャフト10の長手軸方向xおよび周方向pに延在するように配されている。光拡散部21は外周面23を有している。光拡散部21の外周面23はシャフト10の内周面12側に面している。 The optical fiber member 20 preferably has a light diffusing portion 21 extending in the longitudinal direction x in a predetermined section of its distal portion and emitting light outward in the radial direction of the shaft 10 . Fiber optic member 20 has an outer peripheral surface 23 . The light diffusing portion 21 functions as a light emitting area capable of emitting light radially outward. The light diffusing portion 21 is arranged to extend in the longitudinal direction x and the circumferential direction p of the shaft 10 . The light diffusing portion 21 has an outer peripheral surface 23 . An outer peripheral surface 23 of the light diffusion portion 21 faces the inner peripheral surface 12 side of the shaft 10 .
 内視鏡を通じて、装置1を体腔内の対象組織がある位置まで挿入する。このとき、対象組織がシャフト10の外周面13よりも径方向の外方に位置するように配される。光拡散部21から射出された光がシャフト10のうち少なくとも光拡散部21と重なる部分を透過することで、装置1の周りにある対象組織に光が到達する。 The device 1 is inserted through the endoscope to the position where the target tissue is in the body cavity. At this time, the target tissue is positioned radially outward of the outer peripheral surface 13 of the shaft 10 . The light emitted from the light diffusing portion 21 passes through at least a portion of the shaft 10 that overlaps the light diffusing portion 21 , so that the light reaches the target tissue around the device 1 .
 上述のように、光拡散部21からは、少なくともシャフト10の径方向の外方に向かって光が射出されることが好ましく、光拡散部21からは、シャフト10の周方向pの全体に亘ってシャフト10の径方向の外方に向かって光が射出されることが好ましい。光拡散部21からは、さらにシャフト10の遠位方向、すなわち前方に向かって光が射出されてもよい。 As described above, it is preferable that light is emitted from the light diffusion portion 21 at least outward in the radial direction of the shaft 10, and the light is emitted from the light diffusion portion 21 over the entire circumferential direction p of the shaft 10. It is preferable that the light is emitted outward in the radial direction of the shaft 10 . Light may be emitted further from the light diffusing portion 21 toward the distal direction of the shaft 10, that is, toward the front.
 光拡散部21は、光ファイバー部材20のうちの光ファイバーとは別個の拡散部材(例えば拡散板やプリズム)ではなく、光ファイバーの一部を構成する部分である。光ファイバーはコアとクラッドを有している。クラッドはコアの外周に配されて、コアの径方向の外方の一部を覆っている。光拡散部21は(i)コアのみ配されている態様、(ii)コアおよびクラッドが配されている態様、または(iii)一部がコアのみが配されており、他部がコアおよびクラッドが配されている態様のいずれかから構成されていることが好ましい。クラッドの径方向の外方には保護用の被覆材が配されていてもよいが、光拡散部21ではコアおよびクラッド以外の部材は配されていないことが好ましい。 The light diffusing part 21 is not a diffusing member (for example, a diffuser plate or a prism) separate from the optical fiber of the optical fiber member 20, but a part forming part of the optical fiber. An optical fiber has a core and a cladding. The clad is arranged on the outer circumference of the core and covers a part of the radially outer side of the core. The light diffusion part 21 has (i) a mode in which only the core is arranged, (ii) a mode in which the core and the clad are arranged, or (iii) a part in which only the core is arranged and the other part in which the core and the clad are arranged. is preferably configured from any of the aspects in which is arranged. A covering material for protection may be arranged outside the clad in the radial direction, but it is preferable that the light diffusing portion 21 is not arranged with members other than the core and the clad.
 コアおよびクラッドを構成する材料は特に限定されず、プラスチック、石英ガラス、フッ化物ガラス等のガラスを用いることができる。 The materials that make up the core and clad are not particularly limited, and glass such as plastic, quartz glass, and fluoride glass can be used.
 シャフト10のうち少なくとも光拡散部21と重なる部分では、シャフト10を構成する樹脂に酸化チタン、硫酸バリウム、炭酸カルシウム等の無機系粒子、架橋アクリル系粒子、架橋スチレン系粒子等の有機系粒子の光拡散性の材料を添加することができる。光拡散部21から射出される光がシャフト10によって一層拡散されやすくなる。 At least in the portion of the shaft 10 that overlaps the light diffusing portion 21, the resin forming the shaft 10 contains inorganic particles such as titanium oxide, barium sulfate, and calcium carbonate, and organic particles such as crosslinked acrylic particles and crosslinked styrene particles. Light diffusing materials can be added. Light emitted from the light diffusing portion 21 is more easily diffused by the shaft 10 .
 光拡散部21は、光ファイバーの最も遠位側に配されていることが好ましい。光拡散部21は、光ファイバー部材20の最も遠位側に配されていてもよい。これにより光拡散部21の形成が行いやすくなり、光ファイバーの遠位端部での柔軟性も高めることができる。 The light diffusion part 21 is preferably arranged on the most distal side of the optical fiber. The light diffusion part 21 may be arranged on the most distal side of the optical fiber member 20 . This facilitates the formation of the light diffusing portion 21 and increases the flexibility of the distal end portion of the optical fiber.
 長手軸方向xにおいて光拡散部21の長さは光ファイバー部材20の全長の50分の1以上、45分の1以上、30分の1以上の長さに設定されてもよい。このような長さに設定することで一度の照射で対象組織全体を照射しやすくなる。また、長手軸方向xにおいて光拡散部21の長さは光ファイバー部材20の全長の20分の1以下、25分の1以下、30分の1以下の長さに設定されてもよい。このような長さに設定することで対象外の組織への照射を防ぐことができる。 The length of the light diffusion portion 21 in the longitudinal direction x may be set to 1/50 or more, 1/45 or more, or 1/30 or more of the total length of the optical fiber member 20 . By setting such a length, it becomes easy to irradiate the entire target tissue with a single irradiation. In addition, the length of the light diffusion portion 21 in the longitudinal direction x may be set to 1/20 or less, 1/25 or less, or 1/30 or less of the total length of the optical fiber member 20 . By setting such a length, it is possible to prevent irradiation of non-target tissues.
 光拡散部21は、シャフト10の周方向pの一部のみに配されていてもよいが、図2に示すように、光拡散部21は、シャフト10の周方向pの全体に配されていることが好ましい。周方向pの広範囲を一度に照射することができるため、手技の効率化が図られる。 The light diffusing portion 21 may be arranged only in a part of the shaft 10 in the circumferential direction p, but as shown in FIG. preferably. Since a wide range in the circumferential direction p can be irradiated at once, efficiency of the procedure can be improved.
 上記装置1は、シャフト10の内腔11であって光ファイバー部材20よりも遠位側に配置されており、線材42がらせん状に巻回されている第1コイル部材40を有する。長手軸方向xにおいて第1コイル部材40の全体が、シャフト10の内腔11に配置されていることが好ましい。 The device 1 has a first coil member 40 disposed in the lumen 11 of the shaft 10 on the distal side of the optical fiber member 20 and around which a wire 42 is helically wound. The entire first coil member 40 in the longitudinal direction x is preferably arranged in the lumen 11 of the shaft 10 .
 線材42はその長手軸方向に先端と基端を有している。線材42は先端から基端まで単一の線状部材から構成されていてもよく、線材42はその長手軸方向において互いに連結された複数の線状部材から構成されてもよい。 The wire rod 42 has a distal end and a proximal end in its longitudinal direction. The wire 42 may be composed of a single linear member from the distal end to the proximal end, or the wire 42 may be composed of a plurality of linear members connected to each other in the longitudinal direction thereof.
 線材42の長手軸方向に垂直な断面の形状は、円形状、長円形状、多角形状、またはこれらの組み合わせであってもよい。長円形状には楕円形状、卵形状、角丸長方形状が含まれるものとする。本明細書の他の説明においても同様である。 The cross-sectional shape of the wire rod 42 perpendicular to the longitudinal axis direction may be circular, oval, polygonal, or a combination thereof. The oval shape includes an elliptical shape, an egg shape, and a rounded rectangular shape. The same applies to other descriptions in this specification.
 第1コイル部材40を構成する線材42の線径(太さ)や、線材42の巻き数は特に限定されない。第1コイル部材40の軸方向の長さは第1コイル部材40の最大外径より大きくても小さくてもよい。 The wire diameter (thickness) of the wire 42 constituting the first coil member 40 and the number of turns of the wire 42 are not particularly limited. The axial length of the first coil member 40 may be larger or smaller than the maximum outer diameter of the first coil member 40 .
 第1コイル部材40は線材42の線径よりも長いピッチP1を有する。ピッチP1とは、図1に示すように軸方向において第1コイル部材40を形成する隣り合う2つの線材42の中心軸の間隔である。第1コイル部材40のピッチP1は軸方向において一定であってもよく、軸方向の位置によって異なっていてもよい。第1コイル部材40が有する複数のピッチP1のうち、ピッチP1の一部のみが線材42の線径よりも長くてもよいし、ピッチP1全てが線材42の線径よりも長くてもよい。上記のようなピッチP1を有していることによって、シャフト10に対して遠位側方向から近位側方向に向かう力、即ちシャフト10に対して押し込む力が加わった場合に、第1コイル部材40のピッチP1が収縮することによってクッション機能を果たしやすくなるため、光ファイバー部材20の破損を抑制しやすくすることができる。また、第1コイル部材40が上記のようなピッチP1を有していることで、装置1の遠位端部に柔軟性を持たせることができ、操作性を向上させやすくすることができる。 The first coil member 40 has a pitch P1 longer than the wire diameter of the wire rod 42 . The pitch P1 is the distance between the central axes of two adjacent wire rods 42 forming the first coil member 40 in the axial direction, as shown in FIG. The pitch P1 of the first coil members 40 may be constant in the axial direction, or may vary depending on the position in the axial direction. Of the plurality of pitches P1 of the first coil member 40, only a portion of the pitches P1 may be longer than the wire diameter of the wire 42, or the entire pitch P1 may be longer than the wire diameter of the wire 42. Due to the pitch P1 as described above, when a force directed from the distal direction to the proximal direction is applied to the shaft 10, i.e., a pushing force is applied to the shaft 10, the first coil member Since the contraction of the pitch P1 of 40 makes it easier to fulfill the cushioning function, it is possible to make it easier to suppress damage to the optical fiber member 20 . In addition, since the first coil member 40 has the pitch P1 as described above, the distal end portion of the device 1 can be made flexible, and the operability can be easily improved.
 第1コイル部材40は線材42の線径の1.5倍以上のピッチP1を有していることが好ましく、1.6倍以上のピッチP1を有していてもよく、1.7倍以上のピッチP1を有していてもよい。また、第1コイル部材40は線材42の線径の3.0倍以下のピッチP1を有していてもよく、2.5倍以下のピッチP1を有していてもよい。なお、第1コイル部材40に存在する全てのピッチP1が上記の範囲内であってもよいし、一部のピッチP1が上記の範囲内であってもよい。上記のようなピッチを有していることによって、シャフト10に対して遠位側方向から近位側方向に向かう力、即ちシャフト10に対して押し込む力が加わった場合に、第1コイル部材40のピッチが収縮することによってクッション機能を果たしやすくなるため、光ファイバー部材20の破損を抑制しやすくすることができる。また、第1コイル部材40が上記のようなピッチを有していることで、装置1の遠位端部に柔軟性を持たせることができ、操作性を向上させやすくすることができる。 The first coil member 40 preferably has a pitch P1 that is 1.5 times or more the wire diameter of the wire 42, may have a pitch P1 that is 1.6 times or more, or is 1.7 times or more. may have a pitch P1 of Also, the first coil member 40 may have a pitch P1 of 3.0 times or less the wire diameter of the wire 42, or may have a pitch P1 of 2.5 times or less. All the pitches P1 present in the first coil member 40 may be within the above range, or a part of the pitches P1 may be within the above range. With the pitch as described above, when a force directed from the distal direction to the proximal direction is applied to the shaft 10 , that is, a pushing force is applied to the shaft 10 , the first coil member 40 Since the contraction of the pitch of the optical fiber member 20 facilitates the fulfillment of the cushioning function, it is possible to easily suppress the breakage of the optical fiber member 20 . In addition, since the first coil member 40 has the pitch as described above, the distal end portion of the device 1 can be made flexible, and the operability can be easily improved.
 シャフト10の長手軸方向xにおいて第1コイル部材40の外径は一定であってもよく、長手軸方向xの位置によって第1コイル部材40の外径が異なっていてもよい。例えば、長手軸方向xにおいて第1コイル部材40を遠位部と近位部に二等分割したときに、第1コイル部材40の遠位部の平均外径が、第1コイル部材40の近位部の平均外径よりも大きくてもよい。 The outer diameter of the first coil member 40 may be constant in the longitudinal axis direction x of the shaft 10, or the outer diameter of the first coil member 40 may vary depending on the position in the longitudinal axis direction x. For example, when the first coil member 40 is divided into a distal portion and a proximal portion in the longitudinal direction x, the average outer diameter of the distal portion of the first coil member 40 is It may be larger than the average outer diameter of the site.
 シャフト10の長手軸方向xにおいて第1コイル部材40の内径は一定であってもよく、長手軸方向xの位置によって第1コイル部材40の内径が異なっていてもよい。例えば、長手軸方向xにおいて第1コイル部材40を遠位部と近位部に二等分割したときに、第1コイル部材40の遠位部の平均内径が、第1コイル部材40の近位部の平均内径よりも大きくてもよい。 The inner diameter of the first coil member 40 may be constant in the longitudinal axis direction x of the shaft 10, or the inner diameter of the first coil member 40 may vary depending on the position in the longitudinal axis direction x. For example, when the first coil member 40 is divided into a distal portion and a proximal portion in the longitudinal direction x, the average inner diameter of the distal portion of the first coil member 40 is equal to the proximal portion of the first coil member 40. It may be larger than the average inner diameter of the portion.
 第1コイル部材40の近位端部の内径は、光ファイバー部材20の遠位端部の外径よりも小さいことが好ましい。これにより、シャフト10に対して遠位側方向から近位側方向に向かう力、即ちシャフト10に対して押し込む力が加わった場合に、第1コイル部材40のピッチが収縮しやすくすることができるため、第1コイル部材40がクッション機能を果たしやすくなる。このため、光ファイバー部材20の破損を抑制しやすくすることができる。 The inner diameter of the proximal end of the first coil member 40 is preferably smaller than the outer diameter of the distal end of the optical fiber member 20 . As a result, the pitch of the first coil member 40 can be easily contracted when a force directed toward the proximal direction from the distal side to the shaft 10 , that is, a pushing force is applied to the shaft 10 . Therefore, the first coil member 40 can easily perform the cushion function. Therefore, damage to the optical fiber member 20 can be easily suppressed.
 第1コイル部材40は、シャフト10よりも反射率が高い材料から構成されていることが好ましい。この構成により、第1コイル部材40の内周面43で反射光が拡散されやすくなる。ここで、反射率は光拡散部21から射出される光の反射率を指し、単位は%である。反射率は、オーシャンフォトニクス社製 反射率測定システム OP-RF-VIS-GT50を用いて測定することができる。 The first coil member 40 is preferably made of a material having a higher reflectance than the shaft 10. This configuration facilitates diffusion of the reflected light on the inner peripheral surface 43 of the first coil member 40 . Here, the reflectance refers to the reflectance of light emitted from the light diffusing portion 21, and the unit is %. The reflectance can be measured using a reflectance measurement system OP-RF-VIS-GT50 manufactured by Ocean Photonics.
 第1コイル部材40は金属から構成されていることが好ましく、例えば、金、銀、白金、パラジウム、タングステン、タンタル、イリジウムおよびそれらの合金等の放射線不透過性金属でもよく、ステンレス鋼、Ni-Ti合金等の超弾性合金でもよい。 The first coil member 40 is preferably made of metal, such as gold, silver, platinum, palladium, tungsten, tantalum, iridium, and alloys thereof. A superelastic alloy such as a Ti alloy may also be used.
 第1コイル部材40の一部が樹脂から構成されていてもよい。第1コイル部材40が、コイル部材本体と、コイル部材本体の内面に配されている反射層とを有していてもよい。コイル部材本体の材料によらず、反射層によって光拡散部21からの光を反射させることができる。例えば樹脂線材が巻回されたコイル体または樹脂チューブがコイル部材本体であってもよい。反射層は、コイル部材本体の内面に反射材料を含むコート剤が塗布されることで配されてもよく、蒸着、スパッタリング、電気メッキ、化学メッキ等の方法で反射材料をコイル部材本体の内面に付着させることにより配されてもよい。なお、反射層は金属薄膜であってもよい。反射材料としては、例えば、アルミニウム、金、銀、銅、スズ、二酸化チタン、五酸化タンタル、酸化アルミニウム、二酸化ケイ素、フッ化マグネシウムまたはこれらの組み合わせが挙げられる。第1コイル部材40が反射層を有する場合、コイル部材本体にはシャフト10の構成材料として挙げた材料の少なくともいずれか1つを用いることができる。 A part of the first coil member 40 may be made of resin. The first coil member 40 may have a coil member main body and a reflective layer arranged on the inner surface of the coil member main body. The light from the light diffusing portion 21 can be reflected by the reflective layer regardless of the material of the coil member main body. For example, a coil body or a resin tube around which a resin wire is wound may be the coil member main body. The reflective layer may be provided by applying a coating agent containing a reflective material to the inner surface of the coil member body, and the reflective material is applied to the inner surface of the coil member body by a method such as vapor deposition, sputtering, electroplating, or chemical plating. It may be arranged by adhering. Note that the reflective layer may be a metal thin film. Reflective materials include, for example, aluminum, gold, silver, copper, tin, titanium dioxide, tantalum pentoxide, aluminum oxide, silicon dioxide, magnesium fluoride, or combinations thereof. When the first coil member 40 has a reflective layer, at least one of the materials exemplified as the constituent materials of the shaft 10 can be used for the coil member main body.
 第1コイル部材40の遠位端部は、第1コイル部材40を遠位側から見た時の面積が第1コイル部材40の遠位端部の内腔よりも大きい蓋部450を有していることが好ましい。蓋部450は、例えば、第1コイル部材40の遠位端401側を加熱して変形させることによって形成することができる。これにより、図3のような遠位端401側が閉じられた第1コイル部材40を得ることができる。また、1つの内腔を有する筒状コイルと、筒状コイルとは別の金属部材を準備し、金属部材を加熱して筒状コイルの遠位側の開口を塞ぐように溶着することで蓋部450を形成することもできる。このようにして、遠位端401側が閉じられた第1コイル部材40を得ることもできる。 The distal end portion of the first coil member 40 has a lid portion 450 whose area when the first coil member 40 is viewed from the distal side is larger than the lumen of the distal end portion of the first coil member 40. preferably. The lid portion 450 can be formed, for example, by heating the distal end 401 side of the first coil member 40 to deform it. As a result, the first coil member 40 whose distal end 401 side is closed as shown in FIG. 3 can be obtained. Alternatively, a cylindrical coil having one lumen and a metal member separate from the cylindrical coil are prepared, and the metal member is heated and welded so as to close the opening on the distal side of the cylindrical coil. A portion 450 can also be formed. In this way, the first coil member 40 with the distal end 401 side closed can also be obtained.
 装置1の光ファイバー部材20の遠位端部と第1コイル部材40の近位端部は当接しているが、固定されていない。光ファイバー部材20の遠位端部と第1コイル部材40の近位端部が当接していることにより、シャフト10に対して遠位側方向から近位側方向に向かう力、即ちシャフト10に対して押し込む力が加わった場合には、第1コイル部材40のピッチが収縮することによってクッション機能を果たすため、光ファイバー部材20の破損を抑制しやすくすることができる。また、光ファイバー部材20の遠位端部と第1コイル部材40の近位端部が固定されていないことにより、シャフト10に対して近位側方向から遠位側方向に向かう力、即ちシャフト10に対してシャフト10が伸びる方向に力が加わった場合には、第1コイル部材40と光ファイバー部材20とが離れることができるため、光ファイバー部材20の破損を抑制しやすくすることができる。 The distal end of the optical fiber member 20 of the device 1 and the proximal end of the first coil member 40 are in contact, but are not fixed. Since the distal end of the optical fiber member 20 and the proximal end of the first coil member 40 are in contact with each other, a force directed from the distal direction to the proximal direction with respect to the shaft 10 , i.e., the force applied to the shaft 10 When a pushing force is applied, the pitch of the first coil member 40 shrinks to fulfill a cushioning function, so damage to the optical fiber member 20 can be easily suppressed. Further, since the distal end portion of the optical fiber member 20 and the proximal end portion of the first coil member 40 are not fixed, the force directed from the proximal direction to the distal direction with respect to the shaft 10, that is, the shaft 10 When a force is applied in the direction in which the shaft 10 extends, the first coil member 40 and the optical fiber member 20 can be separated from each other, so damage to the optical fiber member 20 can be easily suppressed.
 図4に示すように、装置1は、シャフト10の内腔11に配置されており、第1コイル部材40を覆っている筒部材50を有していてもよい。筒部材50は、シャフト10の長手軸方向xに延在するように形成されることが好ましい。筒部材50のうち、シャフト10の長手軸方向xに平行な方向を筒部材50の軸方向と称する。第1コイル部材40全体が筒部材50によって覆われていてもよいし、第1コイル部材40の一部のみが筒部材50によって覆われていてもよい。これにより、先端部の剛性を高めることができるため、操作性を向上させやすくすることができる。 As shown in FIG. 4 , the device 1 may have a tubular member 50 that is arranged in the lumen 11 of the shaft 10 and covers the first coil member 40 . The tubular member 50 is preferably formed to extend in the longitudinal direction x of the shaft 10 . A direction of the tubular member 50 that is parallel to the longitudinal axis direction x of the shaft 10 is referred to as an axial direction of the tubular member 50 . The entire first coil member 40 may be covered with the tubular member 50 , or only a part of the first coil member 40 may be covered with the tubular member 50 . As a result, it is possible to increase the rigidity of the distal end portion, thereby making it easier to improve the operability.
 筒部材50は、1つの内腔を有していることが好ましい。筒部材50の形状は特に限定されないが、円筒形状、楕円筒形状、または多角筒形状であってもよい。筒部材50の軸方向の長さは筒部材50の最大外径より大きくても小さくてもよい。 It is preferable that the tubular member 50 has one lumen. The shape of the cylindrical member 50 is not particularly limited, but may be cylindrical, elliptical, or polygonal. The axial length of the tubular member 50 may be larger or smaller than the maximum outer diameter of the tubular member 50 .
 図4に示すように、筒部材50の近位端502は光拡散部21の遠位端よりも近位側に位置していてもよい。また、筒部材50は光拡散部21の遠位部の一部を覆っていることが好ましい。本明細書では、光拡散部21のうち、筒部材50に覆われておらずシャフト10側に露出している部分を露出部22と称する。これにより、先端部の剛性を高めることができるため、操作性を向上させやすくすることができる。また、光拡散部21のうち筒部材50に覆われている部分では光拡散部21から射出される光が、図5に示す筒部材50の内周面53で反射するため、反射光が光拡散部21のうち筒部材50で覆われていない部分である露出部22から様々な方向に拡散されやすくなる。その結果、シャフト10の周方向pにおいて露出部22の発光強度分布が均一化されやすくなる。これにより、腫瘍等の対象組織への照射回数や対象組織に対する露出部22の位置調整の回数を減らすことができるため、手技の効率化が図られる。なお、筒部材50が光拡散部21を覆う場合は、光拡散部21の一部のみを覆うのであり、光拡散部21の全部を覆わないことが好ましい。これにより、光拡散部21に露出部22が形成される。なお、筒部材50は光拡散部21の遠位部の一部を覆っていなくてもよい。シャフト10の径方向において、露出部22とシャフト10の間には別の部材が存在しないことが好ましいが、露出部22から射出される光を遮らない部材であれば配されていてもよい。 As shown in FIG. 4 , the proximal end 502 of the tubular member 50 may be positioned closer to the proximal side than the distal end of the light diffusion portion 21 . Moreover, it is preferable that the cylindrical member 50 covers a part of the distal portion of the light diffusing portion 21 . In this specification, the portion of the light diffusing portion 21 that is not covered with the cylindrical member 50 and is exposed to the shaft 10 side is referred to as an exposed portion 22 . As a result, it is possible to increase the rigidity of the distal end portion, thereby making it easier to improve the operability. In addition, in the portion of the light diffusing portion 21 covered with the cylindrical member 50, the light emitted from the light diffusing portion 21 is reflected by the inner peripheral surface 53 of the cylindrical member 50 shown in FIG. It becomes easy to diffuse in various directions from the exposed portion 22 that is the portion of the diffusion portion 21 that is not covered with the cylindrical member 50 . As a result, the emission intensity distribution of the exposed portion 22 is more likely to be uniform in the circumferential direction p of the shaft 10 . As a result, it is possible to reduce the number of times the target tissue such as a tumor is irradiated and the number of times the position of the exposed portion 22 is adjusted with respect to the target tissue, thereby improving the efficiency of the procedure. In addition, when the cylindrical member 50 covers the light diffusing portion 21 , it covers only a part of the light diffusing portion 21 , and preferably does not cover the entire light diffusing portion 21 . Thereby, the exposed portion 22 is formed in the light diffusion portion 21 . Note that the cylindrical member 50 does not have to partially cover the distal portion of the light diffusing portion 21 . In the radial direction of the shaft 10 , it is preferable that there be no separate member between the exposed portion 22 and the shaft 10 , but any member that does not block the light emitted from the exposed portion 22 may be provided.
 図5に示すように、筒部材50の遠位端部は、筒部材50を遠位側から見た時の面積が筒部材50の遠位端部の内腔よりも大きい蓋部550を有していてもよい。このように、筒部材50の遠位端501側が閉じられており、近位端502側が開口した形状となっていることにより、光拡散部21から射出される光は筒部材50の内周面53と内側端面56で反射されることが可能となる。内周面53は曲面部のみから構成されていてもよく、平面部のみから構成されていてもよく、曲面部と平面部の組み合わせから構成されていてもよい。内周面53で反射された光を多方向に拡散しやすくするためには、内周面53は曲面部を有していることが好ましい。また、内側端面56は平面部のみから構成されていてもよく、曲面部のみから構成されていてもよく、曲面部と平面部の組み合わせから構成されていてもよい。 As shown in FIG. 5, the distal end of the tubular member 50 has a cap 550 that has a larger area than the lumen of the distal end of the tubular member 50 when the tubular member 50 is viewed from the distal side. You may have In this way, the distal end 501 side of the cylindrical member 50 is closed and the proximal end 502 side is open, so that the light emitted from the light diffusing portion 21 is directed to the inner peripheral surface of the cylindrical member 50. 53 and the inner end surface 56 can be reflected. The inner peripheral surface 53 may be composed of only the curved surface portion, may be composed of only the flat surface portion, or may be composed of a combination of the curved surface portion and the flat surface portion. In order to facilitate diffusion of the light reflected by the inner peripheral surface 53 in multiple directions, the inner peripheral surface 53 preferably has a curved surface portion. Further, the inner end surface 56 may be composed of only the flat portion, may be composed of only the curved surface portion, or may be composed of a combination of the curved surface portion and the flat surface portion.
 第1コイル部材40の遠位端部と筒部材50の遠位端部とが固定されていてもよい。第1コイル部材40は筒部材50に直接固定されていてもよく、別の部材を介して間接的に固定されていてもよい。第1コイル部材40と筒部材50の固定方法は特に限定されないが、例えば、溶着、溶接、かしめ等の圧着、接着剤による接着、係合、連結、結着、結紮等の物理的な固定等の方法、またはこれらの組み合わせを挙げることができる。なお、第1コイル部材40の遠位端部と筒部材50の遠位端部とが固定されていなくてもよい。 The distal end of the first coil member 40 and the distal end of the tubular member 50 may be fixed. The first coil member 40 may be directly fixed to the cylindrical member 50, or may be indirectly fixed via another member. The method of fixing the first coil member 40 and the cylindrical member 50 is not particularly limited, but for example, welding, welding, crimping such as caulking, bonding with an adhesive, engaging, connecting, binding, ligating, etc. physical fixing. or a combination thereof. Note that the distal end portion of the first coil member 40 and the distal end portion of the tubular member 50 do not have to be fixed.
 図4に示すように、筒部材50の外周面54がシャフト10の内周面12と接していてもよい。この構成により、シャフト10に対する筒部材50や光ファイバー部材20の位置がずれにくくなり露出部22の位置が固定されるため、照射位置を安定させることができる。なお、筒部材50の外周面54がシャフト10の内周面12と接していなくても構わない。 As shown in FIG. 4 , the outer peripheral surface 54 of the tubular member 50 may be in contact with the inner peripheral surface 12 of the shaft 10 . With this configuration, the position of the cylindrical member 50 and the optical fiber member 20 relative to the shaft 10 is less likely to shift, and the position of the exposed portion 22 is fixed, so that the irradiation position can be stabilized. Note that the outer peripheral surface 54 of the cylindrical member 50 does not have to be in contact with the inner peripheral surface 12 of the shaft 10 .
 光拡散部21の外周面23とシャフト10の内周面12とが離れて配置されていてもよい。露出部22において、光拡散部21の外周面23が、シャフト10の内周面12と離れて配されていることがより好ましい。また、長手軸方向xの全体にわたって、光拡散部21の外周面23が、シャフト10の内周面12と離れて配されていることがさらに好ましい。このようにシャフト10の内腔11に光拡散部21を配することで、光拡散部21が存在する位置でのシャフト10の柔軟性を維持することができ、操作性を向上させやすくすることができる。 The outer peripheral surface 23 of the light diffusion portion 21 and the inner peripheral surface 12 of the shaft 10 may be arranged apart from each other. More preferably, the outer peripheral surface 23 of the light diffusing portion 21 is arranged apart from the inner peripheral surface 12 of the shaft 10 in the exposed portion 22 . Further, it is more preferable that the outer peripheral surface 23 of the light diffusing portion 21 is separated from the inner peripheral surface 12 of the shaft 10 over the entire lengthwise direction x. By arranging the light diffusing portion 21 in the lumen 11 of the shaft 10 in this way, the flexibility of the shaft 10 can be maintained at the position where the light diffusing portion 21 exists, and the operability can be easily improved. can be done.
 図6に示すように、シャフト10の内腔11に配置されており、第1コイル部材40を覆っている筒部材は、線材62がらせん状に巻回されている第2コイル部材60であってもよい。第2コイル部材60を構成する素材については第1コイル部材40の説明を参照することができる。 As shown in FIG. 6, the tubular member disposed in the lumen 11 of the shaft 10 and covering the first coil member 40 is the second coil member 60 having a wire rod 62 spirally wound thereon. may The description of the first coil member 40 can be referred to for the material forming the second coil member 60 .
 第2コイル部材60は線材62の線径以上のピッチP2を有していることが好ましく、1.1倍以上のピッチP2を有していてもよく、1.2倍以上のピッチP2を有していてもよい。また、第2コイル部材60は線材62の線径の3.0倍以下のピッチP2を有していてもよく、2.5倍以下のピッチP2を有していてもよい。ピッチP2は、第2コイル部材60を形成する隣り合う2つの線材62の中心軸の間隔である。なお、第2コイル部材60に存在する全てのピッチP2が上記の範囲内であってもよいし、一部のピッチP2が上記の範囲内であってもよい。上記のようなピッチを有していることによって、装置1の遠位端部に柔軟性とほどよい剛性を持たせることができ、操作性を向上させやすくすることができる。 The second coil member 60 preferably has a pitch P2 equal to or greater than the wire diameter of the wire rod 62, may have a pitch P2 that is 1.1 times or more, or has a pitch P2 that is 1.2 times or more. You may have Further, the second coil member 60 may have a pitch P2 of 3.0 times or less the wire diameter of the wire 62, or may have a pitch P2 of 2.5 times or less. The pitch P2 is the interval between the central axes of two adjacent wire rods 62 forming the second coil member 60 . All the pitches P2 present in the second coil member 60 may be within the above range, or a part of the pitches P2 may be within the above range. By having the pitch as described above, the distal end portion of the device 1 can be given flexibility and moderate rigidity, and operability can be easily improved.
 図6、図7に示すように、第2コイル部材60は線材62の線径と同じピッチを有していてもよい。このようなコイルは、一般に密着巻きコイルと称される。密着巻きコイルでは、隣り合う2つの線材62の間に隙間がなく、第2コイル部材60から光が漏れにくいため好ましい。また、第2コイル部材60をマーカーとして使用する場合にも好ましい。 As shown in FIGS. 6 and 7, the second coil member 60 may have the same pitch as the wire diameter of the wire rod 62 . Such coils are commonly referred to as tight wound coils. A tightly wound coil is preferable because there is no gap between two adjacent wire rods 62 and light is less likely to leak from the second coil member 60 . It is also preferable when using the second coil member 60 as a marker.
 線材62の線径が、その長手軸方向で変化している場合(例えば、太径部と、太径部よりも線径が細い細径部がある場合)には、第2コイル部材60は線材62の線径よりも小さいピッチを有していてもよい。 When the wire diameter of the wire rod 62 changes in its longitudinal axis direction (for example, when there is a large-diameter portion and a small-diameter portion with a smaller wire diameter than the large-diameter portion), the second coil member 60 is The pitch may be smaller than the wire diameter of the wire 62 .
 シャフト10の長手軸方向xにおいて第2コイル部材60の外径は一定であってもよく、長手軸方向xの位置によって第2コイル部材60の外径が異なっていてもよい。例えば、長手軸方向xにおいて第2コイル部材60を遠位部と近位部に二等分割したときに、第2コイル部材60の遠位部の平均外径が、第2コイル部材60の近位部の平均外径よりも大きくてもよい。 The outer diameter of the second coil member 60 may be constant in the longitudinal axis direction x of the shaft 10, or the outer diameter of the second coil member 60 may vary depending on the position in the longitudinal axis direction x. For example, when the second coil member 60 is divided into a distal portion and a proximal portion in the longitudinal direction x, the average outer diameter of the distal portion of the second coil member 60 is It may be larger than the average outer diameter of the site.
 第1コイル部材40のピッチP1の平均は、第2コイル部材60のピッチP2の平均よりも大きくてもよい。第1コイル部材40のピッチP1の一部が第2コイル部材60のピッチP2よりも大きくてもよいが、第1コイル部材40のピッチP1の全てが第2コイル部材60のピッチP2よりも大きいことが好ましい。これにより、装置1の径方向の内方に柔軟性を持たせやすくすることができるため、操作性を向上させやすくすることができる。 The average pitch P1 of the first coil members 40 may be larger than the average pitch P2 of the second coil members 60 . Part of the pitch P1 of the first coil members 40 may be greater than the pitch P2 of the second coil members 60, but the entire pitch P1 of the first coil members 40 is greater than the pitch P2 of the second coil members 60. is preferred. As a result, flexibility can be easily imparted to the inner side of the device 1 in the radial direction, and operability can be easily improved.
 第1コイル部材40の線材42の線径は、第2コイル部材60の線材62の線径よりも小さくてもよい。これにより、装置1の径方向の内方に柔軟性を持たせやすくすることができるため、操作性を向上させやすくすることができる。 The wire diameter of the wire 42 of the first coil member 40 may be smaller than the wire diameter of the wire 62 of the second coil member 60 . As a result, flexibility can be easily imparted to the inner side of the device 1 in the radial direction, and operability can be easily improved.
 長手軸方向xに垂直な方向であって、第1コイル部材40の長手軸方向における長さの中点を通る線材42の断面積は、第2コイル部材60の長手軸方向における長さの中点を通る線材62の断面積よりも小さくてもよい。これにより、装置1の径方向の内方に柔軟性を持たせやすくすることができるため、操作性を向上させやすくすることができる。 The cross-sectional area of the wire rod 42 in the direction perpendicular to the longitudinal axis direction x and passing through the midpoint of the length in the longitudinal axis direction of the first coil member 40 is the middle of the length in the longitudinal axis direction of the second coil member 60. It may be smaller than the cross-sectional area of wire rod 62 passing through the point. As a result, flexibility can be easily imparted to the inner side of the device 1 in the radial direction, and operability can be easily improved.
 第1コイル部材40の巻き方向と第2コイル部材60の巻き方向とが同じ方向であることが好ましい。これにより、第1コイル部材40と第2コイル部材60との間の滑りがよくなるため、第1コイル部材40と第2コイル部材60がシャフト10の形状変化に追従しやすくなり、装置1の操作性を向上させやすくすることができる。なお、図示しないが、第1コイル部材の巻き方向と第2コイル部材の巻き方向とが異なる方向であっても構わない。 The winding direction of the first coil member 40 and the winding direction of the second coil member 60 are preferably the same. As a result, the slippage between the first coil member 40 and the second coil member 60 is improved, so that the first coil member 40 and the second coil member 60 can easily follow the shape change of the shaft 10, and the device 1 can be operated. It can make it easier to improve the quality. Although not shown, the winding direction of the first coil member and the winding direction of the second coil member may be different.
 図7に示すように、第2コイル部材60の遠位端部は、第2コイル部材60を遠位側から見た時の面積が第2コイル部材60の遠位端部の内腔よりも大きい蓋部650を有していることが好ましい。第2コイル部材60の蓋部650は、第1コイル部材40の蓋部450と同様の方法によって形成することができる。このように、第2コイル部材60の遠位端601側が閉じられており、近位端602側が開口した形状となっていることにより、光拡散部21から射出される光は第2コイル部材60の内周面63と内側端面66で反射されることが可能となる。 As shown in FIG. 7, the distal end portion of the second coil member 60 has an area larger than the lumen of the distal end portion of the second coil member 60 when the second coil member 60 is viewed from the distal side. It preferably has a large lid 650 . The lid portion 650 of the second coil member 60 can be formed by the same method as the lid portion 450 of the first coil member 40 . In this way, the distal end 601 side of the second coil member 60 is closed and the proximal end 602 side is open. can be reflected by the inner peripheral surface 63 and the inner end surface 66 of the .
 図6に示すように、第2コイル部材60の近位端602は光拡散部21の遠位端よりも近位側に位置していてもよい。また、第2コイル部材60は光拡散部21の遠位部の一部を覆っていることが好ましい。本明細書では、光拡散部21のうち、第2コイル部材60に覆われておらずシャフト10側に露出している部分を露出部22と称する。第2コイル部材60の存在により、先端部の剛性を高めることができるため、操作性を向上させやすくすることができる。また、光拡散部21のうち第2コイル部材60に覆われている部分では光拡散部21から射出される光が第2コイル部材60の内周面63で反射するため、反射光が光拡散部21のうち第2コイル部材60で覆われていない部分である露出部22から様々な方向に拡散されやすくなる。その結果、シャフト10の周方向pにおいて露出部22の発光強度分布が均一化されやすくなる。これにより、腫瘍等の対象組織への照射回数や対象組織に対する露出部22の位置調整の回数を減らすことができるため、手技の効率化が図られる。なお、第2コイル部材60が光拡散部21を覆う場合は、光拡散部21の一部のみを覆うのであり、光拡散部21の全部を覆わないことが好ましい。これにより、光拡散部21に露出部22が形成される。なお、第2コイル部材60は光拡散部21の遠位部の一部を覆っていなくてもよい。シャフト10の径方向において、露出部22とシャフト10の間には別の部材が存在しないことが好ましいが、露出部22から射出される光を遮らない部材であれば配されていてもよい。 As shown in FIG. 6 , the proximal end 602 of the second coil member 60 may be positioned closer to the proximal side than the distal end of the light diffusing portion 21 . Also, the second coil member 60 preferably covers a portion of the distal portion of the light diffusion section 21 . In this specification, the portion of the light diffusing portion 21 that is not covered with the second coil member 60 and is exposed to the shaft 10 side is referred to as an exposed portion 22 . Due to the presence of the second coil member 60, the rigidity of the distal end portion can be increased, so that the operability can be easily improved. In addition, in the portion of the light diffusing portion 21 covered with the second coil member 60, the light emitted from the light diffusing portion 21 is reflected by the inner peripheral surface 63 of the second coil member 60, so that the reflected light is diffused. It becomes easy to diffuse in various directions from the exposed portion 22 , which is the portion of the portion 21 that is not covered with the second coil member 60 . As a result, the emission intensity distribution of the exposed portion 22 is more likely to be uniform in the circumferential direction p of the shaft 10 . As a result, it is possible to reduce the number of times the target tissue such as a tumor is irradiated and the number of times the position of the exposed portion 22 is adjusted with respect to the target tissue, thereby improving the efficiency of the procedure. When the second coil member 60 covers the light diffusing section 21 , it covers only a part of the light diffusing section 21 , and preferably does not cover the entire light diffusing section 21 . Thereby, the exposed portion 22 is formed in the light diffusion portion 21 . In addition, the second coil member 60 may not partially cover the distal portion of the light diffusion section 21 . In the radial direction of the shaft 10 , it is preferable that there be no separate member between the exposed portion 22 and the shaft 10 , but any member that does not block the light emitted from the exposed portion 22 may be provided.
 次に、図8~図11を参照しながら光ファイバー部材20の構成例を説明する。図8~図11では、光ファイバー部材20は、長手軸方向xに延在しているコア25を有し、光ファイバー部材20は、コア25の外周に配されている第1クラッド26を有している第1区間31を有している。第1区間31では、コア25と第1クラッド26の境界で光が全反射しやすくなるため、第1区間31では、光がコア25内に閉じ込められながら光ファイバー部材20の遠位側に伝搬される。 Next, a configuration example of the optical fiber member 20 will be described with reference to FIGS. 8 to 11. FIG. 8-11, the optical fiber member 20 has a core 25 extending in the longitudinal direction x, and the optical fiber member 20 has a first clad 26 disposed around the core 25. It has a first section 31 where In the first section 31, the light is likely to be totally reflected at the boundary between the core 25 and the first clad 26. Therefore, in the first section 31, the light is confined within the core 25 and propagated to the distal side of the optical fiber member 20. be.
 第1区間31では、1つの第1クラッド26の中に1つのコア25が配されていることが好ましい。第1区間31では、光ファイバーをシングルコア光ファイバーと言い換えることができる。 It is preferable that one core 25 is arranged in one first clad 26 in the first section 31 . In the first section 31, the optical fiber can be rephrased as a single-core optical fiber.
 光ファイバー部材20のプロファイルの増加を防ぐために、第1区間31では第1クラッド26が光ファイバー部材20の径方向の最も外側に位置していてもよい。すなわち、第1区間31には被覆材などの他の部材が配されなくてもよい。 In order to prevent the profile of the optical fiber member 20 from increasing, the first clad 26 may be positioned radially outwardly of the optical fiber member 20 in the first section 31 . That is, the first section 31 does not need to be provided with other members such as a covering material.
 図示していないが、光ファイバー部材20の第1区間31には、第1クラッド26の外周に被覆材が配されていてもよい。第1区間31の外側を保護することが可能となり、第1区間31において外への光漏れや射出を抑制することもできる。被覆材は、第1クラッド26の外周面上に配される被覆層であってもよく、第1クラッド26を内包するシースであってもよい。被覆材は、紫外線硬化樹脂等の樹脂から構成することができる。 Although not shown, the first section 31 of the optical fiber member 20 may be provided with a coating material around the outer periphery of the first clad 26 . It is possible to protect the outside of the first section 31 , and it is also possible to suppress light leakage and emission to the outside in the first section 31 . The coating material may be a coating layer arranged on the outer peripheral surface of the first clad 26 or a sheath enclosing the first clad 26 . The covering material can be made of a resin such as an ultraviolet curable resin.
 図8では、光ファイバー部材20が、光拡散部21に、コア25の外周に配されており第1クラッド26よりも外周面の表面粗さが大きい第2クラッド27を有している第2区間32を有している。第2区間32は第1区間31よりも遠位側に位置している。第1区間31よりも第2区間32でクラッドの表面粗さを大きくすることで、光の一部はコア25内に閉じ込められながら光ファイバー部材20の遠位側に伝搬され、残りの光は第2クラッド27から外に漏れて径方向の外方に射出される。なお、第1区間31では光が径方向の外方に射出されないか、または第2区間32よりも光の漏れ量が小さいことが好ましい。 In FIG. 8, the optical fiber member 20 has a second clad 27 disposed on the outer periphery of the core 25 and having a larger surface roughness of the outer peripheral surface than the first clad 26 in the light diffusion part 21. 32. The second section 32 is positioned more distally than the first section 31 . By making the surface roughness of the cladding greater in the second section 32 than in the first section 31, part of the light is confined within the core 25 and propagated distally of the optical fiber member 20, and the remaining light is transmitted to the second section. It leaks out from the second clad 27 and is injected radially outward. It is preferable that the first section 31 does not emit light radially outward, or that the amount of light leakage is smaller than that of the second section 32 .
 第1区間31と同様に、第2区間32では、1つの第2クラッド27の中に1つのコア25が配されていることが好ましい。第1区間31と第2区間32は一の光ファイバーから構成されていてもよい。第1区間31の第1クラッド26と第2区間32の第2クラッド27は一体成形されていてもよい。光ファイバーは、第1区間31用の光ファイバーと第2区間32用の光ファイバーが長手軸方向xに接合されていてもよい。第1区間31の第1クラッド26と第2区間32の第2クラッド27は別々に形成された後で接合されてもよい。 As in the first section 31 , in the second section 32 , one core 25 is preferably arranged in one second clad 27 . The first section 31 and the second section 32 may consist of one optical fiber. The first clad 26 of the first section 31 and the second clad 27 of the second section 32 may be integrally formed. As for the optical fiber, the optical fiber for the first section 31 and the optical fiber for the second section 32 may be spliced in the longitudinal axis direction x. The first clad 26 of the first section 31 and the second clad 27 of the second section 32 may be separately formed and then joined together.
 第2区間32では、第2クラッド27が光ファイバー部材20の径方向の最も外側に位置していることが好ましい。すなわち、第2区間32では、コア25と第2クラッド27以外の部材(例えば被覆材)が配されていないことが好ましい。この構成により、第2区間32からシャフト10の径方向の外方に向かって光を射出することができる。 In the second section 32, it is preferable that the second cladding 27 is located on the outermost side of the optical fiber member 20 in the radial direction. That is, in the second section 32, it is preferable that no member (for example, a covering material) other than the core 25 and the second clad 27 is arranged. With this configuration, light can be emitted outward in the radial direction of the shaft 10 from the second section 32 .
 第2区間32の第2クラッド27の外周面の表面粗さは、第1区間31の第1クラッド26の外周面の表面粗さよりも大きい。ここで、表面粗さは、光ファイバー部材20の外周面の長手軸方向における粗さ曲線の基準長さ間での算術平均粗さRaである。基準長さは、使用するレーザー顕微鏡の拡大率に応じて設定すればよいが、例えば200μmである。上記算術平均粗さRaは、JIS B 0601(2001)に規定される算術平均粗さRaに相当し、JIS B 0633(2001)に準じて測定される。測定には、JIS B 0651(2001)に規定される測定機(例えば、キーエンス社製レーザー顕微鏡 VK-X3000)を用いる。 The surface roughness of the outer peripheral surface of the second clad 27 in the second section 32 is greater than the surface roughness of the outer peripheral surface of the first clad 26 in the first section 31 . Here, the surface roughness is the arithmetic mean roughness Ra between the reference lengths of the roughness curve in the longitudinal axis direction of the outer peripheral surface of the optical fiber member 20 . The reference length may be set according to the magnification of the laser microscope used, and is, for example, 200 μm. The above arithmetic mean roughness Ra corresponds to the arithmetic mean roughness Ra specified in JIS B 0601 (2001) and is measured according to JIS B 0633 (2001). For the measurement, a measuring machine specified in JIS B 0651 (2001) (for example, a laser microscope VK-X3000 manufactured by Keyence Corporation) is used.
 第2区間32の第2クラッド27の外周面の表面粗さの平均値が、第1区間31の第1クラッド26の外周面の表面粗さの平均値よりも大きいことが好ましい。第1区間31ではコア25内に光が閉じ込められやすくなり、第2区間32では第2クラッド27から光が径方向の外方に射出されやすくなる。その結果、長手軸方向xにおいて光拡散部21の発光強度分布が均一化されやすくなる。表面粗さの平均値とは、測定対象となる区間(例えば第1区間31)において、長手軸方向xに並ぶように設定された10点以上の測定点の表面粗さ値の平均値である。 The average value of the surface roughness of the outer peripheral surface of the second clad 27 in the second section 32 is preferably larger than the average value of the surface roughness of the outer peripheral surface of the first clad 26 in the first section 31 . In the first section 31 , light is likely to be confined within the core 25 , and in the second section 32 , light is likely to be emitted radially outward from the second clad 27 . As a result, the light emission intensity distribution of the light diffusing portion 21 is easily made uniform in the longitudinal direction x. The average value of the surface roughness is the average value of the surface roughness values of 10 or more measurement points set so as to be aligned in the longitudinal axis direction x in the section to be measured (for example, the first section 31). .
 図8に示すように長手軸方向xにおいて第2区間32を遠位部323と近位部324に二等分割したときに、近位部324における第2クラッド27の外周面の表面粗さの平均値が、遠位部323における第2クラッド27の外周面の表面粗さの平均値よりも小さいことが好ましい。この構成により、近位部324では遠位部323よりもコア25内に光を閉じ込める効果を高めつつ、遠位部323では第2クラッド27から径方向の外方に向かって光が射出されやすくなるため、長手軸方向xにおいて第2区間32の発光強度分布が均一化されやすくなる。 As shown in FIG. 8, when the second section 32 is divided into a distal portion 323 and a proximal portion 324 in the longitudinal direction x, the surface roughness of the outer peripheral surface of the second clad 27 in the proximal portion 324 is The average value is preferably smaller than the average surface roughness of the outer peripheral surface of the second clad 27 in the distal portion 323 . With this configuration, the proximal portion 324 enhances the effect of confining light within the core 25 more than the distal portion 323, while the distal portion 323 facilitates the radially outward emission of light from the second clad 27. Therefore, the emission intensity distribution of the second section 32 is easily uniformed in the longitudinal direction x.
 長手軸方向xにおいて第1区間31よりも第2区間32の方が短いことが好ましい。光拡散部21を形成しやすくなり、光ファイバー20の遠位端部での柔軟性も高めることができる。長手軸方向xにおいて第2区間32の長さは、第1区間31の長さの20分の1以下、25分の1以下、30分の1以下の長さに設定することができる。また、長手軸方向xにおいて第2区間32の長さは、第1区間31の長さの50分の1以上、45分の1以上、あるいは30分の1以上の長さに設定されてもよい。 The second section 32 is preferably shorter than the first section 31 in the longitudinal direction x. It becomes easier to form the light diffusing portion 21, and the flexibility of the distal end portion of the optical fiber 20 can also be increased. The length of the second section 32 in the longitudinal direction x can be set to 1/20 or less, 1/25 or less, or 1/30 or less of the length of the first section 31 . Also, the length of the second section 32 in the longitudinal axis direction x may be set to 1/50 or more, 1/45 or more, or 1/30 or more of the length of the first section 31. good.
 図8から理解できるように第2区間32の第2クラッド27の平均厚みは、第1区間31の第1クラッド26の平均厚みよりも小さいことが好ましい。このようにクラッドの厚みを調整することで、第1区間31ではコア25内に光が閉じ込められやすくなり、第2区間32では第2クラッド27から光が径方向の外方に射出されやすくなる。ここで、クラッドの厚みは、キーエンス社製レーザー顕微鏡 VK-X3000を用いて測定することができる。 As can be understood from FIG. 8, the average thickness of the second clad 27 in the second section 32 is preferably smaller than the average thickness of the first clad 26 in the first section 31. By adjusting the thickness of the clad in this way, light is more likely to be confined in the core 25 in the first section 31, and light is more likely to be emitted radially outward from the second clad 27 in the second section 32. . Here, the clad thickness can be measured using a laser microscope VK-X3000 manufactured by Keyence Corporation.
 図9、図10に示すように、光ファイバー部材20が第1区間31を有している場合、光ファイバー部材20は、光拡散部21に、クラッドが存在せず第1区間31よりも遠位側に位置している第3区間33を有していてもよい。第3区間33ではクラッドが存在しないことにより、コア25からの光が径方向の外方に射出される。 As shown in FIGS. 9 and 10 , when the optical fiber member 20 has the first section 31 , the optical fiber member 20 has no cladding in the light diffusing portion 21 and is located distally of the first section 31 . may have a third section 33 located at . Since there is no clad in the third section 33, the light from the core 25 is emitted radially outward.
 第3区間33では、コア25の周方向の少なくとも一部でクラッドが存在していないことが好ましく、コア25の周方向の全体でクラッドが存在していないことがより好ましい。 In the third section 33, it is preferable that no clad exists in at least a part of the core 25 in the circumferential direction, and more preferably, no clad exists in the entire circumferential direction of the core 25.
 第3区間33では、光ファイバー部材20の中ではコア25が径方向の最も外側に位置していることが好ましい。但し、第3区間33の少なくとも一部が第2コイル部材60により覆われていることが好ましい。すなわち、第3区間33では、クラッドだけでなく、コア25と第2コイル部材60以外のあらゆる部材(例えば被覆材)が配されていないことが好ましい。 In the third section 33, it is preferable that the core 25 is positioned radially outermost in the optical fiber member 20. However, it is preferable that at least part of the third section 33 is covered with the second coil member 60 . In other words, in the third section 33, it is preferable that not only the clad but also any members (for example, covering material) other than the core 25 and the second coil member 60 are arranged.
 長手軸方向xにおいて、第3区間33のコア25の外径は一定の値であってもよく、長手軸方向xの位置によってコア25の外径が異なる値であってもよい。 In the longitudinal direction x, the outer diameter of the core 25 in the third section 33 may be a constant value, or the outer diameter of the core 25 may be a different value depending on the position in the longitudinal direction x.
 図9、図10に示すように、長手軸方向xにおいて、第3区間33の遠位端は、コア25の遠位端と同じ位置にあることが好ましい。第3区間33を形成しやすくなり、光ファイバー部材20の遠位端部での柔軟性も高めることができる。 As shown in FIGS. 9 and 10, the distal end of the third section 33 is preferably at the same position as the distal end of the core 25 in the longitudinal direction x. The formation of the third section 33 is facilitated, and the flexibility at the distal end of the optical fiber member 20 can also be increased.
 第3区間33のコア25の外周面の表面粗さは、第1区間31の第1クラッド26の外周面の表面粗さよりも大きいことが好ましい。第1区間31ではコア25内に光が閉じ込められやすくなり、第3区間33ではコア25から光が径方向の外方に射出されやすくなる。 The surface roughness of the outer peripheral surface of the core 25 in the third section 33 is preferably larger than the surface roughness of the outer peripheral surface of the first clad 26 in the first section 31 . Light is likely to be confined within the core 25 in the first section 31 , and light is likely to be emitted radially outward from the core 25 in the third section 33 .
 光拡散部21には第2区間32と第3区間33の少なくともいずれか一方が配されていることが好ましく、第2区間32と第3区間33の両方が配されていてもよい。図9に示すように、光拡散部21には、その近位側から遠位側に向かって順に第2区間32、第3区間33が配されていることが好ましい。この構成により、長手軸方向xにおいて光拡散部21の発光強度分布が均一化されやすくなる。この効果を高めるためには、長手軸方向xにおいて第1区間31と第2区間32と第3区間33は隣接していることが好ましく、より詳細には、第1区間31と第2区間32が隣接しており、第2区間32と第3区間33が隣接していることが好ましい。 At least one of the second section 32 and the third section 33 is preferably arranged in the light diffusion section 21, and both the second section 32 and the third section 33 may be arranged. As shown in FIG. 9, it is preferable that the light diffusing portion 21 has a second section 32 and a third section 33 arranged in order from the proximal side to the distal side. With this configuration, the light emission intensity distribution of the light diffusing portion 21 can be easily uniformed in the longitudinal direction x. In order to enhance this effect, it is preferable that the first section 31, the second section 32, and the third section 33 are adjacent to each other in the longitudinal direction x. More specifically, the first section 31 and the second section 32 are adjacent to each other, and the second section 32 and the third section 33 are preferably adjacent to each other.
 光ファイバー部材20が第2区間32と第3区間33を有している場合、図9に示すように長手軸方向xにおいて第2区間32よりも第3区間33の方が短いことが好ましい。この構成により、長手軸方向xにおける露出部22の全体の発光強度分布を均一化させやすくなる。なお、長手軸方向xにおいて第3区間33よりも第2区間32の方が短い態様も許容される。 When the optical fiber member 20 has the second section 32 and the third section 33, it is preferable that the third section 33 is shorter than the second section 32 in the longitudinal axis direction x as shown in FIG. With this configuration, it becomes easier to uniform the emission intensity distribution of the entire exposed portion 22 in the longitudinal direction x. A mode in which the second section 32 is shorter than the third section 33 in the longitudinal direction x is also allowed.
 長手軸方向xにおいて第3区間33の長さは、第2区間32および第3区間33の合計長さの20%以下の大きさであることが好ましく、18%以下の大きさであることがより好ましく、15%以下の大きさであることがさらに好ましい。また、長手軸方向xにおいて第3区間33の長さは、第2区間32および第3区間33の合計長さの5%以上、8%以上、あるいは10%以上の大きさであってもよい。この構成により、長手軸方向xにおける露出部22の発光強度分布を均一化させやすくなる。 The length of the third section 33 in the longitudinal direction x is preferably 20% or less of the total length of the second section 32 and the third section 33, and is preferably 18% or less. More preferably, the size is 15% or less. In addition, the length of the third section 33 in the longitudinal direction x may be 5% or more, 8% or more, or 10% or more of the total length of the second section 32 and the third section 33. . This configuration makes it easier to uniformize the emission intensity distribution of the exposed portion 22 in the longitudinal direction x.
 第2区間32の第2クラッド27の外周面の表面粗さの平均値は、第3区間33のコア25の外周面の表面粗さの平均値よりも小さいことが好ましい。この構成により、第2区間32と第3区間33のそれぞれで、長手軸方向xにおける発光強度分布を均一化させやすくなる。 The average value of the surface roughness of the outer peripheral surface of the second clad 27 in the second section 32 is preferably smaller than the average value of the surface roughness of the outer peripheral surface of the core 25 in the third section 33 . This configuration makes it easier to uniformize the emission intensity distribution in the longitudinal axis direction x in each of the second section 32 and the third section 33 .
 図8に示すように、光ファイバー部材20は、光拡散部21に第2区間32のみを有していてもよい。すなわち、光ファイバー部材20は、光拡散部21に第3区間33を有していなくてもよい。第2区間32のみを有する構成であっても、長手軸方向xにおける露出部22の発光強度分布を均一化させることができる。コア25が露出していないため、手技中の装置1の曲げに伴う光ファイバー部材20の損傷を防ぐ効果も有する。 As shown in FIG. 8, the optical fiber member 20 may have only the second section 32 in the light diffusing portion 21 . That is, the optical fiber member 20 does not have to have the third section 33 in the light diffusing portion 21 . Even with the configuration having only the second section 32, the emission intensity distribution of the exposed portion 22 in the longitudinal axis direction x can be made uniform. Since the core 25 is not exposed, it also has the effect of preventing damage to the optical fiber member 20 due to bending of the device 1 during the procedure.
 光ファイバー部材20が、光拡散部21に第2区間32のみを有している場合、長手軸方向xにおいて、第2区間32の遠位端がコア25の遠位端と同じ位置にあることが好ましい。 If the optical fiber member 20 has only the second section 32 in the light diffusing portion 21, the distal end of the second section 32 may be at the same position as the distal end of the core 25 in the longitudinal direction x. preferable.
 図10に示すように、光ファイバー部材20は、光拡散部21に第3区間33のみを有していてもよい。すなわち、光ファイバー部材20は、光拡散部21に第2区間32を有していなくてもよい。第3区間33のみを有する構成であっても、長手軸方向xにおける露出部22の発光強度分布を均一化させることができる。 As shown in FIG. 10, the optical fiber member 20 may have only the third section 33 in the light diffusing portion 21 . That is, the optical fiber member 20 does not have to have the second section 32 in the light diffusing portion 21 . Even with the configuration having only the third section 33, the emission intensity distribution of the exposed portion 22 in the longitudinal axis direction x can be made uniform.
 第2区間32および第3区間33は、エッチングや研磨によりクラッドを剥離させることで形成することができる。第2区間32や第3区間33の表面粗さを調整するために、第2クラッド27の外周面や第3区間33のコア25の外周面に凹凸が配されていてもよい。凹凸は、機械的または化学的に第2クラッド27または第3区間33のコア25の表面を荒らすことで形成可能である。表面を荒らす方法としては、エッチング加工、ブラスト加工、けがき針、ワイヤブラシ、またはサンドペーパーを用いる方法が挙げられる。 The second section 32 and the third section 33 can be formed by removing the clad by etching or polishing. In order to adjust the surface roughness of the second section 32 and the third section 33, the outer peripheral surface of the second clad 27 and the outer peripheral surface of the core 25 of the third section 33 may be uneven. The unevenness can be formed by mechanically or chemically roughening the surface of the core 25 of the second clad 27 or the third section 33 . Examples of methods for roughening the surface include etching, blasting, a method using a scribe, a wire brush, or sandpaper.
 光拡散部21からは治療用の第1光線が射出されればよい。第1光線は、体内組織を照射し、PDTやPITといった光治療に適した波長のレーザー光であることが好ましい。第1光線のほか、標的化用の第2光線が射出されてもよい。第2光線は、第1光線の射出前に治療部位を把握するために射出される光線であり、第1光線よりも放射エネルギーが低いことが好ましい。 The light diffusing portion 21 should emit the first light beam for treatment. The first light beam is preferably laser light with a wavelength suitable for phototherapy such as PDT and PIT for irradiating internal tissue. In addition to the first beam, a second targeting beam may be emitted. The second light beam is a light beam emitted to grasp the treatment site before the first light beam is emitted, and preferably has a lower radiant energy than the first light beam.
 図11に示すように、光ファイバー部材20は、その遠位端面に反射材200を有していることが好ましい。反射材200とは、例えば反射面が近位側を向くように配されたミラーである。この構成により、第2コイル部材60の内周面だけでなく反射材200によっても光を反射することができるため、反射光が様々な方向に拡散されやすくなる。 As shown in FIG. 11, the optical fiber member 20 preferably has a reflector 200 on its distal end face. The reflector 200 is, for example, a mirror arranged so that the reflecting surface faces the proximal side. With this configuration, light can be reflected not only by the inner peripheral surface of the second coil member 60 but also by the reflector 200, so that the reflected light can be easily diffused in various directions.
 反射材200の表面は、アルミニウム、金、銀、銅、スズ、二酸化チタン、五酸化タンタル、酸化アルミニウム、二酸化ケイ素、またはフッ化マグネシウムから構成されていることが好ましい。 The surface of the reflector 200 is preferably made of aluminum, gold, silver, copper, tin, titanium dioxide, tantalum pentoxide, aluminum oxide, silicon dioxide, or magnesium fluoride.
 反射材200の形状は特に限定されないが、例えば、板状、円柱状、多角柱状等の形状にすることができる。 Although the shape of the reflector 200 is not particularly limited, it can be shaped like a plate, a cylinder, or a polygonal column, for example.
 本願は、2021年9月27日に出願された日本国特許出願第2021-156417号に基づく優先権の利益を主張するものである。2021年9月27日に出願された日本国特許出願第2021-156417号の明細書の全内容が、本願に参考のため援用される。 This application claims the benefit of priority based on Japanese Patent Application No. 2021-156417 filed on September 27, 2021. The entire contents of the specification of Japanese Patent Application No. 2021-156417 filed on September 27, 2021 are incorporated herein by reference.
1:光照射医療装置
10:シャフト
11:内腔
20:光ファイバー部材
21:光拡散部
22:露出部
25:コア
26:第1クラッド
27:第2クラッド
200:反射材
31:第1区間
32:第2区間
323:遠位部
324:近位部
33:第3区間
40:第1コイル部材
42:線材
50:筒部材
60:第2コイル部材
62:線材
70:ハンドル
x:長手軸方向
p:周方向
1: Light irradiation medical device 10: Shaft 11: Lumen 20: Optical fiber member 21: Light diffusion part 22: Exposed part 25: Core 26: First clad 27: Second clad 200: Reflective material 31: First section 32: Second section 323: Distal section 324: Proximal section 33: Third section 40: First coil member 42: Wire rod 50: Tubular member 60: Second coil member 62: Wire rod 70: Handle x: Longitudinal axis direction p: circumferential direction

Claims (16)

  1.  長手軸方向に遠位端と近位端を有し、かつ前記長手軸方向に延在している内腔を有するシャフトと、
     前記シャフトの前記内腔に配置されている光ファイバー部材と、
     前記シャフトの前記内腔であって前記光ファイバー部材よりも遠位側に配置されており、線材がらせん状に巻回されている第1コイル部材と、を有し、
     前記第1コイル部材は前記線材の線径よりも長いピッチを有しており、
     前記光ファイバー部材の遠位端部と前記第1コイル部材の近位端部は当接しているが、固定されていない光照射医療装置。
    a shaft having longitudinal distal and proximal ends and having a lumen extending longitudinally;
    a fiber optic member disposed in the lumen of the shaft;
    a first coil member disposed in the lumen of the shaft and distal to the optical fiber member, the first coil member being helically wound with a wire;
    The first coil member has a pitch longer than the wire diameter of the wire,
    A light irradiation medical device in which the distal end of the optical fiber member and the proximal end of the first coil member abut but are not fixed.
  2.  前記第1コイル部材の近位端部の内径は、前記光ファイバー部材の遠位端部の外径よりも小さい請求項1に記載の光照射医療装置。 The light irradiation medical device according to claim 1, wherein the inner diameter of the proximal end of the first coil member is smaller than the outer diameter of the distal end of the optical fiber member.
  3.  前記シャフトの前記内腔に配置されており、前記第1コイル部材を覆っている筒部材を有している請求項1または2に記載の光照射医療装置。 The light irradiation medical device according to claim 1 or 2, further comprising a tubular member arranged in the lumen of the shaft and covering the first coil member.
  4.  前記第1コイル部材の遠位端部と前記筒部材の遠位端部とが固定されている請求項3に記載の光照射医療装置。 The light irradiation medical device according to claim 3, wherein the distal end of the first coil member and the distal end of the cylindrical member are fixed.
  5.  前記光ファイバー部材はその遠位部の所定区間に前記長手軸方向に延在しており前記シャフトの径方向の外方に向かって光を射出する光拡散部を有し、
     前記筒部材の近位端は前記光拡散部の遠位端よりも近位側に位置している請求項3に記載の光照射医療装置。
    The optical fiber member has a light diffusing portion extending in the longitudinal direction in a predetermined section of its distal portion and emitting light radially outward from the shaft,
    4. The light irradiation medical device according to claim 3, wherein the proximal end of the cylindrical member is positioned closer to the proximal side than the distal end of the light diffusing portion.
  6.  前記筒部材の外周面が前記シャフトの内周面と接しており、前記光拡散部の外周面と前記シャフトの内周面とが離れて配置されている請求項5に記載の光照射医療装置。 The light irradiation medical device according to claim 5, wherein the outer peripheral surface of the tubular member is in contact with the inner peripheral surface of the shaft, and the outer peripheral surface of the light diffusing portion and the inner peripheral surface of the shaft are arranged apart from each other. .
  7.  前記筒部材の遠位端部は、前記筒部材を遠位側から見た時の面積が前記筒部材の遠位端部の内腔よりも大きい蓋部を有している請求項3に記載の光照射医療装置。 4. The distal end portion of the tubular member has a lid portion having a larger area than the lumen of the distal end portion of the tubular member when the tubular member is viewed from the distal side. light irradiation medical device.
  8.  前記筒部材は線材がらせん状に巻回されている第2コイル部材である請求項3に記載の光照射医療装置。 The light irradiation medical device according to claim 3, wherein the tubular member is a second coil member in which a wire is spirally wound.
  9.  前記第1コイル部材のピッチの平均は、前記第2コイル部材のピッチの平均よりも大きい請求項8に記載の光照射医療装置。 The light irradiation medical device according to claim 8, wherein the average pitch of the first coil member is larger than the average pitch of the second coil member.
  10.  前記第1コイル部材の前記線材の線径は、前記第2コイル部材の前記線材の線径よりも小さい請求項8に記載の光照射医療装置。 The light irradiation medical device according to claim 8, wherein the wire diameter of the wire material of the first coil member is smaller than the wire diameter of the wire material of the second coil member.
  11.  前記長手軸方向に垂直な方向であって、前記第1コイル部材の前記長手軸方向における長さの中点を通る前記線材の断面積は、前記第2コイル部材の前記長手軸方向における長さの中点を通る前記線材の断面積よりも小さい請求項8に記載の光照射医療装置。 The cross-sectional area of the wire in the direction perpendicular to the longitudinal axis direction and passing through the midpoint of the length of the first coil member in the longitudinal axis direction is the length of the second coil member in the longitudinal axis direction. 9. The photoirradiation medical device according to claim 8, wherein the cross-sectional area of the wire passing through the midpoint of is smaller than that of the wire.
  12.  前記第1コイル部材の巻き方向と前記第2コイル部材の巻き方向とが同じ方向である請求項8に記載の光照射医療装置。 The light irradiation medical device according to claim 8, wherein the winding direction of the first coil member and the winding direction of the second coil member are the same.
  13.  前記第2コイル部材の遠位端部は、前記第2コイル部材を遠位側から見た時の面積が前記第2コイル部材の遠位端部の内腔よりも大きい蓋部を有している請求項8に記載の光照射医療装置。 The distal end portion of the second coil member has a lid portion whose area when the second coil member is viewed from the distal side is larger than the lumen of the distal end portion of the second coil member. The light irradiation medical device according to claim 8.
  14.  前記光ファイバー部材は、その遠位端面に反射材を有している請求項1に記載の光照射医療装置。 The light irradiation medical device according to claim 1, wherein the optical fiber member has a reflector on its distal end surface.
  15.  前記第1コイル部材は前記線材の線径の1.5倍以上のピッチを有している請求項1に記載の光照射医療装置。 The light irradiation medical device according to claim 1, wherein the first coil member has a pitch of 1.5 times or more the wire diameter of the wire.
  16.  前記第1コイル部材の遠位端部は、前記第1コイル部材を遠位側から見た時の面積が前記第1コイル部材の遠位端部の内腔よりも大きい蓋部を有している請求項1に記載の光照射医療装置。 The distal end portion of the first coil member has a lid portion whose area when the first coil member is viewed from the distal side is larger than the lumen of the distal end portion of the first coil member. The photoirradiation medical device according to claim 1.
PCT/JP2022/022436 2021-09-27 2022-06-02 Light irradiating medical device WO2023047709A1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0412743A (en) * 1990-05-02 1992-01-17 Olympus Optical Co Ltd Laser probe
JPH05285196A (en) * 1992-04-03 1993-11-02 Matsushita Electric Ind Co Ltd Photoacupuncture type phototreating device
US20080051704A1 (en) * 2006-08-28 2008-02-28 Patel Rajnikant V Catheter and system for using same
JP2009247629A (en) * 2008-04-07 2009-10-29 Keio Gijuku Light diffuser having coil form for shining light beam on organism tissue and light-diffusing device including the light diffuser

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0412743A (en) * 1990-05-02 1992-01-17 Olympus Optical Co Ltd Laser probe
JPH05285196A (en) * 1992-04-03 1993-11-02 Matsushita Electric Ind Co Ltd Photoacupuncture type phototreating device
US20080051704A1 (en) * 2006-08-28 2008-02-28 Patel Rajnikant V Catheter and system for using same
JP2009247629A (en) * 2008-04-07 2009-10-29 Keio Gijuku Light diffuser having coil form for shining light beam on organism tissue and light-diffusing device including the light diffuser

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