WO2024154714A1 - Catheter assembly and catheter visualization system - Google Patents

Catheter assembly and catheter visualization system Download PDF

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Publication number
WO2024154714A1
WO2024154714A1 PCT/JP2024/000889 JP2024000889W WO2024154714A1 WO 2024154714 A1 WO2024154714 A1 WO 2024154714A1 JP 2024000889 W JP2024000889 W JP 2024000889W WO 2024154714 A1 WO2024154714 A1 WO 2024154714A1
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WIPO (PCT)
Prior art keywords
light
catheter
light source
catheter assembly
unit
Prior art date
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PCT/JP2024/000889
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French (fr)
Japanese (ja)
Inventor
妻木翔太
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テルモ株式会社
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Publication date
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Publication of WO2024154714A1 publication Critical patent/WO2024154714A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like

Definitions

  • the present invention relates to a catheter assembly and a catheter visualization system.
  • JP 2013-9949 A discloses a catheter having a transparent catheter housing, an introducer needle, a needle housing, and a light source coupler.
  • the catheter housing covers the introducer needle so that the tip of the introducer needle is exposed to the outside.
  • the needle housing supports the introducer needle and the light source coupler so that the base end of the introducer needle and the light source coupler face each other.
  • the light source coupler is connected to an illuminator via an optical fiber. Light emitted from the illuminator propagates through the optical fiber and is emitted from the light source coupler. The light emitted from the light source coupler propagates through the catheter housing that covers the introducer needle. This causes the transparent catheter housing to emit light.
  • the catheter of JP 2013-9949 A is connected to an optical fiber.
  • the optical fiber limits the operability of the catheter.
  • the entire catheter housing emits light. This makes it difficult to distinguish between the tip of the catheter and the rest of the catheter, making it difficult to visually confirm the blood vessel being secured at the tip.
  • the light emitted from the light source coupler is attenuated along the light propagation path until it reaches the tip of the catheter. This makes it difficult to obtain a sufficient amount of light at the tip of the catheter. For these reasons, the catheter of JP 2013-9949 A has poor visibility at the tip.
  • the present invention aims to solve the above-mentioned problems.
  • the catheter assembly of the present invention comprises a catheter member having a catheter body and a catheter hub fixed to the base end of the catheter body, a light source that irradiates light toward the tip end of the catheter body, a fixing part that fixes the light source to the catheter hub, and a support member that is inserted into the catheter body so as to be removable from the catheter body and supports the catheter body, and a light emitting part that emits light in response to receiving light is provided at the tip end of the catheter body, and the fixing part fixes the light source so that the optical axis of the light source is inclined with respect to the axis of the catheter body.
  • the light-emitting portion of the catheter body emits light when directly irradiated with light from the light source. Therefore, the light irradiated from the light source is not attenuated by other parts of the catheter assembly before reaching the light-emitting portion. Furthermore, in the above configuration, the light irradiated from the light source does not propagate through the catheter assembly. Therefore, the difference between the brightness of the tip of the catheter body inserted into the living body and the other parts is clear. For this reason, the above configuration improves the visibility of the tip (light-emitting portion) of the catheter body. Furthermore, in the above configuration, the light source is provided in the catheter assembly itself. Therefore, there is no need to connect the catheter assembly and the light source with an optical fiber or the like. Therefore, the above configuration improves the operability of the catheter assembly.
  • the fixing portion may fix the light source so that the optical axis of the light source intersects with the axis of the catheter body.
  • the above configuration allows selective illumination of the tip of the catheter body. This makes it easier to check whether the tip of the catheter body is positioned inside the blood vessel.
  • the fixing part may removably fix the light source to the catheter hub.
  • the light source can be removed from the catheter hub while the catheter member is placed in the living body. This allows the light source to be reused. Furthermore, with the above configuration, the weight of the catheter member placed in the living body can be reduced. This allows the load on the living body caused by the weight of the catheter member to be reduced.
  • the light source may emit near-infrared light.
  • the above configuration uses near-infrared light that is absorbed by blood, making it easier to confirm whether the tip of the catheter body (light-emitting part) is positioned inside a blood vessel.
  • the light-emitting section may include a wavelength conversion material that converts the near-infrared light irradiated by the light source into visible light.
  • the user can see the light emitted from the light-emitting section with the naked eye.
  • the light-emitting portion may include a phosphorescent material or a fluorescent material.
  • the above configuration improves visibility of the tip (light-emitting portion) of the catheter body.
  • the light-emitting section may have a reflective structure that reflects the light irradiated by the light source.
  • the above configuration improves visibility of the tip (light-emitting portion) of the catheter body.
  • the fixing portion and the catheter hub may be formed integrally.
  • the fixing portion may surround the entire circumference of the light source with the optical axis of the light source as the center.
  • the above configuration allows the light source to be stably fixed to the catheter hub.
  • the support member may have an inner needle that is inserted into the lumen of the catheter body, and an inner needle hub that is fixed to the base end of the inner needle.
  • the above configuration allows the catheter body to be placed in the living body while maintaining its shape.
  • the distance from the tip of the catheter body to the intersection of the optical axis of the light source and the axis of the catheter body may be 7 mm or less, or 6 times the outer diameter of the catheter body or less.
  • the above configuration allows the tip of the catheter body to emit light.
  • the catheter visualization system of the present invention comprises a catheter assembly according to any one of items (1) to (11) above, a light receiving unit that receives transmitted light that has passed through a living body and is emitted by the light emitting unit when the light emitting unit is located inside the living body, and a display unit that displays an image obtained by the transmitted light received by the light receiving unit.
  • the above configuration allows light that cannot be seen with the naked eye to be seen through the display unit.
  • the catheter visualization system described in item (12) above includes an irradiation unit that irradiates the living body with a second light for visualizing blood vessels inside the living body, and a second light receiving unit that receives second transmitted light that has passed through the living body from the second light irradiated by the irradiation unit, and the display unit may display an image obtained by the transmitted light received by the light receiving unit and an image obtained by the second transmitted light received by the second light receiving unit, either individually or in combination.
  • the above configuration makes it possible to check the relative position of the tip of the catheter body and the blood vessel.
  • an irradiation unit may be provided that irradiates the living body with a second light for visualizing blood vessels inside the living body, the light receiving unit may receive a second transmitted light that has passed through the living body out of the second light irradiated by the irradiation unit, and the display unit may display an image obtained by the transmitted light received by the light receiving unit and an image obtained by the second transmitted light received by the light receiving unit.
  • the above configuration makes it possible to check the relative position of the tip of the catheter body and the blood vessel.
  • the irradiation unit and the second light receiving unit may be arranged to sandwich the light emitting unit located inside the living body.
  • the present invention improves visibility of the catheter tip.
  • FIG. 1 is a schematic diagram of a catheter assembly according to one embodiment of the present invention.
  • FIG. 2 is an exploded perspective view of the catheter assembly of FIG.
  • FIG. 3 is a schematic diagram of another embodiment of the catheter assembly.
  • FIG. 4 is a diagram showing the configuration of a catheter visualization system using the catheter assembly of FIG.
  • FIG. 5 is a first explanatory view of a blood vessel puncture procedure using the catheter assembly.
  • FIG. 6 is a second explanatory view of a blood vessel puncture procedure using the catheter assembly.
  • FIG. 7 is a configuration diagram of a catheter visualization system according to another embodiment different from that shown in FIG.
  • FIG. 8 is a configuration diagram of a catheter visualization system according to another embodiment different from those shown in FIGS.
  • FIG. 1 is a schematic diagram of a catheter assembly 10 according to one embodiment of the present invention.
  • FIG. 2 is an exploded perspective view of the catheter assembly 10 of FIG. 1.
  • the catheter assembly 10 is configured as an indwelling needle for administering an infusion (medicinal solution) into a blood vessel 102 (FIG. 5) of a living body 100 (FIG. 5), for example.
  • the catheter assembly 10 is not limited to an indwelling needle for administering an infusion.
  • the catheter assembly 10 can be used as a peripherally inserted central venous catheter (PICC), a central venous catheter (CV), a midline catheter, etc.
  • PICC peripherally inserted central venous catheter
  • CV central venous catheter
  • midline catheter etc.
  • the catheter assembly 10 includes a catheter member 12, a needle member 14, and a light source 16.
  • the catheter member 12 includes a catheter body 18, a catheter hub 20, and a fixing portion 22.
  • the needle member 14 includes an inner needle 24 and an inner needle hub 26.
  • the catheter body 18 is flexible.
  • the catheter body 18 is a tubular member that can be continuously inserted into the blood vessel 102 of the living body 100.
  • the catheter body 18 extends linearly in its natural state.
  • the catheter body 18 has an inner lumen 28 that extends along the axial direction of the catheter body 18 over its entire length.
  • the inner lumen 28 of the catheter body 18 is connected to an opening 30 at the tip 38 of the catheter body 18.
  • the material of the catheter body 18 is not particularly limited, but a transparent or semi-transparent resin material, particularly a soft resin material, is preferable.
  • the material of the catheter body 18 may be a fluororesin, an olefin resin, a mixture of a fluororesin and an olefin resin, polyurethane, polyester, polyamide, polyether nylon resin, a mixture of an olefin resin and an ethylene-vinyl acetate copolymer, etc.
  • the fluororesin include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and perfluoroalkoxy fluororesin (PFA).
  • the olefin resin include polyethylene and polypropylene.
  • the tip of the catheter body 18 is provided with a light emitting section 34.
  • the light emitting section 34 emits light by receiving light L1 irradiated by the light source 16.
  • the light emitting section 34 may contain a wavelength conversion material.
  • a wavelength conversion material that converts the near-infrared light (light L1) irradiated by the light source 16 into visible light may be used.
  • the light emitting section 34 may contain a luminescent material (phosphorescent material, fluorescent material, etc.).
  • the wavelength conversion material or the luminescent material may be mixed into the constituent material of the light emitting section 34, or may be coated on the surface of the light emitting section 34.
  • the light emitting section 34 may have a reflective structure.
  • the reflective structure may be formed of a reflective material. Examples of the reflective structure include embossing and multi-faceted processing.
  • the reflective material may be mixed into the constituent material of the light emitting section 34, or may be coated on the surface of the light emitting section 34.
  • the parts of the catheter body 18 other than the light-emitting section 34 contain a near-infrared absorbing material. This makes the contrast between the light-emitting section 34 and the other parts of the catheter body 18 clearer. As a result, the visibility of the light-emitting section 34 is further improved.
  • the catheter hub 20 is fixed to the base end of the catheter body 18.
  • the catheter hub 20 is formed in a cylindrical shape.
  • the catheter hub 20 is preferably made of a material harder than the catheter body 18.
  • the material of the catheter hub 20 is not particularly limited.
  • the material of the catheter hub 20 may be a thermoplastic resin such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer, polyurethane, acrylic resin, or ABS resin.
  • one or more push tabs 40 are provided on the outer periphery of the catheter hub 20.
  • the push tabs 40 protrude from the outer periphery of the catheter hub 20 radially outward from the catheter hub 20.
  • the multiple push tabs 40 are arranged at equal intervals along the circumferential direction of the catheter hub 20.
  • the push tab 40 may be provided behind the fixing part 22 (the base end side of the catheter hub 20). In this case, the push tab 40 is arranged at a position somewhat away from the fixing part 22. This prevents the push tab 40 from interfering with the insertion of the light source 16 into the fixing part 22.
  • the fixing part 22 is provided on the outer periphery of the catheter hub 20.
  • the fixing part 22 removably fixes the light source 16 to the catheter hub 20.
  • the fixing part 22 may be formed integrally with the catheter hub 20, or may be attached to the catheter hub 20 later.
  • the fixing part 22 may be made of the same material as the catheter hub 20, or may be made of a different material.
  • the material of the fixing part 22 may be a metal such as aluminum in addition to the non-metals that make up the catheter hub 20.
  • the fixed portion 22 is formed in a cylindrical shape.
  • the fixed portion 22 has a first opening 44, a second opening 46, and a lumen 48.
  • the first opening 44 is located at the tip of the fixed portion 22.
  • the second opening 46 is located at the base end of the fixed portion 22.
  • the lumen 48 communicates with the first opening 44 and the second opening 46.
  • the axis 50 of the lumen 48 is disposed at a position radially offset from the axis 32 of the catheter body 18.
  • the axis 50 of the lumen 48 is also inclined with respect to the axis 32 of the catheter body 18.
  • the axis 50 of the lumen 48 intersects with the light-emitting portion 34 of the catheter body 18 at the intersection 36 on the surface of the light-emitting portion 34.
  • the axis 50 of the lumen 48 intersects with the axis 32 of the catheter body 18 forward of the intersection 36.
  • the intersection 36 between the axis 50 of the lumen 48 and the axis 32 of the catheter body 18 is a predetermined distance D away from the tip 38 of the catheter body 18.
  • the tip 38 is the most distal end of the catheter body 18.
  • the predetermined distance D is preferably 7 mm or less.
  • the predetermined distance D may be determined by the outer diameter R of the catheter body 18.
  • the predetermined distance D may be 6 times or less the outer diameter R of the catheter body 18.
  • the fixing part 22 may have a different form from that of this embodiment.
  • the fixing part 22 may be a magnet attached to each of the light source 16 and the catheter hub 20.
  • the fixing part 22 may be a coupler, hook-and-loop fastener, etc. that connects the catheter hub 20 and the light source 16.
  • the fixing part 22 may have a form that can fix the light source 16 to the catheter hub 20 so that light L1 can be irradiated from the light source 16 toward the light-emitting part 34.
  • the fixing part 22 holds the entire circumference of the light source 16 by surrounding the entire circumference of the light source 16 with the optical axis 54 of the light source 16 as the center, but may also hold a part of the entire circumference of the light source 16.
  • the fixing portion 22 may have an adjustment mechanism 52 that allows the position of the light source 16 to be adjusted.
  • the adjustment mechanism 52 has, for example, two rotation axes that are perpendicular to the axis 32 of the catheter body 18. This allows the adjustment mechanism 52 to rotate the light source 16 in the vertical and horizontal directions.
  • the fixing portion 22 may have a structure that concentrates the light L1 emitted from the light source 16 on the light emitting portion 34.
  • a focusing lens may be attached to the first opening 44.
  • materials that may be used for the focusing lens include glass and acrylic resin.
  • the first opening 44 may be a small hole compared to the inner cavity 48.
  • the inner needle 24 of the needle member 14 is a tubular member having a rigidity that allows it to be punctured into the living body 100.
  • the inner needle 24 extends linearly in its natural state. In the initial state (assembled state) of the catheter assembly 10, the inner needle 24 is inserted into the inner cavity 28 of the catheter body 18 and the inner cavity 29 of the catheter hub 20. Examples of materials that can be used to form the inner needle 24 include metal materials such as stainless steel, aluminum, aluminum alloys, titanium, and titanium alloys.
  • the inner needle 24 is formed to be sufficiently long compared to the catheter body 18. In the initial state of the catheter assembly 10, the inner needle 24 protrudes from the opening 30 of the catheter body 18.
  • the inner needle hub 26 is fixed to the base end of the inner needle 24.
  • the needle member 14 can be removed from the catheter body 18.
  • the inner needle 24 supports the catheter body 18 from the inside while inserted into the lumen 28 of the catheter body 18.
  • the needle member 14 is a puncture assisting member for puncturing the catheter body 18 into the blood vessel 102, and also a support member for supporting the catheter body 18.
  • the light source 16 is detachable from the fixed part 22. As shown in FIG. 2, the light source 16 is inserted into the lumen 48 from the second opening 46 of the fixed part 22. The light source 16 is fixed to the fixed part 22 while inserted into the lumen 48. In this state, the optical axis 54 of the light source 16 overlaps with the axis 50 of the lumen 48. In other words, when the light source 16 is fixed to the fixed part 22, the optical axis 54 of the light source 16 is disposed at a position radially offset from the axis 32 of the catheter body 18. The optical axis 54 of the light source 16 is also inclined with respect to the axis 32 of the catheter body 18.
  • the optical axis 54 of the light source 16 intersects with the light emitting part 34 of the catheter body 18 at the intersection 36 on the surface of the light emitting part 34.
  • the light L1 irradiated from the light source 16 reaches the tip of the catheter body 18 without passing through the base end side of the tip of the catheter body 18.
  • the diameter of the light source 16 is preferably smaller than the diameter of the catheter hub 20. This allows the catheter member 12 to be made smaller.
  • the light source 16 emits light L1 that is directional and has a small orientation angle.
  • the light source 16 may be an LD, an LED, or the like.
  • the light source 16 emits light L1 with a wavelength that passes through the living body 100.
  • the light source 16 emits near-infrared light of 600 nm or more and 2500 nm or less.
  • the light source 16 emits near-infrared light of 700 nm or more and 1400 nm or less. More preferably, the light source 16 emits near-infrared light of 780 nm or more and 940 nm or less.
  • Such near-infrared light is absorbed by hemoglobin in blood.
  • the light source 16 may emit light L1 other than near-infrared light.
  • the light source 16 may be a non-flashing light or a flashing light.
  • the brightness of the light source 16 may be adjustable.
  • the power source for the light source 16 may be a battery, a solar cell, or the like.
  • the power source for the light source 16 may be attached to the catheter hub 20 or may be separate from the catheter hub 20.
  • the power source for the light source 16 may be a wired or wireless power source for the light source 16.
  • the light emitting section 34 of the catheter body 18 emits light by being directly irradiated with light L1 from the light source 16. Therefore, the light L1 irradiated from the light source 16 is not attenuated by other parts of the catheter assembly 10 before reaching the light emitting section 34. In addition, in this embodiment, the light L1 irradiated from the light source 16 does not propagate through the catheter assembly 10. Therefore, the brightness and darkness of the tip of the catheter body 18 inserted into the living body 100 and other parts are clearly distinguished. For this reason, according to this embodiment, it is easy to check whether the tip (light emitting section 34) of the catheter body 18 is placed inside the blood vessel 102.
  • the visibility of the tip (light emitting section 34) of the catheter body 18 is improved.
  • the light source 16 is provided in the catheter assembly 10 itself. Therefore, it is not necessary to connect the catheter assembly 10 and the light source 16 with an optical fiber or the like. Therefore, according to this embodiment, the operability of the catheter assembly 10 is improved.
  • the light source 16 is detachable from the fixed portion 22.
  • the weight of the catheter member 12 can be reduced. This reduces the load on the living body 100 caused by the weight of the catheter member 12.
  • the removed light source 16 can be reused.
  • the removed light source 16 can be attached to an unused catheter assembly 10. In other words, the light source 16 can be reused.
  • the light-emitting unit 34 contains a wavelength conversion material that converts the near-infrared light irradiated by the light source 16 into visible light, so that the user can visually recognize the light emitted by the light-emitting unit 34 with the naked eye.
  • the visibility of the light-emitting section 34 is further improved by the light-emitting section 34 including a light-emitting material (phosphorescent material, fluorescent material, etc.).
  • the visibility of the light-emitting section 34 is further improved by the light-emitting section 34 having a reflective structure.
  • the fixing part 22 and the catheter hub 20 are integrally formed, thereby reducing the number of parts. Also, in this embodiment, the fixing part 22 surrounds the entire circumference of the light source 16, thereby allowing the light source 16 to be stably fixed to the catheter hub 20. Also, in this embodiment, the inner needle 24 is inserted into the lumen 28 of the catheter body 18, allowing the catheter body 18 to be placed in the living body 100 while maintaining the shape of the catheter body 18.
  • the user can confirm the position of the light-emitting unit 34 inside the living body 100 with the naked eye.
  • the near-infrared light irradiated from the light source 16 is wavelength-converted to visible light in the light-emitting unit 34
  • the user can confirm the position of the light-emitting unit 34 with the naked eye.
  • the visible light irradiated from the light source 16 is reflected by the light-emitting unit 34
  • the user can confirm the position of the light-emitting unit 34 with the naked eye.
  • the light L1' emitted from the light-emitting unit 34 is not visible light, the user cannot see the position of the light-emitting unit 34 inside the living body 100 with the naked eye.
  • the light L1' emitted from the light-emitting unit 34 is near-infrared light, the user cannot see the position of the light-emitting unit 34 with the naked eye.
  • a device is needed to visualize the light L1' emitted from the light-emitting unit 34.
  • a catheter visualization system 56 that is used when the light L1' emitted from the light-emitting unit 34 is not visible light is described.
  • FIG. 4 is a diagram of a catheter visualization system 56 using the catheter assembly 10 of FIG. 1.
  • the catheter visualization system 56 includes the catheter assembly 10, a light receiving unit 58, and a display unit 60.
  • the light receiving unit 58 is a camera that captures an image of the living body 100.
  • a CCD camera or the like is used as the light receiving unit 58.
  • the light receiving unit 58 receives light L1' emitted from the living body 100.
  • the light receiving unit 58 receives light L1' that has passed through the living body 100 (transmitted light) from the light emitting unit 34 located inside the living body 100.
  • the light receiving unit 58 creates a received light image 62 based on the received light L1'.
  • the display unit 60 is a monitor that displays the received light image 62, a head-mounted display, or a projector that can project an image onto the skin.
  • FIG. 5 is a first explanatory diagram of the blood vessel puncture procedure of the catheter assembly 10.
  • FIG. 5 shows a state in which the light emitting unit 34 of the catheter body 18 is located inside the living body 100 and outside the blood vessel 102.
  • the light source 16 irradiates light L1 (e.g., near-infrared light) toward the light emitting unit 34.
  • L1 e.g., near-infrared light
  • the light emitting unit 34 emits light in response to receiving light.
  • the light emitting unit 34 may be, for example, a phosphorescent or fluorescent material that receives near-infrared light and emits near-infrared light.
  • the light emitting unit 34 may be a reflective structure that receives and reflects near-infrared light.
  • the light receiving unit 58 receives light L1' (transmitted light) that has passed through the living body 100, out of the light L1' emitted from the light emitting unit 34.
  • the light receiving unit 58 creates a received light image 62.
  • the display unit 60 acquires the received light image 62 from the light receiving unit 58 and displays the received light image 62.
  • the received light image 62 displays an image obtained by the light (transmitted light) L1'.
  • the image obtained by the light (transmitted light) L1' indicates the position of the light emitting unit 34 inside the living body 100.
  • Figure 6 is a second explanatory diagram of the blood vessel puncture procedure of the catheter assembly 10.
  • Figure 6 shows a state in which the light-emitting unit 34 of the catheter body 18 is located inside the living body 100 and inside the blood vessel 102.
  • the light source 16 irradiates light L1 toward the light-emitting unit 34.
  • the tip of the catheter assembly 10 is punctured into the blood vessel 102 inside the living body 100
  • the light L1 irradiated from the light source 16 passes through the living body 100 and reaches the blood vessel 102.
  • the light L1 is near-infrared light
  • the light L1 is absorbed by hemoglobin in the blood flowing through the blood vessel 102. For this reason, the light L1 does not reach the light-emitting unit 34.
  • the light-emitting unit 34 does not receive the light. Then, the image of the light (transmitted light) L1' ( Figure 5) disappears from the received light image 62. In this way, the image obtained by the light (transmitted light) L1' in the received light image 62 transitions from a visible state to an invisible state, indicating that the light emitting portion 34 (tip) of the catheter body 18 is positioned inside the blood vessel 102.
  • the user can see light L1' that is not visible to the naked eye through the display unit 60.
  • FIG. 7 is a configuration diagram of a catheter visualization system 56 of another embodiment different from that of FIG. 4.
  • the catheter visualization system 56 shown in FIG. 7 includes an irradiation unit 66 and a second light receiving unit 68 in addition to the catheter assembly 10, a light receiving unit 58, and a display unit 60.
  • the light L1' emitted by the light emitting unit 34 may be visible light or may be non-visible light (near-infrared light).
  • the irradiation unit 66 irradiates the living body 100 with second light L2 for visualizing the blood vessels 102 inside the living body 100.
  • the second light L2 has a wavelength that transmits through the living body 100.
  • the second light L2 is, for example, near-infrared light. Note that it is preferable that the wavelength of the second light L2 irradiated by the irradiation unit 66 is different from the wavelength of the light L1 irradiated by the light source 16 of the catheter assembly 10.
  • the second light receiving unit 68 is a camera that photographs the living body 100.
  • a CCD camera or the like is used as the second light receiving unit 68.
  • the second light receiving unit 68 receives the second light L2' that is irradiated from the irradiation unit 66 and transmitted through the living body 100.
  • the second light receiving unit 68 is disposed in the direction in which the irradiation unit 66 irradiates the second light L2.
  • the irradiation unit 66 and the second light receiving unit 68 are disposed so as to sandwich the living body 100.
  • the second light receiving unit 68 can receive the second light (second transmitted light) L2' that is transmitted through the living body 100 out of the second light L2 irradiated by the irradiation unit 66.
  • the second light receiving unit 68 creates a second received light image 70 based on the received second light (second transmitted light) L2'.
  • the near-infrared light (second light L2) emitted by the irradiation unit 66 passes through the living body 100, but is absorbed by the hemoglobin in the blood flowing through the blood vessels 102. Therefore, in the second received light image 70 created by the second light receiving unit 68, the blood vessels 102 are displayed dark, and the areas other than the blood vessels 102 are displayed bright.
  • the display unit 60 acquires the received light image 62 from the light receiving unit 58, and acquires the second received light image 70 from the second light receiving unit 68.
  • the display unit 60 combines the received light image 62 and the second received light image 70 to display a combined image 72. Note that the display unit 60 may display the received light image 62 and the second received light image 70 separately.
  • the user can check the relative position between the tip of the catheter body 18 and the blood vessel 102.
  • FIG. 8 is a configuration diagram of a catheter visualization system 56 of another embodiment different from those of FIGS. 4 and 7.
  • a single light receiving unit 58 may be provided. That is, the light receiving unit 58 may receive light (transmitted light) L1', L2'.
  • the light receiving unit 58 has a detection wavelength that includes the wavelength of light L1' and the wavelength of the second light L2'.
  • the present invention is not limited to the above disclosure, and various configurations may be adopted without departing from the gist of the present invention.

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Abstract

A catheter assembly (10) comprises: a catheter member (12) having a catheter body (18) and a catheter hub (20); a light source (16) for emitting light (L1) towards a tip portion of the catheter body (18); a fixing part (22) for fixing the light source (16) to the catheter hub (20); and a support member (needle member (14)) for supporting the catheter body (18). At the tip portion of the catheter body (18), a light-emitting part (34) is provided, which emits light upon receiving the light. The fixing part (22) fixes the light source (16) so that the optical axis (54) of the light source (16) is tilted relative to the axis (32) of the catheter body (18).

Description

カテーテル組立体及びカテーテル視認システムCatheter assembly and catheter visualization system
　本発明は、カテーテル組立体及びカテーテル視認システムに関する。 The present invention relates to a catheter assembly and a catheter visualization system.
　特開２０１３－９９４９号公報には、透明なカテーテル筐体、誘導針、針筐体及び光源結合器を有するカテーテルが開示される。カテーテル筐体は、誘導針の先端が外部に露出するように、誘導針を覆う。針筐体は、誘導針の基端と光源結合器とが相対するように、誘導針及び光源結合器を支持する。光源結合器は、光ファイバを介して照明器に接続される。照明器から照射される光は、光ファイバを伝播して光源結合器から放射される。光源結合器から放射された光は、誘導針を覆うカテーテル筐体を伝播する。これにより、透明なカテーテル筐体が発光する。 JP 2013-9949 A discloses a catheter having a transparent catheter housing, an introducer needle, a needle housing, and a light source coupler. The catheter housing covers the introducer needle so that the tip of the introducer needle is exposed to the outside. The needle housing supports the introducer needle and the light source coupler so that the base end of the introducer needle and the light source coupler face each other. The light source coupler is connected to an illuminator via an optical fiber. Light emitted from the illuminator propagates through the optical fiber and is emitted from the light source coupler. The light emitted from the light source coupler propagates through the catheter housing that covers the introducer needle. This causes the transparent catheter housing to emit light.
　特開２０１３－９９４９号公報のカテーテルは、光ファイバに接続される。光ファイバは、カテーテルの操作性を制限する。また、特開２０１３－９９４９号公報のカテーテルにおいては、カテーテル筐体の全体が発光する。このため、カテーテルの先端部とその他の部分との区別が困難になり、先端部の血管確保が視認しづらくなる。さらに、光源結合器から放出される光は、カテーテルの先端に到達するまでの光伝播経路で減衰する。このため、カテーテルの先端部において充分な光量が得られない。こうしたことから、特開２０１３－９９４９号公報のカテーテルは、先端部の視認性が悪い。 The catheter of JP 2013-9949 A is connected to an optical fiber. The optical fiber limits the operability of the catheter. Furthermore, in the catheter of JP 2013-9949 A, the entire catheter housing emits light. This makes it difficult to distinguish between the tip of the catheter and the rest of the catheter, making it difficult to visually confirm the blood vessel being secured at the tip. Furthermore, the light emitted from the light source coupler is attenuated along the light propagation path until it reaches the tip of the catheter. This makes it difficult to obtain a sufficient amount of light at the tip of the catheter. For these reasons, the catheter of JP 2013-9949 A has poor visibility at the tip.
　本発明は上述した課題を解決することを目的とする。 The present invention aims to solve the above-mentioned problems.
　（１）本発明のカテーテル組立体は、カテーテル本体と、前記カテーテル本体の基端部に固定されるカテーテルハブとを有するカテーテル部材と、前記カテーテル本体の先端部に向けて光を照射する光源と、前記光源を前記カテーテルハブに固定する固定部と、前記カテーテル本体から抜去可能に前記カテーテル本体に挿入され、前記カテーテル本体を支持する支持部材と、を備え、前記カテーテル本体の前記先端部には、受光に伴い発光する発光部が設けられ、前記固定部は、前記光源の光軸が前記カテーテル本体の軸線に対して傾斜するように、前記光源を固定する。 (1) The catheter assembly of the present invention comprises a catheter member having a catheter body and a catheter hub fixed to the base end of the catheter body, a light source that irradiates light toward the tip end of the catheter body, a fixing part that fixes the light source to the catheter hub, and a support member that is inserted into the catheter body so as to be removable from the catheter body and supports the catheter body, and a light emitting part that emits light in response to receiving light is provided at the tip end of the catheter body, and the fixing part fixes the light source so that the optical axis of the light source is inclined with respect to the axis of the catheter body.
　上記構成において、カテーテル本体の発光部は、光源から直接光が照射されることによって発光する。このため、光源から照射される光は、発光部に到達するまでにカテーテル組立体の他の部分で減衰しない。また、上記構成においては、光源から照射される光は、カテーテル組立体を伝播しない。このため、生体に穿刺されたカテーテル本体の先端部とその他の部分との明暗が明確になる。こうしたことから、上記構成によれば、カテーテル本体の先端部（発光部）の視認性が向上する。また、上記構成においては、カテーテル組立体自体に光源が設けられる。このため、カテーテル組立体と光源とを光ファイバ等で接続する必要がない。したがって、上記構成によれば、カテーテル組立体の操作性が向上する。 In the above configuration, the light-emitting portion of the catheter body emits light when directly irradiated with light from the light source. Therefore, the light irradiated from the light source is not attenuated by other parts of the catheter assembly before reaching the light-emitting portion. Furthermore, in the above configuration, the light irradiated from the light source does not propagate through the catheter assembly. Therefore, the difference between the brightness of the tip of the catheter body inserted into the living body and the other parts is clear. For this reason, the above configuration improves the visibility of the tip (light-emitting portion) of the catheter body. Furthermore, in the above configuration, the light source is provided in the catheter assembly itself. Therefore, there is no need to connect the catheter assembly and the light source with an optical fiber or the like. Therefore, the above configuration improves the operability of the catheter assembly.
　（２）上記項目（１）に記載のカテーテル組立体において、前記固定部は、前記光源の前記光軸と前記カテーテル本体の前記軸線とが交差するように、前記光源を固定してもよい。 (2) In the catheter assembly described in item (1) above, the fixing portion may fix the light source so that the optical axis of the light source intersects with the axis of the catheter body.
　上記構成によれば、選択的にカテーテル本体の先端部を照射することができる。そのため、カテーテル本体の先端部が血管の内部に配置されたか否かを確認しやすくなる。 The above configuration allows selective illumination of the tip of the catheter body. This makes it easier to check whether the tip of the catheter body is positioned inside the blood vessel.
　（３）上記項目（１）又は（２）に記載のカテーテル組立体において、前記固定部は、前記光源を前記カテーテルハブに対して着脱可能に固定してもよい。 (3) In the catheter assembly described in item (1) or (2) above, the fixing part may removably fix the light source to the catheter hub.
　上記構成によれば、カテーテル部材が生体に留置された状態で、カテーテルハブから光源を取り外すことができる。このため、光源を再利用することができる。また、上記構成によれば、生体に留置されたカテーテル部材の重量を軽くすることができる。このため、カテーテル部材の重量に起因する生体への負荷を低減することができる。 With the above configuration, the light source can be removed from the catheter hub while the catheter member is placed in the living body. This allows the light source to be reused. Furthermore, with the above configuration, the weight of the catheter member placed in the living body can be reduced. This allows the load on the living body caused by the weight of the catheter member to be reduced.
　（４）上記項目（１）～（３）のいずれか１つに記載のカテーテル組立体において、前記光源は、近赤外光を照射してもよい。 (4) In the catheter assembly described in any one of items (1) to (3) above, the light source may emit near-infrared light.
　上記構成によれば、血液に吸収される近赤外光を使用するため、カテーテル本体の先端部（発光部）が血管の内部に配置されたか否かを確認しやすくなる。 The above configuration uses near-infrared light that is absorbed by blood, making it easier to confirm whether the tip of the catheter body (light-emitting part) is positioned inside a blood vessel.
　（５）上記項目（４）に記載のカテーテル組立体において、前記発光部は、前記光源によって照射される前記近赤外光を可視光に変換する波長変換材料を含んでもよい。 (5) In the catheter assembly described in item (4) above, the light-emitting section may include a wavelength conversion material that converts the near-infrared light irradiated by the light source into visible light.
　上記構成によれば、発光部における発光をユーザが肉眼で視認することができる。 With the above configuration, the user can see the light emitted from the light-emitting section with the naked eye.
　（６）上記項目（１）～（５）のいずれか１つに記載のカテーテル組立体において、前記発光部は、燐光材又は蛍光材を含んでもよい。 (6) In the catheter assembly described in any one of items (1) to (5) above, the light-emitting portion may include a phosphorescent material or a fluorescent material.
　上記構成によれば、カテーテル本体の先端部（発光部）の視認性がより向上する。 The above configuration improves visibility of the tip (light-emitting portion) of the catheter body.
　（７）上記項目（１）～（５）のいずれか１つに記載のカテーテル組立体において、前記発光部は、前記光源によって照射される光を反射する反射構造を有してもよい。 (7) In the catheter assembly described in any one of items (1) to (5) above, the light-emitting section may have a reflective structure that reflects the light irradiated by the light source.
　上記構成によれば、カテーテル本体の先端部（発光部）の視認性がより向上する。 The above configuration improves visibility of the tip (light-emitting portion) of the catheter body.
　（８）上記項目（１）～（７）のいずれか１つに記載のカテーテル組立体において、前記固定部と前記カテーテルハブとが一体に形成されてもよい。 (8) In the catheter assembly described in any one of items (1) to (7) above, the fixing portion and the catheter hub may be formed integrally.
　上記構成によれば、部品点数を減らすことができる。 The above configuration allows for a reduction in the number of parts.
　（９）上記項目（１）～（８）のいずれか１つに記載のカテーテル組立体において、前記固定部は、前記光源の前記光軸を中心として前記光源の全周を囲んでもよい。 (9) In the catheter assembly described in any one of items (1) to (8) above, the fixing portion may surround the entire circumference of the light source with the optical axis of the light source as the center.
　上記構成によれば、カテーテルハブに対して光源を安定して固定することができる。 The above configuration allows the light source to be stably fixed to the catheter hub.
　（１０）上記項目（１）～（９）のいずれか１つに記載のカテーテル組立体において、前記支持部材は、前記カテーテル本体の内腔に挿通される内針と、前記内針の基端に固定される内針ハブとを有してもよい。 (10) In the catheter assembly described in any one of items (1) to (9) above, the support member may have an inner needle that is inserted into the lumen of the catheter body, and an inner needle hub that is fixed to the base end of the inner needle.
　上記構成によれば、カテーテル本体の形状を維持したまま、生体にカテーテル本体を留置することができる。 The above configuration allows the catheter body to be placed in the living body while maintaining its shape.
　（１１）上記項目（１）～（１０）のいずれか１つに記載のカテーテル組立体において、前記カテーテル本体の先端から前記光源の前記光軸と前記カテーテル本体の前記軸線との交点までの距離は、７ｍｍ以下、又は、前記カテーテル本体の外径の６倍以下であってもよい。 (11) In the catheter assembly described in any one of items (1) to (10) above, the distance from the tip of the catheter body to the intersection of the optical axis of the light source and the axis of the catheter body may be 7 mm or less, or 6 times the outer diameter of the catheter body or less.
　上記構成によれば、カテーテル本体の先端部を発光させることができる。 The above configuration allows the tip of the catheter body to emit light.
　（１２）本発明のカテーテル視認システムは、上記項目（１）～（１１）のいずれか１つに記載のカテーテル組立体と、生体の内部に前記発光部が位置するときに前記発光部によって発せられた光のうち、前記生体を透過した透過光を受光する受光部と、前記受光部によって受光された前記透過光によって得られた像を表示する表示部と、を備える。 (12) The catheter visualization system of the present invention comprises a catheter assembly according to any one of items (1) to (11) above, a light receiving unit that receives transmitted light that has passed through a living body and is emitted by the light emitting unit when the light emitting unit is located inside the living body, and a display unit that displays an image obtained by the transmitted light received by the light receiving unit.
　上記構成によれば、表示部を介して肉眼で視認できない光を視認することができる。 The above configuration allows light that cannot be seen with the naked eye to be seen through the display unit.
　（１３）上記項目（１２）に記載のカテーテル視認システムにおいて、前記生体の内部の血管を可視化するための第２の光を前記生体に照射する照射部と、前記照射部によって照射された前記第２の光のうち、前記生体を透過した第２の透過光を受光する第２の受光部とを備え、前記表示部は、前記受光部によって受光された前記透過光によって得られた像と、前記第２の受光部によって受光された前記第２の透過光によって得られた像とを個別に又は合成して表示してもよい。 (13) The catheter visualization system described in item (12) above includes an irradiation unit that irradiates the living body with a second light for visualizing blood vessels inside the living body, and a second light receiving unit that receives second transmitted light that has passed through the living body from the second light irradiated by the irradiation unit, and the display unit may display an image obtained by the transmitted light received by the light receiving unit and an image obtained by the second transmitted light received by the second light receiving unit, either individually or in combination.
　上記構成によれば、カテーテル本体の先端部と血管との相対位置を確認することができる。 The above configuration makes it possible to check the relative position of the tip of the catheter body and the blood vessel.
　（１４）上記項目（１２）に記載のカテーテル視認システムにおいて、前記生体の内部の血管を可視化するための第２の光を前記生体に照射する照射部を備え、前記受光部は、前記照射部によって照射された前記第２の光のうち、前記生体を透過した第２の透過光を受光し、前記表示部は、前記受光部によって受光された前記透過光によって得られた像及び前記受光部によって受光された前記第２の透過光によって得られた像を表示してもよい。 (14) In the catheter visualization system described in item (12) above, an irradiation unit may be provided that irradiates the living body with a second light for visualizing blood vessels inside the living body, the light receiving unit may receive a second transmitted light that has passed through the living body out of the second light irradiated by the irradiation unit, and the display unit may display an image obtained by the transmitted light received by the light receiving unit and an image obtained by the second transmitted light received by the light receiving unit.
　上記構成によれば、カテーテル本体の先端部と血管との相対位置を確認することができる。 The above configuration makes it possible to check the relative position of the tip of the catheter body and the blood vessel.
　（１５）上記項目（１３）に記載のカテーテル視認システムにおいて、前記照射部と前記第２の受光部とは、前記生体内に位置する前記発光部を挟むように配置されてもよい。 (15) In the catheter visualization system described in item (13) above, the irradiation unit and the second light receiving unit may be arranged to sandwich the light emitting unit located inside the living body.
　本発明によれば、カテーテルの先端部の視認性が向上する。 The present invention improves visibility of the catheter tip.
図１は、本発明の一実施形態に係るカテーテル組立体の概略構成図である。FIG. 1 is a schematic diagram of a catheter assembly according to one embodiment of the present invention. 図２は、図１のカテーテル組立体の分解斜視図である。FIG. 2 is an exploded perspective view of the catheter assembly of FIG. 図３は、カテーテル組立体の別実施形態の概略構成図である。FIG. 3 is a schematic diagram of another embodiment of the catheter assembly. 図４は、図１のカテーテル組立体を使用したカテーテル視認システムの構成図である。FIG. 4 is a diagram showing the configuration of a catheter visualization system using the catheter assembly of FIG. 図５は、カテーテル組立体の血管穿刺手技の第１説明図である。FIG. 5 is a first explanatory view of a blood vessel puncture procedure using the catheter assembly. 図６は、カテーテル組立体の血管穿刺手技の第２説明図である。FIG. 6 is a second explanatory view of a blood vessel puncture procedure using the catheter assembly. 図７は、図４とは別実施形態のカテーテル視認システムの構成図である。FIG. 7 is a configuration diagram of a catheter visualization system according to another embodiment different from that shown in FIG. 図８は、図４及び図７とは別実施形態のカテーテル視認システムの構成図である。FIG. 8 is a configuration diagram of a catheter visualization system according to another embodiment different from those shown in FIGS.
　図１は、本発明の一実施形態に係るカテーテル組立体１０の概略構成図である。図２は、図１のカテーテル組立体１０の分解斜視図である。カテーテル組立体１０は、例えば、生体１００（図５）の血管１０２（図５）の内部に輸液（薬液）を投与するための留置針として構成されている。ただし、カテーテル組立体１０は、輸液を投与する留置針に限定されない。具体的には、カテーテル組立体１０は、末梢挿入型中心静脈カテーテル（ＰＩＣＣ）、中心静脈カテーテル（ＣＶ）、ミッドラインカテーテル等として使用され得る。 FIG. 1 is a schematic diagram of a catheter assembly 10 according to one embodiment of the present invention. FIG. 2 is an exploded perspective view of the catheter assembly 10 of FIG. 1. The catheter assembly 10 is configured as an indwelling needle for administering an infusion (medicinal solution) into a blood vessel 102 (FIG. 5) of a living body 100 (FIG. 5), for example. However, the catheter assembly 10 is not limited to an indwelling needle for administering an infusion. Specifically, the catheter assembly 10 can be used as a peripherally inserted central venous catheter (PICC), a central venous catheter (CV), a midline catheter, etc.
　図１及び図２に示すように、カテーテル組立体１０は、カテーテル部材１２と、針部材１４と、光源１６とを備える。カテーテル部材１２は、カテーテル本体１８と、カテーテルハブ２０と、固定部２２とを有する。針部材１４は、内針２４と、内針ハブ２６とを有する。 As shown in Figures 1 and 2, the catheter assembly 10 includes a catheter member 12, a needle member 14, and a light source 16. The catheter member 12 includes a catheter body 18, a catheter hub 20, and a fixing portion 22. The needle member 14 includes an inner needle 24 and an inner needle hub 26.
　カテーテル本体１８は、可撓性を有する。カテーテル本体１８は、生体１００の血管１０２の内部に持続して挿入可能な管状部材である。カテーテル本体１８は、自然状態で直線状に延在する。カテーテル本体１８は、その全長に亘ってカテーテル本体１８の軸線方向に沿って延在した内腔２８を有する。カテーテル本体１８の内腔２８は、カテーテル本体１８の先端３８の開口部３０に連通している。 The catheter body 18 is flexible. The catheter body 18 is a tubular member that can be continuously inserted into the blood vessel 102 of the living body 100. The catheter body 18 extends linearly in its natural state. The catheter body 18 has an inner lumen 28 that extends along the axial direction of the catheter body 18 over its entire length. The inner lumen 28 of the catheter body 18 is connected to an opening 30 at the tip 38 of the catheter body 18.
　カテーテル本体１８の構成材料は、特に限定されるものではないが、透明性又は半透明性を有する樹脂材料、特に軟質樹脂材料が好適である。例えば、カテーテル本体１８の構成材料としては、フッ素系樹脂、オレフィン系樹脂、フッ素系樹脂とオレフィン系樹脂との混合物、ポリウレタン、ポリエステル、ポリアミド、ポリエーテルナイロン樹脂、オレフィン系樹脂とエチレン－酢酸ビニル共重合体との混合物等が挙げられる。フッ素系樹脂としては、ポリテトラフルオロエチレン（ＰＴＦＥ）、エチレン・テトラフルオロエチレン共重合体（ＥＴＦＥ）、ペルフルオロアルコキシフッ素樹脂（ＰＦＡ）等が挙げられる。オレフィン系樹脂としては、ポリエチレン、ポリプロピレン等が挙げられる。 The material of the catheter body 18 is not particularly limited, but a transparent or semi-transparent resin material, particularly a soft resin material, is preferable. For example, the material of the catheter body 18 may be a fluororesin, an olefin resin, a mixture of a fluororesin and an olefin resin, polyurethane, polyester, polyamide, polyether nylon resin, a mixture of an olefin resin and an ethylene-vinyl acetate copolymer, etc. Examples of the fluororesin include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and perfluoroalkoxy fluororesin (PFA). Examples of the olefin resin include polyethylene and polypropylene.
　カテーテル本体１８の先端部には、発光部３４が設けられている。発光部３４は、光源１６によって照射される光Ｌ１を受光することによって発光する。発光部３４は、波長変換材料を含んでいてもよい。例えば、光源１６が照射する近赤外光（光Ｌ１）を可視光に変換する波長変換材料が用いられてもよい。発光部３４は、発光材（燐光材、蛍光材等）を含んでいてもよい。波長変換材料又は発光材は、発光部３４の構成材料に混錬されてもよいし、発光部３４の表面にコーティングされてもよい。発光部３４は、反射構造を有してもよい。反射構造は、反射材によって形成されていてもよい。反射構造は、例えばシボ加工、多面加工等が挙げられる。また、反射材は、発光部３４の構成材料に混錬されてもよいし、発光部３４の表面にコーティングされてもよい。 The tip of the catheter body 18 is provided with a light emitting section 34. The light emitting section 34 emits light by receiving light L1 irradiated by the light source 16. The light emitting section 34 may contain a wavelength conversion material. For example, a wavelength conversion material that converts the near-infrared light (light L1) irradiated by the light source 16 into visible light may be used. The light emitting section 34 may contain a luminescent material (phosphorescent material, fluorescent material, etc.). The wavelength conversion material or the luminescent material may be mixed into the constituent material of the light emitting section 34, or may be coated on the surface of the light emitting section 34. The light emitting section 34 may have a reflective structure. The reflective structure may be formed of a reflective material. Examples of the reflective structure include embossing and multi-faceted processing. The reflective material may be mixed into the constituent material of the light emitting section 34, or may be coated on the surface of the light emitting section 34.
　一方、カテーテル本体１８のうち、発光部３４以外の部分は、近赤外吸収材料を含むことが好ましい。これにより、カテーテル本体１８のうち、発光部３４とそれ以外の部分との明暗が明確になる。結果として、発光部３４の視認性がより向上する。 On the other hand, it is preferable that the parts of the catheter body 18 other than the light-emitting section 34 contain a near-infrared absorbing material. This makes the contrast between the light-emitting section 34 and the other parts of the catheter body 18 clearer. As a result, the visibility of the light-emitting section 34 is further improved.
　カテーテルハブ２０は、カテーテル本体１８の基端部に固定されている。カテーテルハブ２０は、円筒状に形成されている。カテーテルハブ２０は、カテーテル本体１８よりも硬い材料によって構成されることが好ましい。カテーテルハブ２０の構成材料は、特に限定されるものではない。例えば、カテーテルハブ２０の構成材料としては、ポリプロピレン、ポリカーボネート、ポリアミド、ポリサルホン、ポリアリレート、メタクリレート－ブチレン－スチレン共重合体、ポリウレタン、アクリル樹脂、ＡＢＳ樹脂等の熱可塑性樹脂が挙げられる。 The catheter hub 20 is fixed to the base end of the catheter body 18. The catheter hub 20 is formed in a cylindrical shape. The catheter hub 20 is preferably made of a material harder than the catheter body 18. The material of the catheter hub 20 is not particularly limited. For example, the material of the catheter hub 20 may be a thermoplastic resin such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer, polyurethane, acrylic resin, or ABS resin.
　カテーテルハブ２０の外周部には、１以上のプッシュタブ４０が設けられていることが好ましい。プッシュタブ４０は、カテーテルハブ２０の外周部から、カテーテルハブ２０の径方向外側に突出する。プッシュタブ４０が複数設けられる場合、複数のプッシュタブ４０は、カテーテルハブ２０の周方向に沿って等間隔に配置されることが好ましい。なお、プッシュタブ４０は、固定部２２の後方（カテーテルハブ２０の基端側）に設けられてもよい。この場合、プッシュタブ４０は、固定部２２からある程度離れた部位に配置される。これにより、プッシュタブ４０が固定部２２への光源１６の挿入を妨げることがなくなる。 It is preferable that one or more push tabs 40 are provided on the outer periphery of the catheter hub 20. The push tabs 40 protrude from the outer periphery of the catheter hub 20 radially outward from the catheter hub 20. When multiple push tabs 40 are provided, it is preferable that the multiple push tabs 40 are arranged at equal intervals along the circumferential direction of the catheter hub 20. The push tab 40 may be provided behind the fixing part 22 (the base end side of the catheter hub 20). In this case, the push tab 40 is arranged at a position somewhat away from the fixing part 22. This prevents the push tab 40 from interfering with the insertion of the light source 16 into the fixing part 22.
　固定部２２は、カテーテルハブ２０の外周部に設けられている。固定部２２は、光源１６をカテーテルハブ２０に対して着脱可能に固定する。固定部２２は、カテーテルハブ２０と一体に形成されてもよいし、カテーテルハブ２０に対して後付けされてもよい。固定部２２は、カテーテルハブ２０と同じ材料によって構成されてもよいし、別の材料によって構成されてもよい。例えば、固定部２２の材料は、カテーテルハブ２０を構成する非金属以外に、アルミニウム等の金属であってもよい。 The fixing part 22 is provided on the outer periphery of the catheter hub 20. The fixing part 22 removably fixes the light source 16 to the catheter hub 20. The fixing part 22 may be formed integrally with the catheter hub 20, or may be attached to the catheter hub 20 later. The fixing part 22 may be made of the same material as the catheter hub 20, or may be made of a different material. For example, the material of the fixing part 22 may be a metal such as aluminum in addition to the non-metals that make up the catheter hub 20.
　固定部２２は、筒状に形成されている。固定部２２は、第１開口部４４と第２開口部４６と内腔４８とを有する。第１開口部４４は、固定部２２の先端に位置する。第２開口部４６は、固定部２２の基端に位置する。内腔４８は、第１開口部４４と第２開口部４６とを連通する。内腔４８の軸線５０は、カテーテル本体１８の軸線３２から径方向にオフセットした位置に配置される。また、内腔４８の軸線５０は、カテーテル本体１８の軸線３２に対して傾斜する。さらに、内腔４８の軸線５０は、カテーテル本体１８の発光部３４と、発光部３４の表面の交点３６で交差する。好ましくは、内腔４８の軸線５０は、交点３６の前方で、カテーテル本体１８の軸線３２と交差する。ただし、内腔４８の軸線５０とカテーテル本体１８の軸線３２とが交差することは必須ではない。 The fixed portion 22 is formed in a cylindrical shape. The fixed portion 22 has a first opening 44, a second opening 46, and a lumen 48. The first opening 44 is located at the tip of the fixed portion 22. The second opening 46 is located at the base end of the fixed portion 22. The lumen 48 communicates with the first opening 44 and the second opening 46. The axis 50 of the lumen 48 is disposed at a position radially offset from the axis 32 of the catheter body 18. The axis 50 of the lumen 48 is also inclined with respect to the axis 32 of the catheter body 18. Furthermore, the axis 50 of the lumen 48 intersects with the light-emitting portion 34 of the catheter body 18 at the intersection 36 on the surface of the light-emitting portion 34. Preferably, the axis 50 of the lumen 48 intersects with the axis 32 of the catheter body 18 forward of the intersection 36. However, it is not essential that the axis 50 of the lumen 48 and the axis 32 of the catheter body 18 intersect.
　内腔４８の軸線５０とカテーテル本体１８の軸線３２との交点３６は、カテーテル本体１８の先端３８から所定距離Ｄだけ離れている。先端３８は、カテーテル本体１８の最先端である。所定距離Ｄは、７ｍｍ以下であることが好ましい。又は、所定距離Ｄは、カテーテル本体１８の外径Ｒによって定められてもよい。例えば、所定距離Ｄは、カテーテル本体１８の外径Ｒの６倍以下であってもよい。内腔４８の軸線５０とカテーテル本体１８の軸線３２との交点３６が上記の範囲に位置することによって、カテーテル本体１８の先端部を発光させることができる。 The intersection 36 between the axis 50 of the lumen 48 and the axis 32 of the catheter body 18 is a predetermined distance D away from the tip 38 of the catheter body 18. The tip 38 is the most distal end of the catheter body 18. The predetermined distance D is preferably 7 mm or less. Alternatively, the predetermined distance D may be determined by the outer diameter R of the catheter body 18. For example, the predetermined distance D may be 6 times or less the outer diameter R of the catheter body 18. By positioning the intersection 36 between the axis 50 of the lumen 48 and the axis 32 of the catheter body 18 within the above range, the tip of the catheter body 18 can be made to emit light.
　なお、固定部２２は、本実施形態とは別の形態であってもよい。例えば、固定部２２は、光源１６とカテーテルハブ２０の各々に取り付けられた磁石であってもよい。例えば、固定部２２は、カテーテルハブ２０と光源１６とを接続するカプラ、面ファスナ等であってもよい。要するに、固定部２２は、光源１６から発光部３４に向けて光Ｌ１を照射できるように、カテーテルハブ２０に光源１６を固定することができる形態であればよい。本実施形態において、固定部２２は、光源１６の光軸５４を中心として光源１６の全周を囲むことによって光源１６の全周を保持するが、光源１６の全周のうちの一部を保持してもよい。 The fixing part 22 may have a different form from that of this embodiment. For example, the fixing part 22 may be a magnet attached to each of the light source 16 and the catheter hub 20. For example, the fixing part 22 may be a coupler, hook-and-loop fastener, etc. that connects the catheter hub 20 and the light source 16. In short, the fixing part 22 may have a form that can fix the light source 16 to the catheter hub 20 so that light L1 can be irradiated from the light source 16 toward the light-emitting part 34. In this embodiment, the fixing part 22 holds the entire circumference of the light source 16 by surrounding the entire circumference of the light source 16 with the optical axis 54 of the light source 16 as the center, but may also hold a part of the entire circumference of the light source 16.
　図３に示すように、固定部２２は、光源１６の姿勢を調整可能とする調整機構５２を有してもよい。調整機構５２は、例えばカテーテル本体１８の軸線３２と直交する２つの回転軸を有する。これにより、調整機構５２は、光源１６を上下方向及び左右方向に回転させることができる。 As shown in FIG. 3, the fixing portion 22 may have an adjustment mechanism 52 that allows the position of the light source 16 to be adjusted. The adjustment mechanism 52 has, for example, two rotation axes that are perpendicular to the axis 32 of the catheter body 18. This allows the adjustment mechanism 52 to rotate the light source 16 in the vertical and horizontal directions.
　固定部２２は、光源１６から照射される光Ｌ１を発光部３４に集中させる構造を有してもよい。例えば、第１開口部４４に集光レンズが取り付けられていてもよい。集光レンズの構成材料としては、ガラス、アクリル樹脂等が挙げられる。又は、第１開口部４４が内腔４８と比較して小さな孔であってもよい。 The fixing portion 22 may have a structure that concentrates the light L1 emitted from the light source 16 on the light emitting portion 34. For example, a focusing lens may be attached to the first opening 44. Examples of materials that may be used for the focusing lens include glass and acrylic resin. Alternatively, the first opening 44 may be a small hole compared to the inner cavity 48.
　針部材１４の内針２４は、生体１００に穿刺可能な剛性を有する管状部材である。内針２４は、自然状態で直線状に延在する。内針２４は、カテーテル組立体１０の初期状態（組立状態）で、カテーテル本体１８の内腔２８及びカテーテルハブ２０の内腔２９に挿通される。内針２４の構成材料としては、例えば、ステンレス鋼、アルミニウム、アルミニウム合金、チタン、チタン合金等の金属材料が挙げられる。内針２４は、カテーテル本体１８に比べて充分に長く形成されている。内針２４は、カテーテル組立体１０の初期状態においてカテーテル本体１８の開口部３０から突出している。内針ハブ２６は、内針２４の基端部に固着されている。 The inner needle 24 of the needle member 14 is a tubular member having a rigidity that allows it to be punctured into the living body 100. The inner needle 24 extends linearly in its natural state. In the initial state (assembled state) of the catheter assembly 10, the inner needle 24 is inserted into the inner cavity 28 of the catheter body 18 and the inner cavity 29 of the catheter hub 20. Examples of materials that can be used to form the inner needle 24 include metal materials such as stainless steel, aluminum, aluminum alloys, titanium, and titanium alloys. The inner needle 24 is formed to be sufficiently long compared to the catheter body 18. In the initial state of the catheter assembly 10, the inner needle 24 protrudes from the opening 30 of the catheter body 18. The inner needle hub 26 is fixed to the base end of the inner needle 24.
　針部材１４は、カテーテル本体１８から抜去可能である。内針２４は、カテーテル本体１８の内腔２８に挿入された状態で、カテーテル本体１８を内側から支持する。つまり、針部材１４は、カテーテル本体１８を血管１０２の内部に穿刺するための穿刺補助部材であり、且つ、カテーテル本体１８を支持する支持部材でもある。 The needle member 14 can be removed from the catheter body 18. The inner needle 24 supports the catheter body 18 from the inside while inserted into the lumen 28 of the catheter body 18. In other words, the needle member 14 is a puncture assisting member for puncturing the catheter body 18 into the blood vessel 102, and also a support member for supporting the catheter body 18.
　光源１６は、固定部２２に対して着脱可能である。図２に示されるように、光源１６は、固定部２２の第２開口部４６から内腔４８に挿入される。光源１６は、内腔４８に挿入された状態で固定部２２に固定される。この状態で、光源１６の光軸５４と内腔４８の軸線５０とは重なり合う。つまり、光源１６が固定部２２に固定された状態で、光源１６の光軸５４は、カテーテル本体１８の軸線３２から径方向にオフセットした位置に配置される。また、光源１６の光軸５４は、カテーテル本体１８の軸線３２に対して傾斜する。さらに、光源１６の光軸５４は、カテーテル本体１８の発光部３４と、発光部３４の表面の交点３６で交差する。これにより、光源１６から照射される光Ｌ１は、カテーテル本体１８の先端部よりも基端側を経由することなく、カテーテル本体１８の先端部に到達する。光源１６の直径は、カテーテルハブ２０の直径よりも小さいことが好ましい。これにより、カテーテル部材１２の小型化が可能となる。 The light source 16 is detachable from the fixed part 22. As shown in FIG. 2, the light source 16 is inserted into the lumen 48 from the second opening 46 of the fixed part 22. The light source 16 is fixed to the fixed part 22 while inserted into the lumen 48. In this state, the optical axis 54 of the light source 16 overlaps with the axis 50 of the lumen 48. In other words, when the light source 16 is fixed to the fixed part 22, the optical axis 54 of the light source 16 is disposed at a position radially offset from the axis 32 of the catheter body 18. The optical axis 54 of the light source 16 is also inclined with respect to the axis 32 of the catheter body 18. Furthermore, the optical axis 54 of the light source 16 intersects with the light emitting part 34 of the catheter body 18 at the intersection 36 on the surface of the light emitting part 34. As a result, the light L1 irradiated from the light source 16 reaches the tip of the catheter body 18 without passing through the base end side of the tip of the catheter body 18. The diameter of the light source 16 is preferably smaller than the diameter of the catheter hub 20. This allows the catheter member 12 to be made smaller.
　光源１６は、指向性を有し且つ配向角度が小さい光Ｌ１を照射する。例えば、光源１６としては、ＬＤ、ＬＥＤ等が挙げられる。光源１６は、生体１００を透過する波長の光Ｌ１を照射する。具体的には、光源１６は、６００ｎｍ以上２５００ｎｍ以下の近赤外光を照射する。好ましくは、光源１６は、７００ｎｍ以上１４００ｎｍ以下の近赤外光を照射する。さらに好ましくは、光源１６は、７８０ｎｍ以上９４０ｎｍ以下の近赤外光を照射する。このような近赤外光は、血液のヘモグロビンに吸収される。ただし、光源１６は、近赤外光以外の光Ｌ１を照射してもよい。 The light source 16 emits light L1 that is directional and has a small orientation angle. For example, the light source 16 may be an LD, an LED, or the like. The light source 16 emits light L1 with a wavelength that passes through the living body 100. Specifically, the light source 16 emits near-infrared light of 600 nm or more and 2500 nm or less. Preferably, the light source 16 emits near-infrared light of 700 nm or more and 1400 nm or less. More preferably, the light source 16 emits near-infrared light of 780 nm or more and 940 nm or less. Such near-infrared light is absorbed by hemoglobin in blood. However, the light source 16 may emit light L1 other than near-infrared light.
　光源１６は、非点滅光であってもよいし、点滅光であってもよい。また、光源１６の輝度は、調整可能であってもよい。光源１６の電源としては、バッテリ、太陽電池等が挙げられる。光源１６の電源は、カテーテルハブ２０に取り付けられてもよいし、カテーテルハブ２０から離れていてもよい。光源１６の電源は、光源１６に対して有線で給電してもよいし、無線で給電してもよい。 The light source 16 may be a non-flashing light or a flashing light. The brightness of the light source 16 may be adjustable. The power source for the light source 16 may be a battery, a solar cell, or the like. The power source for the light source 16 may be attached to the catheter hub 20 or may be separate from the catheter hub 20. The power source for the light source 16 may be a wired or wireless power source for the light source 16.
　本実施形態において、カテーテル本体１８の発光部３４は、光源１６から直接光Ｌ１が照射されることによって発光する。このため、光源１６から照射される光Ｌ１は、発光部３４に到達するまでにカテーテル組立体１０の他の部分で減衰しない。また、本実施形態においては、光源１６から照射される光Ｌ１は、カテーテル組立体１０を伝播しない。このため、生体１００に穿刺されたカテーテル本体１８の先端部とその他の部分との明暗が明確になる。こうしたことから、本実施形態によれば、カテーテル本体１８の先端部（発光部３４）が血管１０２の内部に配置されたか否かを確認しやすくなる。さらに、本実施形態によれば、カテーテル本体１８の先端部（発光部３４）の視認性が向上する。また、本実施形態においては、カテーテル組立体１０自体に光源１６が設けられる。このため、カテーテル組立体１０と光源１６とを光ファイバ等で接続する必要がない。したがって、本実施形態によれば、カテーテル組立体１０の操作性が向上する。 In this embodiment, the light emitting section 34 of the catheter body 18 emits light by being directly irradiated with light L1 from the light source 16. Therefore, the light L1 irradiated from the light source 16 is not attenuated by other parts of the catheter assembly 10 before reaching the light emitting section 34. In addition, in this embodiment, the light L1 irradiated from the light source 16 does not propagate through the catheter assembly 10. Therefore, the brightness and darkness of the tip of the catheter body 18 inserted into the living body 100 and other parts are clearly distinguished. For this reason, according to this embodiment, it is easy to check whether the tip (light emitting section 34) of the catheter body 18 is placed inside the blood vessel 102. Furthermore, according to this embodiment, the visibility of the tip (light emitting section 34) of the catheter body 18 is improved. Also, in this embodiment, the light source 16 is provided in the catheter assembly 10 itself. Therefore, it is not necessary to connect the catheter assembly 10 and the light source 16 with an optical fiber or the like. Therefore, according to this embodiment, the operability of the catheter assembly 10 is improved.
　本実施形態において、光源１６が固定部２２に対して着脱可能である。カテーテル部材１２が生体１００に留置された状態で光源１６を固定部２２から取り外すことによって、カテーテル部材１２の重量を軽くすることができる。このため、カテーテル部材１２の重量に起因する生体１００への負荷を低減することができる。また、取り外された光源１６を再利用することができる。また、取り外した光源１６を、未使用のカテーテル組立体１０に装着することができる。つまり、光源１６を再利用することができる。 In this embodiment, the light source 16 is detachable from the fixed portion 22. By removing the light source 16 from the fixed portion 22 while the catheter member 12 is placed in the living body 100, the weight of the catheter member 12 can be reduced. This reduces the load on the living body 100 caused by the weight of the catheter member 12. Furthermore, the removed light source 16 can be reused. Furthermore, the removed light source 16 can be attached to an unused catheter assembly 10. In other words, the light source 16 can be reused.
　本実施形態において、血液に吸収される近赤外光を使用することによって、カテーテル本体１８の先端部（発光部３４）が血管１０２の内部に配置されたか否かを確認しやすくなる。さらに、上記構成において、発光部３４が光源１６によって照射される近赤外光を可視光に変換する波長変換材料を含むことによって、発光部３４における発光をユーザが肉眼で視認することができる。 In this embodiment, by using near-infrared light that is absorbed by blood, it becomes easier to confirm whether or not the tip of the catheter main body 18 (light-emitting unit 34) is positioned inside the blood vessel 102. Furthermore, in the above configuration, the light-emitting unit 34 contains a wavelength conversion material that converts the near-infrared light irradiated by the light source 16 into visible light, so that the user can visually recognize the light emitted by the light-emitting unit 34 with the naked eye.
　本実施形態において、発光部３４が発光材（燐光材、蛍光材等）を含むことによって、発光部３４の視認性がより向上する。又は、本実施形態において、発光部３４が反射構造を有することによって、発光部３４の視認性がより向上する。 In this embodiment, the visibility of the light-emitting section 34 is further improved by the light-emitting section 34 including a light-emitting material (phosphorescent material, fluorescent material, etc.). Alternatively, in this embodiment, the visibility of the light-emitting section 34 is further improved by the light-emitting section 34 having a reflective structure.
　本実施形態において、固定部２２とカテーテルハブ２０とが一体に形成されることによって、部品点数を減らすことができる。また、本実施形態において、固定部２２が光源１６の全周を囲むことによって、カテーテルハブ２０に対して光源１６を安定して固定することができる。また、本実施形態において、カテーテル本体１８の内腔２８に内針２４が挿通されるため、カテーテル本体１８の形状を維持したまま、生体１００にカテーテル本体１８を留置することができる。 In this embodiment, the fixing part 22 and the catheter hub 20 are integrally formed, thereby reducing the number of parts. Also, in this embodiment, the fixing part 22 surrounds the entire circumference of the light source 16, thereby allowing the light source 16 to be stably fixed to the catheter hub 20. Also, in this embodiment, the inner needle 24 is inserted into the lumen 28 of the catheter body 18, allowing the catheter body 18 to be placed in the living body 100 while maintaining the shape of the catheter body 18.
　ところで、発光部３４から発せられる光Ｌ１´（図５）が可視光の場合、ユーザは、生体１００の内部における発光部３４の位置を肉眼で確認することができる。例えば、光源１６から照射される近赤外光が、発光部３４において可視光に波長変換される場合、ユーザは、発光部３４の位置を肉眼で確認することができる。又は、光源１６から照射される可視光が、発光部３４において反射される場合、ユーザは、発光部３４の位置を肉眼で確認することができる。 When the light L1' (Figure 5) emitted from the light-emitting unit 34 is visible light, the user can confirm the position of the light-emitting unit 34 inside the living body 100 with the naked eye. For example, when the near-infrared light irradiated from the light source 16 is wavelength-converted to visible light in the light-emitting unit 34, the user can confirm the position of the light-emitting unit 34 with the naked eye. Or, when the visible light irradiated from the light source 16 is reflected by the light-emitting unit 34, the user can confirm the position of the light-emitting unit 34 with the naked eye.
　一方、発光部３４から発せられる光Ｌ１´が可視光でない場合、ユーザは、生体１００の内部における発光部３４の位置を肉眼で確認することができない。例えば、発光部３４で発せられる光Ｌ１´が近赤外光である場合、ユーザは、発光部３４の位置を肉眼で確認することができない。このような場合、発光部３４から発せられる光Ｌ１´を可視化するための装置が必要である。以下では、発光部３４から発せられる光Ｌ１´が可視光でない場合に使用されるカテーテル視認システム５６を説明する。 On the other hand, if the light L1' emitted from the light-emitting unit 34 is not visible light, the user cannot see the position of the light-emitting unit 34 inside the living body 100 with the naked eye. For example, if the light L1' emitted from the light-emitting unit 34 is near-infrared light, the user cannot see the position of the light-emitting unit 34 with the naked eye. In such a case, a device is needed to visualize the light L1' emitted from the light-emitting unit 34. Below, a catheter visualization system 56 that is used when the light L1' emitted from the light-emitting unit 34 is not visible light is described.
　図４は、図１のカテーテル組立体１０を使用したカテーテル視認システム５６の構成図である。カテーテル視認システム５６は、カテーテル組立体１０と、受光部５８と、表示部６０とを備える。受光部５８は、生体１００を撮影するカメラである。受光部５８としては、例えば、ＣＣＤカメラ等が用いられる。受光部５８は、生体１００から発せられる光Ｌ１´を受光する。例えば、受光部５８は、生体１００の内部に位置する発光部３４から発せられる光Ｌ１´のうち、生体１００を透過した光（透過光）Ｌ１´を受光する。受光部５８は、受光した光Ｌ１´に基づいて受光画像６２を作成する。表示部６０は、受光画像６２を表示するモニタ、ヘッドマウントディスプレイ又は皮膚に映像を投影可能なプロジェクターである。 FIG. 4 is a diagram of a catheter visualization system 56 using the catheter assembly 10 of FIG. 1. The catheter visualization system 56 includes the catheter assembly 10, a light receiving unit 58, and a display unit 60. The light receiving unit 58 is a camera that captures an image of the living body 100. For example, a CCD camera or the like is used as the light receiving unit 58. The light receiving unit 58 receives light L1' emitted from the living body 100. For example, the light receiving unit 58 receives light L1' that has passed through the living body 100 (transmitted light) from the light emitting unit 34 located inside the living body 100. The light receiving unit 58 creates a received light image 62 based on the received light L1'. The display unit 60 is a monitor that displays the received light image 62, a head-mounted display, or a projector that can project an image onto the skin.
　図５は、カテーテル組立体１０の血管穿刺手技の第１説明図である。図５は、カテーテル本体１８の発光部３４が生体１００の内部且つ血管１０２の外部に位置する状態を示す。光源１６は、発光部３４に向けて光Ｌ１（例えば、近赤外光）を照射する。カテーテル組立体１０が生体１００に穿刺されると、光源１６から照射される光Ｌ１の一部は、生体１００を透過して発光部３４に到達する。発光部３４は受光に伴い発光する。この場合、発光部３４は、例えば、近赤外光を受光して近赤外光を発光する燐光材又は蛍光材であり得る。あるいは、発光部３４は、近赤外光を受光して反射する反射構造であり得る。受光部５８は、発光部３４から発せられる光Ｌ１´のうち、生体１００を透過した光（透過光）Ｌ１´を受光する。受光部５８は、受光画像６２を作成する。表示部６０は、受光部５８から受光画像６２を取得し、受光画像６２を表示する。受光画像６２には、光（透過光）Ｌ１´によって得られた像が表示される。光（透過光）Ｌ１´によって得られた像は、生体１００の内部での発光部３４の位置を示す。 5 is a first explanatory diagram of the blood vessel puncture procedure of the catheter assembly 10. FIG. 5 shows a state in which the light emitting unit 34 of the catheter body 18 is located inside the living body 100 and outside the blood vessel 102. The light source 16 irradiates light L1 (e.g., near-infrared light) toward the light emitting unit 34. When the catheter assembly 10 is inserted into the living body 100, a part of the light L1 irradiated from the light source 16 passes through the living body 100 and reaches the light emitting unit 34. The light emitting unit 34 emits light in response to receiving light. In this case, the light emitting unit 34 may be, for example, a phosphorescent or fluorescent material that receives near-infrared light and emits near-infrared light. Alternatively, the light emitting unit 34 may be a reflective structure that receives and reflects near-infrared light. The light receiving unit 58 receives light L1' (transmitted light) that has passed through the living body 100, out of the light L1' emitted from the light emitting unit 34. The light receiving unit 58 creates a received light image 62. The display unit 60 acquires the received light image 62 from the light receiving unit 58 and displays the received light image 62. The received light image 62 displays an image obtained by the light (transmitted light) L1'. The image obtained by the light (transmitted light) L1' indicates the position of the light emitting unit 34 inside the living body 100.
　図６は、カテーテル組立体１０の血管穿刺手技の第２説明図である。図６は、カテーテル本体１８の発光部３４が生体１００の内部且つ血管１０２の内部に位置する状態を示す。光源１６は、発光部３４に向けて光Ｌ１を照射する。カテーテル組立体１０の先端部が生体１００の内部の血管１０２に穿刺されると、光源１６から照射される光Ｌ１は、生体１００を透過して血管１０２に到達する。しかし、光Ｌ１が近赤外光である場合、光Ｌ１は、血管１０２を流れる血液中のヘモグロビンに吸収される。このため、光Ｌ１は、発光部３４に到達しない。したがって、発光部３４は受光しない。すると、受光画像６２から光（透過光）Ｌ１´（図５）の像が消失する。このように、受光画像６２において光（透過光）Ｌ１´によって得られた像が視認できる状態から視認できない状態に遷移することによって、カテーテル本体１８の発光部３４（先端部）が血管１０２の内部に配置されたことが判る。 Figure 6 is a second explanatory diagram of the blood vessel puncture procedure of the catheter assembly 10. Figure 6 shows a state in which the light-emitting unit 34 of the catheter body 18 is located inside the living body 100 and inside the blood vessel 102. The light source 16 irradiates light L1 toward the light-emitting unit 34. When the tip of the catheter assembly 10 is punctured into the blood vessel 102 inside the living body 100, the light L1 irradiated from the light source 16 passes through the living body 100 and reaches the blood vessel 102. However, if the light L1 is near-infrared light, the light L1 is absorbed by hemoglobin in the blood flowing through the blood vessel 102. For this reason, the light L1 does not reach the light-emitting unit 34. Therefore, the light-emitting unit 34 does not receive the light. Then, the image of the light (transmitted light) L1' (Figure 5) disappears from the received light image 62. In this way, the image obtained by the light (transmitted light) L1' in the received light image 62 transitions from a visible state to an invisible state, indicating that the light emitting portion 34 (tip) of the catheter body 18 is positioned inside the blood vessel 102.
　本実施形態によれば、ユーザは、表示部６０を介して肉眼で視認できない光Ｌ１´を視認することができる。 According to this embodiment, the user can see light L1' that is not visible to the naked eye through the display unit 60.
　図７は、図４とは別実施形態のカテーテル視認システム５６の構成図である。図７に示されるカテーテル視認システム５６のうち、図４に示されるカテーテル視認システム５６と同一の構成には同一の符号を付す。図７に示されるカテーテル視認システム５６は、カテーテル組立体１０と、受光部５８と、表示部６０との他に、照射部６６と、第２の受光部６８とを備える。発光部３４が発する光Ｌ１´は、可視光でもよく、可視光以外（近赤外光）でもよい。 FIG. 7 is a configuration diagram of a catheter visualization system 56 of another embodiment different from that of FIG. 4. In the catheter visualization system 56 shown in FIG. 7, the same components as those of the catheter visualization system 56 shown in FIG. 4 are given the same reference numerals. The catheter visualization system 56 shown in FIG. 7 includes an irradiation unit 66 and a second light receiving unit 68 in addition to the catheter assembly 10, a light receiving unit 58, and a display unit 60. The light L1' emitted by the light emitting unit 34 may be visible light or may be non-visible light (near-infrared light).
　照射部６６は、生体１００の内部の血管１０２を可視化するための第２の光Ｌ２を生体１００に照射する。第２の光Ｌ２は、生体１００を透過する波長を有する。第２の光Ｌ２は、例えば、近赤外光である。なお、照射部６６が照射する第２の光Ｌ２の波長は、カテーテル組立体１０の光源１６が照射する光Ｌ１の波長と異なることが好ましい。 The irradiation unit 66 irradiates the living body 100 with second light L2 for visualizing the blood vessels 102 inside the living body 100. The second light L2 has a wavelength that transmits through the living body 100. The second light L2 is, for example, near-infrared light. Note that it is preferable that the wavelength of the second light L2 irradiated by the irradiation unit 66 is different from the wavelength of the light L1 irradiated by the light source 16 of the catheter assembly 10.
　第２の受光部６８は、生体１００を撮影するカメラである。第２の受光部６８としては、例えば、ＣＣＤカメラ等が用いられる。第２の受光部６８は、照射部６６から照射され、生体１００を透過した第２の光Ｌ２´を受光する。第２の受光部６８は、照射部６６が第２の光Ｌ２を照射する方向に配置される。照射部６６と第２の受光部６８とは、生体１００を挟むように配置される。この配置により、第２の受光部６８は、照射部６６によって照射された第２の光Ｌ２のうち、生体１００を透過した第２の光（第２の透過光）Ｌ２´を受光することができる。第２の受光部６８は、受光した第２の光（第２の透過光）Ｌ２´に基づいて第２の受光画像７０を作成する。 The second light receiving unit 68 is a camera that photographs the living body 100. For example, a CCD camera or the like is used as the second light receiving unit 68. The second light receiving unit 68 receives the second light L2' that is irradiated from the irradiation unit 66 and transmitted through the living body 100. The second light receiving unit 68 is disposed in the direction in which the irradiation unit 66 irradiates the second light L2. The irradiation unit 66 and the second light receiving unit 68 are disposed so as to sandwich the living body 100. With this arrangement, the second light receiving unit 68 can receive the second light (second transmitted light) L2' that is transmitted through the living body 100 out of the second light L2 irradiated by the irradiation unit 66. The second light receiving unit 68 creates a second received light image 70 based on the received second light (second transmitted light) L2'.
　照射部６６が照射する近赤外光（第２の光Ｌ２）は、生体１００を透過する一方で、血管１０２を流れる血液のヘモグロビンに吸収される。このため、第２の受光部６８で作成される第２の受光画像７０においては、血管１０２の部分が暗く表示され、血管１０２以外の部分が明るく表示される。 The near-infrared light (second light L2) emitted by the irradiation unit 66 passes through the living body 100, but is absorbed by the hemoglobin in the blood flowing through the blood vessels 102. Therefore, in the second received light image 70 created by the second light receiving unit 68, the blood vessels 102 are displayed dark, and the areas other than the blood vessels 102 are displayed bright.
　表示部６０は、受光部５８から受光画像６２を取得し、第２の受光部６８から第２の受光画像７０を取得する。表示部６０は、受光画像６２と第２の受光画像７０とを合成して合成画像７２を表示する。なお、表示部６０は、受光画像６２と第２の受光画像７０とを個別に表示してもよい。 The display unit 60 acquires the received light image 62 from the light receiving unit 58, and acquires the second received light image 70 from the second light receiving unit 68. The display unit 60 combines the received light image 62 and the second received light image 70 to display a combined image 72. Note that the display unit 60 may display the received light image 62 and the second received light image 70 separately.
　本実施形態によれば、ユーザは、カテーテル本体１８の先端部と血管１０２との相対位置を確認することができる。 According to this embodiment, the user can check the relative position between the tip of the catheter body 18 and the blood vessel 102.
　図８は、図４及び図７とは別実施形態のカテーテル視認システム５６の構成図である。図７で示されるカテーテル視認システム５６のように２種類の光Ｌ１´、Ｌ２´に対して受光部５８と第２の受光部６８とが設けられる代わりに、１つの受光部５８が設けられてもよい。すなわち、受光部５８が光（透過光）Ｌ１´、Ｌ２´を受光してもよい。この場合、受光部５８は、光Ｌ１´の波長と第２の光Ｌ２´の波長とを含む検出波長を有する。 FIG. 8 is a configuration diagram of a catheter visualization system 56 of another embodiment different from those of FIGS. 4 and 7. Instead of providing a light receiving unit 58 and a second light receiving unit 68 for two types of light L1', L2' as in the catheter visualization system 56 shown in FIG. 7, a single light receiving unit 58 may be provided. That is, the light receiving unit 58 may receive light (transmitted light) L1', L2'. In this case, the light receiving unit 58 has a detection wavelength that includes the wavelength of light L1' and the wavelength of the second light L2'.
　なお、本発明は、上述した開示に限らず、本発明の要旨を逸脱することなく、種々の構成を採り得る。 The present invention is not limited to the above disclosure, and various configurations may be adopted without departing from the gist of the present invention.

Claims (15)

  1. 　カテーテル本体と、前記カテーテル本体の基端部に固定されるカテーテルハブとを有するカテーテル部材と、
    　前記カテーテル本体の先端部に向けて光を照射する光源と、
    　前記光源を前記カテーテルハブに固定する固定部と、
    　前記カテーテル本体から抜去可能に前記カテーテル本体に挿入され、前記カテーテル本体を支持する支持部材と、
    　を備え、
    　前記カテーテル本体の前記先端部には、受光に伴い発光する発光部が設けられ、
    　前記固定部は、前記光源の光軸が前記カテーテル本体の軸線に対して傾斜するように、前記光源を固定する、
    　カテーテル組立体。     a catheter member having a catheter body and a catheter hub fixed to a proximal end of the catheter body;
    a light source that irradiates light toward the distal end of the catheter body;
    a fixing portion for fixing the light source to the catheter hub;
    a support member that is inserted into the catheter body so as to be removably inserted from the catheter body and supports the catheter body;
    Equipped with
    a light emitting unit that emits light in response to receiving light is provided at the tip of the catheter body;
    The fixing portion fixes the light source such that an optical axis of the light source is inclined with respect to an axis line of the catheter body.
    Catheter assembly.
  2. 　請求項１に記載のカテーテル組立体であって、
    　前記固定部は、前記光源の前記光軸と前記カテーテル本体の前記軸線とが交差するように、前記光源を固定する、
    　カテーテル組立体。     2. The catheter assembly of claim 1,
    The fixing portion fixes the light source so that the optical axis of the light source intersects with the axis of the catheter body.
    Catheter assembly.
  3. 　請求項１に記載のカテーテル組立体であって、
    　前記固定部は、前記光源を前記カテーテルハブに対して着脱可能に固定する、
    　カテーテル組立体。     2. The catheter assembly of claim 1,
    The fixing portion removably fixes the light source to the catheter hub.
    Catheter assembly.
  4. 　請求項１に記載のカテーテル組立体であって、
    　前記光源は、近赤外光を照射する、
    　カテーテル組立体。     2. The catheter assembly of claim 1,
    The light source irradiates near-infrared light.
    Catheter assembly.
  5. 　請求項４に記載のカテーテル組立体であって、
    　前記発光部は、前記光源によって照射される前記近赤外光を可視光に変換する波長変換材料を含む、
    　カテーテル組立体。     5. The catheter assembly according to claim 4,
    The light emitting unit includes a wavelength converting material that converts the near-infrared light irradiated by the light source into visible light.
    Catheter assembly.
  6. 　請求項１に記載のカテーテル組立体であって、
    　前記発光部は、燐光材又は蛍光材を含む、
    　カテーテル組立体。     2. The catheter assembly of claim 1,
    The light-emitting portion includes a phosphorescent material or a fluorescent material.
    Catheter assembly.
  7. 　請求項１に記載のカテーテル組立体であって、
    　前記発光部は、前記光源によって照射される光を反射する反射構造を有する、
    　カテーテル組立体。     2. The catheter assembly of claim 1,
    The light emitting unit has a reflective structure that reflects light irradiated by the light source.
    Catheter assembly.
  8. 　請求項１～７のいずれか１項に記載のカテーテル組立体であって、
    　前記固定部と前記カテーテルハブとが一体に形成される、
    　カテーテル組立体。     A catheter assembly according to any one of claims 1 to 7,
    The fixing portion and the catheter hub are integrally formed.
    Catheter assembly.
  9. 　請求項１～７のいずれか１項に記載のカテーテル組立体であって、
    　前記固定部は、前記光源の前記光軸を中心として前記光源の全周を囲む、
    　カテーテル組立体。     A catheter assembly according to any one of claims 1 to 7,
    The fixing portion surrounds the entire circumference of the light source with the optical axis of the light source as a center.
    Catheter assembly.
  10. 　請求項１～７のいずれか１項に記載のカテーテル組立体であって、
    　前記支持部材は、前記カテーテル本体の内腔に挿通される内針と、前記内針の基端に固定される内針ハブとを有する、
    　カテーテル組立体。     A catheter assembly according to any one of claims 1 to 7,
    The support member has an inner needle that is inserted into the lumen of the catheter body, and an inner needle hub that is fixed to a base end of the inner needle.
    Catheter assembly.
  11. 　請求項１に記載のカテーテル組立体であって、
    　前記カテーテル本体の先端から前記光源の前記光軸と前記カテーテル本体の前記軸線との交点までの距離は、７ｍｍ以下、又は、前記カテーテル本体の外径の６倍以下である、
    　カテーテル組立体。     2. The catheter assembly of claim 1,
    A distance from the tip of the catheter body to an intersection point between the optical axis of the light source and the axis of the catheter body is 7 mm or less, or 6 times or less of an outer diameter of the catheter body.
    Catheter assembly.
  12. 　請求項１に記載のカテーテル組立体と、
    　生体の内部に前記発光部が位置するときに前記発光部によって発せられた光のうち、前記生体を透過した透過光を受光する受光部と、
    　前記受光部によって受光された前記透過光によって得られた像を表示する表示部と、
    　を備える、
    　カテーテル視認システム。     A catheter assembly according to claim 1;
    a light receiving unit that receives transmitted light that has passed through the living body out of the light emitted by the light emitting unit when the light emitting unit is located inside the living body;
    a display unit that displays an image obtained by the transmitted light received by the light receiving unit;
    Equipped with
    Catheter visualization system.
  13. 　請求項１２に記載のカテーテル視認システムであって、
    　前記生体の内部の血管を可視化するための第２の光を前記生体に照射する照射部と、
    　前記照射部によって照射された前記第２の光のうち、前記生体を透過した第２の透過光を受光する第２の受光部とを備え、
    　前記表示部は、前記受光部によって受光された前記透過光によって得られた像と、前記第２の受光部によって受光された前記第２の透過光によって得られた像とを個別に又は合成して表示する、
    　カテーテル視認システム。     13. The catheter visualization system of claim 12,
    an irradiation unit that irradiates the living body with a second light for visualizing blood vessels inside the living body;
    a second light receiving unit that receives second transmitted light that has passed through the living body out of the second light irradiated by the irradiating unit,
    The display unit displays an image obtained by the transmitted light received by the light receiving unit and an image obtained by the second transmitted light received by the second light receiving unit, either individually or in combination.
    Catheter visualization system.
  14. 　請求項１２に記載のカテーテル視認システムであって、
    　前記生体の内部の血管を可視化するための第２の光を前記生体に照射する照射部を備え、
    　前記受光部は、前記照射部によって照射された前記第２の光のうち、前記生体を透過した第２の透過光を受光し、
    　前記表示部は、前記受光部によって受光された前記透過光によって得られた像及び前記受光部によって受光された前記第２の透過光によって得られた像を表示する、
    　カテーテル視認システム。     13. The catheter visualization system of claim 12,
    an irradiation unit that irradiates the living body with a second light for visualizing a blood vessel inside the living body;
    The light receiving unit receives second transmitted light that has passed through the living body out of the second light irradiated by the irradiating unit,
    the display unit displays an image obtained by the transmitted light received by the light receiving unit and an image obtained by the second transmitted light received by the light receiving unit.
    Catheter visualization system.
  15. 　請求項１３に記載のカテーテル視認システムであって、
    　前記照射部と前記第２の受光部とは、前記生体内に位置する前記発光部を挟むように配置される、
    　カテーテル視認システム。     14. The catheter visualization system of claim 13,
    The irradiation unit and the second light receiving unit are arranged to sandwich the light emitting unit located inside the living body.
    Catheter visualization system.
PCT/JP2024/000889 2023-01-20 2024-01-16 Catheter assembly and catheter visualization system WO2024154714A1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014136114A (en) * 2013-01-18 2014-07-28 Terumo Corp Arterial sheath introducer
JP2014136115A (en) * 2013-01-18 2014-07-28 Terumo Corp Indwelling needle
WO2021228341A1 (en) * 2020-05-12 2021-11-18 Coloplast A/S Accessory device for a catheter
WO2022176880A1 (en) * 2021-02-22 2022-08-25 テルモ株式会社 Blood vessel puncture device and blood vessel puncture system

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014136114A (en) * 2013-01-18 2014-07-28 Terumo Corp Arterial sheath introducer
JP2014136115A (en) * 2013-01-18 2014-07-28 Terumo Corp Indwelling needle
WO2021228341A1 (en) * 2020-05-12 2021-11-18 Coloplast A/S Accessory device for a catheter
WO2022176880A1 (en) * 2021-02-22 2022-08-25 テルモ株式会社 Blood vessel puncture device and blood vessel puncture system

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