Light irradiation device and light irradiation system

Abstract

A light irradiation device 2 has, on the distal end side of the light irradiation device, a first region 201 having a light emission part 111, and a second region 202 positioned closer to the proximal end side than the first region 201 and having a length of 30 mm or more. The second region 202 has higher flexibility than the first region 201. When the light irradiation device 2 is fixed in a position 30 mm from the distal end, and a position 20 mm from the distal end is pushed in by 1.0 mm in a direction perpendicular to an axis corresponding to the extending direction of the light irradiation device 2, the maximum push-in load is 19.6133 mN or less. The first region has a length of 4.44 mm or less, and the diameter of a circumscribed circle in a cross section in a direction orthogonal to the length direction is 0.7 mm or less.

Description

Light irradiation device and light irradiation system

[0001] The present disclosure relates to a light irradiation device and a light irradiation system that are inserted into a body lumen or the like to irradiate light.

[0002] In recent years, photoimmunotherapy has been proposed, a treatment method in which a drug that attaches to cancer cells is administered and then irradiated with light (e.g., near-infrared light), causing the drug to react with the light and destroy the cancer cells.

[0003] In such treatments, techniques have been proposed for irradiating light from a position closer to the cancer cells, rather than from the surface of the body. For example, a device described in Patent Document 1 is inserted into a blood vessel to irradiate light from deep within the blood vessel.

[0004] JP 2018-000867 A

[0005] An object of one aspect of the present disclosure is to provide a light irradiation device and a light irradiation system that can improve deep insertion capability into a lumen.

[0006] The light irradiation device provided by the embodiments is a light irradiation device that is inserted into a lumen inside the body and used for treatment by irradiating with light emitted from the light emitting portion, the light irradiation device having a first region at a distal end side of the light irradiation device and a second region that is located closer to the base end than the first region and has a length of 30 mm or more, the second region being more flexible than the first region, the maximum pushing load when the light irradiation device is fixed at a position 30 mm from the distal end and a position 20 mm from the distal end is pushed 1.0 mm in a direction perpendicular to the axis along an extension direction of the light irradiation device is 19.6133 mN or less, the length of the first region is 4.44 mm or less, and the diameter of a circumscribed circle in a cross section perpendicular to the length direction is 0.7 mm or less.

[0007] The light irradiation device and light irradiation system according to the present disclosure can improve the ability to be inserted deep into a lumen.

[0008] Fig. 1 is a cross-sectional view of the light irradiation system 1 in a state where the light irradiation device 2 is attached to the catheter 3 (in use); Fig. 2 is a cross-sectional view of the light irradiation system 1 in a state where the light irradiation device 2 is separated from the catheter 3; Fig. 3 is an enlarged longitudinal cross-sectional view of the vicinity of the tip of the light irradiation system 1 in Fig. 1; Fig. 4 is an enlarged longitudinal cross-sectional view of the vicinity of the tip of the light irradiation system 1 of a first modified example; Fig. 5 is an enlarged longitudinal cross-sectional view of the vicinity of the tip of the light irradiation system 1 of a second modified example; Fig. 6 is an enlarged longitudinal cross-sectional view of the vicinity of the tip of the light irradiation system 1 of a third modified example, illustrating a state where the light irradiation system 1 is placed in a blood vessel;

[0009] First Embodiment A light irradiation device and a light irradiation system according to a first embodiment of the present disclosure will be described below. Figures 1 to 3 are diagrams for explaining an exemplary embodiment of a light irradiation device and a light irradiation system.

[0010] The light irradiation system 1 of this embodiment is used by being inserted into the body, specifically into a lumen of a living body (for example, at least one of a blood vessel, lymph node, urethra, respiratory tract, digestive organ, secretory gland, and reproductive organ). The light irradiation system 1 is for medical use and irradiates biological tissue with light (for example, laser light) while inserted into a lumen of a living body. The light irradiation system can be used for at least one of therapies such as PDT (Photodynamic Therapy) and NIR-PIT (Near-infrared Photoimmunotherapy). Furthermore, the light irradiation system 1 of this embodiment can be used as a method for preparing a catheter that a doctor inserts, reaches the tip of the catheter into a blood vessel, and performs treatment using light irradiation.

[0011] As shown in FIG. 1 , the light irradiation system 1 of this embodiment includes a light irradiation device 2 and a catheter 3. When using the light irradiation system 1, first, the catheter 3 is inserted into a biological lumen from outside the human body. Next, the light irradiation device 2 is inserted into the lumen 311 of the catheter 3, which has a long tubular shape, until the tip of the light irradiation device 2, i.e., the light emitting portion 111, reaches a predetermined position within the biological lumen. Once the insertion is complete, light is irradiated onto biological tissue from the light irradiation device 2. However, it is also possible to use the light irradiation device 2 alone, without using the catheter 3.

[0012] 1 to 5 show mutually orthogonal X and Y axes. In these figures, the lower side (+X direction) of the figure is the "distal side," the upper side (-X direction) of the figure is the "proximal side," the left side (+Y direction) of the figure is the "left side," and the right side (-Y direction) of the figure is the "right side." The light irradiation system 1, light irradiation device 2, and catheter 3 are inserted into a biological lumen from the distal side. The proximal side is operated by a medical professional (e.g., a doctor).

[0013] (Light Irradiation Device) A light irradiation device 2 according to this embodiment will be described with reference to FIGS. 1 to 3. As shown in FIGS. 1 and 2, the light irradiation device 2 has an elongated shape extending along an axis O2. The light irradiation device 2 includes a light-emitting element 11 that emits light of a predetermined wavelength, a mirror 17 onto which the light emitted from the light-emitting element 11 is incident, a support 12 on which the light-emitting element 11 and the mirror 17 are mounted, a wiring section 14 electrically connected to the light-emitting element 11, and an insulating layer 16 that integrally covers the outer surface of the structure including the light-emitting element 11, the mirror 17, the support 12, and the wiring section 14. The wiring section 14 includes a first insulated wire 14A and a second insulated wire 14B. The light irradiation device 2 has a light-emitting section 111 at its tip end, which in this embodiment is the light-emitting surface of the light-emitting element 11.

[0014] A space 13 is provided between the light emitting portion 111 and the light incident surface 171 of the mirror 17. By providing the space 13 and shortening the distance that the light emitted from the light emitting element 11 travels through the insulating layer 16, the influence of the refraction of light by the insulating layer 16 can be reduced, making it easier to control the spread of the light emitted from the light emitting element 11.

[0015] The insulating layer 16 can be made of an organic material such as a resin material or an inorganic material. It is desirable for the organic material or resin material to have antithrombogenicity, flexibility, thermal conductivity, and biocompatibility. Examples of resin materials that can be used include polyamide resin, polyimide resin, polyolefin resin, polyester resin, polyurethane resin, polycarbonate resin, polyethylene terephthalate resin, silicone resin, epoxy resin, acrylic resin, and fluororesin. Examples of inorganic materials that can be used include a coating formed by applying a polysilazane solution and silicating it (hereinafter referred to as a "polysilazane coating"). A resin layer made of the aforementioned resin material may be provided on the surface of the polysilazane coating.

[0016] The insulating layer 16 is translucent to the light emitted from the light emitting element 11. By employing a polysilazane coating, it is possible to ensure insulation while improving heat dissipation by reducing the thickness of the insulating layer 16. The light emitting portion 111 and the light incident surface 171 of the mirror 17 face each other with the space 13 therebetween.

[0017] Light emitted from the light emitting portion 111 passes through the insulating layer 16, the space 13, and the insulating layer 16 to be incident on the light incident surface 171 of the mirror 17. The insulating layer 16 shown in FIG. 2 seals the laminated structure along the surface shapes of the support 12 and the components mounted on the support 12. The space 13 may be filled with a refrigerant when the light irradiation device 2 is inserted into the catheter 3 for use. In this case, the light passes through the refrigerant in the space 13 and is incident on the light incident surface 171 of the mirror 17.

[0018] In this configuration example, the longitudinal direction of the support 12 is parallel to the X direction. The light irradiation device 2 is inserted into the catheter 3 in the +X direction, and the wiring part 14 including the first insulated electric wire 14A and the second insulated electric wire 14B extends in the -X direction. The support 12 is made of silicon (Si), aluminum nitride (AlN), silicon nitride (SiN), diamond, sapphire (Al ２ O ３ , an insulating material such as glass, quartz, alumina, or ceramics, or a metal such as copper, and the light emitting element 11 is mounted on a light emitting element mounting surface 121 of the support 12 .

[0019] A mirror 17 is mounted on the light-emitting element mounting surface 121 of the support 12 together with the light-emitting element 11, and the light incident surface 171 of the mirror 17 is inclined with respect to the light-emitting element mounting surface 121. As a result, the light incident surface 171 of the mirror 17 functions as a reflective surface, and the output light Lout of the light irradiation device 2 is extracted in the direction indicated by the dashed arrow. In the configuration example of FIG. 3 , the mirror 17 is a reflective member that guides the light emitted from the light-emitting element 11 in a direction intersecting the light-emitting element mounting surface 121 of the support 12 (for example, the +Y direction). This allows the light to be emitted in the circumferential direction of the light irradiation device 2. The mirror 17 may have a reflective layer made of metal and / or a dielectric multilayer film. This allows the light to be reflected efficiently.

[0020] It should be noted that a prism, a lens, a diffractive optical element, or the like may be used instead of a mirror as long as it is possible to change at least one of the direction and spread angle of the light emitted from the light emitting unit 111. These components are examples of optical control elements. In other words, the optical control element changes at least one of the direction and spread angle of the light emitted from the light emitting unit 111. The optical control element can be made of a material including a resin material, a glass material, a metal material, or the like. The optical control element may be formed integrally with the support body 12.

[0021] The wiring section 14 includes a first insulated wire 14A electrically connected to one electrode (also referred to as the first electrode) of the light-emitting element 11 on the side of a light-emitting element mounting surface 121, which is the first surface of the support body 12 on which the light-emitting element 11 is mounted, and a second insulated wire 14B electrically connected to the other electrode (also referred to as the second electrode) of the light-emitting element 11 on the side of a back surface 122 (also referred to as the second surface) opposite the light-emitting element mounting surface 121. The use of the insulated wires enables current to flow through the light-emitting element 11.

[0022] One of the features of the light irradiation device 2 is that the electrical connection portions between the first insulated wire 14A and the second insulated wire 14B and the light emitting element 11 are sealed together with the support 12, the light emitting element 11, and the mirror 17 by an insulating layer 16. The insulating layer 16 is an example of an insulating sealing member. The thickness of the insulating layer 16 is thinner than the thickness of the light emitting element 11. By integrally covering the light irradiation device 2 with the insulating layer 16 that is thinner than the thickness of the light emitting element 11, a small light irradiation device 2 with ensured electrical insulation is realized, which makes it easier to insert into the catheter 3. Furthermore, by making the thickness of the insulating layer 16 thinner than the thickness of the light emitting element, the thermal resistance of the insulating layer 16 can be reduced and heat dissipation can be improved.

[0023] The insulating layer 16 isolates the electrical connection between the light emitting element 11 and the first insulated wire 14A and the second insulated wire 14B from the refrigerant in the space 13. While maintaining this sealed state, the first insulated wire 14A and the second insulated wire 14B are pulled out from the insulating layer 16 in the −X direction.

[0024] The first insulated wire 14A and the second insulated wire 14B are cooled by a refrigerant and also function as heat dissipation materials. The first insulated wire 14A and the second insulated wire 14B are, for example, enameled wires, in which metal wiring made of a good conductor such as Cu or Ni is insulated and coated with an insulating polyurethane coating. Instead of polyurethane, the wires may be coated with an insulating resin such as polyester, polyesterimide, polyamideimide, or polyimide.

[0025] By using the insulating coating that is the surface coating of the first insulated wire 14A and the second insulated wire 14B as a heat dissipation material, heat generated from the light emitting element 11 can be dissipated to the outside. When rectangular enameled wire is used as the first insulated wire 14A and the second insulated wire 14B, the wiring becomes wide, and the bonding area with the support body 12 can be increased. Furthermore, when the circumscribed circle area is the same, the rectangular enameled wire can have a smaller circumscribed circle area than a round enameled wire, allowing for further miniaturization.

[0026] The width of the support 12 in the Z direction is a width that allows it to be easily inserted into the catheter 3, but from the viewpoint of widening the cooling area (i.e., heat dissipation area) by the refrigerant, it may be set as wide as possible within a range that allows it to be smoothly inserted into the catheter 3. The thickness of the support 12 in the Y direction is a thickness that can stably support the light-emitting element 11 and that allows it to be smoothly inserted into the catheter 3 with the light-emitting element 11 mounted thereon. As an example, the thickness of the support 12 is about 0.075 to 0.5 mm.

[0027] The light-emitting element 11 is, for example, an edge-emitting laser element, and resonates in a direction parallel to the X-axis. When an edge-emitting laser element is used as the light-emitting element 11, one end face in the resonance direction serves as a light-emitting surface, which serves as the light-emitting portion 111. A mirror 17 is disposed on the light-emitting element mounting surface 121 of the support 12 so as to face the light-emitting portion 111, and guides the light emitted from the edge-emitting laser element in a direction intersecting with the light-emitting element mounting surface 121. The direction intersecting with the light-emitting element mounting surface 121 is any direction except for directions parallel to the light-emitting element mounting surface 121, and can be, for example, in the range of 50° to 130° relative to the light-emitting element mounting surface 121. It may also be a direction perpendicular to the light-emitting element mounting surface 121. Here, the "perpendicular" direction does not need to be strictly perpendicular to the light-emitting element mounting surface 121, and can include a range of 90°±5°, taking into account manufacturing errors and surface conditions of the support 12 and the mirror 17.

[0028] The light emitted from the light emitting element 11 is reflected by the light incident surface 171 of the mirror 17 and is emitted in a predetermined direction. When a polysilazane coating is used for the insulating layer 16, the light can also be reflected by the polysilazane coating.

[0029] In the configuration example shown in FIG. 2 , the first insulated wire 14A and the second insulated wire 14B are connected to the top surface of the light-emitting element 11 and the back surface 122 of the support 12, respectively, so as not to interfere with light emission from the light-emitting element 11 in the X direction and reflection by the mirror 17. A conductive layer is formed on at least a portion of the surface of the support 12. In the example shown in FIG. 2 , the support 12 has conductive layers formed on the light-emitting element mounting surface 121, the back surface 122, and at least a portion of the side surface connecting the light-emitting element mounting surface 121 and the back surface 122. As a result, the first insulated wire 14A is electrically connected directly or indirectly to one electrode of the light-emitting element 11 on the light-emitting element mounting surface 121 side of the support 12. The second insulated wire 14B is electrically connected directly or indirectly to the other electrode of the light-emitting element 11 on the back surface 122 of the support 12 via a conductive layer 124 formed on the support 12. Note that the tip of the second insulated wire 14B may protrude in the +X direction relative to the first insulated wire 14A. This structure allows for more efficient heat dissipation. As described above, by using wide wires such as rectangular enameled wires, the bonding area with the support 12 and the light emitting element 11 can be increased. In particular, it is desirable for each insulated wire to be in contact with the support 12 and the light emitting element 11 over the entire width direction.

[0030] The thickness of the insulating layer 16 may be thicker than the thickness of the light-emitting element 11 in at least a part thereof. In this case, the space 13 between the light-emitting portion 111 and the light-incident surface 171 of the mirror 17 may be filled with the insulating layer 16. Light emitted from the light-emitting portion 111 passes through the insulating layer 16 and is incident on the light-incident surface 171 of the mirror 17. By making the insulating layer 16 thick, the support 12, the light-emitting element 11, the mirror 17, and the wiring portion 14 can be stably held as a whole, and it is possible to reliably prevent the optically coupled portions and the electrically connected portions from coming into contact with the refrigerant.

[0031] A portion of the insulating coating of the first insulated wire 14A is removed, and the internal metal wiring is connected to one electrode of the light-emitting element 11. A portion of the insulating coating of the second insulated wire 14B is removed, and the internal metal wiring is electrically connected to the other electrode of the light-emitting element 11. In this embodiment, a conductive layer 124 is formed from the light-emitting element mounting surface 121 of the support 12, through the side surface, to the back surface 122, and the internal metal wiring of the second insulated wire 14B is connected to the conductive layer 124 on the back surface 122 of the support 12. This achieves electrical connection between the other electrode of the light-emitting element 11 and the second insulated wire 14B. By providing the conductive layer 124 for electrical connection on the surface of the support 12, the conductive layer 124 can be used as a heat dissipation member.

[0032] As described above, the mirror 17 is mounted on the support 12 and faces the light emitting portion 111. The body of the mirror 17 is formed of a dielectric material such as glass, and a thin silver film is formed on the light incident surface 171, but this example is not limiting. A thin film of aluminum, aluminum alloy, gold, nickel, platinum, or the like may be formed on the light incident surface (i.e., the reflective surface) of the plastic body. A dielectric multilayer film may be formed instead of a metal reflective film. The support 12, the light emitting element 11, the mirror 17, and a portion of the wiring portion 14 are covered with a light-transmitting insulating layer 16 by a dipping method, a spraying method, or the like.

[0033] The semiconductor material and its composition of the light-emitting element 11 are designed to emit light of a desired wavelength. When the light-emitting element 11 is used as an ultraviolet laser, a violet laser, a blue laser, or a green laser, GaN-based materials such as GaN, InGaN, and AlGaN are used. When the light-emitting element 11 is used as a red laser, an infrared laser, or a near-infrared laser, GaAs-based materials such as GaAs and AlGaAs, or InP-based materials such as InAlGaP and GaInP are used. The ridge width may be wide to ensure the gain of the active layer, from the viewpoint of sealing the light-emitting element 11, the first insulated wire 14A, and the second insulated wire 14B, with the insulating layer 16 when mounted on the support 12. The ridge width may be designed to be, for example, 2 μm to 100 μm. The transverse mode may be multimode or single mode. Furthermore, the number of ridges does not need to be one; multiple ridges may be used. Having multiple ridges allows for heat dispersion, thereby improving heat dissipation.

[0034] When a laser element is used as a light-emitting element, it is easier to emit light with less divergence and higher directionality than a light-emitting diode. Using a laser element makes it possible to selectively irradiate light of a specific wavelength onto a specific location in a living body. As a result, various problems (e.g., side effects) caused by light being irradiated to unintended locations are less likely to occur. Furthermore, compared to light-emitting diodes, laser elements have the property of irradiating light with wavelengths having a narrower spectral width. Therefore, by providing a laser element at the tip of the light irradiation device 2, various problems (e.g., reduced irradiation efficiency and / or unintended tissue changes) caused by irradiating tissue with a wavelength different from the wavelength required for treatment (e.g., the excitation wavelength of a photosensitizer) are also suppressed. This makes it easier to irradiate specific locations in a living body lumen with light more efficiently and appropriately.

[0035] As shown in Figure 6, the laser element can be a vertical cavity surface emitting laser (VCSEL) that emits laser light in a direction perpendicular to the substrate. By using a vertical cavity surface emitting laser, the light emitting device 2 can emit laser light with less power than an edge-emitting laser, and also has high resistance to temperature changes. Furthermore, since a surface emitting laser can emit laser light in a direction perpendicular to the substrate surface, there is no need to use a mirror 17, making it easier to adjust the irradiation position of the laser light more accurately. Note that the vertical cavity surface emitting laser may be used in combination with one or more of a mirror, prism, lens, and diffractive optical element that change the spread angle of the light emitted from the light emitting portion.

[0036] The light irradiation device 2 may include a plurality of light-emitting elements. For example, as shown in Fig. 6, the light irradiation device 2 includes a plurality of light-emitting elements 11A and 11B at its tip. By providing a plurality of light-emitting elements 11A and 11B in one light irradiation device 2, the degree of freedom in light irradiation (e.g., ease of adjusting at least one of the irradiation area, irradiation density, irradiation direction, etc.) is improved compared to when only one light-emitting element is provided. As a result, it becomes easier to obtain an appropriate therapeutic effect.

[0037] The light emission of at least some of the light-emitting elements 11A and 11B may be controllable independently of the other light-emitting elements. For example, the light irradiation device 2 may include a control unit capable of independently controlling the light emission of the two light-emitting elements 11A and 11B. As a result, the degree of freedom in light irradiation is further improved.

[0038] The light-emitting elements 11A, 11B may emit light in the same wavelength range or in different wavelength ranges. The light-emitting elements 11A, 11B may emit light with a wavelength of 300 nm or more and 2000 nm or less. More preferably, the light-emitting elements 11 emit light with a wavelength of 600 nm or more and 1000 nm or less. In this case, by using the light irradiation device 2 in the treatment of a disease using a photosensitive substance, it becomes easier to obtain an appropriate therapeutic effect.

[0039] (Catheter) The catheter 3 of this embodiment will be described with reference to Figures 1 to 3. As shown in Figures 1 and 2, the catheter 3 has a long tubular shape. The catheter 3 includes a connector 301, a shaft 310, and a distal tip 320. The connector 301 is located on the proximal end side of the catheter 3 and is held by the surgeon. The connector 301 includes a pair of wings 302 and a connecting portion 303. The connecting portion 303 is a substantially cylindrical member. The wings 302 are connected to the proximal end of the connecting portion 303. The shaft 310 is connected to the distal end of the connecting portion 303. The wings 302 and the connecting portion 303 may be formed integrally.

[0040] The shaft 310 preferably has antithrombogenicity, flexibility, thermal conductivity, and biocompatibility. The shaft 310 can be made of at least one of a resin material and a metal material. Examples of resin materials include polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin. Examples of metal materials include stainless steel such as SUS304, nickel-titanium alloy, cobalt-chromium alloy, and tungsten steel. The shaft 310 can also be made of a combination of multiple materials. The shaft 310 is a long, tubular member extending along the axis O3. In this embodiment, the shaft 310 is formed as a hollow cylinder with both the distal and proximal ends open. The lumen 311 inside the shaft 310 functions as a guidewire lumen for inserting a guidewire into the catheter 3 during delivery of the catheter 3. After delivery of the catheter 3, the lumen 311 functions as a device lumen for inserting the light irradiation device 2 into the catheter 3.

[0041] The distal tip 320 is connected to the distal end of the shaft 310. The distal tip 320 has an outer shape that tapers from the proximal end to the distal end to allow the catheter 3 to smoothly advance within a biological lumen. A through-hole 321 penetrating the distal tip 320 in the direction of the axis O2 is formed approximately at the center of the distal tip 320. As shown in FIG. 3 , the inner diameter F2 of the through-hole 321 is smaller than the inner diameter F3 of the lumen 311 of the shaft 310 and smaller than the outer diameter F1 of the light irradiation device 2. Here, the outer diameter F1 of the light irradiation device 2 is the diameter of a circumscribed circle in a cross section perpendicular to the direction of the axis O2 (in other words, the longitudinal direction of the light irradiation device 2). The outer diameter F1 of the light irradiation device 2 is equal to or smaller than the inner diameter F3 of the lumen 311 of the catheter 3. Therefore, the light irradiation device 2 can be pushed and moved within the lumen 311 of the catheter 3 along the axis O2.

[0042] The configuration of the distal end of the catheter 3 of this embodiment will be described with reference to Fig. 3. As shown in Fig. 3, a light-transmitting portion 330A that transmits light emitted by the light-emitting portion 111 (in this embodiment, the light-emitting surface of the light-emitting element 11) of the light irradiation device 2 to the outside is provided on the distal end side surface of the shaft 310 of the catheter 3 (in this embodiment, a part of the distal end side surface). Therefore, the light irradiation system 1 of this embodiment can selectively irradiate a specific position of a living body with light emitted by the light-emitting portion 111 of the light irradiation device 2 in a direction intersecting the axes O2 and O3.

[0043] In this embodiment, the light-transmitting portion 330A is provided by partially forming a portion of the shaft 310 of the catheter 3 that transmits the light emitted by the light emitting portion 111 using a light-transmitting material. However, the configuration of the light-transmitting portion can be changed. For example, the light-transmitting portion may be provided in the catheter by using a light-transmitting material for the shaft 310 itself or the entire tip portion of the shaft 310.

[0044] A radiopaque catheter marker 332A is provided on the shaft 310 of the catheter 3 at a position close to the light-transmitting portion 330A. Therefore, when a medical professional (e.g., a surgeon) irradiates biological tissue with light using the light irradiation device 2 while capturing an image of the inside of a living body using radiation (e.g., X-rays), the medical professional can align the position from which light is emitted by the light-emitting portion 111 of the light irradiation device 2 with the position of the catheter marker 332A that appears in the captured image, thereby allowing the light to be appropriately irradiated to the outside from the light-transmitting portion 330A. This makes it easier to further improve the accuracy of treatment.

[0045] 3 and other figures, in this embodiment, at least a portion (in this embodiment, the entirety of the distal tip 320) of the distal tip 320 provided at the distal end of the shaft 310 of the catheter 3 is made of a radiopaque material, so that it can also function as a marker. Therefore, the position of the distal end of the catheter 3 can be properly grasped.

[0046] The catheter 3 may be provided with a magnetic member at its tip. The magnetic member may function as a guide member that guides at least one of the position and direction of the tip of the catheter 3 within the lumen of the living body by a magnetic force generated when the catheter 3 is placed in a magnetic field. In this case, at least one of the position and direction of the tip is appropriately guided when the catheter 3 is inserted into the lumen of the living body.

[0047] The distal tip 320 may be made of a magnetic material so that it also functions as a guide member. In this case, the catheter 3 is endowed with multiple useful functions while suppressing an increase in the number of parts.

[0048] Of the shaft 310 of the catheter 3, at least the distal end portion (in this embodiment, the entire shaft 310) that the light emitting element 11 of the light irradiation device 2 approaches during light irradiation is made of a material with a thermal conductivity of 0.1 W / m·K or more. This makes it easier for the light emitting element 11 to be cooled by a refrigerant such as blood flow or saline. This reduces the possibility of malfunction of the light emitting element 11 due to heat generated by the light emitting element 11 emitting light, particularly laser light. This makes it easier to perform treatment more appropriately.

[0049] The light irradiation device 2 may be provided with an optical sensor that detects light (including reflected light) emitted by the light emitting element 11. This allows the state of the irradiated light to be properly grasped.

[0050] (Method of Use) An example of a method of using the light irradiation system 1 of this embodiment will be described. First, an operator (e.g., a doctor) inserts a guidewire (not shown) into a biological lumen. Next, the operator inserts the proximal end of the guidewire into the lumen 311 through the through-hole 321 of the distal tip 320 of the catheter 3, causing it to protrude from the proximal end of the connector 301. The operator pushes the catheter 3 along the guidewire, moving the light-transmitting portion 330A of the catheter 3 to the target site for light irradiation. Note that, when moving the catheter 3 within the biological lumen, the operator can appropriately move the catheter 3 to the target site by checking the position of the catheter marker portion 332A using a radiographic image. Thereafter, the operator removes the guidewire from the catheter 3.

[0051] The surgeon inserts the light irradiation device 2 through the proximal opening of the connector 301 of the catheter 3 and advances the light irradiation device 2 along the lumen 311 of the catheter 3 within the biological lumen. When the light irradiation device 2 is advanced sufficiently through the lumen 311 of the catheter 3, the distal end of the light irradiation device 2 reaches the vicinity of the distal tip 320 of the catheter 3. As shown in FIG. 3 , the light transmission portion 330A of the catheter 3 is formed at a position along the axes O2 and O3 where the light emitting element 11 is positioned with the distal end of the light irradiation device 2 proximate to the distal end of the lumen of the catheter 3 (the distal tip 320 of the catheter 3). In this state, light is emitted from the light emission portion 111, thereby selectively irradiating the target area with light. It is desirable to fill the interior of the catheter with saline or the like beforehand. This prevents air from entering the body.

[0052] With the light irradiation device 2 inserted into the catheter 3, the surgeon can cause a refrigerant to flow into the lumen 311 of the catheter 3. Therefore, problems caused by a rise in temperature at the tip due to the light emitting element 11 (for example, failure of the light emitting element 11) are appropriately suppressed by the refrigerant.

[0053] As described above, the catheter 3 and the light irradiation device 2 are used by being inserted into a lumen of a living body (for example, at least one of a blood vessel, a lymph node, a urethra, a respiratory tract, a digestive organ, a secretory gland, and a reproductive organ). In order to insert the catheter 3 and the light irradiation device 2 into a lumen that is complexly curved, such as a blood vessel, the catheter 3 and the light irradiation device 2 need to have a desired flexibility.

[0054] 2 , the light irradiation device 2 of this embodiment has a first region 201 having a light emitting portion 111 on the distal end side, and a second region 202 located closer to the proximal end than the first region 201. The second region 202 has higher flexibility than the first region 201. In other words, the second region 202 is a region that is more flexible than the first region 201.

[0055] The first region 201 is a region having a light emitting portion 111 of the light emitting element 11 or the like. When the light emitting element 11 is a semiconductor light emitting element, a semiconductor is laminated on a substrate such as sapphire or GaN. When the light emitting element 11 is mounted on a support 12, the support 12 is made of silicon (Si), aluminum nitride (AlN), silicon nitride (SiN), sapphire (Al ２ O ３ The first region 201 is formed of an insulating material such as glass, quartz, or ceramic. Furthermore, an optical control element such as a mirror 17 that changes at least one of the direction and spread angle of light emitted from the light emitting portion 111 is also disposed in the first region 201. Examples of the optical control element include a mirror, a prism, a lens, and a diffractive optical element. As a result, the first region 201 contains a relatively hard material and is relatively harder than the second region 202. In other words, the first region 201 is less flexible than the second region 202. Thus, the first region 201 is a region that includes the light emitting portion 111, is located near the light emitting portion 111, and is home to a member with very little flexibility. Specifically, the first region 201 includes the light emitting element 11, the support 12, the optical control element, a case 288 (described later), and the like. The first region 201 may be sealed with an insulating sealing member.

[0056] In addition to the light-emitting element 11 and optical control element described above, at least one of a temperature sensor, a light-receiving element, and a protective element may be arranged in the first region. For example, the first region may include at least three elements selected from the group consisting of a light-emitting element, an optical control element, a temperature sensor, a light-receiving element, and a protective element. Among the three or more elements, two or more of the same type may be included. That is, the number of light-emitting elements may be three, or as shown in FIG. 4 described later, one light-emitting element and two optical control elements may be included. The number of these elements arranged in the first region may be four or more, five or more, six or more, or seven or more.

[0057] The second region 202 is a region away from the light emitting portion 111 toward the base end, and mainly includes a wiring portion 14 for supplying power to the light emitting element 11 and a torque wire 15 for imparting rotational tracking ability to the light irradiation device 2.

[0058] FIG. 7 is an explanatory diagram showing the state in which the light irradiation system 1 is placed inside a blood vessel B. In FIG. 7, the blood vessel B is indicated by a dotted line. The distal end portion of the catheter 3 is simplified to facilitate understanding of the structure. In order to irradiate light in a desired direction inside the blood vessel B, the first region 201 is rotatable around the extension direction of the light irradiation device 2, which serves as a rotation axis. In other words, the torque wire 15 is an example of a control unit that can rotate the first region 201 around the extension direction of the light irradiation device 2. As shown in FIG. 7, the torque wire 15 is disposed around the wiring portion 14, for example. The torque wire 15 can be formed, for example, of a flexible wire. The torque wire 15 is made of a material with higher rigidity than the wiring portion 14 disposed inside. The torque wire 15 is, for example, a conductor, and is a metal wire made of a metal such as copper, aluminum, nickel, gold, or platinum, or an alloy thereof, or a Ni-Ti alloy or stainless steel. The metal wire may be either a single metal wire or a twisted wire made by twisting together thin metal wires. Furthermore, instead of using a metal wire, a single resin wire, a twisted resin wire, or a wire made of an inorganic material such as glass may be used as the torque wire 15. It is desirable that the torque wire 15 be biocompatible.

[0059] Typically, the wiring portion 14 is more flexible than the torque wire 15. In other words, the wiring portion 14 is more flexible than the torque wire 15. In this embodiment, the wiring portion 14 is an insulated wire. An insulated wire has excellent flexibility (also referred to as flexibility). The wiring portion 14 may be a flexible substrate.

[0060] When the extension direction of the light irradiation device 2 is taken as an axis, the area of ​​the second region 202 in a planar direction perpendicular to this axis is preferably smaller than the area of ​​the first region 201. This can further improve the ability to insert deep into a lumen.

[0061] Here, a bending test for measuring the flexibility of the light irradiation device 2 will be described. First, one side of a columnar sample is fixed to a support surface at a position 30 mm from the tip. In other words, a portion 30 mm from the tip of the sample is set to protrude into space without contacting the support surface. A position 20 mm from the tip of the fixed sample (i.e., a position 10 mm from the fixed position) is pressed 1.0 mm with a jig in a direction perpendicular to the extension direction of the sample and opposite the normal direction to the support surface, and the maximum indentation load is measured to determine the flexibility of the sample. The indentation speed is 100 μm / sec. In this embodiment, the maximum indentation load of the light irradiation device 2 is preferably 19.6133 mN (2.0 gf) or less. The flexibility of the light irradiation device 2 is measured when it is not inserted into the catheter 3. Furthermore, assuming insertion into the deep brain, the maximum indentation load is preferably 4.90332 mN (0.5 gf) or less. Setting the flexibility of the light irradiation device 2 as described above allows it to follow the shape of most lumens in a living body. In this embodiment, the length of the first region 201 is less than 30 mm, and the location to be measured is the second region 202. Therefore, the flexibility of the light irradiation device 2 can also be referred to as the flexibility of the second region 202. The length of the second region 202 is sufficient as long as it is 30 mm or more. If the length is 1.5 m or more, the region that enters the body, excluding the first region 201, can be the second region 202 that is more flexible than the first region 201.

[0062] It is preferable that the second region 202 has a maximum pushing load of 19.6133 mN or less when pushed 1.0 mm in the vertical direction over a range of at least 30 mm in length. It is preferable that the most flexible part of the second region 202 is the region adjacent to the base end of the first region 201. This is because the closer to the tip of the light irradiation device 2 is to the deeper part of the body, and therefore higher insertability is preferable.

[0063] The expected catheter diameter is, for example, 6 Fr or less. The catheter diameter varies depending on the target area to be irradiated with light. However, when it is desired to reach deep inside the body, the thinner the catheter, the better. For example, 4.2 Fr is used for the pancreatic artery and deep brain, and 3 Fr for the deepest part of the brain. The outer diameter F4 of a 4.2 Fr catheter is 1.4 mm, and the inner diameter F3 of the lumen is approximately 1.1 mm. The outer diameter F4 of a 3 Fr catheter is 0.95 mm, and the inner diameter F3 of the lumen is 0.7 mm. Therefore, the outer diameter F1 of the light irradiation device 2 to be inserted into a 4.2 Fr catheter is preferably 1.1 mm or less, and more preferably 1.0 mm or less. The outer diameter F1 of the light irradiation device 2 to be inserted into a 3 Fr catheter is preferably 0.7 mm or less, and more preferably 0.6 mm or less.

[0064] Furthermore, considering the ease with which the light emitting portion of the light emitting device 2 can reach the target position when inserted into the lumen of the catheter 3, the distal end of the light emitting device 2 is preferably rigid. In this embodiment, the first region 201 is harder than the second region 202, making it easier to reach the target position. On the other hand, because the first region 201 is rigid and difficult to bend, if the first region 201 is too long, it will not be able to follow the body's movements when inserted into a lumen, resulting in poor insertability. Therefore, when using 4.2 Fr and 3 Fr catheters, the allowable outer diameter and length of the first region 201 were determined assuming the outer diameter F1 of the light emitting device 2 to be 0.7 mm or 0.5 mm. The conditions are as shown in Table 1. Furthermore, to insert the light emitting device 2 into a curved blood vessel, the bending radius R is preferably 5 mm or less, and more preferably 3 mm or less.

[0065]

[0066] This calculation shows that when the outer diameter F1 of the light irradiation device 2 is 0.7 mm, the length of the first region 201 should be 3.40 mm or less, and when the outer diameter F1 of the light irradiation device 2 is 0.5 mm, the length of the first region 201 should be 4.44 mm or less. When the outer diameter F1 of the light irradiation device 2 is 0.7 mm and the length of the first region 201 is 4.44 mm, the bending radius is 8.78. Therefore, when the outer diameter F1 of the light irradiation device 2 is 0.5 mm or less and the length is 3.40 mm or less, it is possible to improve deep insertion capability into a lumen under the condition of a bending radius of 5 mm, which is preferable. Furthermore, when the outer diameter F1 of the light irradiation device 2 is 0.5 mm or less and the length of the first region 201 is 1.97 mm or less, it is possible to reach almost all deep body regions. From this result, it is possible to further improve the deep insertion capability into a lumen by setting the length of the first region 201 to 2.0 mm or less and the outer diameter F1 of the light irradiation device 2 to 0.5 mm or less. Here, the "outer diameter F1 of the light irradiation device 2" refers to the diameter of a circumscribed circle in a cross section perpendicular to the longitudinal direction of the light irradiation device 2.

[0067] From the values ​​in Table 1, when the length of the first region is L, the diameter of the circumscribed circle, i.e., the outer diameter of the light irradiation device, is Φ, and the insertable outer diameter of the catheter is F, the light irradiation device 2 satisfies the following formula (1), so that the bending R is 5 mm or less, thereby improving the ability to insert deeply into a lumen. In the case of the following formula (2), the bending R is 3 mm or less, which further improves the ability to insert deeply into a lumen. Note that the insertable outer diameter F is the outer diameter of the light irradiation device that is set smaller than the inner diameter of the catheter so that the light irradiation device can be inserted into the catheter.

[0068] Although an example in which the light irradiation device 2 is used by being inserted into the catheter 3 has been described above, the light irradiation device 2 may also be used without being inserted into the catheter 3. For example, the light irradiation device 2 may be used by being inserted into the forceps port of an endoscope. Alternatively, the light irradiation device 2 may be used by being inserted into a puncture needle. By irradiating light through blood flow, saline, or the like that is stored or has been stored in body tissue, these liquids can be used as a refrigerant.

[0069] (Modifications) The techniques disclosed in the above embodiments are merely examples. Therefore, it is possible to modify the techniques exemplified in the above embodiments. The first modification shown in FIG. 4 and the second modification shown in FIG. 5 can partially adopt the same configuration as the above-described embodiments. Therefore, among the configurations of the first modification and the second modification, parts that can adopt the same configuration as the above-described embodiments are assigned the same numbers as the above-described embodiments, and their description will be omitted or simplified.

[0070] 4 , a light irradiation device 2A of a first modification uses a flexible substrate instead of an insulated wire as the wiring section 14, which is a means for supplying current to the light emitting element 11. The light irradiation device 2A also has a case 288 and an insulating sealant 289 that seals the opening of the case 288. The case 288 accommodates the light emitting element 11, the lens 17A, the mirror 17B, the support 12, and a connection portion between the light emitting element 11 and the flexible substrate. The case 288 is an example of an insulating sealant.

[0071] In the first modification, the divergence angle of the light emitted from the light emitting element 11 is adjusted by the lens 17A, and then the light is reflected by the light incident surface 171 of the mirror 17B and transmitted through the light transmitting portion 330A.

[0072] (Case) The case 288 is a transparent cylinder made of glass, quartz, biocompatible plastic, or the like. The outer diameter of the case 288 is, for example, 0.4 mm to 2.0 mm, preferably 0.5 mm or less. The inner diameter is 0.3 mm to 1.5 mm, preferably 0.45 mm or less. As an example, a biocompatible plastic tube with an outer diameter of 0.5 mm and an inner diameter of 0.38 mm is used. The width of the support 12 in the Z direction is smaller than the inner diameter of the case 288, but may be set as wide as possible within the range that can be accommodated within the case 288 in order to increase the contact area with the refrigerant. The height of the support 12 in the Y direction is a thickness that can stably support the light-emitting element 11, and is, for example, approximately 0.1 to 0.3 mm. The length of the support 12 in the X direction is longer than the length of the cylindrical axis (X direction) of the case 288 and is determined according to the length of the case 288. When the length of the case 288 in the cylindrical axial direction is 1.0 mm, the length of the support 12 is, for example, 1.3 mm to 3.0 mm.

[0073] In the illustrated example, the entire light-emitting element 11 is sealed in the case 288, but only a portion of the light-emitting element 11, including the entire light-emitting portion 111, may be sealed in the case. The case 288 is less flexible than the first insulated wire 14A and the second insulated wire 14B. In this way, when the case 288 has a lower flexibility than the wiring portion 14, the first region 201 is the portion where the case 288 is present, and the second region 202 is the portion including the wiring portion 14 exposed from the case 288 to the outside of the case 288.

[0074] In the first modification, the torque wire is also provided around the wiring portion 14. The torque wire is made of a material that is more rigid than the wiring portion 14, i.e., the flexible substrate, that is disposed inside the torque wire.

[0075] (Second Modification) In a light irradiation device 2B of a second modification shown in Fig. 5, a part of an optical fiber is used as the light emitting portion 111. That is, in the second modification, the light emitting surface of the optical fiber serves as the light emitting portion 111. The light irradiation device 2B has a support 283 that supports an end of an optical fiber 290, a lens 17A, and a mirror 17B. As shown in the cross-sectional views along the arrows CC and DD in Fig. 5, a V-shaped groove is formed in the main surface of the support 283 along the longitudinal axis direction of the light irradiation device 2B.

[0076] Optical fiber 290 is placed on support 283 so that the two inclined surfaces forming the V-groove are in contact with the outer circumferential surface of optical fiber 290. Furthermore, the portion at the end of support 283 where lens 17A and mirror 17B are placed is thinner than the portion where optical fiber 290 is placed, and the size of the V-groove relative to the main surface of support 283 is smaller. This allows these optical control elements to be placed on the flat portion of the upper surface of support 283, even when lens 17A and mirror 17B are placed above the V-groove.

[0077] In the second modification, the first region 201 is the portion where the case 288 is present, and the second region 202 is the portion including a portion of the optical fiber 290 exposed from the case 288 to the outside, the first insulated wire 14A, and the second insulated wire 14B. That is, the optical fiber 290 is disposed in both the first region 201 and the second region 202. The optical fiber 290 itself is flexible and soft, and in the bending test described above, the maximum indentation load can be 19.6133 mN or less. However, the region where the optical fiber 290 is bonded to the support 12 becomes hard because it is fixed to the support 12. Furthermore, to provide rotational tracking capability, a torque wire may be provided as a control unit around the optical fiber 290 in the second region 202. The torque wire is made of a material with higher rigidity than the optical fiber 290 disposed inside. Alternatively, the torque wire and the optical fiber may be bonded by filling a resin between the torque wire and the optical fiber. As a result of hardening the resin, the resin may have higher rigidity than the torque wire, but the second region including the hardened resin has higher flexibility than the first region.

[0078] 6 , a vertical cavity surface emitting laser (VCSEL) is used as the light emitting element 11. The light irradiation device 2C includes two light emitting elements 11A and 11B that emit light of a predetermined wavelength, a support 12 on which the light emitting elements 11A and 11B are mounted, and a wiring section 14 electrically connected to the light emitting elements 11A and 11B. The wiring section 14 includes a first insulated wire 14A and a second insulated wire 14B.

[0079] The light emitting section 111 of the light irradiation device 2C and the electrical connection section between the light emitting element 11 and the wiring section 14 are integrally sealed with the support body 12 by the insulating layer 16. At least one of both ends of the support body 12 along the longitudinal direction (Z direction) may protrude from the insulating layer 16. At least the portion of the insulating layer 16 that covers the light emitting section 111 is translucent. The thickness of the insulating layer 16 may be thicker or thinner than the thickness of the light emitting element 11.

[0080] The light-emitting portion 111 of the VCSEL used in the light-emitting element 11 is parallel to the light-emitting element mounting surface 121 of the support body 12, and the laser light emitted from the VCSEL is emitted in a direction perpendicular to the light-emitting element mounting surface 121, as shown by the white arrow in the figure. In this configuration, no optical components such as mirrors are required.

[0081] In the third modified example, the portion where the light emitting element 11 and the support 12 exist is the first region 201 , and the portion where the wiring portion 14 located closer to the base end than the support 12 exists is the second region 202 .

[0082] As described above with reference to examples, the first region 201 in this embodiment is a region that is less flexible than the second region 202, includes the light emitting portion 111, and is configured integrally with the light emitting portion 111. Specifically, this region includes the light emitting element 11, the support 12, the optical control element, the case 288, etc. The second region 202 is a region that is more flexible and has greater flexibility than the first region 201, and in the bending test described above, the maximum indentation load is 19.6133 mN or less.

[0083] Embodiments of the present disclosure may include, for example, the following configuration: <Item 1> A light irradiation device to be inserted into a lumen in a body and used for treatment by irradiating with light emitted from the light emitting portion, the light irradiation device having, on a distal side of the light irradiation device, a first region having a light emitting portion, and a second region located on a proximal side of the first region and having a length of 30 mm or more, the second region being more flexible than the first region, the maximum pushing load when the light irradiation device is fixed at a position 30 mm from the distal end and a position 20 mm from the distal end is pushed 1.0 mm in a direction perpendicular to an extension direction of the light irradiation device as an axis is 19.6133 mN or less, the length of the first region is 4.44 mm or less, and the diameter of a circumscribed circle in a cross section perpendicular to the length direction is 0.7 mm or less. <Item 2> The light irradiation device according to item 1, wherein the light irradiation device is used by being inserted into a lumen of a catheter, and the maximum pushing load is a value in a state where the light irradiation device is not inserted into the catheter. <Item 3> The light irradiation device according to item 2, wherein the light irradiation device satisfies the following formula (1), where L is the length of the first region, Φ is the diameter of the circumscribed circle, and F is the insertable outer diameter of the catheter. <Item 4> The light irradiation device according to item 1, wherein the second region has a maximum indentation load of 19.6133 mN or less when pressed 1.0 mm in the vertical direction over a range of at least 30 mm in length. <Item 5> The light irradiation device according to any one of items 1 to 4, wherein the area of ​​the second region is smaller than the area of ​​the first region in a planar direction perpendicular to the axis. <Item 6> The light irradiation device according to any one of items 1 to 5, wherein the first region has a support that supports the light emitting section. <Item 7> The light irradiation device according to any one of items 1 to 6, wherein the second region has a control section that can rotate the first region about the axis as a rotation axis. <Item 8> The light irradiation device according to any one of items 1 to 7, wherein the length of the first region is 2.0 mm or less. <Item 9> The light irradiation device according to any one of items 1 to 8, wherein at least three or more elements selected from the group consisting of a light-emitting element, an optical control element, a temperature sensor, a light-receiving element, and a protection element are arranged in the first region. <Item 10> The light irradiation device according to any one of Items 1 to 8, wherein the light irradiation device has a light emitting element, and the light emitting portion is a light emitting surface of the light emitting element. <Item 11> The light irradiation device according to Item 10, wherein the light emitting element is an edge-emitting laser element. <Item 12> The light irradiation device according to Item 10, wherein the light emitting element is a vertical-cavity surface-emitting laser element. <Item 13> The light irradiation device according to any one of Items 1 to 12, wherein the first region has an optical control element that changes at least one of the direction and spread angle of light emitted from the light emitting portion. <Item 14> The light irradiation device according to any one of Items 1 to 13, wherein the first region is sealed with an insulating sealing member. <Item 15> The light irradiation device according to any one of Items 1 to 14, wherein the lumen is a blood vessel. <Item 16> The light irradiation device according to any one of Items 1 to 15, wherein the catheter is inserted from outside a human body, and the tip of the light irradiation device is made to reach a blood vessel having a diameter of 1.4 mm or less, and light can be irradiated.<Item 17> A medical light irradiation system comprising: a catheter having an outer diameter of 1.4 mm or less and a lumen having an inner diameter of 1.1 mm or less; and the light irradiation device according to any one of Items 1 to 16, which is inserted into the lumen of the catheter. <Item 18> A method for preparing a catheter that allows a doctor to insert the catheter and reach a blood vessel with a diameter of 1.4 mm or less, thereby enabling treatment using light irradiation, the method comprising: inserting the catheter by inserting the catheter into a lumen of the catheter having an outer diameter of 1.4 mm or less, the light irradiation device having a first region having a light emitting portion on the tip side, and a second region that is located on the base end side of the first region and has a length of 30 mm or more, the second region being more flexible than the first region, the light irradiation device having a maximum pushing load of 19.6133 mN or less when the tip portion is pushed 1.0 mm in a direction perpendicular to the axis, with the extension direction of the light irradiation device as the axis, when the light irradiation device is not inserted into the catheter, the maximum pushing load is 19.6133 mN or less when the tip portion is pushed 1.0 mm in a direction perpendicular to the axis, the first region having a length of 4.44 mm or less, and the diameter of the circumscribed circle in a cross section perpendicular to the length direction is 0.7 mm or less, the method for preparing the catheter by inserting the light irradiation device into a lumen of the catheter having an outer diameter of 1.4 mm or less.

[0084] 1 Light irradiation system 2, 2A, 2B, 2C Light irradiation device 111 Light emission section 11, 11A, 11B Light emitting element 17 Mirror 171 Light incident surface 12 Support 121 Light emitting element mounting surface 122 Back surface 124 Conductive layer 13 Space 14 Wiring section 14A First insulated wire 14B Second insulated wire 15 Torque wire 16 Insulating layer 17, 17B Mirror 17A Lens 201 First region 202 Second region 283 Support 288 Case 289 Sealant 290 Optical fiber 3 Catheter 301 Connector 302 Wing section 303 Connection section 310 Shaft 311 Lumen 320 Distal tip 321 Through hole 330A Light transmitting section 332A Catheter side marker section

Claims

1. A light irradiation device that is inserted into a lumen inside the body and used for treatment by irradiating with light emitted from the light emitting portion, the light irradiation device having a first region at the distal end side of the light irradiation device and a second region that is located closer to the base end than the first region and has a length of 30 mm or more, the second region being more flexible than the first region, the maximum pushing load when the light irradiation device is fixed at a position 30 mm from the distal end and a position 20 mm from the distal end is pushed 1.0 mm in a direction perpendicular to the axis along the extension direction of the light irradiation device is 19.6133 mN or less, and the length of the first region is 4.44 mm or less, and the diameter of the circumscribed circle in a cross section perpendicular to the length direction is 0.7 mm or less.

2. The light irradiation device according to claim 1, wherein the light irradiation device is used by being inserted into the lumen of a catheter, and the maximum pushing load is a value when the light irradiation device is not inserted into the catheter.

3. The light irradiation device according to claim 2, wherein the light irradiation device satisfies the following formula (1), where L is the length of the first region, Φ is the diameter of the circumscribed circle, and F is the insertable outer diameter of the catheter.

4. The light irradiation device according to claim 1, wherein the second region has a maximum indentation load of 19.6133 mN or less when pressed 1.0 mm in the vertical direction over a range of at least 30 mm in length.

5. The light irradiation device according to claim 1, wherein the area of ​​the second region is smaller than the area of ​​the first region in a plane direction perpendicular to the axis.

6. The light irradiation device according to claim 1, wherein the first region has a support that supports the light emitting portion.

7. The light irradiation device according to claim 1, wherein the second region includes a control unit that can rotate the first region around the axis.

8. The light irradiation device according to claim 1, wherein the length of the first region is 2.0 mm or less.

9. The light irradiation device according to claim 1, wherein at least three elements selected from the group consisting of a light emitting element, an optical control element, a temperature sensor, a light receiving element, and a protective element are arranged in the first region.

10. The light irradiation device according to claim 1, wherein the light irradiation device has a light emitting element, and the light emitting portion is a light emitting surface of the light emitting element.

11. The light emitting device according to claim 10, wherein the light emitting element is an edge-emitting laser element.

12. The light irradiation device according to claim 10, wherein the light emitting element is a vertical cavity surface emitting laser element.

13. The light irradiation device according to claim 1, wherein the first region has an optical control element that changes at least one of the direction and divergence angle of the light emitted from the light emitting portion.

14. The light irradiation device according to claim 1, wherein the first region is sealed with an insulating sealing member.

15. The light irradiation device of claim 1, wherein the lumen is a blood vessel.

16. The light irradiation device according to claim 2, wherein the catheter is inserted from outside the human body, the tip of the light irradiation device is brought into a blood vessel having a diameter of 1.4 mm or less, and light can be irradiated.

17. A medical light irradiation system comprising: a catheter having an outer diameter of 1.4 mm or less and a lumen having an inner diameter of 1.1 mm or less; and a light irradiation device according to any one of claims 1 to 16, which is inserted into the lumen of the catheter.

18. A method for preparing a catheter that allows a doctor to insert the catheter and reach a blood vessel with a diameter of 1.4 mm or less to perform treatment using light irradiation, the method comprising: inserting the catheter into the lumen of the catheter having an outer diameter of 1.4 mm or less; the catheter having a first region with a light-emitting portion on the tip side; and a second region located closer to the base end than the first region and having a length of 30 mm or more; the second region being a light irradiation device that is more flexible than the first region; when the light irradiation device is not inserted into the catheter, the light irradiation device is fixed at a position 30 mm from the tip, and when a position 20 mm from the tip is pressed 1.0 mm in a direction perpendicular to the axis along the extension direction of the light irradiation device, the maximum pressing load is 19.6133 mN or less; the first region is 4.44 mm or less in length; and the diameter of the circumscribed circle in a cross section perpendicular to the length direction is 0.7 mm or less; the method for preparing the catheter by inserting the light irradiation device into the lumen of the catheter having an outer diameter of 1.4 mm or less.

Images