Light irradiation device, light irradiation apparatus, and light irradiation method

Abstract

This light irradiation device has: a cylindrical indwelling tool; a planar light-emitting element formed on the surface of the cylindrical indwelling tool; and a power supply wire for supplying electrical power from outside a living body to the planar light-emitting element. The light irradiation device is used to irradiate the inside of the living body with light from the planar light-emitting element.

Description

Light irradiation device, light irradiation apparatus, and light irradiation method

[0001] The present invention relates to a light irradiation device, a light irradiation apparatus, and a light irradiation method for irradiating light inside a living body.

[0002] When tubular structures in the human body (such as blood vessels, tracheas, and bile ducts) become narrowed due to disease, stent treatment is sometimes performed, in which a stent is inserted into the lumen to widen the duct from the inside and alleviate symptoms. For example, when the bile duct is narrowed due to a tumor or gallstone, impairing bile flow (cholestasis) and causing symptoms such as jaundice, inserting a stent into the bile duct to widen the flow path can facilitate bile flow and alleviate symptoms such as jaundice. However, while stent insertion improves symptoms due to cholestasis, it does not fundamentally treat tumors in the bile duct. Therefore, as a catheter-based treatment device, a photoimmunotherapy device equipped with multiple near-infrared light-emitting diodes (LEDs) has been proposed (see, for example, Non-Patent Document 1). Photoimmunotherapy is a treatment method in which an antibody drug comprising a photosensitizer attached to an antibody is administered to the living body. Once the antibody drug has sufficiently concentrated in the tumor, light is irradiated to activate the photosensitizer and destroy tumor cells. In this case, if an LED attached to the catheter is used as a light source, it is possible to locally irradiate the antibody drug that has accumulated in the tumor at the affected area where the catheter is inserted, thereby reducing side effects during treatment.

[0003] Cancer Science. 2021;112:828-838

[0004] However, LEDs are highly directional point light sources. Therefore, when a catheter equipped with multiple LEDs is used as a treatment device, the light irradiation intensity becomes uneven, making it impossible to uniformly irradiate the entire affected area, such as a tumor. This can lead to problems such as insufficient therapeutic effects or partial increases in light irradiation intensity, causing damage to surrounding tissue. Furthermore, LEDs can increase in temperature due to current concentration, which can cause low-temperature burns to surrounding tissue. The problem to be solved by the present invention is to provide a light irradiation device that can uniformly irradiate surrounding tissue with light while indwelling in a living body.

[0005] As a result of intensive research conducted by the present inventors to solve the above problems, they discovered that by forming a planar light-emitting element on the surface of a stent and supplying power from outside the body via a wire, it is possible to realize a light-irradiation device that can uniformly irradiate light onto the entire target tissue while it is placed inside the body.

[0006] The present invention, which is a specific means for solving the above problems, and preferred embodiments of the present invention are as follows: [1] A light-irradiation device comprising a tubular indwelling device, a surface light-emitting element formed on the surface of the tubular indwelling device, and a power supply wire for supplying power to the surface light-emitting element from outside the body, and used to irradiate light from the surface light-emitting element inside the body. [2] The light-irradiation device according to [1], wherein the surface light-emitting element on the tubular indwelling device is covered with a light-transmitting heat-shrinkable tube. [3] The light-irradiation device according to [1] or [2], wherein the tubular indwelling device is a stent. [4] The light-irradiation device according to [3], further comprising a catheter, wherein the stent is connected to the catheter. [5] The light-irradiation device according to [4], wherein the power supply wire is inserted into the lumen of the catheter. [6] The light-irradiation device according to [1] or [2], wherein the tubular indwelling device is a catheter. [7] The light irradiation device according to [6], wherein the catheter is a catheter with a multi-lumen structure having a plurality of lumens, and the power supply wire is inserted into at least one of the plurality of lumens. [8] The light irradiation device according to any one of [1] to [7], wherein the surface light emitting element is a tape-shaped light emitting element, and the tape-shaped light emitting element is wrapped around the surface of the tubular indwelling device. [9] The light irradiation device according to [8], wherein the tape-shaped light emitting element is wrapped around the outer circumferential surface of the tubular indwelling device multiple times.

[10] The light irradiation device according to [9], wherein there is a gap between tape-shaped light emitting elements on adjacent circumferences.

[11] The light irradiation device according to [8], wherein a plurality of tape-shaped light emitting elements are wrapped around the outer circumferential surface of the tubular indwelling device with gaps between them.

[12] The light irradiation device according to

[11] , wherein only one end side, either the tip end side or the rear end side of the tubular indwelling device, of each tape-shaped light emitting element is fixed to the outer circumferential surface of the tubular indwelling device and wrapped around the outer circumferential surface of the tubular indwelling device.

[13] The light irradiation device according to any one of [1] to

[12] , wherein the surface light emitting element has a slit.

[14] The light irradiation device according to any one of [1] to

[13] , wherein the surface light emitting element is formed on a flexible substrate.

[15] The light-irradiating device according to any one of [1] to

[14] , wherein the surface-emitting element is an organic electroluminescence element.

[16] The light-irradiating device according to [3], wherein at least a portion of the surface-emitting element covers 25% or more of the outer periphery of the stent.

[17] The light-irradiating device according to any one of [1] to

[16] , wherein the surface-emitting element is formed over 2 mm or more in the longitudinal direction of the tubular indwelling device.

[18] The light-irradiating device according to [3], wherein the stent is formed of plastic.

[19] The light-irradiating device according to any one of [1] to

[18] , which has at least one of an illuminance sensor and a temperature sensor.

[20] The light-irradiating device according to any one of [1] to

[19] , wherein light emitted from the surface-emitting element reaches 360 degrees around the outer periphery of the tubular indwelling device.

[21] A light-irradiating apparatus comprising the light-irradiating device according to any one of [1] to

[20] , and a power source electrically connected to the power supply wire of the light-irradiating device.

[22] The light irradiation device according to

[21] , comprising a drive unit electrically connected to the power supply wire of the light irradiation device, wherein the light irradiation device has an illuminance sensor and a temperature sensor, and the drive unit has a control circuit that controls power supply from the power source to the light irradiation device using detection data of the illuminance sensor and the temperature sensor.

[23] A light irradiation method using the light irradiation device according to

[21] , comprising: supplying power from the power source placed outside a living body to the surface light-emitting element implanted in the living body via the power supply wire, thereby causing the surface light-emitting element to emit light.

[0007] The light irradiation device of the present invention can uniformly irradiate the surrounding tissue with light while being placed in a living body, and therefore, the light irradiation device of the present invention can effectively perform treatments such as phototherapy, photodynamic therapy, and photoimmunotherapy while minimizing damage to the tissue.

[0008] 1 is a circuit diagram showing an example of a drive unit for supplying power to the light irradiation device of the present invention. FIG. 2 is a schematic diagram showing a first aspect of the light irradiation device of the present invention. FIG. 3 is a schematic diagram showing a second aspect of the light irradiation device of the present invention. FIG. 4 is a schematic diagram showing a fourth aspect of the light irradiation device of the present invention. FIG. 5 is a schematic diagram showing a state in which the light irradiation device of the present invention is inserted into a bile duct. FIG. 6 is a cross-sectional view of a surface light-emitting element formed by wrapping a plurality of tape-shaped light-emitting elements around the outer peripheral surface of a tubular indwelling device with a gap between adjacent tape-shaped light-emitting elements. FIG. 7 is a diagram showing one embodiment of a state in which tape-shaped light-emitting elements are electrically connected to each other. FIG. 8 is a diagram showing another embodiment of a state in which tape-shaped light-emitting elements are electrically connected to each other.

[0009] The present invention will be described below. The following description of the constituent elements may be based on representative embodiments and specific examples of the present invention, but the present invention is not limited to such embodiments and specific examples. In this specification, a numerical range expressed using "to" means a range that includes the numerical values ​​before and after "to" as the lower and upper limits. Regarding each part constituting the light-irradiating device, the length along the longitudinal direction of the light-irradiating device and the tubular indwelling device is sometimes simply referred to as "length." Furthermore, regarding one end of the light-irradiating device and the other end of the tubular indwelling device, the end that is the leading end when the light-irradiating device is inserted into a living body is referred to as the "front end," and the opposite end is referred to as the "rear end." In this specification, "transparent" means that the transmittance of light emitted by the surface light-emitting element is 50% or more, for example, 80% or more, for example, 90% or more, for example, 99% or more. Transmittance can be measured using an ultraviolet-visible spectrophotometer.

[0010] <Light Irradiation Device> The light irradiation device of the present invention is a light irradiation device that includes a tubular indwelling device, a surface light-emitting element formed on the surface of the tubular indwelling device, and a power supply wire for supplying power to the surface light-emitting element from outside the body, and is used to irradiate light from the surface light-emitting element in the body. With this configuration, when the light irradiation device of the present invention is placed in the body and power is supplied from outside the body via the power supply wire, light is emitted from the surface of the surface light-emitting element, and the light can be uniformly irradiated onto surrounding tissue.

[0011] Preferred embodiments of the light irradiation device of the present invention are described below. The light irradiation device of the present invention is used to irradiate light from a surface light-emitting element inside a living body. The use of irradiating light from a surface light-emitting element inside a living body is preferably to irradiate light from the surface light-emitting element inside the living body's outer skin. For example, implantation of the light irradiation device into a living body, in which the surface light-emitting element is implanted and irradiates light, is particularly preferred. The method of implantation into a living body is not particularly limited, and can be performed by known stent placement or surgical procedures using an endoscope, guide wire, catheter, or the like. The light irradiation device of the present invention is preferably used for treating a living body, and more preferably for treating the internal organs of a living body. In the present invention, the living body is preferably a human or an animal. Examples of animals include mammals (e.g., mice, rats, guinea pigs, pigs, cows, etc.). In particular, the light irradiation device and light irradiation apparatus of the present invention can be preferably used when doctors treat humans or when veterinarians treat animals. Furthermore, the light emitted from the light irradiation device may be irradiated to any part of a living body. In the present invention, it is preferable that light emitted from a light irradiation device implanted in a living body is irradiated onto a target affected area in the tissue surrounding a lumen or an internal organ of the living body.

[0012] The light irradiation device may be implanted in any part of a living body. In a preferred embodiment of the present invention, the light irradiation device is implanted in a lumen of a living body. This allows for effective treatment of abnormalities such as tumors, inflammation, or structural abnormalities due to various causes near the lumen. Applicable tubular organs include the esophagus, stomach, small intestine, and large intestine in the digestive system; the trachea and bronchi in the respiratory system; arteries and veins in the circulatory system; the ureter and urethra in the urinary system; the male testicular ducts, vas deferens, and female fallopian tubes in the reproductive system; and the gallbladder, intrabiliary bile duct, and bile duct in the bile duct. The light irradiation device may be implanted in any lumen, but is preferably implanted in the biliary tract or respiratory tract. When the light irradiation device is implanted in a lumen of a living body or near an organ such as the liver, pancreas, heart, or lung, the outer diameter, length, light-emitting area, and shape of the light irradiation device can be adjusted to match the inner diameter and shape of the lumen and the shape of the organ. Furthermore, it is preferable that the light irradiation device used in the present invention be flexible, allowing it to be curved and used to fit the shape of any living body.

[0013] The maximum outer diameter (the outer diameter of the largest portion) and longitudinal length of the light irradiation device can be appropriately selected depending on the type of living body to which the device is applied, the shape of the implantation site (e.g., lumen), the condition of the affected area, etc. The maximum outer diameter of the light irradiation device can be selected, for example, from a range of 2 to 31 mm, and the longitudinal length can be selected, for example, from a range of 3 to 300 mm or a range of 300 to 1550 mm, but are not limited to these ranges and can be appropriately selected depending on the implantation site of the light irradiation device. For example, the maximum outer diameter can be within a range of 2 to 10 mm, a range of 10 to 20 mm, or a range of 20 to 31 mm. The longitudinal length can be within a range of 3 to 10 mm, a range of 10 to 100 mm, or a range of 100 to 300 mm. Furthermore, the longitudinal length can be within a range of 300 to 500 mm, a range of 500 to 1000 mm, or a range of 1000 to 1550 mm.

[0014] The light irradiation device and light irradiation method of the present invention can be applied to all tubular organs that may develop stenosis. Specific pathologies include cancer (e.g., bile duct cancer, lung cancer (bronchial cancer), ureteral cancer, and fallopian tube cancer), inflammatory diseases (e.g., cholangitis and pancreatitis), vascular diseases (e.g., arteriosclerosis and deep vein thrombosis), infectious diseases (e.g., urethritis and cholangitis), autoimmune diseases (e.g., primary sclerosing cholangitis), structural problems (e.g., prostatic hyperplasia and biliary atresia), and postoperative symptoms, including trauma and catheter manipulation (e.g., scar formation in tubular organs due to injury, and arterial stenosis after coronary angioplasty).

[0015] In the light-irradiating device of the present invention, it is preferable that the surface light-emitting element is formed on the surface of a cylindrical indwelling device and irradiates the periphery of the cylindrical indwelling device. In the light-irradiating device of the present invention, it is preferable that the power supply wire has a conductor, one end of which is electrically connected to an electrode of the surface light-emitting element and the other end of which is a connection part electrically connected to a power source. Here, an electronic circuit such as a driver or a control microcomputer may be interposed between the connection part of the power supply wire and the power source. That is, the electrical connection between the power supply wire and the power source may be a direct connection or an indirect connection via an electronic circuit. The power supply wire and the power source part may be connected using a connector.

[0016] Below, more preferred embodiments of the configuration of the light irradiation device will be described together with preferred embodiments for each component. In addition to the preferred embodiments described below, known materials may also be used as the materials for each component. For example, the materials for organic EL elements described in paragraphs

[0031] to

[0044] of JP 2013-140718 A can be used in the light irradiation device of the present invention, and the contents of this publication are incorporated herein by reference.

[0017] [Cylindrical indwelling device] Examples of the cylindrical indwelling device used in the present invention include stents, catheters, and the like that are placed in a living body. The material of the cylindrical indwelling device is preferably flexible and stretchable. The inside of the cylindrical indwelling device is preferably hollow so as not to impede drainage.

[0018] (Stent) In the present invention, a preferred embodiment of the tubular indwelling device is a stent. The stent is preferably a tubular stent. The stent material is preferably flexible and stretchable, and plastic can be preferably used. By using plastic as the stent material, the light irradiation device can be configured as a flexible one, and can be curved to match the shape of the implantation site. In a preferred embodiment of the present invention, the stent is a tubular stent (tube stent) made of plastic. Specific examples of plastics used for stents include polyolefin resins such as polyethylene and polypropylene, polyurethane, fluororesins such as polytetrafluoroethylene, and silicone resins. In addition, mesh-type stents made of metals such as stainless steel that can be expanded after insertion into the affected area can also be used.

[0019] The outer diameter, wall thickness (thickness of the cylindrical wall), and length of the stent can be selected appropriately depending on the type of living body to which the light irradiation device is applied, the shape of the site (e.g., lumen) where the device is to be implanted, the condition of the affected area, etc. The outer diameter of the stent can be selected, for example, from a range of 2 to 31 mm. The outer diameter of the stent can be, for example, within a range of 2 to 10 mm, a range of 10 to 20 mm, or a range of 20 to 31 mm. The length of the stent can be, for example, within a range of 3 to 300 mm (more specifically, within a range of 3 to 30 mm, a range of 30 to 100 mm, or a range of 100 mm to 300 mm), a range of 300 to 500 mm, a range of 500 to 1000 mm, a range of 1000 to 1500 mm, or a range of 1000 to 2500 mm. However, the size of the stent is not limited to these ranges and can be adjusted appropriately depending on the site where the device is to be implanted.

[0020] The sidewall of the stent may have a structure that allows liquids such as bodily fluids to pass through. For example, the stent may be a mesh stent, or may have holes in the sidewall. The diameter (maximum diameter) of the holes through which liquids such as bodily fluids pass can typically be within a range of 0.1 to 10 mm, for example, within a range of 0.1 to 1 mm, within a range of 1 to 3 mm, or within a range of 3 to 10 mm. When the sidewall of the stent has portions with holes and portions without holes, it is preferable to provide the surface light-emitting element in the portion without holes. A commercially available stent may be used. For example, if the stent is to be implanted in the bile duct, an appropriate size can be selected from known bile duct stents. If the stent is to be implanted in the trachea, an appropriate size can be selected from known tracheal stents. The stent may also have mushroom-shaped or pigtail-shaped ends.

[0021] (Catheter) In the present invention, another preferred embodiment of the tubular indwelling device is a catheter. The material of the catheter is preferably flexible and stretchable. For example, plastic, rubber, etc. can be preferably used.

[0022] A commercially available catheter can be used. The outer diameter, wall thickness (thickness of the cylindrical wall), and length of the catheter can be appropriately selected depending on the type of living body to which the light irradiation device is applied, the shape of the site (e.g., lumen) where the device is to be implanted, the condition of the affected area, etc. The outer diameter of the catheter can be selected, for example, from a range of 2 to 31 mm. The outer diameter of the catheter can be, for example, within a range of 2 to 10 mm, a range of 10 to 20 mm, or a range of 20 to 31 mm. The length of the catheter can be, for example, within a range of 3 to 300 mm (more specifically, within a range of 3 to 30 mm, a range of 30 to 100 mm, or a range of 100 mm to 300 mm), a range of 300 to 500 mm, a range of 500 to 1000 mm, a range of 1000 to 1500 mm, or a range of 1000 to 2500 mm. However, the length of the catheter can be appropriately selected depending on the length and shape of the insertion path of the device.

[0023] The catheter may be a catheter with a single lumen structure or a catheter with a multi-lumen structure having multiple lumens. When using a multi-lumen structure, it is preferable to separate the lumen responsible for drainage from the lumen through which the wiring passes. This embodiment makes it possible to improve the passage during drainage and reduce damage to the wiring.

[0024] [Surface-shaped light-emitting element] In the present invention, a "surface-shaped light-emitting element" refers to a light-emitting element formed on the surface of a cylindrical indwelling device, which has a planar shape when removed from the cylindrical indwelling device and unfolded, and which emits light when power is supplied from a power supply wire. Here, "planar" when removed from the cylindrical indwelling device and unfolded means a shape having a two-dimensionally extending main surface (the surface with the largest area among the surfaces of the surface-shaped light-emitting element), and also includes a tape-like (strip-like) shape that is elongated and stretched with a certain width. Examples of "planar" include a sheet-like, tape-like, and layer-like shape. The layer-like shape may be formed as a single layer, or may be formed as a laminated structure consisting of multiple layers. The area of ​​the main surface is preferably 10 mm ２ or more, for example, 10 to 1000 mm ２ For example, 10 to 50 mm２ or within the range of 50 to 100 mm ２ or within the range of 100 to 1000 mm ２ It can be within the range of.

[0025] The surface light emitting element may have a slit. A plurality of slits may be provided. For example, a plurality of slits may be formed from one end to the other end, so that the surface light emitting element has a comb-like shape. Alternatively, a plurality of slits may be formed alternately from each end.

[0026] The surface light emitting element may be a light emitting element having a layer formed on a cylindrical indwelling device as a substrate, or may be a light emitting element formed directly on a cylindrical indwelling device as described in JP 2018-029067 A.

[0027] The surface light emitting element may be a surface light emitting element produced separately from the cylindrical indwelling device and wrapped around the surface of the cylindrical indwelling device. For example, the surface light emitting element may be a tape-shaped light emitting element, and may be a light emitting element formed by wrapping the tape-shaped light emitting element around the surface of the cylindrical indwelling device.

[0028] One example of such an embodiment is a light-emitting element formed by wrapping tape-shaped light-emitting elements around the outer periphery of a cylindrical indwelling device multiple times. A surface light-emitting element formed from tape-shaped light-emitting elements may be a solid light-emitting element in which tape-shaped light-emitting elements are arranged without gaps on each periphery of the cylindrical indwelling device, or a striped light-emitting element in which tape-shaped light-emitting elements are arranged with a gap between adjacent tape-shaped light-emitting elements on each periphery. When a surface light-emitting element is attached to the surface of an indwelling device and wrapped around it with gaps on the surface, it becomes rigid and may be difficult to insert into an affected area using an endoscope. However, by forming it in a striped pattern as described above, it can be bent with gaps, improving ease of insertion into the affected area. The width of the tape-shaped light-emitting element can be selected, for example, from the range of 0.1 to 10 mm, for example, from the range of 0.2 to 5 mm, or for example, from the range of 0.3 to 3 mm, and is preferably selected from the range of 0.5 to 1 mm. Furthermore, in stripe-shaped light-emitting elements, the spacing between adjacent peripheral light-emitting elements can be selected from the range of, for example, 0.1 to 10 mm, for example, the range of 0.2 to 5 mm, or for example, the range of 0.3 to 3 mm, and is preferably selected from the range of 0.5 to 1 mm. In one aspect of the present invention, the surface light-emitting element is a stripe-shaped light-emitting element, and the spacing between adjacent peripheral tape-shaped light-emitting elements is the same as or smaller than the width of the tape-shaped light-emitting element. In terms of more uniform light irradiation of biological tissue, the smaller the spacing, the better, but a spacing within the above range can achieve sufficiently uniform light irradiation.

[0029] Another embodiment is a light-emitting element formed by wrapping multiple tape-shaped light-emitting elements around the outer periphery of a cylindrical indwelling device with a gap between adjacent tape-shaped light-emitting elements. Since the gap between adjacent tape-shaped light-emitting elements allows for bending, it is possible to improve ease of insertion into the affected area. The gap between adjacent tape-shaped light-emitting elements can be selected from the range of 0.1 to 5 mm, for example, or from the range of 0.2 to 2 mm, or from the range of 0.5 to 1 mm.

[0030] In this embodiment, each tape-shaped light-emitting element may be fixed to the outer peripheral surface of the tubular indwelling device at only one of the distal and proximal ends (preferably only the distal end of the tubular indwelling device) as shown in Figure 7. According to this embodiment, the tubular indwelling device has better bendability at the portion where the tape-shaped light-emitting element is wound, which can further improve the insertion of the light irradiation device of the present invention into a living body.

[0031] Figure 7 is a cross-sectional view of a surface light emitting device formed by winding a plurality of tape-shaped light emitting elements around the outer periphery of a cylindrical indwelling device with a gap between adjacent tape-shaped light emitting elements, where reference numeral 11 denotes the cylindrical indwelling device, reference numeral 21 denotes the tape-shaped light emitting elements, and reference numeral 31 denotes a fixing device such as double-sided tape. In Figure 7, only one end side of either the front or rear end of the cylindrical indwelling device 11 is fixed to the outer periphery of the cylindrical indwelling device 11 with fixing device 31 and wound around the outer periphery of the cylindrical indwelling device.

[0032] In a light-emitting device in which multiple tape-shaped light-emitting elements are wound around the outer periphery of a cylindrical indwelling device with a gap between adjacent tape-shaped light-emitting elements, the tape-shaped light-emitting elements may be electrically connected in series, or at least some of the tape-shaped light-emitting elements may be electrically connected in parallel. Furthermore, the tape-shaped light-emitting elements may be electrically connected to each other using a stretchable wiring board or by wiring. Examples of stretchable wiring boards include substrates made of a stretchable urethane resin material on which a circuit is formed by printing conductive ink. When the tape-shaped light-emitting elements are electrically connected to each other by wiring, the wiring may be undulating. This embodiment further improves the bendability of the light-emitting device.

[0033] When the wiring and the terminals of each tape-shaped light-emitting element are wound around the cylindrical indwelling device, they are preferably arranged on the back side of the tape-shaped light-emitting element.

[0034] The surface light emitting element is preferably formed on the surface of a cylindrical indwelling device so that the light emitting surface (the surface from which light is emitted) faces outward (the opposite side to the cylindrical indwelling device such as a stent). This allows the light emitting device to be implanted in a living body and powered to irradiate surrounding tissue with light in a planar manner. The irradiation intensity of the surface light emitting element is, for example, 0.01 to 80 mW / cm. ２ For example, the range is 0.1 to 20 mW / cm ２ in the range of 0.1 to 10 mW / cm ２ If the living body is a human, the range may be 0.5 to 5 mW / cm ２ The irradiation intensity of the surface light emitting element may be constant or may be varied during treatment. The irradiation intensity of the surface light emitting element can be adjusted by controlling the applied voltage or current.

[0035] When the cylindrical indwelling device is a stent, the surface light-emitting element may be formed over the entire longitudinal length of the stent, but preferably at least both ends of the stent have marginal regions where no surface light-emitting element is formed. This allows the edges of the surface light-emitting element to be recessed from the distal end surface of the stent, thereby protecting the edges of the surface light-emitting element. The length of the marginal region may be, for example, 1 mm or more and, for example, 150 mm or less. Specifically, it may be within a range of 1 to 50 mm or 50 to 150 mm. In one aspect of the present invention, the surface light-emitting element is formed in a region (distal end region) closer to the distal end than the longitudinal center of the stent, preferably in a region of the distal end region excluding the marginal region (a position recessed from the distal end surface). In one aspect of the present invention, the surface light-emitting element is formed in a region including the longitudinal center of the stent, preferably in a region including the center but excluding the marginal region.

[0036] The surface light-emitting element is preferably formed over a length of 2 mm or more, more preferably 3 mm or more, along the longitudinal direction of the tubular indwelling device. For example, the length can be within a range of 2 to 10 mm, 10 to 50 mm, 10 to 20 mm, or 50 to 100 mm. In the following description, the area along the longitudinal direction of the tubular indwelling device where the surface light-emitting element is formed is referred to as the "light-emitting element formation region." In a surface light-emitting element formed by wrapping a tape-shaped light-emitting element around the outer circumferential surface of the tubular indwelling device multiple times, the light-emitting element formation region corresponds to the area between the most distal and most proximal circumferences. In a surface light-emitting element formed by wrapping multiple tape-shaped light-emitting elements around the outer circumferential surface of the tubular indwelling device at intervals, the light-emitting element formation region corresponds to the area between the most distal and most proximal tape-shaped light-emitting elements.

[0037] In the light-emitting element formation region, the surface light-emitting elements may be formed along the entire circumference of the cylindrical indwelling device so as to emit light 360 degrees around the circumference of the cylindrical indwelling device, or may be formed in a region corresponding to a portion of the circumference of the outer surface. In other words, the surface light-emitting elements may be formed on the surface of the cylindrical indwelling device so as to form a cylindrical shape without any notches, or may be formed on the surface of the cylindrical indwelling device so as to form a shape with a partially cut-out cylindrical shape (arc-shaped cross section). In an embodiment in which the surface light-emitting elements are formed in a region corresponding to a portion of the circumference of the cylindrical indwelling device, the proportion of the circumference of the outer surface occupied by the surface light-emitting elements can be adjusted according to the location and size of the lesion, allowing for selective light irradiation of the lesion. This maximizes the therapeutic effect while minimizing damage to normal cells. Therefore, the proportion of the circumference of the outer surface occupied by the surface light-emitting element formation region is preferably 25 to 100%, and can be, for example, within the range of 25 to 50%, 50 to 80%, or 80 to 100%.

[0038] Furthermore, the number of surface light emitting elements formed on the surface of the cylindrical indwelling device may be one or more. In a preferred embodiment of the present invention, the number of surface light emitting elements formed on the cylindrical indwelling device is one.

[0039] It is preferable that the surface light emitting element has higher brightness in the direction of 30 to 60 degrees than in the vertical direction. This allows light to be effectively irradiated even in gaps where no light emitting elements are located, even when tape-shaped light emitting elements are wrapped around the outer peripheral surface of a cylindrical indwelling device multiple times with spaces between adjacent tape-shaped light emitting elements, or when multiple tape-shaped light emitting elements are wrapped around the outer peripheral surface of a cylindrical indwelling device with spaces between them.

[0040] An example of a surface light-emitting device is an organic light-emitting device having a pair of electrodes and at least one organic layer composed of an organic semiconductor between the pair of electrodes. In one embodiment of the present invention, electrode terminals are formed on each of the pair of electrodes of the organic light-emitting device, and power supply wires are electrically connected to these electrode terminals. Examples of organic light-emitting devices include organic electroluminescent devices (also called organic light-emitting diodes (OLEDs)), polymer light-emitting diodes (PLEDs), organic electrochemical light-emitting cells (OLECs), and quantum dot-based electroluminescent devices (QLEDs), with organic electroluminescent devices being preferred. Organic electroluminescent devices exhibit excellent surface emission properties and can be made highly flexible by selecting materials. Below, an organic electroluminescent device will be described as a representative example of a surface light-emitting device.

[0041] (Organic electroluminescence element) An organic electroluminescence element is an element that has a pair of electrodes and an organic layer including at least a light-emitting layer disposed between the pair of electrodes, and that generates light in the light-emitting layer when a voltage is applied between the pair of electrodes. Hereinafter, each part constituting the organic electroluminescence element will be described in detail.

[0042] In the present invention, the stent also functions as a base material for the surface light-emitting element, and therefore the organic electroluminescent element serving as the surface light-emitting element may or may not have a substrate. When the organic electroluminescent element has a substrate, the substrate is preferably a flexible substrate, which makes it easy to wrap the element around the stent and provides flexibility to the light irradiation device.

[0043] Medical-grade plastic substrates can be used as substrates for organic electroluminescent devices. Examples of suitable medical thermoplastic polymer materials include polyethylene terephthalate, polyurethane, polymethyl methacrylate, polycarbonate, cycloolefin polymer, polyphenylsulfone resin, and their analogs. Stretchable (preferably more flexible) materials can also be used. Stretchability enhances adhesion to living bodies when formed from curved surfaces. For example, well-known elastomers such as natural rubber, urethane rubber, and silicone rubber can be used. Furthermore, biocompatible films, such as substrates with hydrogel surfaces grafted with hydrophilic monomers, can be used to impart hydrophilic properties to the substrate surface and improve adhesion to living bodies. It is preferable that the substrate be a biocompatible film. The substrate preferably contains a thermoplastic resin as its main component. The term "main component" refers to a component that accounts for 50% or more by mass of the total mass of the substrate. The substrate preferably contains 80% or more by mass of thermoplastic resin, and more preferably 90% or more by mass. The substrate may be a single layer or a laminate of two or more layers. The substrate is preferably a single layer. The substrate may have a layer that does not primarily contain a thermoplastic resin, such as a layer primarily composed of an inorganic film. For these substrates, it is preferable to use a flexible substrate on which a barrier layer that suppresses water vapor and oxygen permeability is formed. Generally, polymer materials have high moisture and oxygen permeability and often damage light-emitting elements using organic semiconductors. Therefore, it is important to form a light-emitting element on a substrate on which a barrier layer is formed, and to use a substrate on which the sealing film also has low moisture and oxygen permeability. Specific examples of barrier layers include those in which inorganic and organic materials are laminated, and those formed essentially only from inorganic materials, and well-known ones are widely used. Among them, those with a water vapor transmission rate (WVTR) of 10 －２ Unit: g / m 2 / day) or less is preferable, －４ More preferably, －５The following are particularly preferably used. The WVTR value can be measured by bringing in an existing measuring device (e.g., Deltaperm). There are no limitations on the thermoplastic resin that is the main component of the substrate. A curable resin may also be used for the substrate, but when a curable resin is used, it is preferable to control the curing and the content in the substrate to such an extent that flexibility is not completely lost.

[0044] In the present invention, the thickness of the substrate is preferably 5 to 200 μm, more preferably 10 μm to 125 μm, and particularly preferably 10 μm to 80 μm. A thinner film substrate reduces the rigidity of the film, making it easier to wrap the organic electroluminescent element around a stent. The substrate on the light extraction side of the organic electroluminescent element can be made smooth, or the surface on the light extraction side can be roughened or a microprism-type sheet or the like can be attached to improve the light extraction efficiency or emphasize the light emitted in an oblique direction, thereby emphasizing the light irradiation in the gaps when the light-emitting element is divided.

[0045] -Electrodes- The pair of electrodes functions as an anode and a cathode. The pair of electrodes used in the present invention is preferably planar. This allows for easy formation of an organic electroluminescent element having a planar shape as a whole by sequentially forming an organic layer and the other electrode on one surface of the pair of electrodes. Furthermore, the pair of electrodes is preferably flexible. This facilitates wrapping the organic electroluminescent element around a stent and also provides flexibility to the light irradiation device. An electrode terminal for connecting a power supply wire can be formed on each of the pair of electrodes. The electrode terminal may be formed integrally with the electrode or may be a separate member electrically connected to the electrode. Specific examples of materials used for the electrode terminals can be found in the specific examples of materials used for the electrodes below. There are no particular limitations on the material used for the electrodes, and known materials used for electrodes can be used. Examples include conductive oxide materials such as ITO (indium tin oxide) and IZO (indium zinc oxide), as well as silver and aluminum. The electrodes are preferably transparent. ITO is preferred for the anode, and aluminum is preferred for the cathode. Alternatively, a light-emitting device can be used in which electrodes on both sides of the substrate are transparent electrodes, emitting light from both sides. ITO, which has a work function of approximately 5.0 eV, is preferred as the anode from the viewpoint of being able to inject holes into the hole injection layer more efficiently than silver, which has a work function of approximately 4.3 eV, and thus reducing the driving voltage. When fabricating a transparent electrode on the surface of a flexible substrate, it is preferable to fabricate an electrode made of a transparent conductive film with as low a resistance as possible to minimize voltage drop. ITO, which is commonly used as an anode, is formed by sputtering. When using a flexible substrate, ITO sputtered at high temperatures, such as those used on glass substrates, cannot be annealed to enhance crystallization, so the ITO used as the anode tends to have lower crystallinity and higher resistance than usual.

[0046] Various materials and processes are known for forming transparent conductive films. When using a plastic substrate, the above-mentioned water vapor barrier film (e.g., SiO or SiN ) may be formed on the plastic substrate, followed by lamination of a transparent oxide such as ITO or IZO. After the above-mentioned water vapor barrier film is formed on the plastic substrate, silver nanowires, silver nanoparticles, or copper nanoparticles may be fabricated in a striped, mesh, or honeycomb shape and laminated with a transparent conductive film such as ITO. It is also possible to first form a stripe electrode such as silver, and then sputter a transparent conductive film such as ITO on top of it. In these cases, for example, the stripe electrode may be formed with a 1 mm pitch, a 0.1 mm width, and a thickness of 50 nm or the like. Instead of ITO, the entire surface may be covered with a conductive polymer such as polythiophene. Furthermore, many attempts have been made to form a thin-film conductive layer using carbon nanotubes, graphene, etc., to achieve both flexibility and low resistance, and these known techniques can be used. Furthermore, an auxiliary electrode can be used to reduce the electrode resistance. The auxiliary electrode can be made of a single metal or alloy such as aluminum, gold, silver, or copper.

[0047] -Light-emitting layer- The light-emitting layer is an organic layer that emits light when carriers injected from a pair of electrodes recombine. Fluorescent and phosphorescent organic semiconductors can be used as materials for the light-emitting layer. There are no particular restrictions on the material for the light-emitting layer; however, if a photosensitizer is administered, the material must have an emission wavelength that can be absorbed by the photosensitizer. Various light-emitting materials can be selected depending on the type of photosensitizer administered. Various light-emitting materials can be selected depending on the condition of the disease. For example, blue light of approximately 400 to 500 nm can be effective for skin diseases such as skin cancer and acne. When photodynamic therapy (PDT) is used in combination, any material can be used as long as its emission peak overlaps the 500 to 700 nm wavelength range, which is the absorption range of porphyrin derivatives administered or produced in the body. When the photosensitizer used in PDT is, for example, laserphyrin, a material with an emission peak in the wavelength range of 600 to 700 nm can be preferably used. When the photosensitizer used in photoimmunotherapy (PIT) is, for example, phthalocyanine or its derivatives, a material with an emission peak in the wavelength range of 680 to 700 nm can be preferably used. Note that "emission peak overlapping the wavelength range" as used herein means that at least a portion of the emission peak overlaps with the wavelength range. The entire emission peak may overlap, or only a portion of the emission peak may overlap. For examples of luminescent materials that emit light in the 690 to 700 nm range, see Mater. Chem. Front., 2024, 8, 1731-1766. Furthermore, wavelength ranges where hemoglobin and water have significant absorption in vivo make it difficult for light to penetrate the body. Therefore, in order to irradiate light from outside the body and achieve a deeper penetration effect inside the body, long-wavelength light of 600 nm or more is desirable, and in order to avoid light absorption by water in biological tissues, a luminescent material with an emission peak of around 1200 nm is desirable. However, photosensitizers such as porphyrin derivatives also have absorption in the blue and green regions, and by utilizing this absorption, various types of light can be used in addition to emission in the red region of 600 nm or more.In addition to the above-mentioned light-emitting materials that emit light in the 690 to 700 nm wavelength range, materials for the light-emitting layer can be appropriately selected and used, such as low-molecular-weight compounds including vacuum-deposited oligomers, high-molecular-weight compounds, and coating-type low-molecular-weight compounds. Known low-molecular-weight compounds can be used without any particular limitation. (For example, materials described in Organic Light-Emitting Materials and Devices, edited by Zhigang Li and Hong Meng, Taylor & Francis.) Examples of high-molecular-weight compounds include polymeric red phosphorescent materials manufactured by Sumitomo Chemical. Examples of coating-type low-molecular-weight compounds include 1,3-bis(carbazol-9-yl)benzene (mCP) as a host material for the light-emitting layer. mCP is used as a dopant for the red phosphorescent material (bis(2-benzo[b]thiophen-2-ylpyridine)(acetylacetonate)iridium(III), (Ir(btp)). ２ (acac))) and the like. The materials are not limited to these, and a wide range of known light-emitting materials can be used.

[0048] Other Configurations The organic electroluminescent element may have an organic layer other than the light-emitting layer. Examples of organic layers other than the light-emitting layer include a hole injection layer, a hole transport layer, an electron transport layer, an electron injection layer, a hole blocking layer, and an electron blocking layer. There are no particular limitations on the materials used for these organic layers, and known materials can be used. The organic electroluminescent element may also be sealed. For an explanation of the sealing material, see the description in the "Sealing Material" section below. The element structure may be a bottom-emission type, a top-emission type, or the aforementioned double-sided emission type. Various configurations have been considered, such as a structure in which an anode / light-emitting layer / cathode or a cathode / light-emitting layer / anode are stacked on top of a substrate, but these structures can be used in the present invention without particular limitations.

[0049] [Power Supply Wire] The power supply wire in the present invention may be an insulated wire in which a conductor is covered with an insulating coating. The conductor may be made of a known conductive material, such as copper or a copper-containing alloy, and the material may be appropriately selected. The material for the insulating coating may be appropriately selected from the plastics exemplified as the substrate material for the organic electroluminescence element, and medical-grade silicone rubber is preferably used. The power supply wire may be passed directly through a stent or catheter (or a drainage tube). The power supply wire is preferably placed in contact with the inner wall of the stent or catheter so as not to obstruct the flow of body fluids, such as bile, through the stent or catheter.

[0050] When a catheter with a multi-lumen structure having multiple lumens is used, a power feed wire may be inserted into at least one of the multiple lumens. In this case, it is preferable that there be a lumen into which a power feed wire is inserted and a lumen into which no power feed wire is inserted. Taking the example of a catheter with a double-lumen structure, it is preferable that the power feed wire be inserted into only one of the two lumens of the catheter with a double-lumen structure. By having a lumen into which a power feed wire is inserted and a lumen into which no power feed wire is inserted, the lumen into which no power feed wire is inserted can be suitably used, for example, as a flow path for draining body fluids such as bile (a lumen responsible for drainage). The absence of a power feed wire within a lumen allows for smoother drainage of body fluids such as bile.

[0051] The power supply wire can also be placed in contact with the outer surface of the stent or catheter. A stent or catheter with a power supply wire on its outer surface may be further covered with a coating layer. For example, a stent or catheter with a power supply wire on its outer surface may be inserted into a heat-shrinkable tube and heated to form a coating layer. In addition to the power supply wire, a surface light-emitting element, an illuminance sensor, or a temperature sensor (described later) may also be placed between the stent or catheter and the coating layer.

[0052] [Other Components] The light irradiation device of the present invention may include components other than the cylindrical indwelling tool, the planar light emitting element, and the power supply wire, as necessary. Examples of such components include an illuminance sensor, a temperature sensor, and a drainage tube.

[0053] An "illuminance sensor" detects the amount of light emitted by a surface light-emitting element. By monitoring the amount of light emitted by a surface light-emitting element using an illuminance sensor, it is possible to confirm that the element is operating normally, or to confirm the relationship between the amount of light emitted and the therapeutic effect, which can be used to formulate a treatment plan. Examples of illuminance sensors that can be used include photodiodes and phototransistors. The location at which the illuminance sensor is attached is preferably close to the surface light-emitting element, but is not particularly limited when the purpose is to observe changes in relative light-emitting intensity depending on the location. The illuminance sensor can be attached, for example, to the light-emitting surface of the surface light-emitting element, the surface of the sealing material described below, or the inner wall surface of a tubular indwelling device. Attaching the illuminance sensor to the inner wall surface of a tubular indwelling device is preferable because the uneven shape of the illuminance sensor is not visible on the surface, minimizing damage to organs during insertion and placement of the device.

[0054] The "temperature sensor" detects the temperature of the light-emitting device. By using a temperature sensor to monitor the temperature of the light-emitting device and cutting off power supply when the device reaches a specific temperature or higher, thermal damage to tissues surrounding the device due to heat generated by the surface light-emitting element or coil can be prevented. Examples of temperature sensors that can be used include NTC thermistors, PTC thermistors, bimetals, and non-resettable and resettable thermal fuses. Among NTC and PTC thermistors, NTC thermistors are preferred. The temperature sensor is preferably attached to a location where it can accurately detect the temperature of the surface light-emitting element, such as the light-emitting surface or back surface (the surface opposite the light-emitting surface) of the surface light-emitting element, or the inner wall surface of a stent in the area where the surface light-emitting element is formed. Attaching the temperature sensor to the inner wall surface of a tubular indwelling device is preferable because the uneven surface of the temperature sensor is not visible on the surface, minimizing damage to organs during device insertion and placement. A correlation has been observed between the light-emitting intensity of the surface light-emitting element and the device temperature. In other words, increasing the emission intensity requires increasing the drive current, which in turn requires increasing the drive voltage. Increasing these values ​​also increases the device temperature. Increasing the emission area also increases the drive current, resulting in increased heat generation. The quantitative temperature increase varies depending on the thermal conductivity of the surrounding materials and tissues. To prevent the device from overheating, the device temperature can be estimated by monitoring the drive voltage and drive current of the planar light-emitting element. The device can be configured to shut off the power supply when the drive voltage or drive current exceeds a voltage value corresponding to a specific temperature, or when the drive current exceeds a current value corresponding to a specific temperature. These sensors can be continuously powered by an external power source. This allows the device to continuously monitor the surrounding temperature rise and the presence or absence of light emission while emitting light.

[0055] Furthermore, power supply to the surface light-emitting element may be controlled based on detection data from an illuminance sensor or a temperature sensor so that the temperature of the surface light-emitting element and the ambient illuminance are maintained near target values. A circuit diagram of a drive unit that performs this control is shown in Figure 1. As shown in Figure 1, this drive unit includes a drive system consisting of a power supply, a control microcomputer, and a driver, and a control system consisting of a temperature sensor, a temperature control circuit, an illuminance sensor, and an illuminance sensor control circuit. The driver applies a drive voltage to the surface light-emitting element, and the control microcomputer controls the on / off operation of the power supply to the driver. The temperature sensor detects the temperature of the surface light-emitting element and transmits the data to the temperature control circuit. The temperature control circuit compares the temperature data from the temperature sensor with the target temperature and controls the on / off operation of the control microcomputer to minimize the difference. The illuminance sensor detects the illuminance at its mounting position and transmits the data to the illuminance control circuit. The illuminance control circuit compares the illuminance data from the illuminance sensor with the target illuminance and controls the on / off operation of the control microcomputer to minimize the difference. By supplying power to the surface light-emitting element using such a drive circuit, the temperature and illuminance of the surface light-emitting element can be controlled near target values ​​while the light-emitting device is operating, allowing for effective light-based treatment while preventing low-temperature burns to the tissue surrounding the device. The target temperature is preferably set within +5°C, more preferably +2°C, of ​​the temperature when the device is not emitting light. The circuit diagram of FIG. 1 can be modified as appropriate depending on the type of light-emitting device. For example, in a light-emitting device without an illuminance sensor, a drive current input unit and drive current control circuit, or a drive voltage input unit and drive voltage control circuit, may be provided instead of the illuminance sensor and illuminance control circuit of FIG. 1.

[0056] A "drainage tube" is a type of catheter, a tube for passing fluids such as bodily fluids. It is a cylindrical structure that does not have the flexibility or stretchability of a stent. For example, it can be connected to the light irradiation device of the present invention to discharge fluids such as bodily fluids that have passed through a tubular indwelling device or that have entered through side holes in the side wall of the drainage tube. The drainage tube preferably has a flexibility that allows for quick and smooth insertion into the body, and is preferably made of resin. Drainage tubes commonly used for medical purposes can also be used in the present invention. The method for connecting the drainage tube to the light irradiation device is not particularly limited. The connection may be made by wrapping a connecting tape around the outer surface of the connection portion, by applying a heat-shrinkable tube to cover the connection portion and then heat-shrinking it, or by fitting pre-installed connection fittings at the ends of the drainage tube and the light irradiation device together. The length of the drainage tube is determined based on the length of the light irradiation device and the path length from the installation site of the light irradiation device to the outside of the body. It is preferable that the total length of the light irradiation device and the drainage tube is within the range of the length of the light irradiation device in the longitudinal direction.

[0057] The drainage tube may be attached only to the rear end of the light irradiation device, or only to the front end of the light irradiation device. Alternatively, it may be attached to both the front and rear ends of the light irradiation device. The drainage tube attached to the front end of the light irradiation device preferably has a tip structure according to its intended use. If it is required to be positioned at a specific site after insertion, it can be provided with a fixing means that matches the specific conditions of the target site. For example, the tip may be bent or have a folded portion. The drainage tube attached to the front end of the light irradiation device preferably has a side hole formed in its side wall, allowing body fluids such as bile to be delivered into the drainage tube. The hole may be formed at the tip of the drainage tube. The hole diameter of these holes is preferably smaller than the inner diameter of the drainage tube, and may be, for example, ½ or less, ⅕ or less, or 1 / 10 or less of the inner diameter. Typically, the distance can be within a range of 0.1 to 10 mm, for example, within a range of 0.1 to 1 mm, 1 to 3 mm, or 3 to 10 mm. The side holes may be formed in the drainage tube attached to the rear end of the light irradiation device. For example, the side holes may be formed near the rear end of the light irradiation device (e.g., within a range of 0.1 to 50 mm from the rear end of the light irradiation device), with no side holes formed in other areas. When attaching drainage tubes to both the front and rear ends of the light irradiation device, it is preferable to first attach the front end drainage tube to the front end of the light irradiation device, and then attach the rear end drainage tube to the rear end of the light irradiation device. By preparing various types of attached bodies in which the front end drainage tube is attached to the front end of the light irradiation device, an appropriate attached body can be selected depending on the application site and the patient's condition and attached to the rear end drainage tube, allowing for rapid treatment. For example, various assemblies can be prepared, such as assemblies with different lengths of planar light emitting elements, assemblies with different shapes of drainage tubes, etc. The above-described aspects relating to the drainage tube can also be adopted when a catheter other than a drainage tube is used in the present invention.In addition, a single-lumen tube can be used for the drainage portion, and a double-lumen structure can be used where the wiring is pulled out from the electrode where the planar light-emitting element is formed. It is preferable that the wiring inserted into the double-lumen structure is extended to the outside of the body and connected to a power supply.

[0058] [Sealant] The light-irradiating device of the present invention may optionally include a sealant covering the surface-emitting element formed on the surface of the tubular indwelling device. In a preferred embodiment of the present invention, the sealant entirely covers the distal end surface of the tubular indwelling device, the surface-emitting element, and the surface of the tubular indwelling device near the surface-emitting element. The sealant is preferably a film that is transparent to light emitted by the surface-emitting element and is flexible and biocompatible. In the following description, a biocompatible sealant film may be referred to as a "biocompatible film." A preferred example of a sealant is a light-transmitting heat-shrinkable tube. A sealant made of a heat-shrinkable tube can be obtained by heating a laminate of a tubular indwelling device, a surface-emitting element, and a heat-shrinkable tube in this order using a heat gun or a thermostatic bath to heat-shrink the heat-shrinkable tube. Here, the heat-shrinkable tube can be a cylindrically molded plastic material or a pair of semi-cylindrically molded plastic materials, and examples of such materials include polyvinyl chloride, silicone rubber, and fluorine-based polymers. The heat-shrinkable tube may be made of one of these plastics, or may contain two or more plastics and additives. Furthermore, heat-shrinkable tubes whose surfaces have been rendered hydrophilic to impart biocompatibility can also be preferably used as sealing materials. For methods of imparting hydrophilicity, please refer to the description of the biocompatible film that can be used in organic electroluminescence devices. Furthermore, the heat-shrinkable tube may be transparent or translucent and may function as a color filter, as long as it is transparent to the light emitted by the surface light-emitting element. When forming a sealing material using heat-shrinkable tubes, it is preferable to overlap the heat-shrinkable tubes so that they protrude from the tip of the tubular indwelling device. By heating this laminate of overlapping heat-shrinkable tubes, the heat-shrinkable tube protruding from the tip of the tubular indwelling device curls inward, covering the tip surface of the tubular indwelling device and preventing peeling of the sealing material from the edge. Furthermore, covering this tip surface with a bioadhesive can more reliably prevent peeling of the sealing material from the edge.

[0059] Another example of a sealing material is a parylene film containing parylene as a main component. Parylene is a paraxylene-based polymer obtained from paraxylene and has excellent biocompatibility. In parylene, hydrogen atoms in the structural units derived from paraxylene may be substituted with substituents such as halogen atoms. The parylene film preferably contains 70 wt % or more of parylene, and is also preferably composed solely of parylene.

[0060] A known sealing adhesive may also be used as the sealing material. For example, various commercially available products can be used, such as a UV (ultraviolet) curable epoxy resin (TB3124M manufactured by ThreeBond Co., Ltd.) with high water and oxygen blocking properties, or a product manufactured by Moresco (product name: Moisture Cut). A sealing film containing a moisture-proofing agent manufactured by Ajinomoto Fine-Techno Co., Ltd. can also be preferably used. To prevent deterioration of the light-emitting element due to moisture, it is preferable to cover the top of the light-emitting element 2 with OleDry-F manufactured by Futaba Corporation or to apply DryFlex manufactured by SAES Getters.

[0061] The thickness of the sealing material is not particularly limited, but can be selected from the range of, for example, 0.1 to 10 μm.

[0062] [Catheter] When a stent is used as the tubular indwelling device, the light irradiation device of the present invention may further include a catheter, if necessary, connected to the stent. This allows for adding length to a relatively short stent (e.g., a stent of 3 to 300 mm). For example, by inserting the stent distally through the nose and grasping the catheter to advance the insertion operation, the stent having the surface light emitting element formed thereon can be easily placed in the target organ. Alternatively, a power supply wire can be inserted into the lumen of the catheter, or the power supply wire can be embedded in the catheter's tubing. Alternatively, the power supply wire can be placed on the outer surface of the catheter and then covered with a tube, or a heat-shrinkable tube can be placed on top of the catheter and then heat-shrunk. This improves the operability (stretchability, bendability) and reliability of the light irradiation device compared to a state in which the power supply wire is exposed on the surface of the stent. As a result, the risk of organ damage during device insertion or placement can be reduced. When a tube is used to cover the stent and catheter from the outside, the stent and catheter may be covered together with one tube, or multiple tubes may be used to cover them individually. Covering the surface light-emitting element, power supply wire, sensors, etc. formed on the catheter, or the power supply wire wired on the catheter with a tube from the outside, or covering it with a heat-shrinkable tube and then heat-shrinking it, can increase the flexibility of wiring and placement and ensure waterproofing. In particular, using a heat-shrinkable tube to cover the catheter can eliminate the gap between the two layers of tube and reduce the diameter. Commercially available catheters can be used. The length of the catheter can be selected appropriately depending on the length and shape of the insertion path of the device, for example, from a range of 100 to 1500 mm.

[0063] Next, specific embodiments of the light irradiation device of the present invention will be described with reference to Figures 2 to 5. For details of each part constituting the first to fourth embodiments below, the corresponding description of the "Preferred embodiments of the light irradiation device of the present invention" above can be referenced.

[0064] <First Aspect> As shown in FIG. 2 , the light irradiation device of the first aspect includes a cylindrical stent 1, a surface light emitting element 2A formed on the surface of the stent 1, and two power supply wires 3a and 3b. The surface light emitting element has a pair of electrodes, each of which is formed with an electrode terminal 2a or 2b. One end of each of the two power supply wires 3a and 3b is electrically connected to the electrode terminal 2a or 2b, and the other end is electrically connected to a DC power source 4. In the first aspect, the stent is a member corresponding to the cylindrical indwelling device of the present invention. In the first aspect, the longitudinal length of the stent 1 can be selected, for example, from the range of 3 to 1500 mm. In one aspect of the present invention, the longitudinal length of the stent 1 of the first aspect is 10 to 1000 mm, preferably 30 to 200 mm. As a result, by inserting the light-emitting device into the nose from the distal end, grasping the rear side of the stent 1, and advancing the insertion operation, the distal end region on which the surface light-emitting element 2A is formed can be placed in a target organ such as the biliary tract. In this case, the stent 1 functions both as a catheter and as a stent (function of supporting the surface light-emitting element). In one aspect of the present invention, the longitudinal length of the stent 1 of the first aspect is 3 to 300 mm. In this case, the light-emitting device may further include a catheter, which may be connected to the rear end of the stent, and power supply wires 3a and 3b may be inserted into the lumen of the catheter. As a result, by inserting the light-emitting device into the nose from the stent 1 side, grasping the catheter, and advancing the insertion operation, the stent 1 on which the surface light-emitting element 2A is formed can be placed in a target organ such as the biliary tract. In the first aspect, the surface light-emitting element 2A is formed by wrapping a sheet-shaped light-emitting element around the stent 1 with its light-emitting surface facing outward. The length L of the surface light-emitting element 2A ＥThe length of the light-emitting element formation region can be appropriately selected depending on the position and size of the target tissue and the condition of the affected area, for example, within a range of 2 to 50 mm, preferably within a range of 5 to 20 mm. In the light irradiation device shown in FIG. 2 , the surface light-emitting element is formed around the entire outer periphery of the stent, but the surface light-emitting element may be formed only on a portion of the outer periphery of the stent. In the light irradiation device of the first aspect, when the device is placed in a living body and the external DC power source 4 is turned on, power is supplied from the DC power source 4 to the surface light-emitting element 2A, and light is emitted from the light-emitting surface of the surface light-emitting element 2A to the surrounding area. Light emitted from this light-emitting surface allows light to be uniformly irradiated onto the surrounding target tissue compared to when a point light source is used, thereby enabling effective treatment of tumors and other target tissue.

[0065] In the first embodiment, a stent is used as the tubular indwelling device, but the stent may be replaced with a catheter. The same applies to the second to fourth embodiments described below.

[0066] <Second Aspect> The light irradiation device of the second aspect is the same as that of the first aspect, further comprising a temperature sensor 5, an illuminance sensor 6, and a sealant. For descriptions of the stent 1, the surface light-emitting element 2A, the electrode terminals 2a and 2b, and the power supply wires 3a and 3b, please refer to the corresponding descriptions of the first aspect. The temperature sensor 5 and the illuminance sensor 6 are attached to the light-emitting surface of the surface light-emitting element 2A. In the second aspect, the temperature sensor 5 and the illuminance sensor 6 constitute the temperature sensor and the illuminance sensor of the driving unit shown in FIG. 1, and the electrode terminals 2a and 2b are electrically connected to the driver of the driving unit shown in FIG. 1. As shown in FIG. 3, the sealant is a plastic film (heat-shrinkable tube) formed by heat-shrinking a heat-shrinkable tube 7 that covers the electrode terminals 2a and 2b, the surface light-emitting element 2A, the temperature sensor 5, and the illuminance sensor 6 and extends beyond the tip of the stent. The sealant is formed to entirely cover these components and the tip surface of the stent 1. The second embodiment also achieves the same effects as the first embodiment. Furthermore, in the second embodiment, the use of a heat-shrinkable tubing sealant protects the surface-emitting element 2A, electrode terminals 2a and 2b, temperature sensor 5, and illuminance sensor 6, while preventing the unevenness of these components from appearing on the surface, allowing for smooth insertion and placement of the device. Furthermore, in the second embodiment, the temperature sensor 5 and illuminance sensor 6 constitute the temperature sensor and illuminance sensor of the drive unit shown in FIG. 1 , and the electrode terminals 2a and 2b are electrically connected to the driver of the drive unit shown in FIG. 1 . This allows the temperature of the surface-emitting element and the ambient illuminance to be controlled near target values ​​while the light-irradiating device is operating. This allows for effective light-based therapy while minimizing low-temperature burns to tissue surrounding the device.

[0067] <Third Aspect> As shown in FIG. 4 , the light irradiation device of the third aspect includes a cylindrical stent 1, stripe-shaped light-emitting elements 2B formed on the surface of the stent 1, and two power supply wires 3a and 3b. For an explanation of the stent 1, please refer to the description of the stent 1 of the first aspect. The stripe-shaped light-emitting elements 2B are formed by wrapping a tape-shaped light-emitting element around the outer peripheral surface of the stent 1 multiple times. The light-emitting elements 2B have a pair of electrodes, with electrode terminals 2a and 2b formed at the tip and rear ends of one and the other, respectively. The length LE of the light-emitting element formation region on the stent can be appropriately selected depending on the position and size of the target tissue and the condition of the affected area. For example, it can be selected within a range of 2 to 70 mm, 5 to 60 mm, or 10 to 30 mm. Furthermore, LE may be selected so that the total width of the light-emitting elements aligned in the longitudinal direction of the stent is, for example, within a range of 2 to 20 mm, preferably within a range of 10 to 20 mm. For details of the width and spacing of the tape-shaped light-emitting elements, please refer to the description in the "Surface Light-Emitting Element" section above. The third aspect also provides the same effects as the first aspect. Furthermore, in the third aspect, the surface light-emitting elements formed on the surface of the stent 1 are stripe-shaped light-emitting elements 2B, which makes it easy for the light-emitting elements to follow the bending of the stent 1, and thus provides the advantage of being easy to use even when the insertion path or placement site of the device is an organ that bends relatively greatly.

[0068] <Fourth Aspect> The light irradiation device of the fourth aspect is the same as that of the third aspect, further comprising a sealant made of heat-shrink tubing. For descriptions of the stent 1, electrode terminals 2a, 2b, and power supply wires 3a, 3b, see the corresponding descriptions of the first aspect. For descriptions of the sealant, see the corresponding descriptions of the second aspect. For descriptions of the striped light-emitting elements 2B, see the description of the third aspect. The fourth aspect also achieves the same effects as the third aspect. In particular, the fourth aspect includes a sealant made of heat-shrink tubing, which protects the striped light-emitting elements 2B and electrode terminals 2a, 2b and prevents the irregularities of these elements from appearing on the surface, facilitating smooth insertion and placement of the device. Furthermore, the fourth aspect may further include temperature and illuminance sensors attached to the light-emitting surfaces of the striped light-emitting elements 2B and the surface of the stent, and the driver shown in FIG. 1 may control the power supply so that the temperature and illuminance of the striped light-emitting elements 2B are near target values. This allows for effective light-based therapy while minimizing low-temperature burns to tissue surrounding the device.

[0069] <Method for Manufacturing a Light-Illuminating Device> The light-illuminating device of the present invention can be manufactured by combining known manufacturing methods for a surface light-emitting element such as an organic electroluminescence element and a circuit board. For example, when forming the surface light-emitting element, the organic layer of the light-emitting element can be formed by coating or vapor deposition. Metal layers and other inorganic layers, such as electrodes, included in the surface light-emitting element can also be formed by coating or vapor deposition. Specifically, the surface light-emitting element can be manufactured using known methods such as vacuum deposition, sputtering, inkjet printing, screen printing, flexographic printing, and spin coating. The formation of the conductive film on the circuit board and the formation of the sealing material can also be performed using coating or vapor deposition. Patterning of the conductive film can be performed using known microfabrication techniques such as photolithography, and the mounting of electronic components can also be performed using known mounting techniques. For methods for forming a sealing material using a heat-shrinkable tube, please refer to the description in the "Sealing Material" section above.

[0070] In one embodiment, a light emitting device can be manufactured by wrapping a tape-shaped light emitting element around the outer peripheral surface of a cylindrical indwelling device to form a surface light emitting element on the surface of the cylindrical indwelling device.

[0071] When a surface light-emitting element is formed by winding a plurality of tape-shaped light-emitting elements around the outer peripheral surface of a tubular retaining device with a gap between adjacent tape-shaped light-emitting elements, each tape-shaped light-emitting element may be electrically connected before being wound around the outer peripheral surface of the tubular retaining device, or each tape-shaped light-emitting element may be wound around the outer peripheral surface of the tubular retaining device and then electrically connected.

[0072] The tape-shaped light-emitting elements may be electrically connected to each other using a stretchable wiring substrate or the like, or may be electrically connected by wiring. Examples of stretchable wiring substrates include those mentioned above. When the tape-shaped light-emitting elements are electrically connected to each other by wiring, the wiring may have a wavy shape. According to this embodiment, the bendability of the light irradiation device can be further improved. It is preferable that the wiring and the terminals of each tape-shaped light-emitting element are arranged on the back side of the tape-shaped light-emitting element when it is wound around the tubular indwelling device.

[0073] 8 to 10 are diagrams showing an embodiment in which tape-shaped light-emitting elements are electrically connected to each other. Reference numeral 21 denotes the tape-shaped light-emitting element, reference numeral 41 denotes a terminal, and reference numeral 51 denotes wiring. An illumination device can be manufactured by wrapping the tape-shaped light-emitting elements connected in this manner around the outer periphery of a cylindrical indwelling device.

[0074] <Light Irradiation Device and Light Irradiation Method> The light irradiation device of the present invention comprises a light irradiation device and a power source connected to a power supply wire of the light irradiation device. The light irradiation device has a surface light-emitting element formed on the surface of a tubular indwelling device and a power supply wire for supplying power to the surface light-emitting element from outside the body, and is used to irradiate light from the surface light-emitting element in the body. For an explanation of the light irradiation device, please refer to the description in the "Light Irradiation Device" section above. The power source may be any power source, such as an electrical outlet, a primary battery, or a secondary battery. The light irradiation method of the present invention is a light irradiation method using the light irradiation device described above, in which the surface light-emitting element implanted in the body is powered via a power supply wire from a power source placed outside the body, causing the surface light-emitting element to emit light. In the light irradiation method of the present invention, the light irradiation device is preferably implanted in the body by known stent placement or surgery, and more preferably implanted in a lumen such as the bile duct or trachea. The device can be removed when treatment is completed.

[0075] The light irradiation device of the present invention may be configured such that the light irradiation device has a temperature sensor and an illuminance sensor, and further includes a drive unit having a control circuit that controls power supply to the light irradiation device using detection data from each sensor. For a specific configuration of the drive unit, please refer to the description of the drive unit shown in Figure 1.

[0076] (Photosensitizer) The photosensitizer used in the present invention can be selected from known photosensitizers. The mechanism of photodynamic therapy involves first accumulating the photosensitizer in the target tumor by oral administration or intravenous injection, and then irradiating the tumor with light, where it absorbs the light and becomes excited. The excited photosensitizer then transfers energy to intracellular singlet oxygen, generating reactive oxygen species, including triplet oxygen. These reactive oxygen species then attack and kill the tumor cells. Therefore, the photosensitizer used in the present invention can be any substance that absorbs the irradiated light and transfers energy to intracellular oxygen. To date, porphyrin derivatives such as photofrin, laserphyrin, protoporphyrin, and temoporfin, or their precursors, aminolevulinic acid derivatives, and dyes such as methylene blue, have been used. However, quantum dots, such as those described in Nature Communication, 2014 DOI: 10.1038 / ncomms5596, can also be used. In photoimmunotherapy, for example, an antibody drug conjugated with a substance capable of absorbing near-infrared light is bound to a protein attached to cancer cells and then irradiated with near-infrared light. This induces apoptosis in the cancer cells, thereby treating cancer. Therefore, the photosensitizer used in the present invention may be a substance that absorbs light in the near-infrared range and can be bound to an antibody. Examples of substances that absorb light in the near-infrared range include phthalocyanine and phthalocyanine derivatives known as IR700. Here, a "derivative" refers to a compound having a structure in which at least one atom or atomic group in the basic skeleton (e.g., a porphyrin skeleton or a phthalocyanine skeleton) is replaced with another atom or atomic group. Furthermore, the photosensitizer may be selected from metal complexes such as Pt(II) complexes, Ir(III) complexes, and Os(III) complexes, delayed fluorescent materials, exciplex materials, multiple-resonance delayed fluorescent materials, fluorescent materials, and organic radicals.

[0077] (Treatment) Diseases treatable with a light irradiation device include internal diseases (diseases within the body), such as pre-malignant and malignant diseases. Examples of treatable diseases include primary and metastatic tumors, as well as inflammatory diseases, such as connective tissue diseases, all types of arthritis, and inflammatory bowel disease. It is particularly effective against visceral cancers (liver cancer, pancreatic cancer, ovarian cancer, etc.). The mechanisms by which phototherapy can treat these diseases are known (see, for example, CANCER June 15, 1997 / Volume 79 / Number 12, p. 2282). These diseases can be treated with light emitted from the light irradiation device used in the present invention. In photodynamic therapy (PDT), a photosensitive therapeutic agent known as a phytopharmaceutical is applied topically or internally to the area of ​​the body to be treated, and the area is then exposed to light of the appropriate frequency and intensity to activate the photochemotherapeutic agent. Various photochemotherapeutic agents are currently available (see, for example, paragraph

[0002] of Japanese Patent No. 4651281). In photoimmunotherapy, for example, an antibody drug bound to a substance capable of absorbing near-infrared light is bound to a protein that adheres to cancer cells, and then near-infrared light is irradiated using a light irradiation device. This induces apoptosis in the cancer cells, thereby treating cancer. Figure 6 shows an example of treatment using the light irradiation device of the present invention applied to a bile duct. The light irradiation device 101 of the present invention is inserted into a bile duct that has become narrowed due to a tumor 102 that has formed around the bile duct. Conventional stents function to allow sufficient bile flow by inserting them into the bile duct to expand its diameter, but do not function to provide treatment. In contrast, the light irradiation device of the present invention, when inserted into the bile duct, drains accumulated bile 103 into the intestine in the direction of the arrow, and the planar light-emitting element formed on the surface of the stent emits light, thereby providing treatment. Because tumors form around the bile duct, effective treatment cannot be achieved unless the entire area around the bile duct is uniformly irradiated with light. The light irradiation device of the present invention has a planar light emitting element formed on the surface of the stent, and therefore can achieve uniform light irradiation over the entire periphery of the bile duct, thereby enabling effective treatment of cancer.

[0078] REFERENCE SIGNS LIST 1 Stent 2A Planar light emitting element 2B Striped light emitting element (planar light emitting element) 2a, 2b Electrode terminal 3a, 3b Power supply wire 4 DC power source (power source) 5 Temperature sensor 6 Illuminance sensor 7 Heat-shrinkable tube 11 Cylindrical indwelling device 21 Tape-shaped light emitting element 31 Fixing device 41 Terminal 51 Wiring 102 Tumor 103 Accumulated bile

Claims

1. A light irradiation device comprising a cylindrical indwelling device, a surface light emitting element formed on the surface of the cylindrical indwelling device, and a power supply wire for supplying power to the surface light emitting element from outside the body, the light irradiating device being used to irradiate light from the surface light emitting element inside the body.

2. The light irradiation device according to claim 1, wherein the surface light emitting element on the cylindrical indwelling device is covered with a light-transmitting heat-shrinkable tube.

3. The light irradiation device according to claim 1, wherein the tubular indwelling device is a stent.

4. The light irradiation device according to claim 3, further comprising a catheter, said stent being connected to said catheter.

5. The light irradiation device according to claim 4, wherein the power supply wire is inserted into the lumen of the catheter.

6. The light irradiation device according to claim 1, wherein the cylindrical indwelling device is a catheter.

7. The light irradiation device according to claim 6, wherein the catheter is a catheter with a multi-lumen structure having a plurality of lumens, and the power supply wire is inserted into at least one of the plurality of lumens.

8. The light irradiation device according to claim 1, wherein the surface light emitting element is a tape-shaped light emitting element, and the tape-shaped light emitting element is wound around the surface of the cylindrical indwelling device.

9. The light irradiation device according to claim 8, wherein the tape-shaped light emitting element is wound around the outer circumferential surface of the cylindrical indwelling device in multiple turns.

10. The light irradiation device according to claim 9, wherein a gap is provided between the tape-shaped light emitting elements on adjacent peripheries.

11. The light irradiation device according to claim 8, wherein a plurality of tape-shaped light emitting elements are wound around the outer periphery of the cylindrical indwelling device at intervals.

12. The light irradiation device according to claim 11, wherein each of the tape-shaped light-emitting elements is fixed to the outer peripheral surface of the tubular retaining device at only one of the end portions, either the tip end or the rear end, of the tubular retaining device and is wound around the outer peripheral surface of the tubular retaining device.

13. The light irradiation device according to claim 1, wherein the surface light emitting element has a slit.

14. The light irradiation device according to claim 1, wherein the planar light emitting element is formed on a flexible substrate.

15. The light irradiation device according to claim 1, wherein the planar light emitting element is an organic electroluminescence element.

16. The light irradiation device according to claim 3, wherein at least a portion of the surface light emitting element covers 25% or more of the outer circumference of the stent.

17. The light irradiation device according to claim 1, wherein the surface light emitting element is formed over a length of the cylindrical indwelling device of 2 mm or more in the longitudinal direction.

18. The light irradiation device of claim 3, wherein the stent is made of plastic.

19. The light irradiation device according to claim 1, comprising at least one of an illuminance sensor and a temperature sensor.

20. The light irradiation device according to claim 1, wherein the light emitted from the surface light emitting element reaches the circumference of the cylindrical indwelling device over 360 degrees.

21. A light irradiation apparatus comprising: a light irradiation device according to any one of claims 1 to 20; and a power source electrically connected to the power supply wire of the light irradiation device.

22. The light irradiation device according to claim 21, further comprising a driving unit electrically connected to the power supply wire of the light irradiation device, wherein the light irradiation device has an illuminance sensor and a temperature sensor, and the driving unit has a control circuit that controls the power supply from the power source to the light irradiation device using detection data from the illuminance sensor and the temperature sensor.

23. A light irradiation method using the light irradiation device described in claim 21, wherein the surface light emitting element implanted in the living body is made to emit light by supplying power from the power source placed outside the living body to the surface light emitting element via the power supply wire.

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