JP7624650B2 - Light irradiation device and light irradiation system - Google Patents

Description

The present invention relates to a light irradiation device and a light irradiation system.

In cancer treatment, surgical, radiological, and pharmacological (chemical) techniques are used alone or in combination, and each technique has been developed in recent years. However, there are still many cancers for which a satisfactory treatment technique has not yet been found, and further development of treatment techniques is expected. One cancer treatment technique known as photodynamic therapy (PDT) is known. In PDT, a photosensitive substance is administered intravenously and then irradiated with light, which causes active oxygen to be generated in cancer cells, resulting in the death of the cancer cells (see, for example, Non-Patent Document 1). However, PDT has not been widely adopted as a treatment technique due to the low accumulation selectivity of the photosensitive substance in cancer cells and the large side effects caused by its uptake into normal cells.

A treatment technique that has been attracting attention in recent years is NIR-PIT (Near-infrared photoimmunotherapy). In NIR-PIT, a complex is used that combines two compounds: an antibody against a specific antigen of cancer cells and a photosensitizer (e.g., IRDye700DX). When this complex is administered intravenously, it selectively accumulates in cancer cells in the body. The complex is then activated by irradiating it with light of the excitation wavelength (e.g., 690 nm) of the photosensitizer in the complex, and exhibits anticancer effects (see, for example, Patent Document 1). In NIR-PIT, the side effects can be reduced compared to PDT due to the dual selectivity of the antibody's accumulation in cancer and the local light irradiation. In addition, in NIR-PIT, cell death occurs in a short period of time and cells undergo necrosis, so NIR irradiation can also be expected to have an effect on the immune system (see, for example, Non-Patent Document 2).

The above-mentioned specific wavelength range including 690 nm is also called the spectroscopic window of the living body, and although it is a wavelength range in which light is less absorbed by biological components than other wavelength ranges, there is a problem that it cannot be applied to cancer deep inside the body because the light penetration is insufficient when irradiated from the surface of the body. Therefore, in recent years, research has been conducted on NIR-PIT, which irradiates light closer to cancer cells rather than from the surface of the body (see, for example, Non-Patent Document 3). For example, Patent Documents 2 to 4 disclose devices that can be used in such PDT and NIR-PIT. All of the devices described in Patent Documents 2 to 4 are used by inserting them into blood vessels, and can irradiate light deep inside the body.

Special table 2014-523907 publication JP 2018-867 A Special Publication No. 2007-528752 Patent No. 4966640

Makoto Mitsunaga, Mikako Ogawa, Nobuyuki Kosaka Lauren T. Rosenblum, Peter L. Choyke, and Hisataka Kobayashi, Cancer Cell-Selective In Vivo Near Infrared Photoimmunotherapy Targeting Specific Membrane Molecules, Nature Medicine 2012 17(12): , p.1685-1691 Kazuhide Sato, Noriko Sato, Biying Xu, Yuko Nakamura, Tadanobu Nagaya, Peter L. Choyke, Yoshinori Hasegawa, and Hisataka Kobayashi, Spatially selective depletion of tumor-associated regulatory T cells with near-infrared photoimmunotherapy, Science Translational Medicine 2016 Vol.8 Issue352, ra110 Shuhei Okuyama, Tadanobu Nagaya, Kazuhide Sato, Fusa Ogata, Yasuhiro Maruoka, Peter L. Choyke, and Hisataka Kobayashi, Interstitial near-infrared photoimmunotherapy: effective treatment areas and light doses needed for use with fiber optic diffusers, Oncotarget 2018 Feb 16; 9 (13): , p.11159-11169

Here, in PDT and NIR-PIT, as described above, cancer cells in which the complex has accumulated are irradiated with light of the excitation wavelength of the photosensitive substance in the complex, thereby killing the cancer cells. For this reason, in PDT and NIR-PIT, there has been a demand for confirmation of whether or not light is being correctly irradiated toward the target tissue in the living body (specifically, the cancer cells in which the complex has accumulated). In this regard, the devices described in Patent Document 2 and Patent Document 3 do not take into consideration the issue of whether or not light is being irradiated to the target tissue in the living body. In addition, the device described in Patent Document 4 controls the intensity and wavelength of light by utilizing the property that when pulsed laser light is irradiated to living tissue, the blood flow rate temporarily decreases due to spasm. Specifically, the device described in Patent Document 4 has a detection means for detecting blood flow in the shallow part of the body, and increases the intensity of light when blood flow is confirmed in the shallow part of the body, and maintains the intensity of light when blood flow is not confirmed in the shallow part of the body. However, even with such Patent Document 4, there is a problem in that it is not possible to confirm whether or not light is being irradiated to the target tissue in the living body.

In addition, in PDT and NIR-PIT, it is preferable to avoid irradiating normal cells other than cancer cells with light in order to reduce the risk of cell damage. In this regard, the techniques described in Patent Documents 2 and 3 have the problem that it is difficult to determine the position of the light irradiation site within the blood vessel, making it impossible to selectively irradiate light to areas where cancer cells are present.

These issues are not limited to PDT and NIR-PIT, but are common to all devices used in examinations or treatments that involve the process of irradiating light inside a living body for the examination or treatment of cancer, cerebral aneurysms, arrhythmia, Alzheimer's disease, etc. Furthermore, these issues are not limited to devices inserted into blood vessels, but are common to all devices inserted into living lumens, such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs.

The present invention has been made to solve at least some of the problems described above, and aims to make it possible to confirm whether light is being correctly directed toward target tissue in a living body using a light irradiation device that irradiates light inside the living body.

The present invention has been made to solve at least some of the above problems, and can be realized in the following form.

(1) According to one aspect of the present invention, a medical light irradiation device is provided. The light irradiation device includes an elongated main body, a light irradiation unit provided on a portion of the side surface at the tip of the main body and irradiating a target substance in a living body with light, and a detection unit provided in the main body adjacent to the light irradiation unit and detecting a physicochemical phenomenon that occurs as a result of the target substance being irradiated with light.

According to this configuration, the light irradiation device includes a detection unit that detects physicochemical phenomena (e.g., light, ultrasound, pH change of body fluids, temperature change, pressure change, etc.) that occur due to the target substance irradiated with light from the light irradiation unit. Here, for example, in NIR-PIT, when the target substance (e.g., a photosensitive substance such as IRDye700DX) in the complex accumulated in the target tissue (cancer cells) in the living body is irradiated with light of the excitation wavelength of the target substance, it emits light and also emits ultrasound due to the photoacoustic effect. Therefore, the operator can confirm whether or not the light from the light irradiation unit is correctly irradiated toward the target tissue in the living body (cancer cells in which a complex containing the target substance is accumulated) based on the presence or absence of detection of the physicochemical phenomenon by the detection unit. As a result, it is possible to reliably irradiate light to the target tissue, and the efficiency of the procedure can be improved. The effects of such a light irradiation device are not limited to NIR-PIT using the IRDye700DX, but can also be obtained in examinations or treatments using any target substance that has the property of emitting light or ultrasound when irradiated with light.
In addition, in the case of IRDye700DX as a target substance, as the cumulative amount of light irradiation to the target substance increases, the target substance undergoes an irreversible structural change, inducing the death of the target tissue (cancer cells), and the amount of light emitted from the target substance and the amount of ultrasound emitted from the target substance decrease. Therefore, the surgeon can grasp the degree of death of the target tissue (in other words, the progress of the treatment) by the detection value related to the physicochemical phenomenon by the detection unit. As a result, it is possible to suppress excessive irradiation of light to the target tissue, and the safety and efficiency of the procedure can be improved. The effect of such a light irradiation device is not limited to NIR-PIT using IRDye700DX, but can also be obtained in the same way in examinations or treatments using any target substance that has the property of reducing the amount of light or ultrasound emitted when irradiated with light.
Furthermore, since the light irradiation unit is provided on a part of the side surface at the tip of the main body unit, the range of biological tissue to which light is irradiated can be limited compared to a configuration in which the light irradiation unit is provided around the entire circumference of the main body unit, which can contribute to preventing damage to biological tissue caused by light being irradiated to unnecessary biological tissue.

(2) In the light irradiation device of the above embodiment, the detection unit may have a detection element that detects the physicochemical phenomenon, and may be arranged on the side of the tip end of the main body unit on which the light irradiation unit is provided such that the orientation of the detection element is parallel to the irradiation direction of light in the light irradiation unit.
According to this configuration, the detection unit is disposed on the side of the tip of the main body where the light irradiation unit is provided such that the orientation of the detection element is parallel to the irradiation direction of light from the light irradiation unit, thereby improving the detection accuracy by the detection unit compared to a case where the orientations are not parallel.

(3) In the light irradiation device of the above aspect, the detection element of the detection unit may detect light as the physicochemical phenomenon or ultrasound as the physicochemical phenomenon.
According to this configuration, the detection unit can detect light or ultrasound emitted when the target substance in the complex is irradiated with light of the excitation wavelength, thereby confirming whether or not the light from the light irradiating unit is being irradiated correctly.

(4) In the light irradiation device of the above form, the detection unit may be a coil-shaped detection element formed by winding an optical fiber, and may have a detection element that detects ultrasound as the physicochemical phenomenon. The light irradiation unit may be inserted into the detection element on the side surface of the tip of the main body, so that the orientation of the detection element and the irradiation direction of light in the light irradiation unit are aligned.
According to this configuration, the detection unit is arranged on the side surface of the distal end of the main body so that the direction of the detection element and the direction of light irradiation by the light irradiation unit are the same by inserting the light irradiation unit into the detection element, thereby making it possible to further improve the accuracy of ultrasonic detection by the detection unit compared to cases where the light irradiation unit is not coaxially arranged.

(5) The light irradiation device of the above form may further include a radiopaque directional marker portion provided on a side of the main body portion, the directional marker portion enabling the circumferential position of the light irradiation portion to be recognized based on the shape or position of the directional marker portion when viewed from any direction.
According to this configuration, the light irradiation device is provided with a directional marker part that is radiopaque and can recognize the circumferential position of the light irradiation part based on its shape or position when viewed from any direction. Therefore, the surgeon can easily grasp the circumferential position (orientation) of the light irradiation part by checking the shape or position of the directional marker part shown in the X-ray image. As a result, according to the light irradiation device of this configuration, for example, in NIR-PIT, it is possible to selectively irradiate light to the target tissue (cancer cells).

(6) According to one embodiment of the present invention, there is provided a medical light irradiation system, comprising a long tubular catheter and the above-described light irradiation device, which is a long light irradiation device inserted into the catheter for use, the catheter having a light transmitting section provided on at least a part of a side surface at the distal end thereof for transmitting light from inside the tube to the outside, and a first marker section provided adjacent to the light transmitting section and having radiopacity, and the light irradiation device further having a second marker section provided adjacent to the light irradiation section and having radiopacity.
According to this configuration, the catheter and the light irradiation device have radiopaque first and second marker parts provided adjacent to the light transmission part and the light irradiation part, so that the operator can easily determine the position of the light irradiation site (light transmission part and light irradiation part) in the living body lumen by confirming the positions of the first and second marker parts in the living body by X-ray photography. Therefore, according to this light irradiation system, it is possible to selectively irradiate light to a specific position in the living body lumen, for example, by selectively irradiating light to a target tissue (cancer cells) in NIR-PIT. In addition, the first marker part is provided adjacent to the light transmission part, and the second marker part is provided adjacent to the light irradiation part. Therefore, when using the light irradiation system, after inserting the light irradiation device into the catheter, the operator can easily align the light transmission part and the light irradiation part by confirming the positional relationship between the first marker part and the second marker part by X-ray photography. Furthermore, by separately providing the catheter and the light irradiation device, the freedom of device design can be improved and the range of procedures can be expanded.

(7) In the light irradiation system of the above aspect, the first marker portion may be provided at least at two locations on the distal end side and the proximal end side of the light transmitting portion in the axial direction of the catheter.
According to this configuration, the first marker portion is provided at least in two places on the distal end side and the proximal end side of the light transmitting portion, so that it is possible to align the light transmitting portion with the light irradiating portion even more easily.

(8) In the light irradiation system of the above aspect, the second marker portion may be provided at least at two locations on a distal end side and a proximal end side of the light irradiation portion in an axial direction of the light irradiation device.
According to this configuration, since the second marker portion is provided at least in two places on the distal end side and the proximal end side of the light irradiation portion, it is possible to align the light transmission portion and the light irradiation portion even more easily.

(9) In the light irradiation system of the above form, when the light irradiation device is inserted into the catheter and the light transmission section and the light irradiation section are aligned in the axial direction of the light irradiation system, the first marker section on the tip side may be positioned closer to the tip side in the axial direction than the second marker section on the tip side, and the first marker section on the base end side may be positioned closer to the base end in the axial direction than the second marker section on the base end side.
According to this configuration, in a state where the light irradiation device is inserted into the catheter and the light transmission section and the light irradiation section are aligned, the first marker section on the distal end side is disposed on the distal end side in the axial direction relative to the second marker section on the distal end side, and the first marker section on the proximal end side is disposed on the proximal end side in the axial direction relative to the second marker section on the proximal end side. In other words, in a state where the first marker sections of the catheter are aligned, the first marker sections of the catheter are disposed at both ends of the second marker section of the light irradiation device inserted inside, which makes it easy to intuitively grasp the positional relationship between the light transmission section and the light irradiation section.

(10) In the light irradiation system of the above aspect, the first marker portion may be shaped to surround the catheter in a circumferential direction, and the second marker portion may be shaped to surround the light irradiation device in a circumferential direction.
According to this configuration, since the first and second marker parts are both shaped to surround the catheter and the light irradiation device in the circumferential direction, it is easy to grasp the orientations of the catheter and the light irradiation device in the biological lumen, and therefore it is possible to easily and highly accurately align the light transmission part and the light irradiation part.

(11) In the light irradiation system of the above aspect, the catheter may be provided with a plurality of pairs of the light transmitting portion and the first marker portion in the axial direction of the catheter.
According to this configuration, the catheter is provided with a plurality of pairs of light transmitting portions and first marker portions. Therefore, by moving only the light irradiation device in the axial direction inside the catheter without moving the catheter, light can be irradiated in different regions in the axial direction of the catheter. In addition, since the first marker portions are provided on the plurality of light transmitting portions, it is possible to easily align the light irradiating portion with respect to each light transmitting portion.

(12) In the light irradiation system of the above form, the catheter may further include a tip tip joined to the tip side, and the tip tip may have a through hole formed therein that passes through the tip tip in the axial direction of the catheter and has a diameter smaller than an outer diameter of the light irradiation device.
According to this configuration, since a through hole is formed in the distal tip joined to the distal end side of the catheter, the catheter can be easily delivered to a target site in a living body lumen by inserting a guide wire through this through hole. Also, since the diameter of the through hole is smaller than the outer diameter of the light irradiation device, when the light irradiation device is inserted into the catheter, the tip of the light irradiation device hits the distal tip, thereby preventing the light irradiation device from slipping out to the distal end side.

(13) In the light irradiation system of the above aspect, the catheter may further include a temperature sensor that measures a temperature at least in the vicinity of the light transmitting portion.
According to this configuration, since a temperature sensor is provided that measures the temperature at least in the vicinity of the light-transmitting portion, temperature changes in biological tissue due to light irradiation can be observed in real time, which contributes to suppressing blood coagulation and damage to biological tissue due to light irradiation.

The present invention can be realized in various forms, such as a light irradiation device, a catheter, a light irradiation system in which these are separate or integrated, a method for controlling a light source used in these devices or systems, and a method for manufacturing these devices or systems.

1 is an explanatory diagram illustrating a configuration of a light irradiation system according to a first embodiment; FIG. 2 is an explanatory diagram illustrating a cross-sectional configuration along line AA (FIG. 1). 1 is an explanatory diagram illustrating a configuration of a tip side of a light irradiation device. FIG. FIG. 1 is an explanatory diagram illustrating a state in which the light irradiation system is used. 1 is a diagram showing the relationship between ultrasonic waves emitted from a target substance and the integrated amount of light radiation. 13 is an explanatory diagram illustrating a configuration of a tip side of a light irradiation device according to a second embodiment. FIG. 13 is an explanatory diagram illustrating a configuration of a tip side of a light irradiation device according to a third embodiment. FIG. 13A and 13B are explanatory diagrams illustrating the configuration of a light irradiation device according to a fourth embodiment. 13A and 13B are explanatory diagrams illustrating the configuration of a light irradiation device according to a fifth embodiment. 13A and 13B are explanatory diagrams illustrating the configuration of a light irradiation device according to a sixth embodiment. 13 is an explanatory diagram illustrating the configuration of the tip side of a light irradiation system according to a seventh embodiment. FIG. 13 is an explanatory diagram illustrating the configuration of the tip side of a light irradiation system according to an eighth embodiment. FIG. 12A and 12B are explanatory diagrams illustrating the configuration of the catheter as viewed from direction B (FIG. 12). FIG. 13 is an explanatory diagram illustrating the configuration of a light irradiation system according to a ninth embodiment. 23 is an explanatory diagram illustrating the configuration of the tip side of the light irradiation system according to the tenth embodiment. FIG. 23 is an explanatory diagram illustrating the configuration of the tip side of the light irradiation system according to the eleventh embodiment. FIG. 16 is an explanatory diagram illustrating the cross-sectional configuration of a catheter taken along line CC (FIG. 16). 23 is an explanatory diagram illustrating the configuration of the tip side of the light irradiation device according to the twelfth embodiment. FIG. 23 is an explanatory diagram illustrating the configuration of the tip side of the light irradiation device according to the thirteenth embodiment. FIG.

First Embodiment
Fig. 1 is an explanatory diagram illustrating the configuration of a light irradiation system according to a first embodiment. The light irradiation system is a system that is inserted into a biological lumen, such as a blood vessel system, a lymphatic system, a biliary system, a urinary system, a respiratory system, a digestive system, a secretory gland, and a reproductive organ, and is used to irradiate light from the biological lumen toward biological tissue. The light irradiation system includes a catheter 1 and a light irradiation device 2 that is inserted into the catheter 1 when used. In Fig. 1, the catheter 1 and the light irradiation device 2 are individually illustrated.

In this embodiment, the light irradiation system is used in near-infrared photoimmunotherapy (NIR-PIT). In NIR-PIT, a complex of two compounds, an antibody against a specific antigen of cancer cells and a photosensitive substance (e.g., IRDye700DX), is administered intravenously to a patient in advance. The complex administered intravenously selectively accumulates in cancer cells in the living body. The light irradiation system is then inserted into a living body lumen, and a laser beam having an excitation wavelength (e.g., 690 nm) of the photosensitive substance in the complex is irradiated toward the cancer cells in the living body. This activates the complex accumulated in the cancer cells in the living body, and the complex exhibits an anti-cancer effect. Hereinafter, the living tissue that is the target of treatment by the light irradiation system, such as cancer cells, is also called the "target tissue". In addition, the photosensitive substance that is activated by light irradiation, such as IRDye700DX, is also called the "target substance".

In this embodiment, a laser light with a wavelength of 690 nm is exemplified as an example of light, but the wavelength of the laser light may be changed as desired. In addition, the light irradiation system is not limited to laser light, and may use, for example, LED light or white light. Furthermore, the light irradiation system is not limited to NIR-PIT, and may be used in examinations or treatments that include a process of irradiating light inside a living body, such as PDT (Photodynamic Therapy) or examinations or treatments for cancer, cerebral aneurysm, arrhythmia, Alzheimer's disease, etc.

In FIG. 1, the axis passing through the center of the catheter 1 and the axis passing through the center of the light irradiation device 2 are each represented by an axis O (dotted line). Hereinafter, in the state where the light irradiation device 2 is inserted into the catheter 1, the axis passing through their centers coincides with the axis O, but the axes passing through the centers of both in the inserted state may be different. FIG. 1 also illustrates mutually orthogonal XYZ axes. The X axis corresponds to the axial direction (longitudinal direction) of the catheter 1 and the light irradiation device 2, the Y axis corresponds to the height direction of the catheter 1 and the light irradiation device 2, and the Z axis corresponds to the width direction of the catheter 1 and the light irradiation device 2. The left side (-X axis direction) of FIG. 1 is called the "tip side" of the catheter 1, the light irradiation device 2, and each component, and the right side (+X axis direction) of FIG. 1 is called the "base side" of the catheter 1, the light irradiation device 2, and each component. Furthermore, of the two ends in the longitudinal direction (X-axis direction) of the catheter 1, the light irradiation device 2, and each component, the end located on the distal end side is referred to as the "distal end," and the other end located on the proximal end side is referred to as the "proximal end." The distal end and its vicinity are referred to as the "distal portion," and the proximal end and its vicinity are referred to as the "proximal end portion." The distal end side is inserted into the living body, and the proximal end side is operated by an operator such as a doctor. These points are also common to Figure 1 and subsequent figures.

The catheter 1 has a long tubular shape and includes a shaft 110, a distal tip 120, and a connector 140.

The shaft 110 is a long member extending along the axis O. The shaft 110 is hollow and generally cylindrical with both ends, the distal end 110d and the proximal end 110p, open. The shaft 110 has a lumen 110L therein. The lumen 110L functions as a guidewire lumen for inserting a guidewire into the catheter 1 during delivery of the catheter 1. After delivery of the catheter 1, the lumen 110L functions as a device lumen for inserting a light irradiation device 2 into the catheter 1. In this way, by using a single lumen as both the guidewire lumen and the device lumen, the catheter 1 can be made thinner. The outer diameter, inner diameter, and length of the shaft 110 can be determined as desired.

The tip tip 120 is a member that is joined to the tip of the shaft 110 and advances through the body lumen ahead of other members. The tip tip 120 has an outer shape that is tapered from the base end side to the tip side in order to make the catheter 1 advance smoothly through the body lumen. A through hole 120h that penetrates the tip tip 120 in the axial direction O is formed in the approximate center of the tip tip 120. Here, the opening diameter Φ1 of the through hole 120h is smaller than the inner diameter Φ2 of the lumen 110L of the shaft 110. Therefore, at the boundary between the shaft 110 and the tip tip 120, a step is formed due to the protrusion of the inner surface 120i of the tip tip 120. The opening 120o of the tip tip 120 leads to the through hole 120h and is used when inserting a guide wire (not shown) into the catheter 1. The outer diameter and length of the tip tip 120 can be determined arbitrarily.

The connector 140 is a member disposed on the base end side of the catheter 1 and is held by the surgeon. The connector 140 includes a substantially cylindrical connecting portion 141 and a pair of wings 142. The base end 110p of the shaft 110 is joined to the tip of the connecting portion 141, and the wings 142 are joined to the base end. The wings 142 may be integral with the connector 140. The opening 140o of the connector 140 communicates with the lumen 110L via the inside of the connector 140, and is used when inserting the light irradiation device 2 into the catheter 1. The outer diameter, inner diameter, and length of the connecting portion 141 and the shape of the wings 142 can be determined arbitrarily.

The shaft 110 of the catheter 1 is further provided with a light-transmitting portion 139 and first marker portions 131 and 132.

The light transmitting portion 139 transmits light (laser light) irradiated from inside the shaft 110 to the outside. The light transmitting portion 139 is a hollow, substantially cylindrical member, has an outer diameter substantially the same as the outer diameter of the shaft 110, and has an inner diameter substantially the same as the inner diameter Φ2 of the lumen 110L of the shaft 110. The light transmitting portion 139 is provided over the entire circumferential direction, and transmits light inside the shaft 110 to the outside over the entire circumferential direction. The light transmitting portion 139 is joined to the shaft 110 at the base end side and the tip side. The light transmitting portion 139 can be formed of a transparent resin material having optical transparency, such as acrylic resin, polyethylene terephthalate, polyvinyl chloride, etc. An interference filter may be provided on the inner surface or outer surface of the light transmitting portion 139. The interference filter is a film body having a predetermined transmission band (for example, a wavelength of 600 nm or more and 1000 nm or less). An interference filter transmits light with wavelengths within its transmission band, but does not transmit (blocks) light with wavelengths outside the transmission band.

The first marker parts 131 and 132 function as marks indicating the position of the light transmitting part 139. The first marker part 131 is provided close to the tip of the light transmitting part 139 and functions as a mark indicating the position of the tip of the light transmitting part 139. The first marker part 132 is provided close to the base end of the light transmitting part 139 and functions as a mark indicating the position of the base end of the light transmitting part 139. The first marker parts 131 and 132 are each hollow, approximately cylindrical members. In the example of FIG. 1, the first marker parts 131 and 132 are each disposed in a recess formed on the outer surface of the shaft 110 and are joined to the outer surface of the shaft 110. In other words, the first marker parts 131 and 132 are each embedded in the outer surface of the shaft 110 so as to surround the shaft 110 in the circumferential direction. The first markers 131, 132 may be bonded to the outer surface of the shaft 110, which does not have a recess, so that they protrude from the outer surface of the shaft 110.

The light irradiation device 2 has an elongated outer shape and includes a main body 210, a tip 220, a connector 240, a light transmission unit 250, a detection unit 260, and a reinforcing member 272 (described later in FIG. 2).

The main body 210 is an elongated member extending along the axis O. The main body 210 is hollow and has an approximately cylindrical (tubular) shape with both ends, the distal end 210d and the proximal end 210p, open. A light irradiation unit 239 and a detection element 261 are provided on the outer surface of the distal end side of the main body 210 (described later in FIG. 3). The light transmission unit 250, the detection unit 260, and the reinforcing member 272 are respectively housed in the lumen 210L on the inner side (interior) of the main body 210. In addition, the gaps inside the main body 210, excluding the light transmission unit 250, the detection unit 260, and the reinforcing member 272, are filled with a sealing member 271. For example, any resin material such as polyurethane can be used as the sealing member 271.

The distal tip 220 is a member that is joined to the distal end 210d of the main body 210 and advances through the lumen 110L of the catheter 1 ahead of other members. The distal tip 220 is a substantially cylindrical member that extends in the longitudinal direction of the light irradiation device 2. Here, it is preferable that the outer diameter Φ3 of the distal tip 220 and the main body 210 (in other words, the outer diameter Φ3 of the light irradiation device 2) is larger than the opening diameter Φ1 of the through hole 120h of the catheter 1 and smaller than the inner diameter Φ2 of the shaft 110 and the light transmitting portion 139 of the catheter 1 (Φ1<Φ3<Φ2).

The connector 240 is a member disposed on the base end side of the light irradiation device 2 and is held by the surgeon. The connector 240 has a substantially cylindrical connecting portion 241 and a pair of wings 242. The base end portion 210p of the main body portion 210 is joined to the tip end of the connecting portion 241, and the wings 242 are joined to the base end portion of the connecting portion 241. The wings 242 may be an integral structure with the connector 240.

Figure 2 is an explanatory diagram illustrating the cross-sectional configuration along line A-A (Figure 1). Figure 3 is an explanatory diagram illustrating the configuration of the tip side of the light irradiation device 2. Figure 3(A) shows the cross-sectional configuration of the tip side of the light irradiation device 2. Figure 3(B) shows the configuration of the light irradiation device 2 as viewed from direction B in Figure 3(A).

The light transmitting unit 250 irradiates light from the light irradiating unit 239 formed at the tip to the target tissue (cancer cells) in the living body and the target substance (e.g., IRDye700DX) in the complex accumulated in the target tissue. As shown in FIG. 2, the light transmitting unit 250 is composed of an optical fiber having a core 250c extending in the longitudinal direction of the light irradiating device 2 and a clad 250cl covering the outer surface of the core 250c. The core 250c is disposed approximately in the center of the clad 250cl and has a higher optical refractive index than the clad 250cl. The core 250c and the clad 250cl have a uniform refractive index. The light transmitting unit 250 transmits light by total reflection of light utilizing the difference in refractive index between the core 250c and the clad 250cl.

1, the tip side of the light transmission part 250 is inserted inside the main body part 210 and fixed by a sealing member 271. Also, as shown in FIG. 3(A), a curved part is formed at the tip of the light transmission part 250 in which the light transmission part 250 is curved in the +Y axis direction. Then, as shown in FIG. 3(B), the tip (tip surface) of the light transmission part 250 is exposed and disposed on the outer surface of the main body part 210. At the tip of the light transmission part 250, the core 250c is exposed. The exposed core 250c irradiates the laser light LT generated by the light source 3 and transmitted through the light transmission part 250. That is, the core 250c exposed at the tip of the light transmission part 250 functions as a light irradiation part 239 that irradiates the light LT to the outside. In this manner, in the configuration of this embodiment, the tip of the light transmitting section 250 is curved so that the direction of irradiation of the light LT from the light irradiating section 239 is a direction intersecting the longitudinal direction (axis O direction) of the light irradiating device 2, in other words, one direction of the side of the light irradiating device 2. The core 250c of the light irradiating section 239 may be subjected to a known process (for example, a process for cutting the tip surface obliquely, a process for forming a notch, a sandblasting process, a chemical process). In addition, a resin body or a light reflecting mirror for transmitting, refracting, and amplifying the laser light LT may be provided at or near the tip of the core 250c. The resin body can be formed, for example, by applying an acrylic ultraviolet curing resin in which fine quartz powder is dispersed, and curing it with ultraviolet light.

As shown in FIG. 1, the base end side of the light transmission section 250 passes through the inside of the connector 240 and is pulled out to the outside. The base end of the light transmission section 250 is connected to the light source 3 directly via a connector (not shown) or indirectly via another optical fiber. The light source 3 is, for example, a laser light generating device that generates laser light of an arbitrary wavelength. The length of the light transmission section 250 may be determined arbitrarily.

The detection unit 260 is a sensor that detects ultrasonic waves emitted from a target substance (e.g., IRDye700DX). In this embodiment, the detection unit 260 is an optical fiber Doppler sensor (FOD) that is composed of an optical fiber having a core 260c extending in the longitudinal direction of the light irradiation device 2 and a cladding 260cl that covers the outer surface of the core 260c (Figure 2).

As shown in FIG. 3(A), the detection section 260 has a detection element 261 and an extension section 262. As shown in FIG. 3(B), the detection element 261 is a coil-shaped detection element formed by winding a portion of the tip side of an optical fiber. The detection element 261 detects ultrasonic waves emitted from the object to be measured (here, the target substance in the complex accumulated in the biological tissue) using the laser Doppler effect. Also, as shown in FIG. 1, the extension section 262 is composed of the remaining part of the optical fiber, connects the detection element 261 to an external detection device 4, and transmits the detection value (detection signal) by the detection element 261 to the detection device 4.

As shown in FIG. 1, the tip side of the extension 262 is inserted inside the main body 210 and fixed by the sealing member 271. Also, as shown in FIG. 3A, a curved portion is formed at the tip of the extension 262, where the extension 262 is curved in the +Y axis direction (in other words, the same direction as the curved direction of the light irradiation unit 239). The detection element 261 provided at the tip of the extension 262 is exposed and disposed on the outer surface of the main body 210. Specifically, as shown in FIG. 3B, the detection element 261 is provided at a position adjacent to the light irradiation unit 239 in the X axis direction on the side surface of the tip side of the main body 210. In other words, the detection unit 260 and the light irradiation unit 239 are provided in close proximity. Here, as shown in FIG. 3A, on the side surface of the tip side of the main body 210, the direction ED of the detection element 261 is parallel to the light irradiation direction LTD of the light irradiation unit 239. Here, "the orientation ED of the detection element 261" refers to the orientation of the central axis of the coil of the detection element 261. Also, "the light irradiation direction LTD" refers to the center of the irradiation range of light from the light irradiation unit 239.

As shown in FIG. 1, the base end side of the extension portion 262 is pulled out to the outside through the inside of the connector 240. The base end of the extension portion 262 is connected to the detection device 4 directly through a connector (not shown) or indirectly through another optical fiber. The detection device 4 is a device that detects ultrasound and informs the surgeon of the strength of the detected ultrasound by any means such as a screen display, an LED (Light Emitting Diode) display, or audio guidance. The number of turns of the detection element 261 and the length of the extension portion 262 may be determined arbitrarily.

In the present embodiment, the light transmitting section 250 and the detection section 260 are made of plastic optical fibers, both of which have a core and a clad made of resin. The core can be made of, for example, polymethylmethacrylate (PMMA), polystyrene, polycarbonate, deuterated polymer, fluorine-based polymer, silicon-based polymer, norbornene-based polymer, or the like. The core is classified into single mode and multimode depending on the number of modes through which light propagates, and either may be used in the present embodiment. In addition, in the case of a multimode core, it is classified into step index and graded index depending on the refractive index distribution, and either may be used in the present embodiment. The clad can be made of, for example, a fluorine-based polymer. In the light transmitting section 250 and the detection section 260, a quartz glass optical fiber or a multicomponent glass optical fiber may be used instead of a plastic optical fiber.

The reinforcing member 272 is a member for reinforcing the long light irradiation device 2 and suppressing excessive bending of the light irradiation device 2. The reinforcing member 272 is a long core wire extending along the axis O and having a solid, approximately cylindrical shape. The reinforcing member 272 is arranged inside the main body 210 so that its tip is located near the tip tip 220 and its base is located inside the connector 240. The reinforcing member 272 can be formed from any material, for example, any hard resin material such as reinforced plastic (PEEK) or a metal material. The length of the reinforcing member 272 can be determined arbitrarily.

The main body 210 of the light irradiation device 2 is further provided with second markers 231 and 232. The second markers 231 and 232 function as marks indicating the position of the light irradiation unit 239. The second marker 231 is provided close to the tip of the light irradiation unit 239 and functions as a mark indicating the position of the tip of the light irradiation unit 239. The second marker 232 is provided close to the base end of the light irradiation unit 239 (more specifically, the base end of the detection element 261) and functions as a mark indicating the position of the base end of the light irradiation unit 239. The second markers 231 and 232 are each a hollow, approximately cylindrical member. In the example of FIG. 1, the second markers 231 and 232 are each disposed in a recess formed on the outer surface of the main body 210 and are joined to the outer surface of the main body 210. In other words, the second markers 231 and 232 are embedded in the outer surface of the main body 210 so as to surround the main body 210 in the circumferential direction. The second markers 231 and 232 may be bonded to the outer surface of the main body 210 that does not have a recess, so that they protrude from the outer surface of the main body 210.

The first marker parts 131, 132 of the catheter 1 and the second marker parts 231, 232 of the light irradiation device 2 can be formed from a resin material or a metal material that is radiopaque. For example, when a resin material is used, it can be formed by mixing a radiopaque material such as bismuth trioxide, tungsten, or barium sulfate with a polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, or fluororesin. For example, when a metal material is used, it can be formed from a radiopaque material such as gold, platinum, or tungsten, or an alloy containing these elements (for example, a platinum-nickel alloy).

The shaft 110 of the catheter 1 and the main body 210 of the light irradiation device 2 are preferably antithrombotic, flexible, and biocompatible, and can be made of a resin material or a metal material. Examples of the resin material include polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin. Examples of the metal material include stainless steel such as SUS304, nickel-titanium alloy, cobalt-chromium alloy, and tungsten steel. The shaft 110 and the main body 210 can also be a joint structure made by combining a plurality of the above-mentioned materials. The distal tip 120 of the catheter 1 and the distal tip 220 of the light irradiation device 2 are preferably flexible, and can be made of a resin material such as polyurethane or polyurethane elastomer. The connector 140 of the catheter 1 and the connector 240 of the light irradiation device 2 can be made of a resin material such as polyamide, polypropylene, polycarbonate, polyacetal, and polyethersulfone.

Figure 4 is an explanatory diagram illustrating the use of the light irradiation system. The upper part of Figure 4 illustrates the state in which the light irradiation device 2 is inserted into the catheter 1. The lower part of Figure 4 illustrates an enlarged view of a portion of the tip side. The method of using the light irradiation system will be described with reference to Figures 1 and 4. First, the operator inserts a guidewire into the body lumen. Next, the operator inserts the base end side of the guidewire from the opening 120o of the tip tip 120 of the catheter 1 shown in Figure 1 into the lumen 110L and protrudes it from the opening 140o of the connector 140. Next, the operator pushes the catheter 1 along the guidewire into the body lumen, and delivers the light transmitting portion 139 of the catheter 1 to the target site of light irradiation (for example, near the cancer cells in the case of NIR-PIT). In this way, by inserting the guidewire through the through hole 120h formed in the tip tip 120 of the catheter 1, the operator can easily deliver the catheter 1 to the target site in the body lumen. During delivery, the surgeon can position the catheter 1 within the body lumen while checking the positions of the first markers 131, 132 arranged near the light-transmitting portion 139 in the X-ray image. The surgeon then removes the guidewire from the catheter 1.

Next, as shown in FIG. 4, the operator inserts the light irradiation device 2 from the opening 140o of the connector 140 of the catheter 1. The operator pushes the light irradiation device 2 along the lumen 110L of the catheter 1 toward the tip side of the catheter 1. As described above, if the outer diameter Φ3 of the light irradiation device 2 is smaller than the inner diameter Φ2 of the lumen 110L of the catheter 1 and larger than the opening diameter Φ1 of the through hole 120h of the tip tip 120, when the light irradiation device 2 is inserted into the catheter 1, the tip surface 220e of the light irradiation device 2 hits the inner surface 120i of the tip tip 120, thereby preventing the light irradiation device 2 from slipping out toward the tip side (lower part of FIG. 4: dotted circle frame).

Then, the surgeon checks the positional relationship between the first markers 131, 132 and the second markers 231, 232 in the X-ray image, and aligns the positions of the light transmitting section 139 and the light irradiating section 239 in the axial O direction (X-axis direction). This allows the laser light LT transmitted through the light transmitting section 250 and emitted from the light irradiating section 239 to pass through the light transmitting section 139 of the catheter 1 and be emitted to external biological tissue. Note that in the catheter 1 of this embodiment, the light transmitting section 139 is provided over the entire circumferential direction. Therefore, in the light irradiation system of this embodiment, the surgeon only needs to align the light transmitting section 139 and the light irradiating section 239 in the axial O direction (X-axis direction), and does not need to align the light transmitting section 139 and the light irradiating section 239 in the circumferential direction.

Figure 5 shows the relationship between the ultrasound emitted from the target substance and the cumulative radiation amount of light. The horizontal axis of Figure 5 represents the cumulative radiation amount of light (laser light LT in Figure 4) from the light irradiation system, and the vertical axis represents the amount of ultrasound emitted from the target substance. As explained in Figure 4, in the NIR-PIT procedure using the light irradiation system, light with the excitation wavelength of the target substance (e.g., a photosensitive substance such as IRDye700DX) in the complex is irradiated to the target tissue (cancer cells) in the living body. The irradiation of light causes the target substance (IRDye700DX) to undergo an irreversible structural change from hydrophilic to hydrophobic, inducing necrosis of the target tissue. In other words, the irradiation of light activates the complex accumulated in the target tissue in the living body, resulting in an anti-cancer effect.

Here, the target substance (IRDye700DX) has the property of emitting light and emitting ultrasound waves due to the photoacoustic effect when irradiated with light of the excitation wavelength of the target substance. The target substance's property of "emitting light and ultrasound waves" disappears as the structural change of the target substance progresses. For this reason, as shown in Figure 5, as the integrated amount of light emitted from the light irradiation system increases, the amount of ultrasound emitted from the target substance in the complex accumulated in the target tissue (cancer cells) in the living body gradually decreases. Note that while Figure 5 illustrates the amount of ultrasound emitted from the target substance, the same applies to the amount of light emitted from the target substance.

The light irradiation system can detect ultrasonic waves emitted from the target substance (IRDye700DX) by the detection unit 260. The detection device 4 uses the detection value by the detection unit 260 to perform the following processes a1 and a2, for example.
(a1) The detection device 4 acquires and stores the standard value of the detection unit 260. The standard value is the value of ultrasound emitted from biological tissue other than the target substance (e.g., hemoglobin in blood, etc.). The standard value can be obtained by irradiating the target tissue (cancer cells) in the living body with light from the light irradiation unit 239 before administering the complex, and acquiring the detection value of the detection unit 260 at that time. Note that the standard value is not limited to a value directly acquired from a patient who is the target of the procedure, and any data such as a value acquired from a healthy person or a value input by the operator may be used.
(a2) After administration of the complex, the detection device 4 acquires detection values obtained from the detection unit 260 in real time during the NIR-PIT procedure. The detection device 4 informs the operator in real time of the acquired detection values, excluding the standard values of the process a1. The information can be provided by any means, such as a screen display, an LED display, or a voice guide.

In the above example, the detection unit 260 is a sensor that detects "ultrasound waves" emitted from the target substance (IRDye700DX). However, the detection unit 260 may be a sensor that detects "light" emitted from the target substance. In this case, similar to process a1, the standard values of the light irradiated from the light irradiating unit 239 and the reflected light from the biological tissue are acquired and stored in advance for the detection device 4. Then, similar to process a2, the detection value obtained from the detection unit 260 is acquired in real time, and the value obtained by excluding the standard value of process a1 from the detection value is notified to the operator. As described in FIG. 5, the light emitted from the target substance has the same properties as ultrasound. Therefore, even if the detection unit 260 is a sensor that detects light, the same processing can be performed.

In addition to "ultrasound" or "light" emitted from the target substance, the detection unit 260 may be a sensor that detects various physicochemical phenomena caused by the target substance or biological tissue due to the irradiation of the target substance with light. Examples of physicochemical phenomena caused by the target substance include the above-mentioned emission of ultrasound and light. Examples of physicochemical phenomena caused by biological tissue include, for example, a change in the pH of bodily fluids present around the target tissue (cancer cells) and a change in temperature of the biological tissue (including bodily fluids) caused by the emission of light or ultrasound from the target substance. Examples of physicochemical phenomena caused by biological tissue include a change in pressure of bodily fluids caused by cell rupture of the target tissue during the process of killing the target tissue due to the anti-cancer effect of the complex. The detection unit 260 may be configured as a sensor that detects physicochemical phenomena (changes in pH, temperature, and pressure of bodily fluids) caused by the irradiation of the target substance with light.

As described above, the light irradiation device 2 of the first embodiment includes a detection unit 260 that detects physicochemical phenomena (e.g., light, ultrasound, changes in the pH of bodily fluids, temperature changes, pressure changes, etc.) that occur due to the target substance irradiated with light LT from the light irradiation unit 239. Here, for example, in NIR-PIT, when the target substance (e.g., a photosensitive substance such as IRDye700DX) in the complex accumulated in the target tissue (cancer cells) in the living body is irradiated with light LT of the excitation wavelength of the target substance, it emits light and also emits ultrasound due to the photoacoustic effect. Therefore, the operator can confirm whether or not the light LT from the light irradiation unit 239 is correctly irradiated toward the target tissue in the living body (cancer cells in which a complex containing the target substance is accumulated) based on the presence or absence of detection of the physicochemical phenomenon by the detection unit 260. As a result, it is possible to reliably irradiate the light LT to the target tissue, thereby improving the efficiency of the procedure. The effects of this type of light irradiation device 2 are not limited to NIR-PIT using the IRDye700DX, but can also be obtained in examinations or treatments using any target substance that has the property of emitting light or ultrasound when irradiated with light LT.

In addition, in the case of IRDye700DX as the target substance, as the cumulative amount of irradiation of light LT to the target substance increases, the target substance undergoes an irreversible structural change, inducing the death of the target tissue (cancer cells), and the amount of light emitted from the target substance and the amount of ultrasound emitted from the target substance decrease (FIG. 5). Therefore, the surgeon can grasp the degree of death of the target tissue (in other words, the progress of the treatment) from the detection value of the physicochemical phenomenon by the detection unit 260. As a result, it is possible to suppress excessive irradiation of light LT to the target tissue, and the safety and efficiency of the procedure can be improved. The effect of the light irradiation device 2 is not limited to NIR-PIT using IRDye700DX, but can also be obtained in the same way in examinations or treatments using any target substance that has the property of reducing the amount of light or ultrasound emitted when irradiated with light LT.

Furthermore, in the light irradiation device 2, the light irradiation section 239 is provided on a portion of the side surface on the tip side of the main body section 210. Therefore, compared to a configuration in which the light irradiation section 239 is provided on the entire circumference of the main body section 210, it is possible to limit the range of biological tissue to which light is irradiated, which can contribute to suppressing biological tissue damage caused by irradiating unnecessary biological tissue with light.

According to the light irradiation device 2 of the first embodiment, the detection unit 260 is arranged on the side of the tip of the main body 210 where the light irradiation unit 239 is provided, so that the direction ED of the detection element 261 and the irradiation direction LTD of the light LT in the light irradiation unit 239 are parallel (FIG. 3). This improves the detection accuracy of the detection unit 260 compared to a non-parallel arrangement. Here, "parallel" means that it is sufficient to be roughly parallel, and allows for blurring due to manufacturing errors and the like. In addition, the detection unit 260 of the first embodiment can check whether the light LT from the light irradiation unit 239 is being correctly irradiated by detecting ultrasound emitted when the target substance in the complex is irradiated with light LT of an excitation wavelength.

Furthermore, according to the light irradiation system of the first embodiment, the catheter 1 and the light irradiation device 2 have the first marker parts 131, 132 and the second marker parts 231, 232 that are radiopaque and provided adjacent to the light transmission part 139 and the light irradiation part 239. Therefore, the operator can easily determine the position of the light irradiation part (light transmission part 139 and light irradiation part 239) in the living body lumen by confirming the positions of the first marker parts 131, 132 and the second marker parts 231, 232 in the living body by X-ray photography. Therefore, according to the light irradiation system of the first embodiment, it is possible to selectively irradiate light to a specific position in the living body lumen, such as selectively irradiating light to a target tissue (cancer cells) in NIR-PIT. In addition, the first marker parts 131, 132 are provided adjacent to the light transmission part 139, and the second marker parts 231, 232 are provided adjacent to the light irradiation part 239. Therefore, when using the light irradiation system, after inserting the light irradiation device 2 into the catheter 1, the surgeon can easily align the light transmission part 139 with the light irradiation part 239 by checking the positional relationship between the first marker parts 131, 132 and the second marker parts 231, 232 by X-ray photography. Furthermore, by providing the catheter 1 and the light irradiation device 2 separately, the degree of freedom in device design can be improved and the range of procedures can be expanded.

Furthermore, in the catheter 1, the first marker portions 131, 132 are provided at least in two places, the distal end side and the proximal end side of the light transmitting portion 139, so that the surgeon can more easily align the light transmitting portion 139 with the light irradiating portion 239. Similarly, in the light irradiating device 2, the second marker portions 231, 232 are provided at least in two places, the distal end side and the proximal end side of the light irradiating portion 239, so that the surgeon can more easily align the light transmitting portion 139 with the light irradiating portion 239.

Furthermore, in the light irradiation system of this embodiment, as shown in FIG. 4, when the light irradiation device 2 is inserted into the catheter 1 and the light transmission section 139 and the light irradiation section 239 are aligned, the first marker section 131 on the tip side is disposed on the tip side in the axial direction O relative to the second marker section 231 on the tip side, and the first marker section 132 on the base end side is disposed on the base end side in the axial direction O relative to the second marker section 232 on the base end side. In other words, in the light irradiation system of FIG. 4, when aligned, the first marker sections 131 and 132 of the catheter 1 are disposed at both ends of the second marker sections 231 and 232 of the light irradiation device 2 inserted inside. Therefore, the surgeon can easily intuitively grasp the positional relationship between the light transmission section 139 and the light irradiation section 239.

Furthermore, in the light irradiation system of this embodiment, the first marker units 131, 132 and the second marker units 231, 232 are both shaped to surround the catheter 1 and the light irradiation device 2 in the circumferential direction, so that the orientation of the catheter 1 and the light irradiation device 2 within the living lumen can be easily grasped by X-ray photography. Therefore, the surgeon can easily and highly accurately align the light transmission unit 139 and the light irradiation unit 239.

In addition, in the light irradiation system of this embodiment, the tip tip 120 joined to the tip side of the catheter 1 has a through hole 120h formed therein, so that the catheter 1 can be easily delivered to a target site in a living body lumen by inserting a guide wire through this through hole 120h. In addition, since the opening diameter Φ1 of the through hole 120h is smaller than the outer diameter Φ3 of the light irradiation device 2, when the light irradiation device 2 is inserted into the catheter 1, the tip of the light irradiation device 2 hits the tip tip 120, so that the light irradiation device 2 can be prevented from slipping out toward the tip side. In addition, as shown in the lower part of FIG. 4, the light transmission part 139 and the light irradiation part 239 are arranged so that the position of the light irradiation part 239 in the axis O direction is located approximately in the center part of the axis O direction of the light transmission part 139 when the light irradiation device 2 hits the catheter 1. This makes it even easier for the surgeon to align the light transmission part 139 and the light irradiation part 239.

Second Embodiment
Fig. 6 is an explanatory diagram illustrating the configuration of the tip side of the light irradiation device 2A of the second embodiment. Fig. 6(A) shows a cross-sectional configuration of the tip side of the light irradiation device 2A. Fig. 6(B) shows the configuration of the light irradiation device 2A seen from the B direction of Fig. 6(A). The light irradiation system of the second embodiment includes the light irradiation device 2A shown in Fig. 6 and a catheter 1 having the same configuration as that of the first embodiment. The light irradiation device 2A includes a detection unit 260A instead of the detection unit 260.

The detection unit 260A has a detection element 261A and an extension 262. The detection element 261A is a coil-shaped detection element formed by winding a part of the tip side of the optical fiber. As shown in FIG. 6B, the detection element 261A is arranged at the same position as the light irradiation unit 239 on the side surface of the tip side of the main body 210 so as to surround the periphery of the light irradiation unit 239. In other words, the light irradiation unit 239 is inserted inside the coil-shaped detection element 261A. For this reason, as shown in FIG. 6A, on the side surface of the tip side of the main body 210, the direction ED of the detection element 261A is the same (coaxial) as the light irradiation direction LTD of the light irradiation unit 239. Here, "coaxial" means that it is sufficient to be roughly coaxial, and allows for deviations due to manufacturing errors, etc. In FIG. 6A, for convenience of illustration, the dashed arrow representing the direction ED of the detection element 261A and the solid arrow representing the light irradiation direction LTD are slightly shifted, but they represent the same position. The configuration of the extension portion 262 is as described in the first embodiment.

In this way, the configuration of the detection unit 260A can be modified in various ways, and the detection element 261A may be disposed at the same position as the light irradiation unit 239. The light irradiation system of the second embodiment as described above can also achieve the same effects as the first embodiment. In addition, according to the light irradiation device 2A of the second embodiment, the detection unit 260A is disposed on the side surface of the tip side of the main body 210 such that the direction ED of the detection element 261A and the irradiation direction LTD of light in the light irradiation unit 239 are the same by inserting the light irradiation unit 239 into the inside of the detection element 261A. Therefore, compared to the case of a non-coaxial arrangement, the detection accuracy of the ultrasound by the detection unit 260A can be further improved.

Third Embodiment
Fig. 7 is an explanatory diagram illustrating the configuration of the tip side of the light irradiation device 2B of the third embodiment. Fig. 7(A) shows a cross-sectional configuration of the tip side of the light irradiation device 2B. Fig. 7(B) shows the configuration of the light irradiation device 2B seen from the B direction of Fig. 7(A). The light irradiation system of the third embodiment includes the light irradiation device 2B shown in Fig. 7 and a catheter 1 having the same configuration as that of the first embodiment. The light irradiation device 2B includes a detection unit 260B instead of the detection unit 260.

The detection unit 260B has a detection element 261B and an extension 262. The detection element 261B is a coil-shaped detection element formed by winding a portion of the tip side of the optical fiber. As shown in FIG. 7B, the detection element 261B is provided on the side surface of the tip side of the main body 210 in the vicinity of the light irradiation unit 239, but at a position separated from the light irradiation unit 239. In the illustrated example, the detection element 261B is disposed at a different position from the light irradiation unit 239 in both the axial O direction (X-axis direction) and the circumferential direction (YZ-axis direction). As a result, as shown in FIG. 7A, on the side surface of the tip side of the main body 210, the orientation of the detection element 261B is neither parallel to nor coaxial with the light irradiation direction LTD of the light irradiation unit 239.

In this way, the configuration of the detection unit 260B can be modified in various ways, and the detection element 261B can be arranged in any position as long as it is provided in the main body 210 near the light irradiation unit 239. For example, as described in FIG. 7, the detection element 261B and the light irradiation unit 239 may be arranged at a distance. The light irradiation system of the third embodiment as described above can also achieve the same effects as the first embodiment described above.

Fourth Embodiment
Fig. 8 is an explanatory diagram illustrating the configuration of a light irradiation device 2C of the fourth embodiment. The light irradiation system of the fourth embodiment includes the light irradiation device 2C shown in Fig. 8 and a catheter 1 having the same configuration as that of the first embodiment. The light irradiation device 2C further includes a directional marker unit 280 in addition to the configuration described in the first embodiment.

The directional marker portion 280 indicates the circumferential direction of the light irradiation device 2C and functions as a mark for allowing the surgeon to recognize the circumferential position of the light irradiation portion 239. The directional marker portion 280 is formed by bending a wire made of a resin material or a metal material having radiopacity into an arc shape. The directional marker portion 280 is embedded in the thick portion of the main body portion 210 on the side surface of the main body portion 210. In the illustrated example, the directional marker portion 280 is disposed in the approximate center portion of the main body portion 210 in the axis O direction. However, the directional marker portion 280 may be disposed at any position, such as near the light irradiation portion 239. The directional marker portion 280 shown in FIG. 8 is disposed so that the opening 280c faces in the opposite direction (-Y axis direction) to the light irradiation portion 239. Therefore, the surgeon can recognize the circumferential position of the light irradiation unit 239 (in other words, the orientation of the light irradiation unit 239) by checking the shape of the directional marker unit 280 (specifically, the orientation of the opening 280c) from any direction shown in the X-ray image.

In this way, the configuration of the light irradiation device 2C can be modified in various ways, and may have a configuration (directional marker unit 280) for making it possible to recognize the position of the light irradiation unit 239 in the circumferential direction by the shape when viewed from an arbitrary direction. The shape of the directional marker unit 280 can be modified in various ways, such as the above-mentioned arc shape, spiral shape, wave shape, etc. The light irradiation system of the fourth embodiment as described above can also achieve the same effect as the first embodiment described above. In addition, the light irradiation device 2C of the fourth embodiment is provided with a directional marker unit 280 that is radiopaque and can recognize the position of the light irradiation unit 239 in the circumferential direction by the shape when viewed from an arbitrary direction. Therefore, the operator can easily grasp the position (direction) of the light irradiation unit 239 in the circumferential direction by checking the shape of the directional marker unit 280 reflected in the X-ray image. As a result, the light irradiation device 2C of the fourth embodiment can selectively irradiate light to the target tissue (cancer cells), for example, in NIR-PIT.

Fifth Embodiment
Fig. 9 is an explanatory diagram illustrating the configuration of a light irradiation device 2D of the fifth embodiment. The light irradiation system of the fifth embodiment includes the light irradiation device 2D shown in Fig. 9 and a catheter 1 having the same configuration as that of the first embodiment. The light irradiation device 2D includes a directional marker unit 280D instead of the directional marker unit 280 in the configuration described in the fourth embodiment.

The directional marker portion 280D is radiopaque and includes multiple strands (hereinafter also referred to as "sub-markers") bent into an arc shape. Each sub-marker is embedded in the thick portion of the main body portion 210 on the side of the main body portion 210, spaced at equal intervals in the direction of the axis O. Each sub-marker is arranged so that the opening 280c faces in the opposite direction to the light irradiation portion 239. In the illustrated example, the directional marker portion 280D is composed of three sub-markers, but the number of sub-markers that compose the directional marker portion 280D can be changed as desired.

In this way, the configuration of the light irradiation device 2D can be modified in various ways, and a configuration (directional marker section 280D) for making it possible to recognize the circumferential position of the light irradiation section 239 by using multiple sub-markers may be realized. The light irradiation system of the fifth embodiment as described above can also achieve the same effects as those of the first and fourth embodiments described above. Furthermore, according to the light irradiation device 2D of the fifth embodiment, since the directional marker section 280D has multiple sub-markers, it is possible to easily confirm the shape of the directional marker section 280D reflected in the X-ray image. As a result, the surgeon can more easily grasp the circumferential position (orientation) of the light irradiation section 239.

Sixth Embodiment
Fig. 10 is an explanatory diagram illustrating the configuration of a light irradiation device 2E of the sixth embodiment. The light irradiation system of the sixth embodiment includes the light irradiation device 2E shown in Fig. 10 and a catheter 1 having the same configuration as that of the first embodiment. The light irradiation device 2E includes a directional marker unit 280E instead of the directional marker unit 280 in the configuration described in the fourth embodiment.

The directional marker portion 280E is formed of a substantially linear wire having radiopaque properties. The directional marker portion 280E is embedded in the thick portion of the main body portion 210 on the side of the main body portion 210. As shown in FIG. 10, the directional marker portion 280E is arranged on the side of the main body portion 210 in the same direction (+Y axis direction) as the light irradiation portion 239. Therefore, the surgeon can recognize the position of the directional marker portion 280E from any direction shown in the X-ray image (specifically, the positional relationship between the position of the directional marker portion 280E and the second marker portions 231 and 232) in the circumferential direction of the light irradiation portion 239 (in other words, the orientation of the light irradiation portion 239).

In this way, the configuration of the light irradiation device 2E can be modified in various ways, and may have a configuration (directional marker section 280E) that allows the circumferential position of the light irradiation section 239 to be recognized based on the position when viewed from any direction. The shape of the directional marker section 280E can be modified in various ways, such as a straight line as described above, or a wavy shape. The light irradiation system of the sixth embodiment as described above can also achieve the same effects as the first and fourth embodiments described above.

Seventh Embodiment
Fig. 11 is an explanatory diagram illustrating the configuration of the distal end side of the light irradiation system of the seventh embodiment. The light irradiation system of the seventh embodiment includes a catheter 1F and a light irradiation device 2F shown in Fig. 11. Fig. 11 shows a state in which the light irradiation device 2F is inserted into the catheter 1F. The catheter 1F does not have the first marker section 132 described in the first embodiment. Similarly, the light irradiation device 2F does not have the second marker section 232 described in the first embodiment.

In this way, various configurations can be adopted for the first marker section and the second marker section. For example, instead of omitting the first and second marker sections 132, 232, the first and second marker sections 131, 231 may be omitted. The light irradiation system of the seventh embodiment as described above can also achieve the same effects as the first embodiment described above. Furthermore, the light irradiation system of the seventh embodiment can reduce the manufacturing costs of the catheter 1F and the light irradiation device 2F compared to a configuration in which marker sections are provided on both ends of the light transmission section 139 and the light irradiation section 239.

Eighth Embodiment
Fig. 12 is an explanatory diagram illustrating the configuration of the tip side of the light irradiation system of the eighth embodiment. The light irradiation system of the eighth embodiment includes a catheter 1G shown in Figs. 12 and 13 and a light irradiation device 2G shown in Fig. 12. Fig. 12 shows a state in which the light irradiation device 2G is inserted into the catheter 1G. The catheter 1G includes first marker parts 131G and 132G instead of the first marker parts 131 and 132 described in the first embodiment. The light irradiation device 2G includes second marker parts 231G and 232G instead of the second marker parts 231 and 232 described in the first embodiment.

Figure 13 is an explanatory diagram illustrating the configuration of the catheter 1G as viewed from the B direction (Figure 12). Figure 13 (A) shows an example of the configuration of the catheter 1G as viewed from the B direction, and Figure 13 (B) shows another example of the configuration of the catheter 1G as viewed from the B direction. The first marker portions 131G and 132G are each provided in a portion of the circumferential direction of the catheter 1G. In the example of Figure 13 (A), the first marker portion 131G is provided along one side of the tip side of the light transmitting portion 139 in approximately the same range as the light transmitting portion 139. Similarly, the first marker portion 132G is provided along one side of the base end side of the light transmitting portion 139 in approximately the same range as the light transmitting portion 139. In the example of Figure 13 (B), the first marker portions 131G and 132G are provided so as to surround the periphery of the light transmitting portion 139. In FIG. 13, the first marker units 131G and 132G have been described, but the second marker units 231G and 232G of the light irradiation device 2G are also similarly provided along one side of the light irradiation unit 239 or so as to surround the periphery of the light irradiation unit 239.

In this way, various configurations can be adopted for the first marker portion 131G, 132G and the second marker portion 231G, 232G, and as shown, they may be provided only in a portion of the circumference. The light irradiation system of the eighth embodiment as described above can also achieve the same effect as the first embodiment described above. Furthermore, the light irradiation system of the eighth embodiment can reduce the manufacturing costs of the catheter 1G and the light irradiation device 2G compared to a configuration in which marker portions are provided over the entire circumference.

Ninth embodiment
Fig. 14 is an explanatory diagram illustrating the configuration of the light irradiation system of the ninth embodiment. The light irradiation system of the ninth embodiment includes a catheter 1H shown in Fig. 14 and a light irradiation device 2 having the same configuration as that of the first embodiment. The catheter 1H includes a light transmission part 139H instead of the light transmission part 139, and includes first marker parts 131H and 132H instead of the first marker parts 131 and 132. As shown in Fig. 14, the light transmission part 139H is composed of three light transmission parts 1391, 1392, and 1393 arranged side by side in the axis O direction (X-axis direction). The configuration of each of the light transmission parts 1391, 1392, and 1393 is similar to that of the light transmission part 139 described in the first embodiment.

The first marker parts 131H and 132H are composed of first marker parts 1311 and 1321 that function as marks indicating the position of the light transmitting part 1391, first marker parts 1312 and 1322 that function as marks indicating the position of the light transmitting part 1392, and first marker parts 1313 and 1323 that function as marks indicating the position of the light transmitting part 1393. The first marker part 1311 is provided close to the tip of the light transmitting part 1391, and the first marker part 1321 is provided close to the base end of the light transmitting part 1391. The first marker part 1312 is provided close to the tip of the light transmitting part 1392, and the first marker part 1322 is provided close to the base end of the light transmitting part 1392. The first marker portion 1313 is provided adjacent to the tip end of the light transmitting portion 1393, and the second marker portion 1323 is provided adjacent to the base end of the light transmitting portion 1393. The configuration of each of these first marker portions 1311 to 1323 is similar to the first marker portions 131 and 132 described in the first embodiment. Note that first marker portions adjacent to each other in the direction of the axis O, specifically, the first marker portions 1321 and 1312, and the first marker portions 1322 and 1313, may be combined into a single marker portion.

In this way, the catheter 1H may be provided with multiple sets of light transmission parts 1391-1393 and first marker parts 1311-1323. In the example of FIG. 14, three sets are illustrated, but two sets or four or more sets may be used. The light irradiation system of the ninth embodiment as described above can also achieve the same effects as the first embodiment described above. In addition, in the light irradiation system of the ninth embodiment, multiple sets of light transmission parts 1391-1393 and first marker parts 1311-1323 are provided, so that the catheter 1H is not moved in the body lumen, and only the light irradiation device 2 is moved in the axis O direction (X-axis direction) inside the catheter 1H, thereby irradiating light in different regions in the axis O direction of the catheter 1H. In addition, the first marker parts 1311-1323 are provided on the multiple light transmission parts 1391-1393, respectively, so that the positioning of the light irradiation part 239 with respect to each of the light transmission parts 1391-1393 can be easily performed.

Tenth Embodiment
Fig. 15 is an explanatory diagram illustrating the configuration of the distal end side of the light irradiation system of the tenth embodiment. The light irradiation system of the tenth embodiment includes a catheter 1I shown in Fig. 15 and a light irradiation device 2 having the same configuration as that of the first embodiment. Fig. 15 shows a state in which the light irradiation device 2 is inserted into the catheter 1I. The catheter 1H does not include the distal tip 120 described in the first embodiment. Similarly, the distal tip 220 of the light irradiation device 2 may be omitted.

In this way, various configurations can be adopted for the catheter 1I and the light irradiation device 2, and some of the above-mentioned components may be omitted. In the light irradiation system of the tenth embodiment, the light transmission section 139 and the light irradiation section 239 can be aligned by the first marker sections 131, 132 provided at both ends of the light transmission section 139 and the second marker sections 231, 232 provided at both ends of the light irradiation section 239, and the same effect as in the first embodiment can be achieved. Furthermore, in the light irradiation system of the tenth embodiment, the manufacturing cost of the catheter 1I can be reduced compared to a configuration in which a tip tip 120 is provided.

Eleventh Embodiment
Fig. 16 is an explanatory diagram illustrating the configuration of the distal end side of the light irradiation system of the 11th embodiment. Fig. 17 is an explanatory diagram illustrating the cross-sectional configuration of the catheter 1J taken along line CC (Fig. 16). The light irradiation system of the 11th embodiment includes the catheter 1J shown in Figs. 16 and 17, and a light irradiation device 2 having the same configuration as that of the first embodiment. Fig. 16 shows a state in which the light irradiation device 2 is inserted into the catheter 1J.

The catheter 1J further includes a temperature sensor 180 in addition to the components described in the first embodiment. As shown in FIG. 17, the temperature sensor 180 includes two different types of metal conductors and measures the temperature in the vicinity of the light transmitting portion 139. The temperature sensor 180 is embedded inside the light transmitting portion 139 and the shaft 110. The tip side of the temperature sensor 180 is disposed inside the light transmitting portion 139, and the base end side is connected to a thermometer (not shown). At least a portion of the tip side of the temperature sensor 180 may protrude from the outer surface of the light transmitting portion 139 or the shaft 110. The temperature sensor 180 may be provided in at least one of the catheter 1J and the light irradiation device 2, or may be provided in both.

In this way, the catheter 1J and the light irradiation device 2 can be provided with various configurations not described above, such as the temperature sensor 180. The light irradiation system of the eleventh embodiment as described above can also achieve the same effects as the first embodiment described above. In addition, the light irradiation system of the eleventh embodiment is provided with a temperature sensor 180 that measures the temperature at least in the vicinity of the light transmitting portion 139, so that the temperature change of the biological tissue due to the light irradiation can be observed in real time, which can contribute to suppressing blood coagulation and biological tissue damage due to the light irradiation.

<Twelfth embodiment>
Fig. 18 is an explanatory diagram illustrating the configuration of the distal end side of a light irradiation device 2K of the twelfth embodiment. The light irradiation system of the twelfth embodiment includes a light irradiation device 2K shown in Fig. 18 and a catheter 1 having a configuration similar to that of the first embodiment. The light irradiation device 2K includes a light transmission unit 250K instead of the light transmission unit 250, and a light irradiation unit 239K instead of the light irradiation unit 239.

The light transmitting section 250K does not have a curved portion formed at the tip side, and extends linearly inside the main body section 210. The light transmitting section 250K has a light irradiating section 239K at the tip. The light irradiating section 239K is a resin body that covers the core exposed at the tip of the light transmitting section 250K and is exposed on a portion of the side of the main body section 210. The light irradiating section 239K can be formed, for example, by applying an acrylic ultraviolet curing resin in which fine quartz powder is dispersed, and curing it with ultraviolet light. The light irradiating section 239K may be realized in other ways, for example, it may be realized by a light reflecting mirror instead of a resin body.

In this way, the configuration of the light irradiation unit 239K can be modified in various ways, and instead of the core exposed on the side surface of the main body unit 210, it may be configured with an optical member (a resin body or a mirror) exposed on the side surface of the main body unit 210. The light irradiation system of the twelfth embodiment as described above can also achieve the same effects as the first embodiment described above. Furthermore, according to the light irradiation device 2K of the twelfth embodiment, the performance of the light irradiation unit 239K can be adjusted by adjusting the optical properties of the optical member used as the light irradiation unit 239K.

Thirteenth embodiment
Fig. 19 is an explanatory diagram illustrating the configuration of the distal end side of the light irradiation device 2M of the thirteenth embodiment. The light irradiation system of the thirteenth embodiment includes the light irradiation device 2M shown in Fig. 19 and the catheter 1 having the same configuration as that of the first embodiment. The light irradiation device 2M includes a reinforcing member 272M instead of the reinforcing member 272 (Fig. 2). The reinforcing member 272M has a coil shape formed by winding a wire in a spiral shape. The reinforcing member 272M is embedded in the thick part of the main body 210. The wire constituting the reinforcing member 272M can be formed from any resin material or metal material.

In this way, the configuration of the light irradiation device 2M can be modified in various ways, and the reinforcing member 272M for reinforcing the light irradiation device 2M may be in a coil shape or a mesh shape made by weaving wires. In addition, the light irradiation device 2M may be provided with a plurality of reinforcing members 272M. In this case, the shape of one reinforcing member 272M may be the same as or different from the shape of the other reinforcing members 272M. The reinforcing member 272M may be embedded in the thick part of the main body 210, or may be housed inside the main body 210 as in the first embodiment. The light irradiation system of the thirteenth embodiment as described above can also achieve the same effects as the first embodiment described above. In addition, according to the light irradiation device 2M of the twelfth embodiment, the torque transmission, flexibility, shape retention, and the like of the light irradiation device 2M can be adjusted by changing the shape of the reinforcing member 272M.

<Modifications of this embodiment>
The present invention is not limited to the above-described embodiment, and can be embodied in various forms without departing from the spirit and scope of the invention. For example, the following modifications are also possible.

[Modification 1]
In the above first to thirteenth embodiments, examples of the configurations of the catheter 1, 1F to 1J and the light irradiation device 2, 2A to 2G, 2K, and 2M are shown. However, the configurations of the catheter 1 and the light irradiation device 2 can be modified in various ways. For example, the first marker parts 131, 132 of the catheter 1 and the second marker parts 231, 232 of the light irradiation device 2 may be omitted. For example, in FIG. 4, a method of using the catheter 1 and the light irradiation device 2 in combination has been described, but the light irradiation device 2 may be used alone (without being used in combination with the catheter 1).

For example, the catheter 1 may be provided with the reinforcing member described in the thirteenth embodiment. For example, the outer surface of the catheter 1 or the outer surface of the light irradiation device 2 may be coated with a hydrophilic or hydrophobic resin. In this way, the slipperiness of the catheter 1 in the body lumen can be improved. In addition, the slipperiness of the light irradiation device 2 in the lumen 110L of the catheter 1 can be improved. In addition, an antithrombotic material such as heparin may be coated on the outer surface of the catheter 1 or the outer surface of the light irradiation device 2. In this way, a decrease in laser output due to the adhesion of thrombus to the inner and outer surfaces of the catheter 1 and the outer surface of the light irradiation device 2 due to irradiation with the emitted light (laser light) LT can be suppressed.

For example, the catheter 1 may have an expansion section that can be expanded in the radial direction (YZ direction). For example, a balloon made of a flexible thin film or a mesh body made of wires in a net shape can be used as the expansion section. The expansion section can be provided on at least one of the tip side of the light transmitting section 139 and the base end side of the light transmitting section 139 in the shaft 110. In this way, after positioning the catheter 1 in the biological lumen, the expansion section can be expanded to fix the catheter 1 in the biological lumen. In addition, if a balloon is used as the expansion section, blood flow at the light irradiation site can be blocked, so that light blocking due to blood flow can be suppressed. For example, the catheter 1 may be configured as a multi-lumen catheter having multiple lumens different from the lumen 110L.

For example, the inner surface 120i of the distal tip 120 of the catheter 1 and the outer surface of the distal tip 220 of the light irradiation device 2 may be made of a magnetic material, so that they are attracted to each other. In this way, as shown in FIG. 4, the light irradiation device 2 can be inserted into the catheter 1, and the distal tip 220 can be easily maintained in a state pressed against the distal tip 120.

For example, the arrangement of the light transmitting section 250, the extension section 262, and the reinforcing member 272 in the main body section 210 of the light irradiation device 2 can be changed as desired. For example, the member with the largest diameter (light transmitting section 250 in the example of FIG. 2) may be arranged at the center of the main body section 210. For example, the light transmitting section 250, the extension section 262, and the reinforcing member 272 may be arranged at equal intervals. For example, the main body section 210 may further have an inner shaft for forming a fluid lumen or a device lumen. For example, the sealing member 271 in the main body section 210 may be omitted.

[Modification 2]
In the above first to thirteenth embodiments, one example of the configuration of the light transmitting portion 139, 139H and the light irradiating portion 239, 239K has been shown. However, the configuration of the light transmitting portion 139, 139H and the light irradiating portion 239, 239K can be modified in various ways. For example, the light irradiating portion 239 may be embedded in a thick portion of the main body portion 210. Even in this case, it is possible to irradiate light from the light irradiating portion 239 to the outside by forming the main body portion 210 from a light transmitting material or forming a portion of the main body portion 210 that covers the light irradiating portion 239 to be thin-walled.

For example, the light transmitting section 139 may be made of a material having radiopaque properties, so that the light transmitting section 139 and the first marker sections 131, 132 are integrally configured. Similarly, at least the tip portion (light irradiating section 239) of the clad 250cl may be made of a material having radiopaque properties, so that the light irradiating section 239 and the second marker sections 231, 232 are integrally configured. In this way, the number of parts constituting the catheter 1 and the light irradiating device 2 can be reduced, and the manufacturing man-hours for the catheter 1 and the light irradiating device 2 can be reduced.

For example, in the catheter 1, the light transmitting portion 139 may be formed by thinning a portion of the shaft 110. For example, the shaft 110 of the catheter 1 may be formed from a light-transmitting resin, so that the entire shaft 110 functions as the light transmitting portion 139. In this way, the number of parts constituting the catheter 1 can be reduced. For example, at least one of the light transmitting portions 139 may be formed as a notch (a through hole that communicates between the inside and outside of the shaft 110) formed in the shaft 110. In this way, the light transmitting portion 139 can be easily formed.

For example, in the catheter 1, the range in the axial direction (X-axis direction) and the range in the circumferential direction (YZ-axis direction) in which the light transmitting portion 139 is provided can be changed arbitrarily. Specifically, for example, the range in which the light transmitting portion 139 is provided in the axial direction O may be made wider than the range illustrated in FIG. 1. In this way, the light irradiation range can be easily changed by moving the light irradiation device 2 (light irradiation portion 239) in the wide light transmitting portion 139. Therefore, even if the target tissue (cancer cells) is present over a wide range in the living body, it is not necessary to move the position of the catheter 1 in the living body lumen, and the procedure can be easily performed. Similarly, for example, in the light irradiation device 2K of the 12th embodiment, the range in the axial direction (X-axis direction) and the range in the circumferential direction (YZ-axis direction) in which the light irradiation portion 239K is provided can be changed arbitrarily. Specifically, for example, the range in which the light irradiation portion 239 is provided in the axial direction O may be made wider than the range described in FIG. 18. This allows the light to be irradiated over a wider area, making the procedure easier even when the target tissue (cancer cells) is present over a wide area inside the body.

For example, the catheter 1 may further include a separate marker portion arranged at any position, such as the tip side of the light transmitting portion 139 or the base end side of the light transmitting portion 139. For example, the light irradiation device 2 may further include a separate marker portion arranged at any position, such as the tip side of the light irradiation portion 239 or the base end side of the light irradiation portion 239. The shape of the marker portion of the catheter 1 or the light irradiation device 2 can be determined arbitrarily, and may be a shape that extends entirely or partially in the circumferential direction (YZ direction), a shape that extends in the axial direction O (X-axis direction), or a shape that surrounds the periphery of the shaft or the main body. In addition, the tip tip 120 of the catheter 1 or the tip tip 220 of the light irradiation device 2 may be configured as a marker portion.

[Modification 3]
In the above first to thirteenth embodiments, an example of the configuration of the detection units 260, 260A, and 260B has been shown. However, the configuration of the detection units 260, 260A, and 260B can be modified in various ways. For example, the detection element 261 of the detection unit 260 may be embedded in a thick part of the main body 210. Even in this case, the part of the main body 210 that covers the detection element 261 can be made thin to suppress a decrease in the detection accuracy of the detection element 261. In this way, the safety of the light irradiation device 2 can be further improved. For example, the detection unit 260 may be configured to have a configuration other than a fiber optic Doppler sensor (FOD). In this case, the detection unit 260 may be configured, for example, by an ultrasonic probe (also called an ultrasonic transducer, a piezoelectric body, an ultrasonic transmission/reception element, or an ultrasonic element) that receives ultrasonic waves reflected by a biological tissue, and a conductor that connects the ultrasonic probe to the detection device 4.

[Modification 4]
The configurations of the catheters 1, 1F to 1J and the light irradiation devices 2, 2A to 2G, 2K, and 2M of the first to thirteenth embodiments and the configurations of the catheters 1, 1F to 1J and the light irradiation devices 2, 2A to 2G, 2K, and 2M of the first to third modifications may be appropriately combined. For example, the light irradiation device 2 may be configured by combining the detection unit 260 described in any of the second and third embodiments, the directional marker unit 280 described in any of the fourth to sixth embodiments, and the second marker units 231 and 232 described in any of the seventh and eighth embodiments. For example, the catheter 1 described in any of the ninth to eleventh embodiments and the light irradiation device 2 described in any of the twelfth and thirteenth embodiments may be combined to configure a light irradiation system.

Although this aspect has been described above based on the embodiment and modified examples, the embodiment of the above-mentioned aspect is intended to facilitate understanding of this aspect and does not limit this aspect. This aspect may be modified or improved without departing from the spirit and scope of the claims, and equivalents are included in this aspect. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate.

Reference Signs List 1, 1F to 1J...catheter 2, 2A to 2G, 2K, 2M...light irradiation device 3...light source 4...detection device 110...shaft 120...tip 131, 131G, 131H, 132, 132G, 132H...first marker section 139, 139H...light transmitting section 140...connector 141...connecting section 142...wing 180...temperature sensor 210...main body 220...tip 231, 231G, 232, 232G...second marker section 239, 239K...light irradiation section 240...connector 241...connecting section 242...wing 250...light transmitting section 250, 250K...light transmitting section 250c...core 250cl...clad 260, 260A, 260B...detection section 260c...core 260cl...clad 261, 261A, 261B...detection element 262...extension section 271...sealing member 272, 272M...reinforcing member 280, 280D, 280E...directional marker section

Claims (10)

A light irradiation device for testing or treating PDT, NIR-PIT, cancer, cerebral aneurysm, arrhythmia, or Alzheimer's disease ,
An elongated main body portion;
a light irradiation unit provided on a part of a side surface of the tip end of the main body unit and irradiating a target substance in a living body with light;
a detection unit provided in the main body adjacent to the light irradiation unit, the detection unit detecting a physicochemical phenomenon occurring due to the target substance being irradiated with light;
Equipped with
The detection unit is
a coil-shaped detection element formed by winding an optical fiber, the detection element detecting ultrasonic waves as the physicochemical phenomenon;
a light irradiation device in which the light irradiation unit is inserted into the inside of the detection element on a side surface of the tip end of the main body, so that the orientation of the detection element and the irradiation direction of light in the light irradiation unit are aligned with each other. The light irradiating device according to claim 1 , further comprising:
A light irradiation device comprising a radiopaque directional marker portion provided on a side surface of the main body portion, the directional marker portion enabling the circumferential position of the light irradiation portion to be recognized based on the shape or position of the directional marker portion when viewed from any direction. A light irradiation system for testing or treating PDT, NIR-PIT, cancer, cerebral aneurysm, arrhythmia, or Alzheimer's disease, comprising:
A long tubular catheter;
3. The light irradiation device according to claim 1 or 2 , wherein the light irradiation device is a long-shaped light irradiation device that is used by being inserted into the catheter;
Equipped with
The catheter comprises:
a light transmitting portion provided on at least a portion of a side surface on the tip side, which transmits light from inside the tube to the outside;
A first marker portion having radiopacity and provided adjacent to the light transmitting portion,
The light irradiation device further includes a second marker portion having radiopaque properties and disposed adjacent to the light irradiation portion. The light irradiation system according to claim 3 ,
A light irradiation system, wherein the first marker portion is provided at at least two locations on the distal end side and the proximal end side of the light transmitting portion in the axial direction of the catheter. The light irradiation system according to claim 3 or 4 ,
A light irradiation system, wherein the second marker portion is provided at least at two locations on a distal end side and a proximal end side of the light irradiation portion in an axial direction of the light irradiation device. A lighting system according to claim 5 dependent on claim 4 ,
The light irradiation device is inserted into the catheter, and the light transmitting unit and the light irradiation unit are aligned in the axial direction of the light irradiation system.
the first marker portion on the distal end side is disposed on the distal end side in the axial direction relative to the second marker portion on the distal end side,
A light irradiation system, wherein the first marker portion on the base end side is positioned closer to the base end in the axial direction than the second marker portion on the base end side. The light irradiation system according to any one of claims 3 to 6 ,
The first marker portion has a shape that surrounds the catheter in a circumferential direction,
A light irradiation system, wherein the second marker portion has a shape that surrounds the light irradiation device in a circumferential direction. The light irradiation system according to any one of claims 3 to 7 ,
A light irradiation system, wherein the catheter is provided with a plurality of pairs of the light transmitting portion and the first marker portion in the axial direction of the catheter. The light irradiation system according to any one of claims 3 to 8 ,
The catheter further includes a distal tip joined to the distal end side,
A light irradiation system, wherein the distal tip has a through hole formed therein, the through hole passing through the distal tip in the axial direction of the catheter, the through hole having a diameter smaller than an outer diameter of the light irradiation device. The light irradiation system according to any one of claims 3 to 9 ,
The catheter further includes a temperature sensor for measuring a temperature at least in the vicinity of the light transmitting portion.

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