Light irradiation device and light irradiation system

Abstract

The light irradiation device (2) is long and narrow. The light irradiation device (2) includes laser light sources (230A, 230B) at the tip thereof, which emit laser light in a predetermined wavelength range. The laser light sources (230A, 230B) emit laser light in a direction intersecting with the longitudinal direction of the light irradiation device (2). The light irradiation device (2) can selectively irradiate a specific position of a living body with the laser light emitted from the laser light sources (230A, 230B).

Description

[Technical field]

[0001] The present disclosure relates to a light irradiation device and a light irradiation system that are inserted into a biological lumen to irradiate light. [Background technology]

[0002] Photodynamic Therapy (PDT) is known as one of the techniques for treating diseases. In PDT, a photosensitive substance is administered to the living body, and then the body is irradiated with light. As a result, there is a possibility that the cancer cells will be killed by the reactive oxygen generated in the cancer cells. However, with PDT, it is difficult to selectively accumulate the photosensitive substance in cancer cells. One issue with PDT is the occurrence of side effects caused by the photosensitive substance being taken up by normal cells.

[0003] In response to this, NIR-PIT (Near-infrared photoimmunotherapy) has been proposed in recent years. In NIR-PIT, a complex is used that combines two compounds: an antibody against a specific antigen of cancer cells and a photosensitive substance. When the complex is administered to a living body, it is likely to be selectively accumulated in cancer cells in the body. The complex is then activated by being irradiated with light having an excitation wavelength (e.g., a wavelength including 690 nm) of the photosensitive substance in the complex (see, for example, Patent Document 1, etc.). In NIR-PIT, when the complex is selectively accumulated in cancer cells by the antibody and light is locally irradiated to the cancer cells, side effects are less likely to occur compared to PDT.

[0004] The wavelength range including 690 nm is also called the spectroscopic window of the living body, and is a wavelength range where light is less absorbed by biological components than other wavelength ranges. However, light in the wavelength range including 690 nm does not penetrate deep into the body even when irradiated from the body surface, so it is difficult to treat cancer deep inside the body by irradiating it from the body surface.

[0005] Therefore, a technology has been proposed for irradiating light from a position closer to cancer cells, rather than irradiating light from the body surface. For example, the device described in Patent Document 2 irradiates light from deep inside the body by being inserted into a blood vessel. In the device described in Patent Document 3, a radiopaque marker is provided near the light irradiation part in order to make it easier to position the light irradiation part compared to the device described in Patent Document 2. In addition, the device described in Patent Document 4 has multiple light-emitting diodes provided in a hollow shaft. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Special Publication No. 2014-523907 [Patent Document 2] JP 2018-867 A [Patent Document 3] JP 2020-185257 A [Patent Document 4] Special Publication No. 2007-528752 Summary of the Invention

[0007] In the device described in Patent Document 3, it is necessary to transmit light emitted from an external light source to the tip of the device by an optical transmission member (for example, an optical fiber, etc.). When an optical transmission member is used, bending or the like occurs in the optical transmission member in the lumen of the living body, and the light may leak or attenuate before being transmitted to the tip of the device. If light leaks or attenuates, problems such as a decrease in the transmission efficiency of light or a decrease in safety may occur. In addition, in the process of transmitting light by the optical transmission member, the characteristics of the light (for example, wavelength, etc.) may change, making it difficult to obtain the intended therapeutic effect. Furthermore, there are cases where multiple optical transmission members need to be connected. On the other hand, in the device described in Patent Document 4, although an optical transmission member is not used, since the light emitted from multiple light-emitting diodes spreads in multiple directions, it is extremely difficult to selectively irradiate light to a specific position. Therefore, a technology capable of more efficiently and appropriately irradiating light to a specific position in the lumen of the living body is desired.

[0008] A typical object of the present disclosure is to provide a light irradiation device and a light irradiation system capable of more efficiently and appropriately irradiating a specific position within a lumen of a living body with light.

[0009] A light irradiation device provided by a typical embodiment of the present disclosure is a long-shaped medical light irradiation device, and is provided with a laser light source at a tip portion thereof, the laser light source emitting laser light in a predetermined wavelength range, Once inserted into the blood vessels of a living organism, emitting laser light in a direction intersecting with a longitudinal direction of the light irradiation device; and irradiating the laser light to the living tissue outside the blood vessel through the blood vessel wall, so that the light irradiation density of the laser light emitted from the laser light source at the time when the laser light is emitted to the outside from the light irradiation device is 80 W / cm. 2 More than 1600W / cm 2 is less than or equal to .

[0010] A light irradiation system provided by a typical embodiment of the present disclosure is a medical light irradiation system, comprising: a catheter formed in a long tubular shape; and a long light irradiation device inserted into an inner cavity of the catheter, the light irradiation device comprising a laser light source at a tip thereof for emitting laser light in a predetermined wavelength range, the laser light source comprising: Once inserted into the blood vessels of a living organism,A laser beam is emitted in a direction intersecting the longitudinal axis of the light irradiation device. By doing so, the laser light is transmitted through the blood vessel wall and irradiated onto the biological tissue outside the blood vessel, and the light irradiation density of the laser light emitted from the laser light source at the time when the laser light is emitted to the outside from the light irradiation device is 80 W / cm 2 More than 1600W / cm 2 is as follows: A light transmitting portion that transmits the laser light emitted by the laser light source of the light irradiation device to the outside is formed on at least a part of the side surface of the tip end of the catheter.

[0011] According to the light irradiation device and light irradiation system of the present disclosure, light is more efficiently and appropriately irradiated to a specific position within a lumen of a living body.

[0012] The light irradiation device of the present disclosure is an elongated medical light irradiation device, and includes a laser light source at a distal end thereof, the laser light source emitting laser light in a predetermined wavelength range in a direction intersecting with a longitudinal direction of the light irradiation device.

[0013] The light irradiation device of the present disclosure can directly irradiate light from a laser light source provided at the tip to a specific position of a living body without passing through a light transmission member (e.g., optical fiber, etc.). Therefore, various problems that occur when using a light transmission member (e.g., at least one of a problem of light leakage in the middle of the light transmission member and a problem of light characteristics changing during the light transmission process) are appropriately suppressed. In addition, the laser light source emits laser light from the tip of the light irradiation device in a direction intersecting with the long axis direction. Compared to a light-emitting diode, a laser light source can easily emit light that is less likely to diverge and has high directivity. Therefore, the light irradiation device of the present disclosure can selectively irradiate the laser light emitted from the laser light source to a specific position of a living body. As a result, various problems (e.g., occurrence of side effects, etc.) caused by light being irradiated to an unintended position are less likely to occur. Furthermore, a laser light source has a property of being able to irradiate light with a wavelength having a narrower spectral width than a light-emitting diode. Therefore, by providing a laser light source at the tip of the light irradiation device, various problems (e.g., at least one of a decrease in efficiency and unintended changes in tissue) caused by irradiation of tissue with a wavelength different from the wavelength required for treatment (e.g., the excitation wavelength of a photosensitive substance) are suppressed. Therefore, it becomes easier to irradiate light more efficiently and appropriately to a specific position in the living body.

[0014] The "tip" of the light irradiation device does not refer only to the strict tip of the light irradiation device. In other words, the case where the light irradiation unit is provided on the proximal side of the strict tip within a range where selective irradiation of laser light to a specific portion is possible is also included in the scope of "provided at the tip" in the present disclosure.

[0015] The light irradiation device may be provided with a plurality of laser light sources at the tip. By providing a plurality of laser light sources in one light irradiation device, the degree of freedom of laser irradiation (e.g., ease of adjustment of at least one of the laser irradiation area, irradiation density, irradiation direction, etc.) is improved compared to the case where only one laser light source is provided. As a result, it becomes easier to obtain an appropriate treatment effect.

[0016] The emission of laser light from at least some of the multiple laser light sources may be controllable independently of the other laser light sources. In this case, the degree of freedom of laser irradiation is further improved. For example, by adjusting the number of laser light sources that emit laser light, it is also possible to change at least one of the laser irradiation area, irradiation density, irradiation direction, etc. In addition, it is also possible to change the portion to be irradiated with the laser light by switching the laser light source that emits the laser light.

[0017] However, the emission of laser light from a plurality of laser light sources may be controlled collectively. Even in this case, the degree of freedom of laser irradiation can be appropriately improved by appropriately designing the number and arrangement of the plurality of laser light sources.

[0018] The multiple laser light sources may emit laser light in the same wavelength range. In this case, the laser light in the same wavelength range can be irradiated to a specific site with a higher degree of freedom (for example, with at least one of the laser irradiation area, irradiation density, etc. appropriately adjusted). As a result, it becomes easier to obtain an appropriate treatment effect.

[0019] Some of the laser light sources may include a laser light source that emits laser light in a wavelength range different from the wavelength range of the other laser light sources. In this case, for example, it is possible to selectively or multiplex the laser light in different wavelength ranges to irradiate biological tissue. This further improves the flexibility of treatment.

[0020] The laser light source may be contained inside the elongated device body. At least a portion of the device body containing the laser light source may be formed of a material that transmits the laser light emitted by the laser light source. By containing the laser light source inside the device body, the laser light source is held in the device body in a stable state and defects such as failure of the laser light source are less likely to occur compared to a case in which the laser light source is exposed to the outside from the device body. Furthermore, the laser light emitted from the laser light source passes through the device body and is appropriately irradiated to the living tissue. This makes it easier to perform treatment more appropriately.

[0021] However, the configuration of the device body may be changed. For example, a laser light transmission window may be formed in the device body at a portion through which the laser light emitted from the laser light source passes. In this case, the material of the portion of the device body near the laser light source is not limited to a material that transmits the laser light.

[0022] The inventors of the present application conducted the first and second evaluation tests (described later) and found a new desirable range (upper and lower limits) of the light irradiation density of the laser light emitted from the laser light source when it is emitted to the outside from the light irradiation device. The light irradiation density of the laser light emitted from the laser light source when it is emitted to the outside from the light irradiation device is 80 W / cm 2 More than 1600W / cm 2 In this case, it becomes easier to obtain an appropriate therapeutic effect by irradiating the photosensitizer with laser light.

[0023] In addition, the light irradiation density at the time when it is emitted to the outside from the light irradiation device is more preferably 300 W / cm 2 More than 1300W / cm 2 Less than 600W / cm, more preferably 600W / cm 2 More than 1300W / cm 2 As an example, in the present disclosure, the light irradiation density at the time of being emitted to the outside from the light irradiation device may be about 1273 W / cm 2 It is said.

[0024] In addition, the above-mentioned condition of the light irradiation density can be applied regardless of the number of laser light sources provided in the light irradiation device. For example, when laser light is simultaneously emitted from a plurality of laser light sources and the laser light is combined, the condition of the light irradiation density of the combined laser light may be the above-mentioned condition.

[0025] The light irradiation device may include a radiopaque marker portion at the tip where the laser light source is provided. In this case, a medical professional (e.g., a doctor, etc.) can appropriately adjust the irradiation position of the laser light by checking the position of the marker portion that appears in the captured image when irradiating the living tissue with the laser light by the light irradiation device while photographing the inside of the living body using radiation (e.g., X-rays, etc.). This makes it easier to further improve the accuracy of the treatment.

[0026] At least a part of the components of the laser light source may be formed from a material having radiopaque properties, so that the laser light source itself functions as a marker unit. In this case, even if a marker unit is not provided separately from the laser light source, the position of the laser light source can be properly grasped by radiography. Furthermore, since the laser light source itself functions as a marker unit, the position of the laser light source can be more accurately grasped by a medical professional. This makes it easier to perform treatment more appropriately.

[0027] However, it is also possible to change the configuration of the marker part. For example, a marker part may be provided separately from the laser light source. For example, a tip tip may be provided at the tip of the light irradiation member. At least a part of the member of the tip tip may be formed from a material having radiopaqueness, so that the tip tip may function as a marker part. In this case, since the tip tip also functions as a marker part, the adjustment of the irradiation position of the laser light is appropriately assisted while suppressing an increase in the number of parts. In addition, a marker part may be provided separately from the laser light source and the tip tip. When multiple laser light sources are used in one light irradiation device, a marker part may be provided for each laser light source. In this case, it becomes easier to appropriately grasp the position of each of the multiple laser light sources.

[0028] The laser light source may be a surface-emitting laser that irradiates laser light in a direction perpendicular to the substrate. By using a surface-emitting laser, a light-irradiating device can be obtained that appropriately emits laser light with low power and has high resistance to temperature changes. Furthermore, since the surface-emitting laser can emit laser light in a direction perpendicular to the substrate surface, it becomes easier to adjust the irradiation position of the laser light more accurately.

[0029] The laser light source may be a semiconductor laser, which is a circuit element manufactured using semiconductor materials. Semiconductor lasers are easy to miniaturize, so they can be easily incorporated into light irradiation devices with small diameters. In addition, semiconductor lasers can emit highly directional laser light with a uniform phase using small power. This makes it easier to stabilize the treatment effect.

[0030] The light irradiation device may further include a light detection transmission member that transmits the light incident on the tip to the light sensor, or a light sensor provided at the tip. In this case, the state of the light incident on the tip of the light irradiation unit is appropriately detected by the light sensor. In addition, when a light detection transmission member that transmits the light incident on the tip to the light sensor is provided, the state of the light at the tip is appropriately detected in a state in which the configuration of the tip of the light irradiation device is suppressed from becoming complicated. In addition, when a light sensor is provided at the tip, the state of the light at the tip is directly detected by the light sensor at the tip. In other words, the light detected by the light sensor is less likely to have changes in the characteristics of the light that may occur during the transmission process. Therefore, it becomes easier to detect the state of the light more accurately.

[0031] In addition to the optical sensor, or together with the optical sensor, another sensor may be provided at the tip of the light irradiation device. For example, a temperature sensor may be provided at the tip of the light irradiation device. In this case, the temperature at the tip of the light irradiation device is appropriately detected. Therefore, for example, at least one of a temperature rise caused by driving a laser light source provided at the tip and a temperature rise caused by emitting laser light to a living tissue is appropriately grasped. In addition, the light irradiation device may further include a light detection transmission member that transmits light incident on the tip to a spectroscopic sensor, or a spectroscopic sensor provided at the tip. The spectroscopic sensor detects light generated by a substance that absorbs light irradiated from the laser light source. By checking the detection result by the spectroscopic sensor, it is possible to check whether the laser light is appropriately irradiated to the target site (for example, an affected area where a photosensitive substance has accumulated). Furthermore, it is also possible to check the progress of the treatment by monitoring the change over time in the emission intensity of light generated by a substance that absorbs light. In addition, the light irradiation device may include a pressure sensor at the tip. When the photosensitive substance irradiated with the laser light reacts, the cell contents are scattered to the surroundings. By checking the detection result by the pressure sensor, it is possible to check whether the photosensitive substance has reacted appropriately. The light irradiation device may also be equipped with a pH sensor at the tip. In this case, by checking the detection result by the pH sensor, it is possible to properly grasp the pH near the tip of the light irradiation device. The light irradiation device may also be equipped with a flow rate sensor at the tip. In this case, it is possible to check whether the photosensitive substance has reacted appropriately by checking the detection result by the flow rate sensor. As described above, the light irradiation device is equipped with various sensor systems, and thus it is possible to provide various information useful for treatment.

[0032] The light irradiation device may include a plurality of temperature sensors. The temperature measurement positions of the plurality of temperature sensors may be disposed at a plurality of sites at the tip of the light irradiation device. In this case, useful information can be obtained based on the detection results of the temperature at each of the plurality of measurement positions. For example, it is possible to confirm the direction in which the laser light is irradiated by confirming which of the plurality of measurement positions has a higher temperature than the other measurement positions. In addition, medical personnel can improve the accuracy of treatment by more accurately grasping the temperature at each measurement position.

[0033] The light irradiation device may further include wiring extending from the base end side to the tip end. At least one of the wirings may be arranged in a spiral shape in the main body of the light irradiation device. By arranging the wiring in a spiral shape, it becomes easier to appropriately ensure the rigidity of the elongated light irradiation device compared to when the wiring is arranged straight along the axial direction. Therefore, it becomes easier to further improve the accuracy of treatment.

[0034] The wiring arranged in a spiral shape can be appropriately selected. For example, the wiring of a temperature sensor (e.g., a thermocouple, etc.) may be arranged in a spiral shape. In addition, when the measurement positions (measurement points) of a plurality of temperature sensors are arranged at the tip of the light irradiation device, the measurement positions of the temperature sensors may be arranged at each of the plurality of positions of the wiring arranged in a spiral shape. In this case, it is possible to easily and appropriately arrange the measurement positions of the plurality of temperature sensors in each of the axial direction and circumferential direction of the long light irradiation device. In addition, the wiring of the laser light source, etc. may be arranged in a spiral shape.

[0035] At least one of the wires may contain a material having radiopaque properties. In this case, the position of the long light emitting device can be easily and appropriately grasped by radiography. In addition, when the wire having radiopaque properties is arranged in a spiral shape, the position of the light emitting device can be more easily grasped.

[0036] The light irradiation device may further include a position detection member for detecting the position of the tip portion in the lumen of the living body. In this case, the position of the position detection member provided in the light irradiation device is detected, so that the position of the tip portion of the light irradiation device in the lumen of the living body can be easily and appropriately grasped. Note that, as the position detection member, various members for detecting the position in the lumen (for example, at least one of a small ultrasonic oscillator and a magnet, etc.) can be adopted.

[0037] The light irradiating device may further include a magnetic member that guides at least one of the position and direction of the tip of the light irradiating device in the living body by a magnetic force generated by being placed in a magnetic field. In this case, at least one of the position and direction of the tip of the light irradiating device is appropriately guided in a state where the light irradiating device is inserted in the living body. Therefore, it becomes easier to perform treatment more appropriately.

[0038] The specific configuration of the magnetic member can be appropriately selected. For example, the magnetic member may be provided on the side of the laser light source opposite to the side from which the laser light is emitted. In this case, the direction of the magnetic member provided on the laser light source (i.e., the circumferential direction centered on the axial direction of the light irradiation device) is adjusted by magnetic force, so that the irradiation direction of the laser light can be easily controlled appropriately.

[0039] The light emitting device may also include a light emitting member at the tip, which indicates the position of the tip by emitting light through wireless power supply. At least a part of the light emitting member may be made of a magnetic member. In this case, not only is the position of the tip of the light emitting device indicated by emitting light from the light emitting member, but it is also possible to guide at least one of the position and the direction of the tip by generating a magnetic force in the light emitting member. The magnetic member may also serve as the position detection member described above. In this case, a plurality of useful functions are imparted to the light emitting device while suppressing an increase in the number of parts.

[0040] The laser light source may emit a laser light having a wavelength of 300 nm or more and 2000 nm or less. More preferably, the laser light source may emit a laser light having a wavelength of 600 nm or more and 1000 nm or less. In this case, by using the light irradiation device of the present disclosure for treating a disease using a photosensitive substance, it becomes easier to obtain an appropriate therapeutic effect.

[0041] The light irradiation system of the present disclosure includes a catheter and a light irradiation device. The catheter is formed in a long tubular shape and is flexible. The light irradiation device is used by being inserted into the lumen of the catheter and is flexible like the catheter. The light irradiation device includes a laser light source at a tip portion thereof that emits laser light in a predetermined wavelength range. The laser light source emits laser light in a direction intersecting with the longitudinal direction of the light irradiation device. At least a part of the tip side surface of the catheter is formed with a light transmitting portion that transmits the laser light emitted by the laser light source included in the light irradiation device to the outside of the catheter.

[0042] The light irradiation system of the present disclosure can directly irradiate a specific position of a living body with a laser light emitted from a light source through a light transmission part of a catheter from a light source provided at a tip part without passing through a light transmission member (e.g., an optical fiber, etc.). Therefore, various problems that occur when using a light transmission member (e.g., at least one of a problem of light leakage in the middle of the light transmission member and a problem of the characteristics of light changing during the light transmission process, etc.) are appropriately suppressed. Furthermore, the laser light source emits laser light from the tip part of the light irradiation device in a direction intersecting with the longitudinal axis direction. The laser light is irradiated to the outside through the light transmission part of the catheter. Therefore, the light irradiation system of the present disclosure can selectively irradiate a specific position of a living body with a laser light emitted from a laser light source. As a result, various inconveniences (e.g., occurrence of side effects, etc.) caused by the irradiation of light to an unintended position are less likely to occur. Therefore, light can be more efficiently and appropriately irradiated to a specific position in a lumen of a living body. Note that at least one of the configurations of the light irradiation device described above can be adopted for the configuration of the light irradiation device used in the light irradiation system.

[0043] At least the distal end portion of the catheter, which is adjacent to the laser light source of the light irradiation device, may be made of a material with a thermal conductivity of 0.1 W / m·K or more. In this case, the laser light source is easily cooled by, for example, blood flow or saline. This reduces the possibility of the laser light source malfunctioning due to heat generated by emitting the laser light. As a result, it becomes easier to perform treatment more appropriately.

[0044] With the light irradiation device inserted in the catheter, a cooling fluid may be flowed into the lumen of the catheter. In this case, the cooling fluid appropriately suppresses malfunctions (e.g., failure of the laser light source) caused by a rise in temperature at the tip end due to the laser light source.

[0045] The catheter may include a plurality of temperature sensors. The temperature measurement positions of the plurality of temperature sensors may be disposed at a plurality of sites on the catheter. In this case, useful information can be obtained based on the temperature detection results at each of the plurality of measurement positions. For example, by checking which of the plurality of measurement positions has a higher temperature than the other measurement positions, it is also possible to check the direction in which the laser light is irradiated. In addition, medical personnel can improve the accuracy of treatment by more accurately grasping the temperature at each measurement position.

[0046] The catheter may further include wiring extending from the base end side to the tip end side. At least one of the wirings may be arranged in a spiral shape in the catheter. By arranging the wiring in a spiral shape, it becomes easier to ensure appropriate rigidity of the catheter, which has a long tubular shape, compared to a case in which the wiring is arranged straight along the axial direction. This makes it easier to further improve the accuracy of treatment.

[0047] The wiring arranged in a spiral shape can be appropriately selected. For example, the wiring of a temperature sensor (e.g., a thermocouple or the like) may be arranged in a spiral shape. When the measurement positions (measurement points) of a plurality of temperature sensors are arranged on the catheter, the measurement positions of the temperature sensors may be arranged at each of the plurality of positions of the wiring arranged in a spiral shape. In this case, it is possible to easily and appropriately arrange the measurement positions of the plurality of temperature sensors in each of the axial direction and circumferential direction of the long catheter.

[0048] At least one of the wires may include a radiopaque material. In this case, the position of the long catheter can be easily and appropriately determined by radiography. If the radiopaque wires are arranged in a spiral shape, the position of the catheter can be even more easily determined.

[0049] The catheter may be provided with a catheter-side marker section having radiopaque properties at a position close to the light-transmitting section. In this case, when a medical professional (e.g., a doctor, etc.) irradiates a biological tissue with laser light using a light-irradiation device while taking an image of the inside of a living body using radiation (e.g., X-rays, etc.), the medical professional can appropriately irradiate the laser light from the light-transmitting section to the outside by aligning the position of the laser light source of the light-irradiation device with the position of the catheter-side marker section that appears in the captured image. This makes it easier to further improve the accuracy of treatment.

[0050] However, the catheter marker may be omitted. For example, if the entire vicinity of the tip of the catheter is made of a material that transmits laser light, it is possible to easily adjust the emission direction of the laser light from the laser light source even if the catheter marker is not provided.

[0051] The catheter may further include a catheter tip tip joined to the tip side. The catheter tip tip may have a through hole penetrating in the axial direction of the catheter, the through hole having a diameter smaller than the diameter of the light irradiation device. At least a part of the catheter tip tip may be formed of a radiopaque material. In this case, a medical professional (e.g., a doctor, etc.) can position the catheter in an appropriate position by grasping the position of the tip tip that appears in the radiographic image. This makes it easier to further improve the accuracy of treatment.

[0052] The light transmitting portion of the catheter may be formed at a position in the axial direction of the catheter where the laser light source of the light emitting portion is disposed with the tip of the light emitting device in contact with the tip of the lumen of the catheter. In this case, the position of the laser light source and the position of the light transmitting portion in the axial direction are automatically matched by simply pushing the light emitting device until it contacts the tip of the lumen of the catheter. Therefore, it becomes easier to perform treatment more appropriately. [Brief description of the drawings]

[0053] [Figure 1] FIG. 2 is a longitudinal sectional view of the light irradiation system 1 in a state in which the light irradiation device 2 and the catheter 3 are separated. [Diagram 2] FIG. 1 is a longitudinal sectional view of a light irradiation system 1 in a state in which a light irradiation device 2 is attached to a catheter 3 (in use). [Diagram 3] 3 is an enlarged vertical cross-sectional view of the vicinity of a tip portion of the light irradiation system 1 in FIG. 2. [Figure 4] 4 is a cross-sectional view taken along the line AA in FIG. 3. [Diagram 5] 4 is a cross-sectional view taken along the line BB in FIG. 3. [Figure 6] 13 is a diagram showing an example of a catheter side marker part 332A provided on the catheter 3. FIG. [Figure 7] 13 is a diagram showing an example of a catheter side marker part 332A provided on the catheter 3. FIG. [Figure 8]FIG. 11 is an enlarged vertical cross-sectional view of the vicinity of a tip portion of the light irradiation system 1 of a first modified example. [Figure 9] FIG. 11 is an enlarged vertical cross-sectional view of the vicinity of the tip portion of the light irradiation system 1 of a second modified example. [Figure 10] FIG. 13 is an enlarged view of the vicinity of the tip portion of the light irradiation device 2 of a third modified example. [Figure 11] FIG. 13 is an enlarged view of the vicinity of the tip of a catheter 3 of a fourth modified example. [Figure 12] FIG. 11 is a diagram showing the results of a first evaluation test. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0054] A typical embodiment of the present disclosure will be described below with reference to the drawings. The light irradiation system 1 of this embodiment is used by being inserted into a lumen of a living body (for example, at least one of a blood vessel, a lymph node, a urethra, a respiratory tract, a digestive organ, a secretory gland, and a reproductive organ). The light irradiation system 1 irradiates a living tissue with light (laser light in this embodiment) while being inserted into the lumen of the living body. The light irradiation system can be used for at least one of therapies such as PDT (Photodynamic Therapy) and NIR-PIT (Near-infrared photoimmunotherapy).

[0055] The light irradiation system 1 of this embodiment includes a light irradiation device 2 and a catheter 3. When using the light irradiation system 1, first, the catheter 3 is inserted into a living body lumen. Next, the light irradiation device 2 is inserted into the lumen 311 of the catheter 3, which has a long tubular shape. Once the insertion is complete, light is irradiated from the light irradiation device 2 to the living body tissue. However, it is also possible to use only the light irradiation device 2 alone, without using the catheter 3.

[0056] 1 to 3 and 8 to 11 show mutually orthogonal X and Y axes. In these figures, the lower side (+X direction) of the figures is the "distal side", the upper side (-X direction) of the figures is the "base side", the left side (+Y direction) of the figures is the "left side", and the right side (-Y direction) of the figures is the "right side". The light irradiation system 1, the light irradiation device 2, and the catheter 3 are inserted into a living body lumen from the distal end side. The proximal end side is operated by a medical professional (e.g., a doctor, etc.).

[0057] (Light Irradiation Device) The light irradiating device 2 of this embodiment will be described with reference to Figs. 1 to 5. As shown in Fig. 1, the light irradiating device 2 has an elongated shape. The light irradiating device 2 includes a connector 201, a shaft 210, and a distal tip 220. The connector 201 is located on the proximal end side of the light irradiating device 2 and is held by an operator. The connector 201 includes a pair of wing portions 202 and a connecting portion 203. The connecting portion 203 is a substantially cylindrical member. The wing portions 202 are connected to a proximal end of the connecting portion 203. The shaft 210 is connected to a distal end of the connecting portion 203. The wing portions 202 and the connecting portion 203 may be integrally formed.

[0058] The shaft 210 is preferably antithrombotic, flexible, and biocompatible. The material of the shaft 210 may be at least one of a resin material and a metal material. The resin material may be, for example, a polyamide resin, a polyolefin resin, a polyester resin, a polyurethane resin, a silicone resin, and a fluororesin. The metal material may be, for example, a stainless steel such as SUS304, a nickel-titanium alloy, a cobalt-chromium alloy, and a tungsten steel. The shaft 210 may be made of a combination of a plurality of materials.

[0059] The shaft 210 is an elongated member extending along the axis O2. Various wirings (for example, wirings 231A, 231B described below) are arranged inside the shaft 210. The distal tip 220 is connected to the distal end of the shaft 210. The distal tip 220 has a substantially cylindrical shape. The outer diameter of the distal tip 220 is substantially the same as the outer diameter Φ1 of the shaft 210.

[0060] With reference to FIG. 3, the configuration of the tip of the light irradiation device 2 of this embodiment will be described. FIG. 3 is an enlarged vertical cross-sectional view of the tip of the light irradiation system 1 in FIG. 2. As shown in FIG. 3, the light irradiation device 2 includes a small laser light source 230 (230A, 230B) that emits laser light in a predetermined wavelength range at the tip. The laser light source 230 is contained inside a long shaft 210 (which can also be expressed as a "device body"). However, it is also possible to change the fixing method of the laser light source 230. For example, the shaft may be formed in a long tube shape having a lumen inside. In this case, the laser light source 230 (230A, 230B) may be fixed to the inner wall of the lumen of the shaft.

[0061] The laser light source 230 (230A, 230B) emits laser light in a direction intersecting the long axis direction (direction of the axis O2) of the light irradiation device 2 (in the example shown in FIG. 3, the direction of the arrow perpendicularly intersecting the axis O2). Therefore, the light irradiation device 2 can directly irradiate light from the laser light source 230 provided at the tip to a specific position of the living body without using a light transmission member such as an optical fiber. Therefore, various problems that occur when using a light transmission member (for example, at least one of a problem of light leakage and attenuation in the middle of the light transmission member and a problem of light characteristics changing during the light transmission process) are appropriately suppressed. In addition, the laser light source 230 emits laser light from the tip of the light irradiation device 2 in a direction intersecting the direction of the axis O2. The laser light source 230 is easier to emit light that is less likely to diverge and has high directivity than a light-emitting diode. Therefore, the light irradiation device 2 of this embodiment can selectively irradiate a specific position of the living body with the laser light emitted from the laser light source 230. As a result, various problems (e.g., side effects, etc.) caused by light being irradiated to unintended positions are less likely to occur. Furthermore, the laser light source 230 has the property of being able to irradiate light with a wavelength having a narrower spectral width than a light-emitting diode. Therefore, by providing the laser light source 230 at the tip of the light irradiation device 2, various problems (e.g., at least one of a decrease in irradiation efficiency and unintended changes in tissue) caused by irradiating tissue with a wavelength different from the wavelength required for treatment (e.g., the excitation wavelength of a photosensitive substance, etc.) are also suppressed. Therefore, light can be more efficiently and appropriately irradiated to a specific position in a lumen of a living body.

[0062] A surface-emitting laser that irradiates laser light in a direction perpendicular to the substrate can be used as the laser light source 230. By using a surface-emitting laser, the light irradiation device 2 can appropriately emit laser light with small power and has high resistance to temperature changes. Furthermore, since the surface-emitting laser can emit laser light in a direction perpendicular to the substrate surface, it becomes easier to adjust the irradiation position of the laser light more accurately.

[0063] Also, the laser light source 230 can be a semiconductor laser, which is a circuit element manufactured using semiconductor materials. Since a semiconductor laser can be easily miniaturized, it can be easily incorporated into a light irradiation device 2 having a small diameter. Also, a semiconductor laser can emit a highly directional laser light with a uniform phase with a small power. Therefore, the treatment effect can be easily stabilized.

[0064] As shown in Fig. 3, the light irradiation device 2 of this embodiment includes a plurality of laser light sources 230A, 230B at the tip. By providing a plurality of laser light sources 230A, 230B in one light irradiation device 2, the degree of freedom of laser irradiation (e.g., ease of adjustment of at least one of the laser irradiation area, irradiation density, irradiation direction, etc.) is improved compared to the case where only one laser light source is provided. As a result, it becomes easier to obtain an appropriate treatment effect.

[0065] The wiring 231A extending from the control unit 5 (see FIG. 1 and FIG. 2) is connected to the laser light source 230A. The wiring 231B extending from the control unit 5 is also connected to the laser light source 230B. Power is supplied to the laser light sources 230A and 230B through the wiring 231A and 231B. The wiring 231A and 231B are provided along the long axis direction (direction of the axis O2) of the light irradiation device 2. However, as will be described later in detail, the wiring 231A and 231B can also be arranged in a spiral shape or the like. In this embodiment, the wiring 231A and 231B extend from the control unit 5 and are connected to the laser light sources 230A and 230B through the inside of the light irradiation device 2. In FIG. 1 to FIG. 3, the wiring 231A and 231B are indicated by dotted lines. FIG. 4 is a cross-sectional view taken along the arrow AA in FIG. 3. FIG. 3 shows a state in which the wiring 231A is connected to the laser light source 230A. Fig. 5 is a cross-sectional view taken along the line BB in Fig. 3. In Fig. 5, cross sections of two wires 231A and 231B passing through the inside of shaft 210 are shown.

[0066] In this embodiment, the emission of laser light from at least some of the multiple laser light sources 230A and 230B can be controlled independently of the other laser light sources. That is, the control unit 5 can independently control the emission of laser light from the two laser light sources 230A and 230B. As a result, the degree of freedom of laser irradiation is further improved.

[0067] Specifically, in this embodiment, as shown in Fig. 3, the installation directions of the laser light sources 230A and 230B are determined so that the irradiation directions of the laser light from each of the laser light sources 230A and 230B are different from each other. Specifically, the irradiation surface of the laser light from the laser light source 230A faces the +Y direction, and the irradiation surface of the laser light from the laser light source 230B faces the -Y direction. Therefore, the emission of the laser light from the two laser light sources 230A and 230B is independently controlled by the control unit 5, so that the emission direction of the laser light is appropriately changed. This further improves the degree of freedom of treatment.

[0068] In this embodiment, the multiple laser light sources 230A and 230B emit laser light in the same wavelength range. Therefore, the light irradiation device 2 can irradiate a specific area with laser light in the same wavelength range with a higher degree of freedom (i.e., by selecting an appropriate direction for the irradiation of the laser light). As a result, it becomes easier to obtain an appropriate treatment effect.

[0069] The laser light source 230 may emit a laser light having a wavelength of 300 nm or more and 2000 nm or less. More preferably, the laser light source 230 may emit a laser light having a wavelength of 600 nm or more and 1000 nm or less. In this case, by using the light irradiation device 2 for treating a disease using a photosensitive substance, it becomes easier to obtain an appropriate therapeutic effect. In this embodiment, the central wavelength of the laser light emitted by the laser light source 230 is about 690 nm.

[0070] In this embodiment, at least the portion of the elongated shaft (device body) 210 that contains the laser light sources 230A and 230B is made of a material that transmits the laser light emitted by the laser light sources 230A and 230B. By containing the laser light sources 230A and 230B inside the shaft 210, the laser light sources 230A and 230B are held in the shaft 210 in a stable state, and defects such as failure of the laser light sources 230A and 230B are less likely to occur, compared to a case in which the laser light sources 230A and 230B are exposed to the outside from the shaft 210. Furthermore, the laser light emitted from the laser light sources 230A and 230B is transmitted through the material of the shaft 210 and appropriately irradiated to the living tissue. This makes it easier to perform treatment more appropriately.

[0071] In this embodiment, the entire shaft 210 is formed from a material that transmits the laser beams emitted by the laser light sources 230A and 230B. Therefore, compared with a case in which only a portion of the shaft 210 is formed from a material that transmits laser beams, the configuration of the shaft 210 is simplified and the possibility that the laser beams will be blocked by a portion of the shaft 210 is reduced.

[0072] The inventors of the present application conducted a first evaluation test and a second evaluation test (described later) to newly find a desirable range of the light irradiation density of the laser light emitted from the laser light sources 230A and 230B at the time of being emitted to the outside from the light irradiation device 2. In this embodiment, the light irradiation density of the laser light emitted from the laser light sources 230A and 230B at the time of being emitted to the outside from the light irradiation device 2 is set to 80 W / cm based on the results of the evaluation tests. 2 More than 1600W / cm 2 In this case, it is easier to obtain an appropriate therapeutic effect by irradiating the photosensitizer with the laser light. It is more preferable that the light irradiation density at the time when the light is emitted from the light irradiation device 2 to the outside is 300 W / cm or less. 2 More than 1300W / cm 2 Less than 600W / cm, more preferably 600W / cm 2 More than 1300W / cm 2As an example, in this embodiment, the light irradiation density at the time when the light is emitted from the light irradiation device 2 to the outside may be about 1273 W / cm 2 It is said that.

[0073] As shown in Fig. 3 and other figures, the light irradiation device 2 of this embodiment includes light source position marker parts 232A and 232B having radiopaque properties at the tip where the laser light sources 230A and 230B are provided. Therefore, when a medical professional (e.g., an operator) irradiates a living tissue with laser light using the light irradiation device 2 while taking an image of the inside of a living body using radiation (e.g., X-rays), the medical professional can appropriately adjust the irradiation position of the laser light by checking the positions of the light source position marker parts 232A and 232B that appear in the captured image. This makes it easier to further improve the accuracy of treatment.

[0074] In detail, in this embodiment, at least some of the members of the laser light sources 230A and 230B are formed of a material having radiopaque properties, so that the laser light sources 230A and 230B themselves function as the light source position markers 232A and 232B. Therefore, even if a marker is not provided separately from the laser light sources 230A and 230B, the positions of the laser light sources 230A and 230B can be appropriately grasped by radiography. Furthermore, since the laser light sources 230A and 230B themselves function as the light source position markers 232A and 232B, the positions of the laser light sources 230A and 230B can be more accurately grasped by medical personnel. Therefore, it becomes easier to perform treatment more appropriately. As an example, in this embodiment, each of the laser light sources 230A and 230B has a multi-layer structure, and some of the layers are formed of a material having radiopaque properties. Therefore, it becomes easier to grasp the positions of the laser light sources 230A and 230B more accurately.

[0075] Furthermore, in this embodiment, at least a part of the tip tip 220 provided at the tip of the light irradiation device 2 (in this embodiment, the entire tip tip 220) is made of a material having radiopaqueness, and functions as a marker part. Therefore, even if a marker part is not provided separately, the position of the tip of the light irradiation device 2 can be appropriately grasped.

[0076] As shown in FIG. 3 and the like, the light irradiation device 2 includes a light sensor 240 (240A, 240B) at the tip. Therefore, the state of light at the tip of the light irradiation device 2 is directly detected by the light sensor 240 at the tip. That is, the light detected by the light sensor 240 is unlikely to undergo changes in the characteristics of light that may occur during transmission. Therefore, the state of light is more likely to be detected accurately. In this embodiment, a light sensor 240A that detects light (including reflected light, etc.) emitted by the laser light source 230A and a light sensor 240B that detects light emitted by the laser light source 230B are separately provided. Therefore, the state of light for each of the two laser light sources 230A and 230B is appropriately grasped. By providing a plurality of light sensors 240, it is also possible to confirm the direction in which the light is actually emitted. In order to simplify the drawing, the wiring extending from the light sensor 240 is omitted.

[0077] As shown in FIG. 3 and other figures, the distal end of the light irradiation device 2 of this embodiment is provided with a position detection member 250 for detecting the position of the distal end of the light irradiation device 2 in the lumen of the living body. Therefore, by detecting the position of the position detection member 250, the position of the distal end of the light irradiation device 2 in the lumen of the living body can be easily and appropriately grasped. In addition, the position detection member 250 can employ various members for detecting the position in the lumen. For example, when a small ultrasonic oscillator is used as the position detection member 250, the position of the position detection member 250 is detected by using an ultrasonic diagnostic device or the like. In addition, when a magnetic member is used as the position detection member 250, the position of the position detection member 250 is detected by using a magnetic sensor or the like.

[0078] The light irradiation device 2 may include a magnetic member (e.g., the position detection member 250) at the tip. The magnetic member may function as a guide member that guides at least one of the position and direction of the tip of the light irradiation device 2 in the lumen of the living body by a magnetic force generated by being placed in a magnetic field. In this case, at least one of the position and direction of the tip is appropriately guided in a state where the light irradiation device 2 is inserted in the lumen of the living body.

[0079] In addition, by making the position detection member 250 a magnetic member, the position detection member 250 may also function as a guide member. In this case, a plurality of useful functions are imparted to the light irradiation device 2 while suppressing an increase in the number of parts.

[0080] Also, the magnetic members 232A, 232B may be provided at least in part of the laser light sources 230A, 230B (in this embodiment, the part of the laser light sources 230A, 230B located on the side opposite to the side from which the laser light is emitted). In this case, the direction of the magnetic members 232A, 232B provided on the laser light sources 230A, 230B (that is, the circumferential direction centered on the direction of the axis O2 of the light irradiation device 2) is adjusted by magnetic force, so that the irradiation direction of the laser light is easily controlled appropriately. Note that the light source position marker parts 232A, 232B may also serve as the magnetic members, or a magnetic member may be provided separately from the light source position marker parts 232A, 232B.

[0081] The light irradiation device 2 may also be provided with a light emitting member at the tip, which indicates the position of the tip by emitting light through wireless power supply. For example, the above-mentioned position detection member 250 may be a light emitting member. When a light emitting member is provided, at least a part of the light emitting member may be made of a magnetic member. In this case, not only is the position of the tip of the light irradiation device indicated by emitting light from the light emitting member, but at least one of the position and direction of the tip can also be guided by generating a magnetic force in the light emitting member.

[0082] (catheter) The catheter 3 of this embodiment will be described with reference to Figs. 1 to 3, 6 and 7. As shown in Fig. 1, the catheter 3 has a long tubular shape. The catheter 3 includes a connector 301, a shaft 310 and a distal tip 320. The connector 301 is located on the base end side of the catheter 3 and is held by the surgeon. The connector 301 includes a pair of wings 302 and a connecting portion 303. The connecting portion 303 is a substantially cylindrical member. The wings 302 are connected to the base end of the connecting portion 303. The shaft 310 is connected to the distal end of the connecting portion 303. The wings 302 and the connecting portion 303 may be formed integrally.

[0083] The shaft 310 is preferably antithrombotic, flexible, and biocompatible, similar to the shaft 210 of the light irradiation device 2. The shaft 310 may be made of the same material as the shaft 210 of the light irradiation device 2. The shaft 310 is a long tubular member extending along the axis O3. The shaft 310 of this embodiment is formed in a hollow cylindrical shape with both the distal end and the proximal end open. The lumen 311 inside the shaft 310 functions as a guidewire lumen for inserting a guidewire into the catheter 3 during delivery of the catheter 3. The lumen 311 functions as a device lumen for inserting the light irradiation device 2 into the catheter 3 after delivery of the catheter 3.

[0084] The tip 320 is connected to the tip of the shaft 310. The tip 320 has an outer shape that is tapered from the base end side to the tip side in order to smoothly advance the catheter 3 in the body lumen. A through hole 321 is formed in the approximate center of the tip tip 320, penetrating in the direction of the axis O2. As shown in FIG. 3, the inner diameter Φ2 of the through hole 321 is smaller than the inner diameter Φ3 of the lumen 311 of the shaft 310, and smaller than the outer diameter Φ1 of the shaft 210 and the tip tip 220 of the light irradiation device 2. In addition, the outer diameter Φ1 of the shaft 210 and the tip tip 220 of the light irradiation device 2 is equal to or smaller than the inner diameter Φ3 of the lumen 311 of the catheter 3. Therefore, the light irradiation device 2 moves along the axis O2 in the lumen 311 of the catheter 3. When the light irradiation device 2 is sufficiently pushed inside the lumen 311 of the catheter 3, the distal tip 220 of the light irradiation device 2 comes into contact with the distal tip 320 of the catheter 3, thereby positioning the light irradiation device 2 relative to the catheter 3 in the directions of the axes O2 and O3.

[0085] The configuration of the tip of the catheter 3 of this embodiment will be described with reference to Figures 3, 6, and 7. As shown in Figure 3, the tip side surface (part of the tip side surface in this embodiment) of the shaft 310 in the catheter 3 is provided with light transmitting sections 330A, 330B that transmit the laser light emitted by the laser light sources 230A, 230B included in the light irradiation device 2 to the outside. Therefore, the light irradiation system 1 of this embodiment can selectively irradiate a specific position of a living body with the laser light emitted by the laser light sources 230A, 230B of the light irradiation device 2 in a direction intersecting the axis lines O2, O3.

[0086] In this embodiment, the light transmitting portions 330A, 330B are provided by partially forming the portions of the shaft 310 of the catheter 3 that transmit the laser light emitted by the laser light sources 230A, 230B with a material that transmits the laser light. However, it is also possible to change the configuration of the light transmitting portions. For example, the light transmitting portion may be provided in the catheter by making the material of the shaft 310 itself or the entire tip portion of the shaft 310 a material that transmits the laser light.

[0087] The catheter shaft 310 is provided with catheter side markers 332A and 332B having radiopaque properties at positions close to the light transmitting parts 330A and 330B, respectively. Therefore, when a medical professional (e.g., an operator) irradiates a living tissue with laser light using the light irradiation device 2 while taking an image of the inside of a living body using radiation (e.g., X-rays, etc.), the medical professional can appropriately irradiate the laser light from the light transmitting parts 330A and 330B to the outside by aligning the positions of the laser light sources 230A and 230B of the light irradiation device 2 with the positions of the catheter side markers 332A and 332B that appear in the captured image. This makes it easier to further improve the accuracy of treatment.

[0088] The specific configuration of the catheter side marker parts 332A, 332B can be selected as appropriate. For example, as shown in Fig. 6, the catheter marker part 332A may be formed so as to surround the periphery of the light transmitting part 330A. In this case, a medical professional can more accurately grasp the position of the light transmitting part 330A by checking the area surrounded by the catheter marker part 332A using a radiographic image. The shape of the catheter side marker parts 332A, 332B when surrounding the light transmitting parts 330A, 330B may be a shape other than a rectangle (for example, a circular ring shape, etc.).

[0089] 7, the catheter marker 332A may be provided adjacent to each of the distal end side and the proximal end side of the light transmitting portion 330A. In this case, the medical staff can properly grasp the position of the light transmitting portion 330A in the direction along the axes O2, O3. It is also possible to provide the catheter side markers 332A, 332B only on one of the distal end side and the proximal end side of the light transmitting portion 330A.

[0090] 3 and other figures, in this embodiment, at least a part of the distal tip 320 (in this embodiment, the entire distal tip 320) provided at the distal end of the shaft 310 of the catheter 3 is made of a radiopaque material, and functions as a marker. Therefore, the position of the distal end of the catheter 3 can be appropriately grasped.

[0091] The catheter 3 may have a magnetic member (e.g., the distal tip 320) at the distal end. The magnetic member may function as a guide member that guides at least one of the position and direction of the distal end of the catheter 3 in the lumen of the living body by a magnetic force generated by being placed in a magnetic field. In this case, at least one of the position and direction of the distal end is appropriately guided when the catheter 3 is inserted in the lumen of the living body.

[0092] The distal tip 320 may be made of a magnetic material so that the distal tip 320 also functions as a guide member. In this case, the catheter 3 is endowed with a number of useful functions while suppressing an increase in the number of parts.

[0093] At least the tip end portion of the shaft 310 of the catheter 3, which is adjacent to the laser light sources 230A, 230B of the light irradiation device 2 during laser irradiation (the entire shaft 310 in this embodiment) is made of a material with a thermal conductivity of 0.1 W / m·K or more. Therefore, the laser light sources 230A, 230B are easily cooled by, for example, blood flow or saline. This reduces the possibility that the laser light sources 230A, 230B will malfunction due to heat generated by the laser light sources 230A, 230B emitting laser light. This makes it easier to perform treatment more appropriately.

[0094] (How to use) An example of a method of using the light irradiation system 1 of this embodiment will be described. First, the surgeon inserts a guidewire (not shown) into the body lumen. Next, the surgeon inserts the base end side of the guidewire into the lumen 311 from the through hole 321 of the distal tip 320 of the catheter 3, and protrudes it to the base end side of the connector 301. The surgeon pushes the catheter 3 along the guidewire, and moves at least one of the light transmission parts 330A and 330B of the catheter 3 to the target site of light irradiation. When moving the catheter 3 in the body lumen, the surgeon can appropriately move the catheter 3 to the target site by checking the positions of the catheter side marker parts 332A and 332B using a radiographic image. Thereafter, the surgeon removes the guidewire from the catheter 3.

[0095] The operator inserts the light irradiation device 2 from the base end opening of the connector 301 of the catheter 3, and pushes the light irradiation device 2 along the lumen 311 of the catheter 3 in the living body lumen. When the light irradiation device 2 is sufficiently pushed in the lumen 311 of the catheter 3, the distal tip 220 of the light irradiation device 2 comes into contact with the distal tip 320 of the catheter 3. As shown in FIG. 3, the light transmission parts 330A and 330B in the catheter 3 are formed at positions where the laser light sources 230A and 230B are disposed in the direction of the axes O2 and O3 in a state where the distal tip 220 of the light irradiation device 2 comes into contact with the distal end of the lumen of the catheter 3 (the distal tip 320 of the catheter 3). Therefore, the positions of the laser light sources 230A and 230B and the positions of the light transmission parts 330A and 330B in the direction of the axes O2 and O3 automatically coincide with each other by simply pushing the light irradiation device 2 until it comes into contact with the distal tip 320 of the catheter 3. In this state, laser light is emitted from the laser light sources 230A and 230B, so that the target site is selectively irradiated with the laser light.

[0096] With the light irradiation device 2 inserted into the catheter 3, the surgeon can cause a cooling fluid to flow into the lumen 311 of the catheter 3. Therefore, problems caused by a rise in temperature at the tip portion due to the laser light sources 230A and 230B (for example, failure of the laser light sources 230A and 230B) are appropriately suppressed by the cooling fluid.

[0097] (Modification) The techniques disclosed in the above-described embodiments are merely examples. Therefore, the techniques exemplified in the above-described embodiments can be modified. Some modified examples of the above-described embodiments will be described with reference to Figs. 8 to 11. Note that the first modified example shown in Fig. 8, the second modified example shown in Fig. 9, the third modified example shown in Fig. 10, and a part of the configuration of the fourth modified example shown in Fig. 11 can adopt the same configuration as the above-described embodiments. Therefore, the same numbers as those in the above-described embodiments are assigned to the parts of the configurations of the first modified example to the fourth modified example that can adopt the same configuration as the above-described embodiments, and the description thereof will be omitted or simplified.

[0098] In the light irradiation system 1 of the first modified example shown in FIG. 8, the multiple laser light sources 230C, 230D emit laser light of different wavelength ranges. The installation direction of each of the multiple laser light sources 230C, 230D is determined so that the irradiation direction of each laser light of the multiple laser light sources 230C, 230D is parallel. The control unit 5 can independently control the emission of laser light by the two laser light sources 230C, 230D. Therefore, the light irradiation system 1 of the first modified example can selectively emit laser light of different wavelength ranges to living tissue.

[0099] The configuration of the light irradiation system 1 of the first modified example can be further modified. For example, in the light irradiation system 1 shown in FIG. 8, the emission of laser light from the multiple laser light sources 230C and 230D may be controlled collectively. Furthermore, the multiple laser light sources 230C and 230D may emit laser light in the same wavelength range. In this case, the irradiation area of ​​the laser light is enlarged compared to the case where only one laser light source is used.

[0100] The light irradiation device 2 of the second modification shown in FIG. 9 includes one laser light source 230E. As described above, the number of laser light sources provided in the light irradiation device 2 may be one or more. In the second modification, the device body 209 of the light irradiation device 2 includes a marker part 232E having radiopaque properties provided on each of the distal end side and the proximal end side of the position where the laser light from the laser light source 230E is emitted to the outside. As described above, the marker part 232E can be provided separately from the laser light source 230E.

[0101] The light irradiation device 2 of the second modified example is provided with a light detection transmission member 241 that transmits light incident on the tip portion (in this embodiment, near the position where the laser light is emitted to the outside) to an optical sensor (not shown). The light detection transmission member 241 of this embodiment is an optical fiber, which is inserted from the side of the device body 209 through the inside of the device body 209 to the base end side and connected to the optical sensor. In the second modified example, the state of light at the tip portion is appropriately detected in a state in which the configuration of the tip portion of the light irradiation device 2 is prevented from becoming complicated by the optical sensor.

[0102] The light irradiation device 2 of the second modification includes a temperature sensor 260 at the tip. Therefore, for example, at least one of a temperature rise caused by driving the laser light source 230E provided at the tip and a temperature rise caused by emitting the laser light to the living tissue can be appropriately detected.

[0103] In the catheter 3 of the second modification, a light transmitting portion 330E (which can also be expressed as a "laser light transmitting window") is formed by opening a portion of the shaft 310 that transmits the laser light emitted by the laser light source 230E. As described above, the method of forming the light transmitting portion is not limited to the method of using a material that transmits laser light.

[0104] The light irradiation device 2 of the third modified example shown in FIG. 10 includes a plurality of temperature sensors 260 (260A, 260B, 260C). The measurement positions of the plurality of temperature sensors 260 (measurement points shown by 260A, 260B, 260C in this embodiment) are arranged at a plurality of sites at the tip of the light irradiation device 2. Therefore, useful information can be obtained based on the detection results of the temperature at each of the plurality of measurement positions. For example, it is also possible to confirm the direction in which the laser light is irradiated by confirming which of the plurality of measurement positions has a higher temperature than the other measurement positions. In addition, medical personnel can improve the accuracy of treatment by more accurately grasping the temperature at each measurement position.

[0105] In the light irradiation device 2 of the third modified example, the wiring of the temperature sensor 260 is arranged in a spiral shape in the main body of the light irradiation device 2. Therefore, compared with the case where the wiring is arranged straight along the axial direction, the rigidity of the elongated light irradiation device 2 is easily ensured appropriately. Therefore, the accuracy of the treatment is easily improved. As an example, in this embodiment, a long thermocouple having a plurality of measurement points is used as the temperature sensor 260. The rigidity of the light irradiation device 2 is ensured by arranging the wiring of the elongated temperature sensor 260 in a spiral shape.

[0106] In the light irradiation device 2 of the third modified example, the wiring of the temperature sensor 260 contains a material having radiopaqueness. Therefore, the position of the elongated light irradiation device 2 can be easily and appropriately grasped by radiography. In addition, in the third modified example, the wiring of the temperature sensor 260 having radiopaqueness is arranged in a spiral shape, so that the position of the light irradiation device 2 can be more easily grasped.

[0107] The catheter 3 of the fourth modified example shown in FIG. 11 includes a plurality of temperature sensors 360 (360A, 360B, 360C, 360D, 360E). The measurement positions of the plurality of temperature sensors 360 (measurement points indicated by 360A, 360B, 360C, 360D, 360E in this embodiment) are disposed at a plurality of sites at the tip of the catheter 3. Therefore, useful information can be obtained based on the detection results of the temperature at each of the plurality of measurement positions. For example, it is also possible to confirm the direction in which the laser light is irradiated by confirming which of the plurality of measurement positions has a higher temperature than the other measurement positions. In addition, medical personnel can improve the accuracy of treatment by more accurately grasping the temperature at each measurement position.

[0108] In the catheter 3 of the fourth modification, the wiring of the temperature sensor 360 is arranged in a spiral shape on the shaft 310 of the catheter 3. Therefore, it is easier to ensure the appropriate rigidity of the long catheter 3 compared to when the wiring is arranged straight along the axial direction. This makes it easier to further improve the accuracy of treatment. As an example, in this embodiment, a long thermocouple with multiple measurement points is used as the temperature sensor 360. The rigidity of the catheter 3 is ensured by arranging the wiring of the long temperature sensor 360 in a spiral shape.

[0109] In the catheter 3 of the fourth modified example, the wiring of the temperature sensor 360 contains a radiopaque material. Therefore, the position of the long catheter 3 can be easily and appropriately grasped by radiography. In the fourth modified example, the wiring of the temperature sensor 360, which has radiopaque properties, is arranged in a spiral shape, which makes it even easier to grasp the position of the catheter 3.

[0110] (First evaluation test) With reference to FIG. 12, the results of a first evaluation test for evaluating the lower limit of the light irradiation density of the laser light emitted from the laser light source 230 at the time of being emitted to the outside from the light irradiation device 2 will be described. In the first evaluation test, the inventor connected an optical fiber to the laser light source, and arranged a sensor for detecting the laser light in the emission direction of the laser light emitted from the tip of the optical fiber. Next, the inventor changed the state of the optical path of the laser light between the tip of the optical fiber and the sensor to each of (1) a "blank state" in which nothing is arranged, (2) a "carotid artery arrangement state" in which the pig's carotid artery is arranged, and (3) an "aorta arrangement state" in which the pig's aorta is arranged, and confirmed the detection result of the laser light by the sensor while changing the light irradiation density of the laser light in each state. In (2) "carotid artery arrangement state" and (3) "aorta arrangement state", the detection result by the sensor is the detection result of the laser light that has passed through the carotid artery or aorta and reached the sensor.

[0111] The core diameter of the fiber used in the first evaluation test was 400 μm (surface area was 0.001256 cm 2) The "blank state output" shown in FIG. 12 is almost equal to the output of the laser light emitted from the tip of the fiber. Therefore, the light irradiation density of the laser light emitted from the tip of the fiber can be obtained by dividing the "blank state output" by the surface area of ​​the fiber core. The laser light source used in the first evaluation test was "MLL-III-690" manufactured by CNI Optoelectronics Technology. The sensor used in the first evaluation test was "S310C" manufactured by THORLABS. The lower limit of the sensor used in the first evaluation test that can be detected is 10 mW. Although this sensor may detect an output of less than 10 mW, the detection result of less than 10 mW is unreliable. Therefore, in the first evaluation test, when the detection result by the sensor is 10 mW or more, it is determined that the laser light that has passed through the blood vessel has been properly detected (i.e., "detected").

[0112] As shown in FIG. 12, the light irradiation density of the laser light was set to 584.4 W / cm 2 When the laser light irradiation density was set to 78.8 W / cm, a sufficient output of 10 mW or more was detected in both (2) "carotid artery placement state" and (3) "aorta placement state." 2 When the laser light was placed in the (2) "carotid artery", a sufficient output of 21.1 mW was detected, but in the (3) "aortic artery", a sufficient output could not be detected. 2 As shown below, sufficient output was not detected in both (2) "carotid placement state" and (3) "aortic placement state."

[0113] From the above results, the light irradiation density of the laser light was set to about 80 W / cm 2 In this case, if the blood vessel is thick, such as the aorta, the laser light may not penetrate the blood vessel sufficiently, making it difficult to obtain a therapeutic effect. However, if the blood vessel is thin, such as the carotid artery, the light irradiation density of the laser light is approximately 80 W / cm 2By setting the above, there is a high possibility that the laser light will pass through the blood vessel and be appropriately irradiated to the tissue. From the above results, the lower limit of the light irradiation density of the laser light emitted from the laser light source 230 at the time when the laser light is emitted to the outside from the light irradiation device 2 is 80 W / cm 2 It is desirable to set the light irradiation density at 300 W / cm2. The higher the output of the laser light irradiated to the tissue, the more efficient the therapeutic effect. Therefore, the lower limit of the light irradiation density at the time when the light is emitted from the light irradiation device 2 to the outside is 300 W / cm2. 2 Furthermore, as shown in FIG. 12, it is more preferable to set the light irradiation density of the laser light to 584.4 W / cm. 2 This means that the laser light can penetrate even a thick aorta and be appropriately irradiated to the tissue. Therefore, the lower limit of the light irradiation density at the time when the light is emitted from the light irradiation device 2 to the outside is 600 W / cm 2 It would be even more desirable to

[0114] (2nd evaluation test) The results of the second evaluation test for evaluating the upper limit of the light irradiation density of the laser light emitted from the laser light source 230 at the time of being emitted to the outside from the light irradiation device 2 will be described. In the second evaluation test, the inventor connected an optical fiber to the laser light source, and arranged a sensor for detecting the laser light in the emission direction of the laser light emitted from the tip of the optical fiber. Next, the inventor changed the state of the optical path of the laser light between the tip of the optical fiber and the sensor to (1) a "blank state" in which nothing is arranged, and (2) a "carotid artery arrangement state" in which a pig's carotid artery is arranged, and emitted the laser light from the tip of the optical fiber in each state. The inventor evaluated the upper limit of the light irradiation density at the time of being emitted to the outside from the light irradiation device 2 based on the light irradiation density when the carotid artery is burned in (2) the "carotid artery arrangement state".

[0115] The core diameter of the fiber used in the second evaluation test was 400 μm (surface area was 0.001256 cm 2), and NA is 0.39. As in the first evaluation test, the output of the laser light detected by the sensor in the "blank state" is approximately equal to the output of the laser light emitted from the tip of the fiber. Therefore, the light irradiation density of the laser light emitted from the tip of the fiber can be calculated by dividing the output detected in the "blank state" by the surface area of ​​the fiber core. The laser light source used in the second evaluation test was the "Brix690-2500UHP" manufactured by Omicron. The sensor used in the second evaluation test was the "S425C" manufactured by THORLABS.

[0116] First, the inventor set the output of the laser light source to the maximum setting output of 2500mW, and confirmed the output of the laser light detected by the sensor in (1) "blank state", and found that the detected output varied between 1800mW and 2100mW. Next, the inventor set the output of the laser light source to the above-mentioned maximum setting output of 2500mW, and confirmed the output of the laser light detected by the sensor in (2) "carotid artery placement state". As a result, the output of the laser light transmitted through the carotid artery and detected by the sensor varied between 300mW and 350mW. Therefore, in (2) "carotid artery placement state", the output of the laser light emitted from the tip of the fiber when the sensor detects 300mW is estimated to be about 1800mW. Also, the output of the laser light emitted from the tip of the fiber when the sensor detects 350mW is estimated to be about 2100mW. (2) When the laser light was continued to be emitted in the "carotid artery placement state", the carotid artery was not burned as long as the sensor detection result was less than 350 mW. However, when the sensor detection result reached 350 mW, the carotid artery vascular wall was burned. (2) In the "carotid artery placement state", the light irradiation density of the laser light emitted from the tip of the fiber when the sensor detected 350 mW was approximately 1670 W / cm 2 It becomes.

[0117] From the above results, the light irradiation density of the laser light was set to 1670 W / cm 2 However, if the laser light irradiation density is set at 1600 W / cm, the blood vessel wall may be damaged, making it difficult to guarantee safety during treatment.2 From the above results, the upper limit of the light irradiation density of the laser light emitted from the laser light source 230 at the time when the laser light is emitted to the outside from the light irradiation device 2 is 1600 W / cm 2 In order to further increase safety during treatment (i.e., to further reduce the possibility of damaging the blood vessel wall), the upper limit of the light irradiation density at the time when the light is emitted from the light irradiation device 2 to the outside is set to 1300 W / cm. 2 It is desirable to do so.

[0118] It is also possible to adopt only a part of the configurations exemplified in the above-mentioned embodiment and modified example in the light irradiation system, the light irradiation device, or the catheter. It is also possible to combine a plurality of configurations shown in different embodiments. As described above, it is also possible to use only the light irradiation device 2 alone without using the catheter 3. Also, a fluid flow path penetrating from the base end side to the tip end side may be formed in the shaft 210 of the light irradiation device 2. In this case, by flowing a cooling fluid in the flow path of the shaft 210, various malfunctions due to temperature rise (for example, failure due to the laser light source 230 becoming high temperature, etc.) are appropriately suppressed.

Claims

1. A long-shaped medical light irradiation device, A laser light source that emits laser light in a predetermined wavelength range is provided at the tip, The laser light source, when inserted into a blood vessel of a living body, emits laser light in a direction intersecting a longitudinal axis direction of the light irradiation device, thereby transmitting the laser light through a blood vessel wall and irradiating the laser light to a living tissue outside the blood vessel; A light irradiation device, wherein a light irradiation density of the laser light emitted from the laser light source when the laser light is emitted to the outside from the light irradiation device is 80 W / cm 2 or more and 1600 W / cm 2 or less.

2. 2. The light irradiation device according to claim 1, A light irradiation device comprising a plurality of the laser light sources at the tip portion.

3. 3. The light irradiation device according to claim 2, 13. A light irradiation device, comprising: a light source for emitting laser light from at least a part of said plurality of laser light sources, said part being controllable independently of other laser light sources.

4. 3. The light irradiation device according to claim 2, A light irradiation device, wherein the plurality of laser light sources emit laser light in the same wavelength range.

5. 3. The light irradiation device according to claim 2, A light irradiation device, wherein some of the plurality of laser light sources include a laser light source that emits laser light in a wavelength range different from the wavelength ranges of the other laser light sources.

6. 2. The light irradiation device according to claim 1, The laser light source is contained within a long device body, A light irradiation device, wherein at least a portion of the device body that contains the laser light source is formed from a material that transmits the laser light emitted by the laser light source.

7. 2. The light irradiation device according to claim 1, A light irradiation device comprising a radiopaque marker portion at the tip where the laser light source is provided.

8. 8. The light irradiating device according to claim 7, A light irradiation device, characterized in that at least a portion of the laser light source is formed from a material having radiopaque properties, so that the laser light source functions as the marker portion.

9. 2. The light irradiation device according to claim 1, 2. A light irradiation device, wherein the laser light source is a surface emitting laser that irradiates a laser beam in a direction perpendicular to a substrate.

10. 2. The light irradiation device according to claim 1, 2. A light irradiation device, wherein the laser light source is a semiconductor laser that is a circuit element manufactured using a semiconductor material.

11. 2. The light irradiation device according to claim 1, A light irradiation device further comprising a light detection transmission member that transmits light incident on the tip portion to a light sensor, or a light sensor provided at the tip portion.

12. 2. The light irradiation device according to claim 1, Further comprising a plurality of temperature sensors; A light irradiation device, characterized in that the temperature measurement positions of the plurality of temperature sensors are arranged at a plurality of positions on the tip portion.

13. 2. The light irradiation device according to claim 1, Further comprising a wiring extending from the base end side to the tip end portion, A light-emitting device, characterized in that the wiring is arranged in a spiral shape.

14. 2. The light irradiation device according to claim 1, A light irradiation device further comprising a position detection member at the tip for detecting a position of the tip within a lumen of the living body.

15. 2. The light irradiation device according to claim 1, A light irradiation device further comprising a magnetic member that guides at least one of the position and direction of the tip portion within a living body by a magnetic force generated when the magnetic member is placed in a magnetic field.

16. A medical light irradiation system, comprising: A catheter formed into a long tubular shape; a long light irradiation device that is inserted into the lumen of the catheter; Equipped with the light irradiation device is provided with a laser light source at a tip thereof for emitting laser light in a predetermined wavelength range; The laser light source, when inserted into a blood vessel of a living body, emits laser light in a direction intersecting a longitudinal axis direction of the light irradiation device, thereby transmitting the laser light through a blood vessel wall and irradiating the laser light to a living tissue outside the blood vessel; a light irradiation density of the laser light emitted from the laser light source at a time when the laser light is emitted to the outside from the light irradiation device is 80 W / cm 2 or more and 1600 W / cm 2 or less; A light irradiation system, characterized in that a light transmitting portion that transmits laser light emitted by the laser light source provided in the light irradiation device to the outside is formed on at least a portion of the tip side surface of the catheter.

17. 17. The lighting system according to claim 16, A light irradiation system characterized in that at least a tip portion of the catheter adjacent to the laser light source of the light irradiation device is formed from a material having a thermal conductivity of 0.1 W / m·K or more.

18. 17. The lighting system according to claim 16, A light irradiation system, characterized in that a cooling fluid is flowed into an inner cavity of the catheter while the light irradiation device is inserted into the catheter.

19. 17. The lighting system according to claim 16, the catheter further comprising a plurality of temperature sensors; A light irradiation system, characterized in that the temperature measurement positions of each of the plurality of temperature sensors are arranged at each of a plurality of sites on the catheter.

20. 17. The lighting system according to claim 16, The catheter further includes a wire extending from the base end to the tip end, A light irradiation system, characterized in that the wiring is arranged in a spiral shape.

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