JP7795318B2 - Light irradiation system - Google Patents

Description

The present invention relates to a light irradiation system.

In cancer treatment, surgical, radiological, and pharmacological (chemical) techniques are used alone or in combination, and each technique has undergone significant development in recent years. However, there are still many cancers for which satisfactory treatment techniques have not yet been found, and further developments in treatment techniques are anticipated. One known cancer treatment technique is photodynamic therapy (PDT). In PDT, a photosensitizer is administered intravenously followed by light irradiation, which causes active oxygen to be generated in cancer cells and kills them (see, for example, Non-Patent Document 1). However, PDT has not been widely adopted as a treatment technique due to issues such as the low selectivity of the photosensitizer's accumulation in cancer cells and the significant side effects caused by its uptake into normal cells.

One treatment technique that has recently attracted attention is NIR-PIT (near-infrared photoimmunotherapy). NIR-PIT uses a complex that combines two compounds: an antibody specific to a cancer cell antigen and a photosensitizer (e.g., IRDye700DX). When administered intravenously, this complex selectively accumulates in cancer cells within the body. The complex is then activated by irradiation with light at the excitation wavelength (e.g., 690 nm) of the photosensitizer in the complex, thereby exhibiting anti-cancer activity (see, for example, Patent Document 1). NIR-PIT reduces side effects compared to PDT by utilizing the antibody's selective accumulation in cancer cells and localized light irradiation. Furthermore, because NIR-PIT uses light irradiation in the near-infrared region (NIR irradiation), for example, 690 nm, NIR irradiation is also expected to have an effect on the immune system (see, for example, Non-Patent Document 2).

The specific wavelength range exemplified above, including 690 nm, is also known as the biological spectroscopic window. While this wavelength range is less absorbed by biological components than other wavelength ranges, the light does not penetrate well when irradiated from the body surface, making it unsuitable for treating cancers deep inside the body. Therefore, in recent years, research has been conducted into NIR-PIT, which irradiates light closer to cancer cells rather than from the body surface (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 inserted into blood vessels and can irradiate light deep inside the body.

Special table 2014-523907 publication Japanese Patent Application Laid-Open No. 2018-867 Special Publication No. 2007-528752 Special Publication No. 2008-523954

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

As mentioned above, in PDT and NIR-PIT, cancer cells that have accumulated the complex are killed by irradiating them with light of the excitation wavelength of the photosensitizer in the complex. On the other hand, it is preferable to avoid irradiating normal cells other than cancer cells with light in order to reduce the risk of cell damage. Furthermore, because cancer cells can arise in various locations within the body, it is preferable that the devices used in PDT and NIR-PIT be as thin as possible and not block blood flow.

In this regard, the device described in Patent Document 2 has a lumen for a light diffuser, a lumen for a shape-memory wire, a lumen for a tension wire, and a lumen for two electrode wires within the catheter tube, which results in a problem of the device becoming larger in diameter. Furthermore, the device described in Patent Document 3 has a problem of blocking blood flow because the device is fixed within the blood vessel by occluding the blood vessel with an expanded balloon. Furthermore, the device described in Patent Document 4 has a problem of the device becoming larger in diameter because the imaging sheath, which includes an imaging core lumen and a guidewire lumen, is further configured to be spirally wound.

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 the 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 body 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 above-mentioned problems, and aims to provide a light irradiation system that irradiates light inside a living body, making it easier to irradiate target tissue with light without blocking blood flow, and to reduce the diameter of the device.

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

(1) One aspect of the present invention provides a medical light irradiation system. This light irradiation system includes a catheter having a long shaft with a first lumen extending longitudinally and a second lumen arranged alongside the first lumen, and a long light irradiation device having a light irradiation unit at its tip that irradiates light. In the catheter, a first opening communicating with the first lumen is formed at the tip of the shaft, and a second opening located proximal to the first opening and communicating with the second lumen is formed on the side of the shaft. When the light irradiation device is inserted into the second lumen of the catheter and the light irradiation unit is delivered to the position of the second opening, light emitted from the light irradiation unit is irradiated to the outside of the catheter via the second opening.

With this configuration, a first opening communicating with the first lumen is formed at the distal end of the catheter shaft, and a second opening communicating with the second lumen into which the light irradiation device is inserted is formed on the side of the shaft, proximal to the first opening. Therefore, by inserting a guidewire into the first lumen and placing the catheter within the blood vessel with the distal end of the guidewire protruding from the first opening, the guidewire can provide backup force to the catheter. As a result, when delivering the distal end of the light irradiation device (light irradiation unit) inserted into the second lumen to the vicinity of the second opening, movement of the catheter within the blood vessel can be suppressed. In other words, deviation of the second opening of the catheter from the pre-aligned position of the target tissue can be suppressed, facilitating light irradiation of the target tissue. Furthermore, because the catheter shaft is long and has the first and second lumens, the diameter of the device can be made smaller than configurations with as many as five lumens or configurations in which the shaft is spirally wound. Furthermore, because backup force is applied to the catheter by the guidewire inside the first lumen, blood flow is not blocked, as opposed to when a balloon is used. As a result, the light irradiation system of this configuration, which irradiates light inside a living body, makes it easy to irradiate target tissue with light without blocking blood flow, and allows for the device to have a smaller diameter.

(2) In the light irradiation system of the above form, the shaft of the catheter may further include a stopper member that blocks at least a portion of the second opening, thereby preventing the light irradiation device in the second lumen from protruding to the outside through the second opening.
According to this configuration, the catheter shaft includes a stopper member that blocks at least a portion of the second opening, thereby preventing the light irradiation device in the second lumen from protruding outward from the second opening. As a result, contact of the light irradiation device with biological tissue can be prevented, improving the safety of the light irradiation system. Furthermore, deviations in the light irradiation direction (changes in the orientation of the light irradiation unit, resulting in light not being irradiated in the intended direction), which may occur when the light irradiation device protrudes outward, can be prevented, making it easier to irradiate light onto the target tissue.

(3) In the light irradiation system of the above aspect, the stopper member may have a light diffusing property for diffusing light.
According to this configuration, the stopper member has a light diffusing property that diffuses light, and therefore, the accuracy of light irradiation onto the target tissue can be improved.

(4) In the light irradiation system of the above aspect, the stopper member may have a curved convex shape at least on its outer surface.
According to this configuration, the stopper member has a curved convex shape at least on the outer surface, which makes it easier to diffuse light.

(5) In the light irradiation system of the above form, the stopper member may be formed of an elastic body and may block the entire second opening, and the stopper member may be provided with a slit that allows a fluid having a flow rate greater than that of blood flow to pass through.
According to this configuration, the stopper member is made of an elastic material and blocks the entire second opening. The stopper member has a slit that allows a fluid with a flow rate faster than the blood flow to pass through. Therefore, even when the catheter is inserted into a blood vessel, the stopper member can prevent blood from entering the second lumen. Furthermore, because the stopper member has a slit that allows a fluid with a flow rate faster than the blood flow to pass through, when a flushing operation is performed to fill the second lumen with saline, the supplied saline can be discharged to the outside through the slit in the stopper member.

(6) In the catheter of the light irradiation system of the above form, the shaft may further have a third lumen arranged alongside the first lumen and the second lumen, and a third opening may be formed on the side of the shaft, located closer to the base end than the first opening and communicating with the third lumen, and in a cross section of the shaft, the first lumen may be arranged at the center of the shaft, and the second lumen and the third lumen may be arranged on opposite sides of the first lumen.
According to this configuration, the catheter shaft has a third lumen arranged alongside the first lumen and the second lumen, and a third opening communicating with the third lumen is formed on the side of the shaft, closer to the proximal end than the first opening. Therefore, the third lumen can be used as a backup lumen through which a backup device (e.g., a guidewire, a catheter, etc.) is inserted to provide additional backup force to the catheter. Specifically, a guidewire is inserted into the first lumen so that the distal end of the guidewire protrudes from the first opening, and a backup device is inserted into the third lumen so that the distal end of the backup device protrudes from the third opening. The catheter is then placed within the blood vessel with the side of the backup device in contact with the blood vessel wall. This allows backup force to be applied to the catheter by both the guidewire and the backup device. As a result, when the distal end (light irradiation unit) of the light irradiation device inserted into the second lumen is delivered to the vicinity of the second opening, movement of the catheter within the blood vessel can be further suppressed, thereby making it easier to irradiate the target tissue with light. Furthermore, the second lumen into which the light irradiation device is inserted and the third lumen into which the backup device is inserted are located on opposite sides of the first lumen. Therefore, when the backup device is brought into contact with the blood vessel wall, the catheter is lifted toward the side where the second lumen into which the light irradiation device is inserted is located. As a result, light irradiation by the light irradiation device can be performed closer to the target tissue, improving treatment efficiency and preventing light irradiation of normal tissue (including blood) other than the target tissue. Furthermore, since the first lumen, which functions as a guidewire lumen, is located at the center of the shaft in the cross section of the shaft, operability when delivering the catheter to the target tissue can be improved.

(7) In the light irradiation system of the above form, the third opening may be positioned near the second opening in the longitudinal direction of the catheter, and when a first line segment connecting the center of the shaft and the center point of the second opening and a second line segment connecting the center of the shaft and the center point of the third opening are viewed from the longitudinal direction, the angle formed by the first line segment and the second line segment may be 180 degrees.
According to this configuration, the second opening through which light is irradiated and the third opening through which the backup device protrudes are positioned 180 degrees apart in the circumferential direction of the catheter shaft. Therefore, when the backup device is brought into contact with the blood vessel wall, the catheter is lifted toward the second opening through which light is irradiated, bringing the second opening closer to the blood vessel wall on the opposite side from the side in contact with the backup device. As a result, light irradiation by the light irradiation device can be performed from closer to the target tissue, improving treatment efficiency and preventing light irradiation of normal tissue other than the target tissue.

(8) In the catheter of the light irradiation system of the above form, the shaft further has a fourth lumen arranged alongside the first lumen, the second lumen, and the third lumen, and a fourth opening is formed on the side of the shaft, located closer to the base end than the first opening and communicating with the fourth lumen, and the fourth lumen may be arranged on the same side as the third lumen in a cross section of the shaft.
According to this configuration, the catheter shaft further has a fourth lumen extending to the fourth opening on the side, so that a second backup device can be used in addition to the backup device inserted through the third lumen. As a result, a stronger backup force can be applied to the catheter by the guidewire and two backup devices.

(9) In the light irradiation system of the above form, the shaft of the catheter further comprises an outer shaft, a first inner shaft having the first lumen inside, a second inner shaft having the second lumen inside, and a third inner shaft having the third lumen inside, and the first inner shaft, the second inner shaft, and the third inner shaft each extend further toward the base end than the base end of the outer shaft when inserted inside the outer shaft, and at least their base ends are fixed to the outer shaft, and an operating unit that can be rotated may further be fixed to the base end of the outer shaft.
According to this configuration, by rotating the control unit fixed to the proximal end of the outer shaft, the outer shaft can be rotated by the rotation applied to the control unit, and the first, second, and third inner shafts fixed to the outer shaft can also be rotated. This makes it easy to rotate the catheter to adjust its circumferential position within a blood vessel, improving usability.

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

FIG. 1 is an explanatory diagram illustrating a configuration of a light irradiation system. FIG. 1 is an enlarged cross-sectional view of a portion of the distal end of the catheter. 3 is an explanatory diagram illustrating a cross-sectional configuration taken along line AA in FIG. 2. FIG. 3 is an explanatory diagram illustrating the configuration of a catheter as viewed from direction B in FIG. 2 . FIG. 10 is a diagram showing an example of a procedure using the light irradiation system. 10A and 10B are diagrams illustrating another example of a procedure using the light irradiation system. FIG. 10 is an explanatory diagram illustrating the configuration of the distal end side of a catheter according to a second embodiment. FIG. 8 is an explanatory diagram illustrating a cross-sectional configuration taken along line CC in FIG. 7. 10A and 10B are diagrams illustrating an example of a procedure using the light irradiation system according to the second embodiment. FIG. 10 is an explanatory diagram illustrating the configuration of the distal end side of a catheter according to a third embodiment. FIG. 10 is an explanatory diagram illustrating the configuration of the distal end side of a catheter according to a fourth embodiment. FIG. 12 is an explanatory diagram illustrating a cross-sectional configuration taken along line DD in FIG. 11. FIG. 10 is an enlarged cross-sectional view of a portion of the distal end side of the catheter of the fifth embodiment. FIG. 13 is an enlarged cross-sectional view of a portion of the distal end side of the catheter of the sixth embodiment. FIG. 13 is an enlarged cross-sectional view of a portion of the distal end side of the catheter of the seventh embodiment. FIG. 13 is an enlarged cross-sectional view of a portion of the distal end side of the catheter of the eighth embodiment. FIG. 13 is an explanatory diagram illustrating the configuration of a light irradiation system according to a ninth embodiment. FIG. 23 is an explanatory diagram illustrating the configuration of a light irradiation system according to a tenth embodiment. FIG. 23 is an explanatory diagram illustrating the configuration of the tip side of a catheter according to an eleventh embodiment. FIG. 23 is an explanatory diagram illustrating the configuration of the tip side of a catheter according to a twelfth embodiment. FIG. 23 is an explanatory diagram illustrating the cross-sectional configuration of a catheter according to a thirteenth embodiment. FIG. 23 is an explanatory diagram illustrating the configuration of the base end side of the catheter of the fourteenth embodiment. FIG. 23 is an explanatory diagram illustrating the configuration of the base end side of a catheter according to a fifteenth embodiment. 24 is an explanatory diagram illustrating a cross-sectional configuration taken along line H1-H1 in FIG. 23. 24 is an explanatory diagram illustrating a cross-sectional configuration taken along line H2-H2 in FIG. 23.

First Embodiment
FIG. 1 is an explanatory diagram illustrating an example of the configuration of a light irradiation system. The light irradiation system is inserted into a biological lumen, such as the vascular system, lymphatic system, biliary system, urinary system, respiratory system, digestive system, secretory glands, and reproductive organs, and irradiates light from within the biological lumen toward biological tissue. The light irradiation system can be used, for example, in PDT (Photodynamic Therapy) and NIR-PIT (Near-Infrared Photoimmunotherapy). In the following embodiment, laser light is used as an example of light, but the light irradiation system may also be configured using other light sources, such as LED light or white light. The light irradiation system includes a catheter 1 and a light irradiation device 2 that is inserted into the catheter 1 for use. In FIG. 1, the catheter 1 and the light irradiation device 2 are illustrated separately. Note that an example of the cross-sectional configuration of an optical fiber 210 is shown in a speech bubble in the upper part of FIG. 1.

In Figure 1, the axis passing through the center of the catheter 1 is represented by axis O (dotted line). For ease of explanation, Figure 1 includes portions in which the relative size ratios of the various components are depicted differently from the actual size. Also, some of the various components are depicted in an exaggerated manner. Figure 1 also illustrates mutually orthogonal X, Y, and Z axes. The X axis corresponds to the 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 of Figure 1 (-X axis direction) is referred to as the "distal side" of the catheter 1, the light irradiation device 2, and each of the various components, and the right side of Figure 1 (+X axis direction) is referred to as the "proximal side" of the catheter 1, the light irradiation device 2, and each of the various components. Furthermore, of the two ends of the catheter 1, the light irradiation device 2, and each of the various components in the longitudinal direction (X axis direction), the one end located on the distal side is referred to as the "distal end," and the other end located on the proximal side is referred to as the "proximal end." Additionally, the tip and its vicinity are referred to as the "tip portion," and the base end and its vicinity are referred to as the "base end portion." The tip side is inserted into the living body, and the base end side is operated by a surgeon such as a doctor. These points are also common to Figure 1 and subsequent figures.

The catheter 1 comprises an elongated shaft 10, a distal tip 71 provided at the distal end of the shaft 10, and a connector 90 provided at the proximal end of the shaft 10. In Figure 1, the first lumen 20L, second lumen 30L, and third lumen 40L formed in the shaft 10 are indicated by dashed lines.

Figure 2 is an enlarged cross-sectional view of a portion of the distal end of catheter 1. Figure 3 is an explanatory diagram illustrating the cross-sectional configuration along line A-A in Figure 2. Figure 4 is an explanatory diagram illustrating the configuration of catheter 1 as viewed from direction B in Figure 2. Note that the balloon in the upper part of Figure 4 shows an explanatory diagram of the openings of catheter 1. The lower part of Figure 4 shows the configuration of catheter 1, and also shows the distal third opening 41, which is not normally visible from the +Y axis direction, in dashed lines. The configuration of catheter 1 will be explained below using Figures 1 to 4.

As shown in Figures 2 and 3, the shaft 10 of the catheter 1 includes an outer shaft 11, a sealing member 12, a first inner shaft 23, a second inner shaft 33, a third inner shaft 43, a stopper member 39, a first marker portion 72, and a second marker portion 73.

The outer shaft 11, the first inner shaft 23, the second inner shaft 33, and the third inner shaft 43 are all hollow and elongated, and have a substantially circular cross section. The first inner shaft 23, the second inner shaft 33, and the third inner shaft 43 are each inserted into the lumen of the outer shaft 11 and extend substantially parallel to one another along the longitudinal direction (X-axis direction) of the catheter 1. In the cross section shown in FIG. 3, the first inner shaft 23 is disposed in the center of the lumen of the outer shaft 11. In this embodiment, "center" includes the meaning of the center and the vicinity of the center. In addition, in the cross section shown in FIG. 3, the second inner shaft 33 and the third inner shaft 43 are disposed on opposite sides of the first inner shaft 23 in the lumen of the outer shaft 11. In the example shown in FIG. 3, the second inner shaft 33 is disposed in the +Y-axis direction relative to the first inner shaft 23, and the third inner shaft 43 is disposed in the -Y-axis direction relative to the first inner shaft 23.

As shown in FIG. 1, the first inner shaft 23 extends linearly from its tip to its base end. The tip of the first inner shaft 23 is connected to the outside via a tip first opening 21 formed on the tip surface of the shaft 10. The base end of the first inner shaft 23 is connected to the outside via a base first opening 22 formed in the first branch (branch extending in the +X-axis direction) of the connector 90. The second inner shaft 33 has a portion on its tip side and a portion on its base side curved in the +Y-axis direction. The tip of the second inner shaft 33 is connected to the outside via a tip second opening 31 formed on the side surface of the shaft 10 in the +Y-axis direction. The base end of the second inner shaft 33 is connected to the outside via a base second opening 32 formed in the second branch (branch extending in the +Y-axis direction) of the connector 90. The third inner shaft 43 has a portion on its tip side and a portion on its base side curved in the -Y-axis direction. The tip of the third inner shaft 43 communicates with the outside via a tip third opening 41 formed on the side surface of the shaft 10 in the -Y axis direction. The base end of the third inner shaft 43 communicates with the outside via a base third opening 42 formed in the third branch (the branch in the -Y axis direction) of the connector 90.

The sealing member 12 seals (fixes) the first inner shaft 23, second inner shaft 33, and third inner shaft 43 within the outer shaft 11. The sealing member 12 is positioned inside the outer shaft 11 and outside the first inner shaft 23, second inner shaft 33, and third inner shaft 43.

The first lumen 20L formed inside the first inner shaft 23 functions as a "guidewire lumen" through which a delivery guidewire is inserted into the catheter 1. The second lumen 30L formed inside the second inner shaft 33 functions as a "device lumen" through which the light irradiation device 2 shown in FIG. 1 is inserted into the catheter 1. The third lumen 40L formed inside the third inner shaft 43 functions as a "backup lumen" through which a backup device is inserted into the catheter 1. Here, the backup device refers to a device that applies backup force to the catheter 1, and may be, for example, a guidewire or catheter.

That is, in the catheter 1 of this embodiment, the shaft 10 is provided with a first lumen 20L, a second lumen 30L, and a third lumen 40L arranged side by side ( FIG. 2 ). In the cross-section of the shaft 10 shown in FIG. 3 , the first lumen 20L is arranged at the center of the shaft 10. In the cross-section of the shaft 10 shown in FIG. 3 , the second lumen 30L and the third lumen 40L are arranged on opposite sides of the first lumen 20L. In addition, a first distal end opening 21 communicating with the first lumen 20L is formed at the distal end of the shaft 10. Furthermore, a second distal end opening 31 communicating with the second lumen 30L and a third distal end opening 41 communicating with the third lumen 40L are formed on the side surface of the shaft 10 ( FIG. 2 ). The tip first opening 21 corresponds to the "first opening," the tip second opening 31 corresponds to the "second opening," and the tip third opening 41 corresponds to the "third opening."

As shown in FIG. 2 , a portion of the second inner shaft 33 on the distal side is curved and fixed, so that the distal end of the second lumen 30L is curved in the +Y-axis direction toward the distal second opening 31. Hereinafter, the curved portion of the second lumen 30L will also be referred to as the "first curved portion 35." In a longitudinal cross section of the shaft 10 including the first curved portion 35 (i.e., the cross section shown in FIG. 2 ), the acute angle θ1 formed between the central axis O1 of the second lumen 30L on the proximal side of the first curved portion 35 and the central axis O3 of the first curved portion 35 may be 30 degrees or greater and 70 degrees or less. Furthermore, a portion of the third inner shaft 43 on the distal side is curved and fixed, so that the distal end of the third lumen 40L is curved in the -Y-axis direction toward the distal third opening 41. Hereinafter, the curved portion of the third lumen 40L will also be referred to as the "second curved portion 45." 2, a central axis O4 of the second curved portion 45 is illustrated in a vertical cross section (cross section shown in FIG. 2) of the shaft 10 including the second curved portion 45.

As shown in Figure 3, the relationship between the inner diameter Φ20 of the first lumen 20L, the inner diameter Φ30 of the second lumen 30L, and the inner diameter Φ40 of the third lumen 40L is inner diameter Φ20 < inner diameter Φ30 = inner diameter Φ40. Note that this relationship can be determined arbitrarily based on the outer diameter of the light irradiation device 2 that can be used in the catheter 1; for example, inner diameter Φ20 < inner diameter Φ40 < inner diameter Φ30.

As shown in the lower part of Figure 4, in the longitudinal direction (X-axis direction) of the catheter 1, the distal third opening 41 connected to the third lumen 40L is located near the distal second opening 31 connected to the second lumen 30L. In the illustrated example, the distal third opening 41 is located closer to the base end (+X-axis direction) than the distal second opening 31. Here, the length L1 between the center point O3 of the distal second opening 31 (in other words, the point where the central axis O3 of the first curved portion 35 shown in Figure 2 intersects with the outer surface of the shaft 10) and the center point O4 of the distal third opening 41 (in other words, the point where the central axis O4 of the second curved portion 45 shown in Figure 2 intersects with the outer surface of the shaft 10) may be approximately 2 to 5 times the inner diameter of the blood vessel into which the catheter 1 is inserted. For example, if the inner diameter of the blood vessel into which the catheter 1 is inserted is 2 to 4 mm, the length L1 between the center point O3 of the distal end second opening 31 and the center point O4 of the distal end third opening 41 may be 10 mm.

The upper bubble in Figure 4 shows a schematic diagram illustrating the relationship between the shaft 10, the distal end second opening 31, and the distal end third opening 41 as viewed from the longitudinal direction (X-axis direction) of the catheter 1. As shown, a first line segment LS1 (upper dashed line in Figure 4) is defined connecting the center O of the shaft 10 and the center point O3 of the distal end second opening 31. Similarly, a second line segment LS2 is defined connecting the center O of the shaft 10 and the center point O4 of the distal end third opening 41 (upper dashed line in Figure 4). The distal end second opening 31 and the distal end third opening 41 are positioned such that the angle between the first line segment LS1 and the second line segment LS2 is approximately 180 degrees. In other words, the distal end second opening 31 and the distal end third opening 41 are positioned 180 degrees apart circumferentially around the shaft 10. Here, "180 degrees" means that approximately 180 degrees is sufficient, and does not necessarily mean that it is exactly 180 degrees, but rather that deviations due to manufacturing errors, etc. are allowed for.

As shown in the lower part of Figure 4, the opening area of the distal end second opening 31 may be larger than the area of the second lumen 30L in the cross section of the shaft 10 (Figure 3). Similarly, the opening area of the distal end third opening 41 may be larger than the area of the third lumen 40L in the cross section of the shaft 10 (Figure 3). Specifically, in this embodiment, the distal end second opening 31 has an elliptical shape formed by diagonally cutting the second inner shaft 33. Similarly, the distal end third opening 41 has an elliptical shape formed by diagonally cutting the third inner shaft 43.

The stopper member 39 is a member for preventing the light irradiation device 2 inserted into the second lumen 30L from protruding outward from the distal second opening 31 by blocking at least a portion of the distal second opening 31 of the shaft 10. As shown in FIG. 4 , the stopper member 39 of this embodiment has an elliptical shape that conforms to the periphery of the distal second opening 31. As shown in FIG. 2 , the inner surface 39i and the outer surface 39o each have a convex shape that curves toward the outside of the catheter 1. The edge of the stopper member 39 is fixed along the periphery of the distal second opening 31. For fixation, metallurgical joining such as fusion welding, pressure welding, or brazing, or adhesive joining using any adhesive, can be used. In this manner, the stopper member 39 of this embodiment completely blocks the distal second opening 31. The stopper member 39 may be provided with a fluid flow path (a saline discharge flow path) that enables a flushing operation within the second lumen 30L. The fluid flow path of the stopper member 39 can be, for example, a through hole that communicates between the inner surface 39i and the outer surface 39o. The shape of the through hole and the position where the through hole is provided may be determined arbitrarily.

The stopper member 39 has optical transparency, which allows light to pass through, and optical diffusion, which diffuses light. Such a stopper member 39 can be formed, for example, from a resin that is optically transparent and optically diffusive (e.g., polycarbonate, polypropylene, etc.). The stopper member 39 may also be formed by covering a body made of optically transparent resin (e.g., acrylic resin, polyethylene terephthalate, polyvinyl chloride, etc.) with a film that has optical diffusion properties.

The distal tip 71 is joined to the distal end of the shaft 10 and advances through the blood vessel before other components. The distal tip 71 is made of a radiopaque material and functions as a marker indicating the distal end of the catheter 1. As shown in Figure 2, the distal tip 71 has an outer shape that tapers in diameter from the base end to the distal end. A through-hole is formed in the approximate center of the distal tip 71, penetrating the distal tip 71 in the longitudinal direction (X-axis direction) of the catheter 1. The first inner shaft 23 is inserted and fixed inside the through-hole of the distal tip 71. The outer diameter and length of the distal tip 71 can be determined as desired.

The first marker portion 72 is formed from a radiopaque material and functions as a marker indicating the position of the distal second opening 31, through which light is irradiated, in the longitudinal direction (X-axis direction) of the catheter 1. As shown in Figures 1, 2, and 4, the first marker portion 72 is an annular member. The first marker portion 72 is positioned distal to the distal second opening 31, in the vicinity of the distal second opening 31 (in the illustrated example, at a position adjacent to the first marker portion 72). The first marker portion 72 is bonded to the outer surface of the outer shaft 11. Any bonding agent, such as an epoxy adhesive, can be used for bonding.

The second marker portion 73 is formed from a radiopaque material and functions as a mark indicating the circumferential position (YZ axis direction) of the shaft 10 with respect to the distal second opening 31, to which light is irradiated. As shown in FIG. 4, the second marker portion 73 is a disk-shaped member with a hole in its center. The second marker portion 73 is positioned to surround the distal second opening 31, with the central hole aligned with the distal second opening 31. The second marker portion 73 is bonded to the outer surface of the outer shaft 11. Any bonding agent, such as an epoxy adhesive, can be used for bonding. With this configuration, as shown in FIG. 1, the second marker portion 73 allows the surgeon to recognize the circumferential position of the distal second opening 31 based on the shape of the second marker portion 73 when viewed from any direction.

Returning to Figure 1, the explanation will continue. The connector 90 is located at the base end of the shaft 10 and is a component grasped by the surgeon. The connector 90 has a three-pronged branch 91 and wing portions 92 protruding along the Y-axis. The base end of the shaft 10 is inserted into and joined to the tip of the branch 91. The branch 91 has a first branch extending in the +X-axis direction in Figure 1, a second branch extending in the +Y-direction, and a third branch extending in the -Y-direction. A first inner shaft 23 is inserted into the first branch, forming the first lumen 20L. A second inner shaft 33 is inserted into the second branch, forming the second lumen 30L. A third inner shaft 43 is inserted into the third branch, forming the third lumen 40L.

The outer shaft 11, sealing member 12, first inner shaft 23, and third inner shaft 43 are preferably antithrombogenic, flexible, and biocompatible, and can be formed from a resin or metal material. Examples of resin materials that can be used include polyamide resin, polyolefin resin, polyester resin, polyurethane resin, silicone resin, and fluororesin. Examples of metal materials that can be used include stainless steel such as SUS304, nickel-titanium alloy, cobalt-chromium alloy, and tungsten steel. Other well-known materials may also be used, and a joined structure combining multiple materials may also be used. The longitudinal length, outer diameter, and inner diameter of each of the outer shaft 11, first inner shaft 23, second inner shaft 33, and third inner shaft 43 may be determined as desired.

The distal tip 71, first marker portion 72, and second marker portion 73 can be formed from a radiopaque resin or metal material. For example, when using a resin material, they 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 using a metal material, they can be formed from radiopaque materials such as gold, platinum, or tungsten, or alloys containing these elements (e.g., platinum-nickel alloys). Other well-known materials may also be used, or a joint structure combining multiple materials may be used. The connector 90 can be formed from a well-known resin material such as polyamide, polypropylene, polycarbonate, polyacetal, or polyethersulfone. The longitudinal length, outer diameter, and inner diameter of each of the distal tip 71, first marker portion 72, and second marker portion 73 may be determined as desired.

The light irradiation device 2 (Figure 1) is elongated and includes an optical fiber 210, a light diffusion member 220, and a connector 290.

The optical fiber 210 transmits light from the light source 9. The optical fiber 210 is an elongated member extending along the longitudinal direction (X-axis direction) of the light irradiation device 2. As shown in the bubble in the upper part of FIG. 1 , the optical fiber 210 includes a core 210c extending in the longitudinal direction of the light irradiation device 2 and a clad 210cl covering the outer peripheral surface of the core 210c. The core 210c is disposed at the center of the clad 210cl and has a higher optical refractive index than the clad 210cl. The clad 210cl has a uniform refractive index. The optical fiber 210 transmits light by total reflection, utilizing the difference in refractive index between the core 210c and the clad 210cl. The optical fiber 210 is a plastic optical fiber in which both the core 210c and the clad 210cl are made of resin. The core 210c can be made of, for example, polymethylmethacrylate (PMMA), polystyrene, polycarbonate, deuterated polymer, fluorine-based polymer, silicon-based polymer, norbornene-based polymer, etc. The clad 210cl can be made of, for example, a fluorine-based polymer. Instead of a plastic optical fiber, a silica glass optical fiber or a multi-component glass optical fiber may be used for the optical fiber 210. The longitudinal length of the optical fiber 210 can be determined arbitrarily.

The base end of the optical fiber 210 is connected directly to the light source 9 via a connector (not shown), or indirectly via another optical fiber. The light source 9 may be, for example, a laser light generator that generates laser light of any wavelength. At the tip of the optical fiber 210, a light diffusing member 220 is fixed to the exposed core 210c. A reinforcing member may be attached to the optical fiber 210 to maintain its elongated shape extending along the X-axis. For example, the optical fiber 210 may be housed inside a hollow shaft that serves as a reinforcing member. For example, a core shaft that serves as a reinforcing member may be fixed to the optical fiber 210.

The light diffusion member 220 diffuses and irradiates the light transmitted by the optical fiber 210 toward the tip of the light irradiation device 2 (Figure 1: light LT). The light diffusion member 220 has optical transparency, which allows light to pass through, and optical diffusion, which allows light to diffuse. The light diffusion member 220 has a cylindrical shape and is formed, for example, from a resin that has optical transparency and optical diffusion properties (e.g., polycarbonate, polypropylene, etc.). The light diffusion member 220 may also be formed by curing an acrylic ultraviolet-curing resin with dispersed quartz powder using ultraviolet light. In this embodiment, the light diffusion member 220 functions as a "light irradiation unit."

The connector 290 is disposed at the base end of the optical fiber 210 and is a member that is held by the surgeon. The connector 290 has a hollow main body through which the optical fiber 210 is inserted and blades that protrude along the Y-axis. The connector 290 can be formed from any resin material. The light irradiation device 2 may also be provided with a marker that functions as a mark indicating the position of the light diffusion member 220. This marker can be formed from a radiopaque resin material or metal material, and is preferably provided near the light diffusion member 220 (for example, the tip end of the light diffusion member 220, the base end of the light diffusion member 220, the boundary between the light diffusion member 220 and the optical fiber 210, etc.).

Figure 5 is a diagram showing an example of a procedure using a light irradiation system. Figure 5 shows a target blood vessel 101, biological tissue 102, and target tissue 103. Target tissue 103 is tissue with a problem such as cancer, cerebral aneurysm, or arrhythmia, and is the tissue that is the target of treatment using the light irradiation system. Target blood vessel 101 is a blood vessel that is located in a position and has a diameter suitable for irradiating target tissue 103 with light. Biological tissue 102 is normal tissue located near target blood vessel 101 and target tissue 103.

Procedures using the light irradiation system are illustrated in a1 to a6.
(a1) The surgeon delivers the delivery guide wire 3 to the target blood vessel 101.
(a2) The surgeon inserts the base end side of the guide wire 3 into the first lumen 20L from the distal first opening 21 of the catheter 1, and then pushes the catheter 1 along the guide wire 3 to deliver the distal second opening 31 (and the stopper member 39) of the catheter 1 to the vicinity of the target tissue 103. At this time, the surgeon can grasp the longitudinal position of the catheter 1 in the living body using the distal tip 71 and the first marker portion 72 on the X-ray image.
(a3) The surgeon rotates the catheter 1 in the circumferential direction to orient the distal end second opening 31 (and the stopper member 39) toward the target tissue 103. At this time, the surgeon can grasp the circumferential orientation of the catheter 1 in the living body using the second marker portion 73 on the X-ray image.
(a4) The surgeon inserts the guide wire 4 used as a backup device into the third lumen 40L from the third opening 42 at the proximal end of the catheter 1. Note that the guide wire 4 for the backup device has higher rigidity than the guide wire 3 for delivery.
(a5) The surgeon pushes the guide wire 4 toward the distal end, causing it to protrude from the distal third opening 41 to the outside, and positions the guide wire 4 inside the target blood vessel 101 in contact with the inner wall of the target blood vessel 101. As a result, as shown in Figure 5, the distal end of the catheter 1 is raised in the direction opposite to the distal third opening 41 (in other words, in the direction toward the distal second opening 31, the direction indicated by the white arrow in Figure 5).
(a6) The surgeon inserts the light irradiation device 2 into the second lumen 30L from the proximal second opening 32 of the catheter 1 and delivers the light irradiation device 2 so that the light diffusion member 220 of the light irradiation device 2 is positioned near the distal second opening 31 (and the stopper member 39). As a result, the laser light LT transmitted through the optical fiber 210 and emitted from the light diffusion member 220 is diffused by the stopper member 39 of the catheter 1 and irradiated to the external target tissue 103 ( FIG. 5 ). In other words, the laser light LT irradiated from the light diffusion member 220 is irradiated to the outside of the catheter 1 via the distal second opening 31 of the catheter 1.

Figure 6 is a diagram showing another example of a procedure using a light irradiation system. The surgeon may adopt the following steps b4 to b7 instead of steps a4 to a6 described in Figure 5. According to this example, a highly rigid guidewire 6 is placed in the target blood vessel 101 while covered with a flexible microcatheter 5, which can improve safety compared to the method described in Figure 5.
(b4) The surgeon inserts a guide wire (not shown) that is more flexible than the guide wire 4 described in Figure 5 from the base end third opening 42 of the catheter 1 into the third lumen 40L, pushes the guide wire toward the tip side, and protrudes it to the outside from the tip end third opening 41.
(b5) After inserting the base end of the guidewire into the lumen of the microcatheter 5, the surgeon pushes the microcatheter 5 toward the tip along the guidewire, causing it to protrude to the outside from the third tip opening 41 and position itself inside the target blood vessel 101. The microcatheter 5 is made of a flexible material.
(b6) The surgeon removes the guidewire from the microcatheter 5, inserts a guidewire 6 having higher rigidity than the guidewires used in steps b4 and b5 into the microcatheter 5, and pushes the guidewire 6 toward the distal end along the microcatheter 5 until it is positioned outside the distal second opening 31 without protruding from the microcatheter 5. Then, the microcatheter 5 including the highly rigid guidewire 6 is placed inside the target blood vessel 101 in contact with the inner wall of the target blood vessel 101. As a result, as shown in Figure 6, the distal end of the catheter 1 is raised in the direction opposite to the distal third opening 41 (in other words, toward the distal second opening 31, the direction indicated by the white arrow in Figure 6).
(b7) The operator inserts the light irradiation device 2 into the second lumen 30L from the proximal second opening 32 of the catheter 1, and delivers the light irradiation device 2 so that the light diffusion member 220 of the light irradiation device 2 is located near the distal second opening 31 (and the stopper member 39). As a result, the laser light LT transmitted through the optical fiber 210 and emitted from the light diffusion member 220 is diffused by the stopper member 39 of the catheter 1 and is irradiated onto the external target tissue 103 ( FIG. 6 ).

As described above, according to the light irradiation systems 1 and 2 of the first embodiment, a distal first opening 21 (first opening) communicating with the first lumen 20L is formed at the distal end of the shaft 10 of the catheter 1, and a distal second opening 31 (second opening) communicating with the second lumen 30L into which the light irradiation device 2 is inserted is formed on the side of the shaft 10, closer to the base end than the distal first opening 21. Therefore, by inserting a guidewire 3 into the first lumen 20L and placing the catheter 1 in the target blood vessel 101 with the distal end of the guidewire 3 protruding from the distal first opening 21, the guidewire 3 can provide backup force to the catheter 1 (FIGS. 5 and 6). As a result, during step a6 of delivering the distal end portion (light diffusing member 220 functioning as a light irradiator) of the light irradiation device 2 inserted into the second lumen 30L to the vicinity of the distal end second opening 31, movement of the catheter 1 within the target blood vessel 101 can be suppressed. That is, deviation of the distal end second opening 31 of the catheter 1 from the pre-aligned position of the target tissue 103 can be suppressed, facilitating light irradiation of the target tissue 103. Furthermore, because the shaft 10 of the catheter 1 is elongated and includes the first lumen 20L and the second lumen 30L, the diameter of the device (catheter 1) can be reduced compared to configurations having as many as five lumens or configurations in which the shaft is spirally wound. Furthermore, because backup force is applied to the catheter 1 by the guidewire 3 in the first lumen 20L, blood flow is not blocked, as compared to when a balloon is used. As a result, the light irradiation system of the first embodiment, which irradiates light inside a living body, makes it easy to irradiate the target tissue 103 with light without blocking blood flow, and also makes it possible to reduce the diameter of the device (catheter 1).

Furthermore, according to the light irradiation system 1, 2 of the first embodiment, the shaft 10 of the catheter 1 includes a stopper member 39 that blocks at least a portion of the distal end second opening 31 (second opening), thereby preventing the light irradiation device 2 in the second lumen 30L from protruding outward from the distal end second opening 31 (FIGS. 5 and 6). This prevents the light irradiation device 2 from coming into contact with biological tissue, such as a blood vessel wall, thereby improving the safety of the light irradiation system. Furthermore, this prevents deviation in the light irradiation direction (i.e., the light LT is not irradiated in the intended direction due to a change in the orientation of the light diffusion member 220), which is a concern when the light irradiation device 2 protrudes outward, thereby further facilitating light irradiation of the target tissue 103. Furthermore, the stopper member 39 has light diffusive properties that diffuse light, thereby improving the accuracy of light irradiation of the target tissue 103. Furthermore, the stopper member 39 has a curved convex shape at least on the outer surface 39o, thereby further facilitating light diffusion.

Furthermore, according to the light irradiation system 1, 2 of the first embodiment, the shaft 10 of the catheter 1 has a third lumen 40L arranged alongside the first lumen 20L and the second lumen 30L, and a distal third opening 41 (third opening) communicating with the third lumen 40L is formed on the side of the shaft 10, closer to the base end than the distal first opening 21 (first opening). Therefore, the third lumen 40L can be used as a backup lumen through which a backup device 4, 5, 6 (e.g., a guidewire 4, 6 or a catheter 5) can be inserted to provide additional backup force to the catheter 1. Specifically, the guidewire 3 is inserted into the first lumen 20L so that the distal end of the guidewire 3 protrudes from the distal first opening 21, and the backup devices 4, 5, and 6 are inserted into the third lumen 40L so that the distal ends of the backup devices 4, 5, and 6 protrude from the distal third opening 41. With the sides of the backup devices 4, 5, and 6 in contact with the blood vessel wall, the catheter 1 is placed in the target blood vessel 101, whereby backup force can be applied to the catheter 1 by both the guidewire 3 and the backup devices 4, 5, and 6 ( FIGS. 5 and 6 ). As a result, during step a6 of delivering the distal end portion (light diffusing member 220 functioning as a light irradiation portion) of the light irradiation device 2 inserted into the second lumen 30L to the vicinity of the distal second opening 31, movement of the catheter 1 within the target blood vessel 101 can be further suppressed, making it easier to irradiate the target tissue 103 with light. The second lumen 30L, into which the light irradiation device 2 is inserted, and the third lumen 40L, into which the backup devices 4, 5, and 6 are inserted, are located on opposite sides of the first lumen 20L ( FIG. 3 ). Therefore, the backup devices 4, 5, and 6, which are in contact with the blood vessel wall, lift the catheter 1 toward the side where the second lumen 30L, into which the light irradiation device 2 is inserted, is located ( FIG. 5 and 6 : open arrow). As a result, light irradiation by the light irradiation device 2 can be performed from closer to the target tissue 103, improving treatment efficiency and preventing light irradiation of normal tissue (including blood) other than the target tissue 103. Furthermore, the first lumen 20L, which functions as a guidewire lumen, is located at the center of the shaft 10 in the cross section of the shaft 10, improving operability when delivering the catheter 1 to the target tissue ( FIG. 3 ).

Furthermore, according to the light irradiation systems 1 and 2 of the first embodiment, the distal second opening 31 (second opening) through which light from the light irradiation device 2 is irradiated and the distal third opening 41 (third opening) from which the backup devices 4, 5, and 6 protrude are positioned 180 degrees apart in the circumferential direction of the shaft 10 of the catheter 1 ( FIG. 4 ). Therefore, the backup devices 4, 5, and 6 in contact with the blood vessel wall lift the catheter 1 toward the distal second opening 31 through which light is irradiated ( FIGs. 5 and 6 : open arrows), allowing the distal second opening 31 to be brought even closer to the blood vessel wall on the opposite side from the side in contact with the backup devices 4, 5, and 6. As a result, light irradiation by the light irradiation device 2 can be performed from closer to the target tissue 103, improving treatment efficiency and preventing light irradiation of normal tissue other than the target tissue 103.

Furthermore, according to the light irradiation systems 1 and 2 of the first embodiment, the shaft 10 of the catheter 1 further includes a radiopaque annular first marker portion 72 provided near the distal end second opening 31 (second opening), as shown in Fig. 4. Therefore, in step a2 described in Figs. 5 and 6, the surgeon can accurately irradiate the light LT irradiated from the distal end second opening 31 toward the target tissue 103 by adjusting the front-to-rear position of the catheter 1 so that the first marker portion 72 is located near the target tissue.

Furthermore, according to the light irradiation system 1, 2 of the first embodiment, as shown in FIG. 4, the shaft 10 of the catheter 1 further includes a radiopaque second marker portion 73 provided near the distal end second opening 31 (second opening), which allows the position of the distal end second opening 31 in the circumferential direction to be recognized based on the shape of the second marker portion 73 when viewed from any direction. Therefore, in step a3 described in FIGS. 5 and 6, the surgeon can adjust the circumferential position of the catheter 1 (rotate the catheter 1) so that the second marker portion 73 is positioned on the side of the blood vessel wall facing the target tissue 103, thereby enabling the light LT emitted from the distal end second opening 31 to be accurately directed toward the target tissue 103.

Second Embodiment
FIG. 7 is an explanatory diagram illustrating the configuration of the distal end side of a catheter 1A of a second embodiment. FIG. 7 shows the configuration of the catheter 1A as viewed from the +Y-axis direction, and indicates with dashed lines the distal end third opening 41 and the distal end fourth opening 51, which are not normally visible from the +Y-axis direction. FIG. 8 is an explanatory diagram illustrating the cross-sectional configuration taken along line CC in FIG. 7. The light irradiation system of the second embodiment includes the catheter 1A shown in FIGS. 7 and 8 instead of the catheter 1 described in FIG. 1. In the second embodiment, a configuration will be described in which the catheter 1A has two backup lumens. The catheter 1A of the second embodiment includes a shaft 10A instead of the shaft 10 in the configuration described in the first embodiment.

As shown in FIG. 8, the shaft 10A further includes a fourth inner shaft 53. The fourth inner shaft 53 is hollow and elongated, with a substantially circular cross section. Like the other inner shafts, the fourth inner shaft 53 is inserted into the lumen of the outer shaft 11 and extends substantially parallel to each other along the longitudinal direction (X-axis direction) of the outer shaft 11. In the cross section shown in FIG. 8, the third inner shaft 43 and the fourth inner shaft 53 are disposed within the lumen of the outer shaft 11, on the opposite side of the second inner shaft 33 from the first inner shaft 23. The fourth inner shaft 53 has a shorter longitudinal length than the third inner shaft 43, and both a portion on the distal end side and a portion on the proximal end side are curved in the -Y-axis direction. As shown in FIG. 7, the distal end of the fourth inner shaft 53 is connected to the outside via a distal fourth opening 51 formed on the side surface of the shaft 10A in the -Y-axis direction. The base end of the fourth inner shaft 53 communicates with the outside via a fourth base end opening formed in a fourth branch (not shown) of the connector 90. The fourth inner shaft 53 can be made of, for example, the same material as the third inner shaft 43. The material of the fourth inner shaft 53 and the material of the third inner shaft 43 may be the same or different.

The fourth lumen 50L formed inside the fourth inner shaft 53 functions as a "second backup lumen" through which a backup device is inserted into the catheter 1A. That is, in the catheter 1A of the second embodiment, the shaft 10A includes the fourth lumen 50L arranged alongside the first to third lumens 20L, 30L, and 40L. As shown in FIG. 8 , the fourth lumen 50L is arranged on the same side as the third lumen 40L in a cross section of the shaft 10A. The inner diameter Φ50 of the fourth lumen 50L may be the same as or different from the inner diameter Φ40 of the third lumen 40L. Also, as shown in FIG. 7 , a distal fourth opening 51 communicating with the fourth lumen 50L is formed on the side of the shaft 10A, closer to the base end than the distal third opening 41. In the longitudinal direction (X-axis direction) of the shaft 10A, the distal fourth opening 51 is arranged at a different position from the distal third opening 41. The length L2 in the longitudinal direction between the center O4 of the tip third opening 41 and the center O5 of the tip fourth opening 51 may be determined arbitrarily. Furthermore, in the circumferential direction (YZ axis direction) of the shaft 10A, the tip fourth opening 51 is disposed at the same position as the tip third opening 41. Here, "the same position" means approximately the same position, and allows for differences due to manufacturing errors, etc. In this embodiment, the tip fourth opening 51 corresponds to the "fourth opening."

9 is a diagram showing an example of a procedure using the light irradiation system of the second embodiment. The procedure using the light irradiation system of the second embodiment employs the following steps c4 to c7 instead of steps a4 to a6 described in the first embodiment.
(c4) The surgeon inserts the guide wire 4a used as a backup device into the third lumen 40L from the third opening 42 at the proximal end of the catheter 1A.
(c5) The surgeon inserts the guide wire 4b, which is used as a second backup device, from the fourth opening at the proximal end of the catheter 1A into the fourth lumen 50L. Note that the guide wires 4a and 4b have higher rigidity than the guide wire 3.
(c6) The surgeon pushes the guidewires 4a and 4b toward the distal end, causing them to protrude from the distal third opening 41 and the distal fourth opening 51, and positions the guidewires 4a and 4b inside the target blood vessel 101 in contact with the inner wall of the target blood vessel 101. As a result, as shown in Fig. 9, the distal end side of the catheter 1A is raised in the direction opposite the distal third opening 41 and the distal fourth opening 51 (in other words, toward the distal second opening 31). (c7) The surgeon inserts the light irradiation device 2 from the proximal second opening 32 of the catheter 1 into the second lumen 30L, and delivers the light irradiation device 2 so that the light diffusion member 220 of the light irradiation device 2 is located near the distal second opening 31 (and the stopper member 39). As a result, the laser light LT transmitted through the optical fiber 210 and emitted from the light diffusing member 220 is diffused by the stopper member 39 of the catheter 1 and irradiated onto the external target tissue 103 (FIG. 9).

As described above, the configuration of the catheter 1A can be modified in various ways, and it may be configured to allow multiple backup devices to be used in combination. The light irradiation system of the second embodiment, which includes the catheter 1A described above, can also achieve the same effects as the first embodiment. Furthermore, according to the catheter 1A of the second embodiment, the shaft 10A further has a fourth lumen 50L extending to the distal fourth opening 51 (fourth opening) on the side, allowing for the use of a second backup device 4b in addition to the backup device 4a inserted through the third lumen 40L. As a result, the guidewire 3 and the two backup devices 4a and 4b can provide a stronger backup force to the catheter 1A. Furthermore, the distal fourth opening 51 is positioned differently from the distal third opening 41 (third opening) in the longitudinal direction of the shaft 10A, but is positioned at the same position as the third opening in the circumferential direction of the shaft 10A. Therefore, as shown in FIG. 9 , the backup device 4a and the second backup device 4b can support the catheter 1A from different positions in the longitudinal direction.

Third Embodiment
Figure 10 is an explanatory diagram illustrating the configuration of the distal end side of a catheter 1B of a third embodiment. Figure 10 shows the configuration of the catheter 1B as viewed from the +Y-axis direction, and the distal end third opening 41B and the distal end fourth opening 51B, which are not normally visible from the +Y-axis direction, are indicated by dashed lines. The light irradiation system of the third embodiment includes the catheter 1B shown in Figure 10 instead of the catheter 1 described in Figure 1. In the third embodiment, the catheter 1B has two backup lumens, as in the second embodiment, but the positions of the distal end third opening 41B and the distal end fourth opening 51B are different from those in the second embodiment. The catheter 1B of the third embodiment includes a shaft 10B instead of the shaft 10A in the configuration described in the second embodiment.

The cross-sectional configuration of the shaft 10B taken along line CC (FIG. 10) is the same as that of the second embodiment described in FIG. 8. Meanwhile, as shown in FIG. 10, a distal fourth opening 51B is formed on the side of the shaft 10B alongside the distal third opening 41B, and communicates with the fourth lumen 50L. In the longitudinal direction (X-axis direction) of the shaft 10B, the distal fourth opening 51B is located at the same position as the distal third opening 41B. Here, "the same position" means approximately the same position, allowing for differences due to manufacturing errors, etc. Furthermore, in the circumferential direction (YZ-axis directions) of the shaft 10B, the distal fourth opening 51B is located at a different position from the distal third opening 41B. Note that in this embodiment, the distal fourth opening 51B corresponds to the "fourth opening." The procedure for the procedure using the light irradiation system of the third embodiment is the same as that of the second embodiment.

As such, the configuration of the catheter 1B can be modified in various ways, and it may be configured to allow the use of multiple backup devices in combination. The light irradiation system of the third embodiment, which includes the catheter 1B described above, can also achieve the same effects as the first embodiment. Furthermore, according to the catheter 1B of the third embodiment, the shaft 10B further has a fourth lumen 50L extending to the distal fourth opening 51B (fourth opening) on the side, allowing the use of a second backup device 4b in addition to the backup device 4a inserted through the third lumen 40L. As a result, the guidewire 3 and the two backup devices 4a and 4b can apply a stronger backup force to the catheter 1B. Furthermore, the distal fourth opening 51B is positioned in the same position as the distal third opening 41B (third opening) in the longitudinal direction of the shaft 10B, but is positioned in a different position from the distal third opening 41B in the circumferential direction of the shaft 10B. Therefore, the backup device 4a and the second backup device 4b can support the catheter 1B from different circumferential positions.

Fourth Embodiment
FIG. 11 is an explanatory diagram illustrating the configuration of the distal end side of a catheter 1C of a fourth embodiment. FIG. 11 shows the configuration of the catheter 1C as viewed from the +Y-axis direction, and indicates with dashed lines the distal end third opening 41C, the distal end fourth opening 51C, and the distal end fifth opening 61, which are not normally visible from the +Y-axis direction. FIG. 12 is an explanatory diagram illustrating the cross-sectional configuration taken along line D-D in FIG. 11. The light irradiation system of the fourth embodiment includes the catheter 1C shown in FIGS. 11 and 12 instead of the catheter 1 described in FIG. 1. In the fourth embodiment, a configuration will be described in which the catheter 1C has three backup lumens. The catheter 1C of the third embodiment includes a shaft 10C instead of the shaft 10 in the configuration described in the first embodiment.

As shown in FIG. 12 , the shaft 10C further includes a fourth inner shaft 53C and a fifth inner shaft 63. The fourth inner shaft 53C and the fifth inner shaft 63 are each hollow and elongated, with a substantially circular cross section. Like the other inner shafts, the fourth inner shaft 53C and the fifth inner shaft 63 are inserted into the lumen of the outer shaft 11 and extend substantially parallel to each other along the longitudinal direction (X-axis direction) of the outer shaft 11. In the cross section shown in FIG. 12 , the third inner shaft 43C, the fourth inner shaft 53C, and the fifth inner shaft 63 are disposed on the opposite side of the first inner shaft 23 from the second inner shaft 33 within the lumen of the outer shaft 11. The fourth inner shaft 53C has a shorter longitudinal length than the third inner shaft 43C and the fifth inner shaft 63. A distal portion and a proximal portion of the fourth inner shaft 53C and the fifth inner shaft 63 are each curved in the −Y-axis direction. The tip of the fourth inner shaft 53C communicates with the outside via a tip fourth opening 51C formed on the side surface of the shaft 10C. The base end of the fourth inner shaft 53C communicates with the outside via a base fourth opening formed in the fourth branch (not shown) of the connector 90. The tip of the fifth inner shaft 63 communicates with the outside via a tip fifth opening 61 formed on the side surface of the shaft 10C. The base end of the fifth inner shaft 63 communicates with the outside via a base fifth opening formed in the fifth branch (not shown) of the connector 90.

The fourth lumen 50L formed inside the fourth inner shaft 53C functions as a "second backup lumen" through which a backup device is inserted into the catheter 1C. The fifth lumen 60L formed inside the fifth inner shaft 63 functions as a "third backup lumen" through which a backup device is inserted into the catheter 1C. That is, in the catheter 1C of the fourth embodiment, the shaft 10C is provided with a fourth lumen 50L and a fifth lumen 60L arranged alongside the first to third lumens 20L, 30L, and 40L. As shown in FIG. 12, the fourth lumen 50L and the fifth lumen 60L are both arranged on the same side as the third lumen 40L in a cross section of the shaft 10C. As shown in FIG. 11, a fourth distal end opening 51C communicating with the fourth lumen 50L and a fifth distal end opening 61 communicating with the fifth lumen 60L are formed on the side surface of the shaft 10C. In the longitudinal direction (X-axis direction) of the shaft 10C, the distal third opening 41C and the distal fifth opening 61 are located in the same position, while the distal fourth opening 51C is located in a different position. Here, "same position" means approximately the same position, allowing for differences due to manufacturing errors, etc. Furthermore, in the circumferential direction (YZ-axis directions) of the shaft 10C, the distal third opening 41C, the distal fourth opening 51C, and the distal fifth opening 61 are all located in different positions. In the illustrated example, the distal fourth opening 51C is located closer to the base end (+X-axis direction) than the distal third opening 41C and the distal fifth opening 61.

As such, the configuration of the catheter 1C can be modified in various ways, and it may be configured to allow multiple backup devices to be used in combination. The example in Figure 11 illustrates a configuration in which three backup devices can be used in combination, but a sixth lumen and a seventh lumen may be provided, allowing four or more backup devices to be used in combination. The light irradiation system of the fourth embodiment, which includes the catheter 1C described above, can also achieve the same effects as the first, second, and third embodiments.

Fifth Embodiment
Figure 13 is an enlarged cross-sectional view of a portion of the distal end side of a catheter 1D of a fifth embodiment. The light irradiation system of the fifth embodiment includes the catheter 1D shown in Figure 13 instead of the catheter 1 described in Figure 1. The catheter 1D of the fifth embodiment includes a shaft 10D instead of the shaft 10 in the configuration described in the first embodiment. The shaft 10D has a stopper member 39D instead of the stopper member 39. The stopper member 39D has an outer surface 39o that has a convex shape that curves toward the outside of the catheter 1D, while the inner surface 39i is flat and not curved.

As such, the configuration of the stopper member 39D can be modified in various ways, and at least the inner surface 39i may be flat and not curved. Alternatively, both the inner surface 39i and the outer surface 39o may be flat. The light irradiation system of the fifth embodiment, which includes the catheter 1D described above, can also achieve the same effects as the first embodiment.

Sixth Embodiment
Figure 14 is an enlarged cross-sectional view of a portion of the distal end side of a catheter 1E of a sixth embodiment. The configuration of the catheter 1E as viewed from direction E in Figure 14 is shown in a balloon in the upper part of Figure 14. The lower part of Figure 14 shows an enlarged cross-sectional view of a portion of the distal end side of the catheter 1E. The light irradiation system of the sixth embodiment includes the catheter 1E shown in Figure 14 instead of the catheter 1 described in Figure 1. The catheter 1E of the sixth embodiment includes a shaft 10E instead of the shaft 10 in the configuration described in the first embodiment. The shaft 10E has a stopper member 39E instead of the stopper member 39.

In addition to the function described in the first embodiment (i.e., the function of preventing the light irradiation device 2 from protruding outward from the distal second opening 31), the stopper member 39E also functions as a check valve to prevent blood flowing through the target blood vessel 101 from entering the second lumen 30L and to enable flushing of the second lumen 30L. As shown in the upper part of FIG. 14 , the stopper member 39E has an elliptical shape that conforms to the periphery of the distal second opening 31. As shown in the lower part of FIG. 14 , the inner surface 39i and the outer surface 39o of the stopper member 39E are each flat. The stopper member 39E is an elastic body (e.g., rubber, elastomer) having a predetermined thickness. The edge of the stopper member 39E is fixed along the periphery of the distal second opening 31. Fixation can be achieved by metallurgical joining such as fusion welding, pressure welding, or brazing, or by adhesive joining using any adhesive. In this way, the stopper member 39E of this embodiment completely blocks the distal end second opening 31. Furthermore, as shown in the upper part of Figure 4, the stopper member 39E has a slit 391 that connects the inner surface 39i and the outer surface 39o. In the illustrated example, the slit 391 is cross-shaped. The size and shape of the slit 391 and the thickness of the stopper member 39E (specifically, the length from the inner surface 39i to the outer surface 39o in the longitudinal cross section in the lower part of Figure 14) are adjusted to allow fluid with a flow rate faster than that of blood to pass through.

In this way, the configuration of the stopper member 39E can be modified in various ways, and it may also function as a check valve to enable flushing of the second lumen 30L. In the example of Figure 14, the slit 391 is cross-shaped, but the shape of the slit 391 may be modified as desired.

The light irradiation system of the sixth embodiment, which includes the catheter 1E described above, can also achieve the same effects as the first embodiment. Furthermore, according to the catheter 1E of the sixth embodiment, the stopper member 39E is formed of an elastic body and completely blocks the distal second opening 31 (second opening). The stopper member 39E is provided with a slit 391 that allows fluid to pass at a flow rate faster than blood flow. Therefore, even when the catheter 1E is inserted into the target blood vessel 101, the stopper member 39E can prevent blood from entering the second lumen 30L. Furthermore, because the stopper member 39E is provided with a slit 391 that allows fluid to pass at a flow rate faster than blood flow, when a flushing operation is performed to fill the second lumen 30L with saline, the supplied saline can be discharged to the outside through the slit 391 of the stopper member 39E.

Seventh Embodiment
Figure 15 is an enlarged cross-sectional view of a portion of the distal end of a catheter 1F of a seventh embodiment. The configuration of the catheter 1F as viewed from the direction F in Figure 15 is shown in a balloon in the upper part of Figure 15. The lower part of Figure 15 shows an enlarged cross-sectional view of a portion of the distal end of the catheter 1F. The light irradiation system of the seventh embodiment includes the catheter 1F shown in Figure 15 instead of the catheter 1 described in Figure 1. The catheter 1F of the seventh embodiment includes a shaft 10F instead of the shaft 10 in the configuration described in the first embodiment. The shaft 10F has a stopper member 39F instead of the stopper member 39. As shown in the upper part of Figure 15, the stopper member 39F has the same configuration as the first embodiment, except that it blocks a portion of the distal second opening 31 of the shaft 10F (in the illustrated example, a portion of the periphery of the distal second opening 31 on the base end side).

As such, the configuration of the stopper member 39F can be modified in various ways, and it is sufficient for the stopper member 39F to block a portion of the distal second opening 31 of the shaft 10F. In the illustrated example, the stopper member 39F is positioned on the proximal side of the periphery of the distal second opening 31, but the stopper member 39F may also be positioned in a different location, such as on the distal side of the periphery of the distal second opening 31. The light irradiation system of the seventh embodiment, which includes the catheter 1F described above, can also achieve the same effects as the first embodiment.

Eighth Embodiment
Figure 16 is an enlarged cross-sectional view of a portion of the distal end side of a catheter 1G of an eighth embodiment. The light irradiation system of the eighth embodiment includes a catheter 1G shown in Figure 16 instead of the catheter 1 described in Figure 1. The catheter 1G of the eighth embodiment includes a shaft 10G instead of the shaft 10 in the configuration described in the first embodiment. The shaft 10G does not have the stopper member 39 described in the first embodiment.

As such, the configuration of the shaft 10G can be modified in various ways, and the shaft 10G does not need to have the stopper member 39 described in the first embodiment. In this case, too, in step a6 or step b7 described above, the laser light emitted from the light diffusion member 220 of the light irradiation device 2 is irradiated to the outside of the catheter 1G via the distal end second opening 31 of the catheter 1G. The light irradiation system of the eighth embodiment, which includes the catheter 1G described above, can also achieve the same effects as the first embodiment.

Ninth Embodiment
Figure 17 is an explanatory diagram illustrating the configuration of a light irradiation system according to a ninth embodiment. The light irradiation system according to the ninth embodiment includes a catheter 1H shown in Figure 17 instead of the catheter 1 described in Figure 1. The catheter 1H of the ninth embodiment includes a shaft 10H instead of the shaft 10 and a branch portion 91H instead of the branch portion 91 in the configuration described in the first embodiment. The shaft 10H does not include the third inner shaft 43 described in the first embodiment. Therefore, the shaft 10H does not include the third lumen 40L, distal third opening 41, and proximal third opening 42 described in the first embodiment. The branch portion 91H has the same configuration as that of the first embodiment, except that it is bifurcated.

As described above, the configuration of the catheter 1H can be modified in various ways, and it does not have to have a backup lumen (i.e., the third lumen 40L) through which a backup device is inserted. As described with reference to Figures 5 and 6, with the catheter 1H, a guidewire 3 can be inserted into the first lumen 20L, and the catheter 1 can be placed in the target blood vessel 101 with the distal end of the guidewire 3 protruding from the distal first opening 21. This allows the guidewire 3 to apply backup force to the catheter 1. Therefore, the light irradiation system of the ninth embodiment, which includes the catheter 1H described above, can also achieve the same effects as the first embodiment.

Tenth Embodiment
FIG. 18 is an explanatory diagram illustrating the configuration of a light irradiation system according to a tenth embodiment. The upper portion of FIG. 18 depicts the configuration of an optical fiber 210 as viewed from the G direction in FIG. 18 . The light irradiation system according to the tenth embodiment includes a light irradiation device 2I shown in FIG. 18 instead of the light irradiation device 2 described in FIG. 1 . The light irradiation device 2I according to the tenth embodiment does not include the light diffusing member 220 in the configuration described in the first embodiment. As shown in the upper portion of FIG. 18 , the core 210c of the optical fiber 210 is exposed from the clad 210c at the tip, and light LT is emitted from the core 210c. Note that the core 210c may be subjected to a known process (e.g., a process of obliquely cutting the tip surface, a process of forming notches, sandblasting, chemical treatment, etc.). This allows the irradiation direction and diffusion of light LT from the core 210c to be adjusted. In this embodiment, the core 210c exposed at the tip corresponds to the "light irradiation unit."

The light irradiation system of the tenth embodiment including the light irradiation device 2I described above can also achieve the same effects as those of the first embodiment. Furthermore, the light irradiation device 2I of the tenth embodiment does not require the light diffusing member 220, so that the diameter of the light irradiation device 2I can be made thinner, and the number of components constituting the light irradiation device 2I can be reduced, thereby reducing the effort and cost required to manufacture the light irradiation device 2I.

Eleventh Embodiment
Figure 19 is an explanatory diagram illustrating the configuration of the distal end side of a catheter 1J of an eleventh embodiment. Figure 19 shows the configuration of the catheter 1J as viewed from the +Y-axis direction, and indicates with a dashed line the distal end third opening 41, which is not normally visible from the +Y-axis direction. The light irradiation system of the eleventh embodiment includes the catheter 1J shown in Figure 19 instead of the catheter 1 described in Figure 1. In the eleventh embodiment, a configuration will be described in which the shape of the second marker portion 73J is different. The catheter 1J of the eleventh embodiment includes a shaft 10J instead of the shaft 10 in the configuration described in the first embodiment.

The shaft 10J has a second marker portion 73J instead of the second marker portion 73. The second marker portion 73J is radiopaque and functions as a mark indicating the circumferential position (YZ axis direction) of the distal end second opening 31, through which light is irradiated, of the shaft 10J. As shown in FIG. 19 , the second marker portion 73J is formed by spirally winding a radiopaque wire around the outer circumferential surface of the shaft 10J. This configuration allows the surgeon to recognize the circumferential position of the distal end second opening 31 based on the shape of the second marker portion 73J when viewed from any direction.

As such, the configuration of the catheter 1J can be modified in various ways, and the shape of the second marker portion 73J is not limited to a disk shape and can adopt various other shapes. The light irradiation system of the 11th embodiment, which includes the above-described catheter 1J, can also achieve the same effects as the first embodiment.

Twelfth Embodiment
FIG. 20 is an explanatory diagram illustrating the configuration of the distal end side of a catheter 1K according to a twelfth embodiment. FIG. 20 shows the configuration of the catheter 1K as viewed from the +Y-axis direction, and the distal third opening 41, which is not normally visible from the +Y-axis direction, is indicated by a dashed line. The light irradiation system according to the twelfth embodiment includes the catheter 1K shown in FIG. 20 instead of the catheter 1 described in FIG. 1. In the twelfth embodiment, a configuration without a radiopaque marker portion will be described. The catheter 1K according to the twelfth embodiment includes a shaft 10K instead of the shaft 10 and a distal tip 71K instead of the distal tip 71 in the configuration described in the first embodiment. The shaft 10K does not include the first marker portion 72 and the second marker portion 73 described in the first embodiment. Furthermore, the distal tip 71K has a shape similar to that of the distal tip 71 described in the first embodiment, but is formed from a material that does not have radiopaque properties.

As such, the configuration of the catheter 1K can be modified in various ways, and it does not need to have a radiopaque marker portion. In the example of Figure 20, a configuration was described in which the catheter 1K does not have any of the radiopaque distal tip 71 (the distal tip 71 described in the first embodiment), the first marker portion 72, and the second marker portion 73, but the catheter 1K may also be configured to not have one or more of these. The light irradiation system of the twelfth embodiment, which includes the above-described catheter 1K, can also achieve the same effects as the first embodiment.

Thirteenth Embodiment
Figure 21 is an explanatory diagram illustrating the cross-sectional configuration of a catheter 1L of the 13th embodiment. Figure 21 shows the cross-sectional configuration taken along line A-A in Figure 2. The light irradiation system of the 13th embodiment includes the catheter 1L shown in Figure 21 instead of the catheter 1 described in Figure 1. In the 13th embodiment, an example in which the shaft 10L is integrally configured will be described. The catheter 1L of the 13th embodiment includes a shaft 10L instead of the shaft 10 in the configuration described in the first embodiment.

The shaft 10L does not have the outer shaft 11, first inner shaft 23, second inner shaft 33, third inner shaft 43, or sealing member 12 described in the first embodiment, but is composed of a single main body 19. Like the outer shaft 11 described in the first embodiment, the main body 19 can be formed from any resin or metal material. Like the first embodiment, the main body 19 has a first lumen 20L, a second lumen 30L, and a third lumen 40L.

As such, the configuration of the catheter 1L can be modified in various ways, and the shaft 10L may be formed from a single main body 19. Furthermore, any two or more of the outer shaft 11, first inner shaft 23, second inner shaft 33, and third inner shaft 43 described in the first embodiment may be integrally formed. The light irradiation system of the thirteenth embodiment, which includes the above-described catheter 1L, can also achieve the same effects as the first embodiment.

<Fourteenth embodiment>
Figure 22 is an explanatory diagram illustrating the configuration of the base end side of a catheter 1M of a fourteenth embodiment. In Figure 22, as in Figure 1, the first lumen 20L, the second lumen 30L, and the third lumen 40L are represented by dashed lines. The light irradiation system of the fourteenth embodiment includes a catheter 1M shown in Figure 22 instead of the catheter 1 described in Figure 1. In the fourteenth embodiment, an example in which the configuration of the base end side differs from that of the first embodiment will be described. The catheter 1M of the fourteenth embodiment includes first to third inner shafts 23M, 33M, and 43M instead of the first to third inner shafts 23, 33, and 43 in the configuration described in the first embodiment, and includes a connector 80 instead of the connector 90.

The connector 80 has an operating portion 81, a first end member 82, a second end member 83, and a third end member 84. The operating portion 81 is a member having a generally cylindrical shape, and has multiple protrusions 85 on its outer surface. In the illustrated example, the protrusions 85 are linear and extend in the X-axis direction, but the protrusions 85 can have any shape. The first end member 82, the second end member 83, and the third end member 84 are each a generally cylindrical member having a pair of protruding wing portions.

The first inner shaft 23M, the second inner shaft 33M, and the third inner shaft 43M have the same configuration as in the first embodiment, except for the following points. Specifically, the first inner shaft 23M, the second inner shaft 33M, and the third inner shaft 43M each extend further toward the proximal end (+X-axis side) than the proximal end 11p of the outer shaft 11. The proximal end of the first inner shaft 23M is inserted inside the first end member 82 and fixed to the first end member 82. The opening on the proximal side of the first end member 82 corresponds to the proximal first opening 22M for inserting a guidewire. The proximal end of the second inner shaft 33M is inserted inside the second end member 83 and fixed to the second end member 83. The opening on the proximal side of the second end member 83 corresponds to the proximal second opening 32M for inserting a light irradiation device 2. The base end of the third inner shaft 43M is inserted inside the third end member 84 and fixed to the third end member 84. The opening on the base end side of the third end member 84 corresponds to the base end third opening 42M for inserting a backup device.

3, the first inner shaft 23M, the second inner shaft 33M, and the third inner shaft 43M are each fixed to the outer shaft 11 by a sealing member 12. Also, as shown in Fig. 22, the base end of the outer shaft 11 is fixed to the operating section 81 while being inserted inside the operating section 81. Any bonding agent, for example, a metal solder such as silver solder, gold solder, zinc, a Sn-Ag alloy, or a Au-Sn alloy, or an adhesive such as an epoxy adhesive, can be used for the joint 86 that fixes the operating section 81 and the outer shaft 11.

In step a3 described in Figures 5 and 6, when adjusting the circumferential position of the catheter 1M (rotating the catheter 1M) so that the distal second opening 31 (and stopper member 39) faces the target tissue 103, the surgeon in this embodiment of the catheter 1M simply rotates the control unit 81. For example, assume that the surgeon rotates the control unit 81 in the D1 direction (Figure 22: bold black arrow). In this case, as the control unit 81 is rotated, the outer shaft 11 fixed to the control unit 81 also rotates in the D1 direction. Similarly, the first inner shaft 23M, second inner shaft 33M, and third inner shaft 43M fixed to the outer shaft 11 also rotate in the D1 direction.

As such, the configuration of the catheter 1M can be modified in various ways, and a configuration may be adopted in which a connector 80 having an operating unit 81 is provided instead of the connector 90. The light irradiation system of the fourteenth embodiment, which includes the catheter 1M described above, can also achieve the same effects as the first embodiment. Furthermore, with the catheter 1M of the fourteenth embodiment, by performing a rotational operation on the operating unit 81 fixed to the base end of the outer shaft 11, the outer shaft 11 can be rotated by the rotation applied to the operating unit 81, and the first, second, and third inner shafts 23M, 33M, and 43M fixed to the outer shaft 11 can also be rotated. Therefore, the catheter 1M can be easily rotated to adjust the circumferential position of the catheter 1M within a blood vessel, improving usability.

Fifteenth Embodiment
FIG. 23 is an explanatory diagram illustrating the configuration of the proximal end side of a catheter 1N of a fifteenth embodiment. In FIG. 23, the first lumen 20L, the second lumen 30L, and the third lumen 40L are indicated by dashed lines, as in FIG. 1. FIG. 24 is an explanatory diagram illustrating a cross-sectional configuration taken along line H1-H1 in FIG. 23. FIG. 25 is an explanatory diagram illustrating a cross-sectional configuration taken along line H2-H2 in FIG. 23. The light irradiation system of the fifteenth embodiment includes a catheter 1N shown in FIG. 23 instead of the catheter 1 described in FIG. 1. In the fifteenth embodiment, an example will be described in which the configuration of a connector 80N of the catheter 1N differs from that of the fourteenth embodiment. The catheter 1N of the fifteenth embodiment includes a shaft 10N instead of the shaft 10 and a connector 80N instead of the connector 80 in the configuration described in the fourteenth embodiment.

In addition to the components described in the fourteenth embodiment, the connector 80N further includes a support portion 87 and a connection portion 88. The support portion 87 is a generally cylindrical member and is located closer to the base end than the operating portion 81. The connection portion 88 is a generally cylindrical member and is joined to the outer surface of the support portion 87 while communicating with the inner cavity of the support portion 87. The support portion 87 and the connection portion 88 do not rotate, even when the operating portion 81 is rotated.

The shaft 10N has the same configuration as the fourteenth embodiment, except for the following points. Specifically, as shown in FIG. 24 , the shaft 10N does not have a sealing member 12 disposed inside the outer shaft 11. As shown in FIG. 24 , an outer lumen 11L, through which a fluid can flow, is formed inside the outer shaft 11. Furthermore, as shown in FIG. 25 , a fixing member 89 is provided at the proximal end of the shaft 10N. The fixing member 89 fixes the first inner shaft 23M, the second inner shaft 33M, and the third inner shaft 43M inside the proximal end of the outer shaft 11. In the cross section shown in FIG. 25 , the fixing member 89 is disposed on a portion of the inner circumferential surface of the outer shaft 11 and on the entire outer circumferential surfaces of the first, second, and third inner shafts 23M, 33M, and 43M. With this configuration, the shaft 10N has an outer lumen 11L through which a fluid can flow, even in the portion where the fixing member 89 is provided. Similarly, the vicinity of the first curved portion 35 on the tip side of the second inner shaft 33M and the vicinity of the second curved portion 45 on the tip side of the third inner shaft 43M (Figure 2) are fixed to the inside of the outer shaft 11 by fixing members not shown.

As described above, the configuration of the catheter 1M can be modified in various ways, and it may be configured to include a connector 80N having a support portion 87 and a connection portion 88. It may also be configured to include a shaft 10N having an outer lumen 11L. The light irradiation system of the 15th embodiment, which includes the catheter 1N described above, can also achieve the same effects as the first and fourteenth embodiments. Furthermore, according to the catheter 1N of the 15th embodiment, the connector 80N has a support portion 87 and a connection portion 88 that do not rotate in response to rotation of the operation portion 81. This allows the surgeon to rotate the operation portion 81 while supporting the support portion 87, further improving usability. Furthermore, according to the catheter 1N of the 15th embodiment, the shaft 10N has an outer lumen 11L. Therefore, the surgeon can connect a syringe to the connection portion 88 and supply saline to the outer lumen 11L via the inner cavities of the support portion 87 and the connection portion 88.

<Modification 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 of the invention. For example, the following modifications are also possible.

[Modification 1]
In the first to fifteenth embodiments, the configuration of the catheters 1, 1A-1H, 1J-1N included in the light irradiation system is illustrated. However, various modifications to the configuration of the catheter 1 are possible. For example, a port (opening) connecting the first lumen 20L (guidewire lumen) to the outside may be provided on the side surface of the shaft 10, 10A-10H, 10J-10N, closer to the base end than the distal second opening 31 and the distal third opening 41. The catheter may be used as an Rx-type catheter by pulling out the proximal end of the delivery guidewire from this port. For example, at least one of the outer and inner surfaces of the shaft 10 may be coated with a hydrophilic or hydrophobic resin.

For example, the distal end portion of each of the shafts 10, 10A-10H, and 10J-10N may have the configuration described in the first embodiment (FIG. 3), and the proximal end portion may have the configuration described in the thirteenth embodiment (FIG. 21). In this way, the distal end portion, which requires machining of the distal second opening 31, proximal third opening 42, first curved portion 35, and second curved portion 45, can be configured using an outer shaft and inner shaft that are easy to machine (FIG. 3), while the proximal end portion, which does not require machining of these portions, can be configured using an integrated main body portion that can be made thinner (FIG. 21).

For example, the stopper members 39, 39D-39F of the shafts 10, 10A-10H, 10J-10N can have any configuration as long as they can transmit light from the light irradiation device 2. For example, the stopper member 39 may be made of a material that is only optically transparent and does not have light diffusibility. For example, the stopper member 39 may have a mesh shape made of optically opaque wires woven together. In this case, light irradiated by the light irradiation device 2 can transmit through the gaps between the wires. For example, the stopper member 39 may be made of an optically opaque material and have one or more through holes connecting the inner surface 39i and the outer surface 39o. In this case, light irradiated by the light irradiation device 2 can transmit through the through holes.

[Modification 2]
The configurations of the catheters 1, 1A to 1H, and 1J to 1N of the first to fifteenth embodiments and the configurations of Modification 1 may be appropriately combined. For example, the catheter 1 may be configured by appropriately combining any of the configurations having multiple backup lumens described in the second to fourth embodiments, any of the configurations having a stopper member described in the fifth to eighth embodiments, any of the configurations having a marker portion described in the eleventh and twelfth embodiments, and any of the configurations having a connector described in the fourteenth and fifteenth embodiments. For example, a light irradiation system may be configured by combining any of the catheters 1, 1A to 1H, and 1J to 1N described in the second to ninth embodiments or the eleventh to fifteenth embodiments with the light irradiation device 2I described in the tenth embodiment.

This aspect has been described above based on embodiments and variations, but the above-described embodiments are intended to facilitate understanding of this aspect and are not intended to limit this aspect. This aspect may be modified or improved without departing from its spirit or the 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.

DESCRIPTION OF SYMBOLS 1, 1A to 1H, 1J to 1N... Catheter 2, 2I... Light irradiation device 3... Guide wire 4, 4a, 4b, 5, 6... Backup device 9... Light source 10, 10A to 10H, 10J to 10N... Shaft 11... Outer shaft 12... Sealing member 19... Main body 20L... First lumen 21... Distal first opening 22, 22M... Proximal first opening 23, 23M... First inner shaft 30L... Second lumen 31... Distal second opening 32, 32M... Proximal second opening 33, 33M... Second inner shaft 35... First bending portion 39, 39D to 39F... Stopper member 40L... Third lumen 41, 41B, 41C... Distal third opening 42, 42M... Proximal third opening 43, 43C, 43M...Third inner shaft 45...Second curved portion 50L...Fourth lumen 51, 51B, 51C...Fourth distal opening 53, 53C...Fourth inner shaft 60L...Fifth lumen 61...Fifth distal opening 63...Fifth inner shaft 71, 71K...Tip 72...First marker portion 73, 73J...Second marker portion 80, 80N...Connector 81...Operation portion 82...First end member 83...Second end member 84...Third end member 85...Protrusion 86...Joint portion 87...Support portion 88...Connection portion 89...Fixing member 90...Connector 91, 91H...Branch portion 92...Wing portion 210...Optical fiber 210c...Core 210cl...Cladding 220...Light diffusing member 290...Connector 391...Slit

Claims (9)

A medical light irradiation system,
a catheter having an elongate shaft with a first lumen extending longitudinally and a second lumen disposed alongside the first lumen;
an elongated light irradiation device having a light irradiation unit at a tip end thereof for irradiating light;
Equipped with
In the catheter,
a first opening communicating with the first lumen is formed at the distal end of the shaft;
a second opening located on a side surface of the shaft and communicating with the second lumen, the second opening being located on a proximal side of the first opening;
the light irradiation device is inserted into the second lumen of the catheter, and in a state in which the light irradiation unit is delivered to the position of the second opening, light irradiated from the light irradiation unit is irradiated to the outside of the catheter through the second opening ;
The shaft of the catheter further includes a stopper member that blocks the second opening, thereby preventing the light irradiation device in the second lumen from protruding outward from the second opening, the stopper member having a through hole that connects the inner surface and the outer surface . The lighting system according to claim 1 ,
The stopper member has a light diffusing property for diffusing light. The light irradiation system according to claim 1 or 2 ,
A light irradiation system, wherein the stopper member has a curved convex shape on at least an outer surface thereof. The light irradiation system according to claim 1 or 2 ,
A light irradiation system, wherein the stopper member is formed of an elastic body and blocks the entire second opening, and the through hole allows a fluid to pass through at a flow rate greater than that of blood. The light irradiation system according to any one of claims 1 to 4 ,
In the catheter,
The shaft further includes a third lumen disposed side by side with the first lumen and the second lumen,
a third opening located on a side surface of the shaft and communicating with the third lumen, the third opening being located on a proximal side of the first opening;
An illumination system, wherein, in a cross section of the shaft, the first lumen is positioned at the center of the shaft, and the second lumen and the third lumen are positioned on opposite sides of the first lumen. The light irradiation system according to claim 5 ,
the third opening is disposed adjacent to the second opening in the longitudinal direction of the catheter;
a first line segment connecting the center of the shaft and the center point of the second opening, and a second line segment connecting the center of the shaft and the center point of the third opening, when viewed from the longitudinal direction of the catheter , the angle formed by the first line segment and the second line segment is 180 degrees. The light irradiation system according to claim 6,
a distal end portion of the second lumen and a distal end portion of the third lumen are curved outward with respect to the longitudinal direction of the catheter;
A light irradiation system, wherein the bending direction of the tip of the third lumen is opposite to the bending direction of the tip of the second lumen. The light irradiation system according to any one of claims 5 to 7,
In the catheter,
the shaft further includes a fourth lumen arranged alongside the first lumen, the second lumen, and the third lumen,
a fourth opening located on a side surface of the shaft and communicating with the fourth lumen, the fourth opening being located on a proximal end side of the first opening;
A light irradiation system, wherein the fourth lumen is located on the same side as the third lumen in a cross section of the shaft. The light irradiation system according to any one of claims 5 to 8,
The shaft of the catheter further comprises:
An outer shaft;
a first inner shaft having the first lumen therein;
a second inner shaft having the second lumen therein;
a third inner shaft having the third lumen therein;
an operating portion having a cylindrical shape for rotating the outer shaft, the first inner shaft, the second inner shaft, and the third inner shaft in a circumferential direction;
Equipped with
the first inner shaft, the second inner shaft, and the third inner shaft each extend to a proximal end side beyond a proximal end of the outer shaft when inserted inside the outer shaft, and at least a portion of each of the first inner shaft, the second inner shaft, and the third inner shaft is fixed to the outer shaft,
the operating portion covers a base end of the outer shaft and portions of the first inner shaft, the second inner shaft, and the third inner shaft that protrude from the outer shaft,
The operation unit is fixed to a base end of the outer shaft.