Light irradiation device

Abstract

The present invention provides a light irradiation device through which a core wire and a light irradiation body can both be inserted, and which makes it possible to reliably position the light irradiation body with respect to a balloon. Provided is a light irradiation device 10 comprising: a balloon 30 that is formed from an optically transparent material; and a tube-shaped body 40 that is disposed inside the balloon 30 and that has a lumen 41 through which can be inserted a light irradiation body 90 provided with a light irradiation part 92. The balloon 30 has an optically transparent window part 37 that transmits light from the light irradiation part 92 and a light-shielding body 36 that is provided to a region other than the optically transparent window part 37 and that has a lower transmittance of light from the light irradiation part 92 than the optically transparent window part 37. The optically transparent window part 37 has a first end part 37a at the long-axis direction tip end side of the balloon 30 and a second end part 37b at the long-axis direction base end side of the balloon 30. The lumen 41 of the tube-shaped body 40 has a boundary part 42 that abuts the tip end 91 of the light irradiation body 90 at a position which is further to the tip end side than the first end part 37a and which is further to the base end side than the distal end of the balloon 30.

Description

Light irradiation device

[0001] The present invention relates to a light irradiation device used in treatment by irradiating a lesion with light.

[0002] Photodynamic therapy (PDT) and photoimmunotherapy (PIT) are known as local cancer treatments that use photoreactive substances selective for tumor cells. These treatments require a light irradiation device that irradiates the lesion with light. The light irradiation device includes at least a light emitting portion that emits light and an elongated member having the light irradiating portion at its tip.

[0003] Although it does not irradiate light, a light irradiation device including a radiation source that irradiates radiation and a long member having the radiation source at its distal end is disclosed, for example, in Patent Document 1. This light irradiation device has an inner cavity that opens at the distal end of a tubular body, and is configured so that a guide wire can pass through the inner cavity, but a radiation wire having a radiation source does not pass through the inner cavity.

[0004] Japanese Patent Application Laid-Open No. 2001-46532

[0005] To ensure reliable treatment, a light irradiation device that irradiates light is required to locally approach the lesion and stably irradiate only the lesion and its surrounding area with the light necessary for treatment. A device having a balloon at the distal end of an elongated member can be used as a light irradiation device for treating lesions in hollow organs such as the digestive system. This light irradiation device can place a light irradiator having a light irradiation unit inside the balloon, and irradiate light through a light-transmitting window provided in the balloon. By expanding the balloon, the light irradiation device can maintain a constant distance between the lesion and the light irradiation unit and fix the position of the light irradiation unit relative to the lesion, thereby stably irradiating light to the lesion. In the light irradiation device, the light irradiator is inserted into the inner cavity of a tubular body provided inside the elongated member. Since the light irradiation device irradiates the lesion with light from the light irradiator through the light-transmitting window of the balloon, it is required to be able to reliably position the light irradiator relative to the balloon.

[0006] Furthermore, a light irradiation device having a balloon and capable of irradiating light can be delivered to a lesion using the lumen of an endoscope. When the light irradiation device is inserted into the lumen of the endoscope, the balloon is in a wrapped state. However, the distal end of the light irradiation device has a large outer diameter due to the balloon, and the clearance with the inner wall of the endoscope is small. Therefore, in order to suppress deformation such as buckling of the long portion when inserting the light irradiation device into the lumen of the endoscope, it is also required to be able to insert a core wire (stylet) with a different diameter from the light irradiator into the lumen of the tubular body all the way to the distal end of the light irradiation device.

[0007] The present invention has been made to solve the above-mentioned problems, and aims to provide a light irradiation device that allows both a core wire and a light irradiator to be inserted and that allows the light irradiator to be reliably positioned relative to a balloon.

[0008] (1) A light irradiation device according to the present invention that achieves the above-mentioned object includes a balloon formed of a light-transmitting material, and a tubular body that is disposed inside the balloon and has a cavity through which a light irradiator equipped with a light irradiation unit is inserted, the balloon having a light-transmitting window that transmits light from the light irradiation unit, and a light-shielding body that is disposed in an area other than the light-transmitting window and has a lower transmittance of light from the light irradiation unit than the light-transmitting window, the light-transmitting window having a first end on the distal end side of the balloon in the longitudinal direction and a second end on the proximal end side of the balloon in the longitudinal direction, and the cavity of the tubular body has a boundary portion that abuts against the distal end of the light irradiator, at a position distal to the first end and proximal to the forefront of the balloon.

[0009] In the light irradiation device configured as described above, both the light irradiator for treatment and the core wire as a reinforcing body during insertion can be inserted into the lumen of the tubular body. Therefore, the core wire is inserted into the lumen of the tubular body to reliably and easily insert the light irradiation device into the endoscope, and when inserting the light irradiator into the lumen of the tubular body instead of the core wire, the tip of the light irradiator can be abutted against the boundary portion, thereby reliably positioning the light irradiator with respect to the balloon and irradiating the lesion with light.

[0010] (2) In the light irradiation device of (1) above, the inner cavity of the tubular body may have a small diameter portion distal to the boundary portion and a large diameter portion proximal to the boundary portion, the large diameter portion having an inner diameter larger than that of the small diameter portion. This allows the core wire to be inserted all the way to the tip of the light irradiation device and is reliably supported all the way to the tip of the light irradiation device, thereby making it possible to more reliably and easily insert the light irradiation device into an endoscope.

[0011] (3) In the light irradiation device of (2) above, the inner diameter of the narrow diameter portion may be smaller than the outer diameter of the light irradiator, whereby the light irradiator cannot enter the narrow diameter portion, and the tip of the light irradiator can reliably abut against the boundary portion and be positioned.

[0012] (4) In the light irradiation device of (2) or (3) above, the inner diameter of the small diameter portion may be larger than the outer diameter of the core wire to be inserted into the lumen, thereby enabling the core wire to be reliably inserted into the small diameter portion.

[0013] (5) In the light irradiation device according to any one of (1) to (4), the light irradiation unit may be provided on a distal end side of the light irradiator in a longitudinal direction, and when the distal end of the light irradiator is abutted against the boundary portion, the distal end is located distally of the first end and the proximal end is located proximally of the second end. This allows the light irradiation unit to emit light over the entire length of the light-transmitting window portion, thereby enabling light to be uniformly irradiated from the light-transmitting window portion.

[0014] (6) In the light irradiation device according to any one of (2) to (5), the boundary portion may have a diameter that continuously decreases from the large-diameter portion toward the small-diameter portion, thereby facilitating insertion of the core wire from the large-diameter portion toward the small-diameter portion.

[0015] (7) In any of the light irradiation devices (2) to (6) above, the tubular body may have an outer layer portion that covers the outside of the small diameter portion, thereby ensuring rigidity at the distal end of the tubular body and suppressing bending or the like when the light irradiation device is inserted.

[0016] (8) In any of the light irradiation devices (2) to (6) above, the tubular body may have an outer layer portion integrally covering the outside of the narrow diameter portion, the boundary portion, and the thick diameter portion, thereby ensuring rigidity at the distal end of the tubular body, including the boundary portion having a step, and suppressing deflection, etc., during insertion of the light irradiation device.

[0017] (9) In any of the light irradiation devices (2) to (8) above, the tubular body may have a deformation absorbing section at the base end, the deformation absorbing section having an outer diameter smaller than that of the large-diameter section, whereby the deformation absorbing section is easily deformed when the light irradiation device is inserted, thereby suppressing bending, twisting, and the like at the distal end side of the tubular body.

[0018] FIG. 1 is an overall view of a light irradiation device and an endoscope according to an embodiment of the present invention; FIG. 2 is a perspective view of a balloon; FIG. 3 is an enlarged cross-sectional view of the vicinity of the tip of the light irradiation device inserted into an endoscope; FIG. 4 is an enlarged cross-sectional view of the vicinity of a fixed adapter and an operation handle of the light irradiation device inserted into an endoscope; FIG. 5 is an enlarged cross-sectional view of the vicinity of a hub of the light irradiation device; FIG. 6 is a flow chart of treatment using the light irradiation device; and FIG. 7 is an enlarged cross-sectional view of the vicinity of the tip of the light irradiation device in a state where a core wire is inserted into a tubular body.

[0019] Hereinafter, embodiments of the present invention will be described with reference to the drawings. For convenience of explanation, the dimensions of the drawings may be exaggerated and may differ from the actual dimensions. Furthermore, in this specification and the drawings, components having substantially the same functional configurations are designated by the same reference numerals, and redundant explanations will be omitted. In this specification, the side of the device that is inserted into the living body will be referred to as the "distal side," and the side that is operated will be referred to as the "proximal side."

[0020] The light irradiation device 10 according to the present embodiment is used for the treatment of tumors. While the type of tumor is not particularly limited, when inserted into an endoscope 100 and used as an endoscopic system, it can be applied to tumors occurring in hollow organs such as the esophagus, stomach, small intestine, large intestine, urinary tract, blood vessels, external auditory canal, Eustachian tube, and nasal cavity. The light irradiation device 10 according to the present embodiment is used, for example, in photoimmunotherapy, which destroys target cells by irradiating light onto a drug adsorbed on target cells, as taught in Japanese Patent No. 6127045. The target cells are tumor cells, such as cancer cells or cells of precancerous lesions. In this treatment method, a photosensitizer is used as the drug, which comprises an antibody that specifically binds only to a unique antigen on the surface of tumor cells and a photosensitizer that pairs with the antibody. The antibody is not particularly limited, but examples include panitumumab, trastuzumab, HuJ591, pertuzumab, lapatinib, palbociclib, and olaparib. The photosensitizer may be, for example, but is not limited to, a hydrophilic phthalocyanine (IR700) that reacts to near-infrared light with a wavelength of approximately 700 nm. When IR700 is exposed to near-infrared light with a wavelength of approximately 660 to 740 nm, the ligands of the functional group that ensures water solubility are cleaved, causing a structural change from water-soluble to hydrophobic. This structural change pulls out membrane proteins, creating holes in the cell membrane and allowing water to enter the cell, thereby rupturing and destroying tumor cells. IR700 is also excited by near-infrared light and emits fluorescence with a wavelength different from the excitation wavelength. For example, when IR700 is excited by near-infrared light with a wavelength around 690 nm, it emits fluorescence with a wavelength around 700 nm. IR700 undergoes a structural change while emitting fluorescence due to photoreaction, and ceases to emit fluorescence once it has destroyed tumor cells and fulfilled its role as a drug.

[0021] The light irradiation device 10 of this embodiment can be configured to be suitable for treatment that approaches tumor cells via an endoscope 100. As shown in Fig. 1 , the light irradiation device 10 is used by being inserted into the endoscope 100, for example.

[0022] The endoscope 100 has an endoscope 120 connected to the control display unit 110 by a connection line 127. The surgeon inserts the endoscope 120 into a living body and performs various operations. The endoscope 120 has a long insertion section 121 that is inserted into the living body, and a handle section 122 that is provided at the base end of the long insertion section 121.

[0023] The handle 122 has an operation section 122a that the surgeon uses to operate the bending, air supply, water supply, suction, etc. of the long insertion section 121, and a forceps port 122b that communicates with the inner cavity 125 of the long insertion section 121. The light irradiation device 10 is inserted into the endoscope 100 from the forceps port 122b of the handle 122.

[0024] The light irradiation device 10 includes a long shaft portion 20 that is inserted into the endoscope 100, and a balloon 30 that is provided at the distal end of the shaft portion 20 and exposed at the distal side of the long insertion portion 121. The light irradiation device 10 further includes a fixing adapter 50 that is fixed to the forceps port 122b, an operating handle 60 that is used to position the balloon 30, and a hub 70 that is provided at the proximal end of the light irradiation device 10. A stretching device 80 that injects a fluid to expand the balloon 30 is connected to the hub 70. The stretching device 80 can be, for example, an indeflator.

[0025] A light irradiator 90 that emits light within the balloon 30 is inserted into the light irradiation device 10. The light irradiator 90 is exposed proximally from the hub 70 of the light irradiation device 10 and is connected to a light source unit 95 that outputs light. The light irradiator 90 includes a light irradiation unit 92 provided at the distal end of the light irradiator 90 in the longitudinal direction, and an optical fiber connected to the light irradiation unit 92 and extending toward the proximal end of the light irradiator 90 in the longitudinal direction. For example, the light irradiator 90 is configured with a side-emitting optical fiber that can irradiate light radially outward from the distal end. The light irradiation unit 92 and the optical fiber can be configured such that the diameter of the light irradiation unit 92 is larger than the diameter of the optical fiber in the longitudinal direction of the light irradiator 90.

[0026] As shown in Figures 2 and 3, the balloon 30 is radially expandable. As shown in Figure 3, the balloon 30 is a radially expandable portion extending from a distal end 31 to a proximal end 32. The central portion of the balloon 30 in the longitudinal direction is a straight portion 33 having the same diameter along the longitudinal direction, and both ends of the balloon 30 in the longitudinal direction are tapered portions 34 whose diameter decreases toward the ends. As shown in Figure 2, the tapered portion 34 may be hemispherical. However, the shape of the tapered portion 34 is not limited to a hemispherical shape and may be, for example, conical. The distal end 31 is the distal end of the radially expandable and contractible balloon 30 (straight portion 33 and tapered portion 34) in the longitudinal direction, and the proximal end 32 is the proximal end in the longitudinal direction. The balloon 30 is formed of an optically transparent material such as nylon or urethane. The balloon 30 is produced by blow molding a parison made of such an optically transparent material, and tubular portions 39 remain as molding margins distal to the distal end 31 and proximal to the proximal end 32 of the balloon 30. These tubular portions 39 are configured not to expand or contract radially, and are used as fixing portions for the shaft portion 20 and the tubular body 40 described below.

[0027] The light irradiator 90 described above is disposed inside the balloon 30. The balloon 30 has a light-transmitting window 37 that transmits light from the light irradiator 92 of the light irradiator 90, and a light-shielding body 36 that has a lower transmittance of light from the light irradiator 92 than the light-transmitting window 37. The light-shielding body 36 can be formed of ink, a metal film, or the like that coats the surface of the balloon 30. In other words, the balloon 30 includes the light-shielding body 36, which is a film made of a coating material that coats the outer surface of the balloon 30. The light-transmitting window 37 can transmit light from the light irradiator 92 because the surface of the balloon 30 is not covered by the light-shielding body 36. In other words, the portion not covered by the light-shielding body 36 is defined as the light-transmitting window 37. The light-transmitting window 37 may be provided over the entire circumferential direction (360 degrees) or over a portion of the circumferential direction (e.g., 180 degrees).

[0028] As shown in Figure 3, the balloon 30 can be inflated by being exposed to the distal end side from a distal opening 125a of the lumen 125 of the endoscope 100. The endoscope 100 has an endoscope objective lens 123 at its distal end, which allows the state of the balloon 30 to be visually confirmed. The proximal end of the balloon 30 is joined to the distal end of the shaft portion 20, which is inserted into the lumen 125 of the endoscope 100. A distal tip 35 is provided at the distal end of the balloon 30. The light-transmitting window portion 37 of the balloon 30 has a first end 37a at the distal end side of the balloon 30 in the longitudinal direction and a second end 37b at the proximal end side of the balloon 30 in the longitudinal direction.

[0029] A tubular body 40 having a lumen 41 along the longitudinal direction is disposed inside the balloon 30. The tubular body 40 extends along the longitudinal direction inside the shaft portion 20. Inside the shaft portion 20 and outside the tubular body 40 is an inflation lumen 21 through which a fluid flows for inflating the balloon 30. The distal end of the tubular body 40 extends beyond the distal end 31 of the balloon 30 and is fixed to the balloon 30.

[0030] A light irradiator 90 is inserted into the lumen 41 of the tubular body 40. The light irradiator 90 is a side-emitting optical fiber that emits light radially outward all around, and has a light irradiating section 92 at its tip that can irradiate light of uniform intensity in the radial direction along the longitudinal axis. At least the portion of the tubular body 40 located inside the balloon 30 is made of a light-transmitting material to allow light from the light irradiating section 92 to pass through.

[0031] The lumen 41 of the tubular body 40 has a stepped boundary portion 42, with a larger inner diameter at the proximal end and a smaller inner diameter at the distal end, located distally of the first end 37a of the light-transmitting window portion 37 and proximally of the leading edge 31 of the balloon 30. The lumen 41 of the tubular body 40 has a thin-diameter portion 44 distally of the boundary portion 42 and a thick-diameter portion 43 proximal to the boundary portion 42, with an inner diameter larger than that of the thin-diameter portion 44. The thick-diameter portion 43 is larger than the outer diameter of the light irradiator 90, allowing the light irradiator 90 to pass through. The thin-diameter portion 44 is smaller than the outer diameter of the light irradiator 90, preventing the light irradiator 90 from passing through. Therefore, when the tip 91 of the light irradiator 90 abuts against the boundary portion 42, the light irradiator 90 cannot move further distally, and the light irradiator 92 can be positioned at a fixed position within the balloon 30.

[0032] When the tip 91 of the light irradiator 90 is abutted against the boundary portion 42, the tip of the light irradiator 92 is located distally of the first end 37a of the light-transmitting window 37, and the base end is located proximal of the second end 37b of the light-transmitting window 37. This allows the light irradiator 92 to be reliably positioned over the entire longitudinal range of the light-transmitting window 37, and light directed radially from the light irradiator 92 is uniformly irradiated from the inside of the balloon 30 through the light-transmitting window 37.

[0033] The boundary portion 42 continuously reduces in diameter from the large-diameter portion 43 toward the small-diameter portion 44. This prevents discontinuous corners from forming at the boundary portion 42, facilitating insertion of the core wire 200, which will be described later. Furthermore, the small-diameter portion 44, which reduces in diameter from the large-diameter portion 43 via the boundary portion 42, is arranged coaxially with the large-diameter portion 43. This also facilitates insertion of the core wire 200, which will be described later.

[0034] The outer diameter of the tubular body 40 also decreases from the thick-diameter portion 43 to the thin-diameter portion 44. The tubular body 40 may have an outer layer portion 46 that integrally covers the thin-diameter portion 44, the boundary portion 42, and the outside of the thick-diameter portion 43. The outer layer portion 46 only needs to be formed to cover at least the thin-diameter portion 44, or the outer layer portion 46 may be configured to cover the thin-diameter portion 44 and the boundary portion 42. The outer layer portion 46 covers the tubular body 40, including the region where the light irradiation portion 92 of the light irradiator 90 is disposed, and is therefore formed of a light-transmitting material. The outer layer portion 46 can reinforce the tubular body 40 against a decrease in strength due to the formation of a step at the boundary portion 42, thereby facilitating insertion of the light irradiation device 10. The outer layer portion 46 may cover only the thin-diameter portion 44. Alternatively, the outer layer portion 46 may cover only the thin-diameter portion 44 and the boundary portion 42. In these cases, the outer layer portion 46 does not include the region where the light irradiation unit 92 is disposed, and therefore may be formed of a material other than a light-transmitting material. The outer layer portion 46 can reinforce the thin-diameter portion 44, which has a smaller outer diameter and therefore a lower strength, and can prevent the outer diameter from becoming larger after the balloon 30 is folded and wrapped, thereby enabling the light irradiation device 10 to be inserted more reliably and easily by the endoscope 100. As a method for reinforcing the strength of the tubular body 40 due to the step formed at the boundary portion 42, a method of inserting a tubular body having a smaller diameter than the inner diameter of the tubular body 40 into the distal end of the lumen of the tubular body 40 to form the step may be selected. In this case, the step can be formed at the boundary portion 42 without changing the outer diameter of the tubular body 40 throughout the entire longitudinal direction while maintaining the rigidity of the tubular body 40.

[0035] The endoscope 120 of the endoscope 100 has a total length of 1350 mm, and the effective length of the long insertion section 121 is 1030 mm. The light irradiation device 10 has a total length of 1600 mm to 1800 mm. The light irradiator 90 has a total length of 2000 mm or more. However, these lengths are merely examples, and the lengths of the endoscope 100 and the light irradiation device 10 may be outside these ranges.

[0036] The balloon 30 has a straight portion 33 with a length in the longitudinal direction of 30 mm to 60 mm, and an outer diameter of the straight portion 33 when inflated of 10 to 25 mm. The thickness of the balloon 30 is approximately 0.03 mm, and the thickness of the light blocking body 36 is approximately 0.006 to 0.03 mm. However, these dimensions are merely examples, and the length and thickness of the balloon 30 may be outside these ranges.

[0037] As shown in FIG. 4 , a forceps port member 122c is disposed in the forceps port 122b of the endoscope 100. The fixed adapter 50 of the light irradiation device 10 has an endoscope fixing portion 51 that is fitted and fixed to the forceps port member 122c. The endoscope fixing portion 51 is cylindrical, and the shaft portion 20 can be inserted therethrough. The fixed adapter 50 has a flexible fixing member 52 at its proximal end. The fixing member 52 is formed in a ring shape that surrounds the outer periphery of the shaft portion 20. The proximal end of the fixed adapter 50 is provided with a rotating portion 53 that abuts against the fixing member 52. By rotating the rotating portion 53, the rotating portion 53 moves toward the distal end of the fixed adapter 50 and compresses the abutting fixing member 52 in the thickness direction (longitudinal direction). The compressed fixing member 52 deforms so that its inner diameter becomes smaller, allowing the shaft portion 20 to be fixed to the fixed adapter 50.

[0038] The operating handle 60 is located closer to the base end than the part of the shaft portion 20 that is fixed to the fixing adapter 50, and can be grasped by the surgeon to move the shaft portion 20 in the longitudinal direction and rotate it in the circumferential direction. This allows the surgeon to adjust the longitudinal position and circumferential position of the balloon 30 after inserting the light irradiation device 10 into the endoscope 100.

[0039] 5 , the hub 70 is hollow, and the hollow interior communicates with a connection port (side port) 71 to which an expansion device 80 can be connected. The base end of the shaft portion 20 is joined and fixed inside the hub 70. The base end of the tubular body 40 extends inside the hub 70 beyond the base end of the shaft portion 20 toward the base end, and is fixed at a tubular body fixing portion 73.

[0040] The tubular body 40 has a deformation absorbing section 47 at the base end, the deformation absorbing section 47 having an outer diameter smaller than the large diameter section 43. By having the deformation absorbing section 47, when the tubular body 40 is subjected to an external force when inserting the light irradiation device 10 into the endoscope 100, the deformation absorbing section 47, which has a small wall thickness and is easily deformed, deforms, thereby preventing the distal end portion of the tubular body 40 from bending or twisting.

[0041] The light irradiator 90 extends from the proximal end of the tubular body 40 toward the proximal end and penetrates the hub 70. A light irradiation device fixing member 74 is provided at the proximal end of the hub 70 so as to surround the light irradiator 90. In addition, a rotating portion 75 is provided at the proximal end of the hub 70. By rotating the rotating portion 75, the rotating portion 75 moves toward the distal end of the hub 70 and compresses the light irradiation device fixing member 74, and the inner diameter of the light irradiation device fixing member 74 becomes smaller, allowing the light irradiator 90 to be fixed.

[0042] Next, a treatment method using the light irradiation device 10 will be described. Prior to treatment using the light irradiation device 10, a photosensitive substance is administered into the body. The method for administering the photosensitive substance into the body is not particularly limited as long as it can deliver the photosensitive substance to tumor cells, but may be, for example, intravascular administration, which in this embodiment is intravenous administration. Approximately 12 to 36 hours after intravenous administration, light irradiation treatment using the light irradiation device 10 of this embodiment is performed.

[0043] As described above, the light irradiation device 10 approaches the lesion by being inserted into the endoscope 100. Therefore, before treatment with the light irradiation device 10, the endoscope 100 is inserted into the living body in advance.

[0044] As shown in Fig. 6 , before inserting the light irradiation device 10 into the endoscope 100, a core wire 200 is inserted into the light irradiation device 10 (S1). As shown in Fig. 7 , the core wire 200 is inserted into the lumen 41 of the tubular body 40. Before being inserted into the endoscope 100, the balloon 30 of the light irradiation device 10 is folded and wrapped so as to have a diameter that allows it to be inserted into the lumen 125.

[0045] The core wire 200 is covered with a cover portion 201 except for its distal end portion, and has an outer diameter close to the inner diameter of the large-diameter portion 43 of the lumen 41. The distal end portion of the core wire 200 is not provided with the cover portion 201, and has an outer diameter close to the inner diameter of the small-diameter portion 44 of the lumen 41. This allows the core wire 200 to be inserted over substantially the entire length of the lumen 41, from the large-diameter portion 43 to the small-diameter portion 44. That is, the core wire 200 can be inserted further into the light irradiation device 10 than the leading edge 31 of the balloon 30. As described above, the boundary portion 42 of the tubular body 40 is formed so as to continuously decrease in diameter from the large-diameter portion 43 toward the small-diameter portion 44, and therefore the core wire 200 can be easily inserted toward the small-diameter portion 44.

[0046] The core wire 200 can be made of a metal such as stainless steel. The cover portion 201 can be made of a heat-shrinkable tube made of resin. By inserting the core wire 200 into the lumen 41 of the tubular body 40, rigidity can be ensured when inserting the light irradiation device 10 into the endoscope 100, allowing for smooth insertion of the light irradiation device. Furthermore, since the core wire 200 can be inserted up to the small-diameter portion 44, rigidity can be ensured up to the tip of the device, allowing for more reliable and easier insertion of the light irradiation device 10. The tip portion and the cover portion 201 of the core wire 200 may be integrally formed. The core wire 200 may not be covered by the cover portion 201. The core wire 200 may be inserted all the way into the small-diameter portion 44 until it abuts against the innermost portion, or may be inserted until the cover portion 201 of the core wire 200 abuts against the boundary portion 42 of the tubular body 40 after the core wire 200 has entered at least a portion of the small-diameter portion 44. That is, the length of the tip end of the core wire 200 and the length of the small diameter portion 44 may or may not be the same.

[0047] After the core wire 200 is inserted until it hits the small diameter portion 44 of the light irradiation device 10, the light irradiation device 10 is then inserted into the endoscope 100 (S2). The light irradiation device 10 is inserted into the lumen 125 from the fixed adapter 50 fixed to the forceps port 122b of the endoscope 100. The light irradiation device 10 is inserted until the balloon 30 is exposed from the distal end opening 125a of the lumen 125.

[0048] After the light irradiation device 10 is inserted into the endoscope 100, the core wire 200 is removed from the tubular body 40 (S3). Next, the surgeon inserts the light irradiator 90 into the light irradiation device 10 in place of the core wire 200 (S4). The light irradiator 90 is inserted into the lumen 41 of the tubular body 40 from which the core wire 200 has been removed. The light irradiator 90 is inserted until the tip 91 abuts against the boundary portion 42 of the lumen 41. This positions the light irradiation portion 92 of the light irradiator 90 at a predetermined position within the balloon 30 (a position where the light irradiation portion 92 spans the entire length of the light-transmitting window portion 37). After inserting and positioning the light irradiator 90 relative to the balloon 30, the surgeon rotates the rotating portion 75 of the hub 70 to fix the light irradiator 90 to the light irradiation device 10 with the light irradiation device fixing member 74.

[0049] Next, the surgeon grasps the operating handle 60 and aligns the light-transmitting window 37 of the balloon 30 while visually checking the marker on the light irradiation device 10 (not shown) with the lesion so that the light-transmitting window 37 faces the lesion (S5). The surgeon can adjust the longitudinal and circumferential positions of the light-transmitting window 37 using the operating handle 60 to roughly align the balloon 30.

[0050] Next, the surgeon injects fluid into the balloon 30 using the expansion device 80 to temporarily expand the balloon 30 at low pressure, thereby fine-tuning the balloon position (S6). In S6, the expansion pressure of the balloon 30 can be set to 0.5 atm. However, the expansion pressure is not limited to this. After the position of the balloon 30 has been adjusted, the surgeon rotates the rotating portion 55 of the fixing adapter 50 to fix the light irradiation device 10 to the endoscope 100.

[0051] After fine-tuning the balloon position, the surgeon injects fluid into the balloon 30 using the expansion device 80 to expand the balloon at high pressure (S7). In S7, the expansion pressure of the balloon 30 can be set to 2 atm. However, the expansion pressure is not limited to this.

[0052] After expanding the balloon 30 at the lesion, the surgeon irradiates the lesion with light from the light irradiator 92 of the light irradiator 90 (S8). The light is irradiated from the light irradiator 92 to the lesion through the light-transmitting window 37 of the balloon 30. Because the balloon 30 is inflated and comes into contact with the luminal organ and is fixed in place within the body, a constant distance can be maintained between the light irradiator 92 and the lesion, allowing for a stable supply of the necessary light energy to the lesion. Furthermore, because the light is irradiated onto the balloon 30 through the light-transmitting window 37, it is possible to irradiate only the necessary areas with light, thereby reducing the amount of light irradiated onto normal tissue. The light is irradiated for a fixed period of time, for example, 20 minutes. The light irradiation period is not limited to 20 minutes and can be set as needed.

[0053] When the light irradiation is completed, the surgeon deflates the balloon 30 (S9) and removes the light irradiation device 10 from the endoscope 100 (S10).

[0054] As described above, the light irradiation device 10 according to this embodiment includes the balloon 30 formed of a light-transmitting material, and the tubular body 40 that is disposed inside the balloon 30 and has the lumen 41 through which the light irradiator 90 equipped with the light irradiation unit 92 is inserted. The balloon 30 includes the light-transmitting window portion 37 that transmits light from the light irradiation unit 92, and the light-shielding body 36 that is disposed in an area other than the light-transmitting window portion 37 and has a lower transmittance for light from the light irradiation unit 92 than the light-transmitting window portion 37. The light-transmitting window portion 37 has a first end portion 37a on the distal end side of the balloon 30 in the longitudinal direction and a second end portion 37b on the proximal end side of the balloon 30 in the longitudinal direction. The lumen 41 of the tubular body 40 has a boundary portion 42 that abuts against the distal end 91 of the light irradiator 90, at a position distal to the first end portion 37a and proximal to the forefront of the balloon 30. In the light irradiation device 10 configured in this manner, both the light irradiator 90 for treatment and the core wire 200 serving as a reinforcement during insertion can be inserted into the lumen 41 of the tubular body 40. Therefore, the core wire 200 is inserted into the lumen 41 of the tubular body 40 to reliably and easily insert the light irradiation device 10 into the endoscope 100, and when the light irradiator 90 is inserted into the lumen 41 of the tubular body 40 instead of the core wire 200, the tip 91 of the light irradiator 90 can be abutted against the boundary portion 42 to reliably position the light irradiator 90 with respect to the balloon 30, thereby irradiating the lesion with light.

[0055] (2) In the light irradiation device 10 described in (1) above, the lumen 41 of the tubular body 40 may have a small diameter portion 44 located distally of the boundary portion 42 and a large diameter portion 43 located proximally of the boundary portion 42, the large diameter portion 43 having a larger inner diameter than the small diameter portion 44. This allows the core wire 200 to be inserted beyond the distal end of the balloon 30 and further to the distal end side, and the light irradiation device 10 is reliably supported all the way to the distal end, thereby making it possible to more reliably and easily insert the light irradiation device 10 into the endoscope 100.

[0056] (3) In the light irradiation device 10 described in (2) above, the inner diameter of the small diameter portion 44 may be smaller than the outer diameter of the light irradiator 90. This prevents the light irradiator 90 from entering the small diameter portion 44, so that the tip of the light irradiator 90 can reliably abut against the boundary portion 42 and be positioned.

[0057] (4) In the light irradiation device 10 described in (2) or (3) above, the inner diameter of the small diameter portion 44 may be larger than the outer diameter of the core wire 200 inserted into the lumen 41. This allows the core wire 200 to be reliably inserted into the small diameter portion 44.

[0058] (5) In the light irradiation device 10 of any one of (1) to (4) above, the light irradiation unit 92 may be provided on the distal end side of the light irradiator 90 in the longitudinal direction, and the distal end may be located distally of the first end 37a and proximal end may be located proximally of the second end 37b in a state in which the distal end of the light irradiator 90 abuts against the boundary portion 42. In this way, the light irradiation unit 92 emits light over the entire length of the light-transmitting window 37, so that light can be uniformly irradiated from the light-transmitting window 37.

[0059] (6) In any of the light irradiation devices 10 described above in (2) to (5), the boundary portion 42 may have a continuously reduced diameter from the large-diameter portion 43 toward the small-diameter portion 44. This makes it easier to insert the core wire 200 from the large-diameter portion 43 toward the small-diameter portion 44.

[0060] (7) In any of the light irradiation devices 10 described above in (2) to (6), the tubular body 40 may have an outer layer portion 46 that covers the outside of the small diameter portion 44. This ensures rigidity at the distal end of the tubular body 40 and can suppress bending or the like when the light irradiation device 10 is inserted.

[0061] (8) In the light irradiation device 10 of any one of (2) to (6) above, the tubular body 40 may have an outer layer portion 46 that integrally covers the outside of the small diameter portion 44, the boundary portion 42, and the large diameter portion 43. This ensures rigidity at the tip of the tubular body 40, including the boundary portion 42 having a step, and can suppress bending or the like when the light irradiation device 10 is inserted.

[0062] (9) In any of the light irradiation devices 10 described above in (2) to (8), the tubular body 40 may have, at the base end, a deformation absorbing section 47 having an outer diameter smaller than that of the large-diameter section 43. This allows the deformation absorbing section 47 to be easily deformed when the light irradiation device 10 is inserted, thereby preventing bending, twisting, and the like from occurring at the tip end side of the tubular body 40.

[0063] The present invention is not limited to the above-described embodiment, and various modifications may be made by those skilled in the art within the technical spirit of the present invention. In the above-described embodiment, the lumen 41 of the tubular body 40 has the narrowed portion 44 distal to the boundary portion 42, but the distal side of the tubular body 40 distal to the boundary portion 42 may be solid.

[0064] This application is based on Japanese Patent Application No. 2023-167650, filed on September 28, 2023, the disclosures of which are incorporated herein by reference in their entirety.

[0065] DESCRIPTION OF SYMBOLS 10 Light irradiation device 20 Shaft portion 21 Expansion lumen 30 Balloon 33 Straight portion 34 Tapered portion 35 Distal tip 36 Light blocking body 37 Light-transmitting window portion 37a First end portion 37b Second end portion 40 Tubular body 41 Inner cavity 42 Boundary portion 43 Large diameter portion 44 Small diameter portion 46 Outer layer portion 47 Deformation absorbing portion 50 Fixation adapter 60 Operation handle 70 Hub 80 Expansion device 90 Light irradiator 92 Light irradiation portion 100 Endoscope 122 Handle portion 122a Operation portion 122b Forceps port 125 Inner cavity 200 Core wire 201 Cover portion

Claims

1. A light irradiation device comprising: a balloon formed of a light-transmitting material; and a tubular body disposed inside the balloon and having an inner cavity through which a light irradiator equipped with a light irradiation unit is inserted; the balloon has a light-transmitting window portion through which light from the light irradiation unit passes; and a light-shielding body disposed in an area other than the light-transmitting window portion and having a lower transmittance of light from the light irradiation unit than the light-transmitting window portion, the light-transmitting window portion having a first end portion at the distal end side of the balloon in the longitudinal direction and a second end portion at the proximal end side of the balloon in the longitudinal direction, and the inner cavity of the tubular body has a boundary portion at a position distal to the first end portion and proximal to the forefront of the balloon, against which the tip of the light irradiator abuts.

2. The light irradiation device according to claim 1, wherein the inner cavity of the tubular body has a narrow diameter portion on the distal end side of the boundary portion and a wide diameter portion on the proximal end side of the boundary portion, the wide diameter portion having an inner diameter larger than that of the narrow diameter portion.

3. The light irradiating device according to claim 2, wherein the inner diameter of the thin portion is smaller than the outer diameter of the light irradiating body.

4. The light irradiation device according to claim 3, wherein the inner diameter of the thin portion is larger than the outer diameter of a core wire inserted into the inner cavity.

5. A light irradiation device according to any one of claims 1 to 4, wherein the light irradiation section is provided on the tip side of the light irradiator in the longitudinal direction, and when the tip of the light irradiator is abutted against the boundary section, the tip is located further distal than the first end and the base end is located further proximal than the second end.

6. The light irradiation device according to any one of claims 2 to 4, wherein the boundary portion has a diameter that continuously decreases from the large diameter portion toward the small diameter portion.

7. The light irradiation device according to any one of claims 2 to 4, wherein the tubular body has an outer layer portion which covers the outside of the narrow diameter portion.

8. The light irradiation device according to any one of claims 2 to 4, wherein the tubular body has an outer layer portion that integrally covers the outside of the narrow diameter portion, the boundary portion and the wide diameter portion.

9. The light irradiation device according to any one of claims 2 to 4, wherein said tubular body has at its base end a deformation absorbing section having an outer diameter smaller than that of said large diameter section.

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