Treatment Device

Abstract

Provided are a therapy device and a therapy method, which make it possible to treat cancer occurring in a wide region including endocervix effectively.　A therapy device (10) for cervical cancer, provided with: a main body shaft (21) having a tip end part and a base end part; an expanding unit (30) which is arranged on the tip end side of the main body shaft (21) and can be expanded upon the inflow of a fluid; a tip-end shaft (24) which projects toward the tip end side from the expanding unit (30); and at least one irradiation unit (50) which makes it possible to emit excitation light for an antibody-(light-sensitive substance) conjugate from the tip-end shaft (24) and the expanding unit (30).

Description

[Technical field]

[0001] The present invention relates to a method for treating cervical cancer and vaginal cancer. Place Regarding. [Background technology]

[0002] The number of cervical cancer patients is on the rise, especially among young women in their 20s and 30s. The current standard treatment for cervical cancer is to remove the uterus in its entirety from the early stage (stage I), but for young patients, local treatment that can preserve the uterus to maintain fertility is required. In addition, in advanced stages (stage III and later), the cancer spreads to the surrounding tissues, making surgical removal difficult, so a combination of radiation therapy and chemotherapy is the standard treatment. However, the 5-year survival rate is low at 50% in stage III and 20% in stage IV, and more effective treatment is required. As a local cancer treatment, a treatment using a photoreactive substance is known (see, for example, Patent Document 1). In particular, a treatment using an antibody-photosensitive substance (hydrophilic phthalocyanine) can specifically destroy target cells without destroying non-target cells such as normal cells by irradiating excitation light (for example, near-infrared light) to the antibody-photosensitive substance accumulated in the tumor, and is expected to achieve a high therapeutic effect while reducing side effects. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] US Patent Application Publication No. 2018-0113246 Summary of the Invention [Problem to be solved by the invention]

[0004] On the other hand, to obtain a high therapeutic effect of the antibody-photosensitizer, it is necessary to reliably irradiate the antibody-photosensitizer accumulated in the tumor with near-infrared light. However, since light is rapidly attenuated by the influence of biological tissue, the penetration depth of near-infrared light is shallow, and it is very difficult to irradiate solid cancers non-invasively from the body surface with light of the energy required for treatment. Therefore, a method is required to reliably irradiate tumors inside the body with light while minimizing invasiveness. In the case of cervical cancer, the cancer often spreads over a wide area of ​​the cervical canal, and a method is required to irradiate the wide area of ​​the cancer with light from as close as possible.

[0005] The present invention has been made to solve the above-mentioned problems, and provides a treatment device capable of effectively treating cancer in an area including at least a part of the cervix. Place The purpose is to provide. [Means for solving the problem]

[0006] The treatment device according to the present invention for achieving the above object is a treatment device that irradiates excitation light to an antibody-photosensitive substance bound to tumor cells of cervical cancer, and includes a main body shaft having a tip end and a base end, an expansion section that is disposed on the tip side of the main body shaft and can be expanded by an inflow of a fluid, a tip shaft that protrudes from the expansion section to the tip side, and at least one irradiation section that can emit excitation light for the antibody-photosensitive substance from the tip shaft and the expansion section. An irradiation lumen is formed that communicates the inside of the extension portion and the inside of the distal shaft and movably houses the irradiation portion. It is characterized by: Another aspect of the treatment device of the present invention that achieves the above-mentioned object is a treatment device that irradiates excitation light to an antibody-photosensitive substance bound to cervical cancer tumor cells, and is characterized in that it has a main shaft having a tip and a base end, an expansion section that is arranged on the tip side of the main shaft and can be expanded by the inflow of a fluid, a tip shaft that protrudes from the expansion section to the tip side, and at least one irradiation section that can emit excitation light for the antibody-photosensitive substance from the tip shaft and the expansion section, and has an annular reinforcing section that is arranged on the tip side of the expansion section and surrounds the base end of the tip shaft. Effect of the Invention

[0007] The therapeutic device configured as described above can effectively irradiate the antibody-photosensitizer bound to tumor cells in a wide area, including the cervix, with the distal shaft inserted into the cervical canal and the expansion part expanded widely inside the vagina. This allows the therapeutic device to improve the therapeutic effect of cancer in a wide area, including the cervix.

[0008] The distal shaft may irradiate the excitation light in a direction substantially perpendicular to the axis of the distal shaft, and the expansion section may irradiate the excitation light in a direction substantially toward the distal end. This allows the excitation light to be irradiated to tumor cells in the uterine cervix from both the distal shaft and the expansion section, thereby improving the therapeutic effect.

[0009] The treatment device may be formed with an irradiation lumen that communicates the inside of the extension part and the inside of the distal shaft and movably accommodates the irradiation part. This allows the excitation light to be irradiated from the distal shaft and the extension part even in the case of one irradiation part, simplifying the configuration of the treatment device and improving operability. In addition, by moving the irradiation part, the position where the excitation light is irradiated can be appropriately adjusted, improving the treatment effect. The number of irradiation parts is not limited to one.

[0010] The expansion section may have an abutment surface facing the tip side in the expanded state, and a part of the abutment surface away from the axis of the tip shaft may protrude toward the tip side. In this way, by abutting the expansion section against the utero-vaginal portion, the part of the abutment surface protruding toward the tip side can be brought closer to the vaginal vault. Therefore, the excitation light can be effectively irradiated to the vicinity of the vaginal vault where light has difficulty reaching, and the therapeutic effect can be improved.

[0011] The treatment device may have a ring-shaped reinforcing part disposed on the distal side of the expansion part and surrounding the base end of the distal shaft. With this, the distal shaft and the expansion part can be positioned at appropriate positions by inserting the distal shaft into the cervical canal and abutting the reinforcing part against the uterine vagina. Therefore, the excitation light can be irradiated from the distal shaft and the expansion part to a desired position, improving the treatment effect.

[0012] The treatment device may have a detection unit that detects the fluorescence emitted by the antibody-photosensitizer, whereby the degree of destruction of tumor cells by irradiation with excitation light can be confirmed by a change in the fluorescence detected by the detection unit.

[0013] The treatment device further includes a tubular inner shaft that slidably houses the distal shaft, an irradiation shaft including the distal shaft, a movement operation unit to which the base end of the main body shaft is fixed, and a casing that slidably holds the movement operation unit, the inner shaft is fixed to the main body shaft, the distal end of the extension unit is fixed to the inner shaft, and the irradiation shaft is fixed to the casing, and when the movement operation unit moves relative to the casing, the irradiation shaft does not move, and the main body shaft, the inner shaft, and the extension unit move in the axial direction of the main body shaft relative to the casing.This allows the distal shaft to be inserted into the cervical canal while the expansion section is retracted toward the base end relative to the main shaft to ensure a clear field of view. Then, while the distal shaft is maintained at an appropriate position in the cervical canal, the expansion section can be moved and positioned at an appropriate position. This allows both the distal shaft and the expansion section to be accurately and easily positioned at appropriate positions in the cervical canal and vagina. This allows excitation light to be irradiated to a desired position from the distal shaft and the expansion section, improving the therapeutic effect.

[0014] The treatment method of the present invention for achieving the above-mentioned object is a method for treating cervical cancer, comprising the steps of: intravenously administering an antibody-photosensitive substance; 12 to 36 hours after the intravenous administration, inserting into the vagina a treatment device having an expandable expansion section and a tip shaft protruding from the expansion section and capable of irradiating excitation light for the antibody-photosensitive substance; inserting the tip shaft into the cervical canal; expanding the expansion section within the vagina; irradiating excitation light from the tip shaft to surrounding tissues; irradiating excitation light from the expansion section to surrounding tissues; and contracting the expansion section.

[0015] The treatment method configured as described above allows the distal shaft to be inserted from the external cervical os into the cervical canal while visually checking the state in which the expansion part is contracted to ensure a clear field of view, and allows the expansion part to be expanded widely within the vagina. Therefore, by emitting excitation light for the antibody-photosensitizer from the distal shaft and the expansion part, the excitation light can be effectively irradiated onto the antibody-photosensitizer bound to tumor cells in a wide range, including the cervix. Therefore, this treatment method can improve the therapeutic effect of cancer in a wide range, including the cervix.

[0016] In the step of irradiating excitation light from the distal shaft, an irradiation unit capable of irradiating the excitation light is disposed inside the distal shaft and the excitation light is irradiated from the irradiation unit, and in the step of irradiating excitation light from the extension unit, the irradiation unit is disposed inside the extension unit and the excitation light is irradiated from the irradiation unit, and the irradiation unit may be moved between the distal shaft and the extension unit between the step of irradiating excitation light from the distal shaft and the step of irradiating excitation light from the extension unit. As a result, even in the case of one irradiation unit, the excitation light can be irradiated from the distal shaft and the extension unit, simplifying the configuration of the treatment device and improving operability. In addition, by moving the irradiation unit, the position where the excitation light is irradiated can be appropriately adjusted, thereby improving the treatment effect. The order of irradiating excitation light is not limited. Therefore, the excitation light may be irradiated first from the distal shaft, or the excitation light may be irradiated first from the extension unit. The number of irradiation units is not limited to one.

[0017] The step of irradiating the excitation light from the distal shaft and the step of irradiating the excitation light from the extension part may be performed simultaneously. This allows the present treatment method to irradiate the excitation light from various positions and directions simultaneously, thereby improving the therapeutic effect and enabling efficient treatment in a short time.

[0018] In the step of inserting the distal shaft into the cervical canal, a butting surface disposed on the base end side of the distal shaft and facing the distal end side when the distal shaft is led out may be butted against the uterine vaginal portion. This allows the distal shaft and the expansion section to be positioned at appropriate positions. This allows excitation light to be irradiated from the distal shaft and the expansion section to a desired position, improving the therapeutic effect.

[0019] The treatment method may include a step of detecting the fluorescence emitted by the antibody-photosensitizer and confirming the intensity of the fluorescence, thereby enabling the treatment method to confirm the degree of destruction of tumor cells by irradiation with excitation light by detecting the fluorescence.

[0020] The step of checking the intensity of the fluorescence may be performed in parallel with the step of irradiating the excitation light, whereby the present treatment method can treat the tumor cells while checking the degree of destruction of the tumor cells by irradiation with the excitation light by detecting the fluorescence, thereby improving the therapeutic effect.

[0021] The step of checking the intensity of the fluorescence may be performed after the step of irradiating the excitation light, whereby the treatment method can accurately check the result of the destruction of the tumor cells by irradiation with the excitation light by detecting the fluorescence. [Brief description of the drawings]

[0022] [Figure 1] FIG. 2 is a plan view showing a treatment device according to an embodiment. [Diagram 2] Schematic diagram showing the vagina and uterus, (A) showing the patient from the front and (B) showing the patient from the left side. [Diagram 3] 3A and 3B are views showing the distal end of a treatment device according to an embodiment, in which (A) is a cross-sectional view and (B) is a cross-sectional view taken along line AA in FIG. 3A. [Figure 4] 1A and 1B are plan views showing modified examples of the distal shaft, where (A) shows a first modified example and (B) shows a second modified example. [Diagram 5] FIG. 13 is a plan view showing a third modified example. [Figure 6] 11A to 11E are cross-sectional views showing modified examples of the extension portion, where (A) is a fourth modified example, (B) is a fifth modified example, (C) is a sixth modified example, (D) is a seventh modified example, and (E) is an eighth modified example. [Figure 7] 11A to 11C are cross-sectional views showing modified examples of the extension portion, where (A) shows a ninth modified example, (B) shows a tenth modified example, and (C) shows an eleventh modified example. [Figure 8] 11A and 11B are plan views showing modified examples of the extension portion, where (A) is the 12th modified example, (B) is the 13th modified example, (C) is the 14th modified example, (D) is the 15th modified example, (E) is the 16th modified example, and (F) is the 17th modified example. [Figure 9]13A to 13C are perspective views showing modified examples of the reinforcing portion, where (A) shows a 17th modified example, (B) shows an 18th modified example, and (C) shows a 19th modified example. [Figure 10] 13A and 13B are plan views showing modified examples of the abutment surface, where (A) shows a twentieth modified example, and (B) shows a twenty-first modified example. [Figure 11] 13A to 13C are plan views showing modified examples of the irradiation unit, where (A) shows the present embodiment, (B) shows a twenty-second modified example, and (C) shows a twenty-third modified example. [Figure 12] FIG. 24 is a plan view showing a twenty-fourth variant of the treatment device. [Figure 13] 13A and 13B are diagrams showing the distal end portion of a 24th modified example of the treatment device, where (A) is a cross-sectional view, and (B) is a cross-sectional view taken along line AA in FIG. 13A. [Figure 14] 1 is a schematic diagram showing a state in which a distal shaft of a treatment device according to an embodiment is inserted into the cervical canal. [Figure 15] 1 is a schematic diagram showing the state in which near-infrared light is irradiated onto tumor cells from a distal shaft inserted into the cervical canal. [Figure 16] FIG. 1 is a schematic diagram showing near-infrared radiation being irradiated onto tumor cells from an expanded portion inside the vagina. [Figure 17] FIG. 25 is a plan view showing a twenty-fifth variant of the treatment device. [Figure 18] FIG. 26 is a plan view showing a twenty-sixth variant of the treatment device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Hereinafter, an embodiment 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. In this specification and the drawings, components having substantially the same functional configurations are given the same reference numerals to avoid redundant explanation. In this specification, the side of the device that is inserted into a biological lumen is referred to as the "distal side" and the side that is operated is referred to as the "base side".

[0024] The treatment device 10 according to the present embodiment is used in a method for treating cervical cancer. The treatment device 10 and the treatment method can also be used to treat both cervical cancer and vaginal cancer simultaneously. This treatment method is used in photoimmunotherapy, in which an antibody-photosensitizer bound to the cell membrane of a target cell is irradiated with near-infrared light, which is the excitation light for the antibody-photosensitizer, to destroy the target cell. The target cell is a tumor cell such as a cancer cell. In this treatment method, an antibody-photosensitizer, which is a combination of an antibody that specifically binds only to a specific antigen on the surface of a tumor cell and a photosensitizer that pairs with the antibody, is used as a drug. The antibody is not particularly limited, but examples thereof include panitumubab, trastuzumab, HuJ591, pertuzumab, lapatinib, palbociclib, and olaparib. The photosensitizer is, for example, hydrophilic phthalocyanine, which is a substance (IR700) that reacts to near-infrared light with a wavelength of about 700 nm, but is not limited thereto. When IR700 is exposed to near-infrared rays with a wavelength of approximately 660 to 740 nm, the ligand of the functional group that ensures water solubility is broken, and a structural change occurs from water solubility to hydrophobicity. This structural change pulls out membrane proteins, opening holes in the cell membrane and allowing water to enter the cell, rupturing and destroying cancer cells. In addition, IR700 is excited by near-infrared rays and emits fluorescence with a wavelength different from the excitation wavelength. For example, when IR700 is excited by near-infrared rays with a wavelength of 689 nm, it emits fluorescence with a wavelength of 704 nm. IR700 undergoes a structural change while emitting fluorescence due to a photoreaction, and when it destroys tumor cells and fulfills its role as a drug, it no longer emits fluorescence.

[0025] The treatment apparatus 10 shown in Fig. 1 can treat cervical cancer and vaginal cancer in a wide range A, including the cervix U, the external cervical os O, the cervix vaginal portion UV around the external cervical os O, the vaginal vault VF, and the area of ​​the vagina V closer to the vaginal opening side than the vaginal vault VF, as shown in Figs. 2, 14, 15, and 16. The treatment apparatus 10 can irradiate the antibody-photosensitizer bound to tumor cells C in a wide range from the cervix U to the vagina V with excitation light.

[0026] The uterus is located deep inside the vagina V, with the upper part of the uterus connected to the left and right fallopian tubes and the external cervical os O at the lower part of the uterus connected to the vagina V. The uterus is roughly divided into the uterine body and the cervix U, and the cervix U has a cervical canal CC that connects to the external cervical os O. The vagina V has a vaginal vault VF that extends to surround the external cervical os O. The vaginal vault VF is deeper at the posterior vaginal vault RV located at the rear of the vagina V than at the anterior vaginal vault AV located at the front of the vagina V.

[0027] First, a treatment device 10 according to this embodiment will be described.

[0028] 1 and 3, the treatment device 10 has a long shaft portion 20 having a distal end and a proximal end, an expansion portion 30 which is a balloon provided at the distal end of the shaft portion 20, an operation portion 60 connected to the proximal end of the shaft portion 20, and a long irradiation portion 50 which irradiates light. The treatment device 10 is connected to a light output device 80 when used.

[0029] The shaft portion 20 comprises a main body shaft 21 which is a tubular body extending from the operating portion 60 toward the tip, an irradiation shaft 22 which houses the irradiation portion 50, and a flow path shaft 23 through which a fluid such as gas or liquid flows to expand the expansion portion 30.

[0030] The main body shaft 21 is a tube that supports the extension section 30. The main body shaft 21 accommodates the irradiation shaft 22 and the flow path shaft 23 in its lumen. The main body shaft 21 is a circular tube that extends in a straight line, but may be curved or may not be a circular tube. The base end of the main body shaft 21 is fixed to the operation section 60. The tip end of the main body shaft 21 is fixed to the base end of the extension section 30. A sealing member 45 is disposed inside the tip end of the main body shaft 21, isolating the inside of the main body shaft 21 from the inside of the extension section 30. The sealing member 45 prevents fluid from flowing from the inside of the extension section 30 into the lumen of the main body shaft 21.

[0031] The main body shaft 21 preferably has a certain degree of rigidity so that the surgeon can grasp the operation portion 60 and push it to a desired position. The material of the main body shaft 21 is not particularly limited, but may be metals such as stainless steel, aluminum, titanium alloy, tin, magnesium alloy, etc., or resins such as polyetheretherketone (PEEK), polyamide, acrylonitrile-butadiene-styrene (ABS), polycarbonate, polyacetal, polyimide, etc. The length of the main body shaft 21 in the axial direction is not particularly limited, but may be, for example, 100 to 400 mm.

[0032] The irradiation shaft 22 is a tubular member capable of accommodating the irradiation unit 50 therein, and allows light from the irradiation unit 50 to pass therethrough to the outside. A part of the irradiation shaft 22 is disposed inside the main shaft 21 and the extension unit 30. The tip of the irradiation shaft 22 extends further toward the tip side than the main shaft 21 and the extension unit 30. The part of the irradiation shaft 22 protruding further toward the tip side than the extension unit 30 is the tip shaft 24. The tip shaft 24 is a part that is inserted into the cervical canal CC from the external cervical os O in order to irradiate light from inside the cervical canal CC to the cervix U (see FIG. 14). The base end of the irradiation shaft 22 extends further toward the base side than the main shaft 21 and the operation unit 60. An irradiation lumen 25 through which the irradiation unit 50 can move is formed inside the irradiation shaft 22. The irradiation lumen 25 is closed at the tip end of the irradiation shaft 22 and is open at the very base end of the irradiation shaft 22. An insertion port 28 for receiving the irradiation section 50 into the irradiation lumen 25 is arranged on the proximal end side of the irradiation shaft 22 .

[0033] The irradiation shaft 22 is formed of a transparent or translucent material that can transmit light of a wavelength emitted by the irradiation unit 50 housed therein. The material of the irradiation shaft 22 is not particularly limited, but may be, for example, a resin such as polymethyl methacrylate, polyethylene terephthalate, polycarbonate, polytetrafluoroethylene, or glass. It is more preferable that the material of the distal shaft 24 has elasticity and has physical properties that allow it to deform while bending along the cervical canal after being inserted into the cervical canal. This makes it possible to accommodate individual differences in the shape of the cervical canal, reduce the burden on the inner surface of the cervical canal, and further increase the adhesion to the inner surface of the cervical canal. The outer diameter of the irradiation shaft 22 (tip shaft 24) is not particularly limited, but may be, for example, 0.5 to 6 mm. The length of the tip shaft 24 in the axial direction is not particularly limited, but may be, for example, 10 to 50 mm. The distal shaft 24 may have a function of diffusing light. For this purpose, the distal shaft 24 may contain scatterers in at least a part of its constituent material, may have a number of irregularities formed on its inner or outer surface, or may have a multi-layer structure in which materials with different refractive indices are bonded together at a surface on which a number of irregularities are formed, similar to the extension section 30 described later in detail. The distal shaft 24 is formed to be rigid, substantially rigid, or flexible.

[0034] The shape of the tip shaft 24 is not particularly limited. For example, as in the first modified example shown in FIG. 4(A), the tip shaft 24 may have a concave-convex structure 24A aligned in the axial direction. This allows the surgeon to easily grasp how far the tip shaft 24 has been inserted into the cervical canal CC by visually checking the concave-convex structure 24A when inserting the tip shaft 24 from the external cervical os O into the cervical canal CC. In addition, the surgeon can easily grasp how far the tip shaft 24 has been inserted into the cervical canal CC from the change in sensation felt by the hand gripping the operation unit 60 when inserting the concave-convex structure 24A from the external cervical os O into the cervical canal CC. The tip shaft 24 may have lines or notches that serve as scales as a structure that is easy to visually confirm. In addition, the tip shaft 24 may have physical properties that change along the axial direction so that the sensation felt by the surgeon's hand changes when the surgeon inserts the tip shaft 24 from the external cervical os O into the cervical canal CC. For example, the distal shaft 24 may have a decreasing stiffness in a distal direction or may have alternating sections of higher and lower stiffness.

[0035] Also, as in the second modified example shown in FIG. 4(B), the distal end shaft 24 may have one large diameter portion 24B with a large outer diameter at the distal end. This allows the surgeon to easily know that the large diameter portion 24B has passed the internal cervical os I and reached the uterine cavity UC after inserting the distal end shaft 24 from the external cervical os O into the cervical canal CC, from the change in sensation felt by the hand gripping the operation unit 60. For example, after the large diameter portion 24B has passed the internal cervical os I, the surgeon can move the operation unit 60 backward to bring the large diameter portion 24B into contact with the internal cervical os I. Therefore, the distal end shaft 24 having the large diameter portion 24B is effective when it is desired to accurately position the distal end of the distal end shaft 24 relative to the internal cervical os I, or when it is desired to reliably pass through the internal cervical os I. The position of the large diameter portion 24B is not limited to the tip of the distal end shaft 24.

[0036] Also, as in the third modified example shown in FIG. 5, the distal shaft 24 may have a bag-shaped first balloon 24C at the distal end, which is flexibly deformable. The first balloon 24C is in communication with a bag-shaped second balloon 24D arranged in the operation unit 60 through a tube 24E. A fluid such as a gas or liquid is sealed in the first balloon 24C, the second balloon 24D, and the tube 24E. As a result, when the distal shaft 24 enters the cervical canal CC from the external cervical os O, the first balloon 24C collapses and the fluid inside the first balloon 24C moves toward the second balloon 24D, causing the second balloon 24D to expand greatly. As a result, the surgeon can easily recognize that the distal shaft 24 equipped with the first balloon 24C has entered the cervical canal CC by looking at the second balloon 24D. In addition, when the first balloon 24C passes the internal cervical os I, the first balloon 24C expands due to its own restoring force, and the fluid inside the second balloon 24D moves toward the first balloon 24C, causing the second balloon 24D to become smaller. This allows the surgeon to easily understand that the distal shaft 24 equipped with the first balloon 24C has passed the internal cervical os I by looking at the second balloon 24D.

[0037] The surgeon may insert the distal shaft 24 from the external cervical os O into the cervical canal CC while emitting light from the irradiation unit 50 disposed inside the distal shaft 24. The surgeon cannot see the light emitted from the part of the distal shaft 24 inserted into the cervical canal CC. Therefore, the surgeon can easily visually determine how far the distal shaft 24 has been inserted into the cervical canal CC. In this case, even if the distal shaft 24 does not have the uneven structure 24A or the large diameter portion 24B, the surgeon can visually determine how far the distal shaft 24 has been inserted into the cervical canal CC.

[0038] The flow path shaft 23 is disposed inside the main body shaft 21, as shown in Figures 1 and 3. The tip of the flow path shaft 23 is located near the tip of the main body shaft 21. The base end of the flow path shaft 23 extends further toward the base end than the main body shaft 21 and the operation section 60. An expansion lumen 26 is formed inside the flow path shaft 23, through which an expansion fluid for expanding the expansion section 30 flows. The expansion lumen 26 is in communication with the inside of the expansion section 30. A port 27 is disposed at the base end of the flow path shaft 23, to which a syringe or an indeflator for supplying the expansion fluid can be connected.

[0039] The expansion unit 30 is a member that is disposed on the base end side of the distal shaft 24 inserted into the cervical canal CC and expands inside the vagina V, enabling light to be irradiated over a wide area of ​​the vagina V. The expansion unit 30 can transmit to the outside light emitted from the irradiation unit 50 disposed in the irradiation lumen 25 that passes through the inside of the expansion unit 30. For this reason, the expansion unit 30 is formed from a transparent or translucent material that can transmit light of the wavelength emitted by the irradiation unit 50.

[0040] The distal end of the expansion part 30 is adhered to the irradiation shaft 22, and the proximal end of the expansion part 30 is adhered to the main body shaft 21. The inside of the expansion part 30 is in communication with the expansion lumen 26. The expansion part 30 is deformed and expandable by the inflow of fluid therein.

[0041] The expansion section 30 includes a tip expansion section 31 on the tip side, a base end expansion section 32 on the base end side, and an intermediate expansion section 33 disposed between the base end expansion section 32 and the tip expansion section 31. The tip expansion section 31 is fixed to the outer circumferential surface of the irradiation shaft 22. In the expanded state of the expansion section 30, the tip expansion section 31 forms a flat abutment surface 34 facing the tip side. The abutment surface 34 is substantially perpendicular to the axis of the shaft section 20 and abuts against the uterine vaginal portion UV around the external cervical os O. The shape of the abutment surface 34 may change depending on the internal pressure of the expansion section 30. For example, when the internal pressure of the expansion section 30 is high, the abutment surface 34 may be shaped to protrude toward the tip side at a position radially away from the irradiation shaft 22 rather than at a position radially closer to the irradiation shaft 22. The intermediate expansion section 33 is cylindrical in shape with a substantially constant outer diameter in the axial direction between the base end expansion section 32 and the tip expansion section 31. It should be noted that the intermediate expansion portion 33 does not have to be formed with a substantially constant outer diameter.

[0042] The base end of the base end expansion section 32 is fixed to the outer circumferential surface of the main body shaft 21. In the expanded state, the outer diameter of the base end expansion section 32 increases in a tapered manner toward the tip side. The tip end of the base end expansion section 32 is connected to the base end of the intermediate expansion section 33. The tapered base end expansion section 32 prevents the expansion section 30 from being pushed toward the base end and deformed when the tip expansion section 31 hits the uterine vaginal section UV and receives a reaction force in the base end direction. The base end expansion section 32 does not have to be formed in a tapered shape.

[0043] The constituent material of the expansion part 30 is not particularly limited as long as it has a certain degree of flexibility and can transmit light of the wavelength emitted from the irradiation part 50, but examples of such materials include silicone, polyamide, polyethylene terephthalate, and urethane. The maximum outer diameter of the expansion part 30 when expanded is not particularly limited, but is, for example, 5 to 40 mm. The length of the expansion part 30 in the axial direction (longitudinal direction) when expanded is not particularly limited, but is, for example, 10 to 60 mm.

[0044] The extension unit 30 may have a structure that scatters the light received from the irradiation unit 50 inside the extension unit 30. This allows the extension unit 30 itself to emit light by the light received from the irradiation unit 50. Therefore, light can be irradiated to a wide range via the extension unit 30, in addition to the range where light directly reaches from the irradiation unit 50.

[0045] The extension section 30 may have a structure for scattering light on the inner surface side. For example, the extension section 30 has a scatterer coat 36 including scatterers 35 on the inner surface as in the fourth modified example shown in FIG. 6(A). The scatterers 35 may be known, for example, minute particles such as titanium oxide, styrene, silicone, etc. The scatterer coat 36 is coated by mixing the scatterers 35 with a coating base material having a refractive index different from that of the scatterers 35. The extension section 30 may have a number of minute uneven portions 37 on the inner surface as a structure for scattering light as in the fifth modified example shown in FIG. 6(B). The extension section 30 may have a number of minute uneven portions 37 on the outer surface as a structure for scattering light as in the sixth modified example shown in FIG. 6(C). When the uneven portion 37 on the outer surface of the expansion part 30 comes into contact with a living body (organ) such as the cervix UV or vagina V, the light irradiated from inside the expansion part 30 is easily transmitted into the living body without being reflected by the uneven portion 37, and the amount of light inside the expansion part 30 is reduced. For this reason, by providing a detection unit 90 (see FIG. 16) that can detect the amount of light inside the expansion part 30, it is possible to determine that the expansion part 30 is in close contact with the living body. In order for the uneven portion 37 of the expansion part 30 to easily transmit light into the living body when it comes into contact with the living body, it is preferable that the refractive index of the expansion part 30 is greater than the refractive index of air and less than or equal to the refractive index of the living body, for example, greater than 1.0 to about 1.5.

[0046] The extension section 30 may also have a structure that scatters light inside the material of the extension section 30. For example, the extension section 30 may include a scatterer 35 inside the material of the extension section 30, as in a seventh modified example shown in Fig. 6(D). The extension section 30 may also have a structure in which a first layer 38A and a second layer 38B having different refractive indices are bonded together at a surface having projections and recesses, as in an eighth modified example shown in Fig. 6(E).

[0047] Furthermore, the scatterers 35 may be mixed into the expansion fluid supplied to the inside of the expansion section 30. In this case, the expansion section 30 itself may or may not be provided with a structure for scattering light.

[0048] The expansion section 30 may also have a structure for improving the irradiation intensity in a specific direction. For example, it is preferable that the expansion section 30 does not irradiate in the base end direction, but irradiates light in the radial direction and the tip direction. This improves the intensity of light that can be irradiated from the expansion section 30 to the cervix U or tumor cells C in the vagina V close to the cervix U. The structure for improving the irradiation intensity in a specific direction is, for example, a structure that makes it difficult for light to leak from the base end side of the expansion section 30 to the outside. For example, the expansion section 30 may have a reflector coat 39 formed of a reflector that reflects light on the inner surface of the base end expansion section 32, as in the ninth modified example shown in FIG. 7(A). The reflector may be disposed inside the material of the expansion section 30 or on the outer surface of the expansion section 30. 7(B), the material of the extension section 30 may contain scatterers 35, and the concentration of scatterers 35 in the base end extension section 32 may be made higher than the concentration of scatterers 35 in the tip extension section 31 and the intermediate extension section 33. The material of the extension section 30 may contain scatterers 35, and the thickness of the base end extension section 32 may be made thicker than the thicknesses of the tip extension section 31 and the intermediate extension section 33.

[0049] The expansion part 30 can be formed in various shapes. It is preferable that the expansion part 30 can be appropriately selected depending on the shapes of the cervix UV, vaginal vault VF, and vagina V of the patient.

[0050] 8(A), in the expanded state, the abutment surface 34 may be inclined at an angle of less than 90° with respect to a plane perpendicular to the axis of the shaft portion 20. This makes it easy to arrange, for example, the part of the abutment surface 34 that protrudes toward the tip side on the posterior vaginal fornix RV side and the part on the opposite side on the anterior vaginal fornix AV side. This allows light to be effectively irradiated to areas that are difficult for light to reach, including the posterior vaginal fornix RV and the anterior vaginal fornix AV.

[0051] 8(B), the center of the abutment surface 34 (the portion close to the distal shaft 24) may be recessed toward the base end in the expanded state. This allows the external cervical os O to be received in the recessed portion of the abutment surface 34, and the portion of the abutment surface 34 radially distant from the distal shaft 24 (the portion on the outside in the circumferential direction) to be effectively brought close to the vaginal vault VF. This allows light to be effectively irradiated to the vaginal vault VF, which is difficult for light to reach.

[0052] 8(C), in the expanded state, a part of the abutment surface 34 radially away from the center (the part close to the distal shaft 24) may protrude toward the distal end, and the other part may be perpendicular to the axis of the shaft portion 20. This allows the protruding part of the abutment surface 34 to be effectively brought close to the vaginal vault VF. This allows light to be effectively irradiated to the vaginal vault VF, which is difficult for light to reach.

[0053] Furthermore, as in a 15th modified example shown in Figure 8 (D), in the expanded state, the central portion (the portion close to the tip shaft 24) of the abutment surface 34 may be perpendicular to the axis of the shaft portion 20, and the periphery of the perpendicular portion may smoothly protrude radially outward so as to form an arc shape in a cross section passing through the axis of the shaft portion 20.

[0054] Also, as in the 16th modified example shown in FIG. 8(E), in the expanded state, the center of the abutting surface 34 (the part close to the distal shaft 24) is perpendicular to the axis of the shaft part 20, and a protrusion 40 protruding toward the distal end side may be formed on each of both sides of the perpendicular part. The two protrusions 40 are made of a material that is harder than the material of the expansion part 30 and transmits light. The two protrusions 40 approach both of the two parts of the vaginal fornix VF that sandwich the external cervical os O (for example, the posterior vaginal fornix RV and the anterior vaginal fornix AV), and can effectively propagate light to the vaginal fornix VF where light is difficult to reach. The hardness (softness) of the material can be specified by, for example, Rockwell hardness, Brinell hardness, Vickers hardness, Shore hardness, durometer hardness, etc.

[0055] Also, as in the 17th modified example shown in FIG. 8(F), in the expanded state, the expansion section 30 may have a first bent section 41 so that the axis of the tip section is bent at an angle of less than 90° with respect to the axis of the base end section. In the expanded state, the center of the abutment surface 34 (the part close to the distal shaft 24) is formed to be recessed toward the base end side. Also, the distal shaft 24 may have a second bent section 29 so that the axis of the tip section is bent at an angle of less than 90° with respect to the axis of the base end section. This allows the tip of the distal shaft 24 to be shifted from the axis of the shaft section 20, and a better field of view can be secured when the tip of the distal shaft 24 is inserted into the cervix under visual confirmation. Also, the bent side of the distal shaft 24 may be approximately the same as the bent side of the expansion section 30. This makes it easier to insert the distal shaft 24 into the cervical canal CC that extends at an angle with respect to the extension direction of the vagina V, for example. In addition, the height L1 from the recessed portion of the abutting surface 34 on the bending direction side of the extension part 30 is shorter than the height L2 from the recessed portion of the abutting surface 34 on the opposite side. Therefore, by arranging the abutting surface 34 on the bending direction side on the anterior vaginal fornix AV side and the abutting surface 34 on the opposite side on the posterior vaginal fornix RV side, the abutting surface 34 can be brought close to the entire vaginal fornix VF including the anterior vaginal fornix AV and the posterior vaginal fornix RV. Therefore, light can be effectively irradiated to the range where light is difficult to reach, including the posterior vaginal fornix RV and the anterior vaginal fornix AV. The height L1 from the recessed portion of the abutting surface 34 on the bending direction side of the extension part 30 is, for example, 5 to 20 mm. The height L2 from the recessed portion of the abutting surface 34 on the opposite side of the bending direction of the extension part 30 is, for example, 10 to 30 mm. A reinforcing part 70, which will be described later in detail, may be arranged in the recessed portion of the abutting surface 34, but may not be arranged.

[0056] The treatment device 10 may have an annular reinforcing part 70 surrounding the base end of the distal shaft 24, as in the 17th modified example shown in FIG. 8(F) and FIG. 9(A). The base end of the distal shaft 24 includes the part of the distal shaft 24 to which the distal end of the extension part 30 is joined. The reinforcing part 70 is annular with a through hole 71 and is formed with a constant inner diameter and outer diameter. The material of the reinforcing part 70 is not particularly limited as long as it is harder than the extension part 30 and can transmit light of the wavelength emitted from the irradiation part 50, but may be, for example, a resin such as polymethyl methacrylate, polyethylene terephthalate, polycarbonate, polytetrafluoroethylene, or glass. Furthermore, it is more preferable to provide a scatterer or a structure that scatters light.

[0057] The reinforcing part 70 is arranged in contact with or in close proximity to the abutment surface 34 of the expansion part 30. A second abutment surface 72 (abutment surface) is formed on the tip side of the reinforcing part 70. The second abutment surface 72 can abut against the cervix vaginal part UV together with the abutment surface 34 of the expansion part 30. When the reinforcing part 70 is provided in the treatment device 10, the abutment surface 34 of the expansion part 30 may abut against the reinforcing part 70 and not against the cervix vaginal part UV. The reinforcing part 70 is harder than the expansion part 30, and is therefore less likely to deform. For this reason, by abutting the reinforcing part 70 against the cervix vaginal part UV, the expansion part 30 and the distal shaft 24 can be accurately positioned with respect to the cervix U and the vagina V. The reinforcing part 70 may be fixed to the distal shaft 24, but may be slidable along the distal shaft 24.

[0058] Also, as in the 18th modified example shown in FIG. 9(B), the annular reinforcing part 70 may have an outer peripheral surface that forms a smooth convex part on the radially outward side. Also, as in the 19th modified example shown in FIG. 9(C), the annular reinforcing part 70 may have a cylindrical convex part 73 that protrudes toward the tip side around the through hole 71. As a result, the second abutting surface 72 is formed with a step. When the abutting surface 34 is abutted against the uterine vaginal part UV, at least a part of the cylindrical convex part 73 is likely to enter the external cervical os O. Therefore, by abutting the reinforcing part 70 having the cylindrical convex part 73 against the uterine vaginal part UV where the external cervical os O is formed, the expansion part 30 and the tip shaft 24 can be accurately positioned with respect to the uterine cervix U and the vagina V.

[0059] Furthermore, as in a 20th modified example shown in FIG. 10(A), the irradiation shaft 22 may have a step portion at the base end of the tip shaft 24 where the outer diameter increases in a stepped manner, and a third abutment surface 22A (abutment surface) facing the tip side may be formed in this step portion.

[0060] Furthermore, as in a 21st modified example shown in FIG. 10(B), the reinforcing portion 70 may be fixed to the tip side surface of the tip extension portion 31 so as to be deformable together with the extension portion 30, and may be a light-transmitting member.

[0061] As shown in Figs. 1 and 3, the irradiation unit 50 is long and includes at least one optical fiber 51 that propagates light. The irradiation unit 50 includes a light-emitting unit 52 at its tip that irradiates light to the outside. The base end of the irradiation unit 50 can be connected to a light output device 80 that outputs light. The irradiation unit 50 can receive near-infrared rays from the light output device 80, propagate the near-infrared rays to the light-emitting unit 52, and irradiate the near-infrared rays from the light-emitting unit 52. The irradiation unit 50 may be formed of an optical waveguide other than an optical fiber.

[0062] As shown in FIG. 11(A), the light emitting unit 52 is a cylindrical diffuser that is connected to the cut end of the optical fiber 51 and diffuses or scatters the light received from the optical fiber 51. The light emitting unit 52 may be integrally formed by processing the surface or the inside of the optical fiber 51, or may be the cut end of the optical fiber 51. In this case, it is preferable that a plurality of optical fibers 51 are provided in order to irradiate light at a wide irradiation angle. The light emitting unit 52 may be formed by a mirror 53 and / or a lens 54 arranged at the cut end of the optical fiber 51, as in the 22nd modified example shown in FIG. 11(B). The light emitting unit 52 can widen the irradiation angle of light by being formed by the mirror 53 and / or the lens 54. By rotating the optical fiber 51, the light emitting unit 52 can irradiate light to an even wider range.

[0063] In addition, the light emitting unit 52 may not be disposed inside the shaft unit 20 as a method of propagating light to the extension unit 30, or may not be disposed inside the extension unit 30. For example, as in the twenty-third modified example shown in FIG. 11(C), the irradiation unit 50 may have an irradiation auxiliary unit 55 surrounding the shaft unit 20 on the base end side of the extension unit 30, and the light emitting unit 52 may be disposed in the irradiation auxiliary unit 55. The light emitting unit 52 has an inner peripheral surface that expands toward the tip direction so as to cover a part of the base end side surface of the base end extension unit 32 during expansion. The light emitting unit 52 is disposed on this inner peripheral surface. The light emitting unit 52 is a cut end of an optical fiber, a diffuser, a mirror, a lens, or an LED that emits light by electricity. When the light emitting unit 52 of the irradiation auxiliary unit 55 emits light, light is irradiated from the base end side of the extension unit 30 to the inside of the extension unit 30. As a result, the extension unit 30 can receive light from the light emitting unit 52 of the irradiation auxiliary unit 55 and emit light almost entirely. The light emitting section 52 provided in the auxiliary irradiation section 55 may be used together with the irradiation section 50 provided in the irradiation lumen 25 .

[0064] As shown in FIG. 1, the operation unit 60 is a portion that is held and operated by the surgeon. The base end of the main body shaft 21 is fixed to the operation unit 60. The irradiation shaft 22 and the flow path shaft 23 are led out from the base end of the operation unit 60. The irradiation shaft 22 and the flow path shaft 23 may be fixed at the base end of the operation unit 60. The operation unit 60 is curved from the tip end to the base end so that the surgeon can easily secure a field of view inside the vagina V when the expansion unit 30 and the tip shaft 24 are inserted from the vaginal opening. The configuration of the operation unit 60 is not particularly limited.

[0065] The light output device 80 can output light of any wavelength with any intensity (power) or energy to the optical fiber 51 of the irradiation section 50. The light output device 80 can output near-infrared light with a wavelength of, for example, 660 to 740 nm with an intensity (power) of, for example, 1 mW to 5 W and an energy of, for example, 1 to 50 Jcm. -2 The output is sent to the optical fiber 51 so that light can be emitted with this energy.

[0066] As in the twenty-fourth modified example shown in Figs. 12 and 13, the extension section 30 may be movable in the axial direction relative to the tip shaft 24. The tip of the extension section 30 is fixed not to the tip shaft 24 but to the tubular inner shaft 21A that slidably accommodates the tip shaft 24. The inner shaft 21A is fixed to the main body shaft 21 by a sealing member 45. The base end of the main body shaft 21 is slidable in the casing 61 of the operation section 60 and is fixed to the moving operation section 62. The moving operation section 62 is held slidably relative to the casing 61. The irradiation shaft 22 including the tip shaft 24 is fixed to the casing 61. When the moving operation section 62 moves relative to the casing 61, the irradiation shaft 22 does not move, and the main body shaft 21, the flow path shaft 23, the inner shaft 21A, and the extension section 30 move relative to the casing 61. When the treatment device 10 is provided with a reinforcing part 70, the reinforcing part 70 also moves together with the expansion part 30 as the movement operation part 62 moves. Therefore, after the surgeon places the distal shaft 24 at a desired position relative to the cervical canal CC, the surgeon can operate the movement operation part 62 to move the expansion part 30 to a desired position without moving the distal shaft 24 relative to the cervical canal CC. Alternatively, the surgeon can move and adjust the expansion part 30 so that the protruding length of the distal shaft 24 is an appropriate length according to individual differences before use.

[0067] Next, a treatment method using the treatment device 10 according to the embodiment will be described.

[0068] First, the antibody-photosensitizer is intravenously administered. After about 12 to 36 hours from the intravenous administration, the surgeon opens the vaginal opening using a vaginal speculum 100 as shown in FIG. 14, and inserts the treatment device 10, with the expansion section 30 contracted, from the vaginal opening into the vagina V. At this time, the surgeon inserts the treatment device 10 from the distal shaft 24 side. Next, while visually checking the distal end of the distal shaft 24, the surgeon inserts it from the external cervical os O into the cervical canal CC. At this time, since the expansion section 30 has not been expanded, the surgeon can easily insert the distal shaft 24 into the cervical canal CC.

[0069] Next, as shown in FIG. 15, the surgeon connects a syringe or an indeflator containing a fluid such as air or saline to the port 27, and supplies the expansion fluid into the expansion portion 30 through the expansion lumen 26. This causes the expansion portion 30 to expand within the vagina V. It is preferable that the expansion portion 30 is expanded to such an extent that the expansion portion 30 can be moved within the vagina V. Next, the surgeon pushes in the operating portion 60, and presses the abutment surface 34 of the expanded expansion portion 30 against the uterine vaginal portion UV. The uterine vaginal portion UV is a portion of the cervix U on the vagina V side, where the external cervical os O is formed. When the expansion portion 30 is in close contact with the uterine vaginal portion UV, the distal shaft 24 is positioned within the cervical canal CC, and the expansion portion 30 is positioned within the vagina V. Next, the surgeon further expands the expansion portion 30. This causes the expansion portion 30 to expand while being in close contact with the uterine vaginal portion UV. The expansion portion 30 expands to follow the shape of the organ. As a result, the radially outer portion of the expansion portion 30 approaches the vaginal vault VF. Therefore, the radially outer portion of the expansion portion 30 can approach not only the anterior vaginal vault AV, which is close to the vaginal opening, but also the posterior vaginal vault RV, which is far from the vaginal opening. The expansion of the expansion portion 30 may be performed only once, or may be performed three or more times.

[0070] Next, the surgeon places the light-emitting unit 52 of the irradiation unit 50 inside the distal shaft 24. After that, the surgeon operates the light output device 80 to supply near-infrared rays to the irradiation unit 50. This allows the light-emitting unit 52 inside the distal shaft 24 to effectively irradiate the tumor cells C located in the cervix U with near-infrared rays. The irradiation direction of the near-infrared rays from the light-emitting unit 52 includes a direction approximately perpendicular to the axis of the distal shaft 24. Therefore, the light-emitting unit 52 can effectively irradiate the tumor cells C located in the cervix U with near-infrared rays from the cervical canal CC. The surgeon may irradiate the near-infrared rays while moving the light-emitting unit 52 inside the distal shaft 24.

[0071] When near-infrared light is irradiated, it reaches the antibody-photosensitizer bound to tumor cells C in the cervix U. This causes a chemical change in the antibody-photosensitizer that has been exposed to the near-infrared light, which is the excitation light, and further causes a structural change in the antibody-photosensitizer, which opens holes in the cell membrane. As a result, the tumor cells C irradiated with near-infrared light are destroyed.

[0072] When the surgeon determines that the tumor cells C have been sufficiently destroyed or when a predetermined time has elapsed, the surgeon stops the irradiation of near-infrared rays.

[0073] Next, as shown in FIG. 16, the operator pulls the irradiation unit 50 while holding the distal shaft 24 and the extension unit 30, and moves the light emitting unit 52 inside the extension unit 30. Next, the operator operates the light output device 80 to supply near infrared rays to the irradiation unit 50. As a result, the entire extension unit 30 that receives light from the light emitting unit 52 emits light. That is, a part of the near infrared rays that reaches the extension unit 30 passes through the extension unit 30, and a part of the near infrared rays that reaches the extension unit 30 is scattered or reflected by the extension unit 30 and irradiated over a wide range. When the extension unit 30 has a structure (see FIG. 7) that improves the irradiation intensity in the distal direction, the near infrared rays are irradiated in a direction approximately perpendicular to the axis of the irradiation shaft 22 and in the distal direction. Therefore, the light emitting unit 52 and the extension unit 30 can effectively irradiate near infrared rays mainly to the external cervical os O, the uterine vaginal part UV, the vaginal vault VF, and the tumor cells C located in the part of the vagina V that is closer to the vaginal opening than the vaginal vault VF and closer to the vaginal vault VF. In addition, there are many folds on the vaginal wall on the vaginal opening side of the vaginal vault VF of the vagina V, but by expanding the expansion part 30 near the utero-vaginal part UV, the angle of incidence of near-infrared rays on the vaginal wall becomes small. Therefore, the reflection of light can be suppressed as much as possible, and the tumor cells C can be effectively irradiated with near-infrared rays. The surgeon may irradiate near-infrared rays while moving the light emitting part 52 inside the expansion part 30. The surgeon may irradiate near-infrared rays while moving the light emitting part 52 alternately inside the expansion part 30 and the distal shaft 24. If the light emitting part 52 is long in the axial direction and can emit light from both the distal shaft 24 and the expansion part 30 at the same time, the surgeon does not need to move the light emitting part 52 between the distal shaft 24 and the expansion part 30.

[0074] When near-infrared light is irradiated, it reaches mainly the antibody-photosensitizer bound to tumor cells C in the external cervical os O, uterine vaginal part UV, vaginal vault VF, and the part of the vagina V closer to the vaginal opening than the vaginal vault VF and closer to the vaginal vault VF. This causes a chemical change in the antibody-photosensitizer exposed to the near-infrared light, which is the excitation light, and further causes a structural change in the antibody-photosensitizer, which opens a hole in the cell membrane. This destroys the tumor cells C irradiated with near-infrared light.

[0075] When the surgeon judges that the tumor cells C have been sufficiently destroyed or when a predetermined time has elapsed, the surgeon stops the irradiation of near-infrared rays. After that, the surgeon contracts the expansion part 30 and pulls out the treatment device 10 from the cervical canal CC and the vagina V. This ends the present treatment method.

[0076] As described above, the treatment device 10 of this embodiment is a treatment device 10 for cervical cancer, and comprises a main body shaft 21 having a tip end and a base end, an expansion section 30 that is arranged on the tip side of the main body shaft 21 and can be expanded by the inflow of fluid, a tip shaft 24 that protrudes toward the tip side from the expansion section 30, and at least one irradiation section 50 that can emit excitation light for the antibody-photosensitive substance from the tip shaft 24 and the expansion section 30.

[0077] The treatment device 10 configured as described above can effectively irradiate the excitation light to the antibody-photosensitizer bound to the tumor cells C in a wide range from the cervix U to the vagina V, with the distal shaft 24 inserted into the cervical canal CC and the expansion section 30 expanded widely within the vagina V. Therefore, this treatment method can improve the therapeutic effect of cancer in a wide range including the cervix U, the external cervical os O, the cervix vaginal portion UV around the external cervical os O, the vaginal vault VF, and the area of ​​the vagina V closer to the vaginal vault VF on the vaginal opening side than the vaginal vault VF.

[0078] Moreover, the distal shaft 24 irradiates the excitation light in a direction substantially perpendicular to the axis of the distal shaft 24, and the expansion section 30 irradiates the excitation light substantially in the distal direction. This allows the excitation light to be irradiated to the tumor cells C of the cervix U from both the distal shaft 24 and the expansion section 30, improving the therapeutic effect.

[0079] In addition, the treatment device 10 has an irradiation lumen 25 that communicates with the inside of the extension section 30 and the inside of the distal shaft 24 and movably houses the irradiation section 50. This allows the excitation light to be irradiated from the distal shaft 24 and the extension section 30 by the single irradiation section 50, simplifying the configuration of the treatment device 10 and improving operability. In addition, by moving the irradiation section 50, the position at which the excitation light is irradiated can be appropriately adjusted, improving the treatment effect.

[0080] The expansion section 30 may have an abutment surface 34 facing the tip side in the expanded state, and a part of the abutment surface 34 away from the axis of the tip shaft 24 may protrude toward the tip side. This allows the expansion section 30 to abut against the utero-vaginal portion UV, so that the part of the abutment surface 34 protruding toward the tip side can be brought closer to the vaginal vault VF. Therefore, the excitation light can be effectively irradiated near the vaginal vault VF, which is difficult for light to reach, and the therapeutic effect can be improved.

[0081] The treatment device 10 may also have an annular reinforcing part 70 disposed on the distal side of the expansion part 30 and surrounding the base end of the distal shaft 24. This allows the distal shaft 24 and the expansion part 30 to be positioned at appropriate positions by inserting the distal shaft 24 into the cervical canal CC and abutting the reinforcing part 70 against the uterine vaginal part UV. This allows the distal shaft 24 and the expansion part 30 to irradiate excitation light to a desired position, improving the treatment effect.

[0082] The extension section 30 may be movable in the axial direction of the main body shaft 21 relative to the main body shaft 21. This allows the extension section 30 to be retracted toward the base end side relative to the main body shaft 21 to ensure a field of view, and the distal shaft 24 can be inserted into the cervical canal CC. Then, while the distal shaft 24 is maintained at an appropriate position in the cervical canal CC, the extension section 30 can be moved and positioned at an appropriate position. This allows both the distal shaft 24 and the extension section 30 to be accurately and easily positioned at appropriate positions in the cervical canal CC and vagina V. This allows the excitation light to be irradiated to a desired position from the distal shaft 24 and the extension section 30, improving the therapeutic effect.

[0083] In addition, the treatment method in this embodiment is a method for treating cervical cancer, and includes the steps of intravenously administering an antibody-photosensitive substance, and 12 to 36 hours after the intravenous administration, inserting into the vagina V a treatment device 10 having an expandable expansion section 30 and a tip shaft 24 protruding from the expansion section 30 and capable of irradiating excitation light for the antibody-photosensitive substance, inserting the tip shaft 24 into the cervical canal CC, expanding the expansion section 30 within the vagina V, irradiating the excitation light from the tip shaft 24 to the surrounding tissue, irradiating the excitation light from the expansion section 30 to the surrounding tissue, and contracting the expansion section 30.

[0084] In the treatment method configured as described above, the distal shaft 24 can be inserted from the external cervical os O into the cervical canal CC while visually checking with the expansion part 30 contracted to ensure a clear field of view, and the expansion part 30 can be expanded widely within the vagina V. Therefore, by emitting excitation light for the antibody-photosensitizer from the distal shaft 24 and the expansion part 30, the excitation light can be effectively irradiated onto the antibody-photosensitizer bound to the tumor cells C in a wide range from the cervix U to the vagina V. Therefore, this treatment method can improve the therapeutic effect of cancer in a wide range from the cervix U to the vagina V.

[0085] In addition, in the step of irradiating the excitation light from the distal shaft 24, an irradiation unit 50 capable of irradiating the excitation light is disposed inside the distal shaft 24, and the excitation light is irradiated from the irradiation unit 50, and in the step of irradiating the excitation light from the extension unit 30, the irradiation unit 50 is disposed inside the extension unit 30, and the excitation light is irradiated from the irradiation unit 50, and the irradiation unit 50 may be moved between the distal shaft 24 and the extension unit 30 between the step of irradiating the excitation light from the distal shaft 24 and the step of irradiating the excitation light from the extension unit 30. As a result, even in the case where there is only one irradiation unit 50, the excitation light can be irradiated from the distal shaft 24 and the extension unit 30, so that the configuration of the treatment device 10 can be simplified and the operability can be improved. In addition, by moving the irradiation unit 50, the position where the excitation light is irradiated can be appropriately adjusted, so that the treatment effect can be improved. The order in which the excitation light is irradiated is not limited. Therefore, the excitation light may be irradiated first from the distal shaft 24, or the excitation light may be irradiated first from the extension unit 30.

[0086] Also, the step of irradiating the excitation light from the distal shaft 24 and the step of irradiating the excitation light from the extension section 30 may be performed simultaneously. As a result, the present treatment method can irradiate the excitation light from various positions and directions simultaneously, thereby improving the therapeutic effect and enabling efficient treatment in a short time.

[0087] In addition, in the step of inserting the distal shaft 24 into the cervical canal CC, the abutment surface 34, which is disposed on the base end side of the distal shaft 24 and faces the distal end side when the distal shaft 24 is led out, may be abutted against the uterine vaginal part UV. This allows the distal shaft 24 and the expansion part 30 to be positioned at appropriate positions. Therefore, the excitation light can be irradiated from the distal shaft 24 and the expansion part 30 to a desired position, improving the therapeutic effect.

[0088] The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical concept of the present invention.

[0089] For example, as shown in Fig. 17, the treatment device 10 may have a detection unit 90 that detects fluorescence having a wavelength (e.g., 704 nm) different from the wavelength of the irradiated light (e.g., 689 nm) emitted by an antibody-photosensitive substance excited by irradiation with near-infrared light from the light-emitting unit 52. The detection unit 90 includes, for example, an optical waveguide 91 such as an optical fiber that is disposed in the irradiation lumen 25 similar to the irradiation unit 50 and receives light, and an optical sensor 92 that can detect the amount of light. The detection unit 90 may have a semiconductor sensor such as a CMOS image sensor that senses light and converts it into an electrical signal at the light-receiving position.

[0090] When the antibody-photosensitive substance bound to the tumor cells C is irradiated with near-infrared light, the antibody-photosensitive substance undergoes a photoreaction, emitting fluorescence and destroying the tumor cells C. Note that the antibody-photosensitive substance does not emit fluorescence after destroying the tumor cells C. Therefore, by measuring the change in the intensity of the detected fluorescence with the optical sensor 92, the degree of destruction of the tumor cells C due to the irradiation with the excitation light can be confirmed. Therefore, the progress of the photoreaction destroying the tumor cells C can be confirmed.

[0091] In addition, the detection unit 90 may be a device different from the treatment device 10 including the irradiation unit 50 described above, as long as it can detect the fluorescence emitted by the antibody-photosensitizer excited by receiving near-infrared rays. The detection unit 90 may be inserted into the vagina V, uterus, rectum, bladder, urethra, abdominal cavity, blood vessel, ureter, etc., and detect the fluorescence. The detection unit 90 may detect the fluorescence in parallel with the irradiation of near-infrared rays by the treatment device 10, or after the irradiation of near-infrared rays by the treatment device 10 is completed. After the treatment device 10 is pulled out from the cervical canal CC and vagina V, the detection unit 90 may be inserted into the vagina V or cervical canal CC. Alternatively, the detection unit 90 may detect the fluorescence from the body surface outside the body in parallel with the irradiation of near-infrared rays by the treatment device 10, or after the irradiation of near-infrared rays.

[0092] The detection unit 90 may be used to confirm how far the treatment device 10 has been inserted when the operator inserts the treatment device 10 into the vagina V or the cervical canal CC. For example, the position of the treatment device 10 can be confirmed from an image obtained from a CMOS image sensor or a change in the intensity or color of light obtained from an optical waveguide 91 such as an optical fiber.

[0093] As shown in FIG. 18, the expansion section 30 may not have a portion between the base end expansion section 32 and the abutting surface 34 that is in contact with the vaginal wall in a substantially parallel manner. The inner surface of the abutting surface 34 is coated with a scattering coat 36, and the base end expansion section 32, the outer diameter of which gradually decreases toward the base end side, is coated with a reflector coat 39. As a result, the light emitting section 52 emits light inside the expansion section 30, and the excitation light irradiated from the expansion section 30 is reflected and diffused only toward the tip (the direction toward which the external cervical os O and the cervix UV are located relative to the expansion section 30). As a result, the light energy can be efficiently irradiated toward the tip, and the therapeutic effect at the external cervical os O and the cervix UV can be improved. Note that it is preferable that the entire light emitting section 52 is located within the range of the length in the axial direction (long axis direction) of the expansion section 30. As a result, the light irradiated from the light emitting section 52 can be input into the expansion section 30 without waste.

[0094] This application is based on Japanese Patent Application No. 2020-060400 filed on March 30, 2020, the disclosures of which are hereby incorporated by reference in their entirety. [Explanation of symbols]

[0095] 10 Treatment equipment 20 Shaft section 21 Main body shaft 22 Irradiation shaft 22A 3rd abutment surface (abutment surface) 23 Flow path shaft 24 Tip shaft 25 lumens 26 Expanded Lumens 30 Extension 34 Abutment surface 40 Protrusion 50 Irradiation unit 51 Optical Fiber 52 Light emitting part 70 Reinforcement 72 Second abutment surface (abutment surface) 80 Optical output device 90 Detection unit C. Tumor cells CC Cervix I Internal cervical os O external cervical os U cervix UC uterine cavity UV cervix V vagina VF Vaginal vault AV Anterior vault RV posterior vaginal vault

Claims

1. A therapeutic device for irradiating an antibody-photosensitizer bound to a cervical cancer tumor cell with excitation light, a body shaft having a distal end and a proximal end; an expansion section disposed at a distal end of the main shaft and expandable by the inflow of a fluid; A tip shaft protruding from the extension portion to a tip side; and at least one irradiation unit capable of emitting excitation light for the antibody-photosensitizer from the distal shaft and the extension unit, A treatment device characterized in that an irradiation lumen is formed which communicates the inside of the extension portion and the inside of the distal shaft and movably houses the irradiation portion.

2. A therapeutic device for irradiating an excitation light to an antibody-photosensitive substance bound to a cervical cancer tumor cell, a body shaft having a distal end and a proximal end; an expansion section disposed at a distal end of the main shaft and expandable by the inflow of a fluid; A tip shaft protruding from the extension portion to a tip side; and at least one irradiation unit capable of emitting excitation light for the antibody-photosensitizer from the distal shaft and the extension unit, A treatment device characterized in that it has an annular reinforcing portion disposed on the distal side of the expansion portion and surrounding the base end portion of the distal shaft.

3. The distal shaft irradiates the excitation light in a direction substantially perpendicular to an axis of the distal shaft, 3. The treatment device according to claim 1, wherein the extension portion irradiates the excitation light in a substantially distal direction.

4. The treatment device according to any one of claims 1 to 3, characterized in that the expansion portion has an abutment surface that faces toward the tip side when expanded, and a portion of the abutment surface away from the axis of the tip shaft protrudes toward the tip side.

5. The treatment device according to claim 1, further comprising an annular reinforcing portion disposed on the distal side of the expansion portion and surrounding the proximal end portion of the distal shaft.

6. The treatment device according to any one of claims 1 to 5, further comprising a detection unit for detecting fluorescence emitted by the antibody-photosensitive substance.

7. A tubular inner shaft that slidably accommodates the tip shaft; an irradiation shaft including the tip shaft; A moving operation unit to which a base end of the main body shaft is fixed; A casing that slidably holds the moving operation unit, the inner shaft is fixed to the body shaft; a distal end of the extension portion is secured to the inner shaft; The irradiation shaft is fixed to the casing, A treatment device as described in any one of claims 1 to 6, characterized in that when the moving operating unit moves relative to the casing, the irradiation shaft does not move, and the main shaft, the inner shaft and the extension unit move in the axial direction of the main shaft relative to the casing.

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