Therapeutic devices and methods of treatment

Abstract

A treatment device and treatment method are provided that can effectively treat cancers covering at least a portion of the cervix. A treatment device (10) for irradiating an antibody-photosensitive substance aggregated in cervical cancer cells C with excitation light has a tubular instrument (100) having a long tubular component (110) and an irradiation instrument (20) into which the tubular component (110) can be inserted. The irradiation instrument (20) has: a main shaft (21) having a front end and a base end; a disc portion (30) disposed on the front end side of the main shaft (21); a front end shaft (24) protruding from the disc portion (30) towards the front end side; and an irradiation section (50) disposed on the front end shaft (24) capable of emitting excitation light.

Description

Technical Field

[0001] This invention relates to a device and method for treating cervical cancer. Background Technology

[0002] The number of cervical cancer patients is on the rise, especially among young women aged 20-30. Current standard treatment for cervical cancer starts with complete hysterectomy in early stages (Stage I). However, for younger patients, local treatments that preserve the uterus are necessary to maintain fertility. Furthermore, in advanced stages (Stage III and beyond), due to the spread of cancer to surrounding tissues, surgical resection becomes difficult, leading to the use of a combination of radiotherapy and chemotherapy as standard treatment. However, the 5-year survival rates are low, at 50% for Stage III and 20% for Stage IV, necessitating more effective treatments. As a local treatment for cancer, therapies using photosensitive substances are known (see, for example, Patent Document 1). Among these, therapies using antibody-photosensitive substances (hydrophilic phthalocyanines) irradiate the antibody-photosensitive substances accumulated on the tumor with excitation light (e.g., near-infrared light), specifically destroying target cells without damaging normal cells or other non-target cells, aiming to achieve better therapeutic effects while reducing side effects.

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: U.S. Patent Application Publication No. 2018-0113246 Summary of the Invention

[0006] The problem that the invention aims to solve

[0007] On the other hand, to achieve high therapeutic efficacy of antibody-photosensitive substances, it is necessary to accurately irradiate the antibody-photosensitive substances adsorbed on the tumor with near-infrared light. However, near-infrared light has a shallow penetration depth, making it very difficult to non-invasively deliver light from the body surface to solid cancer. Therefore, a method is needed that minimizes invasiveness and accurately delivers light to the tumor within the body. In the case of cervical cancer, where the cancer often spreads extensively throughout the cervical canal, a method is needed to irradiate the large area of ​​cancer at the closest possible distance.

[0008] The present invention was made to solve the above-mentioned problems, and aims to provide a treatment device and method capable of effectively treating cancer in a range including at least a portion of the cervix.

[0009] Methods for solving problems

[0010] The therapeutic device of the present invention, which achieves the above-mentioned objective, is a therapeutic device for irradiating an antibody-photosensitive substance aggregated in cervical cancer tumor cells with excitation light. The therapeutic device is characterized by having a tubular instrument with a long tubular component and an irradiation instrument capable of being inserted into the tubular component. The irradiation instrument has: a main shaft having a front end and a base end; a disk portion disposed on the front end side of the main shaft; a front end shaft protruding from the disk portion toward the front end side; and an irradiation section disposed on the front end shaft capable of emitting the excitation light.

[0011] The effects of the invention

[0012] The treatment device configured as described above can effectively irradiate excitation light onto antibody-photosensitive substances that are aggregated in a large area including the cervix, while the front shaft is inserted into the cervical canal and the tubular component is inserted near the vaginal fornix. Therefore, this treatment device can improve the treatment effect on cancers in at least a portion of the cervix.

[0013] The aforementioned front axis can irradiate the aforementioned excitation light in a direction substantially perpendicular to the axis of the front axis, and the aforementioned disk portion can irradiate the aforementioned excitation light in a direction substantially towards the front end. Therefore, both the front axis and the disk portion can irradiate the tumor cells of the cervix with excitation light, thereby improving the treatment effect.

[0014] The aforementioned tubular component may have a second irradiation section capable of irradiating the aforementioned excitation light in a direction substantially perpendicular to the axial direction of the tubular component and / or in a direction substantially towards the front end. Therefore, the excitation light can be directly irradiated onto tumor cells in the vaginal fornix, which are difficult for light to reach, by the second irradiation section provided in the tubular component, thereby improving the treatment effect.

[0015] The front end of the aforementioned tubular component can be deformable. This allows the deformable front end to deform along the vaginal fornix and be positioned near the vaginal fornix. Therefore, excitation light can be effectively irradiated into the vicinity of the vaginal fornix, which is difficult for light to reach, thereby improving the treatment effect.

[0016] The aforementioned treatment device may include a fixing part for securing the aforementioned irradiation device to the aforementioned tubular device. This allows the irradiation device and the tubular component to be operated as a single unit, thus improving operability. Furthermore, the irradiation device can be maintained in an appropriate position relative to the tubular component, allowing the excitation light emitted from the irradiation device to propagate appropriately to the tubular component. Therefore, the excitation light emitted from the front end shaft, the disc portion, and the tubular component can be appropriately irradiated onto the antibody-photosensitive substance.

[0017] The aforementioned fixing part can be a balloon disposed in the aforementioned disc portion and capable of expanding by fluid flowing into it. Thus, by expanding the balloon inside the tubular component, the irradiation device can be easily and accurately fixed relative to the tubular component.

[0018] The aforementioned fixing portion may be a balloon configured in the aforementioned tubular member and capable of expanding by fluid flowing into the interior. Thereby, by expanding the balloon, the irradiation instrument can be easily and accurately fixed relative to the tubular member.

[0019] The axis of the aforementioned disk portion may be inclined relative to the axis of the aforementioned main body axis. Thereby, it is easy to arrange the disk portion according to the inclination of the uterovaginal portion relative to the vagina. Therefore, the excitation light irradiated from the disk portion can be appropriately irradiated to the antibody-photosensitizer.

[0020] The aforementioned treatment device may have a detection portion for detecting the fluorescence emitted by the aforementioned antibody-photosensitizer. Thereby, the degree of destruction of tumor cells caused by the irradiation of the excitation light can be confirmed by the change in fluorescence detected by the detection portion.

[0021] The treatment method of the present invention for achieving the above object is a treatment method for cervical cancer, characterized by having the following steps: a step of intravenously administering an antibody-photosensitizer; a step of inserting a tubular member into the vagina 12 to 36 hours after the intravenous administration; a step of inserting an irradiation instrument into the aforementioned tubular member, the aforementioned irradiation instrument having a disk portion capable of being arranged inside the aforementioned tubular member, a front end shaft protruding from the aforementioned disk portion toward the front end side, and an irradiation portion capable of emitting the excitation light of the aforementioned antibody-photosensitizer; a step of inserting the aforementioned front end shaft into the cervical canal while visually confirming; a step of causing the aforementioned irradiation portion to emit light and irradiating the aforementioned excitation light from the aforementioned disk portion, the aforementioned front end shaft, and the aforementioned tubular member to the surrounding tissue.

[0022] The treatment method configured as above can insert the front end shaft into the cervical canal from the external cervical os (Japanese original text: outer uterine os), and can insert the tubular member into the vaginal fornix or near the vaginal fornix. Therefore, by emitting the excitation light of the antibody-photosensitizer from the front end shaft, the disk portion, and the tubular member, the excitation light can be effectively irradiated to the antibody-photosensitizer of tumor cells aggregated in a range including at least a part of the cervical portion. Therefore, this treatment method can improve the treatment effect on cancer in a range including at least a part of the cervical portion.

[0023] The aforementioned treatment method may have a step of fixing the position of the aforementioned irradiation instrument relative to the aforementioned tubular member. Thereby, the irradiation instrument and the tubular member can be operated as a unit, so the operability is improved. In addition, the irradiation instrument can be maintained in an appropriate position relative to the tubular member, so the light irradiated from the irradiation instrument can be appropriately transmitted to the tubular member. Therefore, the excitation light irradiated from the front end shaft, the disk portion, and the tubular member can be appropriately irradiated to the antibody-photosensitizer.

[0024] The aforementioned treatment method may include a step of detecting the fluorescence emitted by the aforementioned antibody-photosensitive substance to confirm the intensity of the fluorescence. Therefore, this treatment method can confirm the extent of tumor cell destruction caused by excitation light irradiation by detecting fluorescence.

[0025] The step of confirming the intensity of the aforementioned fluorescence can be performed in parallel with the step of irradiating the aforementioned excitation light. Therefore, this treatment method can improve therapeutic efficacy by simultaneously confirming the extent of tumor cell destruction caused by excitation light irradiation through fluorescence detection.

[0026] The step of confirming the intensity of the aforementioned fluorescence can be performed after the step of irradiating with the aforementioned excitation light. Therefore, this treatment method can accurately confirm the destruction of tumor cells caused by irradiation with the excitation light by detecting fluorescence. Attached Figure Description

[0027] [ Figure 1 [This is a plan view showing the treatment device according to the embodiment.]

[0028] [ Figure 2 To show a schematic diagram of the vagina and uterus, (A) shows the patient's position from the front, and (B) shows the patient's position from the left side.

[0029] [ Figure 3 [A perspective view showing the treatment device according to the embodiment.]

[0030] [ Figure 4 This is a cross-sectional view showing the front end of the treatment device according to the embodiment.

[0031] [ Figure 5 The following is a plan view showing a modified example of the front end shaft. (A) shows the first modified example, and (B) shows the second modified example.

[0032] [ Figure 6 [This is a plan view showing the third variation.]

[0033] [ Figure 7 The following are cross-sectional views showing modified examples of the disk portion: (A) shows the fourth modified example, (B) shows the fifth modified example, and (C) shows the sixth modified example.

[0034] [ Figure 8 The following are cross-sectional views showing modified examples of the disk portion: (A) shows the 7th modified example, and (B) shows the 8th modified example.

[0035] [ Figure 9 The following are cross-sectional views showing modified examples of the disk portion: (A) shows the 9th modified example, and (B) shows the 10th modified example.

[0036] [ Figure 10The following is a plan view showing a modified example of the irradiation section: (A) shows this embodiment, (B) shows the 11th modified example, and (C) shows the 12th modified example.

[0037] [ Figure 11 The plan view showing the modified examples of the ring-shaped component is shown in (A) for the 13th modified example, (B) for the 14th modified example, and (C) for the 15th modified example.

[0038] [ Figure 12 This is a schematic diagram showing the state in which the front end shaft of the treatment device of the embodiment is inserted into the cervical canal.

[0039] [ Figure 13 This is a schematic diagram showing the state of irradiating tumor cells with near-infrared light from the treatment device of the embodiment.

[0040] [ Figure 14 This is a plan view showing the 16th variation of the treatment device. Detailed Implementation

[0041] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. It should be noted that, for ease of explanation, the dimensions in the drawings may be exaggerated and differ from the actual dimensions. Furthermore, in this specification and the accompanying drawings, constituent elements having substantially the same functional configuration are given the same reference numerals, thus omitting redundant descriptions. In this specification, the side of the instrument that is inserted into the lumen of a biological body is referred to as the "front end side," and the side where the operation is performed is referred to as the "base end side."

[0042] The treatment device 10 described in this embodiment is a treatment method for 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 involves irradiating near-infrared light, which serves as the excitation light for the antibody-photosensitive substance, onto the cell membrane of target cells, thereby destroying the target cells using photoimmunotherapy. The target cells are tumor cells such as cancer cells. In this treatment method, an antibody-photosensitive substance, which specifically aggregates on a unique antigen present only on the surface of tumor cells and binds to a photosensitive substance paired with that antibody, is used as a pharmaceutical agent. The antibody is not particularly limited, and examples include panitumumab, trastuzumab, HuJ591, pertuzumab, lapatinib, palbociclib, and olaparib. The photosensitive substance is, for example, a substance that reacts with near-infrared light at a wavelength of approximately 700 nm (IR700), i.e., a hydrophilic phthalocyanine, but is not limited to this. Upon receiving near-infrared radiation at wavelengths of approximately 660–740 nm, the ligands of the water-soluble functional groups of the IR700 break down, resulting in a structural change from water-soluble to hydrophobic. This structural change causes membrane proteins to be pulled out, creating openings in the cell membrane, allowing water to enter the cell and causing tumor cells to rupture and be destroyed. Furthermore, when the IR700 receives and is excited by near-infrared radiation, it emits fluorescence at a wavelength different from the excitation wavelength. For example, when the IR700 receives and is excited by near-infrared radiation at a wavelength of 689 nm, it emits fluorescence at a wavelength of 704 nm. The IR700 emits fluorescence through a photoreaction, and simultaneously undergoes a structural change; once it has destroyed tumor cells and exerted its effect as a drug, it ceases to emit fluorescence.

[0043] Figure 1 The treatment device 10 shown is capable of treating patients with a single device. Figure 2 , 12 The treatment device 10 is shown in Figure 13, which includes the cervix (U), external cervical os (O), the vaginal portion of the uterus surrounding the external cervical os (UV), the vaginal fornix (VF), and the area near the vaginal fornix VF, which is closer to the vaginal opening than the vaginal fornix VF. The treatment device 10 can irradiate the antibody-photosensitive substance that has accumulated in a large area from the cervix (U) to the vagina (V) with excitation light.

[0044] The uterus is located deep within the vagina (V). Its upper part connects to the fallopian tubes on both sides, and the external cervix (O), located in the lower part of the uterus, connects to the vagina (V). The uterus is roughly divided into the uterine body and the cervix (U). The cervical canal (CC), which connects to the external cervical os (O), is located in the cervical U. The vagina (V) has vaginal fornix (VF), which extends around the external cervical os (O). The vaginal fornix (VF) is deeper in the posterior vaginal fornix (RV), located posteriorly to the vagina (V), than in the anterior vaginal fornix (AV), located anteriorly to the vagina (V).

[0045] First, the treatment device 10 of this embodiment will be described.

[0046] like Figure 1 and 3 As shown, the treatment device 10 includes: an irradiation device 20 with near-infrared irradiation function; and a tubular device 100 with a tubular component 110.

[0047] The irradiation device 20 has a main body shaft 21 with a front end and a base end, an irradiation section 50 for irradiating light, a front end shaft 24 for housing the irradiation section 50, a disc section 30 provided at the front end of the main body shaft 21, and a first operation section 60 connected to the base end of the irradiation device 20. The treatment device 10 is used in conjunction with the light output device 80.

[0048] The main shaft 21 is a tube that supports the disc portion 30. The main shaft 21 houses a portion of the elongated irradiation portion 50. The main shaft 21 is a straight, extending cylindrical tube; it can be bent or not be a cylindrical tube. The base end of the main shaft 21 is fixed to the first operating portion 60. The front end of the main shaft 21 is fixed to the base end of the disc portion 30. Scales 22 arranged along the axial direction are attached to the outer circumferential surface of the main shaft 21. The scales 22 can be used to determine the insertion depth of a tubular instrument 100, vagina, or other biological device relative to the main shaft 21.

[0049] In order for the operator to grasp the first operating part 60 and push it into the target position, it is preferable that the main shaft 21 has a certain degree of rigidity. The material of the main shaft 21 is not particularly limited, and can be metals such as stainless steel, aluminum, titanium alloy, tin, and magnesium alloy, or resins such as polyetheretherketone (PEEK), polyamide, acrylonitrile-butadiene-styrene (ABS), polycarbonate, polyacetal, and polyimide. The length of the main shaft 21 in the axial direction is not particularly limited, and can be, for example, 100–400 mm.

[0050] The front end shaft 24 is a tubular component capable of housing the irradiation unit 50 internally and transmitting light from the irradiation unit 50 to the outside. A portion of the front end shaft 24 is disposed inside the disc portion 30. The front end shaft 24 extends towards the front end of the disc portion 30. The front end shaft 24 is the portion into which the external cervical os O is inserted into the cervical canal CC to irradiate light from inside the cervical canal CC to the cervix U (see reference). Figure 12The base end of the front end shaft 24 extends towards the base end side relative to the main body shaft 21 and the first operating part 60. An irradiation cavity 25, capable of housing the irradiation part 50, is continuously formed inside the main body shaft 21 and the front end shaft 24. The irradiation cavity 25 closes at the foremost end of the front end shaft 24 and opens at the base end of the main body shaft 21. An insertion port 28 for accommodating the irradiation part 50 in the irradiation cavity 25 is provided at the base end side of the main body shaft 21. The front end shaft 24 preferably has the function of diffusing light. Therefore, like the disk part 30 described later, the front end shaft 24 can contain a scatterer in at least a portion of the constituent material, or have many irregularities formed on its inner and outer surfaces, or it can be a multilayer structure formed by joining materials with different refractive indices on surfaces with many irregularities.

[0051] The front shaft 24 is preferably formed to be easily curved through the cervical canal CC, which is oblique to the vaginal V, but it can also be formed straight without bending. The front shaft 24 is formed to be rigid, substantially rigid, or flexible. The front shaft 24 is formed of a transparent or translucent material capable of transmitting light of the wavelength emitted by the irradiation part 50 housed inside. The material of the front shaft 24 is not particularly limited, and for example, resins such as polymethyl methacrylate, polyethylene terephthalate, polycarbonate, and polytetrafluoroethylene, as well as glass, are examples. More preferably, the material of the front shaft 24 is elastic, possessing the property of being able to bend and deform along the cervical canal CC after being inserted. This allows for adaptation to individual differences in the shape of the cervical canal CC, reduces the burden on the inner surface of the cervical canal CC, and further improves the tightness of the fit with the inner surface of the cervical canal CC. The outer diameter of the front shaft 24 is not particularly limited, for example, 0.5 to 6 mm. The length of the front shaft 24 in the axial direction is not particularly limited, for example, 10 to 50 mm.

[0052] The shape of the front end shaft 24 is not particularly limited. For example, as shown... Figure 5 In the first variation shown in (A), the front shaft 24 may have a series of concave and convex structures 24A arranged in the axial direction. Therefore, when the operator inserts the front shaft 24 into the cervical canal CC through the external cervical os O, the concave and convex structures 24A can be visually confirmed, allowing the operator to easily determine the position of the front shaft 24 within the cervical canal CC. Furthermore, when the operator inserts the concave and convex structures 24A into the cervical canal CC through the change in sensation felt by the hand holding the first operating part 60, the position of the front shaft 24 within the cervical canal CC can be easily determined. It should be noted that, as a structure easily confirmed visually, the front shaft 24 may have graduations, markings, etc. Additionally, to change the sensation felt by the operator's hand when inserting the front shaft 24 into the cervical canal CC through the external cervical os O, the front shaft 24 may have physical properties that vary along the axial direction. For example, the rigidity of the front shaft 24 may decrease along the front direction, or it may alternately have high-rigidity and low-rigidity portions.

[0053] In addition, such as Figure 5 (B) In the second variation shown, the front shaft 24 may have a large-diameter portion 24B at its front end. Therefore, after the practitioner inserts the front shaft 24 into the cervical canal CC through the external cervical os O, the large-diameter portion 24B can be easily grasped by the change in sensation felt by the hand holding the first operating part 60, allowing it to pass through the internal cervical os I and reach the uterine cavity UC. For example, after the large-diameter portion 24B passes through the internal cervical os I, the practitioner can retract the first operating part 60, thereby bringing the large-diameter portion 24B into contact with the internal cervical os I. Therefore, the front shaft 24 with the large-diameter portion 24B is effective when it is desired to correctly position the front end of the front shaft 24 relative to the internal cervical os I, and when it is desired to accurately pass the front shaft 24 through the internal cervical os I. It should be noted that the position of the large-diameter portion 24B is not limited to the very front end of the front shaft 24.

[0054] In addition, such as Figure 6 In the third modified example shown, the anterior shaft 24 may have a flexible, deformable pouch-shaped first balloon 24C at its anterior end. The first balloon 24C communicates with a pouch-shaped second balloon 24D disposed in the first operating section 60 via a tube 24E. The first balloon 24C, the second balloon 24D, and the tube 24E are fluid-sealed. Thus, when the anterior shaft 24 enters the cervical canal CC from the external cervical os O, the first balloon 24C is compressed, and the fluid inside the first balloon 24C moves towards the second balloon 24D, causing the second balloon 24D to expand significantly. Thus, by observing the second balloon 24D, the operator can easily grasp the situation of the anterior shaft 24 with the first balloon 24C entering the cervical canal CC. Furthermore, when the first balloon 24C extends beyond the internal cervical os I, it expands due to its own restorative force, causing the fluid inside the second balloon 24D to move towards the first balloon 24C, and the second balloon 24D to shrink. Thus, by observing the second balloon 24D, the operator can easily determine whether the anterior axis 24 of the first balloon 24C extends beyond the internal cervical os I.

[0055] It should be noted that, with the irradiation unit 50 located inside the tip shaft 24 emitting light, the tip shaft 24 can be inserted into the cervical canal CC through the external cervical os O. The practitioner cannot see the light emanating from the insertion point of the tip shaft 24 into the cervical canal CC. Therefore, the practitioner can easily determine the position of the tip shaft 24 within the cervical canal CC by visual inspection. In this case, even if the tip shaft 24 does not have the concave-convex structure 24A or the large diameter portion 24B, the practitioner can still visually determine where the tip shaft 24 is inserted into the cervical canal CC.

[0056] like Figure 4 , 12As shown in Figure 13, the disc portion 30 is a component disposed at the base end of the front end shaft 24 inserted into the cervical canal CC and inserted into the vagina V, enabling it to irradiate light over a wide area of ​​the vagina V. The disc portion 30 is disposed inside the portion closer to the base end than the foremost end of the tubular component 110. The disc portion 30 is capable of transmitting light emitted from the irradiation section 50 disposed in the irradiation cavity 25 that passes through the interior of the disc portion 30 to the outside. Therefore, the disc portion 30 is formed of a transparent or translucent material capable of transmitting light of the wavelength emitted by the irradiation section 50.

[0057] like Figure 1 , 3 As shown in Figure 4, the disc portion 30 is a disc-shaped component fixed to the front end of the main body shaft 21. The disc portion 30 is movable relative to the main body shaft 21 along the axis of the main body shaft 21. The disc portion 30 has a front end face 31, a base end face 32, an outer side face 33, and a through hole 34. The front end face 31 and the base end face 32 are substantially perpendicular to the axis of the main body shaft 21. The through hole 34 is located approximately at the center of the front end face 31 and the base end face 32, and passes through between the front end face 31 and the base end face 32. At the through hole 34, the main body shaft 21 is inserted and fixed from the base end side, and the front end shaft 24 is inserted and fixed from the front end side. It should be noted that the structure in which the disc portion 30 is fixed relative to the main body shaft 21 and the front end shaft 24 is not particularly limited. For example, the disc portion 30 can be integrally formed with the front end shaft 24. The outer side face 33 can contact the inner circumferential surface of the tubular component 110. If the practitioner does not apply force, the outer surface 33 will not slide relative to the inner circumferential surface of the tubular member 110; by applying force, the surface can be engaged with friction to the extent of sliding. Alternatively, the outer surface 33 may have clearance to the extent that it can slide freely relative to the inner circumferential surface of the tubular member 110.

[0058] The thickness of the disk portion 30 (the distance between the front end face 31 and the base end face 32) is approximately constant, but it can vary depending on the location. For example, the thickness of the disk portion 30 can decrease radially outward. As a result, light incident from the inner wall of the through hole 34 onto the material of the disk portion 30 can propagate radially outward through the material while being reflected at the surface of the material.

[0059] The material of the disk portion 30 is not particularly limited, as long as it has a certain degree of rigidity and can transmit light of the wavelength emitted from the irradiation portion 50. Examples include silicon, polyamide, polymethyl methacrylate, polyethylene terephthalate, polycarbonate, polytetrafluoroethylene, urethane, or combinations thereof. The maximum outer diameter of the disk portion 30 is not particularly limited, for example, it is 10 to 50 mm. The axial length of the disk portion 30 is not particularly limited, for example, it is 5 to 60 mm.

[0060] The disc portion 30 can be configured to scatter light. Therefore, the disc portion 30 itself emits light by receiving light from the irradiation portion 50. Thus, the treatment device 10 can irradiate light over a wide area, not only to the area directly reached by the light from the irradiation portion 50, but also via the disc portion 30. For example, as... Figure 7 As shown in the fourth variation of (A), the disk portion 30 may contain a scatterer 39 within the material. The scatterer 39 can utilize known scatterers, such as tiny particles of titanium oxide, styrene, or silicone plastics. Furthermore, as... Figure 7 As shown in the fifth modified example (B), the disk portion 30 may have a scattering coating 40 containing a scattering element 39 on its front end face 31. The scattering coating 40 is formed by mixing the scattering element 39 with a coating substrate having a different refractive index than the scattering element 39. The scattering coating 40 may be formed on the base end face 32, or on both the front end face 31 and the base end face 32. Additionally, as... Figure 7 As shown in the sixth modified example (C), the disk portion 30 may have a structure in which a first layer 42 and a second layer 43 with different refractive indices are joined together with surfaces having irregularities. Furthermore, the disk portion 30 may have numerous minute irregularities on its front end surface 31 and base end surface 32. Additionally, the disk portion 30 may also have a structure that reflects light.

[0061] Furthermore, the disc portion 30 can be formed in various shapes. Preferably, the disc portion 30 can be appropriately selected according to the shape of the patient's uterine-vaginal portion UV, vaginal fornix VF, and vaginal V.

[0062] like Figure 8 As shown in the seventh modified example (A), the front end face 31 and the base end face 32 of the disc portion 30 can be inclined relative to a face perpendicular to the axis of the main body shaft 21 (the axis of the through hole 34). Thus, for example, light irradiated from the front end face 31 can be effectively irradiated onto the surface of the uterine vaginal portion UV that is inclined relative to the vaginal V.

[0063] In addition, such as Figure 8 As shown in the eighth variation (B), the disc portion 30 may have a balloon 44 (fixing portion). The balloon 44 may be disposed on the base end face 32 side of the disc portion 30, or on the outer side face 33 side of the disc portion 30. Alternatively, the entire disc portion 30 may be formed of the balloon 44. The balloon 44 can be expanded by supplying fluid through a supply conduit 45 extending from the first operation portion 60. The balloon 44 is sealed to the inner circumferential surface of the tubular member 110 by expansion. Thus, the irradiation device 20 can be fixed to the tubular device 100.

[0064] In addition, such as Figure 9(A) As shown in the 9th modification, a second irradiation section of the light waveguide 119 can be formed in the tubular device 100. The light waveguide 119 can be arranged from the base end of the tubular device 100 to the tubular front end portion 112 provided at the front end portion. The tubular front end portion 112 (described later) can have a structure that diffuses or scatters light. The disk portion 30 of the irradiation device 20 includes: a disk-shaped disk member 37 having a structure that diffuses or scatters light; and a reflective member 36 extending from the outer peripheral surface of the disk member 37 towards the base end side. The reflective member 36 has an outer peripheral surface and an inner peripheral surface that taper towards the base end side from the outer peripheral surface of the disk member 37. The length of the disk portion 30 including the reflective member 36 and the disk member 37 in the axial direction (length direction) is not limited, but it is preferable to be longer than or equal to the length of the light-emitting portion 52 of the irradiation portion 50 described later in the axial direction. Therefore, light irradiated from the light-emitting unit 52 disposed inside the disk portion 30 can be input into the disk portion 30 with minimal loss. The light irradiated from the light-emitting unit 52, input into the disk portion 30, is reflected by the reflecting member 36, and diffuses in the disk portion 37. The light-emitting unit 52 emits light inside the disk portion 30, while the excitation light irradiated from the disk portion 30 is only directed towards the front end (the direction relative to the disk portion 30, which includes the external cervical os O and the uterine vaginal portion UV). Therefore, the therapeutic effect at the external cervical os O and the uterine vaginal portion UV can be improved. It should be noted that the structure of the light waveguide 119 (second irradiation unit) is not particularly limited as long as it can propagate light, and can be an optical fiber.

[0065] In addition, such as Figure 9(B) As shown in the 10th variation, the disk portion 30 includes: a disk-shaped disk member 37 having a structure for diffusing or scattering light; and a reflective member 36 extending from the base end face of the radially outer side of the disk member 37 towards the base end side. The outer peripheral surface of the disk member 37 can contact the inner peripheral surface of the tubular front end portion 112 provided at the front end of the tubular device 100. The reflective member 36 has an outer peripheral surface and an inner peripheral surface that taper towards the base end side from a position radially outer side of the base end face of the disk member 37. The axial length of the disk portion 30, including the reflective member 36 and the disk member 37, is not limited, but it is preferable to be longer than or equal to the axial length of the light-emitting portion 52 of the irradiation portion 50 described later. As a result, light irradiated from the light-emitting portion 52 disposed inside the disk portion 30 can be input into the disk portion 30 with minimal loss. On the base end side of the disk member 37, light irradiated from the light-emitting portion 52 is reflected by the reflective member 36 and diffused in the disk member 37. Inside the disk component 37, light irradiated from the light-emitting part 52 enters the material of the disk component 37 and propagates towards the inner circumferential surface of the tubular front end portion 112 of the tubular device 100. To facilitate light propagation from the outer circumference of the disk component 37 to the inner circumferential surface of the tubular front end portion 112, the portion in contact with the tubular front end portion 112 of the disk component 37 preferably has a structure that allows for transparent or low-loss light propagation. The light propagating towards the tubular front end portion 112 diffuses or scatters at the tubular front end portion 112 and irradiates in a direction approximately perpendicular to the axial direction of the tubular device 100, towards the front end.

[0066] like Figure 1 and Figure 4 As shown, the irradiation unit 50 includes a long optical fiber 51 for propagating light. The irradiation unit 50 has a light-emitting unit 52 at its front end for irradiating light externally. The base end of the irradiation unit 50 can be connected to a light output device 80. The irradiation unit 50 can receive near-infrared light from the light output device 80, propagate the near-infrared light to the light-emitting unit 52, and irradiate the light from the light-emitting unit 52. It should be noted that the irradiation unit 50 can also be formed by a waveguide other than an optical fiber. The irradiation unit 50 is inserted into the irradiation cavity 25 through the insertion port 28. The irradiation unit 50 can move and rotate in the axial direction within the irradiation cavity 25. It should be noted that the irradiation unit 50 can also be immobile and non-rotatable within the irradiation cavity 25.

[0067] like Figure 4 and 10As shown in (A), the light-emitting part 52 is connected to the cut end of the optical fiber 51, forming a cylindrical diffuser that diffuses or scatters the light received from the optical fiber 51. The diffuser can be integrally formed by processing the surface and interior of the optical fiber 51, or it can be the cut end of the optical fiber 51. In this case, since light is irradiated at a wide illumination angle, it is preferable to provide multiple optical fibers 51. Furthermore, as... Figure 10 As shown in the 11th variation (B), the light-emitting portion 52 is formed by a mirror 53 and / or a lens 54 disposed at the cut end of the optical fiber 51. By forming the light-emitting portion 52 by the mirror 53 and / or the lens 54, the illumination angle of the light can be expanded. By rotating the optical fiber 51 within the illumination cavity 25, the light-emitting portion 52 can illuminate a wider range of light.

[0068] It should be noted that the method for propagating light to the disk portion 30 may not be located inside the main body shaft 21 or the front end shaft 24. For example, as... Figure 10 (C) In the 12th variation shown, the irradiation unit 50 may have an irradiation auxiliary unit 55 surrounding the main body shaft 21 on the base end side of the disk portion 30, and a light-emitting unit 52 is disposed on the irradiation auxiliary unit 55. The light-emitting unit 52 has an inner peripheral surface that extends towards the front end in a manner that covers a portion of the surface on the base end side of the disk portion 30. The light-emitting unit 52 is disposed on this inner peripheral surface. The light-emitting unit 52 may be an LED that emits light through the end of an optical fiber, a diffuser, a mirror, a lens, or 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 disk portion 30 into the interior of the disk portion 30. As a result, the disk portion 30 receives light from the light-emitting unit 52 of the irradiation auxiliary unit 55 and can emit light substantially as a whole. The light-emitting unit 52 disposed on the irradiation auxiliary unit 55 can be used together with the irradiation unit 50 disposed on the irradiation cavity 25.

[0069] like Figure 1 and Figure 3 As shown, the first operating part 60 is the part held and operated by the practitioner for the irradiation device 20. The first operating part 60 includes a first operating part body 61 whose base end of the main body shaft 21 is fixed, and a first fixing part 62 for fixing the tubular device 100. An inlet, i.e., an insertion port 28, for the irradiation cavity 25 is provided at the base end of the first operating part body 61. The first fixing part 62 has a plurality of protrusions, for example, that can hook onto a second fixing part 123 provided on the tubular device 100. It is preferable that the first fixing part 62 can fix the second fixing part 123 in any position.

[0070] like Figure 1 , 3As shown in Figure 4, the tubular device 100 includes a tubular component 110 and a second operating section 120. The tubular component 110 includes a tubular base end portion 111 and a tubular front end portion 112. The tubular device 100 is used with the irradiation device 20 inserted into the tubular component 110.

[0071] The tubular base end 111 is a round tube, and the second operating part 120 is fixed to the base end. To ensure the operator's field of vision, the tubular base end 111 is made of a transparent material. A scale 115 arranged along the axial direction is attached to the outer peripheral surface of the tubular base end 111. The scale 115 can be used to confirm the insertion depth of the tubular base end 111 into organisms such as the irradiation instrument 20 and the vaginal V. The material of the tubular base end 111 is not particularly limited as long as it is transparent; for example, it can be made of silicone, polyamide, polymethyl methacrylate, polyethylene terephthalate, polycarbonate, polytetrafluoroethylene, urethane, or combinations thereof.

[0072] The tubular front end portion 112 is a circular tube disposed on the front end side of the tubular base end portion 111. The tubular front end portion 112 is formed of a transparent or translucent material capable of transmitting light of the wavelength emitted by the irradiation portion 50. The constituent material of the tubular front end portion 112 is not particularly limited, for example, silicon, polyamide, polymethyl methacrylate, polyethylene terephthalate, polycarbonate, polytetrafluoroethylene, urethane, or combinations thereof. The tubular front end portion 112 has a structure that diffuses or scatters light. Therefore, like the disk portion 30, the tubular front end portion 112 may contain a scatterer in at least a portion of the constituent material, or have a plurality of irregularities formed on the inner and outer surfaces, or may be a multilayer structure formed by joining materials with different refractive indices on the surfaces with a plurality of irregularities. The foremost point of the tubular front end portion 112 is inclined relative to a plane perpendicular to the axis. Therefore, a protrusion 113 protruding most prominently in the forward direction is formed in a portion of the tubular front end portion 112 in the circumferential direction. Furthermore, the tubular front end 112 forms a recess 114 with minimal protrusion in the forward direction on the opposite side of the circumferential protrusion 113. By positioning the recess 114 on the anterior vaginal fornix AV side, which is closer to the vaginal opening, and positioning the opposite protrusion 113 on the posterior vaginal fornix RV side, which is farther from the vaginal opening, the front end of the tubular member 110 can be brought close to the entire vaginal fornix VF, which includes the anterior vaginal fornix AV and the posterior vaginal fornix RV. Therefore, light can be effectively irradiated into areas that are difficult for light to reach, including the posterior vaginal fornix RV and the anterior vaginal fornix AV. The outer diameter of the tubular member 110 is, for example, 20 to 60 mm.

[0073] The tubular component 110 can be formed in various shapes. It is preferable that the tubular component 110 be appropriately selected according to the shape of the patient's uterine-vaginal region (UV), vaginal fornix (VF), and vaginal v.

[0074] like Figure 11As shown in the 13th variation of (A), the foremost end of the tubular member 110 may be perpendicular to the axis of the tubular member 110. Additionally, as... Figure 11 As shown in the 14th variation (B), the tubular component 110 may have a balloon 115 (fixed portion) inside. The balloon can be expanded by supplying fluid through a supply conduit 116 extending from the second operation portion 120. The balloon is sealed within the disc portion 30 disposed inside the tubular component 110 by expansion. Thus, the irradiation device 20 can be fixed to the tubular device 100.

[0075] In addition, such as Figure 11 As shown in the 15th variation of (C), the tubular base end 111 can be composed of two opposing split members 117. The two split members 117 are slidable in the axial direction. The two split members 117 are housed in a non-separable manner within, for example, a tube body, i.e., an outer tube 118. Furthermore, one split member 117 is fixed to the outer tube 118, while the other split member 117 is slidable on the outer tube 118. The tubular front end 112 is fixed at a position away from each other at the front ends of each split member 117. Furthermore, the tubular front end 112 is formed of a softly deformable material. Therefore, by sliding the two split members 117, the inclination of the very tip of the tubular front end 112 can be arbitrarily changed. Thus, the practitioner can arbitrarily adjust the shape of the tubular member 110 according to the shape of the patient's uterine-vaginal portion UV, vaginal fornix VF, and vaginal V.

[0076] like Figure 1 and Figure 3 As shown, the second operating section 120 is the part where the practitioner holds and operates the tubular instrument 100. The second operating section 120 includes a second operating section body 121 for the practitioner to hold and operate, a support portion 122 for supporting the irradiation instrument 20, and a second fixing portion 123 for fixing the irradiation instrument 20. The second operating section body 121 is fixed to the outer peripheral surface of the base end of the tubular component 110. The second operating section body 121 extends from the outer peripheral surface of the base end of the tubular component 110 towards the base end side, and also extends radially outward from the tubular component 110. The second operating section body 121 connects the support portion 122 and the second fixing portion 123. The support portion 122 is the part that holds the base end of the main shaft 21 in an appropriate position. The support portion 122 is formed, for example, by branching into two branches in a manner that allows it to clamp and hold the main shaft 21. The second fixing part 123 is, for example, an arc-shaped component that can rotate relative to the main body 121 of the second operating part and hook onto the protrusion of the first fixing part 62 provided on the irradiation device 20.

[0077] The light output device 80 is capable of outputting light of any wavelength to the optical fiber 51 of the irradiation unit 50 at any intensity (power) and energy. The light output device 80 is capable of outputting light of any wavelength at an intensity (power) of, for example, 1mW to 5W, at an energy of, for example, 1 to 50 J / cm². -2 The energy is used to irradiate light, and near-infrared rays with wavelengths of, for example, 660 to 740 nm are output to the optical fiber 51.

[0078] Next, the treatment method using the treatment device 10 according to the embodiment will be described.

[0079] First, an antibody-photosensitive substance is administered intravenously. Approximately 12 to 36 hours after intravenous administration, the operator inserts the tubular instrument 100 (without the irradiation device 20) into the vaginal V through the vaginal opening. The tubular component 110 is inserted into the vaginal V through the vaginal opening from the side of its anterior end 112. At this time, the second operating part body 121 of the tubular instrument 100 extends radially outward from the outer periphery of the base end of the tubular component 110 towards the base end, thus not obstructing the operator's view. Furthermore, the tubular component 110 is transparent, thus not obstructing the operator's view. Therefore, the operator can easily insert the treatment device 10 into the vaginal V by opening the vaginal opening using the tubular component 110. Therefore, this treatment method does not require a colposcope. It should be noted that a colposcope can also be used to open the vaginal opening.

[0080] Next, the practitioner inserts the irradiation device 20 into the tubular component 110 from the base end side. At this time, the disc portion 30 of the irradiation device 20 is positioned inside the tubular component 110, and the first fixing portion 62 is not fixed to the second fixing portion 123. Therefore, the irradiation device 20 can move relative to the tubular device 100 along the axis of the tubular component 110. Then, as... Figure 12 As shown, the operator visually confirms the front end of the tip shaft 24 while inserting it into the cervical canal CC through the external cervical os O. At this time, the tubular component 110 is transparent, allowing the operator to easily insert it into the cervical canal CC by visually identifying the tip shaft 24. Furthermore, the irradiation instrument 20 is not fixed relative to the tubular instrument 100, allowing for appropriate movement of the irradiation instrument 20 relative to the tubular instrument 100. Therefore, the operator can easily position the tip shaft 24 relative to the cervical canal CC at the desired location.

[0081] Next, as Figure 13As shown, the practitioner inserts the tubular instrument 100 and presses the tubular component 110 towards the uterine-vaginal portion UV. The front shaft 24 of the cervical canal CC, inserted from the external cervical os O, is connected to the center of the disc portion 30 disposed inside the tubular component 110, thus being located approximately at the center of the opening on the front side of the tubular component 110. Therefore, the uterine-vaginal portion UV located around the external cervical os O can easily enter the recess from the opening on the front side of the tubular component 110 to the disc portion 30. Therefore, the tubular anterior end portion 112, located radially outward and protruding towards the front end of the disc portion 30, approaches the vaginal fornix VF. At this time, the recessed portion 114 of the tubular anterior end portion 112 can contact or approach the anterior vaginal fornix AV, which is closer to the vaginal opening. In addition, the protrusion 113 of the tubular anterior end portion 112 can contact or approach the posterior vaginal fornix RV, which is farther from the vaginal opening. The tubular anterior portion 112, if flexible and deformable, can conform to the shape of the vaginal fornix VF, thereby abutting a large portion of the vaginal fornix VF. It is preferable that at least a portion of the annular tubular anterior portion 112 abuts against the vaginal fornix VF. Thus, the tubular component 110 is positioned relative to the cervix U and the vagina V. It should be noted that when positioning the tubular component 110, the practitioner can also move the anterior shaft 24 together with the tubular component 110. In this case, the tubular component 110 and the anterior shaft 24 are positioned simultaneously relative to the cervix U and the vagina V.

[0082] Next, the practitioner secures the irradiation device 20 and the tubular device 100. Therefore, for example, the second fixing part 123 is fixed to the first fixing part 62. Or, as... Figure 8 As shown in (B), when the disc portion 30 is equipped with a balloon 44 (fixing portion), the balloon 44 can be expanded to fix the irradiation device 20 and the tubular device 100. Or, as Figure 11 As shown in (B), when a balloon 115 is disposed on the tubular component 110, the balloon 115 can be expanded to fix the irradiation device 20 and the tubular device 100.

[0083] Next, the practitioner positions the light-emitting part 52 of the irradiation unit 50 inside the front shaft 24. At this time, the light-emitting part 52 is positioned so that it can also irradiate light onto the disk part 30 and the tubular front end 112. Then, the practitioner operates the light output device 80 to supply near-infrared light to the irradiation unit 50.

[0084] Therefore, the light-emitting part 52 inside the front end shaft 24 can effectively irradiate near-infrared rays onto the tumor cells C located in the cervix U. When the front end shaft 24 has the function of diffusing or scattering light, it diffuses near-infrared rays to emit light. The irradiation direction of the near-infrared rays from the light-emitting part 52 includes a direction approximately perpendicular to the axis of the front end shaft 24. Therefore, the light-emitting part 52 can effectively irradiate near-infrared rays from the cervical canal CC onto the tumor cells C located in the cervix U. It should be noted that near-infrared rays can also be irradiated by the tubular component 110 alone (see [reference]). Figure 9 (A)). In this case, the base of the tubular component 110 is connected to a light source such as the light output device 80.

[0085] When near-infrared light is irradiated from the cervical canal (CC), the light reaches the antibody-photosensitive substance of tumor cells (C) aggregated in the cervix (U). This causes a chemical change in the antibody-photosensitive substance upon receiving the near-infrared light as excitation, followed by a structural change that creates pores in the cell membrane. Consequently, the tumor cells (C) irradiated with near-infrared light are destroyed.

[0086] Furthermore, the disc portion 30 and the tubular front end portion 112, which receive light from the light-emitting portion 52, have the function of diffusing or scattering light, thus emitting light as a whole. That is, a portion of the near-infrared light reaching the disc portion 30 and the tubular front end portion 112 is transmitted through the disc portion 30 and the tubular front end portion 112. A portion of the near-infrared light reaching the disc portion 30 and the tubular front end portion 112 is scattered or diffused by the disc portion 30 and the tubular front end portion 112, irradiating a wide area. Therefore, the light-emitting portion 52, the disc portion 30, and the tubular front end portion 112 can effectively irradiate near-infrared light mainly onto tumor cells C located primarily at the external cervical os O, the uterine vaginal portion UV, the vaginal fornix VF, and the vaginal fornix VF near the vaginal opening, which is closer to the vaginal opening than the vaginal fornix VF. Furthermore, the vaginal wall, located closer to the vaginal opening than the vaginal fornix VF (Vagina V), has numerous folds. However, because the tubular anterior end 112 is positioned near the vaginal fornix VF, the angle of incidence of near-infrared light onto the vaginal wall is reduced. Therefore, light reflection can be suppressed as much as possible, thereby enabling effective irradiation of near-infrared light onto the tumor cells C.

[0087] When near-infrared radiation is irradiated from inside the vagina (V), the radiation primarily reaches the antibody-photosensitive material of tumor cells C located at the external cervical os (O), the vaginal portion of the uterus (UV), the vaginal fornix (VF), and near the vaginal fornix VF, which is closer to the vaginal opening than the vaginal fornix VF. Upon receiving the near-infrared radiation as excitation light, the antibody-photosensitive material undergoes a chemical change, followed by a structural change, resulting in pores opening in the cell membrane. Consequently, the tumor cells C irradiated with near-infrared radiation are destroyed.

[0088] The luminescent part 52 simultaneously irradiates near-infrared rays from both the cervical canal (CC) and the vagina (V). It should be noted that the practitioner can move the luminescent part 52 while irradiating near-infrared rays inside the irradiation cavity 25. Therefore, the practitioner can perform near-infrared irradiation from the cervical canal (CC) and from the vagina (V) separately. The practitioner can also irradiate near-infrared rays while alternately moving the luminescent part 52 within the cervical canal (CC) and the vagina (V).

[0089] The practitioner can move the irradiation device 20 and the tubular device 100 as a whole as needed, allowing the disc portion 30, the tubular component 110, and the irradiation part 50 to move within the vagina (V) and the cervical canal (CC), while repeatedly irradiating near-infrared rays. At this time, the operation is easy as long as the irradiation device 20 and the tubular device 100 are fixed together. Alternatively, the fixing of the irradiation device 20 and the tubular device 100 can be released, allowing the irradiation device 20 and the tubular device 100 to be operated separately. In this case, the irradiation device 20 and the tubular device 100 can be positioned at the desired locations.

[0090] Once the operator determines that sufficient destruction of tumor cells C has been achieved and the prescribed time has elapsed, near-infrared irradiation is stopped. Then, the operator removes the second fixation part 123 from the first fixation part 62, releasing the fixation of the irradiation device 20 and the tubular device 100. The operator then removes both the irradiation device 20 and the tubular device 100 from the body. It should be noted that the fixation of the irradiation device 20 and the tubular device 100 may not be released, and both may be removed simultaneously. This concludes the treatment method.

[0091] As described above, the treatment device 10 of this embodiment is a treatment device irradiating excitation light onto antibody-photosensitive substances aggregated in cervical cancer tumor cells C. It includes: a tubular instrument 100 having a long tubular component 110; and an irradiation instrument 20 that can be inserted into the tubular component 110. The irradiation instrument 20 has: a main body shaft 21 having a front end and a base end; a disk portion 30 disposed on the front end side of the main body shaft 21; a front end shaft 24 protruding from the disk portion 30 toward the front end side; and an irradiation section 50 disposed on the front end shaft 24 that can emit excitation light.

[0092] The treatment device 10 configured as described above can effectively irradiate excitation light onto antibody-photosensitive substances that are aggregated in a large area of ​​tumor cells C contained in the cervix U, while the front end shaft 24 is inserted into the cervical canal CC and the tubular component 110 is inserted near the vaginal fornix VF. Therefore, this treatment device 10 can improve the treatment effect on cancers in at least a portion of the cervix U.

[0093] Furthermore, the front end shaft 24 can irradiate excitation light in a direction substantially perpendicular to its axis, and the disk portion 30 can irradiate excitation light in a direction substantially towards the front end. Thus, both the front end shaft 24 and the disk portion 30 can irradiate excitation light onto the tumor cells C of the cervix U, thereby improving the treatment effect.

[0094] Furthermore, the tubular component 110 may have a light waveguide 119 (second irradiation section) capable of irradiating excitation light in a direction substantially perpendicular to the axis of the tubular component 110 and / or in a direction substantially towards its front end. Thus, both the irradiation section 50 provided in the irradiation device 20 and the light waveguide 119 (second irradiation section) provided in the tubular component 110 can irradiate excitation light onto the tumor cells C of the cervix U, thereby improving the treatment effect. Additionally, excitation light can be directly irradiated from the light waveguide 119 provided in the tubular component 110 onto the tumor cells C of the vaginal fornix VF, which is difficult for light to reach, thereby improving the treatment effect.

[0095] Furthermore, the front end of the tubular component 110 can also be deformable. This allows the front end of the tubular component 110 to deform along the vaginal fornix VF and be positioned near the vaginal fornix VF. Therefore, excitation light can be effectively irradiated into the vicinity of the vaginal fornix VF, which is difficult for light to reach, thereby improving the treatment effect.

[0096] Alternatively, the treatment device 10 may also have a fixing part for fixing the irradiation device 20 to the tubular device 100. This allows the irradiation device 20 and the tubular component 110 to be operated as a single unit, thus improving operability. Furthermore, since the irradiation device 20 can be maintained in an appropriate position relative to the tubular component 110, the excitation light emitted from the irradiation device 20 can be appropriately propagated to the tubular component 110. Therefore, the excitation light emitted from the front end shaft 24, the disk portion 30, and the tubular component 110 can be appropriately irradiated onto the antibody-photosensitive substance.

[0097] Alternatively, the fixing part can be a balloon 44 disposed on the disc part 30 and capable of expanding by fluid flowing into it. Thus, by expanding the balloon 44 inside the tubular member 110, the irradiation device 20 can be easily and accurately fixed relative to the tubular member 110.

[0098] Alternatively, the fixing part can be a balloon 115 disposed in the tubular component 110 and capable of expanding by fluid flowing into it. Thus, by expanding the balloon 115, the irradiation device 20 can be easily and accurately fixed relative to the tubular component 110.

[0099] Furthermore, the axis of the disc portion 30 can be tilted relative to the axis of the main body axis 21. This allows the disc portion 30 to be easily configured according to the tilt relative to the vaginal portion UV of the uterus. Therefore, it is possible to appropriately irradiate the antibody-photosensitive material with excitation light irradiated from the disc portion 30.

[0100] Furthermore, the treatment method in this embodiment is a treatment method for cervical cancer, which includes the following steps: intravenous administration of an antibody-photosensitive substance; 12 to 36 hours after intravenous administration, inserting a tubular component 110 into the vagina V; inserting an irradiation device 20 into the tubular component 110, wherein the irradiation device 20 has a disc portion 30 that can be disposed inside the tubular component 110, a front end shaft 24 protruding from the disc portion 30 toward the front end, and an irradiation portion 50 capable of emitting excitation light of the antibody-photosensitive substance; inserting the front end shaft 24 into the cervical canal CC; and irradiating the irradiation portion 50 to emit light, thereby irradiating the surrounding tissue from the disc portion 30, the front end shaft 24, and the tubular component 110.

[0101] The treatment method described above allows the front end shaft 24 to be inserted into the cervical canal CC from the external cervical os O, and the tubular component 110 to be inserted into or near the vaginal fornix VF. Therefore, by emitting excitation light from the front end shaft 24, the disc portion 30, and the tubular component 110, the excitation light can be effectively irradiated onto the antibody-photosensitive substance aggregated in at least a portion of the cervix U. Thus, this treatment method can improve the therapeutic effect on cancers in at least a portion of the cervix U.

[0102] Furthermore, this treatment method includes a step of fixing the position of the irradiation device 20 relative to the tubular component 110. This allows the irradiation device 20 and the tubular component 110 to be operated as a single unit, thus improving operability. Additionally, by maintaining the irradiation device 20 in an appropriate position relative to the tubular component 110, light emitted from the irradiation device 20 can be appropriately propagated to the tubular component 110. Therefore, light emitted from the front end shaft 24, the disk portion 30, and the tubular component 110 can be used as excitation light to appropriately irradiate the antibody-photosensitive substance.

[0103] It should be noted that the present invention is not limited to the above-described embodiments, and those skilled in the art can make various changes within the technical concept of the present invention.

[0104] For example, such as Figure 14As shown, the treatment device 10 may include a detection unit 90 that detects fluorescence (e.g., 704 nm) emitted by an antibody-photosensitive substance excited by near-infrared light irradiation from the light-emitting unit 52, at a wavelength different from the wavelength of the irradiated light (e.g., 689 nm). The detection unit 90 includes, for example, an optical waveguide 91 such as an optical fiber disposed in the irradiation cavity 25 as the irradiation unit 50 and receiving light, and a light sensor 92 capable of detecting the amount of light. The detection unit 90 may also include a semiconductor sensor such as a CMOS image sensor at the light-receiving position that senses light and converts it into an electrical signal.

[0105] When the antibody-photosensitive substance aggregated on tumor cells C is irradiated with near-infrared light, the antibody-photosensitive substance undergoes a photoreaction and emits fluorescence, thereby destroying tumor cells C. It should be noted that the antibody-photosensitive substance ceases to emit fluorescence after destroying tumor cells C. Therefore, by measuring the change in the intensity of the detected fluorescence using a photosensor 92, the extent of tumor cell C destruction caused by excitation light irradiation can be confirmed. Thus, the progression of the photoreaction that destroys tumor cells C can be determined.

[0106] It should be noted that the detection unit 90 can be a different device from the treatment device 10 equipped with the aforementioned irradiation unit 50, as long as it can detect the fluorescence emitted by the antibody-photosensitive substance excited by receiving near-infrared light. The detection unit 90 can also be inserted into the vagina (V), uterus, rectum, bladder, urethra, abdominal cavity, blood vessels, urinary catheter, etc., to detect fluorescence. Fluorescence detection using the detection unit 90 can be performed in parallel with near-infrared irradiation using the treatment device 10, or it can be performed after near-infrared irradiation using the treatment device 10 is completed. The detection unit 90 can also be inserted into the vagina (V) or cervical canal (CC) after the treatment device 10 has been removed from the cervical canal (CC) and vagina (V). Alternatively, the detection unit 90 can detect fluorescence from the body surface outside the body simultaneously with or after near-infrared irradiation using the treatment device 10.

[0107] It should be noted that the detection unit 90 can also be used to confirm where the treatment device 10 is inserted when the practitioner inserts it into the vagina V or cervical canal CC. For example, the position of the treatment device 10 can be confirmed based on the image obtained from the CMOS image sensor and the changes in the intensity and color of the light obtained from the optical waveguide 91 such as optical fiber.

[0108] It should be noted that, in the tubular component 110, a reflective component (not shown) may be provided between the tubular base end 111 and the tubular front end 112. By using the reflective component to suppress the propagation of light irradiated from the tubular front end 112 to the tubular base end 111, irradiation of the tubular front end 112 can be performed more effectively.

[0109] Furthermore, in the tubular component 110, the material of the tubular base end 111 may not be transparent; for example, it may be a metallic material such as stainless steel. This allows for thinning of the wall thickness while maintaining the rigidity of the tubular component 110, thereby further improving operability.

[0110] It should be noted that this application is based on Japanese Patent Application No. 2020-060402, filed on March 30, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0111] Explanation of reference numerals in the attached figures

[0112] 10 Treatment Devices

[0113] 20 Irradiation equipment

[0114] 21 Main axis

[0115] 24-inch front end axis

[0116] 25 Irradiate the inner cavity

[0117] 30. Disc section

[0118] 31 Front end

[0119] 32 Base end face

[0120] 33. Outer surface

[0121] 34 through holes

[0122] 44, 115 Balloon (Fixture)

[0123] 50 irradiation department

[0124] 62 First fixing part (fixing part)

[0125] 80 Optical Output Device

[0126] 90 Testing Department

[0127] 100 tubular instruments

[0128] 110 Tubular components

[0129] 111 Tubular base end

[0130] 112 Tubular anterior end

[0131] 113 Protrusion

[0132] 114 Depression

[0133] 119 Optical waveguide (Second irradiation section)

[0134] 122 Support section

[0135] 123 Second fixing part (fixing part)

[0136] C Tumor cells

[0137] CC cervical canal

[0138] I. Cervical os

[0139] O cervical os

[0140] U cervix

[0141] UC uterine cavity

[0142] UV uterus and vaginal area

[0143] V vagina

[0144] VF vaginal fornix

[0145] AV Anterior vaginal fornix

[0146] RV posterior vaginal fornix

Claims

1. A treatment device that irradiates an antibody-photosensitive substance with excitation light onto tumor cells aggregated in cervical cancer, characterized in that, The treatment device comprises: a tubular instrument with a long tubular component; and an irradiation device capable of being inserted into the tubular component. The irradiation device has: A main shaft having a front end and a base end; A disk portion disposed on the front end side of the main shaft; A front shaft protruding from the disk portion toward the front end; and An irradiation cavity is continuously formed on the inner side of the main shaft and the front end shaft. The disk portion is disposed inside the tubular component at the front end of the main shaft and is capable of transmitting the excitation light emitted from the irradiation portion disposed in the irradiation cavity to the outside.

2. The treatment device as described in claim 1, characterized in that, The excitation light is irradiated in a direction that is approximately perpendicular to the axis of the front end. The excitation light is irradiated in a generally forward direction from the disk portion.

3. The treatment device as described in claim 1, characterized in that, The tubular component has a second irradiation section capable of irradiating the excitation light in a direction substantially perpendicular to the axial direction of the tubular component and / or in a direction substantially towards the front end.

4. The treatment device according to any one of claims 1 to 3, characterized in that, The front end of the tubular component is deformable.

5. The treatment device according to any one of claims 1 to 4, characterized in that, It has a fixing part for fixing the irradiation device to the tubular device.

6. The treatment device as described in claim 5, characterized in that, The fixing part is a balloon disposed on the disc part and capable of expanding by fluid flowing into it.

7. The treatment device as described in claim 5, characterized in that, The fixing part is a balloon disposed in the tubular component and capable of expanding by fluid flowing into it.

8. The treatment device according to any one of claims 1 to 7, characterized in that, The axis of the disc portion is inclined relative to the axis of the main body axis.

9. The treatment device according to any one of claims 1 to 8, characterized in that, It has a detection unit for detecting the fluorescence emitted by the antibody-photosensitive substance.

Images