Treatment devices

Abstract

To provide a treatment device and a treatment method capable of identifying the extent of the disease and confirming treatment progress in minimally invasive approach while executing treatment to destroy tumor cells.SOLUTION: A treatment device 10 for detecting / destroying tumor cells C by radiating excitation light to an antibody-photosensitive substance adsorbed on tumor cell membrane includes: a long-sized tubular shaft 20 having light permeability; a light irradiation part 30 capable of radiating excitation light of the antibody-photosensitive substance from the inside of the shaft 20 in a side direction Y perpendicular to an axial direction X of the shaft 20; and a side direction fluorescence detection part 40 capable of detecting fluorescence emitted by the excited antibody-photosensitive substance from a side direction Y perpendicular to the axial direction X of the shaft 20, and capable of moving in the axial direction X with respect to the shaft 20.SELECTED DRAWING: Figure 1

Description

[Technical Field]

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

[0002] Therapies using photoreactive substances are known as localized cancer treatments (see, for example, Patent Document 1). In particular, treatments using antibody-photosensitizer (hydrophilic phthalocyanine) are expected to specifically destroy target cells without destroying non-target cells such as normal cells by irradiating excitation light (for example, near-infrared light) onto the antibody-photosensitizer accumulated in tumors, thereby achieving a high therapeutic effect while reducing side effects.

[0003] In the treatment of cervical cancer, preliminary diagnosis involves a cytology test, in which cells collected by swabbing with a brush or spatula are examined under a microscope, or a colposcopy test, which uses a colposcope (a magnifying glass for the vagina) that can be inserted into the vagina to closely observe the entrance to the uterus. After the preliminary diagnosis, a conization procedure is performed, and a definitive diagnosis (pathological diagnosis) is made using the excised tissue. A definitive diagnosis is necessary because the extent and severity of the lesion cannot be accurately determined from the preliminary diagnosis. A definitive diagnosis determines the stage of cancer progression and the treatment method. Furthermore, if the margins of the conized tissue are negative, the treatment is completed by conization, and treatment is completed. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Patent No. 4185313 specification Summary of the Invention [Problem to be solved by the invention]

[0005] Therapies using photoreactive substances do not remove cells, so a definitive diagnosis cannot be made, making it impossible to identify the extent of the lesion before treatment or to confirm after treatment whether all the lesions have been treated or whether additional treatment is required.

[0006] Incidentally, Patent Document 1 describes a minimally invasive method for identifying tumors that emit fluorescence different from that emitted by normal biological tissues by irradiating biological tissues with excitation light (ultraviolet light).

[0007] The present invention has been made to solve the above-mentioned problems, and provides a treatment device that can identify the extent of a lesion and check the progress of treatment in a minimally invasive manner while performing treatment to destroy tumor cells. Place The purpose is to provide. [Means for solving the problem]

[0008] The therapeutic device according to the present invention, which achieves the above-mentioned object, is a therapeutic device that detects and destroys tumor cells by irradiating excitation light onto antibody-photosensitive substance adsorbed to the tumor cell membrane, and is characterized by comprising: a long, optically transparent tubular shaft; a light irradiation unit that can irradiate the excitation light of the antibody-photosensitive substance from inside the shaft in a lateral direction perpendicular to the axial direction of the shaft; and a lateral fluorescence detection unit that can detect fluorescence emitted by the excited antibody-photosensitive substance from a lateral direction perpendicular to the axial direction of the shaft and is movable in the axial direction relative to the shaft. [Effects of the Invention]

[0009] In the treatment device configured as described above, the lateral fluorescence detection unit can be moved in the axial direction, so that the fluorescence emitted by the antibody-photosensitizer excited by the excitation light from the light irradiation unit can be detected at multiple positions in the axial direction by the lateral fluorescence detection unit. As a result, this treatment device can perform treatment to destroy tumor cells while also identifying the extent of the lesion and monitoring the progress of treatment in a minimally invasive manner.

[0010] The treatment device may have a puncture section disposed at the tip of the shaft, so that even if a lesion is located deep below the tissue surface, the tissue can be punctured and the shaft can be inserted into the tissue to treat the lesion, identify the extent of the lesion, and check the progress of the treatment.

[0011] The treatment device may include a light adjusting unit capable of changing the direction of excitation light emitted from the light irradiating unit and a distal fluorescence detecting unit capable of detecting fluorescence from the distal end of the shaft. The shaft may include a proximal shaft having the light adjusting unit disposed at its distal end and a light-transmitting distal shaft protruding from the light adjusting unit in the distal direction. The light irradiating unit may be movable between the interior of the distal shaft and the interior of the light adjusting unit. By disposing the light irradiating unit inside the distal shaft, excitation light can be irradiated laterally while fluorescence from the lateral direction can be detected by the lateral fluorescence detecting unit. Furthermore, by disposing the light irradiating unit inside the light adjusting unit, excitation light can be irradiated distally while fluorescence from the distal direction can be detected by the distal fluorescence detecting unit. Therefore, by disposing the light irradiating unit inside the distal shaft inserted into the cervical canal, cervical tumors can be effectively treated by irradiating them with excitation light from inside the cervical canal. Furthermore, by disposing the light irradiating unit inside the light adjusting unit disposed in a portion of the vagina close to the uterine vagina, cervical tumors can be effectively treated by irradiating them with excitation light from the vaginal side.

[0012] The lateral fluorescence detection unit may include a ring-shaped scatterer that is arranged circumferentially of the light irradiation unit and that is movable in the axial direction along the outer circumferential surface of the light irradiation unit, and an optical waveguide that is arranged on the proximal end side of the scatterer. This allows the lateral fluorescence detection unit to detect fluorescence at multiple positions in the axial direction, thereby enabling the axial lesion range where tumor cells are located to be identified.

[0013] The lateral fluorescence detection unit may have a plurality of optical fibers, and a plurality of incident portions of the optical fibers may be arranged along the circumferential direction of the light irradiation unit and may be movable in the axial direction along the outer peripheral surface of the light irradiation unit. This allows the lateral fluorescence detection unit to individually detect fluorescence at a plurality of positions in the circumferential direction, thereby enabling the circumferential lesion range where tumor cells are present to be identified.

[0014] Another aspect of the therapeutic device according to the present invention that achieves the above-mentioned object is a therapeutic device that detects and destroys tumor cells by irradiating excitation light onto antibody-photosensitive substance adsorbed to the tumor cell membrane, and includes a light adjusting unit that can change the direction of light irradiated from the light irradiating unit, a base shaft having the light adjusting unit located at its tip, a light irradiating unit that can irradiate the excitation light of the antibody-photosensitive substance via the light adjusting unit, and a fluorescence detecting unit that can detect fluorescence emitted by the excited antibody-photosensitive substance and that can move in a circumferential direction around an axis that is approximately parallel to the axis of the base shaft.

[0015] In another aspect of the treatment device configured as described above, the fluorescence detection unit can be moved in the rotational direction, so that the fluorescence emitted by the antibody-photosensitizer excited by the excitation light from the light irradiation unit can be detected at multiple positions in the circumferential direction by the fluorescence detection unit. As a result, this treatment device can perform treatment to destroy tumor cells while also identifying the extent of the lesion and checking the progress of treatment in a minimally invasive manner. [Brief explanation of the drawings]

[0025] [Figure 1] FIG. 1 is a plan view showing a treatment device according to a first embodiment. [Figure 2] 1A and 1B are diagrams showing the distal end of a treatment device according to a first embodiment, in which (A) is a cross-sectional view and (B) is a cross-sectional view taken along line AA of (A). [Figure 3] 10A and 10B are diagrams showing a modified example of a lateral fluorescence detection unit, in which (A) is a perspective view showing the tip of the lateral fluorescence detection unit, and (B) is a perspective view showing one of the optical fibers that make up the lateral fluorescence detection unit. [Figure 4] FIG. 10 is a perspective view showing another modified example of the lateral fluorescence detection unit. [Figure 5] 1 is a schematic diagram showing the state in which the treatment device is inserted into the vagina and cervix. [Figure 6] 1A and 1B are cross-sectional views showing the state in which treatment is being performed using the treatment device of the first embodiment, in which (A) shows the state in which the detection unit is located at the tip of the shaft's lumen, (B) shows the state in which the detection unit is moving in the axial direction, and (C) shows the state in which the light-emitting unit is moved toward the base end. [Figure 7] FIG. 10 is a cross-sectional view showing a state in which treatment is performed using a modified lateral fluorescence detection unit. [Figure 8] FIG. 10 is a plan view showing another modified example of the lateral fluorescence detecting unit. [Figure 9] FIG. 10 is a cross-sectional view showing the distal end portion of a treatment device according to a second embodiment. [Figure 10] FIG. 10 is a cross-sectional view showing a state in which a light-emitting unit of a treatment device according to a second embodiment is disposed on a distal shaft and treatment is being performed. [Figure 11] FIG. 10 is a cross-sectional view showing a state in which a light-emitting unit of a treatment device according to a second embodiment is disposed in a light adjusting unit and treatment is being performed. [Figure 12] FIG. 10 is a cross-sectional view showing a modified example of the treatment device according to the second embodiment. [Figure 13] FIG. 10 is a cross-sectional view showing the distal end portion of a treatment device according to a third embodiment. [Figure 14] 10A and 10B are cross-sectional views showing the state in which treatment is being performed using a treatment device according to the fourth embodiment, where (A) shows the state in which the detection unit is positioned at the tip of the shaft lumen, and (B) shows the state in which the detection unit is moving in the axial direction. DETAILED DESCRIPTION OF THE INVENTION

[0026] Hereinafter, embodiments of the present invention will be described with reference to the drawings. For convenience of explanation, the dimensions of the drawings may be exaggerated and may differ from the actual dimensions. Furthermore, in this specification and the drawings, components having substantially the same functional configurations are designated by the same reference numerals, and redundant explanations will be omitted. In this specification, the side of the device that is inserted into a biological lumen will be referred to as the "distal side," and the side that is operated will be referred to as the "proximal side."

[0027] First Embodiment The treatment device 10 according to the first embodiment is used in a method for treating cervical tumors. The treatment device 10 and treatment method can also be used to simultaneously treat both cervical tumors and vaginal tumors. The treatment device 10 and treatment method are used in photoimmunotherapy, in which an antibody-photosensitizer adsorbed to the cell membrane of a target cell is irradiated with near-infrared light, which serves as excitation light for the antibody-photosensitizer, to destroy the target cell. The target cell is a tumor cell, such as a cancer cell or a cell of a precancerous lesion. In this treatment method, an antibody-photosensitizer is used as a drug, which comprises an antibody that specifically binds to a unique antigen on the surface of the tumor cell and a photosensitizer that pairs with the antibody. The antibody is not particularly limited, but examples include panitumumab, trastuzumab, HuJ591, pertuzumab, lapatinib, palbociclib, and olaparib. The photosensitizer is, for example, but not limited to, a hydrophilic phthalocyanine (IR700), which reacts to near-infrared light with a wavelength of approximately 700 nm. When IR700 is exposed to near-infrared light with a wavelength of approximately 660-740 nm, the functional ligands that ensure its water solubility are cleaved, causing a conformational change from water-soluble to hydrophobic. This conformational change pulls out membrane proteins, creating holes in the cell membrane and allowing water to enter the cell, rupturing and destroying tumor cells. IR700 is also excited by near-infrared light and emits fluorescence at a wavelength different from the excitation wavelength. For example, when IR700 is excited by near-infrared light with a wavelength of 689 nm, it emits fluorescence at a wavelength of 704 nm. IR700 undergoes a conformational change while emitting fluorescence in response to light, and ceases to emit fluorescence once it has destroyed tumor cells and fulfilled its role as a drug.

[0028] The treatment apparatus 10 shown in Fig. 1 can treat tumors in the cervix U (e.g., cervical cancer) and tumors in the vagina V (e.g., vaginal cancer) in a wide range A, including the cervix U, the external cervical os O, the uterine 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 than the vaginal vault VF, as shown in Fig. 5. The treatment apparatus 10 can irradiate the antibody-photosensitizer adsorbed to tumor cells C in a wide range from the cervix U to the vagina V with excitation light.

[0029] 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 broadly 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 around the external cervical os O.

[0030] First, the treatment device 10 according to this embodiment will be described.

[0031] As shown in Figures 1 and 2, the treatment device 10 has a long tubular shaft 20 with a tip and a base, a long light irradiation unit 30 that irradiates excitation light to the antibody-photosensitive substance, a lateral fluorescence detection unit 40 that detects fluorescence emitted by the excited antibody-photosensitive substance, an operation unit 50 connected to the base end of the shaft 20, a light output device 60, a light receiving device 70, and a display device 80.

[0032] The shaft 20 is a tubular body extending from the operating unit 50 toward the distal end. The shaft 20 can accommodate the light irradiation unit 30 and the lateral fluorescence detection unit 40 in its lumen. The base end of the shaft 20 is fixed to the operating unit 50. The lumen of the shaft 20 is closed and sealed at the distal end of the shaft 20. The lumen of the shaft 20 is open at the proximal end of the shaft 20 and can accommodate the lateral fluorescence detection unit 40. The shaft 20 is a circular tube that extends linearly, but it may be curved or not be a circular tube.

[0033] The shaft 20 has a light-transmitting portion 21 at its tip that is capable of transmitting excitation light and fluorescence. The light-transmitting portion 21 is arranged in at least a predetermined range at the tip of the shaft 20. At least a portion of the light-transmitting portion 21 is the portion that is inserted from the external cervical os O into the cervical canal CC (see FIG. 4). The light-transmitting portion 21 is formed from a transparent or translucent material that has optical transparency that allows the excitation light of the wavelength emitted by the light irradiation portion 30 and the fluorescence of the wavelength emitted by the antibody-photosensitizer to pass through. The portion of the shaft 20 on the proximal side of the light-transmitting portion 21 may or may not be transparent. The entire shaft 20 may be the light-transmitting portion 21.

[0034] The shaft 20 preferably has a certain degree of rigidity so that the surgeon can grasp the operation unit 50 and push it to the desired position. The material of the light-transmitting unit 21 is not particularly limited, but examples include resins such as polymethyl methacrylate, polyethylene terephthalate, polycarbonate, and polytetrafluoroethylene, and glass. It is more preferable that the material of the shaft 20 has elasticity and physical properties that allow it to bend and deform along the cervical canal CC after being inserted into the cervical canal CC. 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 adhesion to the inner surface of the cervical canal.

[0035] The portion of the shaft 20 closer to the proximal end than the light-transmitting portion 21 may be formed of the same material as the light-transmitting portion 21, or may be formed of a different material. In this case, the portion of the shaft 20 closer to the proximal end than the light-transmitting portion 21 may be formed of a material that does not transmit excitation light and fluorescence, such as metals typified by stainless steel, aluminum, titanium alloys, tin, magnesium alloys, etc., or resins typified by polyether ether ketone (PEEK), polyamide, acrylonitrile butadiene styrene (ABS), polycarbonate, polyacetal, polyimide, etc. The outer diameter of the shaft 20 is not particularly limited, but is, for example, 0.5 to 6 mm. The length of the shaft 20 in the axial direction X is not particularly limited, but is, for example, 100 to 400 mm. The length of the light-transmitting portion 21 in the axial direction X is not particularly limited, but is, for example, 10 to 50 mm.

[0036] The light irradiation unit 30 has a long irradiation optical waveguide 31, a light emitting unit 32 arranged on the tip side of the irradiation optical waveguide 31, and a stopper 33 arranged on the outer circumferential surface of the irradiation optical waveguide 31. A part of the light irradiation unit 30 is movable within the lumen of the shaft 20 along the axial direction X of the shaft 20.

[0037] The illumination optical waveguide 31 is a long wire that propagates light. The illumination optical waveguide 31 is formed, for example, by a single optical fiber. Note that the illumination optical waveguide 31 may also be formed by a plurality of optical fibers. The base end of the illumination optical waveguide 31 is connectable to a light output device 60 that outputs light. The illumination optical waveguide 31 can receive near-infrared rays from the light output device 60 and propagate the near-infrared rays to the light-emitting unit 32. Note that the light irradiation unit 30 may also be formed by an optical waveguide other than an optical fiber.

[0038] The stopper 33 is a portion that protrudes radially outward from the outer circumferential surface of the illumination optical waveguide 31, on the proximal side of the lateral fluorescence detection unit 40 that slides on the outer circumferential surface of the illumination optical waveguide 31. The stopper 33 is formed, for example, in a ring shape, but the shape is not limited thereto. The stopper 33 is arranged to limit the movement of the lateral fluorescence detection unit 40 that slides on the outer circumferential surface of the illumination optical waveguide 31 in the axial direction X relative to the illumination optical waveguide 31.

[0039] The light emitting unit 32 is a cylindrical diffuser connected to a cut end of the optical fiber and diffuses or scatters light received from the optical fiber. The light emitting unit 32 may be formed integrally with the optical fiber that forms the irradiation optical waveguide 31 by processing the surface or interior of the optical fiber. Alternatively, the light emitting unit 32 may be a cut end of the optical fiber. The light emitting unit 32 may be formed by a mirror and / or a lens disposed on the cut end of the optical fiber. The light emitting unit 32 is capable of irradiating light propagated from the irradiation optical waveguide 31 in a lateral direction Y perpendicular to the axial direction X of the shaft 20 (or the axial direction X of the irradiation optical waveguide 31). The light emitting unit 32 is capable of irradiating light propagated from the irradiation optical waveguide 31 in the lateral direction Y perpendicular to the axial direction X of the shaft 20 (or the axial direction X of the irradiation optical waveguide 31). The light irradiating unit 30 may be capable of irradiating excitation light in a direction other than the lateral direction Y, as long as it can irradiate excitation light in the lateral direction Y. The light-emitting unit 32 may be an LED or the like that emits light using electricity. The light-emitting unit 32 preferably has a certain length L1 in the axial direction X so that it can simultaneously irradiate a relatively wide range with excitation light. The length L1 is not particularly limited, but is, for example, 10 to 400 mm. The length L1 of the light-emitting unit 32 may be shorter or longer than the above-mentioned range.

[0040] The lateral fluorescence detection unit 40 has a long detection optical waveguide 41, a detection unit 42 arranged on the tip side of the detection optical waveguide 41, an optical connector 43 arranged on the base end side of the detection optical waveguide 41, and a connecting optical waveguide 44 arranged on the base end side of the optical connector 43.

[0041] The detection optical waveguide 41 is a long tubular member that propagates light. The detection optical waveguide 41 surrounds the outer peripheral surface of the light irradiation unit 30 and is slidable (movable) in the axial direction X along the light irradiation unit 30. The tip of the detection optical waveguide 41 is connected to the detection unit 42, and the base end of the detection optical waveguide 41 is connected to the optical connector 43. In this embodiment, the detection optical waveguide 41 includes a first detection optical waveguide 45 on the tip side and a second detection optical waveguide 46 on the base end side. The second detection optical waveguide 46 on the base end side is formed by a tubular core that serves as an optical path and a cladding that covers the inner and outer peripheral surfaces of the core and reflects light propagating through the core. This allows the second detection optical waveguide 46 to propagate light efficiently. The first detection optical waveguide 45 on the tip side is formed by a transparent tubular body as a whole. The first detection optical waveguide 45 is capable of transmitting light in the radial direction, although the efficiency of propagating light in the proximal direction is not as high as that of the second detection optical waveguide 46. The length L3 of the first detection optical waveguide 45 along the axial direction X is not particularly limited, but is preferably approximately equal to the length L1 of the light-emitting unit 32 along the axial direction X.

[0042] The detection unit 42 is a member capable of propagating fluorescence received from the lateral direction Y to the detection optical waveguide 41. The detection unit 42 is, for example, a ring-shaped scatterer that circumferentially surrounds the light irradiation unit 30. The detection unit 42 may be, for example, a mirror and / or a lens.

[0043] The detection unit 42 may be formed integrally with the detection optical waveguide 41 by processing the surface or interior of the detection optical waveguide 41, or may be a cut end of the detection optical waveguide 41. The detection unit 42 may be formed by a mirror and / or a lens disposed at the cut end of the detection optical waveguide 41. The detection unit 42 may be capable of detecting fluorescence from directions other than the lateral direction Y as long as it can detect fluorescence from the lateral direction Y. The detection unit 42 may be a sensor that converts light into an electrical signal. In this case, the lateral fluorescence detection unit 40 has a conductor capable of transmitting an electronic signal on the proximal end side of the detection unit 42.

[0044] As a modified example of the lateral fluorescence detection unit 40, the detection optical waveguide 41 may be formed of multiple optical fibers 41A arranged in the circumferential direction so as to surround at least a portion of the light irradiation unit 30, as shown in FIG. 3 . In this case, multiple detection units 42 are arranged at the tip of each optical fiber 41A. Each detection unit 42 is, for example, the incident surface of the distal end of the optical fiber 41A, which is cut obliquely so as to face the respective lateral direction Y. A reflector 47 may be arranged on the outer surface of the optical fiber 41A facing the outer peripheral surface of the light irradiation unit 30 to prevent excitation light irradiated from the light irradiation unit 30 from entering the detection unit 42. Each detection unit 42 arranged in the circumferential direction can detect fluorescence independently. Therefore, by using a lateral fluorescence detection unit 40 having multiple optical fibers 41A, the circumferential position of the lesion area containing tumor cells C as viewed from the shaft 20 can be identified.

[0045] Another variation of the lateral fluorescence detection unit 40, as shown in FIG. 4 , may include a plurality of optical fibers 41A arranged in the circumferential direction so as to surround at least a portion of the light irradiation unit 30, a spherical scatterer 42B that can be arranged near the detection unit 42, which is the distal end of the plurality of optical fibers 41A, and a support tube 42C that supports the scatterer 42B at its tip. The support tube 42C is arranged between the outer circumferential surface of the detection optical waveguide 41, which is formed in a tubular shape by the plurality of optical fibers 41A, and the inner circumferential surface of the shaft 20, and is disposed between the outer circumferential surface of the detection optical waveguide 41 and the inner circumferential surface of the shaft 20. The support tube 42C is extended from the operation unit 50 toward the proximal end. The operator can rotate the portion of the support tube 42C extended outside the proximal end with their fingers to move the scatterer 42B in the circumferential direction at the position where the distal end of the plurality of optical fibers 41A is arranged. As a result, the scatterer 42B that has received the fluorescent light can propagate the fluorescent light to the distal end of the nearby optical fiber 41A.

[0046] 1, the optical connector 43 connects the base end of the detection optical waveguide 41 and the tip end of the connection optical waveguide 44. The optical connector 43 can propagate the light received from the detection optical waveguide 41 to the connection optical waveguide 44 extending in the lateral direction Y. Therefore, the optical connector 43 forms an optical waveguide.

[0047] The connecting optical waveguide 44 propagates light propagated from the detection optical waveguide 41 to the light-receiving device 70 via the optical connector 43. When the detection optical waveguide 41 is a single optical waveguide, it is preferable that the connecting optical waveguide 44 is also a single optical waveguide. When the detection optical waveguide 41 is formed by a plurality of optical fibers 41A arranged in the circumferential direction, it is preferable that the connecting optical waveguide 44 is also formed by a plurality of optical waveguides (e.g., a plurality of optical fibers). The optical connector 43 can independently connect each optical fiber 41A of the detection optical waveguide 41 to each optical fiber of the connecting optical waveguide 44 formed by a plurality of optical fibers. As in a modification shown in FIG. 8, the detection optical waveguide 41 and the connecting optical waveguide 44 may be integrally formed by a common optical fiber 41A. In this case, in the detection optical waveguide 41, the optical fibers 41A arranged so as to surround the outer peripheral surface of the light irradiator 30 extend as a bundle away from the light irradiator 30 in the lateral direction Y so that the light irradiator 30 passes through one of the gaps between the optical fibers 41A in the bundle, thereby forming a connection optical waveguide 44. In this case, the optical connector 43 is not provided.

[0048] 1, the base end of the optical connector 43 can come into contact with the stopper 33 arranged on the outer peripheral surface of the irradiation optical waveguide 31. When the position of the detection unit 42 is arranged so as to surround the tip of the light-emitting unit 32, a distance L2 along the axial direction X from the position of the base end face of the optical connector 43 to the stopper 33 is approximately equal to the length L1 along the axial direction X of the light-emitting unit 32. This allows the detection unit 42 to move in the axial direction X within a range that is approximately equal to the range over which the light irradiation unit 30 can irradiate excitation light (the range from the tip to the base end of the light-emitting unit 32).

[0049] The operation unit 50 is a portion that is held and operated by the surgeon. The proximal end of the shaft 20 is fixed to the operation unit 50. A detection optical waveguide 41 is led out from the proximal end of the operation unit 50 in the proximal direction. An irradiation optical waveguide 31 is led out from an optical connector 43 at the proximal end of the detection optical waveguide 41. The configuration of the operation unit 50 is not particularly limited.

[0050] The light output device 60 can output light of any wavelength with any intensity (power) or energy to the irradiation optical waveguide 31 of the light irradiation section 30. The light output device 60 outputs excitation light, which is 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 excitation light is output to the irradiation optical waveguide 31 so that light can be irradiated with an energy of 1000 kJ / s. The excitation light may be irradiated quantitatively or may be irradiated intermittently in pulses.

[0051] The light receiving device 70 is connected to the base end of the connecting optical waveguide 44 and receives the fluorescence detected by the lateral fluorescence detection unit 40. The light receiving device 70 converts the received light into an electrical signal, performs predetermined arithmetic processing, and can display the signal as image information on the display device 80. The light receiving device 70 includes, for example, a computer equipped with a memory circuit and an arithmetic circuit. The light receiving device 70 may have a filter that removes excitation light from the detected light and leaves behind the fluorescence. The filter may be, for example, a band-pass filter that leaves behind light of the fluorescent wavelength, or a filter that specifically removes pulsed excitation light.

[0052] The display device 80 is a monitor capable of displaying a visually recognizable image. The display device 80 is connected to the light-receiving device 70 so as to receive a signal including image data from the light-receiving device 70. The image displayed on the display device 80 is a two-dimensional image, a three-dimensional image, or the like acquired by the lateral fluorescence detection unit 40. The display device 80 displays an image based on the image data received from the light-receiving device 70.

[0053] Next, a treatment method using the treatment device 10 according to the first embodiment will be described.

[0054] First, the antibody-photosensitizer is administered into the body. The method for administering the antibody-photosensitizer into the body is not particularly limited as long as it can deliver the antibody-photosensitizer to the tumor cells C, but may be, for example, intravascular administration, which in this embodiment is intravenous administration. Approximately 12 to 36 hours after the intravenous administration, the surgeon opens the vaginal opening using a colposcope 200, as shown in Figures 5 and 6(A), and inserts the shaft 20 of the treatment device 10 from the vaginal opening into the vagina V. While visually checking the tip of the shaft 20, the surgeon inserts it from the external cervical os O into the cervical canal CC.

[0055] Next, the surgeon places the light-emitting unit 32 of the light irradiation unit 30 inside the shaft 20. The position of the light-emitting unit 32 is, for example, but not limited to, the most distal position reachable in the lumen of the shaft 20. After this, the surgeon operates the light output device 60 to supply excitation light to the light irradiation unit 30. This allows the light-emitting unit 32 inside the shaft 20 to effectively irradiate the excitation light onto tumor cells C located in the cervix U. The irradiation direction of the excitation light from the light-emitting unit 32 includes the lateral direction Y perpendicular to the axis of the shaft 20. Therefore, the light-emitting unit 32 can effectively irradiate the excitation light from the cervical canal CC onto tumor cells C located in the cervix U. The surgeon may irradiate the excitation light while moving the light-emitting unit 32 inside the shaft 20.

[0056] When the excitation light is irradiated, it reaches the antibody-photosensitizer adsorbed on tumor cells C in the cervix U. This causes a chemical change in the antibody-photosensitizer, which is excited by the excitation light, and a further structural change in the antibody-photosensitizer causes holes to form in the cell membrane. This destroys the tumor cells C irradiated with the excitation light.

[0057] The surgeon irradiates excitation light from the light-emitting unit 32 and detects fluorescence emitted by the antibody-photosensitizer excited by the excitation light using the lateral fluorescence detection unit 40. Because the lateral fluorescence detection unit 40 can detect fluorescence from the lateral direction Y, it can effectively detect fluorescence emitted by tumor cells C located in the cervix U from the cervical canal CC. While irradiating excitation light from the light-emitting unit 32, the surgeon can detect fluorescence by moving the detection unit 42 in the axial direction X within the length L1 of the light-emitting unit 32, as shown in FIG. 6(B). The surgeon can identify (diagnose) the location of tumor cells C in the axial direction X of the shaft 20 by identifying the fluorescence emitted by the excited antibody-photosensitizer adsorbed to tumor cells C from the image displayed on the display device 80. Therefore, the surgeon can focus treatment and diagnosis on the lesion area identified as containing tumor cells C. The light-emitting unit 32 is covered by the detection unit 42 and the first detection optical waveguide 45. However, the length of the detection unit 42 along the axial direction X is shorter than that of the light-emitting unit 32, and the first detection optical waveguide 45 is able to transmit light. Therefore, the excitation light emitted from the light-emitting unit 32 can reach the antibody-photosensitizer adsorbed to the tumor cells C without being affected much by the detection unit 42 and the first detection optical waveguide 45. Therefore, the present treatment device 10 can simultaneously destroy tumor cells C by irradiating them with excitation light and diagnose the lesion site by detecting fluorescence. Note that diagnosis includes identifying the lesion area where tumor cells C are located and confirming the destruction of tumor cells C (confirming their disappearance or reduction).

[0058] When the detecting unit 42 reaches the vicinity of the base end of the light-emitting unit 32, the base end face of the optical connector 43 of the lateral fluorescence detecting unit 40 abuts against the stopper 33 arranged on the outer circumferential surface of the irradiation optical waveguide 31. This prevents the detecting unit 42 from moving away from the light-emitting unit 32.

[0059] In the modified embodiment shown in FIG. 3 , the detection optical waveguide 41 is formed from multiple optical fibers 41A, making it impossible to provide the first detection optical waveguide 45, which transmits light radially, in the detection optical waveguide 41. Therefore, when the detection unit 42 is positioned distal to the proximal end of the light-emitting unit 32, the excitation light irradiated from the area covered by the detection unit 42 or the detection optical waveguide 41 of the light-emitting unit 32 hardly penetrates the detection unit 42 or the detection optical waveguide 41 and fails to reach the tumor cells C. Therefore, when the light-emitting unit 32 irradiates the antibody-photosensitizer adsorbed to the tumor cells C with excitation light, it is preferable to retract the detection unit 42 proximally, as shown in FIG. 7 , so that the detection unit 42 and the detection optical waveguide 41 do not obstruct the irradiation from the light-emitting unit 32. The detection unit 42 detects fluorescence only when fluorescence detection is desired, by moving the detection unit 42 to a predetermined position in the axial direction X. Therefore, in this modified example, it is difficult to continuously detect fluorescence by the detection unit 42 during irradiation with excitation light. However, because multiple detection units 42 are arranged side by side in the circumferential direction, the multiple detection units 42 can be used independently to identify the circumferential positions of tumor cells C. Therefore, even if different tumor cells C are present at multiple locations in the circumferential direction at a given position in the axial direction X, for example, each tumor cell C can be identified separately and appropriately treated.

[0060] 4, when fluorescence is incident on a spherical scatterer 42B that moves in the circumferential direction, the fluorescence is propagated from the scatterer 42B to an optical fiber 41A having an end 42A that faces the scatterer 42B. Therefore, the circumferential position of a tumor cell C can be identified using the scatterer 42B and the multiple optical fibers 41A.

[0061] When the operator determines that the fluorescence has disappeared using the display device 80 or when the operator determines that a predetermined time has passed, the operator determines that the tumor cells C have been sufficiently destroyed and stops irradiating the excitation light. The operator determines that the fluorescence has disappeared when the operator confirms that the fluorescence has disappeared using the display device 80 or when the fluorescence has decreased to a value equal to or less than a preset threshold value (or below the threshold value). The operator may determine whether the tumor cells C have been sufficiently destroyed, or the determination may be made automatically by a program or the like provided in the light-receiving device 70 or the like. The light-receiving device 70 may be capable of displaying the result of the determination on the display device 80.

[0062] Next, as shown in Fig. 6(C), while maintaining the position of the shaft 20, the surgeon pulls the light irradiation unit 30 to move the light emitting unit 32 toward the proximal end. The distance by which the light emitting unit 32 is moved toward the proximal end is preferably equal to or less than the length L1 along the axial direction X of the light emitting unit 32. This makes it possible to prevent the occurrence of an area that cannot be irradiated with excitation light.

[0063] Next, the surgeon operates the light output device 60 to supply excitation light to the light irradiation unit 30. Then, in the same procedure as before moving the light-emitting unit 32 toward the proximal end, the surgeon can perform the following steps: irradiating excitation light from the light-emitting unit 32, detecting fluorescence with the detection unit 42, moving the detection unit 42, identifying the area of ​​tumor cells C, confirming that tumor cells C have been destroyed, and stopping irradiation of the excitation light. The surgeon can then repeat the series of steps (additional steps) of moving the light-emitting unit 32, irradiating excitation light from the light-emitting unit 32, detecting fluorescence with the detection unit 42, moving the detection unit 42, identifying the area of ​​tumor cells C, confirming that tumor cells C have been destroyed, and stopping irradiation of the excitation light one or more times. Note that some steps included in the repeated series of steps may not be performed. For example, the irradiation of excitation light may not be stopped between repeated series of steps.

[0064] As described above, the treatment device 10 according to the first embodiment is a treatment device 10 that detects and destroys tumor cells C by irradiating excitation light onto antibody-photosensitizer adsorbed to the tumor cell membrane, and includes a long, optically transparent tubular shaft 20, a light irradiation unit 30 that can irradiate the antibody-photosensitizer excitation light from inside the shaft 20 in a lateral direction Y perpendicular to the axial direction X of the shaft 20, and a lateral fluorescence detection unit 40 that can detect fluorescence emitted by the excited antibody-photosensitizer in the lateral direction Y perpendicular to the axial direction X of the shaft 20 and is movable in the axial direction X relative to the shaft 20.

[0065] In the treatment device 10 configured as described above, the lateral fluorescence detection unit 40 can be moved in the axial direction X, so that the fluorescence emitted by the antibody-photosensitizer excited by the excitation light from the light irradiator 30 can be detected at multiple positions in the axial direction X by the lateral fluorescence detection unit 40. Therefore, the treatment device 10 can perform treatment to destroy tumor cells C while minimally invasively identifying the lesion area in the axial direction X and checking the progress of treatment without resecting tissue. Note that the light irradiator 30 may be capable of irradiating excitation light in a direction other than the lateral direction Y, as long as it can irradiate excitation light in the lateral direction Y. Furthermore, the lateral fluorescence detection unit 40 may be capable of detecting fluorescence from a direction other than the lateral direction Y, as long as it can detect fluorescence from the lateral direction Y.

[0066] Furthermore, the lateral fluorescence detection unit 40 has a ring-shaped scatterer that is arranged along the circumferential direction of the light irradiation unit 30 and is movable in the axial direction X along the outer circumferential surface of the light irradiation unit 30, and an optical waveguide that is arranged on the proximal end side of the scatterer. This allows the lateral fluorescence detection unit 40 to detect fluorescence at multiple positions in the axial direction X, thereby making it possible to identify the lesion area in the axial direction X where the tumor cells C are located.

[0067] Furthermore, the lateral fluorescence detection unit 40 may have a plurality of optical fibers 41A, and a plurality of incident portions (e.g., stumps or lenses) of the optical fibers 41A may be arranged along the circumferential direction of the light irradiation unit 30 and may be movable in the axial direction X along the outer circumferential surface of the light irradiation unit 30. This allows the lateral fluorescence detection unit 40 to individually detect fluorescence at a plurality of positions in the circumferential direction, thereby enabling the circumferential lesion range where the tumor cells C are located to be identified.

[0068] The treatment device 10 according to the first embodiment may be used for treatment of areas other than the cervix U. For example, the treatment device 10 may be used for treatment of long, thin hollow organs such as the ureter, prostate, and blood vessels.

[0069] Furthermore, the treatment method in the first embodiment is a treatment method for detecting and destroying tumor cells C by irradiating excitation light onto antibody-photosensitizer adsorbed to tumor cell membranes in the cervix U, and includes the steps of: administering the antibody-photosensitizer into the body; after administration, widening the vagina V with a colposcope 200, and inserting into the vagina V a treatment device 10 including a long, light-transmitting tubular shaft 20, a light irradiator 30 capable of irradiating excitation light onto the antibody-photosensitizer, and a lateral fluorescence detector 40 capable of detecting fluorescence emitted by the excited antibody-photosensitizer in a lateral direction Y perpendicular to the axial direction X of the shaft 20; inserting the shaft 20 into the cervical canal CC while visually checking the tip end and the external cervical os O; irradiating excitation light from the light irradiator 30 from inside the shaft 20 in the lateral direction Y; and, while irradiating the excitation light, moving the lateral fluorescence detector 40 in the axial direction X relative to the shaft 20 to detect fluorescence emitted by the antibody-photoabsorbing substance and confirming disappearance or reduction of the fluorescence.

[0070] The treatment method configured as described above detects fluorescence by moving the lateral fluorescence detection unit 40 in the axial direction X while irradiating excitation light from inside the cervical canal. Therefore, while performing treatment to destroy tumor cells C in the cervix U, it is possible to identify the position of the lesion area along the axial direction X and check the progress of treatment without performing resection.

[0071] Furthermore, this treatment method can repeat at least once additional steps after the step of confirming the disappearance or decrease of fluorescence: moving the light irradiating unit 30 in the axial direction X, and detecting the fluorescence emitted by the antibody-light absorbing substance while irradiating excitation light from the light irradiating unit 30 in the lateral direction Y from inside the shaft 20, by moving the lateral fluorescence detecting unit 40 in the axial direction X relative to the shaft 20, and confirming the disappearance or decrease of the fluorescence. This allows this treatment method to treat a wide area along the axial direction X of the shaft 20, identify the lesion area, and check the progress of treatment in a minimally invasive manner without resecting tissue.

[0072] Second Embodiment As shown in Figure 9, the treatment device 10 of the second embodiment differs from the first embodiment in that it is provided with a light adjustment unit 90 that can change the direction of the excitation light irradiated from the light irradiation unit 30, and a tip-direction fluorescence detection unit 100 that can detect fluorescence from the tip direction of the shaft 20.

[0073] The shaft 20 has an expansion tube 22 in which an expansion lumen 23 is formed. The expansion lumen 23 communicates with the interior of the light adjustment unit 90. The proximal end of the expansion tube 22 is located in the operation unit 50, and can be connected to a syringe or indeflator that supplies expansion fluid.

[0074] The light adjusting unit 90 is a member that is disposed on the outer periphery of the tip of the shaft 20 and expands radially outward within the vagina V, enabling light to be irradiated over a wide area of ​​the vagina V. The light adjusting unit 90 can transmit excitation light to the outside while changing the direction of the excitation light emitted from the light emitting unit 32 disposed in the lumen of the shaft 20 that passes through the inside of the light adjusting unit 90. For this reason, the light adjusting unit 90 is formed from a transparent or translucent material that can transmit light of the wavelengths of the excitation light and fluorescence.

[0075] The light adjusting unit 90 has a distal end fixed to the outer peripheral surface of the shaft 20 on the proximal side of the tip thereof, and a proximal end fixed to the outer peripheral surface of the shaft 20 on the further proximal side thereof. The interior of the light adjusting unit 90 communicates with the expansion lumen 23 provided in the shaft 20. The light adjusting unit 90 is a balloon that can be deformed and expanded when a fluid flows into the interior thereof.

[0076] The light adjusting unit 90 includes a distal light adjusting unit 91 on the distal side, a proximal light adjusting unit 92 on the proximal side, and an intermediate light adjusting unit 93 disposed between the proximal light adjusting unit 92 and the distal light adjusting unit 91. The distal light adjusting unit 91 is fixed to the outer peripheral surface of the shaft 20. When the light adjusting unit 90 is in an expanded state, the distal light adjusting unit 91 forms a flat surface facing the distal side. The distal light adjusting unit 91 is substantially perpendicular to the axis of the shaft 20 and abuts against the uterine vaginal portion UV around the external cervical os O (see FIG. 10 ). Note that the shape of the distal light adjusting unit 91 does not have to be flat. The intermediate light adjusting unit 93 is cylindrical and has a substantially constant outer diameter in the axial direction between the proximal light adjusting unit 92 and the distal light adjusting unit 91. Note that the intermediate light adjusting unit 93 does not have to be formed with a substantially constant outer diameter.

[0077] The proximal end of the proximal light adjusting unit 92 is fixed to the outer peripheral surface of the shaft 20, closer to the proximal end than the distal light adjusting unit 91. In the expanded state, the outer diameter of the proximal light adjusting unit 92 increases in a tapered manner toward the distal end. The distal end of the proximal light adjusting unit 92 is connected to the proximal end of the intermediate light adjusting unit 93. The tapered proximal light adjusting unit 92 prevents the light adjusting unit 90 from being pushed toward the proximal end and deforming when the distal light adjusting unit 91 hits the uterine vaginal portion UV and receives a reaction force in the proximal direction (see Figure 10). Note that the proximal light adjusting unit 92 does not have to be formed in a tapered shape.

[0078] The material of the light adjusting unit 90 is not particularly limited as long as it has a certain degree of flexibility and is transmissive to the excitation light emitted from the light irradiator 30 and the fluorescence emitted by the antibody-photosensitizer, but examples include silicone, polyamide, polyethylene terephthalate, and urethane. The maximum outer diameter of the light adjusting unit 90 when expanded is not particularly limited, but is, for example, 5 to 50 mm. The length of the axial direction X of the light adjusting unit 90 when expanded is not particularly limited, but is, for example, 10 to 60 mm. The light adjusting unit 90 can scatter, diffuse, or reflect the excitation light emitted in the lateral direction Y by the light emitting unit 32 disposed therein, and adjust it to a direction different from the lateral direction Y (particularly, toward the distal end). Therefore, light can be irradiated over a wide area via the light adjusting unit 90, even beyond the range directly reached by light from the light emitting unit 32.

[0079] The light adjusting unit 90 can be formed in various shapes. It is preferable that the light adjusting unit 90 can be appropriately selected depending on the shapes of the uterine vaginal portion UV, vaginal vault VF, and vagina V of the patient.

[0080] The shaft 20 has a base shaft 24 having a light adjusting section 90 disposed at its tip, and a tip shaft 25 protruding toward the tip from the light adjusting section 90. A light transmitting section 21 having optical transparency is located in at least a part of the tip shaft 25 and the portion of the base shaft 24 disposed inside the light adjusting section 90.

[0081] The distal fluorescence detection unit 100 includes a second detection unit 101 disposed inside the light adjustment unit 90 and capable of detecting two-dimensional images, and a cable 102 that transmits information about the two-dimensional image detected by the second detection unit 101 to the light receiving device 70. The second detection unit 101 is disposed inside the light adjustment unit 90 but outside the shaft 20. The cable 102 passes between the outer circumferential surface of the shaft 20 and the inner circumferential surface of the proximal light adjustment unit 92 and is introduced from the outside to the inside of the light adjustment unit 90. The second detection unit 101 is, for example, a small CCD image sensor or CMOS image sensor. In this case, the cable 102 is a conductor that transmits electrical signals. The second detection unit 101 may be the ends of multiple optical fibers forming a two-dimensional array. In this case, the cable 102 is formed by multiple optical fibers. A wide-angle lens or the like may be disposed in the sensor or optical fiber.

[0082] The distal fluorescence detecting unit 100 may have two or more second detecting units 101 arranged at different circumferential positions, as in the modified example shown in Fig. 12. This allows the distal fluorescence detecting unit 100 to detect a wide range in a two-dimensional image, thereby enabling the location of lesions over a wide range to be identified and the progress of treatment to be confirmed. Note that although the second detecting units 101 and the expansion tube 22 overlap in Fig. 12, they may also be arranged at different circumferential positions without overlapping.

[0083] Next, a treatment method using the treatment device 10 according to the second embodiment will be described.

[0084] First, the antibody-photosensitizer is administered into the body, for example, intravenously. Approximately 12 to 36 hours after the intravenous administration, the surgeon uses a colposcope 200 to open the vaginal opening and inserts the distal shaft 25 of the treatment device 10 from the vaginal opening into the vagina V. While visually checking the distal end of the shaft 20 and the external cervical os O, the surgeon inserts it from the external cervical os O into the cervical canal CC. At this time, because the light adjustment unit 90 is not expanded, the surgeon can easily insert the distal shaft 25 into the cervical canal CC.

[0085] Next, the surgeon connects a syringe or indeflator containing a fluid such as air or saline to the proximal end of the expansion tube 22 and supplies the expansion fluid into the light adjustment unit 90 via the expansion lumen 23. This causes the light adjustment unit 90 to expand within the vagina V. Note that the expansion of the light adjustment unit 90 is preferably performed to an extent that allows the light adjustment unit 90 to move within the vagina V. Next, the surgeon pushes in the operation unit 50 and presses the distal surface of the expanded light adjustment unit 90 against the utero-vaginal portion UV. The utero-vaginal portion UV is the portion of the cervix U on the vagina V side, where the external cervical os O is formed. When the light adjustment unit 90 comes into close contact with the utero-vaginal portion UV, the distal shaft 25 is positioned within the cervical canal CC, and the light adjustment unit 90 is positioned within the vagina V. Next, the surgeon further expands the light adjustment unit 90. This causes the light adjustment unit 90 to expand while remaining in close contact with the utero-vaginal portion UV. The light adjusting section 90 expands to follow the shape of the organ.

[0086] Next, the surgeon places the light-emitting unit 32 of the light irradiation unit 30 inside the distal shaft 25. The position of the light-emitting unit 32 is, for example, but not limited to, the most distal position reachable within the lumen of the distal shaft 25. After this, the surgeon operates the light output device 60 to supply excitation light to the light irradiation unit 30. This allows the light-emitting unit 32 inside the shaft 20 to effectively irradiate the excitation light onto tumor cells C located in the cervix U. As with the method described in the first embodiment, the surgeon can irradiate excitation light from inside the shaft 20 inserted into the cervical canal CC, detect fluorescence with the detection unit 42, irradiate excitation light from the light-emitting unit 32, detect fluorescence with the detection unit 42, move the detection unit 42, identify the lesion area containing tumor cells C, confirm destruction of tumor cells C, and stop irradiating excitation light. As with the method described in the first embodiment, the surgeon can perform the above-described series of procedures (additional steps) inside the cervical canal CC one or more times.

[0087] After this, while maintaining the position of the shaft 20, the surgeon pulls the light irradiator 30 and the lateral fluorescence detector 40, moving the light emitter 32 and the detector 42 into the light adjuster 90. Next, the surgeon operates the light output device 60 to supply excitation light to the light irradiator 30. As a result, the entire light adjuster 90, receiving light from the light emitter 32, emits light. That is, a portion of the excitation light that reaches the light adjuster 90 passes through the light adjuster 90 and is scattered, diffused, or reflected by the light adjuster 90, irradiating a wide area, including the distal end. Therefore, the light emitter 32 and the light adjuster 90 can effectively irradiate the excitation light primarily onto tumor cells C located in the external cervical os O, the utero-vaginal portion UV, the vaginal vault VF, and the portion of the vagina V closer to the vaginal opening and closer to the vaginal vault VF. The surgeon may also irradiate the excitation light while moving the light emitter 32 inside the light adjuster 90. If the light-emitting unit 32 is long in the axial direction X and can emit light from both the distal shaft 25 and the light adjustment unit 90 simultaneously, the surgeon does not need to move the light-emitting unit 32 between the distal shaft 25 and the light adjustment unit 90.

[0088] When excitation light is applied, it reaches the antibody-photosensitizer adsorbed to tumor cells C mainly in the external cervical os O, uterine vaginal portion UV, vaginal vault VF, and the area of ​​the vagina V closer to the vaginal opening than the vaginal vault VF but closer to the vaginal vault VF. This causes a chemical change in the antibody-photosensitizer exposed to the excitation light, and furthermore, a structural change in the antibody-photosensitizer causes holes to form in the cell membrane. This destroys the tumor cells C irradiated with the excitation light.

[0089] The surgeon irradiates excitation light from the light-emitting unit 32 and detects the fluorescence emitted by the antibody-photosensitizer excited by the excitation light using the distal fluorescence detection unit 100. Note that the light-emitting unit 32 may be covered by the detection unit 42 or the first detection optical waveguide 45, as long as it can emit light into the light adjustment unit 90. The second detection unit 101 of the distal fluorescence detection unit 100 can detect fluorescence from the distal direction, thereby effectively detecting fluorescence emitted by the antibody-photosensitizer adsorbed to the external cervical os O, the utero-vaginal portion UV, the vaginal vault VF, and tumor cells C in the vagina V, located closer to the vaginal opening than the vaginal vault VF and closer to the vaginal vault VF. The surgeon can identify the fluorescence emitted by the excited antibody-photosensitizer adsorbed to the tumor cells C from the two-dimensional image displayed on the display device 80, thereby identifying the location of the tumor cells C located distal to the light adjustment unit 90. The treatment device 10 can simultaneously destroy tumor cells C by irradiating them with excitation light from the light emitting section 32 and diagnose the lesion site by detecting fluorescence with the second detecting section 101.

[0090] When the operator determines that the fluorescence has disappeared on the display device 80 or that a predetermined time has elapsed, the operator determines that the tumor cells C have been sufficiently destroyed and stops irradiating the excitation light. After this, the operator contracts the light adjusting unit 90 and pulls out the treatment device 10 from the cervical canal CC and vagina V. This completes the treatment method.

[0091] As described above, the treatment device 10 according to the second embodiment includes a light adjusting unit 90 capable of changing the direction of excitation light emitted from the light irradiating unit 30, and a distal fluorescence detecting unit 100 capable of detecting fluorescence from the distal direction of the shaft 20. The shaft 20 includes a base shaft 24 at the distal end of which the light adjusting unit 90 is disposed, and a light-transmitting distal shaft 25 that protrudes distally from the light adjusting unit 90. The light irradiating unit 30 is movable between the interior of the distal shaft 25 and the interior of the light adjusting unit 90. Thus, by disposing the light irradiating unit 30 inside the distal shaft 25, excitation light can be irradiated in the lateral direction Y, while fluorescence from the lateral direction Y can be detected by the lateral fluorescence detecting unit 40. Furthermore, by disposing the light irradiating unit 30 inside the light adjusting unit 90, excitation light can be irradiated distally, while fluorescence from the distal direction can be detected by the distal fluorescence detecting unit 100. Therefore, by disposing the light irradiation unit 30 inside the distal shaft 25 inserted into the cervical canal CC, tumors in the cervix U can be effectively treated by irradiating them with excitation light from inside the cervical canal CC, and by disposing the light irradiation unit 30 inside the light adjustment unit 90 located in a region close to the uterine vaginal portion UV in the vagina V, tumors in the cervix U can be effectively treated by irradiating them with excitation light from the vagina V side. The light adjustment unit 90 is, for example, a balloon, but it does not have to be a balloon. The light adjustment unit 90 may be, for example, a member that does not expand or contract radially.

[0092] Furthermore, the treatment method in the second embodiment is a treatment method for detecting and destroying tumor cells C by irradiating excitation light onto antibody-photosensitizer adsorbed on the cell membrane of a tumor occurring in at least a part of the uterine cervix U to the vagina V, and includes the steps of administering the antibody-photosensitizer into the body, and after the administration, widening the vagina V with a colposcope 200, and providing a treatment device including: a long base shaft 24; a light adjustment unit 90 that is disposed at the tip of the base shaft 24 and is capable of changing the direction of light; a long, tubular tip shaft 25 that is optically transparent and protrudes from the light adjustment unit 90 toward the tip; a light irradiation unit 30 that can irradiate the antibody-photosensitizer with excitation light; a lateral fluorescence detection unit 40 that can detect fluorescence emitted by the excited antibody-photosensitizer in a lateral direction Y perpendicular to the axial direction X of the tip shaft 25; and a distal fluorescence detection unit 100 that can detect fluorescence from the tip side. the distal shaft 25 and the external cervical os O are inserted into the cervical canal CC while visually checking the distal shaft 25 and the external cervical os O; the light adjusting unit 90 is expanded to fit the shape of the organ; the light irradiating unit 30 irradiates excitation light in the lateral direction Y from inside the distal shaft 25; while irradiating the excitation light, the lateral fluorescence detecting unit 40 is moved in the axial direction X relative to the distal shaft 25 to detect fluorescence emitted by the antibody-light absorbing substance and confirm disappearance or decrease of the fluorescence; the light irradiating unit 30 is moved in the axial direction X to a position where the light adjusting unit 90 is to be disposed; and while irradiating the excitation light via the light adjusting unit 90, the distal fluorescence detecting unit 100 is used to detect fluorescence emitted by the antibody-light absorbing substance and confirm disappearance or decrease of the fluorescence.

[0093] As a result, this treatment method effectively treats tumors in the cervix U, identifies the extent of the lesion, and monitors the progress of treatment without resection by irradiating excitation light from inside the cervical canal CC and detecting fluorescence with the lateral fluorescence detection unit 40. Furthermore, by irradiating excitation light from inside the light adjustment unit 90 located near the uterocervical portion UV in the vagina V and detecting fluorescence with the distal fluorescence detection unit 100, it is possible to minimally invasively treat tumors distributed in the uterocervical portion UV, which is the cervix U around the external cervical os O on the side closer to the vagina V, identify the extent of the lesion, and monitor the progress of treatment without resection. Note that the light irradiation unit 30 may be capable of irradiating excitation light in a direction other than the lateral direction Y, as long as it can irradiate excitation light in the lateral direction Y. Furthermore, the lateral fluorescence detection unit 40 may be capable of detecting fluorescence from a direction other than the lateral direction Y, as long as it can detect fluorescence from the lateral direction Y.

[0094] <Third embodiment> As shown in FIG. 13, the treatment device 10 according to the third embodiment differs from the second embodiment in that the shaft 20 does not have a distal shaft 25, the shaft 20 does not have a detection unit 42 that can move in the axial direction X, and the second detection unit 101 can move in the circumferential direction.

[0095] The shaft 20 has a light-transmitting section 21 inside the light adjusting section 90, which is capable of transmitting excitation light and fluorescence. The shaft 20 does not pass through the distal light adjusting section 91; it is closed. The distal end of the light adjusting section 90 may have a structure (not shown) that can fix the light adjusting section 90 relative to the central axis. This makes it easy to maintain the shape and position of the light adjusting section 90, which is a balloon. The shaft 20 also has a tubular detection shaft 26 that is connected to the proximal light adjusting section 92 and that has a detection lumen 27 that does not communicate with the inner cavity of the light adjusting section 90. A second detection section 101 is disposed inside the detection lumen 27.

[0096] The distal fluorescence detecting unit 100 is disposed inside the detection lumen 27 so as to be rotatable around the axis of the shaft 20. A second detecting unit 101 disposed at the distal end of the distal fluorescence detecting unit 100 is capable of detecting fluorescence from the distal direction as a two-dimensional image. The second detecting unit 101 may be disposed at the distal end of a tubular member, for example, so as to be rotatable inside the detection lumen 27.

[0097] Next, a treatment method using the treatment device 10 according to the third embodiment will be described.

[0098] First, the antibody-photosensitizer is administered into the body, for example, intravenously. After about 12 to 36 hours have passed since the intravenous administration, the surgeon opens the vaginal opening using a colposcope 200 and inserts the tip of the treatment device 10 into the vagina V through the vaginal opening.

[0099] Next, the surgeon connects a syringe or indeflator containing a fluid such as air or saline to the proximal end of the expansion tube 22 and supplies the expansion fluid into the light adjustment unit 90 via the expansion lumen 23. This causes the light adjustment unit 90 to expand within the vagina V. Note that the expansion of the light adjustment unit 90 is preferably performed to an extent that allows the light adjustment unit 90 to move within the vagina V. Next, the surgeon pushes in the operation unit 50 and presses the distal surface of the expanded light adjustment unit 90 against the uterine vaginal portion UV. Next, the surgeon further expands the light adjustment unit 90. This causes the light adjustment unit 90 to expand while in close contact with the uterine vaginal portion UV. The light adjustment unit 90 expands to follow the shape of the organ.

[0100] Next, the surgeon places the light-emitting unit 32 of the light irradiation unit 30 inside the light adjustment unit 90 of the shaft 20. Then, the surgeon operates the light output device 60 to supply excitation light to the light irradiation unit 30. As a result, the entire light adjustment unit 90, receiving light from the light-emitting unit 32, emits light. That is, a portion of the excitation light that reaches the light adjustment unit 90 passes through the light adjustment unit 90 and is scattered, diffused, or reflected by the light adjustment unit 90, irradiating a wide area, including the distal end. Therefore, the light-emitting unit 32 and the light adjustment unit 90 can effectively irradiate the excitation light primarily to tumor cells C located in the external cervical os O, the uterine vaginal portion UV, the vaginal vault VF, and the portion of the vagina V closer to the vaginal opening than the vaginal vault VF and closer to the vaginal vault VF. The surgeon may also irradiate the excitation light while moving the light-emitting unit 32 inside the light adjustment unit 90.

[0101] When excitation light is applied, it reaches the antibody-photosensitizer adsorbed to tumor cells C mainly in the external cervical os O, uterine vaginal portion UV, vaginal vault VF, and the area of ​​the vagina V closer to the vaginal opening than the vaginal vault VF but closer to the vaginal vault VF. This causes a chemical change in the antibody-photosensitizer exposed to the excitation light, and furthermore, a structural change in the antibody-photosensitizer causes holes to form in the cell membrane. This destroys the tumor cells C irradiated with the excitation light.

[0102] The surgeon irradiates excitation light from the light-emitting unit 32 and detects the fluorescence emitted by the antibody-photosensitizer excited by the excitation light using the distal fluorescence detection unit 100. The surgeon can detect the fluorescence by moving the second detection unit 101 in the circumferential direction around the axis of the shaft 20. The second detection unit 101 of the distal fluorescence detection unit 100 can detect fluorescence from the distal direction, and therefore can effectively detect fluorescence emitted by the antibody-photosensitizer adsorbed to the external cervical os O, the utero-vaginal portion UV, the vaginal vault VF, and tumor cells C in the vagina V, located closer to the vaginal opening than the vaginal vault VF and closer to the vaginal vault VF. The surgeon can identify the fluorescence emitted by the excited antibody-photosensitizer adsorbed to the tumor cells C from the two-dimensional image displayed on the display device 80, thereby identifying the location of the tumor cells C located distally of the light adjustment unit 90. Because the second detection unit 101 can rotate around the axis of the shaft 20, the circumferential position of the lesion area containing tumor cells C can be identified from the image information obtained by the second detection unit 101. The treatment device 10 can simultaneously destroy tumor cells C by irradiating them with excitation light from the light-emitting unit 32 and diagnose the lesion site by detecting fluorescence with the second detection unit 101.

[0103] When the operator determines that the fluorescence has disappeared on the display device 80 or that a predetermined time has elapsed, the operator determines that the tumor cells C have been sufficiently destroyed and stops irradiating the excitation light. After this, the operator contracts the light adjusting unit 90 and pulls out the treatment device 10 from the cervical canal CC and vagina V. This completes the treatment method.

[0104] As described above, the treatment device 10 according to the third embodiment is a treatment device 10 that detects and destroys tumor cells C by irradiating excitation light onto antibody-photosensitive substance adsorbed to the tumor cell membrane, and includes a light adjustment unit 90 that can change the direction of light irradiated from the light irradiation unit 30, a base shaft 24 at the tip of which the light adjustment unit 90 is located, the light irradiation unit 30 that can irradiate the antibody-photosensitive substance excitation light via the light adjustment unit 90, and a tip-direction fluorescence detection unit 100 that can detect fluorescence emitted by the excited antibody-photosensitive substance and that can move circumferentially around an axis that is approximately parallel to the axis of the base shaft 24.

[0105] In the treatment device 10 configured as described above, the distal fluorescence detection unit 100 can be moved in the circumferential direction, so that the fluorescence emitted by the antibody-photosensitizer excited by the excitation light from the light irradiation unit 30 can be detected at multiple positions in the circumferential direction by the distal fluorescence detection unit 100. Therefore, the treatment device 10 can perform treatment to destroy tumor cells C while minimally invasively identifying the circumferential position of the lesion area and checking the progress of the treatment without resecting the tissue. Note that a lateral fluorescence detection unit 40 may be provided instead of the distal fluorescence detection unit 100. In this case, the circumferential position of the lesion area in the lateral direction Y of the light adjustment unit 90 can be identified.

[0106] Furthermore, the treatment method in the third embodiment is a treatment method for detecting and destroying tumor cells C by irradiating excitation light onto antibody-photosensitive substance adsorbed on the cell membrane of a tumor occurring from the cervix U to the vaginal area, and includes the steps of: administering the antibody-photosensitive substance into the body; after administration, widening the vagina V with a colposcope 200, and inserting into the vagina V a treatment device 10 comprising a long base shaft 24, a light adjustment unit 90 located at the tip of the base shaft 24 and capable of changing the direction of light, a light irradiation unit 30 capable of irradiating excitation light for the antibody-photosensitive substance, and a distal fluorescence detection unit 100 capable of detecting fluorescence emitted by the excited antibody-photosensitive substance; expanding the light adjustment unit 90 to fit the shape of the organ; and irradiating excitation light from the light irradiation unit 30 from inside the light adjustment unit 90, while moving the distal fluorescence detection unit 100 in a rotational direction about an axis approximately parallel to the axis of the base shaft 24 to detect the fluorescence emitted by the antibody-photosensitive substance, and confirming the disappearance or decrease of the fluorescence.

[0107] As a result, this treatment method irradiates excitation light from inside the light adjustment unit 90 placed in a region close to the uterine cervix UV inside the vagina V, and detects the fluorescence with the distal fluorescence detection unit 100, thereby enabling minimally invasive treatment of tumors distributed in the uterine cervix U closer to the vagina V, identification of the lesion area, and confirmation of the progress of treatment without resection. Note that the light irradiation unit 30 may be capable of irradiating excitation light in directions other than the lateral direction Y, as long as it is capable of irradiating excitation light in the lateral direction Y.

[0108] The treatment device 10 according to the third embodiment may be used for treatment of areas other than the cervix U. For example, the treatment device 10 may be used for treatment of areas that form a relatively large space, such as the esophagus or the uterine body.

[0109] <Fourth embodiment> 14, the treatment device 10 according to the fourth embodiment differs from the first embodiment in that a puncture section 28 is provided at the tip of the shaft 20. The treatment device 10 is suitable for treating and diagnosing tumors located deep below the tissue surface.

[0110] The shaft 20 has a puncturing portion 28 at its tip that punctures biological tissue. The puncturing portion 28 is formed in a sharp needle shape. Note that the puncturing portion 28 does not have to be sharp as long as it can puncture. An example of a non-sharp puncturing portion 28 is an electrode or a laser irradiation portion. Therefore, the treatment target of the treatment device 10 is not limited to the cervix U, and can be applied to any body part.

[0111] Next, a treatment method using the treatment device 10 according to the fourth embodiment will be described.

[0112] First, the antibody-photosensitizer is administered intravenously into the body. Approximately 12 to 36 hours after administration, the surgeon checks the tip of the treatment device 10 visually or based on images obtained by an image detection device capable of detecting tomographic images of a living body, such as an ultrasound diagnostic device, CT (Computed Tomography), or MRI (Magnetic Resonance Imaging), and pierces the puncture portion 28 into the tissue surface that can reach the vicinity of the tumor cells C. The surgeon then inserts the shaft 20 in the lateral direction Y of the light-transmitting portion 21 of the shaft 20 to the position where the tumor cells C are located.

[0113] Next, the surgeon places the light-emitting unit 32 of the light irradiation unit 30 inside the distal shaft 25. The position of the light-emitting unit 32 is, for example, but not limited to, the most distal position reachable in the lumen of the distal shaft 25. After this, the surgeon operates the light output device 60 to supply excitation light to the light irradiation unit 30. This allows the light-emitting unit 32 inside the shaft 20 to effectively irradiate the excitation light onto tumor cells C located in the cervix U. As with the method described in the first embodiment, the surgeon can irradiate excitation light from inside the shaft 20 inserted into the punctured tissue, detect fluorescence with the detection unit 42, irradiate excitation light from the light-emitting unit 32, detect fluorescence with the detection unit 42, move the detection unit 42, identify the range of tumor cells C, confirm destruction of tumor cells C, and stop irradiating excitation light. As with the method described in the first embodiment, the surgeon can perform the above-described series of procedures (additional steps) one or more times inside the punctured tissue.

[0114] When the operator determines that the fluorescence has disappeared on the display device 80 or that a predetermined time has passed, the operator determines that the tumor cells C have been sufficiently destroyed and stops irradiating the excitation light. After this, the operator pulls out the treatment device 10 from the tissue. This completes the treatment method.

[0115] As described above, the treatment device 10 according to the fourth embodiment has the puncture section 28 disposed at the tip of the shaft 20. As a result, even if a lesion is present deep below the tissue surface, the tissue can be punctured and the shaft 20 can be inserted into the tissue to treat the lesion, identify the extent of the lesion, and check the progress of the treatment.

[0116] Furthermore, a treatment method in the fourth embodiment is a treatment method for detecting and destroying tumor cells by irradiating excitation light onto an antibody-photosensitizer adsorbed to a tumor cell membrane, and includes the steps of administering the antibody-photosensitizer into the body, and after administration, providing a long, tubular shaft 20 having optical transparency, a puncture section 28 disposed at the tip of the shaft 20, a light irradiation section 30 capable of irradiating excitation light onto the antibody-photosensitizer, and a lateral direction fluorescence detection section 31 capable of detecting fluorescence emitted by the excited antibody-photosensitizer in a lateral direction Y perpendicular to the axial direction X of the shaft 20. the step of inserting the treatment device 10 into the living body by forming a hole in the living body with the puncture unit 28 while checking the tip of the treatment device 10 equipped with the puncture unit 40 visually or based on images from an image detection device such as an ultrasound diagnostic device, CT or MRI; the step of irradiating excitation light from the light irradiation unit 30 in the lateral direction Y from inside the shaft 20; and the step of moving the lateral fluorescence detection unit 40 in the axial direction X relative to the shaft 20 while irradiating the excitation light to detect fluorescence emitted by the antibody-light absorbing substance and confirming the disappearance or decrease of the fluorescence.

[0117] As a result, in this treatment method, when the lesion is located deep below the tissue surface, the tissue is punctured to reach the vicinity of tumor cells C, and while irradiating the punctured tissue with excitation light from inside, the lateral fluorescence detection unit 40 can be moved in the axial direction X to detect fluorescence. Therefore, while performing treatment to destroy tumor cells C with excitation light, it is possible to identify the position of the lesion area along the axial direction X and check the progress of the treatment.

[0118] The present invention is not limited to the above-described embodiments, and various modifications may be made by those skilled in the art within the technical spirit of the present invention. Therefore, a portion of the configuration included in each embodiment can be applied to other embodiments as appropriate. For example, the rotatable distal fluorescence detection unit 100 of the third embodiment may be applied to the second embodiment. Furthermore, the puncture unit 28 may be disposed at the distal end of the shaft 20 of the first to third embodiments, as in the shaft 20 of the fourth embodiment. [Explanation of symbols]

[0119] 10 Treatment equipment 20 shaft 21 Light transmission part 22 Expansion tube 23 Extended Lumens 24 Base shaft 25 Tip shaft 28 Puncture site 30 Light irradiation unit 31 Optical waveguide for irradiation 32 Light-emitting part 33 Stopper 40 Lateral fluorescence detection unit 41 Detection optical waveguide 42 Detection unit 45 First detection optical waveguide 46 Second detection optical waveguide 50 Control section 60 Optical output device 70 Photodetector 80 Display device 90 Light adjustment section 100 Fluorescence detection unit for tip direction 101 Second detection unit 200 Vaginal speculum C. Tumor cells CC Cervix O external cervical os U cervix UV cervix Vagina X-axis direction Y-side direction

Claims

1. A therapeutic device that detects and destroys tumor cells by irradiating an antibody-photosensitive substance adsorbed on the tumor cell membrane with excitation light, a long, tubular shaft that is optically transparent; a light irradiation unit capable of irradiating the antibody-photosensitizer excitation light from inside the shaft in a lateral direction perpendicular to the axial direction of the shaft; A treatment device characterized by having a lateral fluorescence detection unit that can detect the fluorescence emitted by the excited antibody-photosensitive substance from a lateral direction perpendicular to the axial direction of the shaft and that can move axially relative to the shaft.

2. The treatment device according to claim 1, further comprising a puncture portion disposed at the tip of the shaft.

3. a light adjusting unit capable of changing the direction of the excitation light irradiated from the light irradiating unit; a distal fluorescence detection unit capable of detecting fluorescence from a distal direction of the shaft, The shaft includes a base shaft having the light adjusting unit disposed at a distal end thereof, and a light-transmitting distal shaft protruding from the light adjusting unit toward the distal end thereof, The treatment device according to claim 1 , wherein the light irradiation unit is movable between the inside of the distal shaft and the inside of the light adjustment unit.

4. The treatment device according to any one of claims 1 to 3, characterized in that the lateral fluorescence detection unit comprises: a ring-shaped scatterer that is arranged along the circumferential direction of the light irradiation unit and is movable in the axial direction along the outer peripheral surface of the light irradiation unit; and an optical waveguide that is arranged on the base end side of the scatterer.

5. The treatment device according to any one of claims 1 to 3, characterized in that the lateral fluorescence detection unit has a plurality of optical fibers, the plurality of incident portions of the optical fibers are arranged along the circumferential direction of the light irradiation unit, and are movable in the axial direction along the outer peripheral surface of the light irradiation unit.

6. A therapeutic device that detects and destroys tumor cells by irradiating an antibody-photosensitive substance adsorbed on the tumor cell membrane with excitation light, a light adjusting unit capable of changing the direction of light emitted from the light emitting unit; a base shaft having the light adjusting unit disposed at a tip thereof; a light irradiation unit capable of irradiating the antibody-photosensitizer with excitation light via the light adjustment unit; A treatment device characterized by having a fluorescence detection unit that is capable of detecting fluorescence emitted by the excited antibody-photosensitive substance and that is movable in a circumferential direction around an axis that is approximately parallel to the axis of the base shaft.

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