Treatment device
The treatment device addresses the challenge of delivering near-infrared light to cervical cancer tumors by using a tubular and irradiation device configuration that allows for effective light delivery to the cervix region, improving treatment efficacy and reducing invasiveness.
Patent Information
- Application Number
- JP2022511742
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-03-30
- Filing Date
- 2021-03-10
- Publication Date
- 2025-06-10
- Estimated Expiration
- 2041-03-10
AI Technical Summary
Current treatments for cervical cancer, especially in advanced stages, face challenges in effectively delivering near-infrared light to tumors due to shallow penetration depth and the invasive nature of existing methods, which limits the treatment's efficacy and increases side effects.
A treatment device comprising a tubular member and an irradiation device with a disk portion and a tip shaft, capable of emitting excitation light, is designed to be inserted into the cervical canal and near the vaginal fornix, allowing for effective irradiation of tumor cells in the cervix region.
The device enables improved treatment of cervical cancer by effectively irradiating excitation light to antibody-photosensitive substances in a wide range, including the cervix, thereby enhancing the therapeutic effect while minimizing invasiveness.
Smart Images

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Abstract
Description
Technical Field
[0001] The present invention relates to a treatment device for cervical cancer. position It relates thereto.
Background Art
[0002] The number of cervical cancer patients is on the rise, especially the number of young female patients in their 20s and 30s is increasing. Currently, the standard treatment for cervical cancer is to completely remove the uterus from the early stage (stage I), but for young patients, local treatment that can preserve the uterus in order to maintain fertility is required. Also, in the advanced stage (stage III and later), since the cancer has spread to surrounding tissues and it is difficult to remove it by surgery, treatment combining radiotherapy and chemotherapy is the standard treatment. However, the 5-year survival rate is as low as 50% for stage III and 20% for stage IV, and more effective treatment is required. As a local treatment for cancer, a treatment method using a photoreactive substance is known (see, for example, Patent Document 1). Among them, a treatment method using an antibody-photosensitive substance (hydrophilic phthalocyanine) can specifically destroy target cells without destroying non-target cells such as normal cells by irradiating the antibody-photosensitive substance accumulated in the tumor with excitation light (for example, near-infrared light), and it is expected to obtain a high treatment effect while reducing side effects.
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0004] On the one hand, in order to obtain a high therapeutic effect of the antibody-photosensitive substance, it is necessary to surely irradiate the antibody-photosensitive substance adsorbed on the tumor with near-infrared light. However, the penetration depth of near-infrared light is shallow, and it is very difficult to non-invasively deliver light from the body surface to solid cancer. Therefore, a means is required to surely deliver light to the tumor in the body while suppressing invasiveness as much as possible. In the case of cervical cancer, the cancer often spreads over a wide range of the cervical canal, and a means is required to irradiate light from as close as possible to the wide range of cancer.
[0005] The present invention has been made to solve the above-described problems, and provides a treatment device that can effectively treat cancer in a range including at least a part of the cervix. placement The purpose is to provide.
Means for Solving the Problems
[0006] The treatment device according to the present invention that achieves the above object is a treatment device that irradiates excitation light to an antibody-photosensitive substance accumulated in tumor cells of cervical cancer, and includes a tubular device having a long tubular member, and an irradiation device that can be inserted into the tubular member. The irradiation device includes a main body shaft having a tip end portion and a base end portion, a disk portion disposed on the tip end side of the main body shaft, a tip shaft protruding from the disk portion toward the tip end side, and an irradiation portion disposed on the tip shaft and capable of emitting the excitation light.
Effects of the Invention
[0007] The treatment device configured as described above can effectively irradiate excitation light to an antibody-photosensitive substance accumulated in tumor cells in a wide range including the cervix while inserting the tip shaft into the cervical canal and inserting the tubular member near the vaginal fornix. Therefore, this treatment device can improve the treatment effect of cancer in a range including at least a part of the cervix.
[0008] The tip shaft may irradiate the excitation light in a direction substantially perpendicular to the axis of the tip shaft, and the disk portion may irradiate the excitation light in a substantially tip direction. Thereby, since the excitation light can be irradiated to the tumor cells in the cervical region from both the tip shaft and the disk portion, the treatment effect can be improved.
[0009] The tubular member may have a second irradiation portion capable of irradiating the excitation light in a direction substantially perpendicular to the axial direction of the tubular member and / or in a substantially tip direction. Thereby, since the excitation light can be directly irradiated to the tumor cells in the vaginal fornix where light hardly reaches from the second irradiation portion provided in the tubular member, the treatment effect can be improved.
[0010] The tip of the tubular member may be deformable. Thereby, the tip deformable portion can be deformed along the vaginal fornix and arranged near the vaginal fornix. Therefore, the excitation light can be effectively irradiated to the vicinity of the vaginal fornix where light hardly reaches, and the treatment effect can be improved.
[0011] The treatment device may have a fixing portion for fixing the irradiation device to the tubular device. Thereby, since the irradiation device and the tubular member can be operated integrally, the operability is improved. Further, since the irradiation device can be maintained at an appropriate position with respect to the tubular member, the excitation light irradiated from the irradiation device can be appropriately propagated to the tubular member. For this reason, the excitation light irradiated from the tip shaft, the disk portion, and the tubular member can be appropriately irradiated to the antibody-photosensitive substance.
[0012] The fixing portion may be a balloon arranged in the disk portion and expandable by the inflow of fluid therein. Thereby, by expanding the balloon inside the tubular member, the irradiation device can be easily and surely fixed to the tubular member.
[0013] The fixing portion may be a balloon arranged in the tubular member and expandable by the inflow of fluid therein. Thereby, by expanding the balloon, the irradiation device can be easily and surely fixed to the tubular member.
[0014] The axis of the disk portion may be inclined with respect to the axis of the main body shaft. Thereby, it becomes easier to arrange the disk portion in accordance with the inclination of the uterine vaginal portion with respect to the vagina. For this reason, the excitation light irradiated from the disk portion can be appropriately irradiated onto the antibody-photosensitive substance.
[0015] The treatment device may include a detection unit that detects fluorescence emitted by the antibody-photosensitive substance. Thereby, the degree of destruction of tumor cells by irradiation with excitation light can be confirmed by changes in the fluorescence detected by the detection unit.
Brief Description of the Drawings
[0022]
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Embodiments for Carrying Out the Invention
[0023] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the dimensions in the drawings may be exaggerated for convenience of explanation and may differ from the actual dimensions. Also, in this specification and the drawings, components having substantially the same functional configuration are denoted by the same reference numerals, and redundant explanations are omitted. In this specification, the side inserted into the body lumen of the device is referred to as the "distal side", and the side for operation is referred to as the "proximal side".
[0024] The treatment device 10 according to this embodiment is used in 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 is used in photodynamic immunotherapy in which near-infrared light, which is the excitation light of the antibody-photosensitive substance, is irradiated onto the antibody-photosensitive substance accumulated on the cell membrane of target cells to destroy the target cells. The target cells are tumor cells such as cancer cells. In this treatment method, an antibody-photosensitive substance in which an antibody that specifically accumulates only on a specific antigen on the surface of tumor cells and a photosensitive substance paired with the antibody are bound is used as a drug. The antibody is not particularly limited, and examples thereof include panitumumab, trastuzumab, HuJ591, pertuzumab, lapatinib, palbociclib, olaparib, and the like. The photosensitive substance is, for example, a hydrophilic phthalocyanine that is a substance (IR700) that reacts to near-infrared light having a wavelength of about 700 nm, but is not limited thereto. When IR700 receives near-infrared light having a wavelength of about 660 to 740 nm, the ligand of the functional group that ensures water solubility is cleaved, and a structural change occurs from water solubility to hydrophobicity. Due to this structural change, membrane proteins are extracted, holes are formed in the cell membrane, and water enters the cell, so that cancer cells can be ruptured and destroyed. In addition, IR700 is excited by receiving near-infrared light and emits fluorescence having a wavelength different from the excitation wavelength. For example, when IR700 is excited by receiving near-infrared light having a wavelength of 689 nm, it emits fluorescence having a wavelength of 704 nm. IR700 undergoes a structural change while emitting fluorescence due to a photoreaction, destroys tumor cells, and plays a role as a drug, and then stops emitting fluorescence.
[0025] The treatment device 10 shown in FIG. 1 can treat cervical cancer and vaginal cancer in a wide range A up to a site near the vaginal fornix VF closer to the vaginal orifice than the vaginal fornix VF of the vaginal fornix VF, the vaginal cervix UV around the external os O, and the external os O in the uterine cervix U shown in FIGS. 2, 12, and 13 with a single device. The treatment device 10 can irradiate excitation light onto the antibody-photosensitive substance accumulated in tumor cells C in a wide range from the uterine cervix U to the vagina V.
[0026] The uterus is located deep within the vagina V. The upper part of the uterus is connected to the left and right fallopian tubes, and the external os O at the lower part of the uterus is connected to the vagina V. The uterus is roughly divided into the uterine body and the uterine cervix U. The uterine cervix U is provided with a cervical canal CC that leads to the external os O. The vagina V has a vaginal hood VF that spreads out to surround the external os O. The vaginal hood VF is deeper at the posterior vaginal hood RV located at the rear part of the vagina V than at the anterior vaginal hood AV located at the front part of the vagina V.
[0027] First, the treatment device 10 according to this embodiment will be described.
[0028] As shown in FIGS. 1 and 3, the treatment device 10 includes an irradiation device 20 having a function of irradiating near-infrared light, and a tubular device 100 including a tubular member 110.
[0029] The irradiation device 20 includes a main body shaft 21 having a tip end portion and a base end portion, a long irradiation portion 50 that irradiates light, a tip shaft 24 that houses the irradiation portion 50, a disk portion 30 provided at the tip end portion of the main body shaft 21, and a first operation portion 60 connected to the base end portion of the irradiation device 20. The treatment device 10 is used by being connected to a light output device 80.
[0030] The main body shaft 21 is a tube that supports the disk portion 30. The main body shaft 21 houses a part of the long irradiation portion 50. The main body shaft 21 is a circular tube that extends linearly, but it may be bent and may not be a circular tube. The base end portion of the main body shaft 21 is fixed to the first operation portion 60. The tip end portion of the main body shaft 21 is fixed to the base end portion of the disk portion 30. Scale marks 22 arranged in the axial direction are provided on the outer peripheral surface of the main body shaft 21. The scale marks 22 can be used to confirm the insertion depth of the main body shaft 21 into a living body such as the tubular device 100 or the vagina V.
[0031] The main body shaft 21 preferably has a certain degree of rigidity so that the operator can grip the first operation unit 60 and push it into the target position. The constituent material of the main body shaft 21 is not particularly limited, and examples include metals typified by stainless steel, aluminum, titanium alloy, tin, magnesium alloy, etc., and resins typified by polyether ether ketone (PEEK), polyamide, acrylonitrile-butadiene-styrene (ABS), polycarbonate, polyacetal, polyimide, etc. The axial length of the main body shaft 21 is not particularly limited, but is, for example, 100 to 400 mm.
[0032] The distal end shaft 24 is a tubular member capable of accommodating the irradiation unit 50 inside and transmitting the light from the irradiation unit 50 to the outside. A part of the distal end shaft 24 is disposed inside the disk portion 30. The distal end shaft 24 extends toward the distal end side from the disk portion 30. The distal end shaft 24 is a portion inserted from the external os O into the endocervical canal CC in order to irradiate light from the inside of the endocervical canal CC to the uterine cervix U (see FIG. 12). The proximal end portion of the distal end shaft 24 extends toward the proximal end side from the main body shaft 21 and the first operation unit 60. Inside the main body shaft 21 and the distal end shaft 24, an irradiation lumen 25 capable of disposing the irradiation unit 50 is continuously formed. The irradiation lumen 25 is closed at the most distal end of the distal end shaft 24 and opens at the most proximal end of the main body shaft 21. An insertion port 28 for receiving the irradiation unit 50 into the irradiation lumen 25 is disposed on the proximal end side of the main body shaft 21. The distal end shaft 24 preferably has a function of diffusing light. For this purpose, similar to the disk portion 30 described in detail later, the distal end shaft 24 may have a multilayer structure in which at least a part of the constituent material contains a scatterer, a large number of irregularities are formed on the inner surface or the outer surface, or materials having different refractive indices are joined at surfaces with a large number of irregularities.
[0033] The distal shaft 24 is preferably formed to be curved so as to easily pass through the cervix CC inclined with respect to the vagina V, but may be formed linearly without being curved. The distal shaft 24 is formed to be rigid, substantially rigid, or flexible. The distal shaft 24 is formed of a transparent or translucent material that can transmit light having a wavelength emitted by the irradiation unit 50 housed therein. The constituent material of the distal shaft 24 is not particularly limited, and examples thereof include resins typified by polymethyl methacrylate, polyethylene terephthalate, polycarbonate, polytetrafluoroethylene, and glass. It is more preferable that the material of the distal shaft 24 has elasticity and can deform while flexing along the cervix CC after being inserted into the cervix CC. Thereby, it is possible to cope with individual differences in the shape of the cervix CC, reduce the burden on the inner surface of the cervix CC, and further enhance the adhesion to the inner surface of the cervix CC. The outer diameter of the distal shaft 24 is not particularly limited, and is, for example, 0.5 to 6 mm. The axial length of the distal shaft 24 is not particularly limited, and is, for example, 10 to 50 mm.
[0034] The shape of the distal shaft 24 is not particularly limited. For example, as in the first modification shown in FIG. 5(A), the distal shaft 24 may have an uneven structure 24A arranged in the axial direction. Thereby, when the operator inserts the distal shaft 24 from the external os O into the cervix CC, the operator can easily grasp how far the distal shaft 24 has been inserted into the cervix CC by visually confirming the uneven structure 24A. Further, when the operator inserts the uneven structure 24A from the external os O into the cervix CC, the operator can easily grasp how far the distal shaft 24 has been inserted into the cervix CC from the change in the feeling received by the hand holding the first operation unit 60. Note that the distal shaft 24 may have scale lines, notches, etc. as a structure that is easy to visually confirm. Further, the distal shaft 24 may have physical properties that change along the axial direction so that the feeling received by the operator's hand changes when the operator inserts the distal shaft 24 from the external os O into the cervix CC. For example, the distal shaft 24 may have a decreasing rigidity toward the distal direction, or may have alternately arranged portions with high and low rigidity.
[0035] Also, as in the second modification example shown in FIG. 5(B), the distal shaft 24 may be provided with one large-diameter portion 24B having a large outer diameter at the distal end portion. Thereby, after the operator inserts the distal shaft 24 from the external os O into the cervical canal CC, the operator can easily grasp from the change in the feeling received by the hand holding the first operation unit 60 that the large-diameter portion 24B has reached the uterine cavity UC beyond the internal os I. For example, after the large-diameter portion 24B has passed beyond the internal os I, the operator can retract the first operation unit 60 to bring the large-diameter portion 24B into contact with the internal os I. Therefore, the distal shaft 24 having the large-diameter portion 24B is effective when it is desired to accurately position the distal end portion of the distal shaft 24 with respect to the internal os I or when it is desired to surely pass through the internal os I. Note that the position of the large-diameter portion 24B is not limited to the very distal end of the distal shaft 24.
[0036] Also, as in the third modification example shown in FIG. 6, the distal shaft 24 may have a flexible and deformable bag-shaped first balloon 24C at the distal end portion. The first balloon 24C communicates with a bag-shaped second balloon 24D disposed in the first operation unit 60 and a tube 24E. A fluid is sealed in the first balloon 24C, the second balloon 24D, and the tube 24E. Thereby, when the distal shaft 24 enters from the external os O into the cervical canal CC, the first balloon 24C collapses and the fluid inside the first balloon 24C moves toward the second balloon 24D, and the second balloon 24D expands greatly. Thereby, the operator can easily grasp that the distal shaft 24 provided with the first balloon 24C has entered the cervical canal CC by looking at the second balloon 24D. Also, when the first balloon 24C passes beyond the internal os I, the first balloon 24C expands by its own restoring force, and the fluid inside the second balloon 24D moves toward the first balloon 24C, and the second balloon 24D becomes smaller. Thereby, the operator can easily grasp that the distal shaft 24 provided with the first balloon 24C has passed beyond the internal os I by looking at the second balloon 24D.
[0037] In addition, the operator may insert the distal shaft 24 from the external os O into the cervical canal CC with the irradiation unit 50 disposed inside the distal shaft 24 emitting light. The light emitted from the site where the distal shaft 24 is inserted into the cervical canal CC becomes invisible to the operator. Therefore, the operator can easily grasp visually how far the distal shaft 24 has been inserted into the cervical canal CC. In this case, even if the distal shaft 24 is not provided with the uneven structure 24A or the large-diameter portion 24B, the operator can grasp visually how far the distal shaft 24 has been inserted into the cervical canal CC.
[0038] As shown in FIGS. 4, 12, and 13, the disk portion 30 is a member that is disposed on the proximal end side of the distal shaft 24 inserted into the cervical canal CC and inserted into the vagina V, and can irradiate light over a wide range of the vagina V. The disk portion 30 is disposed inside a portion on the proximal end side of the foremost end of the tubular member 110. The disk portion 30 can transmit the light emitted from the irradiation unit 50 disposed in the irradiation lumen 25 passing through the inside of the disk portion 30 to the outside. For this purpose, the disk portion 30 is formed of a transparent or translucent material that can transmit light of the wavelength emitted by the irradiation unit 50.
[0039] As shown in FIGS. 1, 3 to 4, the disk portion 30 is a disk-shaped member fixed to the tip of the main body shaft 21. The disk portion 30 may be movable along the axis of the main body shaft 21 with respect to the main body shaft 21. The disk portion 30 includes 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 substantially at the center of the front end face 31 and the base end face 32 and penetrates between the front end face 31 and the base end face 32. The main body shaft 21 is inserted and fixed into the through hole 34 from the base end side, and the tip shaft 24 is inserted and fixed from the tip side. Note that the structure for fixing the disk portion 30 to the main body shaft 21 or the tip shaft 24 is not particularly limited. For example, the disk portion 30 may be integrally formed with the tip shaft 24. The outer side face 33 can contact the inner peripheral face of the tubular member 110. The outer side face 33 may be fitted with the inner peripheral face of the tubular member 110 with a friction such that it does not slide unless the operator applies a force, and slides when the operator applies a force. Alternatively, the outer side face 33 may have a clearance that allows it to slide freely with respect to the inner peripheral face of the tubular member 110.
[0040] The thickness of the disk portion 30 (the distance between the front end face 31 and the base end face 32) is substantially constant, but may vary depending on the location. For example, the thickness of the disk portion 30 may decrease toward the outer side in the radial direction. Thereby, the light incident from the inner wall surface of the through hole 34 into the material of the disk portion 30 can be reflected on the surface of the material and propagated through the material toward the outer side in the radial direction.
[0041] The constituent 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. For example, it is silicon, polyamide, polymethyl methacrylate, polyethylene terephthalate, polycarbonate, polytetrafluoroethylene, urethane, or a combination thereof. The maximum outer diameter of the disk portion 30 is not particularly limited, but is, for example, 10 to 50 mm. The length of the disk portion 30 in the axial direction is not particularly limited, but is, for example, 5 to 60 mm.
[0042] The disk portion 30 may be provided with a structure for scattering light. Thereby, the disk portion 30 itself emits light by the light received from the irradiation portion 50. For this reason, the treatment device 10 can irradiate light over a wide range via the disk portion 30 even to areas outside the range directly reached by the light from the irradiation portion 50. For example, as in the fourth modification shown in FIG. 7(A), the disk portion 30 may contain a scatterer 39 inside the material. As the scatterer 39, known ones can be used, such as fine particles of titanium oxide, styrene, silicone, or the like. Further, as in the fifth modification shown in FIG. 7(B), the disk portion 30 may have a scatterer coat 40 containing the scatterer 39 on the tip surface 31. The scatterer coat 40 is formed by mixing the scatterer 39 with a coat base material having a refractive index different from that of the scatterer 39 and then coating. The scatterer coat 40 may be formed on the base end surface 32, or may be formed on both the tip surface 31 and the base end surface 32. Further, as in the sixth modification shown in FIG. 7(C), the disk portion 30 may have a structure in which a first layer 42 and a second layer 43 having different refractive indexes are joined at a surface having irregularities. Further, the disk portion 30 may have a large number of minute irregularities on the tip surface 31 or the base end surface 32. Further, the disk portion 30 may be provided with a structure for reflecting light.
[0043] Further, the disk portion 30 can be formed in various shapes. It is preferable that the disk portion 30 can be appropriately selected according to the shape of the uterine vaginal portion UV, the vaginal dome VF, or the vagina V of the patient.
[0044] As in the seventh modification shown in FIG. 8(A), the tip surface 31 and the base end surface 32 of the disk portion 30 may be inclined with respect to a plane perpendicular to the axis of the main body shaft 21 (the axis of the through hole 34). Thereby, for example, the light irradiated from the tip surface 31 can be effectively irradiated onto the surface of the uterine vaginal portion UV inclined with respect to the vagina V.
[0045] Also, as in the eighth modification example shown in FIG. 8(B), the disk portion 30 may have a balloon 44 (fixed portion). The balloon 44 is disposed on the base end face 32 side of the disk portion 30, but may be disposed on the outer surface 33 side of the disk portion 30. Alternatively, the entire disk portion 30 may be formed of the balloon 44. The balloon 44 can be expanded by supplying fluid through a supply tube 45 extending from the first operation portion 60. The balloon 44 adheres to the inner peripheral surface of the tubular member 110 by expanding. Thereby, the irradiation device 20 can be fixed to the tubular device 100.
[0046] Also, as in the ninth modification example shown in FIG. 9(A), an optical waveguide 119 (second irradiation portion) may be formed in the tubular device 100. The optical waveguide 119 is disposed from the base end of the tubular device 100 to a tubular tip portion 112 provided at the tip portion. The tubular tip portion 112, which will be described in detail later, may have a structure for diffusing or scattering light. The disk portion 30 of the irradiation device 20 includes a disk-shaped disk member 37 having a structure for diffusing or scattering light, and a reflecting member 36 extending from the outer peripheral surface of the disk member 37 toward the base end side. The reflecting member 36 has an outer peripheral surface and an inner peripheral surface that taper and reduce in diameter from the outer peripheral surface of the disk member 37 toward the base end side. The length of the disk portion 30 in the axial direction (longitudinal direction) including the reflecting member 36 and the disk member 37 is not limited, but is preferably equal to or greater than the length in the axial direction of the light emitting portion 52, which is the light emitting site of the irradiation portion 50 described later. Thereby, the light irradiated from the light emitting portion 52 disposed inside the disk portion 30 can enter the disk portion 30 with less loss. The light irradiated from the light emitting portion 52 enters the disk portion 30, is reflected by the reflecting member 36, and is diffused by the disk member 37. When the light emitting portion 52 emits light inside the disk portion 30, the excitation light irradiated from the disk portion 30 is irradiated only in the tip direction (the direction in which the external os O and the vaginal portion of the uterus UV are located with respect to the disk portion 30). Therefore, the therapeutic effect on the external os O and the vaginal portion of the uterus UV can be improved. Note that the structure of the optical waveguide 119 (second irradiation portion) is not particularly limited as long as it can propagate light, and may be an optical fiber.
[0047] Also, as in the tenth modification example shown in FIG. 9(B), the disk portion 30 includes a disk-shaped disk member 37 having a structure for diffusing or scattering light, and a reflecting member 36 extending from the base end surface on the outer side in the radial direction of the disk member 37 toward the base end side. The outer peripheral surface of the disk member 37 can be in contact with the inner peripheral surface of a tubular tip portion 112 provided at the tip portion of the tubular device 100. The reflecting member 36 has an outer peripheral surface and an inner peripheral surface that taper and reduce in diameter from a position on the outer side in the radial direction of the base end surface of the disk member 37 toward the base end side. The axial length of the disk portion 30 including the reflecting member 36 and the disk member 37 is not limited, but is preferably equal to or greater than the axial length of a light emitting portion 52 which is a light emitting site of the irradiation portion 50 described later. Thereby, the light irradiated from the light emitting portion 52 disposed inside the disk portion 30 can enter the disk portion 30 with less loss. The light irradiated from the light emitting portion 52 on the base end side of the disk member 37 is reflected by the reflecting member 36 and diffused by the disk member 37. The light irradiated from the light emitting portion 52 inside the disk member 37 enters the material of the disk member 37 and is propagated to the inner peripheral surface of the tubular tip portion 112 of the tubular device 100. The portion of the disk member 37 that contacts the tubular tip portion 112 preferably has a structure that is transparent or has low loss and propagates light so that light can be easily propagated from the outer peripheral surface of the disk member 37 to the inner peripheral surface of the tubular tip portion 112. The light propagated to the tubular tip portion 112 is diffused or scattered by the tubular tip portion 112 and irradiated in the tip direction or in a direction substantially perpendicular to the axial direction of the tubular device 100.
[0048] As shown in FIGS. 1 and 4, the irradiation portion 50 is elongated and includes at least one optical fiber 51 that propagates light. The irradiation portion 50 includes a light emitting portion 52 that irradiates light to the outside at the tip portion. The base end portion of the irradiation portion 50 can be connected to a light output device 80 that outputs light. The irradiation portion 50 can receive near-infrared light from the light output device 80, propagate the near-infrared light to the light emitting portion 52, and irradiate it from the light emitting portion 52. Note that the irradiation portion 50 may be formed by an optical waveguide other than an optical fiber. The irradiation portion 50 is inserted into the irradiation lumen 25 from the insertion port 28. The irradiation portion 50 can move in the axial direction and rotate within the irradiation lumen 25. Note that the irradiation portion 50 may be immovable and non-rotatable within the irradiation lumen 25.
[0049] As shown in FIGS. 4 and 10(A), the light-emitting part 52 is a columnar diffuser that is connected to the cut end of the optical fiber 51 and diffuses or scatters the light received from the optical fiber 51. The diffuser may be integrally formed by processing the surface or inside of the optical fiber 51, or may be the cut end of the optical fiber 51. In this case, in order to irradiate light at a wide irradiation angle, it is preferable to provide a plurality of optical fibers 51. Further, as in the 11th modification example shown in FIG. 10(B), the light-emitting part 52 may be formed by a mirror 53 and / or a lens 54 arranged at the cut end of the optical fiber 51. By being formed by the mirror 53 and / or the lens 54, the light-emitting part 52 can widen the irradiation angle of light. By rotating the optical fiber 51 within the irradiation lumen 25, the light-emitting part 52 can irradiate light over an even wider range.
[0050] Note that the light-emitting part 52 does not necessarily have to be arranged inside the main body shaft 21 or the tip shaft 24 as a method of propagating light to the disk part 30. For example, as in the 12th modification example shown in FIG. 10(C), the irradiation part 50 has an irradiation assisting part 55 that surrounds the main body shaft 21 on the proximal end side of the disk part 30, and the light-emitting part 52 may be arranged in the irradiation assisting part 55. The light-emitting part 52 has an inner peripheral surface that expands in the tip direction so as to cover a part of the surface on the proximal end side of the disk part 30. The light-emitting part 52 is arranged on this inner peripheral surface. The light-emitting part 52 is the cut end of an optical fiber, a diffuser, a mirror, a lens, or an LED that emits light by power, etc. When the light-emitting part 52 of the irradiation assisting part 55 emits light, light is irradiated from the proximal end side of the disk part 30 into the inside of the disk part 30. Thereby, the disk part 30 can receive light from the light-emitting part 52 of the irradiation assisting part 55 and emit light substantially as a whole. The light-emitting part 52 provided in the irradiation assisting part 55 may be used together with the irradiation part 50 provided in the irradiation lumen 25.
[0051] As shown in FIGS. 1 and 3, the first operation unit 60 is a part where the operator grips and operates the irradiation device 20. The first operation unit 60 includes a first operation unit main body 61 to which the proximal end portion of the main body shaft 21 is fixed, and a first fixing portion 62 for fixing the tubular device 100. An insertion port 28, which is the entrance of the irradiation lumen 25, is disposed at the proximal end portion of the first operation unit main body 61. The first fixing portion 62 includes, for example, a plurality of convex portions that can hook a second fixing portion 123 provided on the tubular device 100. It is preferable that the first fixing portion 62 can fix the second fixing portion 123 at an arbitrary position.
[0052] As shown in FIGS. 1, 3, and 4, the tubular device 100 includes a tubular member 110 and a second operation unit 120. The tubular member 110 includes a tubular proximal end portion 111 and a tubular distal end portion 112. The tubular device 100 is used with the irradiation device 20 inserted into the tubular member 110.
[0053] The tubular proximal end portion 111 is a circular tube, and the second operation unit 120 is fixed to the proximal end portion. The tubular proximal end portion 111 is formed of a transparent material so as to ensure the operator's field of view. Scale marks 115 arranged in the axial direction are provided on the outer peripheral surface of the tubular proximal end portion 111. The scale marks 115 can be used to confirm the insertion depth of the tubular proximal end portion 111 into a living body such as the irradiation device 20 or the vagina V. The constituent material of the tubular proximal end portion 111 is not particularly limited as long as it is transparent, and examples thereof include silicon, polyamide, polymethyl methacrylate, polyethylene terephthalate, polycarbonate, polytetrafluoroethylene, urethane, and combinations thereof.
[0054] The tubular tip portion 112 is a circular tube disposed on the tip side of the tubular base portion 111. The tubular tip portion 112 is formed of a transparent or translucent material that can transmit light of the wavelength emitted by the irradiation unit 50. The constituent material of the tubular tip portion 112 is not particularly limited, and examples thereof include silicon, polyamide, polymethyl methacrylate, polyethylene terephthalate, polycarbonate, polytetrafluoroethylene, urethane, and combinations thereof. The tubular tip portion 112 has a structure for diffusing or scattering light. For this purpose, similar to the disk portion 30, the tubular tip portion 112 may have a multilayer structure in which at least a part of the constituent material contains a scatterer, a large number of irregularities are formed on the inner or outer surface, or materials having different refractive indices are joined at a surface where a large number of irregularities are formed. The tip of the tubular tip portion 112 is inclined with respect to a plane perpendicular to the axis. Therefore, a protruding portion 113 that protrudes most in the tip direction is formed in a part of the circumferential direction of the tubular tip portion 112. And, a recessed portion 114 having the smallest protruding amount in the tip direction is formed on the opposite side of the protruding portion 113 in the circumferential direction of the tubular tip portion 112. By disposing the recessed portion 114 on the anterior vaginal cap AV side closer to the vaginal orifice and disposing the protruding portion 113 on the opposite side on the posterior vaginal cap RV side farther from the vaginal orifice, the tip portion of the tubular member 110 can be brought closer to the entire vaginal cap VF including the anterior vaginal cap AV and the posterior vaginal cap RV. For this reason, light can be effectively irradiated to a range where light hardly reaches, including the posterior vaginal cap RV and the anterior vaginal cap AV. The outer diameter of the tubular member 110 is, for example, 20 to 60 mm.
[0055] The tubular member 110 can be formed in various shapes. It is preferable that the tubular member 110 can be appropriately selected according to the shape of the uterine vaginal portion UV, the vaginal cap VF, and the vagina V of the patient.
[0056] As shown in the 13th modification example shown in FIG. 11(A), the leading end of the tubular member 110 may be perpendicular to the axis of the tubular member 110. Further, as shown in the 14th modification example shown in FIG. 11(B), the tubular member 110 may have a balloon 115 (fixed portion) inside. The balloon can be expanded by supplying fluid through a supply tube 116 extending from the second operation unit 120. The balloon adheres closely to the disk portion 30 disposed inside the tubular member 110 by expanding. Thereby, the irradiation device 20 can be fixed to the tubular device 100.
[0057] Also, as shown in the 15th modification example shown in FIG. 11(C), the tubular base end portion 111 may be composed of two half members 117 that are split in half. The two half members 117 are slidable in the axial direction. The two half members 117 are accommodated in an outer tube 118, which is, for example, a tube body, so as not to separate. One of the half members 117 is fixed to the outer tube 118, and the other half member 117 is slidable with respect to the outer tube 118. The tubular tip portion 112 is fixed at positions away from each other at the tip ends of the respective half members 117. The tubular tip portion 112 is formed of a material that can be deformed flexibly. Thereby, by sliding the two half members 117, the inclination of the leading end of the tubular tip portion 112 can be arbitrarily changed. Therefore, the operator can arbitrarily adjust the shape of the tubular member 110 according to the shape of the uterovaginal UV, vaginal dome VF, or vagina V of the patient.
[0058] As shown in FIGS. 1 and 3, the second operation unit 120 is a part where the operator grips and operates the tubular device 100. The second operation unit 120 includes a second operation unit main body 121 for the operator to grip and operate, a support unit 122 for supporting the irradiation device 20, and a second fixing unit 123 for fixing the irradiation device 20. The second operation unit main body 121 is fixed to the outer peripheral surface of the proximal end portion of the tubular member 110. The second operation unit main body 121 extends from the outer peripheral surface of the proximal end portion of the tubular member 110 toward the proximal end side and also extends radially outward of the tubular member 110. The support unit 122 and the second fixing unit 123 are connected to the second operation unit main body 121. The support unit 122 is a part that holds the proximal end portion of the main body shaft 21 at an appropriate position. The support unit 122 is formed, for example, to bifurcate so as to hold the main body shaft 21 therebetween. The second fixing unit 123 is, for example, an arch-shaped member that rotates with respect to the second operation unit main body 121 and can be hooked on the convex portion of the first fixing unit 62 provided on the irradiation device 20.
[0059] The light output device 80 can output light of an arbitrary wavelength to the optical fiber 51 of the irradiation unit 50 with an arbitrary intensity (power) and energy. The light output device 80 outputs, for example, near-infrared light having a wavelength of 660 to 740 nm to the optical fiber 51 with an intensity (power) of, for example, 1 mW to 5 W and an energy of, for example, 1 to 50 J / cm -2 so that light can be irradiated with such energy.
[0060] Next, a treatment method using the treatment device 10 according to the embodiment will be described.
[0061] First, the antibody-photosensitive substance is administered intravenously. After about 12 to 36 hours have elapsed since the intravenous administration, the operator inserts the tubular device 100 not combined with the irradiation device 20 into the vagina V from the vaginal orifice. The tubular member 110 passes through the vaginal orifice from the side of the tubular tip 112 and is inserted into the vagina V. At this time, the second operation unit main body 121 of the tubular device 100 extends radially outward of the tubular member 110 while heading toward the proximal end side from the outer peripheral surface of the proximal end of the tubular member 110, so it does not obstruct the operator's view. Also, since the tubular member 110 is transparent, it does not obstruct the operator's view. Therefore, the operator can open the vaginal orifice with the tubular member 110 and easily insert the treatment device 10 into the vagina V from the vaginal orifice. Therefore, this treatment method does not require a vaginoscope. Note that the vaginal orifice may be opened using a vaginoscope.
[0062] Next, the operator inserts the irradiation device 20 into the tubular member 110 from the proximal end side of the tubular member 110. At this time, the disk portion 30 of the irradiation device 20 is disposed inside the tubular member 110, but the first fixing portion 62 is not fixed to the second fixing portion 123. Therefore, the irradiation device 20 is movable along the axial center of the tubular member 110 with respect to the tubular device 100. After this, as shown in FIG. 12, the operator inserts the distal end of the distal end shaft 24 into the endocervical canal CC from the external os O while visually confirming the distal end portion. At this time, since the tubular member 110 is transparent, the operator can visually observe the distal end shaft 24 and easily insert it from the external os O into the endocervical canal CC. Also, since the irradiation device 20 is not fixed to the tubular device 100, the irradiation device 20 can be appropriately moved with respect to the tubular device 100. Therefore, the operator can easily position the distal end shaft 24 at a desired position with respect to the endocervical canal CC.
[0063] Next, as shown in FIG. 13, the operator pushes the tubular device 100 and presses the tubular member 110 against the uterovaginal portion UV. Since the tip shaft 24 inserted from the external os O into the cervical canal CC is connected to the center of the disk portion 30 disposed inside the tubular member 110, it is located substantially at the center of the opening on the tip side of the tubular member 110. For this reason, the uterovaginal portion UV located around the external os O easily enters the recess from the opening on the tip side of the tubular member 110 to the disk portion 30. For this reason, the tubular tip portion 112 located radially outside the disk portion 30 and protruding in the tip direction approaches the vaginal dome VF. At this time, the recessed portion 114 of the tubular tip portion 112 can contact or approach the anterior vaginal dome AV close to the vaginal orifice. Further, the protruding portion 113 of the tubular tip portion 112 can contact or approach the posterior vaginal dome RV far from the vaginal orifice. If the tubular tip portion 112 is deformable flexibly, it can deform following the shape of the vaginal dome VF and abut against a wide range of the vaginal dome VF. At least a part of the tubular tip portion 112 formed in a ring shape preferably abuts against the vaginal dome VF. Thereby, the tubular member 110 is positioned with respect to the uterine neck U and the vagina V. Note that the operator may move the tip shaft 24 together with the tubular member 110 when positioning the tubular member 110. In this case, the tubular member 110 and the tip shaft 24 are simultaneously positioned with respect to the uterine neck U and the vagina V.
[0064] Next, the operator fixes the irradiation device 20 and the tubular device 100. For this purpose, for example, the second fixing portion 123 is fixed to the first fixing portion 62. Alternatively, when the balloon 44 (fixing portion) is disposed on the disk portion 30 as shown in FIG. 8(B), the balloon 44 may be expanded to fix the irradiation device 20 and the tubular device 100. Alternatively, when the balloon 115 is disposed on the tubular member 110 as shown in FIG. 11(B), the balloon 115 may be expanded to fix the irradiation device 20 and the tubular device 100.
[0065] Next, the operator places the light emitting unit 52 of the irradiation unit 50 inside the distal shaft 24. At this time, the light emitting unit 52 is placed at a position where it can also irradiate light to the disk portion 30 and the tubular distal end portion 112. Next, the operator operates the light output device 80 to supply near-infrared light to the irradiation unit 50.
[0066] As a result, the light emitting unit 52 inside the distal shaft 24 can effectively irradiate the tumor cells C located in the uterine cervix U with near-infrared light. When the distal shaft 24 has a function of diffusing or scattering light, it emits light by diffusing the near-infrared light. The irradiation direction of the near-infrared light from the light emitting unit 52 includes a direction substantially perpendicular to the axis of the distal shaft 24. For this reason, the light emitting unit 52 can effectively irradiate the tumor cells C located in the uterine cervix U from the cervical canal CC. Note that the near-infrared light can also be irradiated by the tubular member 110 alone (see Fig. 9(A)). In this case, the proximal end of the tubular member 110 is connected to a light source such as the light output device 80.
[0067] When near-infrared light is irradiated from the cervical canal CC, the near-infrared light reaches the antibody-photosensitive substance accumulated in the tumor cells C of the uterine cervix U. As a result, a chemical change occurs in the antibody-photosensitive substance that has received the near-infrared light, which is excitation light, and further, a structural change of the antibody-photosensitive substance occurs, causing holes to open in the cell membrane. Thereby, the tumor cells C irradiated with the near-infrared light are destroyed.
[0068] In addition, since the disk portion 30 and the tubular tip portion 112 that receive light from the light-emitting portion 52 have the function of diffusing or scattering light, they emit light as a whole. That is, a part of the near-infrared rays that reach the disk portion 30 and the tubular tip portion 112 passes through the disk portion 30 and the tubular tip portion 112. A part of the near-infrared rays that reach the disk portion 30 and the tubular tip portion 112 is scattered or diffused by the disk portion 30 and the tubular tip portion 112 and irradiated over a wide range. For this reason, the light-emitting portion 52, the disk portion 30, and the tubular tip portion 112 can effectively irradiate tumor cells C mainly located at a site closer to the vaginal hood VF than the vaginal orifice side of the vaginal hood VF of the external cervical os O, the uterine vaginal portion UV, the vaginal hood VF, and the vagina V. In addition, although there are a large number of folds on the vaginal wall on the vaginal orifice side of the vaginal hood VF of the vagina V, by arranging the tubular tip portion 112 near the vaginal hood VF, the incident angle of the near-infrared rays on the vaginal wall becomes small. For this reason, light reflection can be suppressed as much as possible, and the tumor cells C can be effectively irradiated with near-infrared rays.
[0069] When irradiating near-infrared rays from within the vagina V, the near-infrared rays mainly reach the antibody-photosensitive substance accumulated in the tumor cells C at a site closer to the vaginal hood VF than the vaginal orifice side of the vaginal hood VF of the external cervical os O, the uterine vaginal portion UV, the vaginal hood VF, and the vagina V. As a result, a chemical change occurs in the antibody-photosensitive substance that has received the near-infrared rays, which are excitation light, and further, a structural change of the antibody-photosensitive substance occurs, causing holes to open in the cell membrane. Thereby, the tumor cells C irradiated with the near-infrared rays are destroyed.
[0070] The light-emitting portion 52 irradiates near-infrared rays simultaneously from within the cervical canal CC and within the vagina V. The operator may irradiate the near-infrared rays while moving the light-emitting portion 52 inside the irradiation lumen 25. Therefore, the operator can also perform the irradiation of the near-infrared rays from within the cervical canal CC and the irradiation of the near-infrared rays from within the vagina V separately. The operator may irradiate the near-infrared rays while alternately moving the light-emitting portion 52 within the cervical canal CC and within the vagina V.
[0071] The operator can repeatedly perform a treatment of irradiating near-infrared light while moving the entire irradiation device 20 and the tubular device 100 as necessary, and moving the disk portion 30, the tubular member 110, and the irradiation portion 50 within the vagina V and the cervical canal CC. At this time, if the irradiation device 20 and the tubular device 100 are fixed to each other, the operation is easy. Alternatively, the fixation of the irradiation device 20 and the tubular device 100 may be released, and the irradiation device 20 and the tubular device 100 may be operated separately. In this case, each of the irradiation device 20 and the tubular device 100 can be arranged at a desired position.
[0072] When the operator determines that the destruction of the tumor cells C has been sufficiently performed or when a predetermined time has elapsed, the irradiation of the near-infrared light is stopped. After that, the operator removes the second fixing portion 123 from the first fixing portion 62 and releases the fixation of the irradiation device 20 and the tubular device 100. After that, the operator removes the irradiation device 20 from the body and removes the tubular device 100 from the body. Note that the irradiation device 20 and the tubular device 100 may be removed simultaneously without releasing the fixation of the irradiation device 20 and the tubular device 100. Thereby, this treatment method is completed.
[0073] As described above, the treatment device 10 according to the present embodiment is a treatment device 10 that irradiates excitation light to an antibody-photosensitive substance accumulated in tumor cells C of cervical cancer, and includes a tubular device 100 having a long tubular member 110 and an irradiation device 20 that can be inserted into the tubular member 110. The irradiation device 20 includes a main body shaft 21 having a tip end portion and a base end portion, a disk portion 30 disposed on the tip end side of the main body shaft 21, a tip shaft 24 protruding from the disk portion 30 toward the tip end side, and an irradiation portion 50 disposed on the tip shaft 24 and capable of emitting excitation light.
[0074] The treatment device 10 configured as described above can effectively irradiate the antibody-photosensitive substance accumulated in the tumor cells C in a wide range including the uterine cervix U in a state where the distal shaft 24 is inserted into the cervical canal CC and the tubular member 110 is inserted near the vaginal fornix VF. Therefore, the present treatment device 10 can improve the therapeutic effect of cancer in a range including at least a part of the uterine cervix U.
[0075] Further, the distal shaft 24 may irradiate the excitation light in a direction substantially perpendicular to the axis of the distal shaft 24, and the disk portion 30 may irradiate the excitation light in a substantially distal direction. Thereby, since the excitation light can be irradiated to the tumor cells C in the uterine cervix U from both the distal shaft 24 and the disk portion 30, the therapeutic effect can be improved.
[0076] Further, the tubular member 110 may have an optical waveguide 119 (second irradiation portion) capable of irradiating the excitation light in a direction substantially perpendicular to the axis of the tubular member 110 and / or in a substantially distal direction. Thereby, since the excitation light can be irradiated to the tumor cells C in the uterine cervix U from both the irradiation portion 50 provided in the irradiation device 20 and the optical waveguide 119 (second irradiation portion) provided in the tubular member 110, the therapeutic effect can be improved. In addition, since the excitation light can be directly irradiated to the tumor cells C in the vaginal fornix VF where light hardly reaches from the optical waveguide 119 provided in the tubular member 110, the therapeutic effect can be improved.
[0077] Further, the distal end portion of the tubular member 110 may be deformable. Thereby, the distal end portion of the tubular member 110 can be deformed along the vaginal fornix VF and arranged near the vaginal fornix VF. Therefore, the excitation light can be effectively irradiated to the vicinity of the vaginal fornix VF where light hardly reaches, and the therapeutic effect can be improved.
[0078] Further, the treatment device 10 may have a fixing portion for fixing the irradiation device 20 to the tubular device 100. Thereby, since the irradiation device 20 and the tubular member 110 can be operated integrally, the operability is improved. Further, since the irradiation device 20 can be maintained at an appropriate position with respect to the tubular member 110, the excitation light irradiated from the irradiation device 20 can be appropriately propagated to the tubular member 110. Therefore, the excitation light irradiated from the distal end shaft 24, the disk portion 30, and the tubular member 110 can be appropriately irradiated onto the antibody-photosensitive substance.
[0079] Further, the fixing portion may be a balloon 44 disposed in the disk portion 30 and expandable by the inflow of fluid therein. Thereby, by expanding the balloon 44 inside the tubular member 110, the irradiation device 20 can be easily and surely fixed to the tubular member 110.
[0080] Further, the fixing portion may be a balloon 115 disposed in the tubular member 110 and expandable by the inflow of fluid therein. Thereby, by expanding the balloon 115, the irradiation device 20 can be easily and surely fixed to the tubular member 110.
[0081] Further, the axis of the disk portion 30 may be inclined with respect to the axis of the main body shaft 21. Thereby, it becomes easy to arrange the disk portion 30 in accordance with the inclination of the uterovaginal portion UV with respect to the vagina V. Therefore, the excitation light irradiated from the disk portion 30 can be appropriately irradiated onto the antibody-photosensitive substance.
[0082] In addition, the treatment method in the present embodiment is a treatment method for cervical cancer, which includes a step of intravenously administering an antibody-photosensitive substance, a step of inserting the tubular member 110 into the vagina V 12 to 36 hours after the intravenous administration, and a step of inserting an irradiation device 20 provided with a disk portion 30 that can be disposed inside the tubular member 110, a tip shaft 24 protruding from the disk portion 30 toward the tip side, and an irradiation portion 50 capable of emitting excitation light of the antibody-photosensitive substance into the tubular member 110, a step of inserting the tip shaft 24 into the cervical canal CC, and a step of emitting light from the irradiation portion 50 to irradiate excitation light from the disk portion 30, the tip shaft 24, and the tubular member 110 to the surrounding tissue.
[0083] The treatment method configured as described above can insert the tip shaft 24 from the external os O into the cervical canal CC, and can insert the tubular member 110 up to the vaginal dome VF or near the vaginal dome VF. Therefore, by emitting excitation light of the antibody-photosensitive substance from the tip shaft 24, the disk portion 30, and the tubular member 110, the excitation light can be effectively irradiated to the antibody-photosensitive substance accumulated in the tumor cells C in the range including at least a part of the uterine cervix U. For this reason, the present treatment method can improve the treatment effect of cancer in the range including at least a part of the uterine cervix U.
[0084] In addition, the present treatment method includes a step of fixing the position of the irradiation device 20 with respect to the tubular member 110. Thereby, since the irradiation device 20 and the tubular member 110 can be operated integrally, the operability is improved. In addition, since the irradiation device 20 can be maintained at an appropriate position with respect to the tubular member 110, the light irradiated from the irradiation device 20 can be appropriately propagated to the tubular member 110. For this reason, the light irradiated from the tip shaft 24, the disk portion 30, and the tubular member 110 can appropriately irradiate the excitation light to the antibody-photosensitive substance.
[0085] Note that the present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention.
[0086] For example, as shown in FIG. 14, the treatment device 10 may have a detection unit 90 that detects fluorescence (e.g., 704 nm) having a wavelength different from the wavelength of the irradiation light (e.g., 689 nm) emitted by the antibody-photosensitive substance excited by irradiation with near-infrared light from the light emitting unit 52. The detection unit 90 includes, for example, an optical waveguide 91 such as an optical fiber disposed in the irradiation lumen 25 to receive light in the same manner as the irradiation unit 50, and a photosensor 92 capable of detecting the amount of light. The detection unit 90 may have a semiconductor sensor such as a CMOS image sensor that senses light and converts it into an electrical signal at the position where it receives light.
[0087] When the antibody-photosensitive substance accumulated in the tumor cell C is irradiated with near-infrared light, the antibody-photosensitive substance undergoes a photoreaction to emit fluorescence and destroys the tumor cell C. Note that the antibody-photosensitive substance does not emit fluorescence after destroying the tumor cell C. Therefore, by measuring the change in the intensity of the detected fluorescence with the photosensor 92, the degree of destruction of the tumor cell C by the irradiation of the excitation light can be confirmed. Accordingly, the progress state of the photoreaction that destroys the tumor cell C can be confirmed.
[0088] Note that the detection unit 90 may be a device different from the treatment device 10 including 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 may be inserted into the vagina V, uterus, rectum, bladder, urethra, abdominal cavity, blood vessel, ureter, etc. to detect fluorescence. The detection of fluorescence by the detection unit 90 may be performed in parallel with the irradiation of near-infrared light by the treatment device 10, or may be performed after the irradiation of near-infrared light by the treatment device 10 is completed. After the treatment device 10 is withdrawn from the cervical canal CC and the vagina V, the detection unit 90 may be inserted into the vagina V or the cervical canal CC. Alternatively, the detection unit 90 may detect fluorescence from the body surface outside the body in parallel with or after the irradiation of near-infrared light by the treatment device 10.
[0089] Note that the detection unit 90 may be used to confirm how far the treatment device 10 has been inserted when the operator inserts the treatment device 10 into the vagina V or the cervical canal CC. For example, the position of the treatment device 10 can be confirmed from an image obtained from a CMOS image sensor or a change in the intensity or color of light obtained from an optical waveguide 91 such as an optical fiber.
[0090] Note that in the tubular member 110, a reflection member (not shown) may be interposed between the tubular base end portion 111 and the tubular tip end portion 112. By suppressing the propagation of the light irradiated from the tubular tip end portion 112 to the tubular base end portion 111 by the reflection member, the irradiation at the tubular tip end portion 112 can be performed more efficiently.
[0091] Also, in the tubular member 110, the constituent material of the tubular base end portion 111 does not have to be a transparent material, and may be a metal material typified by stainless steel or the like. Thereby, the wall thickness can be reduced while maintaining the rigidity of the tubular member 110, and the operability can be further improved.
[0092] This application is based on Japanese Patent Application No. 2020-060402 filed on March 30, 2020, and the disclosures thereof are incorporated herein by reference in their entirety.
Explanation of Reference Numerals
[0093] 10 Treatment device 20 Irradiation device 21 Body shaft 24 Tip shaft 25 Irradiation lumen 30 Disk portion 31 Tip surface 32 Base surface 33 Outer surface 34 Through hole 44, 115 Balloon (fixing portion) 50 Irradiation portion 62 First fixing portion (fixing portion) 80 Light output device 90 Detection unit 100 Tubular device 110 Tubular member 111 Tubular base end portion 112 Tubular tip portion 113 Protrusion 114 Depression 119 Optical waveguide (second irradiation portion) 122 Support portion 123 Second fixing portion (fixing portion) C Tumor cell CC Cervical canal I Internal os O External os U Cervix UC Uterine cavity UV Vaginal portion of the cervix V Vagina VF Vaginal dome AV Anterior vaginal dome RV Posterior vaginal dome
Claims
1. A treatment device for irradiating an antibody-photosensitive substance accumulated in tumor cells of cervical cancer with excitation light, comprising: a tubular device having a long tubular member; an irradiation device insertable into the tubular member, wherein the irradiation device has a main body shaft having a tip end portion and a base end portion, a disk portion disposed on the tip end side of the main body shaft, a tip shaft protruding from the disk portion toward the tip end side, and an irradiation portion disposed on the tip shaft and capable of emitting the excitation light.
2. The tip shaft irradiates the excitation light in a direction substantially perpendicular to the axis of the tip shaft, and the disk portion irradiates the excitation light in a substantially tip end direction. The treatment device according to claim 1.
3. The tubular member has a second irradiation portion capable of irradiating the excitation light in a direction substantially perpendicular to the axial direction of the tubular member and / or in a substantially tip end direction. The treatment device according to claim 1.
4. The tip end portion of the tubular member is deformable. The treatment device according to any one of claims 1 to 3.
5. The treatment device according to any one of claims 1 to 4, further comprising a fixing portion for fixing the irradiation device to the tubular device.
6. The fixing portion is a balloon disposed on the disk portion and expandable by the inflow of fluid therein. The treatment device according to claim 5.
7. The fixing portion is a balloon disposed on the tubular member and expandable by the inflow of fluid therein. The treatment device according to claim 5.
8. The axis of the disk portion is inclined with respect to the axis of the main body shaft. The treatment device according to any one of claims 1 to 7.
9. The treatment device according to any one of claims 1 to 8, further comprising a detection portion for detecting fluorescence emitted by the antibody-photosensitive substance.
Citation Information
Patent Citations
A self-centering light generator within a lumen for photodynamic therapy
JP2007528754A
System and method for ablation therapy of cervical tumors
JP2011524785A
Photonic device and method for treating cervical dysplasia
US20080065003A1
Frontal light diffusing device for use in photoimmunotherapy
US20180113246A1
Radiation-transmitting sheath and methods for its use
US5947958A