Irradiation device

Abstract

To provide an irradiation device capable of effectively irradiating near infrared-ray to antibody-photosensitive substance coupled to a cell membrane of cancer cell.SOLUTION: An irradiation device 10 includes: a long shaft part 20; a balloon 30 that is provided at an end part of the shaft part 20 and expandable; an optical fiber 60 having an end part and a distal end part; and an irradiation part 61 which is provided at the end of the optical fiber 60, arranged inside the balloon 30, and can irradiate light. The irradiation part 61 can irradiate light in the direction almost orthogonal to an axial line of the optical fiber 60 and a nearly end direction parallel to the axial line from the base end part to the end part of the optical fiber 60. The shaft part 20 is provided with an outer pipe 21 to be tubular and an inner pipe 22 disposed inside the outer pipe 21. Between the outer pipe 21 and the inner pipe 22 is formed an expanded lumen 23 where fluid for expansion for expanding the balloon 30 circulates.SELECTED DRAWING: Figure 5

Description

Technical Field

[0001] The present invention relates to an irradiation device used for the treatment of cervical cancer.

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, for the treatment of cervical cancer, total hysterectomy from the early stage (stage I) is the standard treatment. However, 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 perform surgical resection, a treatment combining radiotherapy and chemotherapy is the standard treatment. However, the 5-year survival rate is as low as 50% in stage III and 20% in stage IV, and more effective treatment is required. As a local treatment for cancer, a treatment method using a photosensitive substance is known. Among them, a treatment method using an antibody-photosensitive substance (hydrophilic phthalocyanine) can specifically kill target cells without killing non-target cells such as normal cells by irradiating near-infrared light to the antibody-photosensitive substance accumulated in the tumor, 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 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 depth of penetration 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 for surely delivering light to the tumor in the body while suppressing invasiveness as much as possible is required. In the case of cervical cancer, the cancer often spreads widely in the cervical canal, and a means for irradiating light from as close as possible to the wide-range cancer is required. Also, depending on the stage of progression, the cancer may reach the pelvic wall. In this case, it is difficult to approach the pelvic wall by a minimally invasive method using transvaginal or laparoscopy. For example, Patent Document 1 discloses a method of inserting a long device equipped with an optical fiber transvaginally close to the tumor and irradiating light from inside the blood vessel.

[0005] The present invention has been made to solve the above-described problems, and an object thereof is to provide an irradiation device capable of effectively irradiating near-infrared light to an antibody-photosensitive substance bound to the cell membrane of cancer cells.

Means for Solving the Problems

[0006] The irradiation device according to the present invention that achieves the above object includes a long shaft portion, an expandable balloon provided at the tip of the shaft portion, an optical fiber having a tip end portion and a base end portion, and an irradiation portion provided at the tip of the optical fiber and disposed inside the balloon and capable of irradiating light. The irradiation portion can irradiate light in a direction substantially perpendicular to the axis of the optical fiber and in a substantially tip direction parallel to the axis from the base end portion to the tip end portion of the optical fiber. The shaft portion includes an outer tube that is a tubular body and an inner tube disposed inside the outer tube. An expansion lumen through which an expansion fluid for expanding the balloon flows is formed between the outer tube and the inner tube.

Effect of the Invention

[0007] The irradiation device configured as described above can effectively irradiate near-infrared light onto the antibody-photosensitive substance bound to the cell membrane of cancer cells.

[0008] The irradiation unit may be capable of irradiating light in both the contracted state and the expanded state of the balloon.

[0009] The inside of the balloon may have an X-ray impermeable position confirmation marker.

[0010] The position confirmation marker may have a structure that stores light, a structure that emits fluorescence, or a structure that transmits light.

Brief Description of the Drawings

[0011]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

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Figure 8

Figure 9

Embodiments for Carrying Out the Invention

[0012] 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 be different from the actual dimensions. Also, in this specification and the drawings, for components having substantially the same functional configuration, the same reference numerals are given to omit duplicate explanations. In this specification, the side inserted into the living body lumen of the device is referred to as the "tip side", and the side for operation is referred to as the "base end side". <First Embodiment>

[0013] The treatment method according to the first embodiment is a treatment method for cervical cancer, and relates to a photoimmunotherapy method in which near-infrared light is irradiated onto an antibody-photosensitive substance bound to the cell membrane of cancer cells to kill the cancer cells. In this treatment method, an antibody-photosensitive substance obtained by binding an antibody that specifically binds only to a specific antigen present on the surface of cancer cells and a photosensitive substance paired with the antibody is used as a drug. The antibody is not particularly limited, and examples thereof include panitumumab, trastuzumab, HuJ591, and the like. The photosensitive substance is, for example, a hydrophilic phthalocyanine that is a substance (IR700) that reacts with near-infrared light having a wavelength of about 700 nm, but is not limited thereto. When IR700 receives near-infrared light having a wavelength with a peak around 700 nm, it absorbs the light, causes a chemical change, and makes holes in the cell membrane, thereby being able to kill cancer cells.

[0014] In the treatment method according to the first embodiment, in order to irradiate the antibody-photosensitive substance bound to cancer cells with near-infrared light transvaginally and transvaginally, as shown in FIG. 1, an irradiation device 10 that can be inserted into blood vessels and the cervix is used. First, the irradiation device 10 will be described.

[0015] As shown in FIGS. 1 and 2, the irradiation device 10 includes a long shaft portion 20, a balloon 30 which is a deformed portion provided at the tip of the shaft portion 20, a hub 40 connected to the proximal side of the shaft portion 20, a position confirmation marker 50, and an optical fiber 60. The irradiation device 10 is used by being connected to an optical output device 70.

[0016] The shaft portion 20 includes an outer tube 21 which is a tubular body with openings at the tip and the base, and an inner tube 22 disposed inside the outer tube 21. An expansion lumen 23 through which an expansion fluid for expanding the balloon 30 flows is formed between the outer tube 21 and the inner tube 22, and a guide wire lumen 24 into which a guide wire 80 can be inserted is formed inside the inner tube 22.

[0017] The balloon 30 has its tip side adhered to the inner tube 22 and its base side adhered to the outer tube 21, and the inside of the balloon 30 communicates with the expansion lumen 23. The balloon 30 can be deformed and expanded by the inflow of fluid inside.

[0018] The hub 40 includes a first opening 41 that functions as a port for communicating with the expansion lumen 23 of the outer tube 21 to allow the inflow and outflow of the expansion fluid, a second opening 42 that communicates with the guide wire lumen 24, and a connection cable 43 for connecting the optical fiber 60 to the optical output device 70. The connection cable 43 is detachable from the optical output device 70.

[0019] The balloon 30 is preferably formed of a material having a certain degree of flexibility. Examples of such materials include polyolefins such as polyethylene, polypropylene, polybutene, ethylene - propylene copolymer, ethylene - vinyl acetate copolymer, ionomer, or a mixture of two or more of these, thermoplastic resins such as soft polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, fluororesin, silicone rubber, latex rubber, etc.

[0020] The light output device 70 can output near-infrared light of any wavelength to the optical fiber 60 at any dose. The light output device 70 outputs light to the optical fiber 60 so that it can irradiate light at a dose of, for example, 1 to 50 J / cm -2 at a wavelength of, for example, 660 to 740 nm.

[0021] The optical fiber 60 extends along the outer surface of the inner tube 22 within the expansion lumen 23 from the hub 40 to the balloon 30. The optical fiber 60 may be composed of a single fiber or a plurality of bundled fibers. The optical fiber 60 can receive near-infrared light from the light output device 70 through the connection cable 43 provided on the hub 40. An irradiation unit 61 for irradiating light is provided at the tip of the optical fiber 60.

[0022] The irradiation unit 61 irradiates the light entering from the proximal end side of the optical fiber 60 to the outside. The irradiation unit 61 can be composed of, for example, a lens, a diffuser, a mirror, etc. The irradiation unit 61 is appropriately designed so that it can irradiate near-infrared light in a predetermined direction using a lens, a diffuser, a mirror, etc. Note that the structure of the irradiation unit 61 is not limited as long as it can irradiate light to the outside.

[0023] The irradiation unit 61 irradiates near-infrared light from inside the balloon 30 to a range including both a direction substantially perpendicular to the axis of the optical fiber 60 and a substantially tip direction (a direction parallel to the axis of the optical fiber 60). Therefore, the near-infrared light is irradiated with a predetermined irradiation angle. Alternatively, the irradiation unit 61 may irradiate the near-infrared light only in either a direction substantially perpendicular to the axis of the optical fiber 60 or a substantially tip direction.

[0024] The position confirmation marker 50 is a part for the operator to confirm the position within the body. The position confirmation marker 50 is arranged in the vicinity of the balloon 30 and the irradiation unit 61. The position where the position confirmation marker 50 is arranged and the number of the position confirmation markers 50 are not particularly limited. For example, the position confirmation marker 50 is arranged at two locations on the outer peripheral surface of the inner tube 22 inside the balloon 30. The position confirmation marker 50 may be arranged on the outer tube 21, for example. The position confirmation marker 50 is formed of, for example, an X-ray impermeable material. The X-ray impermeable material is a metal material such as a metal like gold, platinum, tungsten or an alloy containing these. Thereby, the operator can confirm the position of the position confirmation marker 50 under X-ray imaging outside the body. Note that the position confirmation marker 50 does not have to be an X-ray contrast marker as long as the operator can confirm the position within the body. Therefore, the position confirmation marker 50 can be used for confirming the position of the insertion site into the uterine cervix U. The position confirmation marker 50 can function as a marker whose position can be confirmed by X-ray when inserted into a blood vessel, and can also function as a marker whose position can be confirmed by X-ray, ultrasonic wave, etc. when inserted into the uterine cervix U. The position confirmation marker 50 may be a phosphorescent marker containing a phosphorescent material, for example. The position confirmation marker 50 can emit the pre-stored phosphorescent light. Or the position confirmation marker 50 may be a marker that emits fluorescence. The fluorescent marker that emits fluorescence is excited by the irradiation light from a device such as the optical fiber 60 and / or the irradiation unit 61, or another optical fiber that can be inserted into the guide wire lumen 24 and irradiate light, and emits fluorescence of a different wavelength. The operator can perform the positioning of the irradiation device 10 before treatment and the position confirmation of the irradiation device 10 during irradiation for treatment by observing this emission state through a filter that transmits only a specific wavelength or a filter that can cut the wavelength of the irradiation light. Or the position confirmation marker 50 may be a light transmissive marker including a transparent part that can transmit the light from the inside of the shaft part 20. In this case, the position confirmation marker 50 may be arranged to cover the hole penetrating from the inner peripheral surface to the outer peripheral surface of the shaft part 20, or may be arranged inside the hole.The position confirmation marker 50 can be inserted into the guide wire lumen 24 of the shaft portion 20 and transmit the light emitted by a device such as another optical fiber that can irradiate light, and radiate it to the outside. The operator can observe the light emitted by the phosphorescent, fluorescent, or light transmissive position confirmation marker 50 using, for example, a colposcope inserted into the vagina V.

[0025] Next, a treatment method according to the first embodiment will be described.

[0026] First, the antibody-photosensitive substance is administered intravenously. After about 12 to 36 hours have elapsed since the intravenous administration, the operator inserts the guide wire 80 into the blood vessel, for example, from the femoral artery as shown in FIG. 3. Next, the proximal end of the guide wire 80 is inserted into the guide wire lumen 24 of the irradiation device 10, and the irradiation device 10 is advanced along the guide wire 80 to reach the uterine artery UA via the internal iliac artery. Next, while the operator confirms the position of the position confirmation marker 50 under X-ray imaging, the tip of the irradiation device 10 (particularly, the irradiation portion 61) is moved close to the tissue or organ infiltrated by the cancer cells C from the uterine cervix U. The tissues and organs in which the cancer cells C are formed are the uterine cervix, uterine endometrial tissue, pelvis, bladder wall, and rectal mucosa, etc. The operator places the tip of the irradiation device 10 at a position where near-infrared light can be irradiated onto the tissue or organ infiltrated by the cancer cells C.

[0027] Next, as shown in FIG. 4, near-infrared light is irradiated from the optical fiber 60. The irradiation of the near-infrared light is started after 12 to 36 hours have elapsed since the intravenous administration. The irradiation direction of the near-infrared light from the optical fiber 60 includes a direction perpendicular to the axis of the optical fiber 60. Therefore, the optical fiber 60 can effectively irradiate near-infrared light from inside the blood vessel to an extravascular site. Note that the optical fiber 60 may irradiate near-infrared light in the tip direction. The operator can appropriately select the optical fiber 60 to be used according to the position of the cancer cells C relative to the blood vessel into which the irradiation device 10 is inserted.

[0028] Before irradiating near-infrared light from the optical fiber 60, the operator may supply physiological saline to the guide wire lumen 24 from the proximal end side of the irradiation device 10. Thereby, the physiological saline is injected (flashed) from the irradiation device 10 into the uterine artery UA. As a result, the blood in the blood vessel where the tip of the irradiation device 10 is located is washed away, making it difficult for the irradiation of near-infrared light to be affected by the blood. Also, before irradiating near-infrared light from the optical fiber 60, the operator may supply an expanding fluid into the balloon 30 from the expanding lumen 23 to inflate the balloon 30. The balloon 30 adheres tightly to the blood vessel wall and blocks blood flow. Thereby, since there is no blood between the balloon 30 and the blood vessel wall, it is possible to make it difficult for the irradiation of near-infrared light to be affected by the blood. When the operator inflates the balloon 30, after the irradiation of near-infrared light is completed, the operator discharges the expanding fluid from the balloon 30 to deflate the balloon 30.

[0029] When irradiating near-infrared light, the near-infrared light reaches the antibody-photosensitive substance bound to the cell membrane of the cancer cell C. Thereby, a chemical change of the photosensitive substance occurs, and further a structural change of the antibody-photosensitive substance occurs to create holes in the cell membrane, and the cancer cell C can be killed.

[0030] When the operator determines that the death of the cancer cell C has been sufficiently carried out, or when the operator determines that further irradiation is not desirable, or when a predetermined time has elapsed, the operator stops the irradiation of near-infrared light.

[0031] Next, the operator withdraws the irradiation device 10 out of the body. Next, the operator cleans the irradiation device 10. Thereby, the blood is removed from the irradiation device 10. It is preferable that the blood vessel into which the irradiation device 10 is inserted is not infiltrated by the cancer cell C. Thereby, the cancer cell C does not adhere to the irradiation device 10, and the same irradiation device 10 can be used for subsequent transvaginal treatment.

[0032] Next, the operator identifies the position of the cancer cells C irradiated with near-infrared light and records it. It is desirable that the position of the cancer cells C be recorded as electronic data so as to correspond to the position information of data such as pre-acquired CT images or MRI images of the patient. This enables the subsequent procedures to proceed smoothly and the postoperative follow-up to be effectively carried out. For example, when irradiating a plurality of cancer cells C with near-infrared light, by accurately grasping the tumor C that has completed near-infrared irradiation, irradiation of all cancer cells C can be performed smoothly and surely. Note that the identification and recording of the position of the cancer cells C are also appropriately performed in subsequent near-infrared irradiations.

[0033] Next, the operator inserts the irradiation device 10 withdrawn from the blood vessel and washed into the cervical canal CC of the uterine cervix U through the external os O from the vagina V as shown in Fig. 5(A). As a result, the balloon 30 is positioned in the cervical canal CC. Next, the operator irradiates near-infrared light from the optical fiber 60. The irradiation direction of the near-infrared light from the optical fiber 60 includes a direction substantially perpendicular to the axis of the optical fiber 60. Therefore, the optical fiber 60 can effectively irradiate the cancer cells C located in the uterine cervix U from the cervical canal CC with near-infrared light. Note that the optical fiber 60 may irradiate near-infrared light in the tip direction. Note that the operator may insert an irradiation device 10 different from the irradiation device 10 withdrawn from the blood vessel and washed into the cervical canal CC from the vagina V. When irradiating near-infrared light from the cervical canal CC, since the cervical canal CC is narrow, the tip of the irradiation device 10 is in close contact with the uterine cervix U. Therefore, it is not necessary to inflate the balloon 30. Note that the balloon 30 may be inflated in the lumen of the uterine cervix U.

[0034] When near-infrared light is irradiated, the near-infrared light reaches the antibody-photosensitive substance bound to the cell membrane of the cancer cells C in the uterine cervix U. As a result, a chemical change of the photosensitive substance occurs, and further a structural change of the antibody-photosensitive substance occurs, creating holes in the cell membrane, and the cancer cells C in the uterine cervix U irradiated with infrared light die.

[0035] When the operator determines that the cancer cells C have been sufficiently killed, when the operator determines that further irradiation is not desirable, or when a predetermined time has elapsed, the operator stops irradiating the near-infrared light.

[0036] Next, the operator pulls out the irradiation device 10 and pulls out at least a part (or all) of the balloon 30 and the irradiation unit 61 from the external os O. After that, the expansion fluid is supplied into the balloon 30 from the expansion lumen 23, and the balloon 30 is inflated as shown in FIG. 5(B). Next, the operator pushes in the irradiation device 10 and presses the tip of the inflated balloon 30 against the vaginal portion UV of the uterus. The vaginal portion UV of the uterus is a part on the vaginal V side of the uterine cervix U where the external os O is formed. Therefore, the balloon 30 adheres closely to the vicinity of the external os O of the vaginal portion UV of the uterus and inflates so as to follow the shape of the vaginal portion UV (organ). Note that when a part of the balloon 30 is located in the cervical canal CC, the balloon 30 may be able to maintain a state of closely adhering to the vicinity of the external os O of the vaginal portion UV of the uterus even if the operator does not push in the irradiation device 10.

[0037] Next, the operator irradiates near-infrared light from the optical fiber 60. The irradiation direction of the near-infrared light from the optical fiber 60 includes a substantially tip direction and / or a direction substantially perpendicular to the axis of the optical fiber 60. The near-infrared light irradiated from the optical fiber 60 in the tip direction can effectively reach the cancer cells C located in the vaginal portion UV of the uterus. The near-infrared light irradiated from the optical fiber 60 in a direction perpendicular to the axis of the optical fiber 60 reaches the cancer cells C at a site away from the external os O of the vaginal portion UV of the uterus from a direction different from the irradiation in FIG. 5(A) and can effectively reach the cancer cells C located in the vagina V. Therefore, the optical fiber 60 can effectively irradiate the cancer cells C located in the vaginal portion UV of the uterus and the vagina V with near-infrared light.

[0038] When the operator determines that the cancer cells C have been sufficiently killed, when the operator determines that further irradiation is not desirable, or when a predetermined time has elapsed, the operator stops irradiating the near-infrared light. Next, the operator discharges the expansion fluid from the balloon 30 and contracts the balloon 30.

[0039] Next, the operator rotates the irradiation device 10 by a predetermined angle about the axis of the irradiation device 10. The rotation angle is not particularly limited, but is, for example, 90° to 180°. Then, the operator inflates the balloon 30 again as described above and brings the balloon 30 into close contact with the vicinity of the external os O of the uterine cervix UV of the vaginal part of the uterus. The balloon 30 inflates so as to follow the shape of the vaginal part of the uterus (organ) UV. After this, the operator irradiates near-infrared light from the optical fiber 60. Thereby, by irradiating near-infrared light at a location different from that before rotation, near-infrared light can be irradiated to cancer cells C at different positions of the vaginal part of the uterus UV and the vagina V. After this, the operator stops the irradiation of near-infrared light. A series of steps combining the rotation of the irradiation device 10, the inflation of the balloon 30, the irradiation of near-infrared light, the stop of irradiation, and the contraction of the balloon 30 can be repeated one or more times. Note that this series of steps may not be performed even once. After this, the operator withdraws the irradiation device 10 outside the body. Thereby, this treatment method ends.

[0040] During the procedure, the operator can also position the irradiation device 10 at the target position of the uterine cervix U while confirming the position of the position confirmation marker 50 by X-ray or ultrasonic wave. When the position confirmation marker 50 is a phosphorescent or light-transmissive marker, the operator can insert the irradiation device 10 from the vaginal part V into the uterine cervix U while observing the light emitted from the position confirmation marker 50 through a colposcope or the like. Then, when the operator can no longer observe the light, the operator can grasp that the part of the irradiation device 10 where the position confirmation marker 50 is provided has been inserted from the vagina V into the cervical canal CC of the uterine cervix U. Therefore, the position confirmation marker 50 can function as a positioning mechanism for accurately positioning the irradiation device 10 so that a part of the irradiation device 10 is in a state of being inserted into the cervical canal CC.

[0041] The operator can also pull out the irradiation device 10 inserted into the uterine cervix U from the uterine cervix U to the vaginal V side while observing the light emitted from the position confirmation marker 50 through a colposcope or the like from the vaginal V side. Then, by being able to observe the light, the operator can grasp that the part where the position confirmation marker 50 of the irradiation device 10 is provided has been pulled out from the uterine cervix U to the vagina V. Therefore, the position confirmation marker 50 can function as a positioning mechanism for accurately positioning the irradiation device 10 so that a part of the irradiation device 10 is inserted into the cervical canal CC. When the operator repeats the insertion into the uterine cervix U and the pulling out from the uterine cervix U, in each operation, the operator can observe the light emitted from the position confirmation marker 50 from the vaginal V side and accurately position the irradiation device 10.

[0042] As described above, the treatment method according to the first embodiment is a treatment method for cervical cancer, which includes a step of intravenously administering an antibody-photoabsorbing substance, a step of inserting a first irradiation device 10 having a first optical fiber 60 and a position confirmation marker 50 into the uterine artery UA after 12 to 36 hours have elapsed since the intravenous administration, a step of advancing the irradiation device 10 to a target position while confirming the position of the first irradiation device 10 by the position confirmation marker 50, a step of irradiating near-infrared light with the first optical fiber 60 in a direction substantially perpendicular to the first optical fiber 60, a step of pulling out the first irradiation device 10 outside the body, a step of inserting a second irradiation device 10, which is the first irradiation device 10 or another irradiation device 10, from the vagina V into the uterine cervix U, a step of irradiating near-infrared light with the second optical fiber 60 of the second irradiation device 10 in a direction substantially perpendicular to the second optical fiber 60, a step of pulling out at least a part of the deformed portion of the second irradiation device 10 to the external os O and inflating the balloon 30, which is the deformed portion, so as to follow the shape of the organ, a step of irradiating near-infrared light with the second optical fiber 60 in a substantially tip direction and / or a direction substantially perpendicular to the optical fiber 60, and a step of deflating the balloon 30.

[0043] The treatment method configured as described above inserts the first irradiation device 10 into the uterine artery UA and irradiates near-infrared light from the inside of the blood vessel in a substantially perpendicular direction. Therefore, near-infrared light can be effectively irradiated onto the tissue and organs infiltrated by cancer cells C near the uterine artery UA. In addition, in this treatment method, since the second irradiation device 10 is inserted into the narrow cervical canal CC and near-infrared light is irradiated in a substantially perpendicular direction, near-infrared light can be effectively irradiated from the cervical canal CC of the uterine cervix U to the cancer cells C of the uterine cervix U. Furthermore, in this treatment method, since the balloon 30, which is a deformed part, drawn out from the external os O is inflated and near-infrared light is irradiated in the tip direction and / or the perpendicular direction, near-infrared light can be effectively irradiated onto the cervical cancer near the vaginal portion UV of the uterus. For this reason, this treatment method can effectively irradiate near-infrared light onto the antibody-photosensitive substance bound to the cell membranes of the cancer cells C in the uterine cervix U and the cancer cells C in the tissue and organs infiltrated from the uterine cervix U. This treatment method is effective not only in the early stage where the cancer cells C are confined to the uterine cervix but also in stage IIB where the cancer cells C infiltrate the parametrium, stage IIIA where the infiltration of the vaginal wall reaches the lower one-third of the vagina, stage IIIB where the infiltration of the parametrium reaches the pelvic wall, and stage IVA where there is infiltration of cancer cells C into the bladder or rectal mucosa.

[0044] In addition, in this treatment method, after the step of shrinking the balloon 30, which is a deformed part, the step of rotating the second irradiation device 10, the step of inflating the balloon 30 so as to follow the shape of the organ, the step of irradiating near-infrared light in the substantially tip direction and / or the substantially perpendicular direction of the second optical fiber 60 by the second optical fiber 60, and the step of shrinking the balloon 30 are repeated at least once. Thereby, this treatment method can irradiate near-infrared light over a wide range in the circumferential direction of the uterine cervix U. In addition, this treatment method can also irradiate near-infrared light over a wide range in the circumferential direction of the vagina V.

[0045] Also, the second irradiation device 10 is the same as the first irradiation device 10. Thereby, this treatment method can irradiate near-infrared light from the uterine artery UA and irradiate near-infrared light from the uterine cervix U with one irradiation device 10. Therefore, this treatment method can improve medical economy. Note that the second irradiation device 10 does not have to be the same as the first irradiation device 10.

[0046] Also, after the step of removing the first irradiation device 10 from the body, this treatment method cleans the first irradiation device 10. Thereby, this treatment method can remove the blood adhering to the first irradiation device 10 inserted into the blood vessel and make the first irradiation device 10 in a desirable state for insertion from the vagina V to the uterine cervix U.

[0047] Also, this treatment method may include a step of inflating the balloon 30 of the first irradiation device 10 before the step of irradiating near-infrared light with the first optical fiber 60, and a step of deflating the balloon 30 of the first irradiation device 10 after the step of irradiating near-infrared light with the first optical fiber 60. Thereby, when irradiating near-infrared light from the first irradiation device 10 in the uterine artery UA, the blood flow in the uterine artery UA can be blocked. Therefore, the influence of blood on near-infrared light can be reduced and near-infrared light can be effectively irradiated to the target site.

[0048] Also, in the first embodiment, the treatment device does not have to be inserted into a blood vessel. That is, a modified example of the treatment method according to the first embodiment is a treatment method for cervical cancer, which includes a step of intravenously administering an antibody-photoabsorbing substance, and after 12 to 36 hours have elapsed since the intravenous administration, a step of inserting a second irradiation device 10 having a second optical fiber 60 from the vagina V into the cervix U, a step of irradiating the second optical fiber 60 in a direction substantially perpendicular to the second optical fiber 60 by the second optical fiber 60 included in the second irradiation device 10, a step of pulling out at least a part of the balloon 30 included in the second irradiation device 10 to the external os O and inflating the balloon 30 so as to follow the shape of the organ, a step of irradiating near-infrared light in a substantially tip direction and / or a direction substantially perpendicular to the second optical fiber 60 by the second optical fiber 60, and a step of deflating the balloon 30.

[0049] The treatment method configured as described above inserts the irradiation device 10 into the narrow cervix U, inflates the balloon 30, and irradiates near-infrared light in the tip direction and / or the vertical direction, so that the near-infrared light can be effectively irradiated to cervical cancer in a wide range of the cervix U. Therefore, this treatment method can effectively irradiate near-infrared light to the antibody-photosensitive substance bound to the cell membrane of the cancer cells C in the cervix U. This treatment method is effective not only in the early stage where the cancer cells C are localized in the cervix but also in stage IIA and stage IIIA in which the cancer cells C have invaded the vaginal wall.

[0050] <Second Embodiment> The treatment method according to the second embodiment is different from the treatment method according to the first embodiment in that the irradiation device 10 is inserted from the vagina V into the cervix U. The irradiation device 10 to be used is the same as the irradiation device 10 used in the treatment method according to the first embodiment.

[0051] In the treatment method according to the second embodiment, the operator inserts the irradiation device 10 into the uterine artery UA in the same manner as in the first embodiment and irradiates near-infrared light from inside the uterine artery UA to the tissue and organ invaded by the cancer cells C.

[0052] After the operator withdraws the irradiation device 10 from the blood vessel and cleans it, as shown in FIG. 6, the operator inserts it from the vagina V through the external os O into the cervical canal CC. As a result, the distal end portion of the balloon 30 is disposed in the uterine cavity UC on the distal side of the internal os I, and the proximal end portion of the balloon 30 is disposed in the vagina V on the proximal side of the external os O. Therefore, the balloon 30 penetrates the cervical canal CC. Next, the operator irradiates near-infrared light from the optical fiber 60. Thereby, the optical fiber 60 disposed in the cervical canal CC can effectively irradiate the cancer cells C located in the uterine cervix U with near-infrared light. In addition, the distal end portion of the optical fiber 60 disposed in the uterine cavity UC can effectively irradiate the cancer cells C located in the uterine cavity UC and the uterine cervix U close to the uterine cavity UC with near-infrared light. Further, the proximal end portion of the optical fiber 60 disposed in the vagina V can effectively irradiate the cancer cells C located in the uterovaginal portion UV and the vagina V with near-infrared light.

[0053] As described above, the treatment method according to the second embodiment is a treatment method for cervical cancer, and includes a step of intravenously administering an antibody-photoabsorbing substance, a step of inserting a first irradiation device 10 having a first optical fiber 60 and a position confirmation marker 50 into the uterine artery UA after 12 to 36 hours have elapsed since the intravenous administration, a step of advancing the irradiation device 10 to a target position while confirming the position of the first irradiation device 10 by the position confirmation marker 50, a step of irradiating near-infrared light by the first optical fiber 60 in a direction substantially perpendicular to the first optical fiber 60, a step of withdrawing the first irradiation device 10 from the body, a step of inserting a second irradiation device 10, which is the first irradiation device 10 or another irradiation device 10, from the vagina V into the uterine cervix U, a step of inflating the balloon 30 included in the second irradiation device 10 so as to follow the shape of the organ, a step of irradiating near-infrared light by the second optical fiber 60 in a substantially distal direction and / or a direction substantially perpendicular to the second optical fiber 60, and a step of deflating the balloon 30.

[0054] The treatment method configured as described above inserts the first irradiation device 10 into the uterine artery UA and irradiates near-infrared light in a substantially vertical direction from inside the blood vessel, so that the near-infrared light can effectively irradiate the tissue and organs infiltrated by the cancer cells C near the uterine artery UA. Further, in this treatment method, the second irradiation device 10 is inserted into the narrow uterine cervix U and the balloon 30 is inflated to irradiate near-infrared light in the tip direction and / or the vertical direction, so that the near-infrared light can effectively irradiate a wide range of cervical cancer in the uterine cervix U. Therefore, this treatment method can effectively irradiate the antibody-photosensitive substance bound to the cell membrane of the cancer cells C in both sites, such as the uterine cervix U and the infiltrated pelvic wall. This treatment method is effective not only in the early stage where the cancer cells C are localized in the uterine cervix, but also in stage IIB where the cancer cells C infiltrate the parametrium, stage IIIA where the vaginal wall infiltration reaches the lower one-third of the vagina, stage IIIB where the infiltration of the parametrium reaches the pelvic wall, and stage IVA where there is infiltration of the cancer cells C into the bladder or rectal mucosa.

[0055] Further, in the second embodiment, the treatment device may not be inserted into the blood vessel. That is, a modified example of the treatment method according to the second embodiment is a treatment method for cervical cancer, which includes a step of intravenously administering an antibody-photoabsorbing substance, a step of inserting an irradiation device 10 having a second optical fiber 60 from the vagina V into the uterine cervix U 12 to 36 hours after the intravenous administration, a step of inflating the balloon 30 provided in the irradiation device 10 so as to follow the shape of the organ, a step of irradiating near-infrared light in a substantially tip direction and / or a substantially vertical direction of the optical fiber 60 by the optical fiber 60, and a step of deflating the balloon 30.

[0056] The treatment method configured as described above inserts the irradiation device 10 into the narrow cervix U, inflates the balloon 30, and irradiates near-infrared light in the tip direction and / or the vertical direction. Therefore, near-infrared light can be effectively irradiated to the cervical cancer in a wide range of the cervix U. For this reason, this treatment method can effectively irradiate near-infrared light to the antibody-photosensitive substance bound to the cell membrane of the cancer cells C in the cervix U. This treatment method is effective not only in the early stage where the cancer cells C are localized in the cervix but also in stages IIA and IIIA where the cancer cells C infiltrate the vaginal wall.

[0057] In addition, in the step of inflating the balloon 30 which is a deformed part, in the treatment method, a part of the balloon 30 may be inflated so as to follow the shape of the uterovaginal part UV on the proximal side of the external os O. The tip of the balloon 30 may be located in the cervix U or in the uterine cavity UC. Thereby, this treatment method can effectively irradiate near-infrared light to the antibody-photosensitive substance bound to the cell membrane of the cancer cells in the cervix U including the uterovaginal part UV and the tissues and organs infiltrated downward from the cervix U.

[0058] In addition, in the step of inflating the balloon 30 which is a deformed part, in the treatment method, the proximal end part of the balloon 30 may be inflated so as to follow the shape of the uterovaginal part UV on the proximal side of the external os O, and the tip part of the balloon 30 may be inflated so as to follow the shape of the uterine cavity UC on the distal side of the internal os I. Thereby, this treatment method can effectively irradiate near-infrared light to the antibody-photosensitive substance bound to the cell membrane of the cancer cells in the cervix U and the tissues and organs infiltrated in the vertical direction from the cervix U.

[0059] 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. For example, as in the first modification example of the irradiation device 10 shown in Fig. 7(A), the irradiation part 61 of the optical fiber 60 may be arranged on the outer surface side of the balloon 30 instead of inside the balloon 30. The optical fiber 60 may be one or two or more. Thereby, since the distance from the irradiation part 61 to the cancer cell C can be shortened, the loss of light energy can be reduced, and near-infrared light can effectively reach the cancer cell C. Note that the optical fiber 60 has no stretchability unlike the balloon 30. Therefore, as shown in Fig. 7(B), it is preferable that the optical fiber 60 is, for example, meandered or coiled so as to be deformable following the expandable and contractible balloon 30.

[0060] Also, for example, as in the second modification example of the irradiation device 10 shown in Fig. 8(A), the deforming part may be at least one wire 31 instead of the balloon 30. The tip of the wire 31 is fixed to the inner tube 22, and the base end of the wire 31 is fixed to the outer tube 21. In the second modification example, the inner tube 22 and the outer tube 21 are relatively movable in the axial direction. Therefore, by bringing the tip of the inner tube 22 and the tip of the outer tube 21 closer to each other in the axial direction, each wire 31 receives a compressive force and can be deformed to protrude outward in the radial direction as shown in Fig. 8(B). And the irradiation part 61 of the optical fiber 60 is arranged on the outer surface of each wire 31. Therefore, since the distance from the irradiation part 61 to the cancer cell C can be shortened, the loss of light energy can be reduced, and near-infrared light can effectively reach the cancer cell C.

[0061] Further, for example, as in the third modification of the irradiation device 10 shown in FIG. 9(A), the deformable part is the balloon 30, and the optical fiber 60 may have an inner optical fiber 62 disposed inside the balloon 30 and an outer optical fiber 63 disposed on the outer surface of the balloon 30. The inner optical fiber 62 irradiates near-infrared light, for example, in a substantially tip direction. The outer optical fiber 63 irradiates near-infrared light in a range including a direction perpendicular to the axis of the outer optical fiber 63 and the tip direction. Thereby, since the distance from the irradiation portion 61 of the outer optical fiber 63 to the cancer cell C can be shortened, the loss of light energy can be reduced, and the near-infrared light can effectively reach the cancer cell C. Also, in the tip direction, it can be effectively irradiated by the inner optical fiber 62. Note that, unlike the balloon 30, the outer optical fiber 63 has no stretchability. Therefore, as shown in FIG. 9(B), it is preferable that the outer optical fiber 63 is, for example, meandered or coiled so as to be deformable following the stretching and contracting balloon 30.

[0062] This application is based on Japanese Patent Application No. 2019-180489 filed on September 30, 2019, the disclosure of which is incorporated herein by reference in its entirety.

Explanation of Reference Numerals

[0063] 10 Irradiation device 30 Balloon (deformable part) 31 Wire (deformable part) 50 Position confirmation marker 60 Optical fiber 61 Irradiation portion 62 Inner optical fiber 63 Outer optical fiber C Cancer cell CC Cervix uteri I Internal os uteri O External os uteri UA Uterine artery U Cervix UC Uterine cavity UV Vaginal portion of uterus V Vagina

Claims

Claim 1 An irradiation device, comprising: a long shaft portion; an expandable balloon provided at a tip of the shaft portion; an optical fiber having a tip end and a base end; an irradiation portion provided at the tip of the optical fiber and disposed inside the balloon for irradiating light; and the irradiation portion is capable of irradiating light in a direction substantially perpendicular to the axis of the optical fiber and in a substantially tip direction parallel to the axis from the base end to the tip end of the optical fiber; the shaft portion includes an outer tube that is a tubular body and an inner tube disposed inside the outer tube; An irradiation device, characterized in that an expansion lumen through which an expansion fluid for expanding the balloon flows is formed between the outer tube and the inner tube. Claim 2 The irradiation device according to claim 1, wherein the irradiation portion is capable of irradiating light in a contracted state and an expanded state of the balloon. Claim 3 The irradiation device according to claim 1 or 2, characterized in that the inside of the balloon has an X-ray impermeable position confirmation marker. Claim 4 The irradiation device according to claim 3, wherein the position confirmation marker has a structure that stores light, a structure that emits fluorescence, or a structure that transmits light.

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