US-12616846-B2 - Treatment apparatus and treatment method

Abstract

A treatment apparatus and a treatment method capable of effectively treating cancer including a cervix. The treatment apparatus includes: a main shaft including a distal portion and a proximal portion; an inflation portion disposed on a distal side of the main shaft and configured to be inflated by inflowing a fluid; a distal shaft protruding from the inflation portion toward the distal side; and at least one irradiation unit configured to emit excitation light of an antibody-photosensitive substance from the distal shaft and the inflation portion.

Inventors

• Satoru Suehara
• Mayu Hata

Assignees

• TERUMO KABUSHIKI KAISHA

Dates

Publication Date

20260505

Application Date

20220913

Priority Date

20200330

Claims (20)

1. 1 . A treatment apparatus configured to irradiate an antibody-photosensitive substance bound to a tumor cell with excitation light, the treatment apparatus comprising: a main shaft including a distal end portion and a proximal end portion; an inflation portion disposed distal of the main shaft and configured to be inflated by inflowing a fluid, a proximal end portion of the inflation portion is fixed to the distal end portion of the main shaft; an irradiation shaft accommodated in the main shaft, the irradiation shaft protruding from the distal end portion of the main shaft, passing through an inside of the inflation portion and extending beyond a distal end of the inflation portion so as to form a distal shaft that is a portion of the irradiation shaft protruding from the distal end of the inflation portion; at least one irradiation unit including a light-emitting unit at a distal portion of the irradiation unit, the light-emitting unit configured to emit outward the excitation light of the antibody-photosensitive substance; wherein the irradiation shaft includes an irradiation lumen that is closed at a most distal end of the irradiation shafter and opened at a most proximal end of the irradiation shaft, the irradiation lumen passing through the inside of the inflation portion to an inside of the distal shaft and configured to movably accommodate the irradiation unit; an insertion port for receiving the irradiation unit into the irradiation lumen is disposed on a proximal side of the irradiation shaft; the distal shaft includes the most distal end of the irradiation shaft, which closes a distal end of the irradiation lumen and protrudes distally relative to the distal end of the inflation portion by a predetermined protrusion length in a range of 10 mm to 50 mm; wherein an outer diameter of the distal shaft is smaller than a maximum outer diameter of the inflation portion when being inflated the inflation portion; and wherein the light-emitting unit of the irradiation unit is configured to be disposed in a first portion of the irradiation lumen disposed on the inside of the inflation portion and a second portion of the irradiation lumen disposed on the inside of the distal shaft, so as to emit the excitation light of the antibody-photosensitive substance from the inflation portion and the distal shaft.
2. 2 . The treatment apparatus according to claim 1 , wherein the distal shaft is configured to emit the excitation light in a direction substantially perpendicular to an axial center of the distal shaft; and the inflation portion is configured to emit the excitation light in a substantially distal direction.
3. 3 . The treatment apparatus according to claim 1 , wherein the inflation portion has an abutment surface facing the distal side of the inflation portion in an inflated state of the inflation portion; and the abutment surface has a portion that is separated from an axial center of the distal shaft and that partially protrudes toward the distal side.
4. 4 . The treatment apparatus according to claim 1 , further comprising: an annular reinforcement portion disposed on a distal side of the inflation portion and surrounding a proximal portion of the distal shaft.
5. 5 . The treatment apparatus according to claim 1 , wherein the inflation portion is configured to move relative to the main shaft in an axial center direction of the main shaft.
6. 6 . The treatment apparatus according to claim 1 , wherein the light-emitting unit of the irradiation unit is configured to move from the first portion of the irradiation lumen to the second portion of the irradiation lumen.
7. 7 . The treatment apparatus according to claim 1 , wherein the distal shaft includes a bent portion such that an axial center of a distal portion of the distal shaft is bent at an angle of less than 90° with respect to an axial center of a proximal portion of the distal shaft.
8. 8 . A treatment method, comprising: intravenously administering an antibody-photosensitive substance; inserting a treatment apparatus into a living body after 12 hours to 36 hours from the intravenous administration of the antibody-photosensitive substance, the treatment apparatus including a main shaft including a distal end portion and a proximal end portion, an inflation portion disposed distal of the main shaft and configured to be inflated by inflowing a fluid, a proximal end portion of the inflation portion is fixed to the distal end portion of the main shaft, an irradiation shaft accommodated in the main shaft, the irradiation shaft protruding from the distal end portion of the main shaft, passing through an inside of the inflation portion and extending beyond a distal end of the inflation portion so as to form a distal shaft that is a portion of the irradiation shaft protruding from the distal end of the inflation portion, and at least one irradiation unit including a light-emitting unit at a distal portion of the irradiation unit, the light-emitting unit configured to emit outward the excitation light of the antibody-photosensitive substance, and wherein the irradiation shaft includes an irradiation lumen that is closed at a most distal end of the irradiation shaft and opened at a most proximal end of the irradiation shaft, the irradiation lumen passing through the inside of the inflation portion to an inside of the distal shaft and configured to movably accommodate the irradiation unit, an insertion port for receiving the irradiation unit into the irradiation lumen is disposed on a proximal side of the irradiation shaft, the distal shaft includes the most distal end of the irradiation shaft, which closes a distal end of the irradiation lumen and protrudes distally relative to the distal end of the inflation portion by a predetermined protrusion length in a range of 10 mm to 50 mm, wherein an outer diameter of the distal shaft is smaller than a maximum outer diameter of the inflation portion when being inflated the inflation portion, wherein the light-emitting unit of the irradiation unit is configured to be disposed in a first portion of the irradiation lumen disposed on the inside of the inflation portion and a second portion of the irradiation lumen disposed on the inside of the distal shaft, so as to emit the excitation light of the antibody-photosensitive substance from the inflation portion and the distal shaft; inserting the distal shaft into a body lumen; inflating the inflation portion in the living body; emitting the excitation light from the distal shaft to a surrounding tissue; emitting the excitation light from the inflation portion to the surrounding tissue; and deflating the inflation portion.
9. 9 . The treatment method according to claim 8 , further comprising: simultaneously performing the emitting of the excitation light from the distal shaft and the emitting of the excitation light from the inflation portion.
10. 10 . The treatment method according to claim 8 , wherein the body lumen is a cervical canal, and wherein in the inserting of the distal shaft into the cervical canal, the method further comprises: abutting an abutment surface against a uterine vagina, the abutment surface being disposed on a proximal side of the distal shaft, the distal shaft extending from the abutment surface and the abutment surface facing a distal side of the distal shaft.
11. 11 . The treatment method according to claim 8 , further comprising: detecting fluorescence emitted by the antibody-photosensitive substance and checking an intensity of the fluorescence.
12. 12 . The treatment method according to claim 8 , wherein the living body is a vagina of a patient, and the body lumen is a cervical canal of the patient.
13. 13 . The treatment method according to claim 8 , further comprising: treating the surrounding tissue for cervical cancer.
14. 14 . The treatment method according to claim 8 , further comprising: moving the light-emitting unit of the irradiation unit from the first portion of the irradiation lumen to the second portion of the irradiation lumen.
15. 15 . The treatment method according to claim 8 , wherein the distal shaft includes a bent portion such that an axial center of a distal portion of the distal shaft is bent at an angle of less than 90° with respect to an axial center of a proximal portion of the distal shaft.
16. 16 . A treatment method comprising: intravenously administering an antibody-photosensitive substance; inserting a treatment apparatus into a living body after the intravenous administration of the antibody-photosensitive substance, the treatment apparatus including a main shaft including a distal end portion and a proximal end portion, an inflation portion disposed distal of the main shaft and configured to be inflated by inflowing a fluid, a proximal end portion of the inflation portion is fixed to the distal end portion of the main shaft, an irradiation shaft accommodated in the main shaft, the irradiation shaft protruding from the distal end portion of the main shaft, passing through an inside of the inflation portion and extending beyond a distal end of the inflation portion so as to form a distal shaft that is a portion of the irradiation shaft protruding from the distal end of the inflation portion, and at least one irradiation unit including a light-emitting unit at a distal portion of the irradiation unit, the light-emitting unit configured to emit outward the excitation light of the antibody-photosensitive substance, and wherein the irradiation shaft includes an irradiation lumen that is closed at a most distal end of the irradiation shaft and opened at a most proximal end of the irradiation shaft, the irradiation lumen passing through the inside of the inflation portion to an inside of the distal shaft and configured to movably accommodate the irradiation unit, an insertion port for receiving the irradiation unit into the irradiation lumen is disposed on a proximal side of the irradiation shaft, the distal shaft includes the most distal end of the irradiation shaft, which closes a distal end of the irradiation lumen and protrudes distally relative to the distal end of the inflation portion by a predetermined protrusion length in a range of 10 mm to 50 mm, wherein an outer diameter of the distal shaft is smaller than a maximum outer diameter of the inflation portion when being inflated the inflation portion, wherein the light-emitting unit of the irradiation unit is configured to be disposed in a first portion of the irradiation lumen disposed on the inside of the inflation portion and a second portion of the irradiation lumen disposed on the inside of the distal shaft, so as to emit the excitation light of the antibody-photosensitive substance from the inflation portion and the distal shaft; inserting the distal shaft into a body lumen; inflating the inflation portion in the living body; and emitting the excitation light from the distal shaft and the inflation portion to surrounding tissue.
17. 17 . The treatment method according to claim 16 , further comprising: simultaneously performing the emitting of the excitation light from the distal shaft and the emitting of the excitation light from the inflation portion.
18. 18 . The treatment method according to claim 16 , further comprising: detecting fluorescence emitted by the antibody-photosensitive substance and checking an intensity of the fluorescence.
19. 19 . The treatment method according to claim 16 , further comprising: moving the light-emitting unit of the irradiation unit from the first portion of the irradiation lumen to the second portion of the irradiation lumen.
20. 20 . The treatment method according to claim 16 , wherein the distal shaft includes a bent portion such that an axial center of a distal portion of the distal shaft is bent at an angle of less than 90° with respect to an axial center of a proximal portion of the distal shaft.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS This application is a continuation of International Application No. PCT/JP2021/009428 filed on Mar. 10, 2021, which claims priority to Japanese Application No. 2020-060400 filed on Mar. 30, 2020, the entire content of both of which is incorporated herein by reference. TECHNOLOGICAL FIELD The present disclosure generally relates to a treatment apparatus and a treatment method for cervical cancer and vaginal cancer. BACKGROUND DISCUSSION The number of patients with cervical cancer has an increasing tendency, and in particular, the number of young female patients in their 20s and 30s is increasing. In current treatments for cervical cancer, treatment can include removing an entire uterus from an early stage (stage I). However, for young patients, local treatment is required to conserve the uterus in order to maintain fertility. Further, in an advanced stage (stage III and subsequent stages), when cancer has spread to surrounding tissues, it is difficult to remove by surgery, and thus treatment can include combining radiation therapy and chemotherapy. However, a five-year survival rate is as low as 50% in stage III and 20% in stage IV, and more effective treatment is required. As the local treatment for cancer, a treatment method using a photoreactive substance is known (for example, see United States Patent Application Publication No. 2018/0113246). In particular, 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 a tumor with excitation light (for example, near-infrared rays), and is expected to achieve a relatively high treatment effect while minimizing side effects. Meanwhile, in order to achieve a high treatment effect by the antibody-photosensitive substance, the antibody-photosensitive substance accumulated in the tumor is required to be reliably irradiated with the near-infrared rays. However, since light is rapidly attenuated due to an influence of a biological tissue, the near-infrared rays have a relatively small penetration depth, and it can be extremely difficult to non-invasively irradiate a solid cancer with light having energy required for treatment from a body surface. Therefore, a method for reliably irradiating the tumor in a body with light while reducing invasiveness as much as possible is required. In the case of cervical cancer, cancer often spreads over a wide area of a cervical canal, and a method for irradiating cancer in a wide range with light from as close as possible is required. SUMMARY A treatment apparatus and a treatment method capable of effectively treating cancer in a range including at least a part of a cervix. A treatment apparatus is disclosed, which is configured to irradiate an antibody-photosensitive substance bound to a tumor cell of cervical cancer with excitation light. The treatment apparatus includes: a main shaft including a distal portion and a proximal portion; an inflation portion disposed on a distal side of the main shaft and configured to be inflated by inflowing a fluid; a distal shaft protruding from the inflation portion toward the distal side; and at least one irradiation unit configured to emit the excitation light of the antibody-photosensitive substance from the distal shaft and the inflation portion. According to the treatment apparatus described above, the excitation light can be effectively emitted to the antibody-photosensitive substance bound to the tumor cell in a wide range including a cervix in a state in which the distal shaft is inserted into a cervical canal and the inflation portion is inflated in a vagina. Therefore, this treatment apparatus can improve a treatment effect of cancer in a relatively wide range including the cervix. The distal shaft may emit the excitation light in a direction substantially perpendicular to an axial center of the distal shaft, and the inflation portion may emit the excitation light in a substantially distal direction. Accordingly, the excitation light can be emitted to the tumor cell of the cervix from both the distal shaft and the inflation portion, and thus the treatment effect can be improved. The treatment apparatus may be formed with an irradiation lumen communicating with an inside of the inflation portion and an inside of the distal shaft and configured to movably accommodate the irradiation unit. Accordingly, even if only one irradiation unit is provided, the excitation light can be emitted from the distal shaft and the inflation portion, and thus a configuration of the treatment apparatus can be simplified and operability can be improved. By moving the irradiation unit, a position where the excitation light is emitted can be appropriately adjusted, and thus the treatment effect can be improved. The number of the irradiation unit is not limited to one. The inf