Intravaginal insertion devices and medical instruments

Abstract

To provide: a virginal insertion device for easily and visually recognizing operation of pushing a distal end against the vicinity of an uterine opening through a virginal opening; a medical device; and a treatment method.SOLUTION: According to the embodiment, a virginal insertion device includes: a light irradiation member that can be inserted into a vagina and can irradiate light to the outside; and an abutment member capable of abutting a vicinity of an uterine opening on a distal side of the light irradiation member in the vagina. The light irradiation member defines a through path that penetrates from a proximal end side to a distal end side, the abutment member includes: a shaft part inserted into the through path relatively movably along the through path with respect with the light irradiation member; and a distal abutment part continuous to a distal end of the shaft part. Therein, a maximum diameter of the distal abutment part is larger than a maximum diameter of the shaft part.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to intravaginal insertion devices, medical instruments, and treatment methods.

Background Art

[0002] Phototherapy is known in which a target cell is killed by irradiating light to activate a photosensitive substance. Patent Document 1 discloses a guiding catheter used for this type of phototherapy in blood vessels.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] In phototherapy, it is desirable not to irradiate light to normal tissues as much as possible. Therefore, when irradiating light from the vagina to a target site such as abnormal tissue, it is desirable to place an intravaginal insertion device at an appropriate position in the vagina. To place the intravaginal insertion device at an appropriate position in the vagina, the distal end of the intravaginal insertion device may be positioned by abutting it around the cervical os. However, in a state where the intravaginal insertion device is inserted into the vagina, it may be difficult to visually recognize the position of the distal end of the intravaginal insertion device and the position of the cervical os through the vaginal orifice.

[0005] An object of the present disclosure is to provide an intravaginal insertion device, a medical instrument, and a treatment method in which an operation of abutting the distal end around the cervical os is easily visible through the vaginal orifice.

Means for Solving the Problems

[0006] A vaginal insertion device according to a first aspect of the present disclosure comprises a light-emitting member that can be inserted into the vagina and emit light externally, and a buttock member that can be abutted against the cervix distal to the light-emitting member within the vagina, wherein the light-emitting member defines a through passage that penetrates from the proximal end to the distal end, and the buttock member comprises a shaft portion inserted through the through passage and movable relative to the light-emitting member along the through passage, and a distal buttock portion connected to the distal end of the shaft portion, wherein the maximum diameter of the distal buttock portion is greater than the maximum diameter of the shaft portion.

[0007] In one embodiment of the present disclosure, the maximum diameter of the distal abutment portion is greater than the maximum diameter of the distal opening of the through passage.

[0008] In one embodiment of the present disclosure, the distal abutment portion is a disc plate portion arranged substantially coaxially with the shaft portion, and the distal surface of the disc plate portion is configured as a curved convex surface projecting distally.

[0009] In one embodiment of the present disclosure, the shaft portion of the abutment member defines an insertion path into which a light-emitting element can be inserted, and the light-irradiating member includes a light-transmitting window that can transmit light from the light-emitting element inserted into the insertion path of the shaft portion.

[0010] In one embodiment of the present disclosure, the light-irradiating member comprises a balloon that can be expanded within the vagina, and the light-transmitting window is provided in the balloon.

[0011] In one embodiment of the present disclosure, the light irradiation member includes a display unit that indicates the state in which the light irradiation member has been moved to the most distal side relative to the abutment member.

[0012] In one embodiment of the present disclosure, the distal abutment portion of the abutment member is configured to propagate light toward the distal side.

[0013] In one embodiment of the present disclosure, the distal abutment portion of the abutment member is configured to propagate light to the distal side by utilizing at least one of light transmission, scattering, and reflection.

[0014] A medical device in a second aspect of the present disclosure comprises the intravaginal insertion device and a holding device that independently holds the light-emitting member and the abutment member of the intravaginal insertion device in an axial direction along the central axis of the through passage.

[0015] In one embodiment of the present disclosure, the holding device includes a movement restricting unit that restricts the relative movement of the abutment member in the axial direction.

[0016] In one embodiment of the present disclosure, at least one of the holding device and the light-emitting member of the intravaginal insertion device is provided with an axial movement amount display unit that displays the amount of axial movement of the light-emitting portion due to the relative axial movement of the light-emitting member of the intravaginal insertion device with respect to the holding device.

[0017] In one embodiment of the present disclosure, at least one of the holding device and the abutment member of the intravaginal insertion device is provided with an axial position indicator that displays the relative positional relationship with the other in the axial direction.

[0018] In one embodiment of the present disclosure, the light-emitting member of the intravaginal insertion device is capable of emitting light to the outside at a position in the circumferential direction of a portion of the through passage's central axis, and the holding device holds the light-emitting member so as to be rotatable in the circumferential direction.

[0019] A third aspect of the present disclosure is a treatment method using an intravaginal insertion device, the intravaginal insertion device comprising: a light-emitting member that can be inserted into the vagina and emits light to the outside; and a buttock member that can be abutted against the periphery of the cervix distal to the light-emitting member within the vagina, wherein the light-emitting member has a through passage that penetrates from the proximal end to the distal end, the buttock member is inserted through the through passage and is movable relative to the light-emitting member along the through passage, and the abutment step includes inserting the abutment member into the vagina by making the abutment member protrude distal to the emitting member and abutting the distal end of the abutment member against the periphery of the cervix, and inserting the light-emitting member into the vagina by moving the light-emitting member relative to the distal end of the abutment member while the distal end of the abutment member is abutting against the periphery of the cervix.

[0020] In one embodiment of the present disclosure, the light irradiation member insertion step is performed by moving the light irradiation member to a position that is furthest distal to the abutment member.

[0021] In one embodiment of the present disclosure, the light irradiation member includes a display unit that indicates the state in which the light irradiation member has been moved to the most distal side relative to the abutment member, and in the light irradiation member insertion step, the display unit is used to move the light irradiation member to the most distal side relative to the abutment member.

[0022] In one embodiment of the present disclosure, the light-emitting member of the intravaginal insertion device includes a light-emitting section capable of emitting light to the outside at a position in the circumferential direction of a portion of the central axis of the through passage, and includes an alignment step of rotating the light-emitting member in the circumferential direction to align the circumferential position of the light-emitting section with the target area for light irradiation inside the vagina.

[0023] As one embodiment of the present disclosure, the abutting member defines an insertion path into which a light emitter can be inserted. The light emitter is inserted into the insertion path, and a light irradiation step of irradiating a target site with light from the light emitter through the light irradiation unit is included.

Advantages of the Invention

[0024] According to the present disclosure, it is possible to provide a vaginal insertion device, a medical instrument, and a treatment method that allow an operation of abutting a distal end portion around the uterine os to be easily visually recognized through the vaginal orifice.

Brief Description of the Drawings

[0025] [Figure 1] It is a diagram showing a vaginal insertion device as one embodiment of the present disclosure. [Figure 2] It is a diagram showing a state in which a light irradiation member and an abutting member are relatively moved in an axial direction in the vaginal insertion device shown in FIG. 1. [Figure 3A] It is a diagram showing an abutting step in an exemplary treatment method using the vaginal insertion device shown in FIG. 1 as an example. <00001​​​​​​​​​​​​​​​​​​Figure 1 shows an example of a treatment method using a medical device as one embodiment of the present disclosure, which includes the intravaginal insertion device shown in Figure 1. The method involves moving the light-irradiating member of the intravaginal insertion device axially to perform light irradiation in two stages, and the figure shows the state during the first light irradiation. [Figure 5B] This figure shows the state after the light-irradiating element has moved proximal to the side, compared to the state shown in Figure 5A. [Figure 5C] This figure shows the state after the second light irradiation, where only the light-emitting element has moved proximal to the other side, compared to the state in Figure 5B. [Figure 6A] Figure 5A shows a view of the medical device holding device from above. [Figure 6B] Figures 5B and 5C show a view of the medical device holding device from above. [Figure 7A] This figure shows another example of a treatment method in which a medical device, as an embodiment of the present disclosure, including the intravaginal insertion device shown in Figure 1, is used to perform light irradiation in two stages by moving the light irradiation member of the intravaginal insertion device in the axial direction, and the figure shows the state during the first light irradiation. [Figure 7B] This figure shows the state after the light-irradiating member, abutment member, and light-emitting element have all moved to the proximal side, compared to the state shown in Figure 7A. [Figure 7C] This figure shows the state during the second light irradiation, where, starting from the state in Figure 7B, only the abutment member has moved distally, and the distal end of the abutment member has once again abutted against the area around the cervix. [Modes for carrying out the invention]

[0026] Hereinafter, embodiments of the intravaginal insertion device, medical instrument, and treatment method relating to this disclosure will be illustrated with reference to the drawings. In each figure, identical components are denoted by the same reference numerals.

[0027] Figures 1 and 2 show a vaginal insertion device 1 as one embodiment of the vaginal insertion device according to this disclosure. As shown in Figures 1 and 2, the vaginal insertion device 1 comprises a light irradiation member 2 and a stopper member 3. In Figures 1 and 2, the relative positions of the light irradiation member 2 and the stopper member 3 of the vaginal insertion device 1 are different. The details of this will be described later.

[0028] The intravaginal device 1 can be used, for example, for photodynamic therapy (PDT) and photoimmunotherapy (PIT). More specifically, the intravaginal device 1 is inserted into the vagina and used to irradiate abnormal tissue, such as cancerous tissue, with light from within the vagina. As will be described in detail later, an optical fiber 200a, which serves as a light-emitting element 200, can be inserted into the intravaginal device 1 of this embodiment (see Figure 3D). In the intravaginal device 1 of this embodiment, the inserted optical fiber 200a is used to irradiate abnormal tissue with light and perform phototherapy.

[0029] The light-emitting member 2 is insertable into the vagina and can emit light externally. The light-emitting member 2 also has a through passage 2a that penetrates from the proximal end to the distal end. For the sake of explanation, the direction along the central axis O of the through passage 2a of the light-emitting member 2 will be referred to as "axial direction A of the vaginal insertion device 1" or simply "axial direction A". The direction around the central axis O of the through passage 2a of the light-emitting member 2 will be referred to as "circumferential direction B of the vaginal insertion device 1" or simply "circumferential direction B". Furthermore, the radial direction of the circle around the central axis O of the through passage 2a of the light-emitting member 2 will be referred to as "radial direction C of the vaginal insertion device 1" or simply "radial direction C".

[0030] The abutment member 3 can be abutted against the area around the cervix distal to the light-emitting member 2 inside the vagina. More specifically, the abutment member 3 comprises a shaft portion 4 and a distal abutment portion 5. The shaft portion 4 is inserted through the through passage 2a and is movable relative to the light-emitting member 2 along the through passage 2a. In other words, the shaft portion 4 is movable relative to the light-emitting member 2 in the axial direction A. The distal abutment portion 5 is connected to the distal end of the shaft portion 4.

[0031] As will be described in detail later, the shaft portion 4 of the stopper member 3 in this embodiment defines an insertion path 4a into which a light-emitting element 200 such as an optical fiber 200a can be inserted. The light-irradiating member 2 in this embodiment is provided with a light-transmitting window 12a that serves as a light-irradiating section 12 through which light from the light-emitting element 200 inserted into the insertion path 4a of the shaft portion 4 of the stopper member 3 can pass.

[0032] Furthermore, as will be described in detail later, the light-emitting member 2 of this embodiment has an insertion portion 11 at its distal end that is inserted into the vagina. The insertion portion 11 of this embodiment has a balloon 13 that can be expanded inside the vagina. The light-transmitting window 12a, which serves as the light-emitting part 12 of this embodiment, is provided in this balloon 13. The light-transmitting window 12a, which serves as the light-emitting part 12 of this embodiment, is provided only at a part of the circumferential direction B of the balloon 13.

[0033] Here, the maximum diameter R2 of the distal abutment portion 5 is greater than the maximum diameter R1 of the shaft portion 4.

[0034] The maximum diameter R1 of the shaft portion 4 refers to the maximum value obtained by comparing the maximum straight lengths at any cross-section perpendicular to the axial direction A of the shaft portion 4. In this embodiment, the shaft portion 4 is cylindrical and has a constant outer diameter regardless of its position in the axial direction A. Therefore, the maximum diameter R1 of the shaft portion 4 in this embodiment is the same as the outer diameter at any position in the axial direction A of the shaft portion 4.

[0035] Furthermore, the maximum diameter R2 of the distal abutment portion 5 refers to the maximum value obtained by comparing the maximum linear lengths in each arbitrary cross-section perpendicular to the axial direction A of the distal abutment portion 5. The outer shape of the cross-section of the distal abutment portion 5 at any position in the axial direction A of this embodiment is substantially circular. Therefore, the maximum linear length in each arbitrary cross-section perpendicular to the axial direction A of the distal abutment portion 5 of this embodiment refers to the outer diameter of each cross-section. Also, the outer diameter of the cross-section perpendicular to the axial direction A of the distal abutment portion 5 of this embodiment is maximum at the proximal end. Therefore, the maximum diameter R2 of the distal abutment portion 5 of this embodiment refers to the outer diameter in the cross-section perpendicular to the axial direction A at the position of the proximal end of the distal abutment portion 5.

[0036] As will be explained in more detail later, in the intravaginal insertion device 1, by making the maximum diameter R2 of the distal abutment portion 5 larger than the maximum diameter R1 of the shaft portion 4, the operation of abutting the distal abutment portion 5, which is the distal end of the intravaginal insertion device 1, against the area around the cervix 300 becomes easier to see through the vaginal opening 500 (see Figure 3A).

[0037] Next, an example of a treatment method using the intravaginal insertion device 1 will be explained with reference to Figures 3A to 3D.

[0038] First, an overview of an example of a treatment method including the steps shown in Figures 3A to 3D will be described. In this treatment method, a photosensitive substance is first administered to the patient as a drug, and the photosensitive substance accumulates in the target site X, such as cancerous tissue, which is the target site for light irradiation. Then, the patient is given local or general anesthesia as needed. After that, a vaginal speculum 70 (see Figure 3A, etc.) is used to confirm the position of the target site X inside the vagina 400 from the vaginal opening. Then, the abutment member 3 of the intravaginal insertion device 1 is inserted into the vagina 400 ahead of the light irradiation member 2 (see Figure 3A). The distal abutment portion 5, which constitutes the distal end of the abutment member 3, is inserted into the vagina 400 until it abuts against the area around the cervix 300 (see Figure 3A).

[0039] Subsequently, while the distal abutment portion 5 is pressed against the periphery of the cervix 300, the light-emitting member 2 is moved distally in the axial direction A and inserted into the vagina 400 (see Figure 3B). In other words, while the distal abutment portion 5 is pressed against the periphery of the cervix 300, the light-emitting member 2 is moved relative to the abutment member 3 toward the distal abutment portion 5, which is the distal end of the abutment member 3. In this way, the light-emitting member 2 is inserted into the vagina 400. The insertion portion 11 of the light-emitting member 2 in this embodiment that is inserted into the vagina 400 is equipped with a balloon 13 as described above. When the insertion portion 11 is inserted into the vagina 400, the balloon 13 is in a deflated state. The light-emitting member 2 is inserted into the vagina 400 until its distal end abuts against the distal abutment portion 5 of the abutment member 3 (see Figure 3B). The distal end of the light-emitting member 2 in this embodiment is the distal end of the insertion portion 11.

[0040] Subsequently, the vaginal insertion device 1 may be rotated in the circumferential direction B while confirming its position within the vagina 400 using an imaging diagnostic device such as an ultrasound. In this way, the position of the light irradiation part 12 of the insertion part 11 of the light irradiation member 2 in the circumferential direction B can be aligned with the target area X for light irradiation within the vagina 400.

[0041] Subsequently, the speculum 70 is withdrawn from the vagina 400. Then, the balloon 13 of the insertion portion 11 of the light irradiation member 2 is expanded from a contracted state to an expanded state (see Figure 3C). However, the speculum 70 may be withdrawn from the vagina 400 after the balloon 13 of the insertion portion 11 has been expanded. Then, from the proximal end side of the intravaginal insertion device 1, the optical fiber 200a, which serves as the light emitter 200, is inserted into the insertion path 4a of the shaft portion 4 of the stopper member 3 (see Figure 3D). The light emitter 200a1 of the optical fiber 200a is inserted to the position where the balloon 13 is located in the axial direction A. Then, the target area X is irradiated with light by the optical fiber 200a through the peripheral wall of the shaft portion 4 and the light-transmitting window 12a, which serves as the light irradiation portion 12 provided in the balloon 13 (see Figure 3D).

[0042] For example, if the area of ​​the target site X is large, the light irradiation member 2 of the vaginal insertion device 1 may be moved axially A or rotated circumferentially B to irradiate light at multiple locations. For example, by moving the light irradiation member 2 of the vaginal insertion device 1 axially A, the target site X may be irradiated with light in multiple stages along the axial direction A. Alternatively, by rotating the light irradiation member 2 of the vaginal insertion device 1 circumferentially B, the target site X may be irradiated with light in multiple stages along the circumferential direction B. Furthermore, a combination of axial movement A and circumferential rotation B of the light irradiation member 2 of the vaginal insertion device 1 may be used. After the light irradiation of the target site X is complete, the light irradiation member 2 and the stopper member 3 of the vaginal insertion device 1 are withdrawn from the vagina 400. It is desirable that the balloon 13 be in a contracted state during insertion and withdrawal, in an expanded state during light irradiation, and in a contracted state or slightly contracted state from the expanded state when the light irradiation member 12 moves within the vagina 400.

[0043] Figure 3A shows the abutting step, which is part of the series of steps described above. In the abutting step, the abutting member 3 is made to protrude distally from the light irradiation member 2, and the abutting member 3 is inserted into the vagina 400, and the distal abutting portion 5, which is the distal end of the abutting member 3, is abutted against the area around the cervix 300. As described above, in the vaginal insertion device 1, the shaft portion 4 of the abutting member 3 is movable in the axial direction A within the through passage 2a of the light irradiation member 2. Therefore, as shown in Figure 3A, the distal abutting portion 5 of the abutting member 3 can be made to protrude distally from the distal opening 2a1 of the through passage 2a of the light irradiation member 2. This allows the abutting member 3 to be inserted into the vagina 400 ahead of the light irradiation member 2.

[0044] As described above, the maximum diameter R2 of the distal abutment portion 5 is larger than the maximum diameter R1 of the shaft portion 4. With this configuration, compared to a configuration where the maximum diameter of the distal abutment portion 5 is less than or equal to the maximum diameter of the shaft portion 4, a wider distal end surface of the distal abutment portion 5, which constitutes the distal end surface of the intravaginal insertion device 1 that abuts against the cervix 300, can be secured in the abutment process shown in Figure 3A. Therefore, the distal end surface of the distal abutment portion 5 can be stably abutted against the cervix 300. In addition, the burden on the tissues surrounding the cervix 300 when the distal end surface of the distal abutment portion 5 abuts against it can be reduced. Furthermore, if a wider distal end surface of the distal abutment portion 5 is secured, the shape of the inside of the vagina can be adjusted while pressing against the cervix. In this way, it becomes easier to insert the light irradiation member 2 into the vagina in the light irradiation member insertion process described later.

[0045] On the other hand, the shaft portion 4 connected to the proximal side of the distal abutment portion 5 can be made thinner. As a result, in the abutment process shown in Figure 3A, the position of the distal abutment portion 5 can be easily seen through the space between the vaginal wall W and the shaft portion 4. In other words, the operation of abutting the distal abutment portion 5, which is the distal end of the intravaginal insertion device 1, against the area around the cervix 300 can be easily seen through the vaginal opening 500.

[0046] Figure 3B shows the light irradiation member insertion step, which is part of the series of steps described above. In the light irradiation member insertion step, the light irradiation member 2 is inserted into the vagina 400 by moving it distally relative to the abutment member 3 while the distal abutment portion 5, which is the distal end of the abutment member 3, is abutting against the area around the cervix 300. Since the light irradiation member 2 can be inserted into the vagina 400 while the distal abutment portion 5 is abutting against an appropriate position around the cervix 300, the light irradiation member 2 is easy to insert into the vagina.

[0047] In the light irradiation member insertion step shown in Figure 3B, it is preferable to move the light irradiation member 2 to the position furthest distal to the abutment member 3 (the position shown in Figure 3B). By doing so, the light irradiation portion 12 of the insertion portion 11 of the light irradiation member 2 can be reliably positioned near the cervix 300. At this time, it is preferable for medical personnel to use the display unit 41, which will be described later. By using the display unit 41, which will be described later, medical personnel can easily confirm whether or not the light irradiation portion 12 is positioned near the cervix 300. Details of the display unit 41 will be described later.

[0048] Figure 3C shows the balloon expansion step, which is part of the series of steps described above. As described above, the insertion portion 11 of the light irradiation member 2 in this embodiment is equipped with a balloon 13 that can be expanded inside the vagina 400. The balloon 13 in this embodiment is also equipped with a light-transmitting window 12a that serves as a light irradiation portion 12. Therefore, in the balloon expansion step shown in Figure 3C, the balloon 13 is expanded inside the vagina 400, and the balloon 13 is brought into close contact with the area around the cervix 300, the vaginal wall W, etc.

[0049] Furthermore, as described above, the light-emitting member 2 of the vaginal insertion device 1 of this embodiment is equipped with a light-transmitting window 12a that serves as a light-emitting section 12 capable of emitting light to the outside, at only a portion of the position in the circumferential direction B. Therefore, it is preferable to perform an alignment step before expanding the balloon 13, in which the light-emitting member 2 is rotated in the circumferential direction B to align the position of the light-transmitting window 12a, which serves as the light-emitting section 12, with the target area X for light irradiation inside the vagina 400.

[0050] Figure 3D shows the light irradiation step among the series of steps described above. As described above, the shaft portion 4 of the abutment member 3 in this embodiment demarcates an insertion path 4a into which a light-emitting element 200 such as an optical fiber 200a can be inserted. In the light irradiation step, the light-emitting element 200 is inserted into the insertion path 4a, and the target area X is irradiated with light by the light-emitting element 200 through the light-transmitting window 12a, which serves as the light irradiation section 12. In this way, a photochemical reaction is induced in photosensitive substances accumulated in the target area X, such as cancerous tissue, causing cancer cells to degenerate or necrotize. As shown in Figure 3D, since the light-transmitting window 12a, which serves as the light irradiation section 12, is provided on the balloon 13, the balloon 13 can be expanded, and the light-transmitting window 12a, which serves as the light irradiation section 12, can be brought into close contact with the target area X. Therefore, the target area X can be concentrated with light by the optical fiber 200a through the light-transmitting window 12a, which serves as the light irradiation section 12.

[0051] As described above, the location of the target site X for light irradiation may be visually identified in advance using a vaginal speculum 70 (see Figure 3A) before treatment with the intravaginal device 1. Alternatively, the location of the target site X for light irradiation may be identified in advance before treatment with the intravaginal device 1, or continuously from before treatment with the intravaginal device 1 through treatment with the intravaginal device 1. Depending on the location of the target site X, the vaginal speculum 70 may remain in the vagina 400 even during treatment with the intravaginal device 1. In such cases, the location of the target site X may be identified using the vaginal speculum 70 continuously from before treatment with the intravaginal device 1 through treatment with the intravaginal device 1.

[0052] Furthermore, while the light-emitting section 12 of the insertion section 11 of the light-emitting member 2 in this embodiment is a light-transmitting window 12a that can transmit light from a light-emitting body 200 inserted into the insertion section 11, the configuration is not limited to this. The light-emitting section 12 may also be an opening that can pass light from the light-emitting body 200 inserted into the insertion section 11. Moreover, the light-emitting section 12 may include, for example, the light-emitting body itself. In other words, the vaginal insertion device 1 may include a light-emitting section 12 that is a part of the circumferential direction B of the insertion section 11 and can emit light outward in the radial direction C. Conversely, the vaginal insertion device 1 does not have to include the light-emitting body itself. If the vaginal insertion device 1 does not include the light-emitting body 200, as in this embodiment, the vaginal insertion device 1 is used together with a light-emitting body 200 that is separately inserted into the insertion section 11 of the light-emitting member 2. In this embodiment, the optical fiber 200a, which serves as the light-emitting element 200, is inserted into the insertion section 11 of the light-irradiating member 2 and into the insertion path 4a within the shaft section 4 of the abutment member 3.

[0053] Furthermore, although the insertion portion 11 of the light-emitting member 2 in this embodiment is equipped with a balloon 13, it is not limited to this configuration. The insertion portion 11 of the light-emitting member 2 does not need to be equipped with a balloon 13. An insertion portion 11 without a balloon 13 may be, for example, a tube body that has a hollow portion inside into which a light-emitting body 200 can be inserted, and a light-emitting portion 12 provided on a part of its side wall. Thus, the insertion portion 11 does not need to be configured to expand and contract. However, the fact that the insertion portion 11 is equipped with a balloon 13 and the light-emitting portion 12 is formed on the balloon 13 makes it easier to bring the light-emitting portion 12 into close contact with the target area X (see Figures 3A to 3D) inside the vagina 400. This makes it possible to increase the light irradiation efficiency to the target area X.

[0054] Further details of the vaginal insertion device 1 of this embodiment will be described below.

[0055] <Light Irradiation Member 2> The light-emitting member 2 of the vaginal insertion device 1 of this embodiment comprises an insertion portion 11 and an operating portion 14 that is connected to the proximal side of the insertion portion 11 and extends outside the body when the insertion portion 11 is inserted into the vagina 400 (see Figures 3A to 3D).

[0056] More specifically, the light irradiation member 2 of this embodiment comprises a balloon 13, a tubular member 15, and a hub 19. The tubular member 15 extends from the proximal end to the distal end of the light irradiation member 2. The balloon 13 is attached to the distal end of the tubular member 15. The hub 19 is attached to the tubular member 15 and has a port portion 19a to which a fluid supply device can be connected. The insertion portion 11 of this embodiment is composed of the balloon 13 and the distal end of the tubular member 15. The operating portion 14 of this embodiment is composed of the hub 19 and the portion of the tubular member 15 located proximal to the balloon 13. Here, the central axis O of the light irradiation member 2 of this embodiment is the central axis of the tubular member 15. In other words, the axial direction A of the intravaginal insertion device 1 of this embodiment is the same as the direction parallel to the central axis of the tubular member 15. Also, the circumferential direction B of the intravaginal insertion device 1 of this embodiment is the same as the direction around the central axis of the tubular member 15. Furthermore, the radial direction C of the vaginal insertion device 1 in this embodiment is the same as the radial direction of the circle around the central axis of the tubular member 15.

[0057] More specifically, the tubular member 15 has a passage 2a inside through which the shaft portion 4 of the abutment member 3 is inserted. The tubular member 15 also has an inflation lumen 15b that can supply a fluid such as air into the balloon 13. The tubular member 15 of this embodiment comprises an inner tube 16 and an outer tube 17. The inner tube 16 and the outer tube 17 are arranged concentrically. The inner tube 16 protrudes distally to the outer tube 17. The inner tube 16 protrudes proximally to the outer tube 17. Furthermore, the inner tube 16 of this embodiment protrudes proximally to the hub 19 which is connected to the proximal side of the outer tube 17. The passage 2a is defined inside the inner tube 16. The inflation lumen 15b is defined between the inner surface of the outer tube 17 and the outer surface of the inner tube 16.

[0058] In this embodiment, the balloon 13 is formed by a membrane attached to the tubular member 15. Specifically, the membrane forming the balloon 13 is an endless membrane that covers the entire circumferential area B of the distal end of the tubular member 15, radially C outward from the distal end of the tubular member 15. The distal end of this membrane is joined to the distal end of the inner tube 16 by adhesive or the like over the entire circumferential area B. The proximal end of this membrane is joined to the distal end of the outer tube 17 by adhesive or the like over the entire circumferential area B. The space between the distal and proximal ends of the membrane is not joined to the inner tube 16 of the tubular member 15, and an annular space 13a capable of containing fluid is partitioned between the inner tube 16 and the membrane. The distal opening of the inflation lumen 15b partitioned between the inner tube 16 and the outer tube 17 communicates with this annular space 13a. When fluid is supplied to the annular space 13a through the inflation lumen 15b, the membrane forming the balloon 13 expands outward in the radial direction C. Conversely, when fluid is discharged from the annular space 13a through the inflation lumen 15b, the membrane forming the balloon 13 contracts inward in the radial direction C.

[0059] As described above, the shaft portion 4 of the abutment member 3 is inserted through the through passage 2a of the tubular member 15. The optical fiber 200a inserted into the insertion passage 4a of the shaft portion 4 of the abutment member 3 is inserted to a position within the balloon 13 in the axial direction A. The inner tube 16 that demarcates the through passage 2a in this embodiment may be formed of, for example, a transparent resin material that can transmit light. Alternatively, the inner tube 16 may have, for example, an opening that can pass light through.

[0060] The forming material for the inner tube 16 and outer tube 17 of the tubular member 15 is not particularly limited, but may be, for example, a resin material. Examples of resin materials used to form the inner tube 16 and outer tube 17 include: polyethylene, polypropylene, polyolefins such as ethylene-propylene copolymer; ethylene-vinyl acetate copolymer (EVA); polyvinyl chloride; polyvinylidene chloride; polystyrene; polyamide; polyimide; polyamideimide; polycarbonate; poly-(4-methylpentene-1); ionomer; acrylic resin; polymethyl methacrylate; acrylonitrile-butadiene-styrene copolymer (ABS resin); acrylonitrile-styrene copolymer (AS resin); butadiene-styrene copolymer; polyethylene. Examples of resin materials include polyesters such as terephthalate (PET), polybutylene terephthalate (PBT), and polycyclohexane terephthalate (PCT); polyethers; polyether ketones (PEK); polyether ether ketones (PEEK); polyetherimides; polyacetals (POM); polyphenylene oxide; modified polyphenylene oxide; polysulfone; polyether sulfone; polyphenylene sulfide; polyarylate; aromatic polyesters (liquid crystal polymers); polytetrafluoroethylene, polyvinylidene fluoride, and other fluororesins. A blend containing one or more of these materials is also acceptable. Furthermore, the outer tube 17 may be made of metal such as stainless steel, iron, nickel-titanium alloy, or aluminum. By using a metal outer tube 17, improvements in operability can be expected compared to a resin configuration, such as reduced diameter and increased rigidity.

[0061] The tubular member 15 in this embodiment has a double-tube structure comprising an inner tube 16 and an outer tube 17 arranged concentrically, but is not limited to this configuration. The tubular member 15 may, for example, partition a through passage 2a and an inflation lumen 15b that extend linearly in parallel inside it.

[0062] As shown in Figures 1 and 2, the balloon 13 of this embodiment is equipped with a light-transmitting window 12a as a light-irradiating section 12. More specifically, the balloon 13 of this embodiment is equipped with a light-transmitting window 12a only on a part of the circumferential direction B. In other words, the part of the balloon 13 of this embodiment other than the part of the circumferential direction B on which the light-transmitting window 12a is formed is a light-reflecting section 24 that does not transmit light but reflects it. Therefore, the light from the optical fiber 200a that emits light inside the balloon 13 and the inner tube 16 passes through the inner tube 16 and is irradiated toward the outside in the radial direction C of the balloon 13 through the light-transmitting window 12a which is formed only on a part of the circumferential direction B of the balloon 13. Conversely, the light from the optical fiber 200a that has passed through the inner tube 16 and reached the light-reflecting section 24 of the balloon 13 is reflected with almost no transmission and is not irradiated toward the outside in the radial direction C of the balloon 13 at the location of the light-reflecting section 24. Thus, the insertion portion 11 of the light irradiation member 2 in this embodiment includes a light irradiation portion 12 that has a directionality that allows light to be irradiated only in a part of the circumferential direction B toward the outside in the radial direction C.

[0063] The film body constituting the balloon 13 comprises, for example, a light-transmitting layer 18a formed of a light-transmitting material, and a light-reflecting layer 18b formed of a light-reflective material laminated on the light-transmitting layer 18a. Examples of light-transmitting materials include resin materials such as polyethylene terephthalate, polyurethane, and nylon. Examples of light-reflecting materials include various metallic materials such as titanium dioxide, barium sulfate, and zinc oxide. The light-reflecting layer 18b formed of the light-reflecting material may be formed, for example, by coating the surface of the light-transmitting layer 18a described above. The coating method is not particularly limited, and for example, dipping, spray coating, roll coating, screen printing, etc., may be used. The light-transmitting window 12a of the balloon 13 as the light-irradiating part 12 of this embodiment is composed of the portion of the light-transmitting layer 18a where the light-reflecting layer 18b is not laminated. The light-reflecting part 24 of the balloon 13 of this embodiment is composed of the portion where the light-reflecting layer 18b is laminated on the light-transmitting layer 18a described above. However, the configuration of the light-transmitting window 12a and the light-reflecting portion 24 of the balloon 13 is not particularly limited and is not limited to the configuration of the light-transmitting layer 18a and the light-reflecting layer 18b described above.

[0064] Furthermore, as shown in Figure 1, the balloon 13 of this embodiment comprises a substantially cylindrical cylindrical wall portion 13b, a distal wall portion 13c connected to the distal side of the cylindrical wall portion 13b, and a proximal wall portion 13d connected to the proximal side of the cylindrical wall portion 13b. The light-transmitting window 12a, which serves as the light-irradiating portion 12 in this embodiment, is formed only in a part of the circumferential direction B of the balloon 13, extending from the cylindrical wall portion 13b to the distal wall portion 13c. However, the region in which the light-irradiating portion 12 of the balloon 13 is formed is not limited to this region. The light-irradiating portion 12 may be formed, for example, only in a part of the circumferential direction B of the cylindrical wall portion 13b. That is, the distal wall portion 13c and the proximal wall portion 13d of the balloon 13 do not need to have a light-transmitting window 12a as the light-irradiating portion 12. Furthermore, the light-irradiating portion 12 may be arranged over the entire circumferential direction B. However, in order to selectively irradiate only abnormal tissue, it is preferable that the light irradiation unit 12 be positioned only at a portion of the circumferential direction B.

[0065] As shown in Figures 1 and 2, a hub 19 is attached to the proximal end of the outer tube 17 of the tubular member 15 in this embodiment. As described above, the hub 19 has a port portion 19a to which a fluid supply device can be connected. The fluid supply device connected to the port portion 19a can supply fluid to the annular space 13a of the balloon 13 through the inflation lumen 15b. In addition, the hub 19 in this embodiment partitions a through hole 19b through which the inner tube 16 is inserted.

[0066] <Buttock member 3> As described above, the abutment member 3 comprises a shaft portion 4 and a distal abutment portion 5.

[0067] In this embodiment, the shaft portion 4 extends into a through passage 2a partitioned within the inner tube 16 of the light irradiation member 2, and the through passage 2a is movable in the axial direction A.

[0068] The shaft portion 4 in this embodiment is a tubular body in which the inner and outer diameters of the cross-section perpendicular to the axial direction A are constant, regardless of the position in the axial direction A. The shaft portion 4 in this embodiment has a fiber lumen inside, which serves as an insertion path 4a into which a light-emitting element 200 such as an optical fiber 200a can be inserted.

[0069] In this embodiment, the fiber lumen, which serves as the insertion passage 4a, has its distal end closed by the occlusion member 23. However, the configuration is not limited to this, and the distal end may be closed by the distal abutment portion 5.

[0070] The side wall of the shaft portion 4 that demarcates the insertion passage 4a in this embodiment may be formed of, for example, a transparent resin material that can transmit light. Alternatively, an opening that allows light to pass through may be formed in the side wall of the shaft portion 4.

[0071] The material used to form the shaft portion 4 is not particularly limited, but may be, for example, a resin material. Examples of resin materials used to form the shaft portion 4 include the materials listed above as examples for forming the inner tube 16 and outer tube 17.

[0072] Furthermore, the shaft portion 4 of this embodiment includes a display unit 41. The display unit 41 displays the state in which the light irradiation member 2 has been moved to the most distal side relative to the abutment member 3. In other words, the display unit 41 of this embodiment displays the state in which the distal end of the inner tube 16 constituting the distal end of the insertion portion 11 of the light irradiation member 2 is abutting against the distal abutment portion 5 of the abutment member 3. The display unit 41 of this embodiment is provided on the shaft portion 4 of the abutment member 3 so as to be exposed on the proximal side of the light irradiation member 2 when the distal end of the inner tube 16 constituting the distal end of the insertion portion 11 of the light irradiation member 2 is abutting against the distal abutment portion 5 of the abutment member 3. In other words, medical professionals can recognize the state in which the distal end of the inner tube 16 constituting the distal end of the insertion portion 11 of the light irradiation member 2 is abutting against the distal abutment portion 5 of the abutment member 3 by confirming that the display unit 41 is exposed on the proximal side of the light irradiation member 2.

[0073] The display unit 41 may be, for example, a color marker located on the outer surface of the shaft portion 4 and formed in a different color from its surroundings by paint or the like. Alternatively, the display unit 41 may be a three-dimensional marker, such as a projection that protrudes outward in the radial direction C on the shaft portion 4, or an annular groove that is recessed inward in the radial direction C. In this way, the display unit 41 only needs to be able to identify from the outside the state in which the light irradiating member 2 has been moved to the most distal side relative to the abutment member 3, and its configuration and position are not particularly limited.

[0074] As described above, the distal abutment portion 5 of this embodiment is connected to the distal end of the shaft portion 4 and constitutes the distal end of the intravaginal insertion device 1.

[0075] As described above, the maximum diameter R2 of the distal abutment portion 5 is greater than the maximum diameter R1 of the shaft portion 4. Furthermore, in this embodiment, the maximum diameter R2 of the distal abutment portion 5 is greater than the maximum diameter R3 of the distal opening 2a1 of the through passage 2a.

[0076] The maximum diameter R3 of the distal opening 2a1 of the through passage 2a refers to the maximum straight length of the through passage 2a in a cross section perpendicular to the axial direction A at the location of the distal opening 2a1. In this embodiment, the through passage 2a is cylindrical with a constant inner diameter regardless of its position in the axial direction A. Therefore, the maximum diameter R3 of the distal opening 2a1 of the through passage 2a in this embodiment is the same as the inner diameter at any position in the axial direction A of the through passage 2a.

[0077] In the intravaginal insertion device 1, the maximum diameter R2 of the distal abutment portion 5 is set to be larger than the maximum diameter R3 of the distal opening 2a1 of the through passage 2a, so that the distal abutment portion 5 does not enter the through passage 2a through the distal opening 2a1. Therefore, by moving the abutment member 3 proximal in the axial direction A, the light irradiation member 2 can follow and move proximal. As a result, although the details will be described later, the operational efficiency can be improved when performing light irradiation on the target site X in multiple steps in the axial direction A (see Figures 7A to 7C).

[0078] Furthermore, as shown in Figures 1 and 2, the distal abutment portion 5 in this embodiment is a disc plate portion arranged substantially coaxially with the shaft portion 4. The distal surface of the disc plate portion, which serves as the distal abutment portion 5, is composed of a curved convex surface 5a that protrudes distally. This makes it easier to position the top of the curved convex surface 5a so that it is pressed into the cervix 300, and the distal abutment portion 5 is less likely to shift radially C (see Figure 3A). There may also be a second protrusion further protruding from the center of the curved convex surface 5a. This allows the curved convex surface 5a to contact the periphery of the cervix 300 while the second protrusion enters the cervix 300, making it less likely for the distal abutment portion 5 to shift radially C while contacting the periphery of the cervix 300, and enabling more reliable and stable abutment.

[0079] The material used to form the distal abutment portion 5 is not particularly limited, but may be, for example, a resin material. Examples of resin materials used to form the distal abutment portion 5 include the materials listed above as examples for forming the inner tube 16 and outer tube 17.

[0080] However, it is preferable that the distal abutment portion 5 is configured to allow light to propagate to the distal side, which is the side of the cervix 300. Figure 4A shows an example in which the distal abutment portion 5 is configured to allow light to pass through (one mode of propagation) to the distal side, which is the side of the cervix 300. The distal abutment portion 5 shown in Figure 4A may be formed of, for example, a light-transmitting material. By using such a distal abutment portion 5, light emitted from a light-emitting body 200, such as an optical fiber 200a inserted into the insertion path 4a of the shaft portion 4, can be transmitted through the distal abutment portion 5 and irradiated to the distal side beyond the distal abutment portion 5.

[0081] Figures 4B and 4C show another example of a distal abutment 5 configured to propagate light to the distal side facing the cervix 300. Figure 4B shows a configuration in which the distal abutment 5 is both light-transmitting and light-scattering. Such a distal abutment 5 may be formed, for example, by mixing a light-scattering material such as metal powder with a light-transmitting material. Figure 4C also shows a distal abutment 5 equipped with a light-distributing member 42 that can distribute light by reflecting it in a predetermined direction. The distal abutment 5 shown in Figure 4C is configured to propagate light to the distal side facing the cervix 300 by the light-distributing member 42. By providing such a light-distributing member 42, the distal abutment 5 can propagate light emitted from a light-emitting body 200, such as an optical fiber 200a inserted into the insertion path 4a of the shaft portion 4, to the distal side facing the cervix 300. This allows the light emitted from the light-emitting body 200 to be concentrated on a predetermined area, such as a target area X around the cervix 300 (see Figures 3A to 3D).

[0082] Next, with reference to Figures 5A to 5C, an example of a treatment method in which the light irradiation member 2 of the intravaginal insertion device 1 is moved axially A while the target area X in the vagina 400 is irradiated with light in multiple stages will be described. Figures 5A to 5C show an example of a treatment method in which the light irradiation member 2 of the intravaginal insertion device 1 is moved axially A while light irradiation is performed in two stages using a medical device 100.

[0083] Here, we will illustrate a treatment method using a medical device 100 that includes a vaginal insertion device 1 and a holding device 50, but the same treatment method may also be performed using only the vaginal insertion device 1.

[0084] First, let's describe the overview of the holding device 50 of the medical device 100 shown in Figures 5A to 5C. The holding device 50 holds the light irradiation member 2 and the abutment member 3 of the intravaginal insertion device 1 so that they can move independently in the axial direction A. More specifically, the holding device 50 shown in Figures 5A to 5C holds the inner tube 16 of the tubular member 15 of the light irradiation member 2 so that it can move in the axial direction A. In addition, the holding device 50 shown in Figures 5A to 5C holds the light irradiation member 2 so that it can rotate in the circumferential direction B. Furthermore, the holding device 50 shown in Figures 5A to 5C holds the shaft portion 4 of the abutment member 3 so that it can move in the axial direction A.

[0085] More specifically, the holding device 50 comprises a circumferential position indicator 31, a gear train 32, an operating lever 33, and a housing 34.

[0086] The circumferential position indicator unit 31 operates in conjunction with the rotation of the light-emitting member 2 of the intravaginal insertion device 1 in the circumferential direction B, and displays the position of the light-emitting member 12 in the circumferential direction B. The circumferential position indicator unit 31 shown in Figures 5A to 5C is a rotating marker that rotates in conjunction with the rotation of the light-emitting member 2 in the circumferential direction B. The rotating marker as the circumferential position indicator unit 31 is configured to rotate by an angle equal to the rotation angle of the light-emitting member 2 in the circumferential direction B.

[0087] The gear train 32 includes a first gear 32a and a second gear 32b. The gear train 32 transmits the rotational torque of the light irradiating member 2 in the circumferential direction B to a rotational marker which serves as a circumferential position indicator 31.

[0088] The first gear 32a of the gear train 32 rotates in the circumferential direction B, following the rotation of the tubular member 15 of the light-emitting member 2 in the circumferential direction B. The tubular member 15 is inserted into the central opening of the first gear 32a so as to be movable in the axial direction A relative to the first gear 32a. The tubular member 15 also has one or more rib-like projections 21 that protrude outward in the radial direction C and transmit torque in the circumferential direction B to the first gear 32a. However, the first gear 32a is not particularly limited as long as it allows the tubular member 15 to move in the axial direction A and transmits torque in the circumferential direction B of the tubular member 15.

[0089] The second gear 32b of the gear train 32 engages with the first gear 32a and rotates in accordance with the rotation of the first gear 32a. The second rotation plane, which is perpendicular to the rotation axis of the second gear 32b, is perpendicular to the first rotation plane, which is perpendicular to the rotation axis of the first gear 32a. Specifically, the first rotation plane of the first gear 32a is a plane perpendicular to the axial direction A, while the second rotation plane of the second gear 32b is a plane parallel to the axial direction A.

[0090] The rotating marker, which serves as the circumferential position indicator 31, is connected concentrically to the second gear 32b. In other words, when the second gear 32b rotates by a predetermined angle around the central axis, the rotating marker, which serves as the circumferential position indicator 31, also rotates by the same predetermined angle around the central axis.

[0091] In this way, the gear train 32 can transmit the rotation of the light irradiating member 2 in the circumferential direction B to the circumferential position indicator unit 31. The rotation marker, which serves as the circumferential position indicator unit 31, is configured to rotate by the same predetermined angle around the central axis when the light irradiating member 2 rotates by the same predetermined angle in the circumferential direction B.

[0092] By providing such a circumferential position indicator 31 and gear train 32, the circumferential position B of the light-emitting part 12 of the light-emitting member 2 within the vagina 400 can be identified from outside the body.

[0093] The operating lever 33 is engaged with the light irradiating member 2 so as to be movable in the axial direction A together with the light irradiating member 2. As shown in Figures 5A to 5C, the operating lever 33 comprises a gripping portion 33a exposed to the outside of the housing 34 and an engaging portion 33b located inside the housing 34 that engages with the light irradiating member 2. The gripping portion 33a and the engaging portion 33b are connected through a slot 34a of the housing 34. The engaging portion 33b is located between two annular protrusions 20a, 20b located on the outer surface of the inner tube 16 of the light irradiating member 2. The operating lever 33 is movable relative to the housing 34 within the slot 34a of the housing 34 which extends along the axial direction A. When the operating lever 33 moves distally in the axial direction A within the slot 34a of the housing 34, the engaging portion 33b presses against one of the annular protrusions 20a, and the light irradiating member 2 also moves distally in the axial direction A relative to the housing 34. Conversely, when the operating lever 33 moves proximal to the axial direction A within the slot 34a of the housing 34, the engaging portion 33b presses against the other annular projection 20b, and the light irradiating member 2 also moves proximal to the axial direction A relative to the housing 34. In other words, the operating lever 33 can move in accordance with the axial direction A of the light irradiating member 2. Furthermore, the operating lever 33 does not interfere with the rotation of the light irradiating member 2 in the circumferential direction B. In other words, the light irradiating member 2 can rotate independently in the circumferential direction B relative to the operating lever 33.

[0094] Figures 6A and 6B are top views of the holding device 50. As shown in Figures 6A and 6B, the gripping portion 33a of the operating lever 33 is equipped with a marker portion 33a1. This marker portion 33a1 indicates the axial position A of the light-emitting portion 12 (see Figure 5A, etc.) of the insertion portion 11 (see Figure 5A, etc.) of the light-emitting member 2, and the range of the axial position A of the light-emitting portion 12. Further details will be described later.

[0095] The housing 34 is fitted with the circumferential position indicator 31, the gear train 32, and the operating lever 33 described above. In other words, the rotating marker as the circumferential position indicator 31 and the gear train 32 are held rotatably relative to the housing 34. The operating lever 33 is inserted into the slot 34a of the housing 34 and is held movably relative to the housing 34 in the axial direction A.

[0096] Here, the housing 34 is equipped with a scale section 34b that displays the amount of movement of the light-emitting section 12 in the axial direction A due to the relative movement of the light-emitting member 2 in the axial direction A. As described above, the operating lever 33 is movable in the axial direction A together with the light-emitting member 2. In other words, when the operating lever 33 moves in the axial direction A, the light-emitting section 12 of the insertion section 11 of the light-emitting member 2 also moves in the axial direction A. Therefore, by checking the amount of movement of the gripping section 33a of the operating lever 33 in the axial direction A using the scale section 34b, the amount of movement of the light-emitting section 12 of the light-emitting member 2 in the axial direction A can be identified. In other words, the scale section 34b of the housing 34 constitutes an axial movement amount display section 40 that displays the amount of movement of the light-emitting section 12 in the axial direction A due to the relative movement of the light-emitting member 2 in the axial direction A with respect to the holding device 50.

[0097] Furthermore, as described above, the gripping portion 33a of the operating lever 33 is equipped with a marker portion 33a1. The marker portion 33a1 is a linear marker that is long in the axial direction A. The length of the marker portion 33a1 in the axial direction A indicates the range of the light irradiation portion 12 in the axial direction A. In this way, by using the marker portion 33a1 and the scale portion 34b which serves as the axial movement amount display portion 40, both the position of the light irradiation portion 12 in the axial direction A and the range of the axial direction A to which light is irradiated by the light irradiation portion 12 at that position can be identified. Therefore, when irradiating a target area X (see Figure 5A, etc.) inside the vagina 400 (see Figure 5A, etc.) in multiple stages while moving the light irradiation member 2 in the axial direction A, the marker portion 33a1 and the scale portion 34b which serves as the axial movement amount display portion 40 can be used to appropriately adjust the light irradiation position and the light irradiation area for each stage.

[0098] The scale portion 34b, which serves as the axial movement amount display unit 40, is provided on the holding device 50, but the configuration is not limited to this. The light irradiation member 2 may also be provided with the axial movement amount display unit 40, or both the light irradiation member 2 and the holding device 50 may be provided with the axial movement amount display unit 40.

[0099] Furthermore, the housing 34 includes a mounting portion 34c that can be attached to a patient's treatment table. The mounting portion 34c includes a shaft portion 34c1 that extends in the axial direction A. The treatment table may, for example, support the shaft portion 34c1 of the mounting portion 34c of the housing 34. However, the configuration of the mounting portion 34c of the housing 34 is not particularly limited.

[0100] Next, referring to Figures 5A to 5C, an example of a treatment method in which the light irradiation member 2 is moved axially A while the target area X inside the vagina 400 is irradiated with light in multiple stages will be described.

[0101] Figure 5A shows the state after the first light irradiation. In other words, the state shown in Figure 5A is the same as the state shown in Figure 3D, so we will omit the explanation here.

[0102] Figure 5B shows the state in which only the light-irradiating member 2 has been moved proximal to the state shown in Figure 5A. Figure 5C shows the state in which only the light-emitting element 200 has been moved proximal to the state shown in Figure 5B. The state shown in Figure 5C is the state during the second light irradiation.

[0103] In other words, in the example shown in Figures 5A to 5C, when moving the light irradiation member 2 proximal to the axial direction A from the state during the first light irradiation (see Figure 5A) to the state during the second light irradiation (see Figure 5C), the position of the abutment member 3 in the axial direction A is not moved. That is, the distal abutment portion 5 of the abutment member 3 remains in contact with the area around the cervix 300. In this state, only the light irradiation member 2 and the light emitter 200 are moved proximal to the axial direction A.

[0104] In this way, by changing the state from the state during the first light irradiation to the state during the second light irradiation without moving the abutment member 3 in the axial direction A, the light irradiation member 2 can be moved proximal to the vagina 400 while maintaining its shape. Therefore, during the above state change, it is possible to suppress the discrepancy between the amount of movement of the light irradiation member 2 itself and the amount of movement of the light irradiation member 2 relative to the target area X.

[0105] In the example shown in Figures 5A to 5C, the light-emitting member 2 can be moved to the proximal side of the axial direction A by using the operating lever 33 of the holding device 50. At this time, as shown in Figures 6A and 6B, the marker portion 33a1 and the scale portion 34b, which serves as the axial movement amount display portion 40, can be used to identify both the position of the light-emitting portion 12 in the axial direction A and the range of the axial direction A that is irradiated by the light-emitting portion 12 at that position. Therefore, by moving the light-emitting member 2 in the axial direction A while checking the marker portion 33a1 and the scale portion 34b, which serves as the axial movement amount display portion 40, the position and range of the first light irradiation and the position and range of the second light irradiation can be appropriately adjusted.

[0106] Furthermore, as shown in Figures 6A and 6B, the holding device 50 can operate independently of the axial A movement of the light-emitting member 2 of the intravaginal insertion device 1, and may include an axial position display unit 57 capable of displaying the history of the axial A position of the light-emitting unit 12. The axial position display unit 57 shown in Figures 6A and 6B is a linear marker. The holding device 50 shown in Figures 6A and 6B includes an axial position display unit 57 in addition to a marker unit 33a1 of the operating lever 33 and a scale unit 34b as an axial movement amount display unit 40. The axial position display unit 57 shown in Figures 6A and 6B is movable in the axial A direction within a slot 34d of the housing 34 that extends in the axial A direction.

[0107] Here, Figure 6A shows the positional relationship between the marker portion 33a1 and the axial position indicator portion 57 during the first light irradiation (see Figure 5A). In other words, both the marker portion 33a1 and the axial position indicator portion 57 shown in Figure 6A display the axial position A and the region of axial A of the light irradiation portion 12 during the first light irradiation. In Figure 6A, the distal end of the marker portion 33a1 of the operating lever 33 is at the distal end of the slot 34a. Also, the distal end of the axial position indicator portion 57 is at the distal end of the slot 34d. In this example, this state is adjusted so that the distal end of the insertion portion 11 of the light irradiation member 2 abuts against the distal abutment portion 5 that abuts against the periphery of the cervix 300 (see Figure 5A).

[0108] In contrast, Figure 6B shows the positional relationship between the marker portion 33a1 and the axial position indicator portion 57 during the second light irradiation (see Figure 5C). After the first light irradiation shown in Figure 6A is completed, the insertion portion 11 of the light irradiation member 2 is moved axially to A, and the axial position A of the light irradiation unit 12 is moved to the position for the second light irradiation. During this movement, the marker portion 33a1 of the operating lever 33 moves in conjunction with the axial movement A of the light irradiation member 2, and moves to a position indicating the axial position A of the light irradiation unit 12 for the second light irradiation. In contrast, the axial position indicator portion 57 does not move in conjunction with the axial movement A of the light irradiation member 2. That is, as shown in Figure 6B, the axial position indicator portion 57 does not move from the position in Figure 6A. In this way, the marker portion 33a1 of the operating lever 33 indicates the position for the second irradiation, and the axial position indicator portion 57 displays the position for the first irradiation in axial A as part of the past irradiation history. This makes it easier to appropriately control the position and area of ​​the first and second light irradiations.

[0109] Furthermore, in the examples shown in Figures 5A to 5C, the optical fiber 200a, which serves as the light-emitting body 200, can be moved to the proximal end of the axial direction A by manipulating the portion of the optical fiber 200a that is exposed proximal to the proximal end of the abutment member 3.

[0110] Furthermore, in the example shown in Figures 5A to 5C, the holding device 50 may be equipped with a movement restricting unit that restricts the movement of the abutment member 3 in the axial direction A. By providing a movement restricting unit, it is possible to suppress the abutment member 3 from unintentionally moving in the axial direction A during the state changes shown in Figures 5A to 5C. The configuration of the movement restricting unit is not particularly limited, but an example of a movement restricting unit will be described later (see Figures 7A to 7C).

[0111] Furthermore, when the state changes from the state during the first light irradiation (see Figure 5A) to the state during the second light irradiation (see Figure 5C), the light irradiation member 2 may be rotated in the circumferential direction B as needed to adjust the position of the light irradiation portion 12 of the light irradiation member 2 in the circumferential direction B.

[0112] Next, with reference to Figures 7A to 7C, we will explain variations of the treatment methods shown in Figures 5A to 5C.

[0113] Figure 7A shows the state after the first light irradiation. In other words, the state shown in Figure 7A is the same as the state shown in Figures 3D and 5A, so we will omit the explanation here.

[0114] Figure 7B shows the state after moving the light irradiation member 2, the abutment member 3, and the optical fiber 200a (which acts as the light emitter 200) to the proximal side, compared to the state in Figure 7A. Figure 7C shows the state after moving only the abutment member 3 to the distal side, so that the distal abutment portion 5 is again pressed against the area around the cervix 300. The state shown in Figure 7C is the state during the second light irradiation.

[0115] In other words, in the example shown in Figures 7A to 7C, when moving the light irradiation member 2 proximal to the axial direction A from the state during the first light irradiation (see Figure 7A) to the state during the second light irradiation (see Figure 7C), the abutment member 3 is moved back and forth in the axial direction A. That is, the distal abutment portion 5 of the abutment member 3 is moved proximal to the state where it is abutting against the periphery of the cervix 300, and then moved distally again to return to the state where it is abutting against the periphery of the cervix 300.

[0116] Thus, when the state changes from the state during the first light irradiation (see Figure 7A) to the state during the second light irradiation (see Figure 7C), the light irradiation member 2 and the light emitter 200 can be moved together to the proximal side of axial A by moving the abutment member 3 to the proximal side of axial A. In other words, when the abutment member 3 is moved to the proximal side of axial A, the distal abutment portion 5 presses the light irradiation member 2 and the light emitter 200 to the proximal side of axial A. As a result, the light irradiation member 2 and the light emitter 200 move to the proximal side of axial A, following the abutment member 3. That is, by moving the abutment member 3 to the proximal side of axial A, the light irradiation member 2 and the light emitter 200 can be moved together to the proximal side of axial A. Therefore, compared to the treatment method shown in Figures 5A to 5C, the light irradiation member 2 and the light emitter 200 can be easily moved to the second light irradiation position. As a result, the operational efficiency can be improved when performing light irradiation on the target area X in multiple stages along axial A. Furthermore, if the light irradiation member 2 includes a balloon 13 into which a light-emitting element 200 is inserted, the position of the light-emitting element 200 within the balloon 13 can be maintained compared to the treatment method shown in Figures 5A to 5C.

[0117] However, by moving the abutment member 3 proximal to the axial direction A, the distal abutment portion 5 moves away from the periphery of the cervix 300, changing the shape inside the vagina 400. Therefore, in the state during the second light irradiation (see Figure 7C), the distal abutment portion 5 of the abutment member 3 is again pressed against the periphery of the cervix 300 to reshape the inside of the vagina 400. As a result, even during the second light irradiation, the shape inside the vagina 400 is restored to its reshaped state, making it easier for the light irradiation portion 12 of the light irradiation member 2 to adhere closely to the target area X.

[0118] Finally, the differences between the medical device 100 shown in Figures 7A to 7C and the configuration shown in Figures 5A to 5C will be explained. In the medical device 100 shown in Figures 7A to 7C, the abutment member 3 is equipped with an axial position indicator 58 that displays the relative positional relationship with the holding device 50 in the axial direction A. The axial position indicator 58 may be a marker that moves in the axial direction A together with the shaft portion 4 of the abutment member 3. By providing such an axial position indicator 58, it is possible to identify the amount of movement when the abutment member 3 is pulled back to the proximal side in the axial direction A in order to change the state from the state during the first light irradiation (see Figure 7A) to the state during the second light irradiation (see Figure 7C). Therefore, when moving the abutment member 3 distally again and abutting the distal abutment portion 5 against the periphery of the cervix 300 (when changing the state from the state in Figure 7B to the state in Figure 7C), the abutment member 3 should be pushed distally so that it is in the same position as during the first light irradiation by checking the axial position indicator 58.

[0119] In the medical device 100 shown in Figures 7A to 7C, the abutment member 3 is equipped with an axial position indicator 58, but the configuration is not limited to this. The holding device 50 may be equipped with an axial position indicator 58, or both the holding device 50 and the abutment member 3 may be equipped with an axial position indicator 58.

[0120] Furthermore, in the medical device 100 shown in Figures 7A to 7C, the holding device 50 includes a movement restricting unit 59 that restricts the relative movement of the abutment member 3 in the axial direction A. By including the movement restricting unit 59, it is possible to suppress the abutment member 3 from unintentionally moving in the axial direction A during, for example, the first and second light irradiations. Then, when moving the abutment member 3 in the axial direction A, the restriction by the movement restricting unit 59 can be released.

[0121] The configuration of the movement restricting section 59 is not particularly limited. As an example of the movement restricting section 59 shown in Figures 7A to 7C, it comprises a male threaded member 61a and a receiving section 61b of the housing 34. The male threaded member 61a is screwed into a female threaded section 60a formed on the inner surface of a through hole 60 formed in the housing 34. The receiving section 61b of the housing 34 sandwiches the shaft section 4 of the abutment member 3 between itself and the male threaded member 61a. More specifically, the housing 34 shown in Figures 7A to 7C comprises two protruding sections 62a and 62b that protrude proximally and face each other in the radial direction C. The aforementioned through hole 60 penetrates one of the protruding sections 62a of the housing 34 in the radial direction C. The male threaded member 61a is inserted into the through hole 60 of one of the protruding sections 62a of the housing 34 from the outside to the inside in the radial direction C and screwed into the female threaded section 60a. Then, the shaft portion 4 of the abutment member 3 is sandwiched between the tip of the male screw member 61a and the other protruding portion 62b, which acts as a receiving portion 61b. This restricts the movement of the abutment member 3 in the axial direction A.

[0122] The intravaginal insertion device, medical instrument, and treatment method relating to this disclosure are not limited to the specific configurations and processes shown in the embodiments and modifications described above, and various modifications, changes, and combinations are possible as long as they do not depart from the scope of the claims. In the embodiments described above, the light irradiation member 2 and the abutment member 3 of the intravaginal insertion device 1 are independently movable in the axial direction A, but a locking mechanism may be provided to fix and release the light irradiation member 2 and the abutment member 3. By providing such a locking mechanism, the light irradiation member 2 and the abutment member 3 can be moved together in the axial direction A as needed.

[0123] Furthermore, in the embodiment described above, the shaft portion 4 and optical fiber 200a of the abutment member 3 are independently movable in the axial direction A, but a locking portion that can fix and release the shaft portion 4 and optical fiber 200a may be provided. By providing such a locking portion, the shaft portion 4 and optical fiber 200a can be moved together in the axial direction A as needed. [Industrial applicability]

[0124] This disclosure relates to intravaginal insertion devices, medical instruments, and treatment methods. [Explanation of Symbols]

[0125] 1: Vaginal insertion device 2: Light-irradiating member 2a: Passageway 2a1: Distal opening 3: Butt piece 4: Shaft section 4a: Insertion path 5: Distal thrusting area 5a: Curved convex surface 11: Insertion part 12: Light-irradiating section 12a: Light irradiation window 13: Balloon 13a: Ring space 13b: Cylinder wall part 13c: Distal wall 13d: Proximal wall 14:Operation unit 15: Tubular member 16: Inner tube 17:Outer tube 18a: Light transmission layer 18b: Light reflective layer 19: Hub 19a: Port section 19b: Through hole 20a, 20b: Annular protrusion 21: Rib-like projections 23: Closure member 24: Light reflecting part 31: Circumferential position display section 32: Gear train 32a: First gear 32b: Second gear 33: Operating lever 33a: Grip part 33a1: Marker section 33b: Engagement part 34: Housing 34a: Slot 34b: Scale section (an example of a section that displays the amount of axial movement) 34c: Mounting part 34c1:Shaft part 34d: Slot 40: Axial movement amount display section 41: Display section 42: Light distribution component 50: Holding device 57: Axial position display section 58: Axial position display section 59: Movement Control Department 60: Through hole 60a: Female thread section 61a: Male threaded member 61b: Receiving part 62a, 62b: Protrusion 70: Vaginal speculum 100: Medical devices 200: Luminous material 200a: Optical fiber 200a1: Light-emitting part 300: Cervical opening 400: Vagina 500: Vaginal opening A: Axial axis of the intravaginal insertion device (axis along the central axis of the penetration passage) B: Circumferential direction of the intravaginal insertion device (circumferential direction around the central axis of the penetration). C: Circumferential direction of the intravaginal insertion device (radial direction of the circle around the central axis of the penetration). O: Central axis of the passage R1: Maximum diameter of the shaft R2: Maximum diameter of the distal abutment portion R3: Maximum diameter of the distal opening of the through-passage W: Vaginal wall X: Target area

Claims

1. A light-emitting member that can be inserted into the vagina and emit light externally, The device includes a thrusting member that is located distal to the light-irradiating member within the vagina and can be thrust against the area around the cervix, The light-irradiating member defines a through-passage that extends from the proximal end to the distal end, up to the distal opening. The aforementioned abutment member is A shaft portion inserted through the aforementioned through passage and movable relative to the light irradiating member along the aforementioned through passage, It comprises a distal abutment portion connected to the distal end of the shaft portion, positioned distal to the distal opening of the through passage, and capable of abutting against the periphery of the cervix, The maximum diameter of the distal abutment portion is greater than the maximum diameter of the shaft portion. The light-irradiating member is a vaginal insertion device that is movable relative to the abutment member while the distal abutment portion is in contact with the area around the cervix.

2. The intravaginal insertion device according to claim 1, wherein the maximum diameter of the distal abutment portion is greater than the maximum diameter of the distal opening of the through passage.

3. The distal abutment portion is a disc plate portion arranged substantially coaxially with the shaft portion. The intravaginal insertion device according to claim 1 or 2, wherein the distal surface of the disc portion is formed by a curved convex surface that protrudes distally.

4. The shaft portion of the abutment member defines an insertion path into which the light-emitting element can be inserted. The intravaginal insertion device according to any one of claims 1 to 3, wherein the light-emitting member is provided with a light-transmitting window capable of transmitting light from the light-emitting body inserted into the insertion passage of the shaft portion.

5. The light-irradiating member comprises a balloon that can be expanded inside the vagina, The intravaginal insertion device according to claim 4, wherein the light-transmitting window is provided in the balloon.

6. The intravaginal insertion device according to any one of claims 1 to 5, wherein the light-emitting member is provided with a display unit that shows the state in which the light-emitting member has been moved to the most distal side relative to the abutment member.

7. The intravaginal insertion device according to any one of claims 1 to 6, wherein the distal abutment portion of the abutment member is configured to transmit light distally.

8. The intravaginal insertion device according to claim 7, wherein the distal abutment portion of the abutment member is configured to propagate light distally by utilizing at least one of light transmission, scattering, and reflection.

9. The vaginal insertion device according to claims 1 to 8, A medical device comprising: a holding device that independently holds the light-emitting member and the abutment member of the intravaginal insertion device so as to be movable in the axial direction along the central axis of the through passage.

10. The medical device according to claim 9, wherein the holding device includes a movement restricting portion that restricts the relative movement of the abutment member in the axial direction.

11. The medical device according to claim 9 or 10, wherein at least one of the holding device and the light-emitting member of the intravaginal insertion device is provided with an axial movement amount display unit that displays the amount of axial movement of the light-emitting portion due to the relative axial movement of the light-emitting member of the intravaginal insertion device with respect to the holding device.

12. The medical device according to any one of claims 9 to 11, wherein at least one of the holding device and the abutment member of the intravaginal insertion device is provided with an axial position indicator that displays the relative positional relationship with the other in the axial direction.

13. The light-emitting member of the intravaginal insertion device is capable of emitting light to the outside at a position in the circumferential direction around the central axis of the through passage, The medical device according to any one of claims 9 to 12, wherein the holding device holds the light irradiation member so as to be rotatable in the circumferential direction.

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