Insertion tool with light source

Abstract

To provide an insertion tool inserted into a natural opening in a body such as a vagina, rectum, and the like, which allows light to efficiently and safely enter a tissue in a body cavity from the distal end of the insertion tool in the state where the insertion tool 1A is inserted into the body, and enables satisfactorily observing, from the abdominal cavity side, light which enters the tissue in the body cavity from the distal end.SOLUTION: An inserting tool 1A to be inserted into a natural opening part of a body, includes: a light source 10 for irradiating light, without passing through an optical fiber, at a proximal end of a cylindrical body 2 formed of a light-conductive resin; and a light emission part at a distal end. The light emission part at the distal end is configured to irradiate the light incident at the proximal end at a high intensity outward in a radial direction of the cylindrical body 2. An example of the light emission part at the distal end has an inclined surface at which the cylindrical body decreases in outside diameter toward a tip end of the cylindrical body.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] The present invention relates to an insertion tool with a light source for use in laparoscopic total hysterectomy and the like. [Background technology]

[0002] In general, laparoscopic total hysterectomy involves cutting the round ligament, pelvic infundibulum ligament, sacral uterine ligament, uterine artery, ovarian artery, etc., and dissection of the bladder. The end of the uterus enters the upper part of the vagina and is surrounded by the vaginal vault (the wing-like extension at the upper end of the vagina). The uterus is separated from the vaginal canal at or near the vaginal vault using a scalpel inserted into the abdominal cavity under laparoscopic observation, and is removed from the body, and the vaginal wound is closed by sutures. The line along which the uterus is separated at this time is called the "resection line." It is important to determine the resection line that allows total hysterectomy with minimal invasiveness. However, it is difficult to determine the resection line because the vaginal vault cannot be directly seen when observing from the abdominal cavity.

[0003] Conventionally, the method of determining the resection line involves inserting a finger or a hard pipe (commercially available, for example, Vagi-Pipe, manufactured by Hakko Co., Ltd.) described in Patent Document 1 etc., into the body vaginally, pressing it against the vaginal vault (the wing-like extension at the upper end of the vagina surrounding the end of the uterus), and determining the resection line from the movement of the vaginal vault observed with a laparoscope in the abdominal cavity while moving and pushing the hard pipe. However, this method only allows the operator to roughly estimate the position of the actual resection line.

[0004] Other methods for determining the resection line include a method in which an optical fiber connected to a light source outside the body is passed through a tube and inserted into the body transvaginally, the end of the optical fiber at the tip of the tube is moved along the vaginal vault, and the light that has passed through the vaginal vault is observed with a laparoscope in the abdominal cavity to determine the resection line (Patent Document 2); a method in which an optical fiber is embedded in the wall of a pipe inserted into the vagina, light is input from an external light source outside the body into the optical fiber and emitted from the end of the optical fiber at the tip of the pipe, and the light that has passed through the vaginal vault is observed with a laparoscope in the abdominal cavity to determine the resection line; a method in which a resin ring with embedded light-emitting diodes (LEDs) is attached to the distal end of a pipe to be inserted into the vagina, power is supplied to the LEDs via wiring from outside the body to cause them to emit light, and the light that passes through the vaginal vault is observed with a laparoscope inside the abdominal cavity to determine the resection line (Patent Document 4); and a method in which LEDs are arranged in a ring shape on the rim of a cervical cup which is inserted transvaginally into the body and pressed against the vaginal vault, and the light emitted by the LEDs is observed with a laparoscope inside the abdominal cavity to determine the resection line (Patent Document 5).

[0005] However, when light emitted from an external light source is passed through an optical fiber to illuminate the boundary between the uterus and the vagina from the vaginal side as described in Patent Documents 2 and 3, the transmission loss of light is large, making it difficult to determine the resection line. Also, the optical fiber connecting the external light source and the intravaginal device often gets in the way of the surgical procedure.

[0006] On the other hand, placing an LED inside the body as described in Patent Documents 4 and 5 increases the risks associated with using the LED as a medical device due to the risk of electric shock and the risk of a temperature rise in the internal device. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] JP 2004-41395 A [Patent Document 2] Patent No. 4038590 [Patent Document 3] Japanese Patent Application Publication No. 11-336 [Patent Document 4] Patent No. 6133423 [Patent Document 5] JP 2017-202317 A Summary of the Invention [Problem to be solved by the invention]

[0008] In contrast to the above-mentioned prior art, an object of the present invention is to provide an insertion tool that is inserted into a natural opening of the body, such as the vagina or rectum, that allows light to be efficiently and safely incident on tissue within a body cavity from the distal end of the insertion tool while it is inserted into the body, and enables the light that has entered the tissue within the body cavity from the distal end to be clearly observed from the abdominal cavity side. [Means for solving the problem]

[0009] The inventors have discovered that (i) when an insertion tool to be inserted into a natural opening of the body is a tubular body made of a light-conducting resin and a light source is placed directly at its proximal end (i.e., a light source that emits light not through an optical fiber is placed at the proximal end) and the distal end is the light-emitting end, the light emitted from the light source can be efficiently sent to the distal end, (ii) when the distal end is given a specific shape, the distal end of the tubular body inserted into the natural opening comes into close contact with the tissue inside the body cavity, thereby allowing the light emitted from the distal end to be efficiently incident on the tissue inside the body cavity, and further, (iii) when the distal end is given a specific shape, the intensity of the light emitted from the distal end radially outward from the tubular body is increased, making it easier to confirm the light emission from the tissue inside the body cavity from the serous membrane side of the tissue inside the body cavity. Thus, the present invention has been completed.

[0010] That is, the present invention provides an insertion device to be inserted into a natural opening of the body, comprising: A cylindrical body made of a light-guiding resin has a light source at a proximal end thereof that emits light without passing through an optical fiber, and a light-emitting unit at a distal end thereof; The light-emitting section has a curved surface that comes into close contact with tissue within the body cavity when the insertion tool is inserted into a natural opening of the body, and provides an insertion tool with a light source that has a structure that emits light that enters the proximal end at the distal end radially outward from the tubular body with high intensity.

[0011] In a first aspect, the present invention provides an insertion device for insertion into a natural opening of the body, comprising: The light-emitting device includes an insertion tool with a light source, which has a proximal end of a cylindrical body formed of a light-conducting resin and emits light without passing through an optical fiber, and a light-emitting unit at a distal end, the light-emitting unit having a structure for emitting light incident at the proximal end radially outward of the cylindrical body at the distal end, the light-emitting unit having a single annular protrusion protruding with a convex curved surface radially outward of the cylindrical body, the region including at least the radially outer protruding point of the curved surface in the central portion being in close contact with tissue within the body cavity when the insertion tool is inserted into a natural opening of the body, and the thickness of the curved surface at the protruding point in a longitudinal cross section of the cylindrical body is less than the wall thickness of the cylindrical body on the proximal end side of the annular protrusion.

[0012] In a second aspect, there is provided an insertion device for insertion into a natural orifice of the body, comprising: The insertion tool with light source includes a cylindrical body formed of a light-conducting resin, which has a light source at its proximal end that emits light without passing through an optical fiber, and a light-emitting unit at its distal end, the light-emitting unit having a structure for causing light incident at the proximal end to be emitted radially outward of the cylindrical body at the distal end, the light-emitting unit having a single annular convex portion that protrudes with a convex curved surface radially outward of the cylindrical body, and when the insertion tool is inserted into a natural opening of the body, an area including at least the outward protruding point of the curved surface is in close contact with tissue within the body cavity, and in a longitudinal cross section of the cylindrical body, the thickness of the annular convex portion is greater than the wall thickness of the cylindrical body on the proximal end side than the annular convex portion, the difference being 1 / 4 or more of the wall thickness of the cylindrical body.

[0013] As a third aspect, there is provided an insertion device for insertion into a natural orifice of the body, comprising: A cylindrical body made of a light-guiding resin has a light source at a proximal end thereof that emits light without passing through an optical fiber, and a light-emitting unit at a distal end thereof; The light-emitting section has a structure for causing light incident at the proximal end to be emitted radially outward from the tubular body at the distal end, the light-emitting section having a single annular protrusion that protrudes with a convex curved surface radially outward from the tubular body, and when the insertion tool is inserted into a natural opening of the body, an area including at least the radially outer protruding point of the curved surface is in close contact with tissue within the body cavity, and the insertion tool includes an insertion tool having a light-diffusing agent contained in the light-emitting section at the distal end.

[0014] As a fourth aspect, there is provided an insertion device for insertion into a natural opening of the body, comprising: A cylindrical body made of a light-guiding resin has a light source at a proximal end thereof that emits light without passing through an optical fiber, and a light-emitting unit at a distal end thereof; The light-emitting section has a structure for emitting light incident at the proximal end radially outward from the tubular body at the distal end, the light-emitting section having a single annular convex portion protruding with a convex curved surface radially outward from the tubular body, and when the insertion tool is inserted into a natural opening of the body, an area including at least the radially outer protruding point of the curved surface is in close contact with tissue within the body cavity, and the tubular body includes an insertion tool having a light-emitting scale on its outer peripheral surface a predetermined distance from the light-emitting section at the distal end for emitting light incident at the proximal end in a scale pattern.

[0015] As a fifth aspect, there is provided an insertion device for insertion into a natural orifice of the body, comprising: A cylindrical body made of a light-guiding resin has a light source at a proximal end thereof that emits light without passing through an optical fiber, and a light-emitting unit at a distal end thereof; The corners of the cylindrical body at the distal end are rounded so that the light emitting unit closely contacts tissue in the body cavity when the insertion tool is inserted into a natural opening of the body, The light emitting section includes an insertion tool having a cylindrical body with a rough outer circumferential surface.

[0016] As a sixth aspect, there is provided an insertion device for insertion into a natural orifice of the body, comprising: A cylindrical body made of a light-guiding resin has a light source at a proximal end thereof that emits light without passing through an optical fiber, and a light-emitting unit at a distal end thereof; The corners of the cylindrical body at the distal end are rounded so that the light emitting unit closely contacts tissue in the body cavity when the insertion tool is inserted into a natural opening of the body, The light emitting portion includes an insert having a cylindrical body and a light diffusing agent contained on the outer peripheral surface thereof.

[0017] As a seventh aspect, there is provided an insertion device for insertion into a natural opening of the body, comprising: A cylindrical body made of a light-guiding resin has a light source at a proximal end thereof that emits light without passing through an optical fiber, and a light-emitting unit at a distal end thereof; The corners of the cylindrical body at the distal end are rounded so that the light emitting unit closely contacts tissue in the body cavity when the insertion tool is inserted into a natural opening of the body, The light emitting portion includes an insertion tool having an inclined surface in which the outer diameter of the cylindrical body becomes smaller toward the tip of the cylindrical body.

[0018] In particular, the seventh aspect includes an aspect in which the inclined surface is formed from the inner surface of the distal end of the cylindrical body to the outer surface of the distal end of the cylindrical body. Effect of the Invention

[0019] According to the present invention, a cylindrical body to be inserted into a natural opening of the body such as the vagina or rectum is made of a light-conducting resin, and the cylindrical body has a light source at its proximal end and a light-emitting portion at its distal end. Thus, light emitted from the light source enters the proximal end and exits from the annular convex portion at the distal end without transmission loss due to the optical fiber.

[0020] Furthermore, the light emitting section at the distal end has a structure that emits light incident on the proximal end radially outward from the cylindrical body with high intensity, and as a result, the light intensity emitted from the light emitting section radially outward (i.e., in the range of 90°±45° with respect to the axial direction) is greater than the light intensity emitted in the axial direction. Therefore, when the insertion tool of the present invention is inserted into a natural opening of the body such as the vagina or rectum with the light source at the proximal end turned on, the light emitted from the light emitting section can be clearly observed from the serosal side of the tissue in the body cavity at the insertion site, making it easy to determine the resection line from the serosal side.

[0021] In addition, in this insertion tool, the light source is provided at the proximal end of the tubular body, so that the light source is located outside the body, thereby avoiding the risk of electric shock and temperature rise that would occur if the light source were placed inside the body. [Brief description of the drawings]

[0022] [Figure 1A] FIG. 1A is a perspective view of a light-emitting insertion tool 1A of an embodiment with a cap open, as viewed from the distal end side. [Figure 1B] FIG. 1B is a perspective view of the light-emitting insertion tool 1A of the embodiment with the cap closed, as viewed from the proximal end side. [Figure 1C] FIG. 1C is a side view of the light-emitting insertion tool 1A of the embodiment with the cap open. [Figure 1D] FIG. 1D is a cross-sectional view, a view taken along an arrow a, and a view taken along an arrow b of the light-emitting insertion tool 1A of the embodiment with the cap open. [Diagram 2] FIG. 2 is a vertical cross-sectional view of the annular protrusion 20A formed as a light-emitting portion at the distal end of the light-sourced insertion tool 1A of the embodiment, showing the function of the annular protrusion 20A. [Figure 3A] FIG. 3A is a perspective view of a normal vagina into which the light-emitting insertion tool 1A of the embodiment has been inserted, as viewed from the abdominal cavity side. [Figure 3B] FIG. 3B is an explanatory diagram of the position of the uterine incision line determined in a normal vagina into which the light-emitting insertion tool 1A of the embodiment is inserted. [Figure 4A] FIG. 4A is a perspective view of a deep vagina into which the light-emitting insertion tool 1A of the embodiment has been inserted, as viewed from the abdominal cavity side. [Figure 4B] FIG. 4B is an explanatory diagram of the position of the incision line of the uterus determined in a deep vagina into which the light-emitting insertion tool 1A of the embodiment is inserted. [Diagram 5] FIG. 5 is a vertical cross-sectional view of an annular protrusion formed as a light-emitting portion 20B at the distal end of the light-source-equipped insertion tool of the embodiment, illustrating the function of the annular protrusion. [Figure 6] FIG. 6 is a vertical cross-sectional view of an annular protrusion, illustrating the function of the annular protrusion formed as the light-emitting portion 20C at the distal end of the light-sourced insertion tool of the embodiment. [Figure 7] FIG. 7 is a vertical cross-sectional view of an annular protrusion, illustrating the function of the annular protrusion formed as the light-emitting portion 20D at the distal end of the light-sourced insertion tool of the embodiment. [Figure 8] FIG. 8 is a vertical cross-sectional view of a blasted portion, illustrating the effect of the blasted portion formed on the light-emitting portion 20E at the distal end of the light-source-equipped insertion tool of the embodiment. [Figure 9] FIG. 9 is a vertical cross-sectional view of a light diffusing agent-containing portion, illustrating the function of a light diffusing agent-containing layer formed on the light emitting portion 20F at the distal end in the light-sourced insertion tool of the embodiment. [Figure 10] FIG. 10 is a longitudinal cross-sectional view of a light-emitting section 20G at the distal end of the light-source-equipped insertion device of the embodiment, illustrating the effect of the annular protrusion formed on the light-emitting section 20G having a blasted portion and containing a light diffusing agent. [Figure 11] FIG. 11 is a vertical cross-sectional view of the light-emitting unit 20H, illustrating the function of the light-emitting unit 20H at the distal end of the light-sourced insertion tool of the embodiment. [Figure 12] FIG. 12 is a vertical cross-sectional view of a light-emitting unit 20I, illustrating the function of the light-emitting unit 20I at the distal end of the light-sourced insertion tool of the embodiment. [Figure 13] FIG. 13 is a vertical cross-sectional view showing the function of the distal end of the light-sourced insertion tool of the comparative example. [Figure 14] FIG. 14 is a vertical cross-sectional view showing the function of the distal end of the light-source-equipped insertion tool of the comparative example. [Figure 15] FIG. 15 is a vertical cross-sectional view showing the function of the distal end of the light-source-equipped insertion tool of the comparative example. [Figure 16A] FIG. 16A is a side view of an insertion tool 1B according to an embodiment. [Figure 16B] FIG. 16B is a cross-sectional view of the insertion device 1B of the embodiment. [Figure 17] FIG. 17 is a photograph showing a light emission test of the insertion device 1A of the embodiment covered with a skin sheet. [Figure 18A] FIG. 18A is a photograph of a light emission test of an insertion tool with a rounded tip. [Figure 18B] FIG. 18B is a photograph of a luminescence test of an insertion tool without tip R processing. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] The following describes in detail the insertion tool with light source of the present invention (hereinafter, simply referred to as the "insertion tool") with reference to the drawings, taking as an example a vaginal insertion tool used in laparoscopic total hysterectomy surgery, etc. In each drawing, the same reference numerals represent the same or equivalent components.

[0024] The insertion device of the present invention is not limited to being used in the vagina, but may also be configured as an insertion device to be inserted into a natural opening of the body, such as the rectum.

[0025] (Overall structure) As shown in Figures 1A, 1B, 1C, and 1D, a vaginal light-emitting insertion device 1A according to an embodiment of the present invention has a substantially cylindrical tubular body 2 to be inserted into the vagina. The length of the tubular body 2 in the axial A direction is determined so that the proximal end is outside the body when the tubular body 2 is inserted into the vagina, and is, for example, 180 mm or more. The wall thickness d1 of the tubular body 2 is preferably about 2 to 4 mm.

[0026] The distal end of the tubular body 2 is open, and the opening surface 2a is inclined with respect to the axis A of the tubular body 2 in accordance with the fact that the posterior vaginal fornix is ​​located deeper than the anterior vaginal fornix.

[0027] A handle 3 is attached near the proximal end of the cylindrical body 2 as necessary, and a cap 4 is fitted on it. An opening 4a for inserting an instrument used during surgery is formed in the center of the cap 4, and a plug 4b that fits into the opening 4a as shown by the arrow is formed integrally with the cap 4. The handle 3 and cap 4 can be configured in the same way as the insertion tool described in Patent Document 1.

[0028] On the other hand, the insertion tool of the present invention is mainly configured such that a light source is attached to the proximal end of the cylindrical body 2, and the cylindrical body 2 is formed from a light-guiding resin. This reduces the transmission loss of light when guiding the light incident from the light source at the proximal end to the distal end, compared to when guiding the light to the distal end using an optical fiber.

[0029] Here, examples of the light-conducting resin that can be used include polymethyl methacrylate, polycarbonate, and polystyrene.

[0030] As a light source, the insertion tool 1A of this embodiment is provided with a ring-shaped illuminator 10 in which a plurality of chip LEDs 11 are embedded. The ring-shaped illuminator 10 has the light-emitting surface of the chip LEDs 11 facing the distal end of the cylindrical body 2.

[0031] In addition, the insertion device of the present invention has a light-emitting section at the distal end of the cylindrical body 2, and this light-emitting section has a structure that emits light incident on the proximal end radially outward at the distal end of the cylindrical body with high intensity.In other words, a major component of the insertion device is that in the intensity distribution of light emitted from the distal end, the light intensity emitted radially outward from the cylindrical body is stronger than the light intensity emitted in the axial direction of the cylindrical body.

[0032] The structure of the light emitting part at the distal end can have various configurations as long as it can emit light with high intensity radially outward from the distal end when light is incident on the proximal end. For example, the light-emitting insertion tool 1A of this embodiment has a single annular convex part that is convex on the radially outward side of the cylindrical body 2 as the light emitting part 20A at the distal end. This light emitting part (annular convex part) 20A has a curved surface 21 with which the tissue inside the body cavity comes into close contact when the insertion tool 1A is inserted into the body cavity. Since the curved surface 21 is convex on the radially outward side of the cylindrical body 2, the light emitted by the light source 10 can be emitted from the light emitting part (annular convex part) 20A radially outward from the cylindrical body 2 with high intensity. Moreover, since the tissue inside the body cavity comes into close contact with the curved surface 21 when the insertion tool 1A is inserted into the vagina, the light emitted from the curved surface 21 enters the tissue inside the body cavity without losing light intensity in the gap between the curved surface 21 and the tissue inside the body cavity, and passes through the tissue inside the body cavity. Therefore, the light-emitting part inside the body cavity can be observed well by a laparoscope inserted into the body cavity on the serous membrane side of the tissue inside the body cavity. Thus, the insertion tool of the present invention has a curved surface such that substantially the entire surface of the light-emitting part is in close contact with the tissue inside the body cavity when the insertion tool is inserted into a natural opening of the body, and preferably 80% or more of the light-emitting part, more preferably the entire surface, is in close contact with the tissue inside the body cavity.

[0033] In contrast, as will be explained in Figure 14 below, when multiple annular protrusions are arranged in series in the axial direction of the cylindrical body at the distal end of the cylindrical body, gaps s are likely to occur between adjacent annular protrusions, resulting in a loss of light intensity.

[0034] (light source) In the present invention, the light source 10 is attached to the proximal end of the cylindrical body 2 without an optical fiber. It is preferable to use an LED or the like as the light source. It is also preferable to use the light source 10 with its light-emitting surface facing the end face of the proximal end of the cylindrical body 2. More specifically, for example, as shown in FIG. 1D, a plurality of chip LEDs 11 are arranged in a ring shape along the end face with their light-emitting surfaces facing the end face of the proximal end of the cylindrical body 2. In this case, the chip LED 11 may be embedded in a ring-shaped member 12 formed of a resin having a refractive index similar to that of the cylindrical body 2, and the light-emitting surface of the chip LED 11 may be directed to the end face of the proximal end of the cylindrical body 2, and the ring-shaped member 12 and the end face of the proximal end of the cylindrical body 2 may be bonded using an adhesive having a refractive index similar to that of the cylindrical body 2. Alternatively, the chip LED 11 may be directly bonded to the end face of the proximal end of the cylindrical body 2 using an adhesive having a refractive index similar to that of the resin constituting the cylindrical body 2.

[0035] The emission wavelength of the light source 10 is preferably in the range of visible light to near infrared light (approximately 400 to 1000 nm) from the viewpoint of visibility of the light-emitting site with a laparoscope.

[0036] It is also preferable to provide a battery box 13, which houses a battery 14 serving as a power source for the chip LED 11, at the proximal end of the cylindrical body 2. In the insertion tool 1A of the embodiment, the battery box 13 is provided in parallel with the ring-shaped member 12. This can prevent the wiring of the light source 10 from interfering with the surgical procedure.

[0037] (Annular convex part) 2 is a longitudinal cross-sectional view (cross-sectional view along the axis A of the cylindrical body) of the annular protrusion 20A at the distal end of the insertion tool 1A of the embodiment when the insertion tool 1A is inserted into the vagina 100 and the annular protrusion 20A at the distal end of the insertion tool 1A is pressed against the vaginal vault 101. The annular protrusion 20A has a curved surface 21 that is convex on the radially outer side of the cylindrical body 2. As shown in the figure, the curved surface 21 is not formed radially inward of the cylindrical body 2 beyond the inner end point P1 of the arc that forms the curved surface 21, but is a curved surface that protrudes radially outward of the cylindrical body 2 beyond the outer end point P2 of the arc that forms the curved surface 21. In addition, the inner end point P1 of the curved surface 21, the point that protrudes most radially outward (outer protrusion point) P3, and the outer end point P2 are smoothly connected, and in the region that includes the outer protrusion point P3 in the center, i.e., both on the inner end point P1 side of the outer protrusion point P3 and on the outer end point P2 side of the outer protrusion point P3, the curved surface 21 is shaped to fit closely to the intracavity tissue 120.

[0038] More specifically, in the cross-sectional view shown in FIG. 2, the inner end point P1 of the arc of the curved surface 21 is on the inner surface 2b of the cylindrical body 2, and the curved surface 21 is located radially outward of the cylindrical body 2 from the inner end point P1. The thickness d2 of the annular convex portion 20A (i.e., the wall thickness of the cylindrical body 2 at the outward protruding point P3) is equal to or less than the wall thickness d1 of the cylindrical body proximal to the annular convex portion (hereinafter, simply referred to as the wall thickness d1 of the cylindrical body). That is, the curved surface 21 is formed within the wall thickness d1 of the cylindrical body 2, and is an arc of about 3 / 4 circle (θ1: 240 to 285°). The curved surface 21 continues about 1 / 4 circle (θ2: 60 to 105°) from the outward protruding point P3, which protrudes most radially outward, to the proximal end side. Therefore, when the cylindrical body 2 is pressed against the vaginal vault 101, the substantially entire surface of the curved surface 21 is in close contact with the tissue in the body cavity. It is not necessary for the entire surface of curved surface 21 to be in close contact with the body cavity tissue, but it is preferable for it to be in close contact with the outer protruding point P3, its inner end point P1 side, and its outer end point P2 side, preferably the protruding region including outer protruding point P3 in the center.

[0039] When the insertion tool 1A having the annular protrusion 20A at the distal end shown in Fig. 2 is pressed against the vaginal vault 101 transvaginally, the light source 10 at the proximal end is turned on, and light is emitted from the annular protrusion 20A at the distal end, the light diffuses upward (in the direction of axis A) and to the side as shown by the arrows in the figure, and particularly diffuses diagonally to the side with strong light intensity. Therefore, as shown in Fig. 3A, the light emitted from the annular protrusion 20A pressed against the vaginal vault 101 can be observed from the abdominal cavity side as the light-emitting part B with the endoscope 200, and as shown in Fig. 3B, the resection line X can be appropriately determined.

[0040] Although the shapes of the vagina and uterus as viewed from the abdominal cavity are the same as those shown in Figures 3A and 3B, there are cases in which the vagina 100 is long and the vaginal vault 101 is recessed as shown in Figures 4A and 4B. Even in this case, by using the insertion tool 1A of the embodiment, the light-emitting part B can be observed in accordance with the position of the vaginal vault 101. Therefore, as shown in Figure 4B, the incision line X can be appropriately determined.

[0041] In contrast, when the tip 2x of the distal end of the cylindrical body 2 is a plane perpendicular to the axis A direction, as in the light emitting part of the insertion tool of the comparative example shown in Fig. 13, the intensity of the light incident from the light source at the proximal end of the cylindrical body 2 at the distal end is strong in the axis A direction, and the intensity of the light emitted to the side is weak. Furthermore, as shown in the enlarged view in the figure, a gap s is generated between the cylindrical body 2 and the tissue in the body cavity, including the uterus 110, in the region 2r from the corner of the tip 2x of the distal end toward the proximal end, so that they do not come into close contact. The refractive index of the cylindrical body 2 (for example, 1.49 in the case of acrylic resin), the refractive index of the tissue in the body cavity (the refractive index of biological tissue is about 1.55, and the refractive index of the water contained therein is 1.33), and the refractive index of these gaps (the refractive index of air is 1.00) are different, so reflection occurs at the interface between them, and the intensity of the light passing through the tissue in the body cavity from the distal end to the side of the cylindrical body 2 becomes even weaker. This makes it difficult to observe the light emitted from the distal end of the cylindrical body 2 as a light-emitting portion from the abdominal cavity side, and also makes it difficult to determine the resection line X.

[0042] Therefore, as shown in Figure 14, since multiple annular protrusions 20 are connected in the axial direction of the tubular body 2 at the distal end of the tubular body 2, even if a gap s occurs between adjacent annular protrusions, reflection occurs at the interface between the annular protrusions 20 and the gap s, and at the interface between the gap s and the tissue 120 inside the body cavity, resulting in a loss of light intensity.

[0043] In addition, simply rounding the corners of the tip 2x of the distal end of the tubular body 2, like the light-emitting part of the insertion tool of the comparative example shown in Fig. 15, makes the light emitted from the distal end more diffuse than in the comparative example shown in Fig. 13, but the intensity of the light emitted to the side of the tubular body 2 is weak. For this reason, simply rounding the corners of the tip 2x of the distal end of the tubular body 2 makes it still difficult to observe the light emitted from the distal end as a light-emitting part from the abdominal cavity side.

[0044] (Deformation of the light emitting part at the distal end) As shown in Fig. 3A or 4A, in order to enable clear observation from the abdominal cavity side of the light emitted from the annular convex portion provided as a light emitting portion at the distal end of the cylindrical body 2, in the present invention, as in the annular convex portion 20B at the distal end of the cylindrical body 2 shown in Fig. 5, the radial thickness d2 of the annular convex portion 20B at the outward protruding point P3 may be made larger than the wall thickness d1 at the proximal end of the cylindrical body 2. The difference d3 between the thickness d2 of the annular convex portion 20B and the wall thickness d1 of the cylindrical body 2 is preferably ¼ or more of the wall thickness d1.

[0045] 5, in order to improve the adhesion between the annular protrusion 20B and the tissue in the body cavity, the annular protrusion 20B has a smoothly continuous curved surface from the inner end point P1 to the outer protrusion point P3 and the outer end point P2. The curved surface 21 continues for about 1 / 6 of a circle (θ2: 40-70°) on the proximal end side from the outer protrusion point P3.

[0046] The annular convex portion 20C at the distal end of the cylindrical body 2 shown in FIG. 6 is obtained by inclining the tip of the inner surface 2b of the cylindrical body 2, as compared with the annular convex portion 20A shown in FIG. 2, so that the opening diameter of the inner surface 2b of the cylindrical body 2 becomes wider as it approaches the tip of the cylindrical body 2. The inclination angle θ3 is preferably set to 35 to 60° from the axis A direction. By forming this inclined surface 2y, the proportion of light incident on the proximal end of the cylindrical body 2 that is reflected radially outward from the inclined surface 2y can be increased, and the amount of light emitted radially outward from the curved surface 21 can also be increased. Therefore, when light is emitted from the annular convex portion 20C shown in FIG. 6 to the tissue in the body cavity, the light-emitting portion of the tissue in the body cavity can be observed well from the abdominal cavity side.

[0047] The annular convex portion 20D at the distal end of the cylindrical body 2 shown in FIG. 7 is the annular convex portion 20C shown in FIG. 6 with a reflective film 22 formed on the inner surface 2b of the cylindrical body. The reflective film 22 may be formed from a metal film such as an aluminum deposition film, or may be formed using a commercially available mirror-like spray. The presence of the reflective film 22 increases the intensity of the light reflected radially outward from the inclined surface 2y. This makes it possible to more clearly observe the annular convex portion 20D as a light-emitting portion from the abdominal cavity side.

[0048] In the light-emitting section 20E of the cylindrical body 2 shown in Fig. 8, the corners of the distal end of the cylindrical body 2 are rounded so that the entire surface of the light-emitting section 20E comes into close contact with the tissue in the body cavity, and the inner surface 2b and the outer surface 2c of the cylindrical body are smoothly curved and continuous. In addition, the outer peripheral surface of the distal end of this light-emitting section 20E is roughened to form a rough surface p. The rough surface p is preferably formed by blasting. Blasting is a surface roughening technique that forms countless fine scratches on the surface, and can be performed using a laser processing machine, a sandblasting machine, or the like.

[0049] If the outer peripheral surface of the distal end of the cylindrical body 2 is roughened surface p, the light incident on the proximal end of the cylindrical body 2 is diffused from this rough surface p. Therefore, even if this rough surface p is formed on the distal end of the cylindrical body 2, the light emitted from the rough surface 20p can be observed from the abdominal cavity side.

[0050] The light-emitting section 20F of the cylindrical body 2 shown in Fig. 9 has rounded corners at the distal end of the cylindrical body 2 and has a light-diffusing agent-containing layer q formed on the outer circumferential surface of the distal end, similar to the light-emitting section 20E of Fig. 8. As the light-diffusing agent contained in the light-emitting section 20F, a known light-diffusing agent used in lighting fixtures can be used, and for example, micron-sized silicone particles, polystyrene particles, etc. can be used.

[0051] When a light diffusing agent-containing layer q is provided on the outer peripheral surface of the distal end of the cylindrical body 2, light incident on the proximal end of the cylindrical body 2 is diffused from the light diffusing agent-containing layer q. Therefore, by forming the light diffusing agent-containing layer q on the outer peripheral surface of the distal end of the cylindrical body 2, the light emission from the light diffusing agent-containing layer q can be observed from the abdominal cavity side.

[0052] By combining the above-mentioned configurations of the light emitting part (annular convex parts 20A to 20F, rough surface p, and light diffusing agent-containing layer q), the light incident on the proximal end of the cylindrical body may be more strongly emitted radially outward from the cylindrical body at the distal end. For example, the light emitting part 20G shown in Fig. 10 is formed by forming a light diffusing agent-containing layer q on the outer peripheral surface of the distal end of the cylindrical body 2, shaping the distal end like the annular convex part 20A shown in Fig. 2, and blasting the curved surface to form a rough surface p.

[0053] The light-emitting unit 20H of the cylindrical body 2 shown in Fig. 11 has rounded corners at the distal end of the cylindrical body 2, and has an inclined surface 2z on the outer surface 2c of the distal end of the cylindrical body 2, where the outer diameter of the cylindrical body 2 becomes smaller as it approaches the tip of the cylindrical body 2. This inclined surface 2z is linear in the vertical cross section of the cylindrical body. Light is also emitted from the light-emitting unit 20H having this inclined surface 2z to the radially outward direction of the cylindrical body.

[0054] The light emitting section 20I of the cylindrical body 2 shown in FIG. 12 is the light emitting section 20H of FIG. 11, in which the inclined surface 2z is formed from the inner surface 2b of the distal end of the cylindrical body to the outer surface 2c of the distal end of the cylindrical body, and the inclined surface 2z itself is a curved surface that is convex outward. In this way, the inclined surface 2z is preferably formed on almost the entire tip surface of the distal end of the cylindrical body 2. In addition, the shape of the inclined surface 2z in the longitudinal section of the cylindrical body may be a straight line as shown in FIG. 11, but may also be a curve with a small curvature as shown in FIG. 12. In the longitudinal section of the cylindrical body, the origin of the inclined surface 2z is located on the axis of the cylindrical body, and the distance from the origin in the radial direction of the cylindrical body increases as the distance from the origin in the axial direction of the cylindrical body decreases.

[0055] (Luminous scale) The light-emitting insertion tool of the present invention preferably has a luminous scale that emits light incident on the proximal end in a scale-like manner on the outer peripheral surface at a predetermined distance from the light-emitting part at the distal end of the cylindrical body. For example, as in the embodiment of the insertion tool 1A shown in Figures 1C and 1D, an annular convex part 30 can be provided as a luminous scale around the entire circumference of the cylindrical body at a predetermined distance L1 from the light-emitting part (annular convex part) 20A at the distal end of the cylindrical body 2. A plurality of luminous scales (annular convex parts) 30 are formed, and the luminous scales 30 are spaced apart by a predetermined interval L2.

[0056] In this embodiment, each luminous scale 30 is formed in a plane perpendicular to the axis A of the cylindrical body 2. Each luminous scale 30 protrudes in a kamaboko shape in a vertical section (a section cut in the axial direction) of the cylindrical body 2. The protruding length L3 of the luminous scale 30 from the outer surface 2c of the cylindrical body is preferably 1 / 4 to 1 time the wall thickness d1 of the cylindrical body 2. The width L4 of the luminous scale in the direction of the axis A is preferably 1 / 4 to 1 time the wall thickness d1 (FIG. 1D).

[0057] The luminous scale 30 may be formed by adhering a ring made of hard rubber such as transparent silicone rubber to the cylindrical body 2, or may be molded integrally with the cylindrical body 2 using the same resin as the cylindrical body 2.

[0058] In addition, as the luminous scale, a band-like rough surface may be formed on the outer surface of the cylindrical body in the circumferential direction, or a light diffusing agent-containing layer may be provided. The rough surface for the luminous scale can be formed by blasting or the like in the same manner as the rough surface 20p of the distal end described above, and the light diffusing agent-containing layer can be formed in the same manner as the light diffusing agent-containing layer 20q of the distal end described above.

[0059] These configurations (annular convex portion 30, rough surface, light diffusing agent-containing layer) may be appropriately combined. For example, the surface of the annular convex portion 30 may be blasted to form a luminous scale, or a light diffusing agent-containing layer having annular convex portion 30 formed thereon may be used as a luminous scale.

[0060] By providing the luminous scale 30 on the cylindrical body 2, as shown in the examples described later, when light incident from the proximal end of the cylindrical body 2 is emitted from the light emitting part 20 at the distal end, light is also emitted from the luminous scale 30 to the radially outward direction of the cylindrical body, and the resulting light emitting part can be observed in the form of a scale from the abdominal cavity side. Therefore, the light emitting part of the luminous scale 30 can be used as a scale marker when treating the wall of the vagina or rectum from the serosal side at a desired position from the light emitting part (annular convex part) 20 at the distal end.

[0061] 1A, 1B, 1C, and 1D, the insertion device 1B has luminous marks (annular convex portions) 30 provided equidistantly around the entire circumference from the luminous portion (annular convex portion) 20A at the distal end. Therefore, the surface surrounded by the luminous marks (annular convex portions) 30 is inclined with respect to the axis A of the cylindrical body 2, similar to the opening surface 2a of the cylindrical body 2. In the insertion device 1B, the luminous portion (annular convex portion) 20A at the distal end and the luminous marks (annular convex portion) 30 are integrally formed with the cylindrical body 2.

[0062] By providing the luminous scale 30 at an equal distance from the annular protrusion 20A at the distal end around its entire circumference in this manner, it becomes easier to determine the distance from the vaginal vault.

[0063] In the insertion device of the present invention, the various modified embodiments described above can be combined as appropriate. EXAMPLES

[0064] Luminescence test 1 The insertion tool 1A shown in Figures 1A, 1B, 1C, and 1D was made using a Vagi pipe (medium size) (pipe outer diameter 35 mm, inner diameter 29 mm, pipe effective length 180 mm) manufactured by Hakko Co., Ltd. That is, eight surface-mounted chip LEDs 11 (diameter 3 mm, emission wavelength 850 nm (near infrared) or 624 nm (red)) were arranged in a ring shape on the end face of the Vagi pipe on the handle side (i.e., the proximal end of the cylindrical body 2) and fixed with an acrylic adhesive. Each chip LED 11 was connected to a battery 14 in a battery box 13. Moreover, the annular protrusion 20A of the cylindrical body 2 was formed so as to have the cross section shown in FIG.

[0065] The prepared insertion tool 1A was covered with a 4 mm thick, light orange, silicone resin skin sheet, and each chip LED 11 was turned on. The skin sheet was photographed diagonally above the cylindrical body in a dark room with a near-infrared observation camera.

[0066] As a result, in both cases where the LED emission wavelength was 850 nm and 624 nm, the light emission from the light-emitting part (annular convex part) 20A at the distal end of the cylindrical body 2 and the light emission from the light-emitting scale (annular convex part) 30 could be clearly confirmed on the human skin sheet. The image in the case of 850 nm is shown in Figure 17.

[0067] Luminescence test 2 In the insertion tool of luminescence test 1, an insertion tool (with tip R processing) was produced in which the luminescent scale (annular convex portion) 30 was not provided, and the luminescent portion at the distal end of the cylindrical body 2 was processed into the cross section shown in Figure 2. In addition, an insertion tool (without tip R processing) was produced in the same manner, except that no tip R processing was performed on the distal end of the cylindrical body 2, and the distal end had the cross section shown in Figure 13.

[0068] The insertion tools prepared with and without tip R were covered with a skin sheet in the same manner as in luminescence test 1, the LED was turned on, and the skin sheet was photographed with a near-infrared observation camera in a dark room. The results are shown in FIG. 18A (with tip R processing) and FIG. 18B (without tip R processing).

[0069] In Fig. 18A, the luminance (256 gradations) of the light-emitting part exceeded 240, whereas the luminance of the light-emitting part in Fig. 18B was 195. Since the luminance exceeding 240 was over-range for the camera used to take the photograph, it is believed that the actual luminance intensity ratio was 240 / 195 or more. From these results, it was confirmed that the light intensity observed through the human skin sheet was increased by processing the tip R. [Explanation of symbols]

[0070] 1A, 1B Insertion tool with light source 2. Cylindrical body 2a Opening surface of cylindrical body 2b Inner surface of cylindrical body 2c Outer surface of the cylindrical body 2r: The area from the corner of the distal end to the proximal end 2x tip of the distal end of the tubular body 2y slope 2z slope 3 Handle 4 Cap 4a opening 4b Stopper 10 Light source, ring-shaped lighting 11 Chip LED 12 Ring-shaped member 13 Battery box 14 Batteries 20, 20A, 20B, 20C, 20D, 20E, 20F, 20G, 20H Illuminating part (annular convex part) 21 Curved surface 22 Reflective film 30 Luminous scale, annular protrusion for luminous scale 100 Vagina 101 Vaginal vault 110 Uterus 120 Body cavity tissues 200 Endoscope A: Axis of cylindrical body B Light-emitting unit L1 Distance between the annular protrusion and the annular protrusion for the luminous scale L2 Distance between luminous scale annular projections L3 Length of projection of annular projection for luminous scale L4 Width of the annular projection for the luminous scale in the direction of axis A P1 Inner end point of the surface P2 Outer end point of the surface P3 Outer protruding point of a surface X Separation line d1 wall thickness of the cylindrical body d2 Thickness of the annular protrusion d3 Difference between the thickness d2 of the annular protrusion and the wall thickness d1 of the cylindrical body p Rough surface q Light diffusing agent-containing layer s gap

Claims

[Claim 1] An insert for insertion into a natural orifice of the body, comprising: a light source that emits light without passing through an optical fiber at a proximal end of a cylindrical body formed of a light-conducting resin, and a light-emitting unit that is at a distal end of the cylindrical body separated from the proximal end; the distal end has rounded corners so that the insertion tool fits closely to tissue within the body cavity when inserted into a natural opening in the body; The light-emitting portion is a rough surface formed by blasting on the rounded corners of the distal end and on the outer peripheral surface adjacent to the corners, and the light-source-equipped insertion tool emits light incident on the proximal end radially outwardly of the cylindrical body at the rough surface of the distal end.

Images