Insertion tool with light source

Abstract

The present invention provides an insertion tool for insertion into a natural opening of the body, such as the vagina or rectum, that efficiently and safely introduces light into tissue within a body cavity from the distal end of the insertion tool while the insertion tool is inserted into the body, thereby enabling the light that has entered the tissue within the body cavity from the distal end to be clearly observed from the abdominal cavity side. The insertion tool 1A for insertion into a natural opening of the body has a light source 10 at the proximal end of a tubular body 2 formed of a light-guiding resin, and a light-emitting unit at the distal end. The light-emitting unit at the distal end has a structure that allows light that has entered the proximal end to be emitted with high intensity from the light-emitting unit at the distal end radially outward from the tubular body 2. An example of the light-emitting unit at the distal end is an annular convex portion 20A that is convex radially outward from the tubular body 2 and has a curved surface 21 that comes into close contact with tissue within the body cavity.

Description

[Technical Field]

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

[0002] Laparoscopic hysterectomy typically involves cutting the round ligament, infundibular ligament, uterosacral ligament, uterine artery, and ovarian artery, as well as 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 top of the vagina). Under laparoscopic observation, the uterus is separated from the vaginal canal at or near the vaginal vault using a scalpel inserted into the abdominal cavity, removed from the body, and the vaginal incision is closed with sutures. The line along which the uterus is separated is called the "resection line." It is important to determine the resection line to enable minimally invasive hysterectomy. However, because the vaginal vault cannot be directly visualized through abdominal observation, determining the resection line is difficult.

[0003] Conventionally, the method for determining the resection line involves inserting a finger or a rigid pipe (commercially available products such as the Vagi-Pipe manufactured by Hakko Co., Ltd.) described in Patent Document 1 or the like into the body transvaginally, 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 inside the abdominal cavity while moving the rigid pipe. However, this method only allows for a rough estimate of the actual position of the 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 transvaginally into the body, 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 inside the abdominal cavity to determine the resection line (Patent Document 2), and 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 inside 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 inserted into the vagina, and the LEDs are made to emit light by supplying power from outside the body via wiring, and the light transmitted 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 that 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 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 involved in using the LED as a medical device due to the risk of electric shock and the risk of temperature rise in the device inside the body. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] Japanese Patent Application Laid-Open No. 2004-41395 [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] Japanese Patent Publication No. 2017-202317 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 the tissue within the body cavity from the distal end of the insertion tool while the insertion tool 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 cylindrical body made of a light-conducting resin, a light source is placed directly at the proximal end of the cylindrical body, 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 cylindrical 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 increases as it travels radially outward from the cylindrical body, making it easier to confirm the light emitted from the tissue inside the body cavity from the serous membrane side of the tissue inside the body cavity, and have completed the present invention.

[0010] That is, the present invention provides an insertion tool to be inserted into a natural opening of the body, comprising: Provided is an insertion tool with a light source, which has a light source at the proximal end of a cylindrical body formed of a light-conducting resin and a light-emitting section at the distal end, and which has a structure in which light incident on the proximal end is emitted at the distal end radially outward of the cylindrical body with high intensity. [Effects of the Invention]

[0011] 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 unit 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 optical fibers.

[0012] Furthermore, the light-emitting unit at the distal end is configured to emit light incident on the proximal end radially outward of the cylindrical body with high intensity. 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 unit can be clearly observed from the serous membrane side of the tissue in the body cavity at the insertion site, making it easy to determine the resection line from the serous membrane side.

[0013] Furthermore, in this insertion tool, the light source is provided at the proximal end of the tubular body, so 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 explanation of the drawings]

[0014] [Figure 1A] FIG. 1A is a perspective view of an embodiment of an insertion tool with a light source 1A with an open cap, 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 arrow a, and a view taken along arrow b of the light-emitting insertion tool 1A of the embodiment with the cap open. [Figure 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-emitting insertion instrument 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-equipped 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 uterine incision line determined in the deep vagina into which the light-equipped insertion tool 1A of the embodiment has been inserted. [Figure 5] FIG. 5 is a longitudinal cross-sectional view of the annular protrusion formed as the light-emitting portion 20B at the distal end of the light-sourced insertion tool of the embodiment, illustrating the function of the annular protrusion. [Figure 6] FIG. 6 is a longitudinal cross-sectional view of the annular protrusion formed as the light-emitting portion 20C at the distal end of the light-emitting insertion tool of the embodiment, illustrating the function of the annular protrusion. [Figure 7] FIG. 7 is a longitudinal cross-sectional view of the annular protrusion formed as the light-emitting portion 20D at the distal end of the light-emitting insertion tool of the embodiment, illustrating the function of the annular protrusion. [Figure 8] FIG. 8 is a vertical cross-sectional view of a blasted portion, which illustrates the function of the blasted portion formed as the light-emitting portion 20p 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 the light diffusing agent-containing layer formed as the light emitting portion 20q at the distal end of the light-sourced insertion tool of the embodiment. [Figure 10] FIG. 10 is a longitudinal cross-sectional view of the light-emitting portion 20Apq, which is an annular convex portion formed in association with the light-emitting portion 20Apq at the distal end of the light-sourced insertion device of the embodiment, and which shows the effect of the light-emitting portion 20Apq having a blasted portion and containing a light diffusing agent. [Figure 11] FIG. 11 is a longitudinal cross-sectional view showing the function of the distal end of the light-emitting insertion tool of the comparative example. [Figure 12] FIG. 12 is a longitudinal cross-sectional view showing the function of the distal end of the light-emitting insertion tool of the comparative example. [Figure 13A] FIG. 13A is a side view of an insertion tool 1B of the embodiment. [Figure 13B] FIG. 13B is a cross-sectional view of the insertion tool 1B of the embodiment. [Figure 14] FIG. 14 is a photograph of a light emission test of the insertion device 1A of the example covered with a skin-care sheet. [Figure 15A] FIG. 15A is a photograph of a light emission test of an insertion tool with a rounded tip. [Figure 15B] FIG. 15B is a photograph of a light emission test of an insertion tool without tip rounding. DETAILED DESCRIPTION OF THE INVENTION

[0015] The following describes in detail the light-emitting insertion device (hereinafter simply referred to as the "insertion device") of the present invention with reference to the drawings, taking as an example a vaginal insertion device used in laparoscopic total hysterectomy surgery, etc. In each drawing, the same reference numerals represent the same or equivalent components.

[0016] The insertion device of the present invention is not limited to being used in the vagina, but can also be configured as an insertion device to be inserted into a natural opening of the body such as the rectum.

[0017] (Overall structure) 1A, 1B, 1C, and 1D, a vaginal light-equipped insertion device 1A according to one 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 direction of axis A is determined so that the proximal end of the tubular body 2 is outside the body when inserted into the vagina, and is set to, for example, 180 mm or more. The wall thickness d1 of the tubular body 2 is preferably about 2 to 4 mm.

[0018] The distal end of the cylindrical body 2 is open, and the opening surface 2a is inclined with respect to the axis A of the cylindrical body 2 in accordance with the fact that the posterior vaginal fornix is ​​located deeper than the anterior vaginal fornix.

[0019] A handle 3 is attached near the proximal end of the cylindrical body 2 as needed, and a cap 4 is fitted on it. An opening 4a is formed in the center of the cap 4 for inserting an instrument used during surgery, 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.

[0020] On the other hand, the insertion device 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 light incident from the light source at the proximal end to the distal end.

[0021] Here, examples of the light-conducting resin that can be used include polymethyl methacrylate, polycarbonate, and polystyrene.

[0022] As a light source, the insertion tool 1A of this embodiment is provided with a ring-shaped illuminator 10 embedded with a plurality of chip LEDs 11. The light-emitting surface of the chip LEDs 11 of this ring-shaped illuminator 10 faces the distal end of the cylindrical body 2.

[0023] Furthermore, the insertion tool 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 causes light incident on the proximal end to be emitted radially outward at the distal end of the cylindrical body with high intensity. In other words, a major component of this structure is that the intensity of light emitted radially outward from the cylindrical body is stronger in the intensity distribution of light emitted from the distal end.

[0024] The light-emitting portion at the distal end can have a variety of configurations as long as it can emit light incident on the proximal end radially outward at the distal end with high intensity. For example, the light-emitting insertion tool 1A of this embodiment has a light-emitting portion 20A at its distal end that is an annular convex portion that is convex on the radially outward side of the tubular body 2. This light-emitting portion (annular convex portion) 20A has a curved surface 21 that comes into close contact with the tissue inside the body cavity when the insertion tool 1A is inserted into the body cavity. Because the curved surface 21 is convex on the radially outward side of the tubular body 2, light emitted by the light source 10 can be emitted from the light-emitting portion (annular convex portion) 20A radially outward from the tubular body 2 with high intensity. Moreover, because 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 and passes through the tissue inside the body cavity without any loss of light intensity in the gap between the curved surface 21 and the tissue inside the body cavity. Therefore, it is possible to clearly observe the light-emitting portion inside the body cavity using a laparoscope inserted into the body cavity on the serous membrane side of the intracavity tissue.

[0025] (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. An LED or the like is preferably used as the light source. The light source 10 is preferably used with its light-emitting surface facing the end face of the proximal end of the cylindrical body 2. More specifically, as shown in FIG. 1D , multiple chip LEDs 11 are arranged in a ring shape along the end face of the proximal end of the cylindrical body 2 with their light-emitting surfaces facing the end face. In this case, the chip LEDs 11 may be embedded in a ring-shaped member 12 made of a resin having a refractive index similar to that of the cylindrical body 2, with the light-emitting surfaces of the chip LEDs 11 facing 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 together using an adhesive having a refractive index similar to that of the cylindrical body 2. Alternatively, the chip LEDs 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.

[0026] 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.

[0027] It is also preferable to provide a battery box 13, which houses a battery 14 that serves as the 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 prevents the wiring of the light source 10 from interfering with the surgical procedure.

[0028] (Annular convex part) 2 is a longitudinal cross-sectional view (cross-sectional view taken along the axis A of the cylindrical body) of the annular protrusion 20A at the distal end of the insertion device 1A when the insertion device 1A of the embodiment is inserted into the vagina 100 and the annular protrusion 20A 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 rather protrudes radially outward of the cylindrical body 2 beyond the outer end point P2 of the arc that forms the curved surface 21. Furthermore, 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 the curved surface 21 is shaped to fit closely to the intracavity tissue 120 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.

[0029] More specifically, in the cross-sectional view shown in FIG. 2 , the inner end point P1 of the curved surface 21 is located on the inner surface 2b of the cylindrical body 2, and the curved surface 21 is located radially outward of the cylindrical body 2 relative to the inner end point P1. The curved surface 21 is an approximately ¾-circle arc (θ1: 240-285°) formed within the wall thickness of the cylindrical body 2. The curved surface 21 continues approximately ¼ of a circle (θ2: 60-105°) proximal to the outer protrusion point P3, which protrudes most radially outward. Therefore, when the cylindrical body 2 is pressed against the vaginal vault 101, substantially the entire surface of the curved surface 21 adheres closely to the tissue within the body cavity. While the entire surface of the curved surface 21 does not necessarily adhere closely to the tissue within the body cavity, it is preferable that the outer protrusion point P3, its inner end point P1 side, and its outer end point P2 side, preferably the protrusion region including the central portion of the outer protrusion point P3, adhere closely.

[0030] When the insertion tool 1A having the annular protrusion 20A at its distal end shown in Fig. 2 is transvaginally pressed against the vaginal vault 101, the light source 10 at its proximal end is turned on, and light is emitted from the annular protrusion 20A at its distal end, the light diffuses upward (in the direction of axis A) and to the side as indicated by the arrows in the figure, and diffuses with particularly strong light intensity diagonally to the side. 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 light-emitting portion B with the endoscope 200, and as shown in Fig. 3B, the resection line X can be appropriately determined.

[0031] 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, it is possible to observe the light-emitting part B in accordance with the position of the vaginal vault 101. Therefore, as shown in Figure 4B, it is possible to appropriately determine the incision line X.

[0032] In contrast, when the distal end 2x of the cylindrical body 2 is a flat surface perpendicular to the axial direction A, as in the comparative insertion tool shown in Figure 11, the intensity of light incident from a light source at the proximal end of the cylindrical body 2 at the distal end 2x is strong in the axial direction A, and the intensity of light emitted laterally is weak. Furthermore, as shown in the enlarged view in the same figure, the cylindrical body 2 is not in close contact with the tissue 120 inside the body cavity in a region 2r from the corner of the distal end 2x toward the proximal end. Because the refractive index of the cylindrical body 2 (e.g., 1.49 for acrylic resin), the refractive index of the tissue inside the body cavity (the refractive index of biological tissue is approximately 1.55, and the refractive index of the water contained therein is 1.33), and the refractive index of the gap between them (the refractive index of air is 1.00) are different, reflection occurs at these interfaces, and the intensity of light passing through the tissue inside the body cavity from the distal end 2x to the side of the cylindrical body 2 becomes even weaker. This makes it difficult to observe the light emitted from the distal end 2x 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.

[0033] Furthermore, when the corners of the distal end 2x of the tubular body 2 are simply rounded as in the insertion tool of the comparative example shown in Fig. 12, the diffusion of light emitted from the distal end 2x becomes stronger than in the case shown in Fig. 11, but the intensity of the light emitted to the sides of the tubular body 2 is weaker. For this reason, simply rounding the corners of the distal end 2x of the tubular body 2 still makes it difficult to observe the light emitted from the distal end 2x as a light-emitting portion from the abdominal cavity side.

[0034] (Deformation of the light emitting part at the distal end) 3A or 3B, in order to enable clear observation from the abdominal cavity side of light emitted from an 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 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 at least ¼ of the wall thickness d1.

[0035] 5, in order to improve the adhesion between the annular protrusion 20B and the tissue inside 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 to 70°) on the proximal side of the outer protrusion point P3.

[0036] The annular protrusion 20C at the distal end of the cylindrical body 2 shown in FIG. 6 is different from the annular protrusion 20A shown in FIG. 2 in that the distal end of the inner surface 2b of the cylindrical body 2 is inclined so that the opening diameter of the inner surface 2b of the cylindrical body 2 increases toward the tip of the cylindrical body 2. The inclination angle θ3 is preferably 35 to 60° from the direction of the axis A. The formation of this inclined surface 2y allows light incident on the proximal end of the cylindrical body 2 to be reflected radially outward from the inclined surface 2y and then emitted radially outward from the curved surface 21 of the cylindrical body 2. This increases the intensity of the light emitted radially outward. Therefore, when light is emitted from the annular protrusion 20C shown in FIG. 6 to tissue within the body cavity, the light-emitting portion of the tissue within the body cavity can be clearly observed from the abdominal cavity side.

[0037] The annular protrusion 20D at the distal end of the cylindrical body 2 shown in FIG. 7 is the annular protrusion 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 vapor deposition film, or may be formed using a commercially available mirror-like spray. The presence of the reflective film 22 increases the intensity of light reflected radially outward from the inclined surface 2y. This allows the annular protrusion 20D to be more clearly observed as a light-emitting area from the abdominal cavity side.

[0038] The light-emitting section 20p of the cylindrical body 2 shown in Fig. 8 has rounded corners at the distal end of the cylindrical body 2 and a rough outer circumferential surface at the distal end. The rough surface is preferably formed by blasting. Blasting is a surface roughening technique that creates countless fine scratches on the surface, and can be performed using a laser processing machine, a sandblasting machine, or the like.

[0039] When the outer peripheral surface of the distal end of the cylindrical body 2 is roughened 20p, light incident on the proximal end of the cylindrical body 2 is diffused from this roughened surface 20p. Therefore, even when this roughened surface 20p is formed on the distal end of the cylindrical body 2, the light emitted from the roughened surface 20p can be observed from the abdominal cavity side.

[0040] 9, the light-emitting section 20q of the cylindrical body 2 has rounded corners at the distal end of the cylindrical body 2 and a light-diffusing agent-containing layer formed on the outer peripheral surface of the distal end. As the light-diffusing agent contained in the light-emitting section 20q, a known light-diffusing agent used in lighting fixtures can be used, such as micron-sized silicone particles or polystyrene particles.

[0041] When the light diffusing agent-containing layer 20q 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 20q. Therefore, by forming the light diffusing agent-containing layer 20q on the outer peripheral surface of the distal end of the cylindrical body 2, the luminescence of the light diffusing agent-containing layer 20q can be observed from the abdominal cavity side.

[0042] By combining the above-described configurations of the light-emitting section (annular convex sections 20A-20D, rough surface 20p, and light-diffusing agent-containing layer 20q), light incident on the proximal end of the cylindrical body may be more strongly emitted radially outward from the distal end of the cylindrical body. For example, light-emitting section 20Apq shown in Fig. 10 has a light-diffusing agent-containing layer formed on the outer peripheral surface of the distal end of cylindrical body 2, and the distal end is molded into annular convex section 20A shown in Fig. 2, with the curved surface being blasted.

[0043] (Luminous scale) The light-emitting insertion device of the present invention preferably has a luminous scale on the outer surface of the cylindrical body at a predetermined distance from the light-emitting portion at the distal end, which emits light incident on the proximal end in the form of a scale. For example, as in the example insertion device 1A shown in Figures 1C and 1D, annular convex portions 30 can be provided as luminous scales around the entire circumference of the cylindrical body at a predetermined distance L1 from the light-emitting portion (annular convex portion) 20A at the distal end of the cylindrical body 2. A plurality of luminous scales (annular convex portions) 30 are formed, and the luminous scales 30 are spaced a predetermined distance L2 apart.

[0044] 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 semi-cylindrical shape in a longitudinal 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.

[0045] 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.

[0046] The luminous scale may be formed by forming a band-like rough surface 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, similar to 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.

[0047] These configurations (annular convex portion 30, rough surface, light diffusing agent-containing layer) may be combined as appropriate. 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 on which the annular convex portion 30 is formed may be used as a luminous scale.

[0048] By providing the luminous scale 30 on the cylindrical body 2, as will be shown in the examples described later, when light incident from the proximal end of the cylindrical body 2 is emitted from the light-emitting unit 20 at the distal end, light is also emitted from the luminous scale 30 radially outward from the cylindrical body, and the resulting light-emitting unit can be observed as a scale from the abdominal cavity side. Therefore, the light-emitting unit formed by the luminous scale 30 can be used as a scale marker when treating the vaginal or rectal wall from the serous membrane side at a desired position from the light-emitting unit (annular convex portion) 20 at the distal end.

[0049] 1A, 1B, 1C, and 1D, the insertion device 1B shown in Figures 1A, 1B, 1C, and 1D has luminous scales (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 each luminous scale (annular convex portion) 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) 20 at the distal end and the luminous scale (annular convex portion) 30 are integrally molded with the cylindrical body 2.

[0050] By providing the luminous scale 30 at an equal distance from the annular protrusion 20 at the distal end around its entire circumference, it becomes easier to determine the distance from the vaginal vault.

[0051] In the insertion device of the present invention, the various modified embodiments described above can be combined as appropriate. [Example]

[0052] Luminescence test 1 The insertion device 1A shown in Figures 1A, 1B, 1C, and 1D was fabricated using a Vagi pipe (medium size) manufactured by Hakko Co., Ltd. (pipe outer diameter: 35 mm, inner diameter: 29 mm, effective pipe length: 180 mm). Eight surface-mounted chip LEDs (diameter: 3 mm, emission wavelength: 850 nm (near infrared) or 624 nm (red)) were arranged in a ring shape on the handle-side end face of the Vagi pipe (i.e., the proximal end of the cylindrical body 2) and fixed with acrylic adhesive. Each chip LED 11 was connected to a battery 14 in a battery box 13. The annular projection 20 of the cylindrical body 2 was formed in a cross section shown in FIG.

[0053] The manufactured 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 in a dark room from diagonally above the cylindrical body using a near-infrared observation camera.

[0054] 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) 20 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 skin sheet. The image in the case of 850 nm is shown in Figure 14.

[0055] Luminescence test 2 In the insertion device of luminescence test 1, an insertion device (with tip R processing) was produced in which the luminous scale (annular convex portion) 30 was not provided and the luminous portion at the distal end of the cylindrical body 2 was processed into the cross section shown in Figure 2. In addition, an insertion device (without tip R processing) was produced in the same manner except that the distal end of the cylindrical body 2 was not processed into the rounded tip at all and the cross section of the distal end was shown in Figure 11.

[0056] The prepared insertion tools with and without tip rounding were each covered with a skin-touching sheet in the same manner as in Light Emission Test 1, the LED was turned on, and the skin-touching sheet was photographed in a dark room with a near-infrared observation camera. The results are shown in FIG. 15A (with tip R processing) and FIG. 15B (without tip R processing).

[0057] In Figure 15A, the brightness (256 levels) of the light-emitting area exceeded 240, whereas in Figure 15B the brightness was 195. Because brightness levels above 240 were over-range for the camera used to take the photographs, the actual brightness intensity ratio was thought to be 240 / 195 or higher. From these results, it was confirmed that the light intensity observed through the human skin sheet was increased by processing the tip into a rounded shape. [Explanation of symbols]

[0058] 1A, 1B Insertion tool with light source 2. Cylindrical body 2a Opening surface of the 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 distal end of the cylindrical body 2y slope 3 Handle 4 Cap 4a opening 4b Stopper 10 light sources, ring-shaped lighting 11 Chip LED 12 Ring-shaped member 13 Battery box 14 Batteries 20A, 20B, 20C, 20D Light-emitting part (annular convex part) 20p Light-emitting part (rough surface) 20q Light-emitting part (light-diffusing agent-containing layer) 21 Curved surface 22 Reflective film 30 Illuminated 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 part L1 Distance between the annular projection and the annular projection for the luminous scale L2 Distance between the annular projections for the luminous scale L3 Projection length of annular convex part 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 Outward projecting point of the surface X Separation line d1 wall thickness of the cylindrical body d2 Thickness of the annular projection d3 The difference between the thickness of the annular projection d2 and the wall thickness d1 of the cylindrical body

Claims

1. An insert for insertion into a natural orifice of the body, comprising: An insertion device with a light source having a proximal end of a cylindrical body formed of a light-conducting resin, which has a light source that 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 that is incident at the proximal end radially outward of the cylindrical body at the distal end with high intensity, the light-emitting unit having a single annular convex portion that is convex radially outward of the cylindrical body and has a curved surface that fits closely to tissue within the body cavity, and in a longitudinal cross section of the cylindrical body, the curved surface is formed within the wall thickness of the cylindrical body.

2. An insert for insertion into a natural orifice of the body, comprising: An insertion device with a light source having a proximal end of a cylindrical body formed of a light-conducting resin, which has a light source that 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 that is incident at the proximal end radially outward of the cylindrical body at the distal end with high intensity, the light-emitting unit having a single annular convex portion that is convex radially outward of the cylindrical body and has a curved surface that fits closely to tissue within a 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, the difference being 1 / 4 or more of the wall thickness of the cylindrical body.

3. An insertion tool as described in claim 1 or 2, wherein the inner end point of the arc of the curved surface in the longitudinal section of the cylindrical body is on the inner surface of the cylindrical body.

4. An insertion tool as described in claim 1 or 2, wherein the tip portion of the inner surface of the cylindrical body is inclined so that the opening diameter of the inner surface of the cylindrical body becomes wider as it approaches the tip of the cylindrical body.

5. 3. The insertion tool according to claim 1, wherein the outer surface of the cylindrical body at the light emitting portion at the distal end is rough.

6. 3. The insertion tool according to claim 1, wherein the light-emitting portion at the distal end contains a light diffusing agent.

7. 3. The insertion tool according to claim 1, wherein the cylindrical body has a luminous scale on its outer circumferential surface at a predetermined distance from the light emitting portion at the distal end, the luminous scale emitting light incident on the proximal end in a scale pattern.

8. 8. The insertion tool according to claim 7, wherein the luminous scale comprises an annular protrusion formed in the circumferential direction on the outer surface of the cylindrical body.

9. 8. The insertion tool according to claim 7, wherein the luminous scale has a roughened surface formed in a band shape in the circumferential direction on the outer surface of the cylindrical body.

10. 8. The insertion tool according to claim 7, wherein the luminous scale has a light diffusing agent-containing portion formed in a band shape in the circumferential direction on the outer surface of the cylindrical body.

11. 3. The insertion tool according to claim 1, wherein the light emitting surface of the chip LED is in contact with the proximal end of the cylindrical body, and a battery box is provided at the proximal end.

Images