Insertion tool

The insertion tool with a fluorescent light-emitting feature and design improvements addresses the challenge of guiding the resection position, enabling precise and efficient laparoscopic hysterectomies by enhancing visibility and operational control.

WO2026134031A1PCT designated stage Publication Date: 2026-06-25TERUMO KK +1

Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
TERUMO KK
Filing Date
2025-12-09
Publication Date
2026-06-25

AI Technical Summary

Technical Problem

Existing insertion tools for laparoscopic hysterectomy procedures face challenges in accurately guiding the resection position due to difficulty in visually identifying the lifted vaginal part from the ventral side during surgery.

Method used

An insertion tool with a tubular main body featuring a light-emitting portion that emits fluorescence, allowing surgeons to clearly visualize the resection position from inside the vagina, combined with protrusions to prevent gas leakage and a grippable handle for easy operation.

Benefits of technology

Enhances the surgeon's ability to accurately confirm the resection position, facilitating smoother and more precise laparoscopic hysterectomy procedures.

✦ Generated by Eureka AI based on patent content.

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Abstract

[Problem] To provide an insertion tool that enables an operator to easily and accurately confirm a portion serving as a reference for the site of uterine resection. [Solution] An insertion tool 10 includes a cylindrical body part 100 to be inserted into the vagina N. The body part includes: a lumen 105; a first portion 110 provided to a portion including a tip 101 where a tip opening 101a communicating with the lumen is located; and a second portion 120 located closer to the base end side than the first portion. At least a part of the first portion has a light-emitting part 130 that emits light by fluorescence.
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Description

Insertion tool

[0001] The present invention relates to an insertion tool.

[0002] Conventionally, an insertion tool (transvaginal tube) used in a procedure for removing the uterus under laparoscopy or the like (for example, "total laparoscopic hysterectomy") is known. Patent Document 1 discloses an insertion tool including a tubular main body (tube body) inserted into the vagina through the vaginal opening.

[0003] In a procedure using the insertion tool of Patent Document 1, when the surgeon removes the uterus, the surgeon supports a part of the vagina to be lifted by pressing the tip of the main body inserted into the vagina against the vagina. The surgeon can smoothly proceed with the removal of the uterus from the ventral access by checking the supported part of the vagina under laparoscopy or the like from the ventral side and using the supported part of the vagina as a guide for the resection position (the cutting position between the vagina and the uterus).

[0004] JP-A-2004-41395

[0005] However, when the surgeon checks the part serving as a guide for the resection position from the ventral side outside the vagina, it is often not easy to grasp the lifted part of the vagina only from the appearance.

[0006] The present invention aims to solve the above problems and provides an insertion tool that enables the surgeon to easily and accurately check the part serving as a guide for the resection position of the uterus.

[0007] The above object of the present invention is achieved by any one of the following means (1) to (7).

[0008] (1) An insertion tool having a tubular main body inserted into the vagina, the main body having a lumen, a first part provided in a part including a tip where a tip opening communicating with the lumen is located, and a second part located on the proximal side of the first part, and at least a part of the first part having a light-emitting part that emits light by fluorescence.

[0009] (2) The insertion tool according to (1), wherein the light-emitting part is continuously provided over a predetermined range in the axial direction from the tip to the proximal side of the main body.

[0010] (3) The insertion device according to (1) or (2), wherein the outer circumferential surface of the main body portion at a position closer to the base end than the tip portion is provided with a projection that protrudes in a direction away from the central axis of the main body portion.

[0011] (4) The insertion device according to any one of (1) to (3), having a grippable handle portion provided at the base of the main body or near the base end thereof.

[0012] (5) An insertion device according to any one of (1) to (4), having a cylindrical main body portion that is inserted into the vagina, wherein the main body portion has a lumen and a tip portion where a tip opening communicating with the lumen is located, and a fluorescent light-emitting member is provided on the outer circumferential surface of the main body portion at a predetermined position in the axial direction from the tip portion toward the proximal end.

[0013] (6) The insertion device according to (5), wherein the light-emitting member is made of a separate component from the main body.

[0014] (7) The inserting device according to (5) or (6), wherein the light-emitting member constitutes a projection that protrudes from the outer circumferential surface of the main body.

[0015] The above-described insertion device has a luminescent portion, at least a part of which is located at the tip of the main body and emits fluorescence. During laparoscopy, the surgeon can more easily and accurately confirm the position of vaginal resection by visualizing the luminescent portion, along with the part lifted by the main body, from inside the vagina. This allows the surgeon to perform procedures such as laparoscopic hysterectomy more smoothly.

[0016] This is a perspective view showing an insert according to an embodiment of the present invention. This is a side view of the insert. This is a schematic diagram showing an example of use of the insert. This is a schematic diagram showing an example of use of the insert. This is a perspective view showing an insert according to Modification 1. This is a side view showing a part of the insert according to Modification 1. This is a perspective view showing an insert according to Modification 2. This is a side view showing a part of the insert according to Modification 2. This is a perspective view showing an insert according to Modification 3. This is a side view showing a part of the insert according to Modification 3. This is a perspective view showing an insert according to Modification 4. This is a side view showing a part of the insert according to Modification 4.

[0017] Embodiments of the present invention will be described below with reference to the attached drawings. Note that the following description does not limit the technical scope or the meaning of terms as defined in the claims. Furthermore, the dimensional ratios in the drawings are exaggerated for illustrative purposes and may differ from actual ratios.

[0018] An inserting device 10 according to an embodiment of the present invention will be described with reference to Figures 1 to 4.

[0019] Figures 1 and 2 show the insert 10 according to an embodiment. Figures 3 and 4 are schematic diagrams illustrating an example of how to use the insert 10.

[0020] In this specification, the longitudinal direction in which the main body portion 100 of the insertion device 10 extends is defined as the "axial direction," and is indicated by arrows X1-X2 in each figure. Furthermore, in the insertion device 10, the side that is inserted into the vagina N (the side indicated by arrow X1) is defined as the tip side, and the side that is operated by the hand, located opposite the tip side (the side indicated by arrow X2), is defined as the base end side.

[0021] <Insertion device 10> As shown in Figures 3 and 4, the insertion device 10 can be used in a procedure to remove a patient's uterus (for example, laparoscopic total hysterectomy). With at least a part of the main body 100 of the insertion device 10 inserted into the vagina N, the surgeon can place various medical instruments in the vagina N via the insertion device 10, or use the insertion device 10 to support the excision of the uterus U from the ventral side using a surgical instrument 300 such as a scalpel, or to suture the vaginal stump.

[0022] As shown in Figures 1 to 4, the insertion device 10 has a cylindrical main body portion 100 that is inserted into the vagina N through the opening of the vagina N.

[0023] As shown in Figures 1 and 2, the main body portion 100 has a lumen 105, a first portion 110 provided in the portion including the tip 101 where the tip opening 101a communicating with the lumen 105 is located, and a second portion 120 located on the proximal end side of the first portion 110.

[0024] As shown in Figure 1, the base end 103 of the main body 100 is provided with a base end opening 103a that communicates with the lumen 105.

[0025] The lumen 105 connects the tip opening 101a located at the tip 101 of the main body 100 with the base opening 103a located at the base 103.

[0026] The axial length L1 of the main body 100 (the straight-line distance from the tip of the main body 100 to the base) can be formed to be, for example, 100 mm to 300 mm. When the axial length L1 of the main body 100 is the above length, the axial length of the first part 110 (the straight-line distance from the tip of the main body 100 shown in Figure 2 to a position further forward than the projection 160 located at the tip) can be formed to be, for example, 5 mm to 50 mm.

[0027] The insertion device 10 has a lid member 150 that can open and close the base end opening 103a of the main body portion 100.

[0028] In procedures using the insertion device 10, the surgeon can insert various medical instruments into the lumen 105 through the proximal opening 103a while the main body 100 is inserted into the vagina N. The surgeon can then make the medical instrument inserted into the lumen 105 protrude towards the tip 101 side of the main body 100 through the tip opening 101a. The surgeon can then perform a predetermined procedure using the medical instrument protruding from the tip opening 101a. The medical instrument is, for example, a forceps used when suturing the vaginal stump (the cut portion of the vagina N), but is not limited to this.

[0029] The lid member 150 may be provided with a mechanism for holding medical instruments such as forceps (for example, a cap made of an elastic material with a holding hole) when the lid member 150 is positioned to close the base opening 103a.

[0030] The main body portion 100 extends substantially in a straight line along its central axis c1. The cross-sectional shape of the main body portion 100 (the shape of the cross section perpendicular to the central axis c1) is preferably circular, for example, taking into consideration the load when the main body portion 100 is inserted into the vagina N. However, the cross-sectional shape of the main body portion 100 may be rectangular, polygonal, or other shapes.

[0031] As shown in Figure 2, the tip surface 102 of the first portion 110 (corresponding to the tip surface of the main body portion 100) has a shape that is inclined obliquely with respect to the central axis c1 along the extending direction of the main body portion 100.

[0032] The tip opening 101a, located on the same plane as the tip surface 102, has an opening surface that is inclined parallel to the tip surface 102. The tip surface 102 can be configured such that, in the side view shown in Figure 2, the portion on the opposite side (lower side) from the side (upper side) where the handle portion 140 is provided protrudes more towards the tip.

[0033] As shown in Figures 1 and 2, at least a portion of the first part 110 has a light-emitting part 130 that emits fluorescence.

[0034] The light-emitting section 130 can be made of a phosphor containing a fluorescent dye that emits red light or near-infrared light when irradiated with excitation light of a predetermined wavelength. In order to clearly indicate the portion (range) in which the light-emitting section 130 is provided on the drawing, the light-emitting section 130 is marked with a dot.

[0035] When performing a hysterectomy using the insertion device 10, the surgeon inserts at least a portion of the first part 110 of the main body 100 of the insertion device 10 into the vagina N through the opening of the vagina N, as shown in Figure 3. The surgeon then presses a portion of the first part 110 inserted into the vagina N against the inner wall of the vagina N from the inside, as shown in Figure 4. The portion of the vagina N to which the first part 110 is pressed is supported by the main body 100 from the inside of the vagina N, and is lifted ventrally compared to the rest of the vagina N. The surgeon can confirm the supported portion of the vagina N from the ventral side using a laparoscope or the like, and use this supported portion as a guide for the resection position P where the uterus U is removed from the vagina N, thereby enabling the resection of the uterus U to proceed smoothly.

[0036] Furthermore, the first portion 110 located at the tip of the main body 100 of the insertion device 10 has a fluorescent light-emitting portion 130. Therefore, when the surgeon excises the uterus U, by activating the fluorescent light-emitting portion 130 positioned inside the vagina N, the surgeon can more clearly confirm the position of the first portion 110, on which the fluorescent light-emitting portion 130 is located, from the ventral side under a laparoscope or the like. Consequently, the surgeon can more easily and reliably confirm the excision position P of the vagina N by confirming the fluorescent light-emitting portion 130 along with the supported portion of the vagina N when the main body 100 is pressed against it, from the ventral side under a laparoscope or the like.

[0037] The excitation light for causing the light-emitting unit 130 to emit light can be the light emitted from the light source (light guide) of the laparoscope. However, the source of the excitation light is not limited to the light source provided by the laparoscope, but may be a separate, independent device or instrument. Furthermore, the wavelength of the excitation light used to cause the light-emitting unit 130 to emit light can be arbitrarily adjusted and changed according to the configuration of the light-emitting unit 130 (type and composition of fluorescent dye).

[0038] As the fluorescent dye used in the phosphor constituting the light-emitting section 130, known dyes such as water-soluble dyes like ribobravin, thiamine, NADH (nicotinamide a denine dinucleotide), and indocinian green (ICG), and oil-soluble dyes such as the azo-boron complex compound described in Japanese Patent Application Publication No. 2011-162445 can be used. However, there are no particular restrictions on the specific type of fluorescent dye.

[0039] Furthermore, there are no particular restrictions on the method of providing the phosphor containing the fluorescent dye to the first portion 110 of the main body 100. For example, it is possible to incorporate the phosphor containing the fluorescent dye into the material constituting the first portion 110 (for example, a resin material), to attach or hold a member having the phosphor containing the fluorescent dye (for example, a sheet-like member, etc.) to the first portion 110, or to coat or impregnate the phosphor containing the fluorescent dye to the first portion 110.

[0040] As shown in FIGS. 1 and 2, the light-emitting portion 130 can be continuously provided over a predetermined range in the axial direction from the tip 101 to the base end 103 side of the main body portion 100.

[0041] In the present embodiment, the light-emitting portion 130 is arranged over substantially the entire axial length of the first portion 110 from the tip 101 of the main body portion 100. By arranging the light-emitting portion 130 in such a range, in the procedure using the inserter 10, it becomes possible to more clearly confirm the first portion 110 provided with the light-emitting portion 130.

[0042] As shown in FIGS. 1 and 2, the light-emitting portion 130 can be continuously provided over the entire circumference around the central axis c1 of the main body portion 100. By providing the light-emitting portion 130 in this way, in the procedure using the inserter 10, it becomes possible to more clearly confirm the excision position P indicated by the light-emitting portion 130.

[0043] The light-emitting portion 130 may be provided in at least a part of the first portion 110. For example, it can also be configured by a pattern (e.g., dots or dashed lines) that extends intermittently in the axial direction and / or circumferential direction of the main body portion 100, a predetermined geometric pattern, a pattern forming characters or graphic symbols, etc. However, when the light-emitting portion 130 is configured by a pattern that extends continuously in the axial direction and circumferential direction of the main body portion 100 as in the present embodiment, in the procedure using the inserter 10, it becomes possible to more easily and clearly confirm the first portion 110 having the light-emitting portion 130.

[0044] As shown in FIGS. 1 and 2, a protrusion 160 that protrudes in a direction away from the central axis c1 of the main body portion 100 can be provided on the outer peripheral surface at a position on the base end side rather than the tip 101 of the main body portion 100.

[0045] In the present embodiment, three protrusions 160 are arranged at a predetermined interval on the outer peripheral surface 121 of the second portion 120 located on the base end side rather than the first portion 110.

[0046] Each protrusion 160 extends continuously along the entire circumference of the outer peripheral surface of the main body portion 100.

[0047] As shown in FIGS. 3 and 4, the plurality of protrusions 160 prevent a gap through which the gas used for pneumoperitoneum can flow from being formed between the inner wall of the vagina N and the main body 100 in the procedure using the inserter 10. By preventing the formation of the above-described gap, the plurality of protrusions 160 prevent the gas used for pneumoperitoneum from leaking from inside the vagina N to the outside of the living body through the opening of the vagina N.

[0048] Each protrusion 160 protrudes substantially perpendicularly in the axial orthogonal cross-section with respect to the central axis c1 of the main body 100. That is, each protrusion 160 protrudes in a direction orthogonal to the central axis c1 in the side view shown in FIG. 2. By configuring each protrusion 160 in this way, the sealing function of preventing the gas used for pneumoperitoneum from leaking to the outside of the living body can be enhanced. However, each protrusion 160 may protrude so as to be inclined at a predetermined angle with respect to the central axis c1. Further, the number of protrusions 160 installed, the installation position, the cross-sectional shape of the protrusion 160, the protruding length of the protrusion 160, etc. are not particularly limited as long as the above-described sealing property can be exhibited.

[0049] As shown in FIGS. 1 and 2, the inserter 10 has a grippable handle portion 140 provided at the proximal end 103 of the main body 100 or in the vicinity of the proximal end 103.

[0050] The handle portion 140 has a base portion 141 connected to the main body 100 and protruding outward from the main body 100 in the direction of the outer side of the central axis c1, and an extending portion 142 extending from the proximal end of the base portion 141 to the proximal side of the proximal end 103 of the main body 100.

[0051] In the procedure using the inserter 10 shown in FIGS. 3 and 4, the operator can easily and smoothly operate the inserter 10 by gripping the handle portion 140 with fingers or the like outside the living body (outside the vagina N).

[0052] The main body 100 can be made of, for example, a resin material. As the resin material constituting the main body 100, for example, silicone or polycarbonate can be used.

[0053] As described above, the insertable device 10 according to this embodiment has a cylindrical main body portion 100 that is inserted into the vagina N, and the main body portion 100 has a lumen 105, a first portion 110 provided in the portion including the tip 101 where the tip opening 101a communicating with the lumen 105 is located, and a second portion 120 located on the proximal end side of the first portion 110, and at least a part of the first portion 110 has a light-emitting portion 130 that emits fluorescence.

[0054] The surgeon can more easily and accurately confirm the resection position P of the vaginal canal by visualizing the fluorescent light-emitting part 130, along with the part lifted by the main body 100, from the inside of the vaginal canal N under laparoscopy. This allows the surgeon to perform procedures such as laparoscopic total hysterectomy smoothly.

[0055] The following describes variations of the insert. As shown in each variation, there are no particular restrictions on the range (area) or pattern in which the light-emitting part 130 is placed, as long as it is provided on at least a part of the first portion 110 of the main body 100.

[0056] For example, as shown in the modified example 1 of Figures 5 and 6, the light-emitting part 130 can be positioned only at the tip 101 of the main body 100 (the tipmost position of the first part 110).

[0057] Furthermore, as shown in the modified example 2 insert 10B in Figures 7 and 8, the light-emitting portion 130 can be provided only in a portion of the main body portion 100 that is located closer to the base end 103 than to the tip end 101. In this modified example, the light-emitting portion 130 is arranged in a linear pattern that extends substantially parallel to the tip surface 102 of the tip opening 101a (in a direction inclined with respect to the central axis c1).

[0058] In the modified example 3 shown in Figures 9 and 10, the insert 10C, similar to the modified example 2, has the light-emitting portion 130 provided only in a portion of the main body portion 100 that is located closer to the base end 103 than to the tip end 101. In this modified example, the light-emitting portion 130 is arranged in a linear pattern extending in a direction perpendicular to the central axis c1.

[0059] Furthermore, as shown in the modified example 4 insert 10D in Figures 11 and 12, the light-emitting part 130 may be provided as a projection 160a (the projection located at the very tip) on the first part 110 in the form of a light-emitting member that is a separate component from the main body part 100. In this embodiment, the projection 160a may be provided on the second part 120 or at the boundary between the base end of the first part 110 and the tip of the second part 120.

[0060] Although the inserts according to the present invention have been described through embodiments and modifications, the present invention is not limited to the configurations described in the specification and can be modified as appropriate based on the claims.

[0061] This application is based on Japanese Patent Application No. 2024-223809, filed on 19 December 2026, the disclosures of which are incorporated herein by reference in their entirety.

[0062] 10 Insertion device 10A Insertion device 10B Insertion device 10C Insertion device 10D Insertion device 100 Main body 101 Tip 101a Tip opening 102 Tip surface 103 Base 103a Base opening 105 Lumen 110 First part 111 Outer surface 120 Second part 121 Outer surface 130 Light-emitting part 140 Handle part 150 Lid member 160 Projection 300 Treatment device c1 Central axis of the main body N Vagina P Excision location U Uterus

Claims

1. An insertion device having a cylindrical main body portion that is inserted into the vagina, wherein the main body portion has a lumen, a first portion provided in the portion including the tip where a tip opening communicating with the lumen is located, and a second portion located on the proximal side of the first portion, and at least a part of the first portion has a light-emitting portion that emits fluorescence.

2. The inserting device according to claim 1, wherein the light-emitting portion is continuously provided over a predetermined axial range from the tip of the main body toward the base end.

3. The insertion device according to claim 1, wherein a projection is provided on the outer circumferential surface of the main body at a position closer to the base end than the tip, projecting in a direction away from the central axis of the main body.

4. The insertion device according to claim 1, further comprising a grippable handle portion provided at or near the base end of the main body.

5. An insertion device having a cylindrical main body portion that is inserted into the vagina, wherein the main body portion has a lumen and a tip portion where a tip opening communicating with the lumen is located, and a fluorescent light-emitting member is provided on the outer circumferential surface of the main body portion at a predetermined position in the axial direction from the tip portion toward the proximal end portion.

6. The inserting device according to claim 5, wherein the light-emitting member is made of a separate component from the main body.

7. The insert according to claim 5 or claim 6, wherein the light-emitting member constitutes a projection that protrudes from the outer circumferential surface of the main body.