Access device for natural opening

Abstract

To provide an access device for a natural opening being stably fixed even when it is molded with an insertion length into the natural opening shortened.SOLUTION: An access device 1 for a natural opening comprises a cylindrical body 20 to be disposed in the natural opening, a flange part 30 formed at a proximal end of the cylindrical body 20 and coming into contact with a body surface, and two rings juxtaposed to each other on an outer peripheral surface of the cylindrical body 20, where inner and outer peripheries of the two rings are eccentric, axes of the respective inner peripheries are constantly coaxial and axes of the respective outer peripheries are so formed as to expand / contract an axis-to-axis distance. Preferably, one of the two rings is a fixed ring 40 to be fixed to the cylindrical body 20 and the other is a movable ring part 50 to rotationally turn around the outer periphery of the cylindrical body 20. Further preferably, the cylindrical body 20 and the movable ring part 50 include rotational range limiting means, and are so configured that the axis-to-axis distance is minimum at a start point of the rotational range and is maximum at an end point of the rotational range.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a natural orifice access device that is inserted into a natural orifice of the human body to ensure a surgical route. [Background technology]

[0002] In endoscopic surgery, the insertion of surgical instruments such as endoscopes and forceps and the removal of excised tissue may be performed through natural openings in the body, for example, via the vagina or anus. This technique has the advantage of allowing for quicker postoperative recovery than when incising the body surface, and leaving less noticeable scars for better cosmetic appearance.

[0003] When access is made through a natural orifice in this way, an access device has been proposed that is inserted into the natural orifice and keeps the surgical path open (Patent Document 1). The access device in Patent Document 1 is equipped with a mechanical balloon (a structure consisting of multiple elastic plates arranged in the axial direction, which expands its diameter in the radial direction by compressing both ends of the cylinder (see FIG. 6G in Patent Document 1)) on the circumferential surface of a cylindrical body placed in the natural orifice, and is configured so that the balloon expands and contracts in the axial direction and can expand and contract in the radial direction by rotating a ring at the proximal end of the mechanical balloon. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2017-523874 Summary of the Invention [Problem to be solved by the invention]

[0005] According to the access device having a mechanical balloon of Patent Document 1, the pressure against the inner wall of the natural orifice is increased by expanding the balloon, and the access device can be prevented from slipping out of the orifice. However, in order to expand the mechanical balloon to a width that can stably fix the access device, the axial length of the elastic plate needs to be increased, and it is difficult to form the cylindrical body into a short length. Therefore, when the surgical site is near the entrance of the natural orifice, there is a problem that the access device covers the target site, making it impossible to perform the surgery.

[0006] SUMMARY OF THE PRESENTLY PREFERRED EMBODIMENTS An object of the present invention is to provide an access device for a natural orifice that can be stably fixed even when the length inserted into the natural orifice is shortened. [Means for solving the problem]

[0007] The natural orifice access device of the present invention is composed of a tubular body that is placed within a natural orifice, a flange portion formed at the proximal end of the tubular body and abutting the body surface, and two ring portions that are parallel to each other on the outer circumferential surface of the tubular body, the inner and outer peripheries of the two ring portions being eccentric, the axes of the respective inner peripheries being always coaxial, and the axes of the respective outer peripheries being formed so that the distance between the axes can be expanded or contracted.

[0008] The natural orifice access device is preferably constructed or formed as follows. One of the two ring portions is a fixed ring portion that is fixed to the cylindrical body, and the other is a movable ring portion that rotates relative to the outer circumferential surface of the cylindrical body. The cylindrical body is provided with a guide that guides the rotation of the movable ring portion, and the movable ring portion is provided with a guide engagement portion that engages with the guide. The cylindrical body and the movable ring portion are provided with a rotation range limiting means, and the axis distance is minimum at the start point of the rotation range and maximum at the end point of the rotation range. The rotation range limiting means is formed so as to lock the rotation of the cylindrical body and the movable ring portion in one direction by a guide provided on the cylindrical body and a rotation stop protrusion provided on the movable ring portion. The rotation direction of the cylindrical body corresponding to the expansion or contraction of the axis-to-axis distance is displayed by a rotation direction display means provided on the flange portion. The fixing ring portion is integrally formed with the cylindrical body. At least one of the two ring portions is formed with an outer diameter that increases toward the proximal end.

[0009] (action) According to the natural orifice access device of the above means, the inner circumferences of the two parallel ring parts provided on the outer circumferential surface of the cylindrical body are coaxial, and the axial distance of the outer circumferences can be expanded or contracted, so that the ring part mismatch surface, which is the range where the two ring parts do not overlap when viewed in the axial direction, can be changed. That is, when the axial distance is small, the ring part mismatch surface is small, and catching on the inner wall of the natural orifice is suppressed. On the other hand, when the axial distance is large, the ring part mismatch surface is large, and each ring part forms a step in a different direction with respect to the cylindrical body, so that catching on the inner wall of the natural orifice becomes large.

[0010] Furthermore, as described above, since the configuration is such that two rings are simply provided in parallel in the axial direction of the cylindrical body, there is no need to increase the axial dimension of the cylindrical body.

[0011] Furthermore, by providing the cylindrical body and the movable ring portion with a rotation range limiting means so that the inter-axis distance between the outer peripheries of the two ring portions is minimum at the start point of the rotation range and maximum at the end point of the rotation range, it is possible to adjust the inter-axis distance between the start point and the end point and change the mismatch surface of the ring portions. In addition, by providing the flange portion with a rotation direction indicating means corresponding to the expansion and contraction of the axis distance, the flange portion can be rotated circumferentially in accordance with the rotation direction indicating means while the natural opening access device is inserted into the natural opening, thereby expanding and contracting the ring portion mismatch surface. Effect of the Invention

[0012] According to the above-mentioned means, it is possible to provide an access device for a natural orifice that can be stably fixed even if it is formed to have a short length to be inserted into the natural orifice. [Brief description of the drawings]

[0013] [Figure 1] 1 is a perspective view of an access device for a natural orifice according to an embodiment of the present invention; [Diagram 2] FIG. 2 is a side view of the natural orifice access device of the embodiment. [Diagram 3] FIG. 2 is a side cross-sectional view of the natural orifice access device of the embodiment. [Figure 4] FIG. 2 is a perspective view of a tubular body and a flange portion of the natural orifice access device of the embodiment. [Diagram 5] 3A and 3B are a front view and a side cross-sectional view of a fixing ring portion of the natural orifice access device of the embodiment. [Figure 6] 4A and 4B are a side view and a circumferential cross-sectional view of the movable ring portion of the natural orifice access device of the embodiment in a state where the movable ring portion is at a rotation start position. [Figure 7] 4A and 4B are a side view and a circumferential cross-sectional view of the movable ring portion of the natural orifice access device of the embodiment in a state where the movable ring portion is at a rotation end position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, an embodiment of an access device for a natural orifice according to the present invention will be described in detail with reference to the drawings. FIG. 1 is a perspective view of the access device for natural orifices of the present embodiment, FIG. 2 is a side view, and FIG. 3 is a side cross-sectional view (cross-sectional view taken along line xx in FIG. 2).

[0015] As shown in Figures 1 to 3, the natural orifice access device 1 of this embodiment is composed of a tubular body 20 having a diameter and length that allows it to be inserted into a natural orifice, a flange portion 30 that is formed radially from the proximal end of the tubular body 20 and abuts against the body surface when worn, a fixed ring portion 40 that is fixed to the proximal side of the outer peripheral surface of the tubular body 20, and a movable ring portion 50 that is rotatably connected to the tubular body 20 on the distal side of the outer peripheral surface of the tubular body 20.

[0016] The cylindrical body 20 is formed in a thin-walled cylindrical shape. A resin material that is rigid and not easily broken is selected in consideration of insertion into the natural orifice, maintenance of the expanded state, and durability when contacted with a surgical instrument. Furthermore, if a transparent resin such as polycarbonate or acrylic is selected, the inner wall of the natural orifice adjacent to the cylindrical body 20 can be seen through the cylindrical body 20 from inside, and the operator can grasp the condition of the inner wall, such as bleeding, during surgery. The size of the tubular body 20 may be selected to suit the target natural opening, such as the vagina, anus, or mouth, and the patient's body shape, but in this example, it is set to an outer diameter of 54 mm, an inner diameter of 50 mm, and a length of 50 mm, assuming application to the vagina.

[0017] 4, guides 21 for mounting a fixed ring part 40 and a movable ring part 50, which will be described later, are provided on the outer peripheral surface of the cylindrical body 20 at two locations parallel to the axial direction and at four locations approximately equally spaced apart in the circumferential direction, and each guide 21 is formed with an upper guide 211 and a lower guide 212 facing each other with a gap in the axial direction so as to sandwich the ring part. Note that only the lower guide 212 is provided at two opposing locations of the guides 21 on the axial distal side. Furthermore, a fixing claw 22 for stopping the rotation of the fixing ring portion 40 is formed in the circumferential vicinity of the upper guide 211 on the proximal side. In this example, the circumferential length of the guide 21 is 4 mm, the axial length is 5 mm, and the distance between the upper guide 211 and the lower guide 212 and the distance between the upper guide 211 and the fixed claw 22 are 3.2 mm.

[0018] The flange portion 30 is provided upright, expanding in a trumpet shape from the proximal end of the cylindrical body 20, and is formed integrally with the cylindrical body 20. The outer diameter of the flange portion 30 is formed to a size that makes it difficult to insert into the natural opening (outer diameter 97 mm in this example) so that the flange portion 30 abuts against the body surface and prevents it from entering the natural opening. In addition, a marker 31 is provided on the surface of the flange portion 30 to indicate the rotation direction relative to the movable ring portion 50 described below. The marker 31 is formed by imprinting letters or figures into the uneven shape during molding of the flange portion 30, painting the flange portion 30 molded product, attaching a sticker, or other means.

[0019] 5, and is attached to the proximal side of the outer circumferential surface of the cylindrical body 20. An elastic material that can be attached to the guide 21 of the cylindrical body by press-fitting is selected, and is formed of a resin such as a styrene-based thermoplastic elastomer, for example. The fixed ring part 40 is composed of an annular part 41 which is the ring part main body including a curved outer circumferential surface, and a rib 42 which is erected in the inward direction from the annular part 41 and includes an inner circumferential surface, and the radial width of at least one of the annular part 41 and the rib 42 is made uneven, giving the fixed ring part 40 a shape with eccentric inner and outer circumferences. The rib 42 serves as a guide engagement part which is clamped by the guide 21 which is arranged opposite the outer circumferential surface of the cylindrical body 20, and is fixed in the axial direction of the cylindrical body. Furthermore, the rib 42 is provided with a rotation stopper protrusion 43 that protrudes in the axial direction, and is clamped between the guide 21 and the fixed claws 22 of the cylindrical body and fixed in the circumferential direction of the cylindrical body. By attaching the fixing ring part 40 to the outer circumferential surface of the cylindrical body 20 in this manner, an uneven step that is eccentric with the cylindrical body 20 is formed.

[0020] In this example, the fixing ring portion 40 has an inner diameter of 54 mm, an outer diameter of 70 mm, and a center distance D between the inner circumference and the outer circumference of 5 mm. Furthermore, the annular portion 41 has a thickness of 16 mm, and the rib 42 has a thickness of 3.0 mm, which are adapted to the groove width of the cylindrical guide 21 (3.2 mm in this example).

[0021] The movable ring portion 50 in this embodiment is made of the same material, shape, size, etc. as the fixed ring 40, and is attached by press fitting to the guide 21 on the distal side of the outer circumferential surface of the cylindrical body 20. Since there is no fixed claw 22 on the distal side of the cylindrical body 20, the movable ring portion 50 is not fixed and can rotate. Furthermore, when the movable ring part 50 is rotated, the rotation stopper protrusions 53 of the movable ring part 50 come into contact with the upper guides 211 of the cylindrical body 20 to stop the rotation. As described above, of the four guides 21 provided on the distal side of the outer circumferential surface of the cylindrical body 20, the upper guides 211 are disposed only at two opposing locations, so that the rotation range is limited to approximately 180 degrees.

[0022] By forming the fixed ring portion 40 and the movable ring portion 50 from the same material and shape in this manner, the cylindrical body can be given a simple shape while reducing the number of types of parts that form the natural opening access device 1, thereby reducing manufacturing costs. When it is desired to set the step between the two ring parts and the cylindrical body larger, it is only necessary to largely change the outer circumferential dimensions of the fixed ring part 40 and the movable ring part 50, and it is not necessary to largely increase the axial dimension of the cylindrical body 20, so that the cylindrical body 20 to be placed in the natural orifice can be formed to be short. As a result, even if the surgical site is near the entrance of the natural orifice, the natural orifice access instrument 1 does not cover the surgical site, and the surgical target can be expanded to the vicinity of the entrance of the natural orifice.

[0023] The fixing ring portion 40 does not necessarily have to have the above-mentioned configuration, as long as the inner and outer circumferences of the fixing ring portion 40 can be formed into an eccentric shape. For example, the cylindrical body 20 and the fixing ring portion 40 may be molded integrally. Furthermore, the fixed ring portion 40 and the movable ring portion 50 may be set to different outer diameters as long as the range is such that a ring portion mismatch surface is formed, that is, a range in which the two ring portions do not overlap when viewed in the axial direction. Furthermore, the contact portion between the cylindrical body 20 and the two ring portions may be configured so as to fix or rotate the two ring portions relative to the cylindrical body 20. For example, contrary to this example, the guide of the cylindrical body 20 may be rib-shaped, and the guide engagement portions of the two ring portions may be groove-shaped to clamp the rib.

[0024] The two ring parts may be formed so that the outer diameter increases toward the proximal end. As a result, when the natural orifice access device 1 is inserted into the natural orifice, the fixed ring part 40 and / or the movable ring part 50 are inserted first with the small diameter side, so that the device is less likely to get caught on the inner wall of the natural orifice and the insertion resistance is reduced. On the other hand, when the natural orifice access device 1 moves in the removal direction, the large diameter side gets caught and locked on the inner wall of the natural orifice, so that the natural orifice access device 1 in the inserted state can be prevented from falling out of the body.

[0025] Next, the positional relationship between the two ring portions of the natural orifice access device of this embodiment will be described. FIG. 6 is an explanatory diagram of a state in which the movable ring portion of the natural orifice access device of this embodiment is at the rotation start position, where A is a side view and B is a cross-sectional view in the ring circumferential direction (xx cross-sectional view in FIG. 6A). The movable ring portion 50 at the rotation start position is in a position where the rotation stopper protrusion 53 abuts against the start point locking portion 211a of the upper guide 211 of the cylindrical body, and the outer circumferences of the two ring portions are coaxial, and the outer circumferences of the two ring portions are arranged to completely overlap each other when viewed in the axial direction, resulting in a state where there are no mismatching surfaces of the ring portions. In this state, it is possible to reduce the insertion / removal resistance when inserting or removing the natural orifice access device 1 into or from the natural orifice.

[0026] On the other hand, Figure 7 is an explanatory diagram of the state in which the movable ring portion of the natural orifice access device of this embodiment is at the end point of rotation, where A is a side view and B is a cross-sectional view in the circumferential direction of the ring (xx cross-sectional view in Figure 7A). The movable ring portion 50 at the rotation end position is in a position where the rotation stopper protrusion 53 abuts against the end point locking portion 211b of the upper guide 211 of the cylindrical body, and is rotated 180 degrees from the rotation start position. At this time, the outer circumferential axes of the two ring portions are disposed at the furthest apart, and the ring portion mismatch surface is maximized. In this state, the ring portions form steps in 180-degree opposite directions, and the steps are caught on the inner wall of the natural opening, thereby strengthening the fixing force of the natural opening access device 1.

[0027] The rotation may be stopped at any position between the rotation start position and the rotation end position, and the desired fixing force may be obtained. With the above configuration, the expansion and contraction of the ring portion mismatch surface is matched with the rotation direction of the movable ring portion, so that even if the operator performs the rotation operation blindly, the rotation operation will be stopped when the ring portion mismatch surface is at its minimum or maximum.

[0028] Next, a method of using the natural orifice access device of this embodiment will be described in accordance with the procedure. 1. The movable ring portion 50 and the cylindrical body 20 or the flange portion 30 are operated outside the body to set them to the rotation start position (a state in which there are no mismatched surfaces of the ring portions). 2. The natural orifice access device 1 is inserted into the natural orifice from the distal end of the tubular body 20. 3. With the fixing ring portion 40 fully inserted into the natural orifice, rotate the flange portion 30 in the expansion direction indicated by the marker 31 to expand the mismatched surfaces of the ring portions and fix the device 1 in the natural orifice. Here, when the flange portion 30 outside the body is rotated in the circumferential direction with the natural orifice access device 1 inserted in the natural orifice, the movable ring portion 50 is rotatably attached to the cylindrical body 20 and therefore does not follow the rotation of the flange portion 30. On the other hand, the fixed ring portion 40 rotates together with the cylindrical body 20. 4. Surgical operations are performed through the inside of the cylindrical body 20 and the flange portion 30. 5. After the surgical procedure is completed, the flange portion 30 is rotated in the contracting direction indicated by the marker 31, and the natural orifice access device 1 is returned to the rotation start position. 6. The flange portion 30 is grasped and the natural orifice access device 1 is removed from the natural orifice.

[0029] According to the natural opening access device 1 of this embodiment, by rotating the flange portion 30, it is possible to change the state between one in which resistance during attachment and detachment is small (the ring portion has a small mismatched surface) and one in which the device strongly catches on the inner wall of the natural opening and is less likely to slip off (the ring portion has a large mismatched surface). Furthermore, the natural orifice access device 1 has a structure that is difficult to slip out of the natural orifice by simply providing two rings in parallel in the axial direction of the cylindrical body 20, so there is no need to increase the axial dimension of the cylindrical body, and the cylindrical body 20 placed in the natural orifice can be formed to be short. As a result, even if the surgical site is near the entrance of the natural orifice, the natural orifice access device 1 does not cover the surgical site, and the surgical target can be expanded to the vicinity of the entrance of the natural orifice.

[0030] Furthermore, by providing the cylindrical body 20 and the movable ring portion 50 with a rotation range limiting means, and configuring the inter-axis distance between the outer peripheries of the two ring portions to be minimum at the start point of the rotation range and maximum at the end point of the rotation range, the inter-axis distance can be adjusted between the start point and the end point. Furthermore, when the natural opening access device 1 is inserted into the natural opening, the mismatched surfaces of the ring portions can be expanded or contracted by rotating the flange portion 30 circumferentially according to the markers 31. Therefore, even if the positional relationship between the two ring portions cannot be visually confirmed in the inserted state, the desired expansion or contraction operation can be performed.

[0031] In addition, the two ring portions may be formed so that their outer diameters increase toward the proximal end, which reduces the likelihood of the ring portions getting caught when inserted into the natural opening, and when moved in the removal direction, the larger diameter side of the ring portions gets caught and locked on the inner wall of the natural opening, preventing the natural opening access device 1 from falling out of the body when inserted. As described above, a natural orifice access device is provided that can be stably fixed even when the length inserted into the natural orifice is shortened. [Explanation of symbols]

[0032] 1 Natural orifice access devices 20 Cylindrical body 21 Guide 211 Upper guide 211a Starting point locking part 211b End stop part 212 Lower guide 22 Fixed claw 30 Flange section 31 Marker 40 Fixing ring part 41 Circular Ring 42 Ribs 43 Rotation stopper protrusion 50 Movable ring part 53 Rotation stopper protrusion

Claims

1. A natural orifice access device that is inserted into a natural orifice of a human body to secure a surgical route, the device comprising: a tubular body that is placed in the natural orifice; A flange portion formed at a proximal end of the cylindrical body and adapted to come into contact with a body surface; The device is characterized in that it has two ring portions arranged in parallel to each other on the outer peripheral surface of the cylindrical body, the inner and outer peripheral surfaces of the ring portions are eccentric, the inner peripheral axes of the two ring portions are always coaxial, and the axis distance between the outer peripheral axes of the two ring portions is expandable and contractable.

2. 2. The natural orifice access device according to claim 1, wherein one of the two ring portions is a fixed ring portion fixed to the cylindrical body, and the other is a movable ring portion rotatable around the outer circumferential surface of the cylindrical body.

3. The natural orifice access device according to claim 2 , wherein the cylindrical body is provided with a guide for guiding the rotation of the movable ring portion, and the movable ring portion is provided with a guide engagement portion for engaging with the guide.

4. 3. The natural orifice access device according to claim 2, further comprising a rotation range limiting means for limiting the axis distance between the cylindrical body and the movable ring portion, the axis distance being minimum at the start point of the rotation range and maximum at the end point of the rotation range.

5. The natural orifice access device of claim 4, wherein the rotation range limiting means prevents the tubular body and the movable ring portion from rotating in one direction by a guide provided on the tubular body and a rotation stop protrusion provided on the movable ring portion.

6. 5. The natural orifice access device according to claim 4, wherein a rotation direction of said tubular body relative to said movable ring portion which expands and contracts said inter-axial distance is indicated by a rotation direction indicating means provided on said flange portion.

7. The natural orifice access device according to claim 2 , wherein said fixing ring portion is integrally formed with said tubular body.

8. 8. The natural orifice access device according to claim 1, wherein at least one of the two ring portions has an outer diameter that increases toward a proximal end.

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