JP7558560B2 - Insertion Tool - Google Patents

Description

The present invention relates to an insertion device that is inserted through the vaginal opening during laparoscopic hysterectomy.

Laparoscopic hysterectomy is performed, for example, using a uterine manipulator as shown in Patent Document 1 below. Specifically, a uterine manipulator is inserted into the vagina and the uterus is held in a specified position. The uterus is then separated by incising the vaginal vault with a laser scalpel or the like using a laparoscope, and the separated uterus is then removed from the abdominal cavity.

After the uterus is removed, the cut opening of the vagina (vaginal stump) is sutured closed using, for example, a vaginal stump suturing aid as shown in Patent Document 2 below. Specifically, a vaginal stump suturing aid is inserted through the vaginal opening, and the vaginal stump is sutured while being supported by the tip of the aid. At this time, the annular protrusion on the outer peritoneal surface of the aid is brought into close contact with the inner wall of the vagina, thereby preventing pneumoperitoneum gas from leaking out of the vagina.

Special Publication No. 10-507384 JP 2020-75019 A

As mentioned above, different insertion tools (uterine manipulator, vaginal stump suturing aid) are usually used for the hysterectomy and the subsequent vaginal stump suturing, but sometimes a simple insertion tool (aid) such as that described in Patent Document 2 is used to support the uterus during the hysterectomy. In this case, when the vaginal vault is cut with an ultrasonic scalpel, there is a risk that the tip of the insertion tool will melt due to contact with the ultrasonic scalpel.

Therefore, the present invention aims to provide an insertion tool that is highly resistant to ultrasonic scalpels and can be used not only for suturing vaginal stumps but also for holding the uterus during laparoscopic hysterectomy.

The inventors have verified the resistance of various resins to ultrasonic scalpels. As a result, even highly heat-resistant resins (e.g., LCP, PEEK, PES, etc.) had low resistance to ultrasonic scalpels, with the exception of thermosetting acrylic, which had high resistance to ultrasonic scalpels. From these results, it became clear that it is preferable to form the insertion tool from thermosetting acrylic.

However, because thermosetting acrylic has poor moldability, it is difficult to mold the entire insertion device out of thermosetting acrylic. In particular, when the outer surface of the cylindrical main body has protrusions to prevent gas leakage, it is extremely difficult to mold the main body having such protrusions integrally out of thermosetting acrylic.

The present invention provides an insertion tool having a tubular main body that is inserted from the opening of the vagina during laparoscopic hysterectomy, the main body having a first portion at the tip and a second portion at the base end of the first portion with a protrusion on the outer circumferential surface, the first portion being formed from a thermosetting acrylic resin, and the second portion being injection molded with a resin different from that of the first portion by inserting the first portion into the second portion.

In this way, by forming the first part of the body that comes into contact with the ultrasonic scalpel from a thermosetting acrylic resin, resistance to the ultrasonic scalpel is increased. In addition, by forming the second part of the body from a resin different from that of the first part, a resin with excellent formability can be selected, making it possible to injection mold the second part having protrusions on its outer circumferential surface. Furthermore, by inserting the first part into the second part and injection molding it, the process of fixing the first part and the second part can be omitted, and the connection between the first part and the second part can be made smoothly continuous.

It is preferable that the insertion tool has a handle at or near the base end of the main body for adjusting the position of the main body inserted through the vaginal opening. In this case, if the handle and the second part of the main body are integrally injection molded, the process of fixing them can be omitted.

When inserting the first part and injection molding the second part with resin, it is necessary to adjust the molding conditions (injection pressure, cooling time, etc.) to prevent the end of the cavity (particularly the tip part that contacts the first part) from being underfilled or overfilled with molten resin (the occurrence of burrs). At this time, it is preferable to provide a gate for injecting molten resin into the cavity at a position away from the first part (specifically, at or near the base end of the cavity). In this case, by adjusting the molding conditions, it becomes possible to precisely control the filling state of the resin at the tip part of the cavity, making it easier to prevent underfilling or overfilling with resin. At or near the base end of the injection molded product including the main body thus formed, a gate mark (a cut mark of the resin solidified within the gate, or a mark of its removal) is provided.

When laparoscopic surgery is performed using the above insertion tool, the abdomen is filled with pneumoperitoneum gas while the insertion tool is inserted into the vagina. At this time, in order to prevent leakage of pneumoperitoneum gas through the tubular main body, it is preferable to provide a cap that closes the opening at the base end of the main body. This cap can be provided with a hole for inserting an instrument (forceps, etc.). In this case, by manipulating the instrument inserted into the hole in the cap, a gap is formed between the hole in the cap and the instrument, and there is a risk that pneumoperitoneum gas will leak from this gap.

The above insertion tool can therefore be provided with a cap having a plate-like portion covering the opening at the base end of the main body, a hole provided in the plate-like portion, and a tubular portion extending from around the hole in the plate-like portion toward the tip. By providing a tubular portion extending from around the hole in the plate-like portion toward the tip, the instrument inserted into the hole in the cap is in close contact with the inner circumferential surface of the tubular portion. This increases the contact area between the cap and the instrument, making it less likely for a gap to form between them, thereby suppressing leakage of pneumoperitoneum gas.

As described above, the insertion device of the present invention is highly resistant to ultrasonic scalpels and can therefore be used not only for suturing the vaginal stump but also for holding the uterus during laparoscopic hysterectomy.

FIG. 1 is a perspective view of an insertion tool according to an embodiment of the present invention. FIG. FIG. 2 is a cross-sectional view of the insertion tool. 6 is a cross-sectional view (YY cross-sectional view of FIG. 5) of a mold for injection molding the insert. FIG. FIG. 5 is a cross-sectional view (cross-sectional view taken along the line XX in FIG. 4) of a mold for injection molding the insert. FIG. 2 is a cross-sectional view showing the insertion tool in use during a hysterectomy. FIG. 11 is a cross-sectional view showing the use of the insertion tool in suturing the vaginal stump after hysterectomy.

The following describes an embodiment of the present invention with reference to the drawings.

As shown in Figures 1 to 3, an insertion device 1 according to one embodiment of the present invention has a main body 10, and a handle 20 and a cap 30 provided at one end of the main body 10 (the right end in Figures 2 and 3). In the following description, the side of the main body 10 in the axial direction where the handle 20 and cap 30 are provided (the right side in Figures 2 and 3) is referred to as the "base end side," and the opposite side (the left side in Figures 2 and 3) is referred to as the "tip side."

The main body 10 has a tip ring 11 as a first part provided at the tip, and a tube portion 12 as a second part provided on the base end side of the tip ring 11. The area of the main body 10 that is distal to the handle 20 is the effective area L that can be inserted into the vagina (see FIG. 2).

The tip ring 11 is made of a thermosetting acrylic resin. Specifically, the tip ring 11 is formed by injecting liquid thermosetting acrylic resin into a mold, sealing it, and curing it while heating it in this state. Alternatively, the tip ring 11 may be formed by cutting a cylindrical extrusion molded product made of thermosetting acrylic resin. The tip 11a of the tip ring 11 is formed on a surface that is inclined with respect to a plane perpendicular to the axis. The outer circumferential surface of the tip ring 11 is formed with a large diameter outer circumferential surface 11b provided on the tip side, and a small diameter outer circumferential surface 11c provided on the base end side of the large diameter outer circumferential surface 11b and smaller in diameter than the large diameter outer circumferential surface 11b (see FIG. 3). The large diameter outer circumferential surface 11b is exposed to the outside, and the small diameter outer circumferential surface 11c is covered from the outside by the cylindrical portion 12. In the illustrated example, the small diameter outer circumferential surface 11c is tapered in diameter toward the base end side. The large diameter outer peripheral surface 11b has the same diameter as the outer peripheral surface of the tip of the tubular portion 12, and they are continuous with no gaps. The inner peripheral surface of the tip ring 11 has the same diameter as the inner peripheral surface of the tip of the tubular portion 12, and they are continuous with no gaps.

The tubular portion 12 is generally cylindrical and has an inner hole 15 that penetrates in the axial direction. The tubular portion 12 has a small-diameter cylindrical portion 12a at the tip, a large-diameter cylindrical portion 12b at the base end that is larger in diameter than the small-diameter portion 12a, and a tapered portion 12c that connects these portions.

The cylindrical portion 12 is provided with protrusions 14a and 14b that protrude from the outer peripheral surface to the outer diameter. In the illustrated example, the protrusions 14a and 14b are provided at multiple locations spaced apart in the axial direction on the cylindrical outer peripheral surface of the small diameter portion 12a. Of these, the protrusion 14a at the most distal end is not continuous around the entire circumference, but is provided only in a portion of the circumference. The other protrusions 14b form a ring that is continuous around the entire circumference of the main body 10. Each of the protrusions 14a and 14b forms an ellipse that is inclined with respect to a plane perpendicular to the axial direction. The radial height of the protrusions 14a and 14b gradually increases toward the base end. The configuration of the protrusions is not limited to the above, and for example, the protrusion 14a at the most distal end may be omitted to form only the ring-shaped protrusion 14b, the protrusions may be circular along the circumferential direction of the cylindrical portion 12, or the radial heights of the multiple protrusions may be uniform.

The tubular portion 12 is formed by injection molding of a resin with the tip ring 11 inserted. In the illustrated example, the tubular portion 12 and the handle 20 are integrally injection molded with the same resin material. In this embodiment, in order to ensure the strength of the boundary between the tubular portion 12 and the handle 20, it is preferable to form them with a high-strength resin material. In addition, it is preferable that the insert 1 is transparent so that the instrument inserted into the inner circumference of the tubular portion 12 can be visually confirmed when the insert 1 is in use. Considering the balance between the required characteristics and the cost as described above, for example, polycarbonate or ABS can be used as the resin for the injection molded product including the tubular portion 12. Note that, if necessary, a filler such as a reinforcing fiber (e.g., glass fiber) may be added to the resin.

The cylindrical portion 12 is molded, for example, by a mold 40 shown in Figures 4 and 5. This mold 40 has a fixed mold 41, a movable mold 42, and a slide core 43. The fixed mold 41 and the movable mold 42 are opened, and the slide core 43 is retracted. The tip ring 11 is placed at a predetermined position in the fixed mold 41, and the large diameter outer peripheral surface 11b of the tip ring 11 is fitted into the inner peripheral surface of the fixed mold 41. In this state, the movable mold 42 is moved in the direction of arrow A in Figure 5 to close the mold, and the slide core 43 is slid in the direction of arrow B to insert it into the inner circumference of the tip ring 11. As a result, a cavity 44 for molding the cylindrical portion 12 is formed by the fixed mold 41, the movable mold 42, the slide core 43, and the tip ring 11. The gate 45 is provided at or near the end of the base end side (right side in the figure) of the cavity 44 (see Figure 4). In the illustrated example, a gate 45 is provided at the base end of the portion of the cavity 44 where the handle 20 is molded.

Molten resin is injected from the gate 45 to fill the cavity 44, and the molten resin filled in the cavity 44 is brought into contact with the tip ring 11. In this state, the resin filled in the cavity 44 is cooled and solidified, so that the tube portion 12 and the handle 20 are molded as one unit, and the tube portion 12 and the tip ring 11 are fixed. At this time, the molding conditions (injection pressure, cooling time, etc.) are adjusted so that the tip of the cavity 44 is not underfilled or overfilled (burrs are generated) with resin. As described above, since the gate 45 is provided at a position (base end of the cavity 44) away from the tip ring 11, the filling state of the resin at the tip of the cavity 44 can be finely controlled by adjusting the molding conditions. As a result, the tip ring 11 is inserted and a resin molded product having the tube portion 12 and the handle 20 as one unit is formed. A gate mark 21 is provided at the base end of the handle 20 of this resin molded product (see Figures 2 and 3). The gate marks 21 include cut marks of the resin that has solidified inside the gate 45, or removal marks where the cut marks have been removed by machining or other methods.

In the above-mentioned resin molded product, since the tip ring 11 and the tubular portion 12 are formed from different resin materials, there is a concern that the tip ring 11 and the tip of the tubular portion 12 do not melt sufficiently during injection molding of the tubular portion 12, and the adhesive strength between them is insufficient. Therefore, it is preferable to provide a slip-out prevention structure at the contact portion of the tip ring 11 and the tubular portion 12, which engages them in a direction that separates them from each other in the axial direction. In the illustrated example, the tubular portion 12 is tightly attached to the tapered small-diameter outer peripheral surface 11c of the tip ring 11 (see FIG. 3), and these are engaged in the axial direction to prevent the tip ring 11 from slipping out of the tubular portion 12. In addition, the tip ring 11 may be provided with a tapered inner peripheral surface with a reduced diameter on the base end side, and the tubular portion 12 may be tightly attached to this inner peripheral surface to form a slip-out prevention structure. Alternatively, the tip ring 11 may be provided with a convex or concave portion on the outer peripheral surface or inner peripheral surface, and the tubular portion 12 may be tightly attached to these to form a slip-out prevention structure.

The cap 30 is attached to the opening at the base end of the main body 10 (see FIG. 2). The cap 30 has a disk portion 31 as a plate-shaped portion that covers the opening at the base end of the main body 10, a first cylindrical portion 32 that extends from the outer circumferential end of the disk portion 31 toward the tip side, and a second cylindrical portion 33 provided on the inner circumference of the first cylindrical portion 32. The cap 30 is formed of a flexible material such as rubber. The cap 30 is attached to the main body 10 by bringing the inner circumferential surface of the first cylindrical portion 32 and the outer circumferential surface of the second cylindrical portion 33 into close contact with the outer circumferential surface and inner circumferential surface of the main body 10, respectively.

The cap 30 is provided with a hole 34 penetrating the disk portion 31 and a third cylindrical portion 35 as a tube portion extending from the periphery of the hole 34 of the disk portion toward the tip side. In the illustrated example, the hole 34 and the third cylindrical portion 35 are provided at the axis of the disk portion 31. In the illustrated example, the inner circumferential surface of the hole 34 and the inner circumferential surface of the third cylindrical portion 35 are continuous on the same cylindrical surface. The hole 34 of the cap 30 is blocked by a plug 40. In the illustrated example, the cap 30, the plug 40, and the connecting portion 41 connecting them are integrally formed from a flexible material. The hole 34 of the cap 30 is blocked by inserting the plug 40 into the hole 34 of the cap 30. By removing the plug 40 from the hole 34 of the cap 30, an instrument such as forceps can be inserted through the hole 34.

The following describes an example of how to use the insertion device 1.

Figure 6 is a cross-sectional view of the abdominal cavity showing the state of laparoscopic hysterectomy, with the upper side being the abdominal side and the lower side being the dorsal side. As shown in the figure, the insertion tool 1 is inserted from the opening of the vagina 102, and the uterus 101 is held in a predetermined position by the tip 11a of the insertion tool 1. Then, with the abdominal cavity filled with pneumoperitoneum gas to inflate it, the vicinity of the entrance of the uterus 101, specifically the tip 11a of the insertion tool 1 being pressed against the deformed part P, is cut from the abdominal side with an ultrasonic scalpel. At this time, since the tip 11a of the insertion tool 1 is formed of a tip ring 11 made of a thermosetting acrylic resin, it is possible to prevent the tip 11a of the insertion tool 1 from melting due to contact with the ultrasonic scalpel.

By cutting near the entrance of the uterus 101, the pneumoperitoneum gas in the abdominal cavity enters the vagina 102 and the inside of the insertion tool 1. At this time, the protrusions 14a, 14b and the tapered portion 12c on the outer circumferential surface of the main body 10 of the insertion tool 1 are brought into close contact with the inner wall of the vagina 102, thereby restricting the leakage of the pneumoperitoneum gas to the outside from between the outer circumferential surface of the main body 10 and the inner wall of the vagina 102. In addition, the hole 34 in the cap 30 of the insertion tool 1 is blocked with a plug 36, so the leakage of the pneumoperitoneum gas from the hole 34 is restricted.

After that, with the insertion tool 1 inserted into the vagina 102, the plug 36 of the cap 30 is removed and an instrument such as forceps is inserted through the hole 34 to extract the resected uterus 101. In the illustrated example, the cap 30 is provided with a third cylindrical portion 35, and the inner surface of the third cylindrical portion 35 is in close contact with the instrument, thereby increasing the contact area between the cap 30 and the instrument compared to when the third cylindrical portion 35 is not provided. In addition, since the cap 30 is formed of a flexible material such as rubber, the third cylindrical portion 35 is easily deformed to follow the shape of the instrument. Furthermore, since the tip of the third cylindrical portion 35 is a free end that is not supported from the outer periphery, the third cylindrical portion 35 is easily deformed to follow the movement of the instrument. As a result, a gap is less likely to form between the cap 30 and the instrument, and leakage of pneumoperitoneum gas can be suppressed.

After that, the instrument is removed from the hole 34 in the cap 30, and the hole 34 is closed again with the plug 36. Then, as shown in FIG. 7, the cut opening of the vagina 102 (vaginal stump 102a) is sutured from the abdominal side by laparoscopic surgery. Specifically, the insertion tool 1 inserted into the vagina 102 is slightly retracted, and the vaginal stump 102a is supported from the inside by the tip 11a of the main body 10. In this state, the vaginal stump 102a is sutured from the abdominal side using a laparoscope.

The present invention is not limited to the above embodiment. For example, in the above embodiment, the tubular portion 12 of the main body 10 and the handle 20 are integrally molded from the same resin, but this is not limiting, and they may be formed separately and then fixed by appropriate means. In this case, the tubular portion 12 is injection molded from resin with the tip ring 11 inserted. At this time, it is preferable to provide a gate at or near the base end of the cavity in which the tubular portion 12 is molded.

1 Insertion tool 10 Main body 11 Tip ring (first part)
12 Cylinder part (second part)
14a, 14b Protrusion 20 Handle 21 Gate mark 30 Cap 31 Disk portion (plate-shaped portion)
32 First cylindrical portion 33 Second cylindrical portion 34 Hole 35 Third cylindrical portion (tube portion)
36 Plug 37 Connecting portion 40 Mold 41 Fixed mold 42 Movable mold 43 Slide core 44 Cavity 45 Gate

Claims (5)

An insertion tool having a tubular body that is inserted from an opening of a vagina in a laparoscopic hysterectomy,
the main body has a first portion provided at a tip end and a second portion provided on a base end side of the first portion and having a protrusion on an outer circumferential surface,
The first portion is formed of a thermosetting acrylic resin;
The second portion is injection molded from a different resin than the first portion. 2. The insertion tool according to claim 1 , wherein the main body is provided with a handle for controlling the position of the main body inserted from the opening of the vagina . The insert according to claim 2, wherein the handle and the second portion of the body are integrally injection molded. The insertion tool according to any one of claims 1 to 3, wherein a gate mark is provided at a base end of an injection molded part which includes the second portion of the main body and is integrally injection molded therewith . The insertion device according to any one of claims 1 to 4, comprising a cap having a plate-like portion covering an opening on the base end side of the cylindrical main body, a hole provided in the plate-like portion, and a tubular portion extending from the periphery of the hole in the plate-like portion toward the tip side.

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