JP2015116347A - Insertion tool and insertion tool insertion method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an insertion tool and an insertion tool insertion method which allow safe execution of a technique to bury in a living body an indwelling object for supporting biological tissue.SOLUTION: A vagina insertion tool 5 comprises: a body part 54 with a suction part 543; and wires 811 and 812 which expand in a width direction of the suction part 543 from the body part 54. The body part 54 has: an upper surface 52a and a lower surface in a front and rear relation; and a pair of side surfaces 52b and 52c interconnecting the upper surface 52a and the lower surface. The suction part 543 is provided on the upper surface 52a and the wires 811 and 812 are provided on the side surfaces 52b and 52c.

Description

  The present invention relates to an insertion tool and an insertion tool insertion method.

  In the case of urinary incontinence, particularly stress urinary incontinence, urine leakage occurs due to abdominal pressure applied during normal exercise, laughing, coughing, sneezing and the like. The cause of this is, for example, that the pelvic floor muscle, which is a muscle that supports the urethra, is loosened due to childbirth and the like.

  Surgical therapy is effective for the treatment of urinary incontinence. For example, using a band-like tissue-supporting indwelling material called a “sling”, the sling is placed in the body, and the sling supports the urethra (for example, Patent Document 1). In order to place the sling in the body, the operator incises the vagina with a scalpel, peels off the space between the urethra and the vagina, and uses the puncture needle or the like to connect the peeled portion and the outside through a closed hole. In such a state, the sling is left in the body.

  However, if the vagina is incised, there is a risk that a sling may be exposed in the vagina from the wound created by the incision, and there may be complications such as infection from the wound. In addition, since the vagina is incised, there is a disadvantage that the invasion is large and the burden on the patient is large. In addition, there is a risk that the urethra or the like may be damaged during the procedure by the surgeon, and the surgeon himself may also damage the fingertip.

JP 2010-99499 A

  An object of the present invention is to provide an insertion tool and an insertion tool insertion method capable of safely performing a procedure for embedding a living tissue supporting indwelling object in a living body.

Such an object is achieved by the present inventions (1) to (10) below.
(1) a main body having a suction part that is inserted into a living body lumen and sucks the living body lumen;
An insertion tool comprising: an extension portion that extends in a direction different from the suction direction of the suction portion from the main body portion.

  (2) The insertion tool according to (1), wherein the suction part and the expansion part are arranged side by side in a direction crossing the insertion direction into the living body lumen.

(3) The extension portion has a linear portion,
The insertion tool according to (1) or (2), wherein the insertion is performed by bending the linear portion.

(4) The extension portion has a belt-like portion,
The insertion tool according to (1), wherein the band-shaped portion is expanded by curving in the thickness direction.

(5) The expansion part has a balloon,
The insertion tool according to (1), wherein the balloon is expanded by expanding the balloon.

(6) The extension portion includes a long body that is rotatably provided with respect to the main body portion.
The insertion tool according to (1), wherein the insertion tool is expanded by rotating the elongated body.

  (7) The insertion tool according to any one of (1) to (6), further including an urging portion that presses the body portion against the living body lumen.

(8) The main body has a pair of main surfaces in a front-back relationship and a pair of side surfaces connecting the pair of main surfaces,
The suction part is provided on at least one of the main surfaces,
The insertion portion according to any one of (1) to (7), wherein the extension portion is provided on at least one of the pair of side surfaces and expands in a facing direction of the pair of side surfaces.

(9) The biological lumen is a vagina,
The insertion device according to any one of (1) to (6), wherein the expansion portion expands the vagina in a direction intersecting with a facing direction of the vagina front wall and the vagina rear wall.

(10) Inserting an insertion tool having a main body part having a suction part and an expansion part extending from the main body part in a direction different from the suction direction of the suction part into the living body lumen,
Expanding the extension within the body lumen;
An insertion tool insertion method, wherein the living body lumen is aspirated by a suction part in a state where the expansion part is expanded.

  According to the present invention, when the expansion portion is expanded in a state where the main body portion is inserted into a biological lumen (for example, the urethra or vagina), the suction portion can be deformed so as to crush the biological lumen. Thus, a living body lumen wall (for example, a urethral wall or a vaginal wall) can be more reliably aspirated. Therefore, for example, a wide space can be secured between the urethra and the vagina, and a procedure for embedding the living tissue supporting indwelling object in the living body can be performed safely. In particular, when the insertion tool is inserted into the vagina, further effects can be exhibited.

  In other words, depending on the patient, when the central part of the anterior wall of the vagina hangs down into the vagina and has a vagina with a shape that is recessed on both sides (also referred to as “button holes”, hereinafter referred to as “button holes”) There is. When the insertion tool of the present invention is inserted into the vagina having such a shape, the expansion part is expanded to reduce the buttonhole, and the vagina wall located in the buttonhole can be attracted to the suction part side. Therefore, the vagina wall located in the buttonhole can be easily sucked, and a wide space between the urethra and the vagina can be secured. As a result, the procedure for embedding the living tissue supporting indwelling object in the living body can be performed safely.

It is a perspective view which shows an example of an implant. It is a perspective view which shows the puncture apparatus which concerns on 1st Embodiment. It is a side view of the puncture device shown in FIG. It is a top view which shows the operation member which the puncture apparatus shown in FIG. 2 has. It is a figure which shows the puncture member which the puncture apparatus shown in FIG. 2 has, (a) is a perspective view, (b) is the sectional view on the AA line in (a). It is sectional drawing of the puncture member shown in FIG. It is a figure which shows the state maintenance mechanism which the puncture member shown in FIG. 5 has, (a) is a top view, (b) And (c) is sectional drawing. It is the elements on larger scale which show the state maintenance mechanism which the puncture member shown in FIG. 5 has, (a) And (b) is a top view which respectively shows a modification, (c) is a top view which shows this embodiment. It is a top view which shows the guide part of the flame | frame with which the puncture apparatus shown in FIG. 2 is provided. It is sectional drawing which shows the puncture member of the state with which the flame | frame was mounted | worn. It is a top view which shows the fixing | fixed part of the flame | frame with which the puncture apparatus shown in FIG. 2 is provided. It is a side view of the insertion tool which the puncture apparatus shown in FIG. 2 has. It is a longitudinal cross-sectional view of the urethral insertion tool shown in FIG. 12, (a) shows a retracted state, (b) shows a protruding state. It is a cross-sectional view of the urethral insertion tool shown in FIG. 12, (a) shows a retracted state, (b) shows a protruding state. It is sectional drawing which shows the usage method of the urethral insertion tool shown in FIG. It is a figure which shows the positional relationship of a puncture member and a closing hole (pelvis), (a) is a side view, (b) is a front view. It is a figure which shows the front-end | tip part which the vagina insertion tool shown in FIG. 12 has, (a) is a top view, (b) is sectional drawing. It is a cross-sectional view of the front-end | tip part shown in FIG. 17, (a) shows a retracted state, (b) shows a protrusion state. It is sectional drawing which shows the usage method of the vaginal insertion tool shown in FIG. It is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. It is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. It is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. It is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. It is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. It is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. It is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. It is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. It is a figure which shows the vagina insertion tool which the puncture apparatus which concerns on 2nd Embodiment has, (a) And (c) is a side view, (b) is a top view. It is a side view explaining the movement of the suction hole which the vagina insertion tool shown in FIG. 28 has, (a) shows a 1st state and (b) shows a 2nd state. It is a cross-sectional view of the vaginal insertion tool shown in FIG. 28, (a) shows a 1st state, (b) shows a 2nd state. It is sectional drawing which shows the usage method of the vaginal insertion tool shown in FIG. It is a longitudinal cross-sectional view of the urethral insertion part which the puncture apparatus concerning 3rd Embodiment has, (a) shows a retracted state, (b) shows a protrusion state. It is a cross-sectional view of the urethra insertion part shown in FIG. It is a cross-sectional view of the urethra insertion part shown in FIG. It is a longitudinal cross-sectional view of the urethral insertion part which the puncture apparatus which concerns on 4th Embodiment has, (a) shows a retracted state, (b) shows a protrusion state. It is a cross-sectional view of the urethra insertion part shown in FIG. 35, (a) shows a retracted state, (b) shows a protruding state. It is a longitudinal cross-sectional view of the urethral insertion part which the puncture apparatus which concerns on 5th Embodiment has, (a) shows a retracted state, (b) shows a protrusion state. It is a longitudinal cross-sectional view of the urethral insertion part which the puncture apparatus concerning 6th Embodiment has, (a) shows a retracted state, (b) shows a protrusion state. It is a top view of the vagina insertion part which the puncture device concerning a 7th embodiment has, (a) shows a retracted state and (b) shows a protruding state. It is sectional drawing which shows the usage method of the vaginal insertion part shown in FIG. It is a figure which shows the retracted state of the vagina insertion part which the puncture apparatus which concerns on 8th Embodiment has, (a) is a top view, (b) is a side view. It is a figure which shows the expanded state of the vaginal insertion part shown in FIG. 41, (a) is a top view, (b) is a side view. It is sectional drawing which shows the usage method of the vaginal insertion part shown in FIG. It is a figure of the vagina insertion part which the puncture apparatus concerning 9th Embodiment has, (a) is a top view, (b) is a cross-sectional view. It is sectional drawing which shows the use condition of the vagina insertion part shown in FIG. It is a figure of the vagina insertion part which the puncture apparatus concerning 10th Embodiment has, (a) is a top view, (b) is a BB line cross-sectional view. It is sectional drawing which shows operation | movement of the vagina insertion part shown in FIG. It is sectional drawing which shows the usage method of the vaginal insertion part shown in FIG. It is a side view of the vagina insertion part which the puncture device concerning an 11th embodiment has. These are the top views of the vaginal insertion part which the puncture apparatus concerning 12th Embodiment has, (a) shows a retracted state, (b) shows an expanded state. It is a top view of the vagina insertion part which the puncture apparatus concerning 13th Embodiment has, (a) shows a retracted state, (b) shows an expanded state. It is a side view of the vagina insertion part shown in FIG. It is sectional drawing which shows the usage method of the vaginal insertion part shown in FIG.

  Hereinafter, an insertion tool and an insertion tool insertion method according to the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

<First Embodiment>
FIG. 1 is a perspective view showing an example of an implant. FIG. 2 is a perspective view showing the puncture device according to the first embodiment. FIG. 3 is a side view of the puncture device shown in FIG. FIG. 4 is a plan view showing an operation member included in the puncture device shown in FIG. 5A and 5B are diagrams showing a puncture member included in the puncture device shown in FIG. 2, wherein FIG. 5A is a perspective view, and FIG. 5B is a cross-sectional view taken along line AA in FIG. 6 is a cross-sectional view of the puncture member shown in FIG. FIG. 7 is a view showing a state maintaining mechanism of the puncture member shown in FIG. 5, in which (a) is a top view, and (b) and (c) are cross-sectional views. FIG. 8 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 5, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. It is. FIG. 9 is a plan view showing a guide portion of a frame provided in the puncture device shown in FIG. FIG. 10 is a cross-sectional view showing the puncture member mounted on the frame. FIG. 11 is a plan view showing a frame fixing portion provided in the puncture device shown in FIG. 2. FIG. 12 is a side view of the insertion tool included in the puncture device shown in FIG. 2. 13 is a longitudinal sectional view of the urethral insertion tool shown in FIG. 12, in which (a) shows a retracted state and (b) shows a protruding state. 14 is a cross-sectional view of the urethral insertion device shown in FIG. 12, in which (a) shows a retracted state and (b) shows a protruding state. FIG. 15 is a cross-sectional view showing a method of using the urethral insertion tool shown in FIG. FIG. 16 is a diagram showing a positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view. 17A and 17B are views showing the distal end portion of the vaginal insertion tool shown in FIG. 12, where FIG. 17A is a top view and FIG. 17B is a cross-sectional view. 18 is a cross-sectional view of the tip shown in FIG. 17, where (a) shows a retracted state and (b) shows a protruding state. FIG. 19 is a cross-sectional view showing a method of using the vaginal insertion tool shown in FIG. 20 to 27 are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.

  In the following, for convenience of explanation, the left side in FIG. 3 is also referred to as “tip”, the right side is also referred to as “base end”, the upper side is also referred to as “upper”, and the lower side is also referred to as “lower”. 2 and 3 each show a state that is not yet used, and hereinafter, this state is also referred to as an “initial state” for convenience of explanation. For convenience of explanation, the state where the puncture device (insertion tool) shown in FIGS. 2 and 3 is attached to the patient is also referred to as “attached state”. Moreover, in FIG. 6 and FIG. 7, the puncture member currently extended in circular arc shape is linearly extended and shown for convenience of explanation, respectively.

1. Implant First, an example of an implant (living tissue supporting indwelling object) 9 embedded in a living body by a puncture device will be described.

  An implant 9 shown in FIG. 1 is a device that can be implanted in a living body for the treatment of female urinary incontinence. Specifically, the implant 9 is an instrument that supports the urethra, for example, an instrument that supports movement of the urethra in a direction away from the vagina wall when the urethra is about to move toward the vagina wall. It is. As such an implant 9, for example, a long object having flexibility can be used.

  As shown in FIG. 1, the implant 9 includes an implant main body 91 and a band (connecting portion) 92 connected to one end of the implant main body 91. In place of the band 92, for example, a guide wire, string, thread, or the like may be used. The implant body 91 has a net shape, and the entire shape thereof is a band shape. The implant main body 91 can be configured by, for example, a braided body in which a linear body is crossed, that is, a braided body. Examples of the linear body include a circular cross section, a flat cross section, that is, a strip.

  The implant 9 having such a configuration is accommodated in a packaging material 90 sterilized in an unused state. Thereby, contamination of the implant 9 can be prevented.

  The constituent materials of the implant body 91, the band 92, and the packaging material 90 are not particularly limited, and for example, various resin materials having biocompatibility such as polypropylene, polyester, and nylon, fibers, and the like can be used. .

  Although the implant 9 has been described above, the implant 9 is not limited to the net-like one as long as the same effect can be exhibited.

2. Puncture device A puncture device 1 shown in FIG. 2 is a device used to embed the above-described implant 9 in a living body.

  As shown in FIG. 2, the puncture device 1 includes a frame 2, an insertion tool 6, an operation member 7, and a puncture member 3. The puncture member 3, the insertion tool 6, and the operation The member 7 is supported, and the puncture member 3 is supported by the operation member 7. The insertion tool 6 includes a urethral insertion tool 4 and a vaginal insertion tool 5.

Hereinafter, each of these units will be described in order.
2-1. Operation member The operation member 7 is a member for supporting and operating the puncture member 3. As shown in FIGS. 2, 3, and 4, the operation member 7 has an insertion portion 71, a shaft portion 73, and a connecting portion 72 that connects the insertion portion 71 and the shaft portion 73. Yes. The insertion portion 71, the coupling portion 72, and the shaft portion 73 may be integrally formed, or at least one portion may be formed as a separate body from other portions.

  The insertion portion 71 is a part that is inserted into the puncture member 3 and functions as a stylet that reinforces the puncture member 3 from the inside. By inserting the insertion portion 71 into the puncture member 3, the puncture member 3 is connected to the operation member 7, and the operation member 7 can be operated (puncture into a living body).

  The insertion portion 71 has an arc shape corresponding to the shape of the puncture member 3. Further, the center angle and the radius of curvature of the insertion portion 71 are set according to the center angle and the radius of curvature of the puncture member 3. Moreover, the front-end | tip part 711 of the insertion part 71 is tapering, Thereby, the insertion of the puncture member 3 to the insertion part 71 can be performed smoothly.

  In this embodiment, the cross-sectional shape of the insertion portion 71 is circular. However, the cross-sectional shape of the insertion portion 71 is not limited to this. For example, an elliptical shape or other rounded corners are rounded. A rhombus, a rectangular shape with rounded corners (flat shape, plate shape), and a spindle shape with a central portion wider (enlarged) than both ends may be used. By having such a cross-sectional shape, in a state where the insertion portion 71 is inserted into the puncture member 3, rotation of the puncture member 3 with respect to the insertion portion 71, that is, unnecessary deformation or displacement of the puncture member 3 is effectively performed. Can be suppressed.

  The shaft portion 73 intersects the center O of the insertion portion 71 and extends on an axis J1 orthogonal to the plane f1 including the insertion portion 71. The connecting portion 72 connects the proximal end portion of the insertion portion 71 and the distal end portion of the shaft portion 73. The connecting portion 72 has a substantially L shape bent at a substantially right angle on the way.

  The operation member 7 having such a configuration is configured to have higher rigidity than the puncture member 3. The constituent material of the operation member 7 is not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy can be used. In addition, in order to suppress the bending | flexion etc. of the puncture member 3, you may make the connection part 72 and the axial part 73 thicker than the insertion part 71 as needed.

  A handle 74 is fixed to the base end portion of the shaft portion 73. By rotating the handle 74, the operation member 7 can be rotated around the axis J1. Note that the handle 74 may be omitted, and the operation member 7 may be rotated by holding the connecting portion 72, for example.

2-2. Puncture member The puncture member 3 is a member for puncturing a living body. As shown in FIG. 5A, the puncture member 3 has a long sheath (medical tube) 30 and a needle body 35 provided at the distal end of the sheath 30. The sheath 30 includes a tubular main body 31 and a state maintaining unit 34.

  The main body 31 is composed of a long tubular body (tube), and the distal end and the proximal end are open. The inside of the main body 31 functions as a space for inserting the insertion portion 71 and a space for inserting the implant 9.

  The main body 31 has a curved shape that is curved in an arc shape. Further, as shown in FIG. 5B, the main body 31 has a flat cross-sectional shape having a short axis J31 and a long axis J32. By making the main body 31 into a flat shape, the implant main body 91 can be controlled in a desired posture within the main body 31.

  The flat shape of the main body 31 is not particularly limited, and for example, an oval shape, a convex lens shape in cross section, a rhombus with rounded corners, a rectangle with rounded corners (flat shape), and a central portion at both ends A spindle shape or the like that is larger (expanded) than the portion can be used.

  The width of the internal space of the main body 31 (the length in the direction of the long axis J32) is designed to be substantially the same as the width of the implant main body 91. Thereby, the frictional resistance between the implant 9 and the main body 31 is reduced, and unnecessary force is not applied to the implant 9, and the implant main body 91 can be disposed in the main body 31 in a sufficiently expanded state. However, the width of the internal space of the main body 31 may be shorter than the width of the implant main body 91. In this case, since the width of the main body 31 can be suppressed, the puncture member 3 is less invasive.

  In the following, for convenience of explanation, as shown in FIG. 5B, the end located on the inner side in the major axis J32 direction (the side proximal to the center) is also referred to as “inner peripheral part A1”. An end located on the outer side (distal side with respect to the center) in the direction of the long axis J32 is also referred to as “outer peripheral part A2”, a surface facing upward in the drawing is also referred to as “surface A3”, and a surface facing downward Also referred to as “back A4”.

  As shown in FIG. 5B, a plane including both the center point of the arc of the central portion S4 and the center point of the cross-sectional shape with respect to the longitudinal direction of the main body 31 (surface including the central axis of the main body 31) is defined as a plane f9. When the angle formed between the plane f9 and the short axis J31 at the central portion S4 is defined as an inclination angle θ1, the inclination angle θ1 is preferably an acute angle. By setting the inclination angle θ1 to an acute angle, the implant body 91 can be disposed substantially parallel to the urethra, as will be described later. Therefore, the urethra can be supported more effectively.

  The inclination angle θ1 is not particularly limited as long as it is an acute angle, but for example, it is preferably about 20 ° to 60 °, more preferably 30 ° to 45 °, and about 35 ° to 40 °. Is more preferable. Thereby, the above-mentioned effect improves further.

  The tilt angle θ1 preferably satisfies the above numerical range over the entire extending direction of the main body 31, but it is sufficient that the above numerical range is satisfied at least in the central portion S4. Here, the “central portion S4” means at least a region including a portion located between the urethra and the vagina in a state where the puncture member 3 is punctured into the living body (a state where the main body 31 is disposed in the living body). .

  Markers may be provided at both ends of the main body 31 at positions that are equal from the central portion S4 and project outside the living body in a state where the main body 31 is disposed on the living body. Thereby, the position in the living body of center part S4 can be confirmed by comparing the position of both markers.

  The configuration of the main body 31 can be paraphrased as follows. That is, as shown in FIG. 5B, the main body 31 is formed such that the long axis J32 is inclined with respect to the central axis J5 of the arc, and an extension line J32 ′ between the central axis J5 and the long axis J32 is formed. It can also be said that it is configured to have an intersection P. In this case, the angle θ5 formed by the central axis J5 and the extension line J32 ′ is equal to the inclination angle θ1 described above.

  In other words, as shown in FIG. 9, the main body 31 has an inner peripheral portion that is located at the inner peripheral edge and has a minimum curvature radius r1 in a plan view as viewed from the direction of the central axis J5 of the main body 31. A1 and an outer peripheral portion A2 located at the outer peripheral edge and having a maximum radius of curvature r2, as shown in FIGS. 5B and 10, the inner peripheral portion A1 and the outer peripheral portion A2 are displaced in the direction of the central axis J5. It can be said that it is configured to be located.

  Such a main body 31 has a configuration in which two divided pieces are connected so that they can be divided in the middle. Specifically, as shown in FIG. 5A, the main body 31 includes a distal end split piece 32 positioned on the needle body 35 side and a proximal end split positioned on the proximal end side of the distal end split piece 32. It has the piece 33 and these are connected so that isolation | separation is possible. Moreover, in the main body 31, the front-end | tip division | segmentation piece 32 and the base end division | segmentation piece 33 become substantially the same length, These boundaries are located in center part S4.

  As shown in FIG. 6, the distal end divided piece 32 has a tube shape and has a distal end side opening 321 and a proximal end side opening 322. Further, the base end split piece 33 also has a tube shape and has a front end side opening 331 and a base end side opening 332. And the front-end | tip part of the base end split piece 33 is inserted in the base end part of the front end split piece 32, and, thereby, the front end split piece 32 and the base end split piece 33 are connected. By inserting the proximal end divided piece 33 into the distal divided piece 32, a step that may occur at the boundary between the divided pieces 32 and 33 becomes difficult to be caught by the living tissue when the puncture member 3 is punctured, and the puncture member 3 is punctured into the living body. Can be performed smoothly. However, contrary to the present embodiment, the split pieces 32 and 33 may be connected by inserting the base end of the tip split piece 32 into the base split piece 33.

  The state where the divided pieces 32 and 33 are connected (connected state) is maintained by the state maintaining unit 34. As shown in FIG. 7A, the state maintaining unit 34 includes holes 342a, 342b, and 342c, an endless thread 341 inserted through the holes 342a, 342b, and 342c, and an exposure hole 345 that exposes the thread 341. 346 and a slit 347 that connects the exposure holes 345 and 346.

  The hole 342a is provided at the base end portion of the base end split piece 33 and closer to the inner peripheral portion A1 of the surface A3. On the other hand, the holes 342b and 342c are the base end portions of the tip split piece 32, and are provided facing the inner peripheral portion A1 of the front surface A3 and the back surface A4.

  The thread 341 is disposed in the main body 31 and is routed outside the main body 31 between the hole 342b and the hole 342c, and between the hole 342a and the proximal end opening 332, respectively. Thereby, the connection state of the division | segmentation pieces 32 and 33 can be maintained easily. Further, the exposure of the thread 341 to the outside of the main body 31 can be suppressed, and the thread 341 is hardly caught on the living tissue. Further, since the entire length of the thread 341 can be shortened as much as possible, the thread 341 is hardly caught by the implant 9 when the implant 9 is inserted into the main body 31. In particular, as described above, since the holes 342a, 342b, and 342c are respectively disposed closer to the inner peripheral portion A1, the yarn 341 is also biased toward the inner peripheral portion A1. Therefore, the thread 341 is hardly caught by the implant 9.

  The thread 341 is prepared, for example, as a thread with ends, and one end of the thread 341 is inserted into the main body 31 from the proximal end opening 332, pulled out of the main body 31 from the hole 342b, and inserted into the main body 31 from the hole 342c. It is obtained by pulling it out of the main body 31 from the hole 342a and finally tying it with the other end in the vicinity of the base end side opening 332. However, the position of the knot is not limited.

  Here, as shown in FIG. 7C, the shaft (inner peripheral surface) of the hole 342a is inclined such that the outer opening is located closer to the base end side than the inner opening. On the other hand, as shown in FIG. 7B, the holes (342b, 342c) each have an axis (inner peripheral surface) inclined so that the outer opening is located closer to the tip than the inner opening. Thereby, each hole 342a, 342b, 342c can be extended along the path | route of the thread | yarn 341, and the thread | yarn 341 becomes difficult to be caught in each hole 342a, 342b, 342c.

  The number and arrangement of the holes through which the thread 341 passes are not particularly limited as long as the connection state between the distal end split piece 32 and the proximal end split piece 33 can be maintained by the thread 341. Moreover, the thread | yarn 341 does not need to be endless shape, and the end shape which has one end and the other end may be sufficient as it. For example, an end-shaped thread may be prepared, and one end thereof may be a loop that passes through the hole 342a and the proximal end opening 332, and the other end may be a loop that passes through the holes 342b and 342c. Further, the thread 341 includes a string, a band, and the like that can be used in the same manner as the thread 341.

  The exposure holes 345 and 346 are provided to face the front surface A3 and the back surface A4 of the base end portion of the base end split piece 33. Further, the exposure holes 345 and 346 are provided in a portion exposed from the body surface when the main body 31 is disposed in the living body. The exposure holes 345 and 346 are located on the path of the yarn 341, and the yarn 341 is exposed from the exposure holes 345 and 346. Further, the exposure holes 345 and 346 are connected by a slit 347 provided in the inner peripheral portion A1 along the circumferential direction of the main body 31.

  In such a state maintaining unit 34, the tip split piece 32 and the base end split piece 33 are separable by cutting the thread 341. By setting it as such a structure, the front end division | segmentation piece 32 and the base end division | segmentation piece 33 can be made into the state which can be isolate | separated by simple operation. Moreover, since the cutting | disconnection of the thread | yarn 341 is visible, it can confirm easily that the front end division | segmentation piece 32 and the base end division | segmentation piece 33 became a state which can be isolate | separated.

  The thread 341 can be easily cut by providing the exposure holes 345 and 346 and the slit 347 as in the present embodiment. For example, a scissors is prepared, one blade is inserted into the exposure holes 345 and 346, and the thread 341 is positioned between the other blade. When the heel is closed, at least one of the pair of blades passes through the slit 347 and the pair of blades overlap, and the thread 341 is cut in the process.

  Thus, in this embodiment, the slit 347 is used as the blade passage. Accordingly, the thread 341 can be easily cut as described above, and deformation of the main body 31 due to the tension of the thread 341 is prevented. For example, as shown in FIG. 8A, the blade passage may be replaced with a slit 347 and configured with a hole 348. However, in this case, depending on the hardness of the main body 31, as shown in FIG. 8B, the hole 348 may buckle and collapse due to the tension of the thread 341, and the main body 31 may be deformed. On the other hand, in the slit 347, as shown in FIG. 8C, the portions 347a and 347b sandwiching the slit 347 are in contact and are stretched. Is prevented.

  A needle body 35 is provided at the tip of the main body 31 as described above. As shown in FIG. 6, the needle body 35 has a tapered needle tip 351 and a proximal end portion 352 provided on the proximal end side of the needle tip 351. Then, the base end portion 352 is inserted into the main body 31, whereby the needle body 35 is detachably held on the main body 31. The proximal end portion 352 is fitted into the main body 31 with a force that can prevent unintentional detachment of the needle body 35 from the main body 31.

  The needle body 35 may be configured integrally with the main body 31. In this case, the needle body 35 only needs to be cut from the main body 31 with a scissors or the like.

  An engagement portion 353 that engages with the distal end portion 711 of the insertion portion 71 is provided at the proximal end portion 352 of the needle body 35. The engaging portion 353 is configured by a concave portion, and the distal end portion 711 of the inserting portion 71 is positioned in the engaging portion 353 in the insertion state in which the puncture member 3 is inserted into the inserting portion 71. Thereby, the displacement of the puncture member 3 with respect to the insertion portion 71, specifically, the rotation of the puncture member 3 with respect to the insertion portion 71, the displacement of the puncture member 3 with respect to the insertion portion 71 in the width direction, and the like are suppressed. The puncture member 3 can be punctured more smoothly.

  The puncture member 3 has been described above. The central angle θ4 (see FIG. 9) of the puncture member 3 is not particularly limited and is appropriately set according to various conditions. However, the needle body 35 enters the body from one buttock of the patient, and the urethra It is set so that it can pass between the vagina and protrude from the other buttocks. Specifically, the central angle θ4 is preferably about 150 ° to 270 °, more preferably about 170 ° to 250 °, and further preferably about 190 ° to 230 °.

  The constituent material of the main body 31 and the needle body 35 is preferably a hard material that maintains its shape and internal space when inserted into the body. Examples of such a hard material include various resin materials such as polyethylene, polyimide, polyamide, polyester elastomer, and polypropylene, and various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like. .

  In addition to employing a hard material as the configuration of the main body 31 and the needle body 35, when a material other than the hard material is employed, the wall can be reinforced by a reinforcing member. For example, by embedding a high-strength braided body in the wall, the shape and the internal space can be maintained while being inserted into the body. As another example of the reinforcing member, by embedding a spiral object in the wall of the main body 31, it is possible to provide flexibility while maintaining the internal space to the extent that the insert can slide.

  Moreover, it is preferable that the main body 31 has a light transmittance, and the inside can be visually recognized from the outside. Thereby, for example, it is possible to easily confirm from the outside whether the distal end portion 711 of the insertion portion 71 inserted inside is engaged with the engagement portion 353 or whether the thread 341 is not broken.

  As described above, the insertion portion 71 of the operation member 7 is inserted into the puncture member 3 having such a configuration in the initial state, and in this state, the distal end portion 711 of the insertion portion 71 is engaged with the needle body 35. The proximal end of the puncture member 3 is in contact with the connecting portion 72 while being located in the joint portion 353. Since the distal end portion 711 of the insertion portion 71 is positioned in the engagement portion 353, the rotation of the puncture member 3 with respect to the insertion portion 71 is suppressed as described above, and the proximal end of the puncture member 3 is connected to the connection portion 72. By abutting, the puncture member 3 is not displaced in the extending direction of the insertion portion 71 during puncture, and the needle body 35 is not detached from the main body 31.

  In the puncture device 1, the medical tube assembly 10 is configured by the puncture member 3 as described above and the insertion portion 71 inserted into the main body 31, and these are used in the state of the medical tube assembly 10. Is started.

2-3. Frame The frame 2 rotatably holds the operation member 7 to which the puncture member 3 is attached, and fixes the insertion tool 6 so as to be detachable. Such a frame 2 has a function of determining a puncture route of the needle body 35 when the puncture member 3 punctures a living tissue. Specifically, the frame 2 is configured so that when the puncture member 3 punctures a living tissue, the needle body 35 passes between the urethra insertion tool 4 and the vaginal insertion tool 5 without colliding with them. 3. The positional relationship between the urethral insertion tool 4 and the vaginal insertion tool 5 is defined.

  As shown in FIGS. 2 and 3, the frame 2 connects the bearing portion 21 that supports the shaft portion 73 of the operation member 7, the guide portion 22 that guides the puncture member 3, and the bearing portion 21 and the guide portion 22. And a fixing portion 24 for fixing the insertion tool 6.

  The bearing portion 21 is located on the proximal end side of the puncture device 1 and extends in a direction substantially orthogonal to the axis J1. A through hole 211 is formed on the shaft J1 of the bearing portion 21, and the shaft portion 73 is rotatably inserted into the through hole 211. As a result, the operation member 7 is supported on the frame 2 in a state of being rotatable about the axis J1.

  The guide portion 22 is located on the distal end side of the puncture device 1 and is disposed to face the bearing portion 21. As shown in FIGS. 2 and 9, the guide portion 22 is located inside the puncture member 3, has an arc shape extending along the puncture member 3, and is configured to support the puncture member 3 from the inside. . As shown in FIG. 10, the puncture member 3 is arranged in the guide portion 22 so that the back surface A4 faces the distal end side and the front surface A3 faces the proximal end side.

  The connecting portion 23 connects the bearing portion 21 and the guide portion 22. Further, the connecting portion 23 has a rod shape extending substantially parallel to the axis J1. The connection part 23 also functions as a grip part. The operator can use the puncture device 1 in a stable state by gripping the connecting portion 23.

  The fixed portion 24 is disposed to face the connecting portion 23 via the axis J1. As shown in FIG. 11, the fixing portion 24 includes a concave portion 243 into which support portions 40 and 50 (described later) of the insertion tool 6 are fitted, and a male screw 244. In such a fixing part 24, the insertion tool 6 can be fixed to the fixing part 24 by fitting the supporting parts 40 and 50 into the recessed part 243 and further tightening the male screw 244 into the supporting part 40.

2-4. Insertion Tool As shown in FIGS. 2, 3, and 12, the insertion tool 6 includes a urethral insertion tool 4 and a vaginal insertion tool 5.

-Urethral insertion device-
The urethral insertion device 4 includes a long urethral insertion portion 41 that is inserted into the urethra halfway and a support portion 40 that supports the urethral insertion portion 41. The constituent materials of the urethral insertion portion 41 and the support portion 40 are not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials can be used. .

  Further, the length of the urethral insertion portion 41 (portion on the distal end side from the support portion 40) is not particularly limited, and is appropriately set depending on the length of the urethra of the patient, the shape of the bladder, and the like. Therefore, the length is preferably about 50 to 100 mm.

  The urethral insertion portion 41 has a straight tubular shape. At the distal end portion of such a urethral insertion portion 41, a balloon 421 which is an expandable and expandable / shrinkable expansion body, and a urine discharge portion 422 are provided.

  The balloon 421 is disposed so as to be located in the bladder when the urethral insertion portion 41 is inserted into the urethra. The balloon 421 passes through the urethral insertion portion 41 and is connected to a balloon port 431 provided at the proximal end portion thereof. A balloon expansion device such as a syringe can be connected to the balloon port 431. When a working fluid (liquid such as physiological saline, gas, etc.) is supplied from the balloon expansion device to the balloon 421, the balloon 421 is expanded. In addition, when the working fluid is extracted from the balloon 421 by the balloon expanding device, the balloon 421 is deflated. 3 and 12, the state where the balloon 421 is contracted is indicated by a two-dot chain line, and the state where the balloon 421 is expanded is indicated by a solid line.

  The urine drainage unit 422 is used to drain urine in the bladder with the urethral insertion unit 41 inserted into the urethra. The urine discharge part 422 is provided with a urine discharge hole 422 a that communicates the inside and outside of the urine discharge part 422. Further, the urine drainage hole 422a passes through the urethral insertion portion 41 and is connected to a urine drainage port 432 provided at the base end portion thereof. Therefore, the urine introduced from the urine drainage hole 422a can be discharged from the urine discharge port 432.

  The balloon 421 and the urine discharge part 422 can be constituted by, for example, a double lumen.

  A suction mechanism 44 for sucking the urethra wall is provided in the middle of the urethra insertion portion 41 (the base end side of the balloon 421). The suction mechanism 44 includes a main body portion 45, a suction portion 46 provided so as to be movable with respect to the main body portion 45, and a moving mechanism 48 for moving the suction portion 46 with respect to the main body portion 45. ing.

  As shown in FIG. 13 and FIG. 14, the main body 45 has a long, substantially cylindrical shape with a rounded tip. In addition, a cavity constituting the decompression chamber 451 is provided inside the main body 45. Further, a suction port 452 for sucking air in the decompression chamber 451 is formed in the main body 45, and the air in the decompression chamber 451 is sucked through the suction port 452 to decompress the inside of the decompression chamber 451. Can do. In addition, an annular recess that opens to the peripheral surface of the main body 45 is formed around the decompression chamber 451, and this recess constitutes an accommodating portion 453 for accommodating the suction portion 46. In addition, a plurality of slits (long holes) 454 that communicate with the inside and outside of the decompression chamber 451 and extend in the axial direction of the main body 45 are formed at the bottom of the housing portion 453 along the circumferential direction of the main body 45. Each of these slits 454 functions as a guide for guiding the movement of the suction unit 46 with respect to the main body 45 and also functions as an inlet for guiding the air outside the main body 45 into the decompression chamber 451.

  The suction part 46 is accommodated in the accommodating part 453 of the main body part 45 as described above. Further, as shown in FIG. 14, a plurality of suction units 46 (ten in this embodiment) are provided along the circumferential direction on the entire circumference of the main body 45.

  Each suction portion 46 has a long shape extending in the axial direction of the main body 45, and is provided on the outer periphery of the front and rear portions of the main body 45 (the boundary portions 458 and 459 with the storage 453). A plate-like base portion 461 that is curved in a circular arc shape along with a pair of guide portions (projections) 462 and 463 that protrude from the base portion 461 to the inside of the main body portion 45, and each guide portion 462 and 463 is a main body By being inserted into the slit 454 of the portion 45, the main body portion 45 is supported so as to be movable. The base portion 461 is formed with a plurality of suction holes 464 that penetrate the base portion 461 in the thickness direction, and the suction holes 464 are connected to the decompression chamber 451 through the slits 454.

  Each such suction part 46 can be moved in the radial direction with respect to the main body part 45 by being guided by the slit 454. Specifically, each suction portion 46 is in a retracted state in which it is retracted into the accommodating portion 453 as shown in FIGS. 13 (a) and 14 (a), and FIGS. 13 (b) and 14 (b). ) And the protruding state protruding from the housing portion 453 as shown in FIG. In the protruding state, the plurality of suction portions 46 protrude radially from the retracted state, and the suction portion 46 is expanded in diameter as a whole as compared with the retracted state.

  In the present embodiment, in the retracted state, the base portion 461 of each suction portion 46 is substantially flush with the outer periphery of the portions (boundary portions 458 and 459) located in front of and behind the accommodating portion 453 of the main body portion 45. In other words, the main body portion 45 is arranged so as to coincide with the line segment connecting the boundary portions 458 and 459 in the longitudinal sectional view. Therefore, there is substantially no step between the main body portion 45 and the suction portion 46, and the main body portion 45 can be smoothly inserted into the urethra as described later. However, the position of the base portion 461 in the retracted state is not limited to the position of the present embodiment, and may be located inside the line segment, and if slightly, located outside the line segment. Also good.

  Further, a film 47 is provided between the adjacent suction parts 46 or between the suction part 46 and the main body part 45, and a gap between the adjacent suction parts 46 or between the suction part 46 and the main body part 45 is provided. Air does not leak from the gap. That is, the membrane 47 prevents the inside and outside of the decompression chamber 451 from communicating with each other through a portion other than the suction hole 464. Such a film 47 is folded between adjacent suction parts 46 when the suction part 46 is in the retracted state or between the suction part 46 and the main body part 45, and is adjacent when it is in the protruding state. It extends and extends between the suction portions 46 and between the suction portion 46 and the main body portion 45. Such a film 47 is not particularly limited as long as it is flexible and airtight.

  Next, the moving mechanism 48 for moving the suction part 46 with respect to the main body part 45 will be described. The moving mechanism 48 can switch between the retracted state and the protruding state by moving the suction portions 46 simultaneously (integrally).

  Such a moving mechanism 48 is provided inside the main body 45, and is provided on the base end side of the moving portion 481 and a ring-shaped moving portion 481 that can slide in the axial direction with respect to the main body 45. And a plurality of deformable portions 483 provided corresponding to the plurality of suction portions 46 (that is, one-to-one) on the distal end side of the moving portion 481.

  The operation unit 482 is pulled out of the main body unit 45, and the moving unit 481 can be slid with respect to the main body unit 45 by pushing or pulling the operation unit 482. Each deformable portion 483 is inserted between the guide portions 462 and 463 of the corresponding suction portion 46, and is connected to the base portion 461 so as to be slidable, and the base end of the press portion 483a. A first connecting portion 483b that connects the moving portion 481 and the second connecting portion 483c that connects the distal end portion of the pressing portion 483a and the main body 45, and the first connecting portion 483b includes the pressing portion 483a. The second connecting portion 483c is rotatably connected to the pressing portion 483a and the main body portion 45.

  According to the moving mechanism 48 having such a configuration, when the operating portion 482 is pushed into the distal end side of the main body 45 from the retracted state as shown in FIGS. 13A and 14A, the first, The second connecting parts 483b and 483c rise, and the pressing part 483a moves toward the outside of the main body part 45 along with it. Then, the base 461 moves outward along the slit 454 due to the movement of the pressing portion 483a, and a protruding state as shown in FIGS. 13B and 14B is obtained.

  In the present embodiment, in order to prevent an unintended operation by the operation unit 482, the suction mechanism 44 further includes a lock mechanism 49 that restricts the movement of the operation unit 482. According to such a lock mechanism 49, in addition to the above effect, the suction portion 46 can be protruded to suck the urethra wall and can be fixed again when retracted while maintaining the suction state. The operability of the tool 4 is improved, and the procedure can be performed more smoothly and safely.

  The lock mechanism 49 has a concave portion 491 formed on the outer peripheral surface of the main body portion 45 and a claw portion 492 provided at the proximal end portion of the operation portion 482. The claw portion 492 is engaged with the concave portion 491. This prevents the operation unit 482 from moving. Thereby, an unintended operation by the operation unit 482 can be prevented with a simple configuration.

  Such a urethral insertion part 41 can be used as follows. That is, first, as shown in FIG. 15A, the urethra insertion part 41 is inserted into the urethra 1300 while the suction part 46 is in the retracted state. At this time, since it is in the retracted state, the suction part 46 and the urethra are not caught, and the urethra insertion part 41 can be smoothly inserted into the urethra. Next, after releasing the lock mechanism 49, the operation portion 482 is pushed in, and the suction portion 46 is brought into a protruding state as shown in FIG. By projecting the suction part 46, the urethra wall can be extended and the suction part 46 can be pressed against the urethra wall, so that the urethra wall and the suction hole 464 can be brought into close contact with each other. Next, the urethral wall can be adsorbed and fixed to the suction hole 464 by decompressing the decompression chamber 451 with a suction pump or the like connected to the suction port 452 in this state. After the urethral wall is adsorbed and fixed, it is preferable to return the suction unit 46 to the retracted state by pulling back the operation unit 482 as shown in FIG. As a result, the diameter of the urethra 1300 can be reduced, and contact between the puncture member 3 and the urethra 1300, that is, erroneous puncture of the urethra 1300 by the puncture member 3 can be more effectively prevented.

  In particular, as described above, since the plurality of suction portions 46 are arranged over the entire circumference in the circumferential direction of the main body portion 45, the entire circumference of the urethral wall can be sucked, and the above effects can be more effectively exhibited. .

  Here, as will be described later, when the urethra insertion part 41 is pushed into the body (the distal end side of the urethra insertion part 41) while the urethra wall is adsorbed and fixed to the urethra insertion part 41, the urethra and bladder together with this It is pushed into the body and the bladder can be shifted to a position that does not overlap the puncture path of the puncture member 3. Therefore, a larger puncture path of the puncture member 3 can be secured, and the puncture of the puncture member 3 can be performed accurately and safely.

  Next, the inclination of the urethral insertion part 41 and the puncture member 3 will be described. As shown in FIG. 3, the axis J1 of the puncture member 3 is inclined with respect to the axis of the urethra insertion part 41 so that the separation distance from the axis J2 of the urethra insertion part 41 increases toward the distal end side. ing. The angle formed by the axis J1 and the axis J2, that is, the inclination angle θ2 of the plane f9 (plane f1) with respect to the plane f2 orthogonal to the axis J2 of the urethral insertion portion 41 is not particularly limited, but is about 20 ° to 60 °. The angle is preferably about 30 ° to 45 °, more preferably about 35 ° to 40 °. Thereby, the puncture of the puncture member 3 can be performed easily, and the puncture distance by the puncture member 3 can be further shortened.

  Specifically, by setting the inclination angle θ2 within the above range, as shown in FIG. 16A, the puncture member 3 can broadly grasp one closing hole 1101 of the pelvis 1100 in a plane, A wide puncture space for the puncture member 3 can be secured. That is, the puncture member 3 can be punctured in a relatively vertical direction with respect to the closing holes 1101 and 1102 in a state where the patient is in a predetermined body position (crushed stone position). Therefore, the puncture member 3 can be punctured easily.

  Further, since the puncture member 3 passes through a shallow portion of the tissue by puncturing the puncture member 3 in a relatively vertical direction with respect to the closure holes 1101 and 1102, the tip (needle body 35) of the puncture member 3 is closed. It passes between 1101 and 1102 at a shorter distance. Therefore, as shown in FIG. 16B, the puncture member 3 can pass through the closure holes 1101 and 1102 closer to the pubic joint 1200, preferably through the safety zone S5. Since the safety zone S5 is a region where there are few nerves and blood vessels to avoid damage, the puncture member 3 can be punctured safely by passing through the safety zone S5. Therefore, it becomes less invasive and can reduce the burden on the patient.

  As described above, by setting the inclination angle θ2 within the above range, the patient can be punctured with the puncture member 3 more appropriately. In addition, puncturing at the above-described angle makes it easy to target the tissue between the middle urethra and the vagina that indicate the middle portion in the length direction of the urethra. Here, since the position between the middle urethra and the vagina is suitable as a site for implanting the implant 9 and treating urinary incontinence, targeting the tissue between the middle urethra and the vagina is more effective. Can be treated.

  When the inclination angle θ2 is less than the above lower limit value or exceeds the above upper limit value, the puncture member 3 captures the closed holes 1101 and 1102 widely in a plane depending on individual differences of patients, posture during the procedure, and the like. In some cases, the puncture route of the puncture member 3 cannot be shortened sufficiently.

  The configuration of the urethral insertion tool 4 has been described above. In such a urethral insertion device 4, the urethral insertion portion 41 may not be slidable with respect to the support portion 40, and may be slidable with respect to the support portion 40. In the case of being slidable, for example, if a screw (not shown) provided in the support portion 40 is loosened, the urethral insertion portion 41 is slidable with respect to the support portion 40, and the screw is tightened. For example, the urethral insertion part 41 may be configured to be fixed to the support part 40. According to this configuration, since the length of the urethral insertion portion 41 can be adjusted, the urethral insertion tool 4 is more convenient to use. This also applies to the vaginal insertion tool 5 described later.

  In the puncture device 1, the urethral insertion tool 4 is fixed to the frame 2 so that the inclination angle θ2 is constant, but the present invention is not limited to this, and the inclination angle θ2 may be variable. Thereby, since inclination-angle (theta) 2 can be adjusted according to a patient, it becomes the puncture apparatus 1 which is more convenient.

-Vaginal insertion tool-
As shown in FIGS. 2, 3, and 12, the vaginal insertion tool 5 includes a long vagina insertion portion 51 that is inserted into the vagina partway and a support portion (vaginal insertion portion) that supports the vagina insertion portion 51. Support part) 50. The vaginal insertion portion 51 has a distal end portion 52 located on the distal end side and a shaft portion 53 connected to the proximal end portion of the distal end portion 52, and the shaft portion 53 is supported by the support portion 50.

  The constituent materials of the vaginal insertion part 51 and the support part 50 are not particularly limited. For example, as with the urethra insertion device 4 (urethra insertion part 41 and support part 40), stainless steel, aluminum or an aluminum alloy, titanium or titanium Various metal materials such as alloys and various resin materials can be used.

  As shown in FIG. 17, the distal end portion 52 is a portion that is inserted into the vagina and has a substantially constant width as a whole, and the distal end portion is rounded. Moreover, the front-end | tip part 52 has comprised the flat shape crushed in the thickness direction. Although it does not specifically limit as length L2 of the front-end | tip part 52, It is preferable that it is about 20 mm-100 mm, and it is more preferable that it is about 30 mm-60 mm. The width W1 of the tip 52 is not particularly limited, but is preferably about 10 mm to 50 mm, and more preferably about 20 mm to 40 mm. By setting such length (L2) × width (W1), the tip 52 has a shape and size suitable for a general vagina. Therefore, the stability of the puncture device 1 in the mounted state is increased, and the burden on the patient is reduced.

  Further, the upper surface 52 (the surface on the urethral insertion portion 41 side) 52a is inclined with respect to the urethral insertion portion 41 so that the distal end portion 52 is separated from the urethral insertion portion 41 toward the distal end. Thereby, compared with the case where it is not inclined, the positional relationship between the urethral insertion portion 41 and the distal end portion 52 can be made closer to the actual positional relationship between the urethra and the vagina. Therefore, the puncture device 1 is more stably held by the patient in the wearing state, and the burden on the patient is reduced.

  The inclination angle θ3 of the upper surface 52a with respect to the urethral insertion portion 41 is not particularly limited, but is preferably about 0 ° to 45 °, and more preferably about 0 ° to 30 °. Thereby, the said effect can be exhibited more notably. On the other hand, when the inclination angle θ3 is less than the above lower limit value or exceeds the above upper limit value, the vagina and urethra deform unnaturally in the wearing state depending on individual differences of patients, posture during the procedure, etc. However, the puncture device 1 may not be stably held.

  Such a distal end portion 52 includes a main body portion 54 that forms the outer shape of the distal end portion 52 and suction portions (first and second suction portions) 55 and 56 that are provided so as to be movable with respect to the main body portion 54. And a moving mechanism 57 for moving the suction portions 55 and 56 with respect to the main body portion 54.

  As shown in FIG. 17B, a cavity constituting the decompression chamber 541 is formed inside the main body 54. Further, the main body portion 54 is provided with a suction port 542 for sucking air in the decompression chamber 541, and the inside of the decompression chamber 541 can be decompressed via the suction port 542. The main body 54 is provided with a suction part 543 that is connected to the decompression chamber 541 and adsorbs the vagina wall. The suction part 543 is located at the center of the upper surface 52a. The suction part 543 includes a plurality of suction holes 544 arranged in a matrix. Each suction hole 544 has a bottomed recess 544a that opens to the upper surface 52a, and a communication hole (pore) 544b that connects the recess 544a and the decompression chamber 541. The number of suction holes 544 is not particularly limited, and may be one, for example. Further, the arrangement of the suction holes 544 is not particularly limited, and may be arranged irregularly, for example.

  As shown in FIG. 17 (a), the suction portions 55 and 56 have both end sides in the width direction of the upper surface 52a (the direction intersecting the insertion direction of the vagina insertion tool 5 into the vagina) with the suction portion 543 interposed therebetween. Is located. The suction portions 55 and 56 are located across the upper surface 52a and the side surfaces. The suction portions 55 and 56 are inserted into guide holes 547 and 548 communicating with the decompression chamber 541, and are movable with respect to the main body portion 54 along the guide holes 547 and 548 (protrusion / retraction). Possible).

  Such a suction part 55 has a recess 551 opening at the tip, and a communication hole (pore) 552 connecting the recess 551 and the decompression chamber 541. Similarly, the suction part 56 is at the tip. It has a recess 561 that opens, and a communication hole (fine hole) 562 that connects the recess 561 and the decompression chamber 541.

  The guide holes 547 and 548 gradually increase in distance from each other toward the urethra insertion portion 41 (upper surface 52a) in a plan view including the width direction and the thickness direction (that is, the plan view shown in FIG. 18). Thus, it inclines with respect to the thickness direction of the front-end | tip part 52, and is provided in substantially "V" shape. Therefore, the suction portions 55 and 56 are arranged so as to be inclined so that the distance between them is gradually increased toward the urethra insertion portion 41, and toward each other, toward the urethral insertion portion 41 side (front vaginal wall side). It protrudes in the shape of "V" diagonally outward.

  Next, a moving mechanism 57 for moving the suction portions 55 and 56 relative to the main body portion 54 will be described. The moving mechanism 57 moves the suction portions 55 and 56 simultaneously (integrally) so that the suction portions 55 and 56 are retracted into the main body portion 54 (guide holes 547 and 548) as shown in FIG. The retracted state and the protruding state protruding from the main body 54 can be switched as shown in FIG.

  Such a moving mechanism 57 has a structure utilizing the expansion and contraction of a spring. As shown in FIGS. 17 and 18, the moving mechanism 57 is fixed to a coil spring 571 provided in the decompression chamber 541 and the tip of the coil spring 571. A moving body 572, a connecting portion 573 that connects the moving body 572 and the suction portion 55, a connecting portion 574 that connects the moving body 572 and the suction portion 56, and an operation portion 575 that operates the coil spring 571. Have.

  The connecting portions 573 and 574 are rotatably connected to the moving body 572 and the suction portions 55 and 56. The operation portion 575 has a long shape, one end portion is rotatably connected to the moving body 572, and the other end portion is drawn out from the base end portion of the main body portion 54. Further, the operation unit 575 is connected to the main body part 54 in the middle so as to be rotatable with respect to the main body part 54.

  According to such a moving mechanism 57, as shown in FIG. 18A, when the coil spring 571 is contracted and the moving body 572 is positioned on the lower surface side of the main body portion 54, the connecting portions 573 and 574 The suction portions 55 and 56 are moved into the main body portion 54 (guide holes 547 and 548) to be in a retracted state. On the contrary, as shown in FIG. 18B, when the coil spring 571 is extended and the moving body 572 is positioned on the upper surface side of the main body portion 54, the suction portions 55 and 56 are connected to the main body by the connecting portions 573 and 574. It is moved out of the part 54 and becomes a protruding state. Note that the coil spring 571 can be expanded and contracted by the operation unit 575.

  The moving mechanism 57 further includes a lock mechanism (maintenance mechanism) 576 that maintains the contracted state of the coil spring 571 in order to prevent unintentional protrusion of the suction portions 55 and 56. According to such a lock mechanism 576, in addition to the above-described effects, the suction portions 55 and 56 are protruded to suck the vagina wall (living body) and can be fixed again when it is retracted while maintaining the suction state. Therefore, the operability of the insertion tool 6 is improved, and the procedure can be performed more smoothly and safely.

  The lock mechanism 576 includes a recess 576a formed on the outer peripheral surface of the base end portion of the main body portion 54 and a claw portion 576b provided on the base end portion of the operation portion 575, and the claw portion 576b is recessed. By engaging with 576a, the movement of the operation portion 575 is prevented, and the coil spring 571 is maintained in the contracted state. Therefore, when the projecting state is set, it is necessary to release the lock mechanism 576.

  Such a vaginal insertion part 51 can be used as follows, for example. That is, first, as shown in FIG. 19A, the vagina insertion portion 51 is inserted into the vagina 1400 while the suction portions 55 and 56 are in the retracted state. In addition, the vagina 1400 shown in FIG. 19 (a) is a portion where the central portion 1401 of the front wall of the vagina hangs down into the vagina and is depressed on both sides thereof (also referred to as “button hole”, hereinafter referred to as “button hole”). 1402 and 1403. Next, the lock mechanism 576 is released, and as shown in FIG. 19B, the coil spring 571 is extended to bring the suction portions 55 and 56 into a protruding state. As a result, the suction part 543 faces the central part 1401 of the vagina front wall, and the suction parts 55 and 56 enter the buttonholes 1402 and 1403. Next, the decompression chamber 541 is decompressed by a suction pump or the like connected to the suction port 542 in this state, whereby the central portion 1401 is sucked and fixed to the suction portion 543, and the button holes 1402 and 1403 are positioned in the suction portions 55 and 56. Adsorb and fix the vaginal wall. After the vaginal wall is adsorbed and fixed, the operating portion 575 is operated so that the coil spring 571 is contracted again, so that the suction portions 55 and 56 are returned to the retracted state as shown in FIG. Good. Thereby, the vagina wall located in the buttonholes 1402 and 1403 can be moved away from the puncture route of the puncture member 3, and the contact between the puncture member 3 and the vagina can be more effectively prevented.

  Here, as will be described later, when the vagina insertion portion 51 is pushed into the body (the distal end side of the vagina insertion portion 51) with the vagina wall adsorbed and fixed to the vagina insertion portion 51 as described above, Since the wall is pushed into the body, the arrangement and shape of the vagina wall can be adjusted, and the puncture route of the puncture member 3 can be sufficiently secured. As a result, the puncture member 3 can be punctured accurately and safely.

  As shown in FIG. 12, the region S2 where the suction portions 543, 55, and 56 are provided is opposed to the region S1 where the suction portion 46 is formed. The puncture device 1 is configured such that the needle tip (needle body 35) of the puncture member 3 passes between these regions S1 and S2. As described above, since the urethral wall is adsorbed by the urethral insertion portion 41 in the region S1 and the vagina wall is adsorbed by the vaginal insertion portion 51 in the region S2, the urethral wall and the vaginal wall are between the regions S1 and S2. It is wider and more reliably spaced. By passing the puncture member 3 through such a region, the puncture member 3 can be punctured more safely.

  In addition, the main body 54 is provided with a marker 58 that can confirm the puncture route of the puncture device 1. Since the marker 58 is provided so that the puncture member 3 punctures between the vagina wall and the urethral wall located above, the puncture route of the puncture member 3 can be easily confirmed by checking the position of the marker 58. As a result, the operability and safety of the puncture apparatus 1 are improved. It is preferable that the marker 58 is provided on at least one of the lower surface and the side surface of the main body portion 54. Since the lower surface and the side surface are easily visible to the operator even when the main body 54 is inserted into the vagina, the puncture route of the puncture member 3 can be easily confirmed by providing the marker 58 at such a position. can do. Also, the insertion depth of the main body 54 into the vagina can be confirmed. Such a marker 58 is only required to be visible from the outside, and can be constituted by, for example, a colored portion, an uneven portion, or the like.

  The distance D between the main body 54 and the urethra insertion part 41 is not particularly limited, but is about 5 to 40 mm in accordance with the distance between the urethral opening and the vaginal opening in a general woman. Is preferred.

  The shaft portion 53 has a thin rod shape extending substantially parallel to the urethral insertion portion 41. The length of the shaft portion 53 (the separation distance between the main body portion 54 and the support portion 50) is not particularly limited, but is preferably about 100 mm or less, and more preferably about 20 to 50 mm. Thereby, the axial part 53 can be made into appropriate length and the operativity of the puncture apparatus 1 improves. If the length of the shaft portion 53 exceeds the above upper limit value, the center of gravity of the puncture device 1 is greatly separated from the patient depending on the configuration of the frame 2 and the stability of the puncture device 1 in the mounted state is lowered. There is a case.

3. Method of using puncture device 1 (puncture method)
Next, a method for using the puncture device 1, that is, a method for implanting the implant 9 in the living body using the puncture device 1 will be described.

  First, the patient is placed in the crushed position on the operating table, and the insertion tool 6 is attached to the patient as shown in FIG.

  Specifically, first, the urethral insertion portion 41 of the urethral insertion tool 4 is inserted into the urethra 1300, and the balloon 421 is placed in the bladder 1310. Thereby, the urethra 1300 is corrected to a predetermined shape (straight shape) by the urethra insertion part 41. Next, the balloon 421 is expanded, and urine is discharged from the bladder 1310 through the urine drainage hole 422a as necessary. On the other hand, the distal end portion 52 of the vagina insertion portion 51 of the vagina insertion tool 5 is inserted into the vagina 1400. Then, after positioning using the marker 58 while confirming the puncture path of the puncture member 3, the support portion 50 is fixed to the support portion 40. Thereby, mounting | wearing of the insertion tool 6 to a patient is completed.

  Next, the moving mechanism 48 of the urethra insertion part 41 is operated to bring each suction part 46 into a protruding state, and the urethra wall and the suction part 46 are brought into close contact with each other. Next, a suction device is connected to the suction port 452, the suction device is operated, the urethral wall is adsorbed to the suction portion 46, and each suction portion 46 is again retracted while maintaining the suction state. On the other hand, the moving mechanism 57 of the vaginal insertion portion 51 is operated to bring the suction portions 55 and 56 into a protruding state, the suction portion 543 is opposed to the central portion 1401, and the suction portions 55 and 56 are directed toward the button holes 1402 and 1403. Make it protrude. Next, the suction device is connected to the suction port 542, the suction device is operated, and the vaginal wall (the portion located in the central portion 1401, the buttonhole 1402, 1403) is adsorbed to the suction portions 543, 55, 56, and the adsorbed state The suction portions 55 and 56 are set in the retracted state while maintaining the above. As a result, the diameter of the urethra 1300 can be reduced, and the portions of the vagina 1400 positioned in the buttonholes 1402 and 1402 can be moved away from the urethra 1300, and a large space between the urethra 1300 and the vagina 1400 is secured. can do. However, the suction part 46 and the suction parts 55 and 56 may be left in a protruding state.

  Here, for example, if the urethra wall is properly adsorbed by the suction part 46, the suction hole 464 is blocked by the urethra wall, so that suction from the suction port 452 is stopped or weakened. Similarly, if the vagina wall is properly adsorbed by the suction portions 543, 55, and 56, the suction holes 544, 551, and 561 are blocked by the vagina wall, so that suction from the suction port 542 is stopped or weakened. Therefore, the surgeon determines whether or not the urethral wall and the vagina wall are properly adsorbed to the urethral insertion portion 41 and the vagina insertion portion 51 from the state of suction from the suction ports 452 and 542 (for example, the magnitude of sound generated by suction). Can be confirmed.

  The insertion tool 6 may have a confirmation mechanism that mechanically confirms the suction state. The confirmation mechanism is not particularly limited as long as the adsorption state can be confirmed. For example, a flow rate measurement unit (negative pressure gauge) that measures the flow rate from the suction ports 452 and 542 and a measurement result from the flow rate measurement unit are used. It can be set as the structure which has a judgment part which judges whether adsorption | suction is performed properly based on.

  Next, liquid peeling is performed as necessary. Specifically, as shown in FIG. 20 (b), the puncture needle of the syringe 2000 is punctured into the anterior wall of the vagina from between the urethra insertion part 41 and the vaginal insertion part 51 (between the urethral opening and the vaginal opening) A liquid such as physiological saline or a local anesthetic is injected into the living tissue between the urethra 1300 and the vagina 1400 (between the regions S1 and S2). As a result, the living tissue between the regions S1 and S2 expands, whereby the urethra wall is pressed against the urethral insertion portion 41 and the vagina front wall is pressed against the vagina insertion portion 51.

  Here, it is preferable to continue the suction from the suction ports 452 and 542 during the above-described liquid peeling. When the urethral wall is pressed against the suction part 46 by liquid peeling, the urethra wall is further brought into close contact with the suction part 46, and suction from the suction port 452 is stopped or weakened. Similarly, when the anterior vaginal wall is pressed against the suction portions 543, 55, and 56, the vaginal wall is more closely attached to the suction portions 543, 55, and 56, and suction from the suction port 542 is stopped or weakened. Therefore, the surgeon can confirm whether or not the liquid separation has been properly performed based on the suction conditions from the suction ports 452 and 542.

  After the liquid separation as described above is performed and the urethral wall and the vagina wall are sufficiently separated from each other, the frame 2 is fixed to the insertion tool 6 as shown in FIG. Thereby, the puncture apparatus 1 will be in the state with which the patient was mounted | worn. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.

  Then, the puncture device 1 is pushed into the body. As described above, the urethra wall is adsorbed to the urethra insertion part 41 and the vagina wall is adsorbed to the vagina insertion part 51. Therefore, when the puncture device 1 is pushed into the body, the urethra 1300 and the vagina 1400 are simultaneously pushed. Is pushed in and the tissue between them is extended. Therefore, sagging of the tissue is reduced, and puncture of the puncture member 3 into the tissue becomes easier.

  Next, in a state where the puncture device 1 is pushed into the body, the puncture device 1 is positioned so that the puncture path of the puncture member 3 passes through the safety zones S5 of the left and right closure holes 1101, 1102 of the pelvis. While maintaining, the handle 74 is rotated. Accordingly, as shown in FIG. 23 (a), the needle body 35 of the puncture member 3 punctures the body surface H of the right buttock of the patient or a portion in the vicinity thereof and enters the body, and the one closed hole 1101 After passing through the other closing hole 1102 in order between the urethra 1300 and the vagina 1400, it protrudes from the body surface H of the left buttocks or in the vicinity thereof. At this time, the puncture member 3 is punctured substantially perpendicularly to the left and right closure holes 1101 and 1102 of the pelvis, whereby a passage can be formed at a position suitable for placement of the implant 9. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.

  Next, the handle 74 is operated to rotate the operation member 7 in the opposite direction, and only the operation member 7 is removed from the living body while the puncture member 3 is placed in the living body. Next, the frame 2 is removed from the insertion tool 6, and the needle body 35 is removed from the main body 31. Thereby, as shown in FIG.35 (b), the main body 31 will be in the state arrange | positioned in the biological body. The main body 31 is disposed in the living body with both the distal end side opening and the proximal end side opening exposed to the outside of the living body.

  Next, the position of the main body 31 is adjusted as necessary. Specifically, the left and right protruding lengths of the main body 31 are aligned, and the central portion S4 of the main body 31 is positioned between the urethra 1300 and the vagina 1400. In this state, as shown in FIG. 25, the central portion S4 of the main body 31 is arranged such that its width direction (long axis J32 direction) W is substantially parallel to the urethra 1300. That is, the urethra 1300 that has been corrected by inserting the urethral insertion portion 41 and the width direction W of the central portion S4 of the main body 31 are substantially parallel to each other.

  Next, the implant 9 is inserted into the main body 31 while being taken out of the packaging material 90, and the implant main body 91 is protruded from the proximal end opening and the distal end opening of the main body 31, as shown in FIG. To do. Thus, contamination of the implant 9 can be prevented by accommodating the implant 9 in the wrapping material 90 until just before being disposed in the main body 31. As described above, since the main body 31 has a flat shape, the posture of the implant main body 91 follows this flat shape. That is, the implant main body 91 is disposed in the main body 31 such that the width direction thereof coincides with the width direction of the main body 31. From the relationship with the urethra 1300, the implant body 91 is arranged in parallel with the corrected urethra 1300.

  Next, as shown in FIG. 26B, the thread 341 exposed from the exposure holes 345 and 346 is cut. As a result, the main body 31 can be divided into the tip split piece 32 and the base split piece 33. Next, adsorption of the urethral wall by the urethral insertion part 41 and adsorption of the vagina wall by the vagina insertion part 51 are stopped. As a result, the positions and shapes of the urethra 1300 and the vagina 1400 return to the original natural state.

  Next, the connection between the distal end split piece 32 and the proximal end split piece 33 is released, the distal end split piece 32 is pulled out from the living body toward the distal end side, and the proximal end split piece 33 is pulled out from the living body toward the proximal end side. At this time, the tip split piece 32 and the base end split piece 33 are moved substantially simultaneously in opposite directions, and the tip split piece 32 and the base end split piece 33 are each moved in an arc shape along the shape thereof. Thereby, the main body 31 is smoothly removed from the living body.

  When the distal-end divided piece 32 and the proximal-end divided piece 33 are removed from the living body as described above, the surrounding tissue that has been spread by the main body 31 returns to the original position, and both end portions from the central portion of the implant main body 91 are restored. The tissue gradually comes into contact with the implant body 91 toward the end. As described above, the distal end divided piece 32 and the proximal end divided piece 33 are moved in the direction along the shape thereof, and the main body 31 has an internal space in which the implant main body 91 can move with a sufficiently low sliding. As a result, an unnecessary tensile force is not applied to the implant body 91, and the implant body 91 can be placed as it is. Thereby, adjustment of the tension of the implant main body 91 becomes unnecessary. As described above, as shown in FIG. 27, the implant main body 91 is embedded in the living body.

  In a state where the implant 9 is embedded in the living body, the implant main body 91 is disposed substantially parallel to the urethra 1300 in a region between the urethra 1300 and the vagina 1400. Therefore, the urethra 1300 can be supported in a wider area by the implant body 91.

  Thus, by removing the main body 31 from the living body by dividing it, the main body 31 can be easily removed from the living body. In addition, since the divided pieces 32 and 33 being removed hardly affect the posture of the implant body 91 in the region between the urethra 1300 and the vagina 1400, the implant body 91 can be embedded in a desired posture.

  Further, since the split pieces 32 and 33 are removed from the living body with the urethral insertion portion 41 inserted into the urethra 1300, the implant body 91 placed in the living body prevents excessive tension from being applied to the urethra 1300. I can do it.

Next, the insertion tool 6 is removed from the living body. That is, the urethral insertion part 41 is removed from the urethra 1300 and the vagina insertion part 51 is removed from the vagina 1400. After the urethral insertion tool 4 is removed, the urethra 1300 returns to the natural state, but the urinary tract 1300 in the natural state and the implant main body 91 remain parallel because the implant body 91 is embedded in the living tissue. can do.
Thereafter, unnecessary portions of the implant body 91 are excised, and the procedure is finished.

  As described above, according to the puncture device 1, when the implant 9 is placed, it can be handled only by a minimally invasive technique such as puncture of the puncture member 3, and it is not necessary to perform a highly invasive incision or the like. Therefore, the burden on the patient is small and the safety of the patient is high. Further, since the implant body 91 can be embedded in parallel with the urethra 1300, the urethra 1300 can be supported in a wider area. Further, the puncture member 3 can puncture the living body while avoiding the urethra 1300 and the vagina 1400, and the puncture member 3 can be prevented from puncturing the urethra 1300 and the vagina 1400, which is safe. Further, it is possible to prevent the occurrence of complications such as the exposure of the implant 9 into the vagina from the wound created by the incision and the infection from the wound as in the case of the conventional incision of the vagina. It is possible to embed the implant 9 reliably.

Second Embodiment
FIG. 28 is a view showing the vaginal insertion tool of the puncture device according to the second embodiment, wherein (a) and (c) are side views, and (b) is a top view. FIG. 29 is a side view for explaining the movement of the suction hole of the vaginal insertion tool shown in FIG. 28, wherein (a) shows the first state and (b) shows the second state. 30 is a cross-sectional view of the vaginal insertion tool shown in FIG. 28, where (a) shows the first state and (b) shows the second state. FIG. 31 is a cross-sectional view showing a method of using the vaginal insertion tool shown in FIG.

  Hereinafter, the second embodiment of the puncture device will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the first embodiment described above except that the configuration of the distal end portion of the vaginal insertion tool is different.

  As shown in FIG. 28, in the front-end | tip part 52 of this embodiment, the suction part 543 which has the several suction hole 544 in the upper surface 52a is provided. The suction part 55 is provided to be opened on one side surface of the main body part 54, and the suction part 56 is provided to be opened on the other side face of the main body part 54. The suction portions 55 and 56 can move in the thickness direction of the main body 54 along the side surfaces of the main body 54. Further, the suction portions 55 and 56 move while retracted inside the main body portion 54. By moving the suction portions 55 and 56 while being retracted inside the main body portion 54, friction between the suction portions 55 and 56 and the urethra wall is reduced, and the suction portions 55 and 56 can be moved smoothly.

  The suction units 55 and 56 are moved by operation levers 578 and 579 provided in the suction units 55 and 56. Specifically, by operating the operation lever 578, as shown in FIG. 29A, a first state in which the suction portion 55 is located on the upper surface 52a (one main surface) side of the main body portion 54, and FIG. As shown to 29 (b), the suction part 55 can switch to the 2nd state located in the lower surface (other main surface) side of the main-body part 54. FIG. The first state and the second state are maintained by the two protrusions 545 and 546 formed on the side surface of the main body portion 54. That is, the first state is maintained when the operation lever 578 gets over the protrusion 545, and the second state is maintained when the operation lever 579 gets over the protrusion 546. This also applies to the suction part 56.

  Further, as shown in FIGS. 30A and 30B, a cavity constituting the decompression chamber 541 is provided in the main body portion 54, and the suction portions 55 and 56 are opened on the side surface of the main body portion 54. Recesses 551, 561, and communication holes (fine pores) 552, 562 that connect the recesses 551, 561 and the decompression chamber 541. The communication holes 552 and 562 are designed so as to always communicate the recesses 551 and 561 with the decompression chamber 541 regardless of the position of the suction portions 55 and 56 with respect to the main body 54. .

  Such a vaginal insertion part 51 can be used as follows, for example. That is, first, as shown in FIG. 31A, the distal end portion 52 is inserted into the vagina 1400 while the suction portions 55 and 56 are in the first state. Next, as shown in FIG. 31B, the decompression chamber 541 is decompressed by a suction pump or the like connected to the suction port 542, thereby adsorbing and fixing the vaginal walls to the suction portions 543, 55, and 56, respectively. In this state, the vaginal wall (the central part 1401 of the vaginal wall and the vaginal side wall 1404) located on both sides of the buttonhole 1402 is adsorbed and fixed by the suction parts 543 and 55, and the vaginal wall located on both sides of the buttonhole 1403. (The central part 1401 of the vagina front wall and the vagina side wall 1405) are adsorbed and fixed by the suction parts 543 and 56. Next, the operation levers 578 and 579 are operated to move the suction portions 55 and 56 from the first state to the second state as shown in FIG. As the suction portions 55 and 56 move, the vaginal side walls 1404 and 1405 are pulled downward (rear vaginal wall side), and the vaginal wall located at the buttonholes 1402 and 1403 moves downward. Thereby, the vagina wall located in the buttonholes 1402 and 1403 can be moved away from the puncture route of the puncture member 3, and the contact between the puncture member 3 and the vagina can be more effectively prevented. In addition, it is preferable that the vagina wall located in the buttonholes 1402 and 1403 close to the lower side by the movement of the suction portions 55 and 56 is sucked by the suction portion 543. Thereby, the above effect becomes more remarkable.

  Also according to the second embodiment, the same effects as those of the first embodiment described above can be exhibited.

<Third Embodiment>
FIG. 32 is a longitudinal sectional view of the urethral insertion portion of the puncture device according to the third embodiment, where (a) shows a retracted state and (b) shows a protruding state. FIG. 33 is a cross-sectional view of the urethral insertion portion shown in FIG. FIG. 34 is a cross-sectional view of the urethra insertion part shown in FIG.

  Hereinafter, the third embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the first embodiment described above except that the configuration of the suction part of the urethral insertion part is different.

  As shown in FIGS. 32, 33, and 34, in the suction mechanism 44 of the present embodiment, each suction portion 46 is curved in a circular arc shape along the outer periphery of the main body portion 45, and the base portion 461 to the main body portion. A pair of guide portions 462 and 463 projecting inwardly of 45 and a plurality of suction holes 464 are provided. Each suction part 46 is supported by the main body part 45 so that the guide parts 462 and 463 are inserted into the slits 454 of the main body part 45.

  The suction hole 464 included in each suction part 46 includes a bottomed recessed part 464a that opens to the outer peripheral surface of the base part 461, and a plurality of communication holes (pores) 464b that allow the recessed part 464a and the decompression chamber 451 to communicate with each other. doing. The plurality of communication holes 464b are provided so as to pass through the guide portions 462 and 463, respectively, and both ends open to the bottom surface of the concave portion 464a and the bottom surfaces of the guide portions 462 and 463. A plurality of communication holes 464b are provided in the guide part 462 along the extending direction, and a plurality of communication holes 464b are provided in the guide part 463 along the extending direction.

  In this way, by providing the suction hole 464 provided in each suction portion 46 with the recess 464a, the urethral wall can be adsorbed over a wider range. Further, since a plurality of communication holes 464b are formed, even if a certain communication hole 464b is blocked, the adsorption of the urethral wall can be maintained through the other communication hole 464b. Further, since the urethral wall bites into the recess 464a during adsorption, an anchor effect is exhibited. Therefore, by pushing the urethra insertion tool 4 into the body, the urethra and the bladder can be pushed more reliably into the body.

  In the case of this embodiment, since the suction holes 464 provided in each suction part 46 face the decompression chamber 451 directly without passing through the slit 454, the slit 454 is formed in the first embodiment described above. It does not have to have such a function as an inlet. That is, the guide portions 462 and 463 of each suction portion 46 may be inserted into the slit 454 with substantially no gap.

  Also according to the third embodiment, the same effects as those of the first embodiment described above can be exhibited.

<Fourth embodiment>
FIG. 35 is a longitudinal sectional view of a urethral insertion portion included in the puncture device according to the fourth embodiment, where (a) shows a retracted state and (b) shows a protruding state. 36 is a cross-sectional view of the urethral insertion portion shown in FIG. 35, where (a) shows a retracted state and (b) shows a protruding state.

  Hereinafter, the fourth embodiment of the puncture device will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the first embodiment described above except that the configuration of the suction part of the urethral insertion part is different.

  As shown in FIG. 35, the main body 45 has a long, substantially cylindrical shape with a rounded tip. An annular decompression chamber 451 is provided inside the base end of the main body 45. The main body 45 is provided with a suction port 452 for sucking air in the decompression chamber 451, and the air in the decompression chamber 451 is sucked through the suction port 452 to decompress the inside of the decompression chamber 451. Can do. In addition, a housing part 453 in which a plurality of suction parts 46 are housed is provided on the distal end side of the decompression chamber 451. As shown in FIGS. 35 (a) and 36 (a), the plurality of suction portions 46 are retracted into the main body 45, and as shown in FIGS. 35 (b) and 36 (b). In addition, it is possible to move between the protruding state projecting radially from the main body 45 and the moving mechanism 48 can switch between the retracted state and the protruding state.

  Each suction portion 46 has a long shape extending in the axial direction of the main body portion 45, a base portion 461 having a surface curved in an arc shape along the outer periphery of the main body portion 45, and the base portion 461 to the main body portion. 45 and a pair of guide portions (projections) 462 and 463 projecting inward. Further, the base 461 is provided with a suction hole 464 connected to the decompression chamber 451. The suction hole 464 includes a bottomed recess 464 a that opens on the outer peripheral surface of the base 461, and a communication hole (pore) 464 b that communicates the recess 464 a with the decompression chamber 451. Thus, the suction hole 464 has the recess 464a, so that the urethral wall can be adsorbed over a wider range. Further, since the urethral wall bites into the recess 464a during adsorption, an anchor effect is exhibited. Therefore, by pushing the urethra insertion tool 4 into the body, the urethra and the bladder can be pushed more reliably into the body.

  The communication hole 464b is designed to always communicate the recess 464a and the decompression chamber 451 regardless of the position of the suction part 46 with respect to the main body part 45. Moreover, the recessed part 464a and the decompression chamber 451 are connected substantially without a gap, and are treated with, for example, a sealing member so that air does not substantially leak from between these. Therefore, the film 47 is omitted from the suction mechanism 44 of the present embodiment.

  In addition, as shown in FIGS. 36A and 36B, in this embodiment, a pair of protruding strips 453 a and 453 b facing the guide portions 462 and 463 are provided on the bottom surface of the housing portion 453. It is provided corresponding to. And the deformation | transformation part 483 is arrange | positioned so that it may be pinched | interposed into the guide parts 462 and 463 and the protruding item | line 453a, 453b. Therefore, the deformation of the deformable portion 483 (the rise of the first and second connecting portions 483b and 483c) is guided and smoothly performed by the guide portions 462 and 463 and the ridges 453a and 453b.

  According to the fourth embodiment, the same effect as that of the first embodiment described above can be exhibited.

<Fifth Embodiment>
FIG. 37 is a longitudinal sectional view of a urethral insertion portion included in the puncture device according to the fifth embodiment, wherein (a) shows a retracted state and (b) shows a protruding state.

  Hereinafter, the fifth embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  The present embodiment is mainly the same as the fourth embodiment described above except that the configuration of the moving mechanism of the urethral insertion portion is different.

  As shown in FIGS. 37A and 37B, the moving mechanism 48 of the present embodiment is provided with a spring (biasing member) 484 that urges the operation portion 482 toward the distal end side. In the retracted state shown in FIG. 37A, the spring 484 is contracted, and when the lock mechanism 49 is released, the operating portion 482 is moved to the distal end side by the urging force of the spring 484 as shown in FIG. As a result, the suction part 46 enters a protruding state. According to such a configuration, when the lock mechanism 49 is released, the projecting state is automatically achieved, so that a smoother operation can be performed. Further, when the urethra is in the protruding state in the urethra, the suction portion 46 stops protruding in a state where the force that the urethral wall tends to contract and the force that the suction portion 46 tries to protrude by the spring 484 is balanced. Therefore, excessive protrusion of the suction part 46 can be prevented. Therefore, a safer procedure is possible.

  According to the fifth embodiment, the same effect as that of the first embodiment described above can be exhibited.

<Sixth Embodiment>
FIG. 38 is a longitudinal sectional view of the urethral insertion portion of the puncture device according to the sixth embodiment, where (a) shows a retracted state and (b) shows a protruding state.

  Hereinafter, the sixth embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the fifth embodiment described above except that the configuration of the moving mechanism of the urethral insertion portion is different.

  In the moving mechanism 48 of the first to fifth embodiments described above, all the suction portions 46 are configured to move simultaneously (integrally). However, in the moving mechanism 48 of the present embodiment, each suction portion 46 is moved. Are configured to move independently. Specifically, as shown in FIG. 38, the moving mechanism 48 of the present embodiment does not include the ring-shaped moving part 481, and a plurality of operation parts corresponding to each suction part 46 (deformation part 483). 482 is provided. And the front-end | tip part of the operation part 482 is connected with the base end of the 2nd connection part 483c which the deformation | transformation part 483 to which it corresponds corresponds so that rotation is possible. According to such a configuration, since the state of each suction part 46 can be selected according to the shape of the urethra, a safer procedure is possible.

  Also according to the sixth embodiment, the same effects as those of the first embodiment described above can be exhibited.

<Seventh embodiment>
FIG. 39 is a top view of the vaginal insertion part of the puncture device according to the seventh embodiment, wherein (a) shows a retracted state and (b) shows an expanded state. 40 is a cross-sectional view showing a method of using the vaginal insertion part shown in FIG.

  Hereinafter, the seventh embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the first embodiment described above except that the configuration of the vaginal insertion portion is different.

  As shown in FIGS. 39A and 39B, in the vaginal insertion portion 51 of the present embodiment, the suction portions 55 and 56 that are movable with respect to the main body portion 54 are omitted, and instead, the distal end portion 52. The expansion mechanism 8 can project in the width direction. The expansion mechanism 8 includes a wire (linear body) 811 as an expansion portion provided on one side surface 52b of the distal end portion 52 (main body portion 54) and a wire as an expansion portion provided on the other side surface 52c. (Linear body) 812 and an operation portion 82 for bending and deforming the wires 811 and 812.

  The distal end of the wire 811 is fixed to the side surface 52 b of the distal end 52, and the proximal end of the wire 811 passes through the insertion hole 521 provided in the distal end 52, and is pulled out to the proximal end of the distal end 52. ing. Similarly, the wire 812 has a distal end portion fixed to the side surface 52 c of the distal end portion 52, and a proximal end portion that passes through the insertion hole 522 provided in the distal end portion 52 to the proximal end side of the distal end portion 52. Has been pulled out. Both ends of the insertion hole 521 open to the side surface 52b and the base end surface 52e of the tip end portion 52, and both ends of the insertion hole 522 open to the side surface 52c and the base end surface 52e of the tip end portion 52.

  And the base end part of these wires 811 and 812 is being fixed to the operation part 82, respectively, and the operation part 82 is provided in the axial part 53 so that a slide is possible. In addition, the operation unit 82 is provided with a fixing unit 821 that fixes the operation unit 82 to the shaft unit 53. By operating the fixing unit 821, a slidable state with respect to the shaft unit 53, and the shaft unit The state fixed to 53 can be switched. The configuration of the fixing portion 821 is not particularly limited, but a screw tightening structure, a quick release structure, or the like can be used.

  As shown in FIG. 39A, such an expansion mechanism 8 moves the operation portion 82 to the proximal end side and stretches the wires 811 and 812 so that the wires 811 and 812 follow the side surfaces 52b and 52c. On the contrary, as shown in FIG. 39 (b), the operating portion 82 is moved to the distal end side so that the wires 811 and 812 are moved to the distal end side from the insertion holes 521 and 522. The wires 811 and 812 are in a direction different from the width direction of the distal end portion 52 (the suction direction of the suction portion 543 (thickness direction of the distal end portion 52) and the side surfaces 52b and 52 The expanded state can be expanded in the opposite direction.

  A region where the wires 811 and 812 are bent (a region where the wire 811 is actually expanded) is preferably arranged in the width direction of the suction portion 543 and the tip portion 52. That is, it is preferable that the suction part 543 and the region where the wires 811 and 812 bend are arranged side by side in a direction crossing the insertion direction into the living body lumen.

  In addition, although it does not specifically limit as a constituent material of the wires 811 and 812, For example, stainless steel (For example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS430F, SUS302, etc. ), Various metal materials such as pseudo-elastic alloys (including superelastic alloys) can be used. Among these, a superelastic alloy is preferable. The superelastic alloy is relatively flexible and has a restoring property, and is difficult to bend, so that a decrease in operability can be prevented.

  In addition, a decompression chamber 541 is provided inside the main body 54, and a suction portion 543 connected to the decompression chamber 541 is provided on the upper surface (one main surface) 52a. The suction portion 543 includes a bottomed recess 543a that opens to the upper surface 52a, a plurality of communication holes (pores) 543b that connect the recess 543a and the decompression chamber 541, and a lattice that divides the interior of the recess 543a into a plurality of regions. Shaped ribs 543c. The rib 543c is erected from the bottom surface of the recess 543a, and intersects the plurality of wall portions extending in the length direction (first direction) of the main body portion 54 and the width direction (first direction) of the main body portion 54. A plurality of wall portions extending in the second direction). A plurality of communication holes 543b are arranged so as to overlap these intersections 543d. Thus, by arranging the communication hole 543b so as to overlap the intersection 543d, the communication hole 543b is blocked by the vagina wall by the vagina wall that bites into the recess 543a when adsorbing the vagina wall. Can be prevented. For this reason, the vaginal wall can be more reliably adsorbed. In addition, the height of the rib 543c is not specifically limited, For example, the height may be the same as the recessed part 543a, and may be lower than the recessed part 543a.

  The vaginal insertion part 51 as described above can be used as follows, for example. That is, first, as shown in FIG. 40A, the vagina insertion portion 51 is inserted into the vagina 1400 while the wires 811 and 812 are in the retracted state. Next, the operation unit 82 is moved to the distal end side, and the wires 811 and 812 are set in the expanded state as shown in FIG. At this time, each of the wires 811 and 812 expands in the lateral direction of the vagina 1400 (direction orthogonal to (intersects with) the opposing direction of the anterior vagina wall and the posterior vagina wall). Thereby, the vagina is laterally expanded by the wires 811 and 812, and as a result, the buttonholes 1402 and 1403 are reduced. That is, the vagina wall located in the buttonholes 1402 and 1403 approaches the vagina insertion portion 51 side. In particular, since the wires 811 and 812 are linear bodies, the wires 811 and 812 are easily sunk into the vagina wall, slippage is suppressed, and the vagina can be expanded more effectively in the lateral direction. Moreover, since the area | region where the wires 811 and 812 bend is located in a line with the suction part 543, the vagina wall located in the buttonhole 1402 and 1403 can be brought near to the vagina insertion part 51 side more effectively. Next, the decompression chamber 541 is decompressed by a suction pump or the like connected to the suction port 542, and the vaginal wall is adsorbed and fixed to the suction portion 543 as shown in FIG. Thereby, not only the central part 1401 but also the vaginal wall located in the buttonholes 1402 and 1403 on both sides thereof can be adsorbed and fixed. Therefore, the vagina wall can be moved away from the puncture path of puncture member 3, and contact between puncture member 3 and vagina 1400 (erroneous puncture of vagina 1400) can be more effectively prevented. Therefore, the puncture member 3 can be punctured accurately and safely. In particular, in this embodiment, since the wires 811 and 812 expand in the width direction of the distal end portion 52, the buttonholes 1402 and 1403 can be effectively reduced.

  The wires 811 and 812 may be subjected to a high friction treatment. Thereby, since the wires 811 and 812 are less likely to slip with respect to the vagina wall, the above effects can be more effectively exhibited. Although it does not specifically limit as a high-friction process, For example, the process of roughening the surface by embossing etc. is mentioned. Moreover, the process which coat | covers the coating layer with high frictional resistance on the surface of the wires 811 and 812 is also mentioned.

  Further, in order to more reliably project the wires 811 and 812 in the width direction, for example, the cross-sectional shape of the wires 811 and 812 may be a flat shape crushed in the width direction of the tip portion 52. According to such a shape, the wires 811 and 812 can be more reliably protruded in the width direction, and deformation of the distal end portion 52 in the thickness direction can be suppressed. Therefore, the above effect can be exhibited more effectively.

  Also according to the seventh embodiment, the same effect as that of the first embodiment described above can be exhibited.

<Eighth Embodiment>
FIGS. 41A and 41B are views showing a retracted state of the vaginal insertion portion of the puncture device according to the eighth embodiment, wherein FIG. 41A is a top view and FIG. 41B is a side view. 42 is a diagram showing an expanded state of the vaginal insertion portion shown in FIG. 41, wherein (a) is a top view and (b) is a side view. 43 is a cross-sectional view showing a method of using the vaginal insertion portion shown in FIG.

  Hereinafter, the eighth embodiment of the puncture apparatus will be described with reference to this drawing, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the seventh embodiment described above, except that the configuration of the extension unit is different.

  As shown in FIGS. 41A and 41B, the expansion mechanism 8 of this embodiment includes a wire 811 provided on the side surface 52b of the distal end portion 52, a wire 812 provided on the side surface 52c, and a bottom surface. It has a wire (biasing part) 813 provided on (the other main surface) 52d and an operation part 82 for deforming these wires 811, 812, 813.

  The wire 813 has its distal end fixed to the lower surface 52 d of the distal end 52, and its proximal end passes through an insertion hole 523 provided in the distal end 52, and is pulled out to the proximal end of the distal end 52. ing. Note that both ends of the insertion hole 523 open to the lower surface 52d and the base end surface 52e of the distal end portion 52. The proximal end portion of the wire 813 is fixed to the operation portion 82 together with the proximal end portions of the wires 811 and 812. Note that the wire 813 can have the same structure as the wires 811 and 812.

  As shown in FIG. 41, such an expansion mechanism 8 moves the operating portion 82 to the proximal end side and stretches the wires 811, 812, 813 so that the wires 811, 812, 813 have the side surfaces 52b, 52c and the lower surface. 52d, the operation unit 82 is moved to the distal end side and the wires 811, 812, 813 are inserted through the insertion holes 521, 522, as shown in FIG. The wire 811 and 812 expands in the width direction of the distal end portion 52 and the wire 813 expands in the thickness direction of the distal end portion 52 by bending at the distal end side from 523.

  The vaginal insertion part 51 as described above can be used as follows, for example. That is, first, as shown in FIG. 43A, the vagina insertion portion 51 is inserted into the vagina 1400 while the wires 811, 812, and 813 are in the retracted state. Next, the operation unit 82 is moved to the distal end side, and the wires 811, 812, and 813 are set in the expanded state as shown in FIG. As a result, the vagina is laterally expanded by the wires 811 and 812, and the distal end portion 52 (suction portion 543) is pressed against the vagina front wall by the wire 813. As a result, the suction part 543 is more closely attached to the vagina front wall, and the buttonholes 1402 and 1403 are reduced. Next, the decompression chamber 541 is decompressed by a suction pump or the like connected to the suction port 542, thereby adsorbing and fixing the vagina wall to the suction part 543 as shown in FIG. Thereby, not only the central part 1401 but also the vaginal wall located in the buttonholes 1402 and 1403 on both sides thereof can be adsorbed and fixed. Therefore, the vaginal wall can be moved away from the puncture path of the puncture member 3, and contact between the puncture member 3 and the vagina can be more effectively prevented.

  Note that the suction direction of the suction part 543 is a direction (upper side in FIG. 43) facing the vagina front wall (center part 1401) that is a suction target, and therefore the wire 813 is connected to the suction direction of the suction part 543. Is expanding in different directions.

  Also according to the eighth embodiment, the same effects as those of the first embodiment described above can be exhibited.

<Ninth Embodiment>
FIGS. 44A and 44B are views of the vaginal insertion portion of the puncture device according to the ninth embodiment, where FIG. 44A is a top view and FIG. 44B is a cross-sectional view. 45 is a cross-sectional view showing a usage state of the vaginal insertion portion shown in FIG.

  Hereinafter, the ninth embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the seventh embodiment described above, except that the configuration of the extension unit is different.

  As shown in FIG. 44, in the expansion mechanism 8 of the present embodiment, the wires 811 and 812 are inclined toward the lower surface (the other main surface) 52d side and expanded obliquely in the lateral direction. Thus, as shown in FIG. 45, when the wires 811 and 812 are expanded in the vagina 1400, the vagina is laterally expanded and the vagina sidewalls 1404 and 1405 are in contact with the wires 811 and 812. Is urged downward (back vagina wall side). Therefore, the buttonholes 1402 and 1403 can be reduced more effectively.

  According to the ninth embodiment, the same effect as that of the first embodiment described above can be exhibited.

<Tenth Embodiment>
46A and 46B are views of the vaginal insertion part of the puncture device according to the tenth embodiment, wherein FIG. 46A is a top view and FIG. 46B is a cross-sectional view taken along the line BB. 47 is a cross-sectional view showing the operation of the vaginal insertion section shown in FIG. 48 is a cross-sectional view showing a method of using the vaginal insertion portion shown in FIG.

  Hereinafter, the tenth embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the seventh embodiment described above, except that the configuration of the extension unit is different.

  As shown in FIG. 46, the expansion mechanism 8 of the present embodiment deforms the wire 811 provided on the side surface 52b of the distal end portion 52, the wire 812 provided on the side surface 52c, and these wires 811 and 812. An operation unit 82 and rotating units 831 and 832 for rotating the wires 811 and 812 are provided.

  The rotating portion 831 is provided in the operating portion 82 so as to be rotatable around the axis of the shaft portion 53, and the base end portion of the wire 811 is fixed to the rotating portion 831. Similarly, the rotation unit 832 is provided in the operation unit 82 so as to be rotatable around the axis of the shaft unit 53, and the base end portion of the wire 812 is fixed to the rotation unit 832. That is, the base end portions of the wires 811 and 812 are fixed to the operation unit 82 via the rotation units 831 and 832.

  In the expansion mechanism 8 having such a configuration, the wires 811 and 812 can be set in the expanded state or the retracted state by moving the operation unit 82 toward the distal end side or the proximal end side, as in the above-described embodiment. Further, in the expanded state, the rotating unit 831 is rotated with respect to the operation unit 82, whereby the wire 811 in the expanded state is connected to the tip of the wire 811 and the insertion hole 521 as shown in FIG. It can be rotated around J61. Similarly, by rotating the rotation unit 832 with respect to the operation unit 82, the expanded wire 812 can be rotated around the axis J <b> 62 connecting the tip end of the wire 812 and the insertion hole 522.

  The vaginal insertion part 51 as described above can be used as follows, for example. That is, first, as shown in FIG. 48A, the vagina insertion portion 51 is inserted into the vagina 1400 while the wires 811 and 812 are in the retracted state. Next, the operation unit 82 is moved to the distal end side, and the wires 811 and 812 are set in the expanded state as shown in FIG. Thereby, the vaginal wall is expanded laterally by the wires 811 and 812. Next, the rotation parts 831 and 832 are rotated with respect to the operation part 82, and the wires 812 and 813 are rotated to the lower surface 52d side (rear vaginal wall side) as shown in FIG. As a result, the vaginal side walls 1404 and 1405 that are in contact with the wires 811 and 812 move downward (toward the posterior wall of the vagina). Therefore, the buttonholes 1402 and 1403 can be reduced more effectively. Next, the decompression chamber 541 is decompressed by a suction pump or the like connected to the suction port 542, so that the vaginal wall is adsorbed and fixed to the suction part 543. Thereby, a vagina wall can be kept away from the puncture path | route of the puncture member 3, and the contact with the puncture member 3 and vagina can be prevented more effectively.

  Also according to the tenth embodiment, the same effects as those of the first embodiment described above can be exhibited.

<Eleventh embodiment>
FIG. 49 is a side view of the vaginal insertion part included in the puncture device according to the eleventh embodiment.

  Hereinafter, the eleventh embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the seventh embodiment described above, except that the configuration of the extension unit is different.

  As shown in FIGS. 49 (a) and 49 (b), in the expansion mechanism 8 of the present embodiment, the strips 841 and 842 are used as the expansion portions instead of the wires 811 and 812, and the thickness direction thereof is increased. It is in an expanded state by being bent and deformed. By using such strips 841 and 842, the vaginal wall can be effectively expanded laterally. In particular, the strips 841 and 842 are less likely to be deformed in the thickness direction of the distal end portion 52 than the wires 811 and 812, and have a larger contact area with the vagina wall than the wires 811 and 812. Therefore, the vagina wall can be expanded more reliably.

  Also according to the eleventh embodiment, the same effects as those of the first embodiment described above can be exhibited.

<Twelfth embodiment>
FIG. 50 is a top view of the vaginal insertion part of the puncture device according to the twelfth embodiment, where (a) shows the retracted state and (b) shows the expanded state.

  Hereinafter, the twelfth embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the seventh embodiment described above, except that the configuration of the extension unit is different.

  As shown in FIG. 50, in the expansion mechanism 8 of the present embodiment, balloons 851 and 861 are used instead of the wires 811 and 812 as the expansion portions. The balloon 851 is provided on the side surface 52b of the distal end portion 52, and the balloon 852 is provided on the side surface 52c. The balloons 851 and 861 are connected to balloon ports 853 and 854 provided at the proximal end portion of the distal end portion 52, respectively.

  A balloon expansion device such as a syringe can be connected to the balloon ports 853 and 854. When a working fluid (liquid such as physiological saline or gas) is supplied from the balloon expansion device to the balloons 851 and 852, FIG. As shown in FIG. 50B, when the balloons 851 and 852 are expanded in the width direction of the distal end portion 52, and when the working fluid is extracted from the balloons 851 and 852 by the balloon expansion device, FIG. As shown, the balloons 851 and 852 are retracted.

  By using such balloons 851 and 852, the vaginal wall can be effectively expanded laterally. In particular, the balloons 851 and 852 are not bent like the wires 811 and 812, and have a larger contact area with the vagina wall than the wires 811 and 812. Therefore, the vagina wall can be expanded more reliably.

  Also according to the twelfth embodiment, the same effects as those of the first embodiment described above can be exhibited.

<13th Embodiment>
FIGS. 51A and 51B are top views of the vaginal insertion part of the puncture device according to the thirteenth embodiment, where FIG. 51A shows the retracted state and FIG. 51B shows the expanded state. FIG. 52 is a side view of the vaginal insertion portion shown in FIG. 53 is a cross-sectional view showing a method of using the vaginal insertion portion shown in FIG.

  Hereinafter, the thirteenth embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is mainly the same as the seventh embodiment described above, except that the configuration of the extension unit is different.

  As shown in FIG. 51, in the expansion mechanism 8 of the present embodiment, hard rod members (long bodies) 861 and 862 are used as the expansion portions. The rod member 861 is provided along the side surface 52b of the distal end portion 52, and is rotatably connected to the distal end portion 52 in the middle thereof. On the other hand, the bar member 862 is provided along the side surface 52c of the front end portion 52, and is rotatably connected to the front end portion 52 in the middle thereof. The rotation axes J71 and 72 of the rod members 861 and 861 are substantially orthogonal to both the extending direction of the shaft portion 53 and the width direction of the distal end portion 52, respectively.

  Further, the rod members 861 and 862 have shapes bent in the middle according to the inclination of the shaft portion 53 and the tip portion 52, respectively. That is, as shown in FIG. 52, the base end sides of the rod members 861 and 862 extend substantially parallel to the shaft portion 53 in a plan view of the distal end portion 52 viewed from the side surface side, and the distal end side is The tip 52 extends substantially in parallel. Further, the tip portions of the rod members 861 and 862 (portions on the tip side with respect to the rotation axes J71 and J72) are slightly curved in a substantially arc shape in a plan view of the tip portion 52, respectively.

  Further, the ends of the rod members 861 and 862 are rounded. Further, the distal ends of the rod members 861 and 862 are located on the distal end side of the region (region S2) where the suction portion 543 is provided. However, the positions of the tips of the rod members 861 and 862 are not limited to this, and may be located in the region S2, for example.

  According to such an expansion mechanism 8, the base end portions of the bar members 861 and 862 are operated to rotate the bar members 861 and 862 around the rotation axes J71 and J72, as shown in FIG. As shown in FIG. 51 (b), the rod members 861 and 862 can be in a retracted state in which the distal ends of the rod members 861 and 862 are retracted along the side surfaces 52b and 52c of the distal end portion 52. By separating the distal ends of the members 861 and 862 from the side surfaces 52b and 52c in the width direction, the rod members 861 and 862 can be in an expanded state protruding in the width direction.

  The expansion mechanism 8 further includes a lock mechanism (maintenance mechanism) 87 for maintaining the above-described expanded state. The lock mechanism 87 includes projections 871 and 872 provided at the base end portions of the rod members 861 and 862 and recesses 873 and 874 provided in the shaft portion 53, and the projections 871 and 872 are the recesses. By being inserted into 873 and 874, the postures of the rod members 861 and 862 are fixed, and the expanded state is maintained.

  The vaginal insertion part 51 as described above can be used as follows, for example. That is, first, as shown in FIG. 53A, the vagina insertion portion 51 is inserted into the vagina 1400 while the rod members 861 and 862 are in the retracted state. Next, the base end portions of the rod members 861 and 862 are operated to bring the rod members 861 and 862 into an expanded state as shown in FIG. As a result, the vagina is expanded laterally by the bar members 861 and 862, and the buttonholes 1402 and 1403 are reduced. Next, the decompression chamber 541 is decompressed by a suction pump or the like connected to the suction port 542, thereby adsorbing and fixing the vagina wall to the suction part 543 as shown in FIG. 53 (c). Thereby, not only the central part 1401 but also the vaginal wall located in the buttonholes 1402 and 1403 on both sides thereof can be adsorbed and fixed. Therefore, the vaginal wall can be moved away from the puncture path of the puncture member 3, and contact between the puncture member 3 and the vagina can be more effectively prevented.

  Also according to the thirteenth embodiment, the same effects as those of the first embodiment described above can be exhibited.

  As mentioned above, although the insertion tool and the insertion method of the insertion tool of the present invention have been described based on the illustrated embodiment, the present invention is not limited to this, and the configuration of each part is an arbitrary function having the same function. It can be replaced with that of the configuration. In addition, any other component may be added to the present invention. Moreover, you may combine each embodiment suitably.

  In particular, the moving mechanisms described in the fifth and sixth embodiments may be applied to the first, third, and fourth embodiments, respectively. In addition, the configuration of the suction mechanism of the urethral insertion portion described in the first, third to sixth embodiments may be used as the configuration of the distal end portion of the vaginal insertion portion, and conversely in the first and second embodiments. You may use the structure of the front-end | tip part of the described vaginal insertion part as a structure of the suction mechanism of a urethral insertion part. Further, the configuration of the suction part 543 of the vaginal insertion part described in the seventh to thirteenth embodiments may be applied to the suction part 543 of the vaginal insertion part described in the first to sixth embodiments. The configuration of the suction part 543 of the vaginal insertion part described in the first to sixth embodiments may be applied to the suction part 543 of the vaginal insertion part described in the seventh to thirteenth embodiments.

  In the above-described embodiment, the case where the puncture device is applied to a device used when an implantable implant for treating urinary incontinence in women is embedded in a living body has been described. It is not limited.

  For example, the present invention relates to excretion disorder (urinary urgency, frequent urination, urinary incontinence, stool incontinence, urinary retention, difficulty in urination, etc.), pelvic organ prolapse, vesicovaginal fistula, urethral vagina, as the pelvic floor muscles weaken Pelvic floor diseases including epilepsy, pelvic pain, etc. are included in the application target. Pelvic organ prolapse includes diseases such as cystocele, small intestinal aneurysm, rectal aneurysm, and uterine prolapse. Alternatively, diseases such as anterior vaginal wall prolapse, posterior vaginal wall prolapse, vaginal stump prolapse, and vaginal vault prolapse are classified according to the vagina wall site being removed.

  The hypermovable tissue includes the bladder, vagina, uterus, intestine and the like. Micro-movable tissues include bones, muscles, fascia, ligaments and the like. In particular, in pelvic floor disease, it includes obturator fascia, coccyx fascia, base ligament, sacral uterine ligament, sacral ligament, and the like.

  In pelvic floor disease, procedures that connect hypermovable tissue to micromovable tissue include retropubic sling surgery, transobturator sling surgery (transobturator tape; TOT), and transvaginal mesh surgery (Tension-free Vaginal). Mesh; TVM), elevation using the sacral uterine ligament (Uterosacral Ligament Suspension; USLS), fusion using the sacrospinous ligament (SSLF), fixation using the iliac coccyx fascia, tailbone Includes fusion using the fascia.

  In the above-described embodiment, the tip of the vaginal insertion portion is flattened in the thickness direction. However, the shape of the tip of the vaginal insertion portion is not limited to this, for example, it is crushed in the width direction. It may be a flat shape or a substantially cylindrical shape.

DESCRIPTION OF SYMBOLS 1 Puncture apparatus 2 Frame 21 Bearing part 211 Through-hole 22 Guide part 23 Connection part 24 Fixing part 243 Concave part 244 Male screw 3 Puncture member 30 Sheath 31 Main body 32 Tip split piece 321 Tip side opening 322 Base end side opening 33 Base end split piece 331 Tip side opening 332 Base end side opening 34 State maintaining part 341 Thread 342a Hole 342b Hole 342c Hole 345 Exposed hole 346 Exposed hole 347 Slit 347a part 347b Part 348 Hole 35 Needle body 351 Needle tip 352 Base end part 35 Urethral insertion tool 40 Support part 41 Urethral insertion part 421 Balloon 422 Urine discharge part 422a Urine discharge hole 431 Balloon port 432 Urine discharge port 44 Suction mechanism 45 Main body part 451 Decompression chamber 452 Suction port 453 Storage part 453a Projection line 453b Projection line 454 slit 458 Boundary part 459 Boundary part 46 Suction part 461 Base part 462 Guide part 463 Guide part 464 Suction hole 464a Recessed part 464b Communication hole 47 Film 48 Movement mechanism 481 Movement part 482 Operation part 483 Deformation part 483a Press part 483b First connection part 483c Portion 484 Spring 49 Locking mechanism 491 Recessed portion 492 Claw portion 5 Vaginal insertion tool 50 Support portion 51 Vaginal insertion portion 52 Front end portion 52a Upper surface 52b Side surface 52c Side surface 52d Lower surface 52e Base end surface 521 Insertion hole 522 Insertion hole 523 Insertion hole 53 Main body Portion 541 decompression chamber 542 suction port 543 suction portion 543a recess 543b communication hole 543c rib 543d intersection 544 suction hole 544a recess 544b communication hole 545 projection 546 projection 547 guide hole 548 guide hole 55 suction portion 55 Communication hole 56 Suction part 561 Concave part 562 Communication hole 57 Movement mechanism 571 Coil spring 572 Moving body 573 Connection part 574 Connection part 575 Operation part 576 Lock mechanism 576a Recess 576b Claw part 578 Operation lever 579 Operation lever 58 Marker 6 Operation tool 7 71 Insertion section 711 End section 72 Connection section 73 Shaft section 74 Handle 8 Expansion mechanism 811 Wire 812 Wire 813 Wire 82 Operation section 821 Fixing section 831 Rotating section 832 Rotating section 841 Band-shaped body 842 Band-shaped body 851 Balloon 852 Balloon 853 Balloon port 854 Balloon port 861 Rod member 862 Rod member 87 Lock mechanism 871 Protrusion 872 Protrusion 873 Concavity 874 Concavity 9 Implant 90 Packaging material 91 Implant body 92 Band 10 Medical tube Assembly 1100 Pelvis 1101 Closure hole 1102 Closure hole 1200 Pubic joint 1300 Urethra 1310 Bladder 1400 Vagina 1401 Central part 1402 Button hole 1403 Button hole 1404 Vaginal side wall 1405 Vaginal side wall 2000 Syringe A1 Inner peripheral part A2 Outer part A3 Outer part A3 Surface H Body Surface J1 Axis J2 Axis J31 Short Axis J32 Long Axis J32 'Extension Line J5 Central Axis J61 Axis J62 Axis J71 Rotating Axis J72 Rotating Axis L2 Length O Center P Intersection S1 Area S2 Area S4 Central Part S5 Safety Zone W Width direction W1 width f1 plane f2 plane f9 plane r1 minimum radius of curvature r2 maximum radius of curvature θ1 inclination angle θ2 inclination angle θ3 inclination angle θ4 center angle θ5 angle

Claims (10)

A main body having a suction part that is inserted into the body lumen and sucks the body lumen;
An insertion tool comprising: an extension portion that extends in a direction different from the suction direction of the suction portion from the main body portion.   The insertion tool according to claim 1, wherein the suction part and the extension part are arranged side by side in a direction crossing the insertion direction into the living body lumen. The extension part has a linear part,
The insertion tool according to claim 1 or 2, wherein the linear part is expanded by curving. The extension portion has a belt-like portion,
The insertion tool according to claim 1, wherein the band-shaped portion is expanded by bending it in the thickness direction. The extension includes a balloon;
The insertion tool according to claim 1, wherein the insertion tool is expanded by expanding the balloon. The extension part has a long body provided so as to be rotatable with respect to the main body part,
The insertion tool according to claim 1, wherein the insertion tool is expanded by rotating the elongated body.   The insertion tool according to any one of claims 1 to 6, further comprising an urging portion that presses the body portion against the living body lumen. The main body has a pair of main surfaces in a front-back relationship and a pair of side surfaces connecting the pair of main surfaces,
The suction part is provided on at least one of the main surfaces,
The insertion tool according to any one of claims 1 to 7, wherein the extension portion is provided on at least one of the pair of side surfaces and expands in a direction opposite to the pair of side surfaces. The biological lumen is a vagina;
The insertion device according to any one of claims 1 to 6, wherein the expansion portion expands the vagina in a direction intersecting with a direction in which the front wall of the vagina and the rear wall of the vagina are opposed to each other. An insertion tool having a main body part having a suction part and an expansion part extending from the main body part in a direction different from the suction direction of the suction part is inserted into a biological lumen;
Expanding the extension within the body lumen;
An insertion tool insertion method, wherein the living body lumen is aspirated by a suction part in a state where the expansion part is expanded.

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