JP2015116344A - Organism insertion tool and suction method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an organism insertion tool and a suction method which allow the reliable sucking of biological tissues in a proper quantity.SOLUTION: A vaginal insertion tool 5 as the organism insertion tool is a medical tool to be used while being inserted to a vaginal cavity. The vaginal insertion tool 5 comprises a first suction part 54a for sucking biological tissues in the state of being inserted. The first suction part 54a comprises a first recess and a first suction hole formed in the bottom of the first recess. The vaginal insertion tool 5 further comprises a rib 56 provided so as to surround the whole periphery of the first recess in a plane view.

Description

  The present invention relates to a living body insertion tool and a suction 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 treating urinary incontinence. For example, a band-like implant called a “sling” is used, and the sling is placed in the body, and the urethra is supported by the sling (see, for example, Patent Document 1). . To place the sling in the body, the operator incises the vagina with a scalpel, peels off the living tissue between the urethra and the vagina, and uses a puncture needle or the like to connect the peeled site and the outside through a closed hole. Communicate. In such a state, the sling is left in the body.

  Further, when the living tissue between the urethra and the vagina is peeled, a suction tool having a large number of suction ports may be inserted into the vagina, for example, to suck the vagina wall. By this suction, the living tissue constituting the vagina wall expands in the thickness direction and is easily peeled off.

  However, when the vagina wall is sucked, if there is a gap between the portion to be sucked of the vagina wall and the suction tool, there is a problem that suction is not performed sufficiently.

JP 2010-99499 A

  An object of the present invention is to provide a living body insertion tool and a suction method capable of reliably sucking a living tissue without excess or deficiency.

Such an object is achieved by the present inventions (1) to (8) below.
(1) A biological insertion tool used in an inserted state inserted into a biological lumen,
A suction section for sucking the living tissue in the inserted state;
A living body insertion tool comprising: a protrusion provided to protrude so as to surround at least a part of the suction part.

  (2) The living body insertion tool according to (1), wherein the protrusion is disposed so as to surround the entire circumference of the suction portion.

(3) The living body insertion tool has a long overall shape,
The protrusions are arranged at the front and rear in the insertion direction in which the living body insertion tool is inserted into the living body lumen with respect to the suction section, and ribs formed along the circumferential direction of the living body insertion tool. The living body insert described in (1) or (2) above.

  (4) The living body insertion tool according to (3), wherein each of the ribs can expand and contract in a direction orthogonal to the insertion direction.

  (5) The living body insertion tool according to (1), wherein at least a part of the protrusion is supported so as to be close to and away from the living tissue in the inserted state.

  (6) The living body insertion tool according to (5), further including an operation unit that performs an operation of moving the protrusion toward and away from the living tissue.

  (7) The biological insertion tool according to any one of (1) to (6), further including an auxiliary unit that assists the insertion operation when the biological insertion tool is inserted into the biological lumen.

(8) A suction method for sucking a living tissue in a living body lumen,
A living body insertion tool having a protrusion is inserted into the living body lumen, and a part of the closed space is defined in the living body lumen by at least a part of the protrusion and the portion where the living tissue is sucked. In this state, the suction is performed by sucking the inside of the closed space.

  According to the present invention, the protrusion can be brought into close contact with the living tissue in the inserted state in which the living body insertion tool is inserted into the living body lumen. When the living tissue is sucked by the suction portion in this state, suction leakage (air leak) from the gap between the living tissue is prevented, and thus the living tissue can be reliably sucked without excess or deficiency.

FIG. 1 is a perspective view showing an example of an implant. FIG. 2 is a perspective view showing a puncture device provided with the vaginal insertion tool (biological insertion tool (first embodiment)) of the present invention. 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 portion 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 portion of the puncture member shown in FIG. 5, (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. is there. FIG. 9 is a plan view showing a guide portion of a frame provided in the puncture device shown in FIG. 10 is a cross-sectional view of the guide portion shown in FIG. 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. FIG. 13 is a cross-sectional view for explaining the function of the marker provided in the urethral insertion portion, where (a) shows an inappropriate case, and (b) shows an appropriate case. FIG. 14 is a cross-sectional view for explaining the function of the marker provided in the urethra insertion part. FIG. 15 is a diagram showing the positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view. 16 is a partially enlarged view of the vaginal insertion tool included in the insertion tool shown in FIG. 12, wherein (a) is a top view and (b) is a side view. 17A is a cross-sectional view showing an example of the shape of the vagina wall, FIG. 17B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. 17A, and FIG. It is sectional drawing which shows the state which attracted | sucked the vagina from the state of. 18A and 18B are diagrams for explaining the maintenance portion and the displacement portion of the insertion tool shown in FIG. 12, in which FIG. 18A shows a locked state, and FIG. 18B shows a released state. . 19 (a) and 19 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 20 (a) and 20 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIGS. 21A and 21B are diagrams for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 22 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 23 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. 24 (a) and 24 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 25 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 26 is a cross-sectional view showing the posture of the puncture member relative to the urethra in the state shown in FIG. FIGS. 27A and 27B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 28 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. FIG. 29 is a diagram showing a usage state of the vaginal insertion tool (biological insertion tool (second embodiment)) of the present invention, in which (a) is a cross-sectional view showing an example of the shape of the vagina wall, Sectional drawing which shows the state which inserted the vagina insertion part in the vagina shown to (a), (c) is sectional drawing which shows the state which attracted | sucked the inside of the vagina with the 2nd suction part from the state of (b), (d) It is sectional drawing which shows the state which attracted | sucked the inside of a vagina with the 1st suction part from the state of (c). FIG. 30 is a partial cross-sectional view showing a third embodiment of the vaginal insert (biological insert) of the present invention. FIG. 31 is a partial cross-sectional view showing a fourth embodiment of the vaginal insert (biological insert) of the present invention. FIG. 32 is a view of the fifth embodiment of the vaginal insertion tool (biological insertion tool) of the present invention viewed from the distal end side. FIG. 33 is a view showing a sixth embodiment of the vaginal insertion tool (biological insertion tool) of the present invention, in which (a) is a side view and (b) is a front view. FIG. 34 is a view showing a seventh embodiment of the vaginal insert (biological insert) of the present invention, in which (a) is a plan view and (b) is a side view. FIG. 35 is a side view showing the operation process of the eighth embodiment of the vaginal insert (biological insert) of the present invention. FIG. 36 is a partial vertical cross-sectional side view showing a ninth embodiment of the vaginal insert (biological insert) of the present invention. FIG. 37 is a longitudinal sectional view showing an operation process of the tenth embodiment of the vaginal insertion tool (biological insertion tool) of the present invention. FIG. 38 is a longitudinal sectional view showing an operation process of the tenth embodiment of the vaginal insertion tool (biological insertion tool) of the present invention. FIG. 39 is a longitudinal sectional view showing an operation process of the tenth embodiment of the vaginal insertion tool (biological insertion tool) of the present invention. 40 is a cross-sectional view of the vaginal insertion tool (biological insertion tool) shown in FIG. 41 is a cross-sectional view of the vaginal insertion tool (biological insertion tool) shown in FIG. FIG. 42 is a longitudinal sectional view showing an operation process of the eleventh embodiment of the vaginal insertion tool (biological insertion tool) of the present invention.

  Hereinafter, the living body insertion tool and suction method of 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 a puncture device provided with the vaginal insertion tool (biological insertion tool (first embodiment)) of the present invention. 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 portion 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 portion of the puncture member shown in FIG. 5, (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. is there. FIG. 9 is a plan view showing a guide portion of a frame provided in the puncture device shown in FIG. 10 is a cross-sectional view of the guide portion shown in FIG. 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. FIG. 13 is a cross-sectional view for explaining the function of the marker provided in the urethral insertion portion, where (a) shows an inappropriate case, and (b) shows an appropriate case. FIG. 14 is a cross-sectional view for explaining the function of the marker provided in the urethra insertion part. FIG. 15 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. 16 is a partially enlarged view of the vaginal insertion tool included in the insertion tool shown in FIG. 12, wherein (a) is a top view and (b) is a side view. 17A is a cross-sectional view showing an example of the shape of the vagina wall, FIG. 17B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. 17A, and FIG. It is sectional drawing which shows the state which attracted | sucked the vagina from the state of. 18A and 18B are diagrams for explaining the maintenance portion and the displacement portion of the insertion tool shown in FIG. 12, in which FIG. 18A shows a locked state, and FIG. 18B shows a released state. . 19 (a) and 19 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 20 (a) and 20 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIGS. 21A and 21B are diagrams for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 22 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 23 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. 24 (a) and 24 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 25 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 26 is a cross-sectional view showing the posture of the puncture member relative to the urethra in the state shown in FIG. FIGS. 27A and 27B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 28 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.

  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”. FIG. 3 shows a state that is not yet used. Hereinafter, for convenience of explanation, this state is also referred to as an “initial state”. For convenience of explanation, the state where the puncture device (insertion tool) shown in FIG. 3 is attached to the patient is also referred to as “wearing 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 the puncture device 1 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. More specifically, the implant 9 is a device that supports the urethra (urethral cavity) 1300, for example, when the urethra 1300 is about to move toward the vagina wall, the urethra 1300 is moved away from the vagina wall. It is a device that supports to regulate. 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 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.

  Further, such an implant 9 and a sheath 30 described later can constitute a “pelvic treatment kit”.

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 (support portion) 2, an insertion tool (biological insertion tool) 6 that is a member inserted into the living body, an operation member 7, and a puncture member 3. The puncture member 3, the insertion tool 6, and the operation member 7 are supported by the frame 2, 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 connection portion 72 that connects the insertion portion 71 and the shaft portion 73. . 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 central angle of the insertion portion 71 is set according to the central angle 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 setting it as such a cross-sectional shape, in the state which inserted the insertion part 71 in the puncture member 3, rotation of the puncture member 3 with respect to the insertion part 71 etc. can be suppressed effectively.

  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 long axis J32 direction is also referred to as “inner peripheral part A1”, and the end located on the outer side in the long axis J32 direction. The portion is also referred to as “outer peripheral portion A2”, the surface facing upward is also referred to as “front surface A3”, and the surface facing downward is also referred to as “back surface 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 1300 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” is located between the urethra 1300 and the vagina (vaginal cavity) 1400 at least 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). The area including the part is said.

  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.

  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, and as shown in FIG. 5B, the inner peripheral portion A1 and the outer peripheral portion A2 are shifted from each other in the direction of the central axis J5. It can be said that it is configured as follows.

  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, the main body 31 has a tip split piece 32 positioned on the needle body 35 side and a base end split piece 33 positioned on the base end side of the tip split piece 32, which are separated. Connected as 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 axis 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 and 342c each have an inclined axis so that the outer opening is located at the tip of 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.

  In addition, the proximal end portion 352 is provided with an engaging portion 353 that engages with the distal end portion 711 of the insertion portion 71. The engaging portion 353 is configured by a concave portion, and the distal end portion 711 is positioned in the engaging portion 353 in the inserted 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 1300 and the vagina 1400 and project outside the body 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.

  In the puncture device 1, the medical tube assembly 10 is configured by the puncture member 3 (main body 31) as described above and the insertion portion 71 inserted into the main body 31, and these are the states of the medical tube assembly 10. The use begins.

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 FIG. 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 disposed in the guide portion 22 so that the back surface A4 is located on the distal end side and the front surface A3 is located on 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 FIG. 12, the insertion tool 6 includes a urethral insertion tool 4 used in an insertion state inserted into the urethra 1300 and a vaginal insertion tool 5 used in an insertion state inserted into the vagina 1400. ing.

-Urethral insertion device-
The urethral insertion device 4 includes a long urethral insertion portion 41 that is inserted into the urethra 1300 partway and a support portion (urethra insertion portion 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 tip side from the support portion 40) is not particularly limited, and is appropriately set depending on the length of the patient's urethra 1300, the shape of the bladder 1310, and the like. Since the length of the urethra 1300 is about 30 mm to 50 mm, it is preferably about 50 mm 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 (contact portion) 42 that is an expandable and expandable / shrinkable expansion body and a urine discharge portion 47 are provided.

  The balloon 42 is disposed so as to be positioned in the bladder 1310 when the urethral insertion portion 41 is inserted into the urethra 1300. The balloon 42 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 42, the balloon 42 expands. In addition, when the working fluid is extracted from the balloon 42 by the balloon expanding device, the balloon 42 is deflated. In FIG. 12, a state where the balloon 42 is deflated is indicated by a two-dot chain line, and a state where the balloon 42 is expanded is indicated by a solid line.

  The urine drainage unit 47 is used to drain urine in the bladder 1310 in a state where the urethra insertion unit 41 is inserted into the urethra. The urine discharge part 47 is provided with a urine discharge hole 471 that communicates the inside and outside of the urine discharge part 47. The urine drainage hole 471 passes through the urethral insertion portion 41 and is connected to a urine discharge port 432 provided at the base end portion thereof. Therefore, urine introduced from the urine drainage hole 471 can be discharged from the urine discharge port 432.

  The balloon 42 and the urine discharge part 47 can be constituted by, for example, a double lumen.

  A plurality of suction holes 44 are formed in the middle of the urethra insertion part 41 as suction parts for adsorbing the urethra wall to the urethra insertion part 41.

  The plurality of suction holes 44 are arranged over the entire area in the circumferential direction of the urethral insertion portion 41. Each suction hole 44 passes through the urethral insertion portion 41 and is connected to a suction port 433 provided in the support portion 40. A suction device such as a pump can be connected to the suction port 433. When the suction device is operated with the urethra insertion part 41 inserted into the urethra 1300, the urethra wall can be adsorbed and fixed to the suction hole 44. . In particular, as in the present embodiment, by providing a plurality of suction holes 44 over the entire area in the circumferential direction of the urethra insertion part 41, a wide range of the urethra wall can be adsorbed and fixed to the urethra insertion part 41.

  The number of suction holes 44 is not particularly limited, and may be one, for example. The arrangement of the suction holes 44 is not particularly limited, and may be formed only in a part of the circumferential direction of the urethral insertion portion 41, for example.

  When the urethra insertion part 41 is pushed into the body (the distal end side of the urethra insertion part 41) with the urethra wall adsorbed and fixed to the urethra insertion part 41 in this way, the urethra 1300 and the bladder 1310 are pushed into the body along with this. Thus, the bladder 1310 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.

  Further, a visible marker (detection unit) 46 is provided in the middle of the urethral insertion unit 41 and on the proximal side of the balloon 42. This marker 46 is used to detect the distance between the bladder 1310 and the urethral orifice 1320, in other words, the length of the urethra 1300.

  More specifically, as shown in FIG. 13A, when the separation distance between the bladder 1310 and the urethral opening 1320 is less than a predetermined distance, the urethral insertion portion 41 is inserted into the urethra 1300 and the balloon 42 is expanded. In the state of being in contact with the bladder neck, the marker 46 is exposed from the urethral opening 1320. On the other hand, as shown in FIG. 13B, when the separation distance between the bladder 1310 and the urethral orifice 1320 is equal to or greater than a predetermined distance, the urethral insertion portion 41 is inserted into the urethra 1300 and the balloon 42 is expanded to expand the bladder neck In the state of being in contact with the part, the marker 46 is located in the urethra 1300 and is not exposed from the urethral opening 1320.

  As shown in FIG. 13A, if the marker 46 is exposed from the urethral opening 1320, the distance between the bladder 1310 and the urethral opening 1320 is short, and there is a sufficient space between them to puncture the puncture member 3. Expected not to exist. Therefore, in this case, it is determined that the puncture member 3 cannot be punctured.

  Conversely, as shown in FIG. 13B, if the marker 46 is not exposed from the urethral opening 1320, the distance between the bladder 1310 and the urethral opening 1320 is sufficiently long, and the puncture member 3 is punctured between them. It is expected that there will be sufficient space for Therefore, in this case, it is determined that the puncture member 3 can be punctured.

  Thus, by providing the marker 46, it is possible to easily determine whether or not the puncture member 3 can be punctured by the puncture apparatus 1, in other words, whether or not the puncture apparatus 1 is applicable to the patient. . In particular, by disposing the balloon 42 and bringing the balloon 42 into contact with the bladder neck, the separation distance between the bladder 1310 and the urethral opening 1320 can be accurately detected, and the above-described determination can be performed more accurately. Can do.

  The configuration of the marker 46 is not particularly limited as long as the surgeon can be visually recognized from the outside. For example, the marker 46 may be configured by a colored portion colored in a color different from the surroundings (the distal end side and the proximal end side). It may be configured by a concave portion or a convex portion.

  The marker 46 may be a scale on which the distance from the base end of the balloon 42 is written. In this case, since it is not possible to determine whether or not the puncture member 3 can be punctured based on whether or not the marker 46 is exposed from the urethral opening 1320 as in this embodiment, the scale of the urethra 1300 can be determined using the scale. It is only necessary to measure the length and determine whether or not the puncture member 3 can be punctured according to the length.

  As shown in FIGS. 12 and 13, the distal end portion of the urethra insertion portion 41 is in contact with the urethra wall (tissue in the urethra 1300) to increase the sliding resistance against the urethra 1300. 49 is provided. As described above, during the procedure using the puncture device 1, the urethra wall is adsorbed and fixed to the urethra insertion part 41, and the urethra insertion part 41 is pushed into the body, whereby the bladder 1310 is punctured by the puncture member 3. However, if the suction hole 44 does not sufficiently adsorb the urethral wall, the urethral wall may come off from the suction hole 44, and the bladder 1310 may not be pushed in sufficiently. Therefore, as in the present embodiment, the sliding resistance amplifying portion 49 is provided in the urethra insertion portion 41 so that the urethral insertion portion 41 is not easily slid with respect to the urethra wall. Even in such a case, if the suction through the suction hole 44 is sufficient, the bladder 1310 can be pushed into the body more reliably by a synergistic effect therewith. Therefore, the puncture member 3 can be punctured more safely.

  The configuration of the sliding resistance amplifying unit 49 is not particularly limited as long as the above effects can be exhibited. In this embodiment, it is composed of fine irregularities (rough surface) formed on the surface of the urethral insertion portion 41. Thereby, the structure of the sliding resistance amplification part 49 becomes simple. In addition, the said unevenness | corrugation means that it should just have at least one of a recessed part and a convex part.

  The sliding resistance amplifying unit 49 is provided over the entire circumferential direction of the urethral insertion unit 41. Thereby, since the area of the sliding resistance amplification part 49 can be enlarged more, the sliding resistance with respect to the urethra 1300 can be raised more. The sliding resistance amplifier 49 can be formed by embossing, sandblasting, laser processing, or the like.

  The sliding resistance amplifying portion 49 is provided so as to overlap with the region S1 where the suction hole 44 is formed. In other words, the suction hole 44 is formed in the sliding resistance amplifying portion 49. When the urethra wall is adsorbed by the suction hole 44, the urethra wall bites into the suction hole 44 and is caught. By exhibiting such an anchor effect in the sliding resistance amplifying section 49, the sliding resistance of the urethral insertion section 41 with respect to the urethra 1300 can be further increased. Further, by providing the sliding resistance amplifying portion 49 so as to overlap the region S1, both the sliding resistance amplifying portion 49 and the region S1 can be widely arranged, so that the mutual effects can be exerted more greatly. .

  Further, the urethral insertion portion 41 is provided with a cylindrical marker (positioning portion) 45 so as to be slidable. Further, a restricting portion 48 is mounted between the marker 45 of the urethral insertion portion 41 and the support portion 40, and when the marker 45 abuts on the restricting portion 48, further to the proximal end side of the marker 45. Sliding is regulated. The restriction part 48 can be easily removed from the urethra insertion part 41. When the restriction part 48 is removed from the urethra insertion part 41, the marker 45 can slide to the proximal end side.

  The structure of the control part 48 will not be specifically limited if the said effect can be exhibited. In the present embodiment, it has a main body 481 having a semi-cylindrical shape with a substantially C-shaped cross section, and a knob 482 provided on the main body 481. For example, the main body 481 is attached to the urethra insertion part 41 in a slightly expanded diameter so as not to be separated from the urethra insertion part 41 by its own weight or to slide with respect to the urethra insertion part 41.

  The marker 45 is in contact with the restricting portion 48 and in a state where further sliding toward the proximal end is restricted (the state shown in FIG. 12), the puncture route of the puncture member 3 and a predetermined relative positional relationship It is positioned so that Therefore, as shown in FIG. 14, by inserting the urethral insertion portion 41 into the urethra 1300 and positioning the marker 45 at the urethral opening 1320 (or in the vicinity of the urethral opening 1320), the urethral opening 1320 (or in the vicinity of the urethral opening 1320). On the other hand, the puncture path X of the puncture member 3 can be positioned. In this way, positioning the puncture route X with respect to the urethral opening 1320 (or the vicinity of the urethral opening 1320) increases the positioning accuracy compared to, for example, positioning with respect to the bladder 1310, and the puncture member 3 Accurate puncture can be performed. Here, the “predetermined relative positional relationship” means, for example, a positional relationship in which the puncture route X of the puncture member 3 does not overlap the bladder 1310 in a state where the marker 45 is positioned at the urethral opening 1320. Can do.

  Further, since the marker 45 has an outer diameter larger than that of the urethra insertion part 41 and protrudes to the outer periphery of the urethra insertion part 41, the marker 45 cannot enter the urethra 1300. Therefore, when the urethra insertion part 41 is inserted into the urethra 1300, the marker 45 abuts on the urethral opening 1320 (or tissue around the urethral opening 1320; the same applies hereinafter), and the marker 45 is naturally placed in the urethra. It can be located at the mouth 1320. In this way, the marker 45 can be positioned at the urethral opening 1320 easily and reliably by using physical catching. Further, when the marker 45 comes into contact with the urethral opening 1320, the further insertion of the urethra insertion part 41 into the urethra 1300 is restricted, so that excessive insertion of the urethra insertion part 41 into the urethra 1300 can be prevented. This increases the safety of the puncture device 1.

  Such a marker 45 has a function of positioning the puncture route of the puncture member 3 with respect to the urethral opening 1320 as described above, and the urethral insertion portion 41 is inserted into the urethra 1300 via the urethral opening 1320. It has a function as an inflow reduction unit 450 that suppresses the inflow of air into the urethra 1300. Specifically, as shown in FIG. 14, when the urethral insertion portion 41 is inserted into the urethra 1300 and the marker 45 is in contact with the urethral opening 1320, the urethral opening 1320 is covered with the marker 45. ing. Therefore, it is difficult for air to flow into the urethra 1300 from the urethral opening 1320, and the inflow of air into the urethra 1300 (suction hole 44) via the urethral opening 1320 can be suppressed. As a result, the suction of the urethra wall by the suction hole 44 can be performed more reliably and effectively.

  Thus, since the marker 45 also serves as the inflow reducing unit 450, the configuration of the urethral insertion tool 4 is simplified and the operation thereof is also simplified. In addition, the number of components is reduced, which contributes to cost reduction.

  Next, the inclination of the urethral insertion part 41 and the puncture member 3 will be described. As shown in FIG. 3, the inclination angle (in other words, the angle formed by the axes J1 and J2) θ2 of the plane f9 (plane f1) with respect to the plane f2 orthogonal to the axis J2 of the urethra insertion portion 41 is not particularly limited. It is preferably about 60 ° to 60 °, more preferably about 30 ° to 45 °, and still 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.

  More specifically, by setting the inclination angle θ2 within the above range, the puncture member 3 can broadly grasp the left and right closure holes 1101 and 1102 of the pelvis 1100 in a plane as shown in FIG. It is possible to secure a wide puncture space for the puncture member 3. 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.

  In addition, 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 needle body 35 of the puncture member 3 is closed to the left and right closure holes. It passes between 1101 and 1102 at a shorter distance. Therefore, as shown in FIG. 15 (b), the puncture member 3 can pass through the closure holes 1101 and 1102 near 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 that points to the middle portion in the length direction of the urethra 1300 and the vagina 1400. Here, since the position between the middle urethra and the vagina 1400 is a position suitable as a site for implanting the implant 9 and treating urinary incontinence, by targeting the tissue between the middle urethra and the vagina 1400, More effective treatment can be performed.

  On the other hand, when the inclination angle θ2 is less than the lower limit value or exceeds the upper limit value, the puncture member 3 planarly closes the closing holes 1101 and 1102 depending on individual differences in the patient, the posture during the procedure, and the like. There are cases where it is not possible to capture widely or the puncture route 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 FIG. 12, the vaginal insertion tool 5 has an elongated shape and is inserted into the vagina 1400 halfway along the vaginal insertion portion 51 and a support portion (vaginal insertion portion support portion) that supports the vaginal insertion portion 51. ) 50. The vaginal insertion portion 51 is located on the distal end side, and has a distal end portion 52 serving as a main body portion and a shaft portion 53 connected to the proximal end portion of the distal end portion 52. It is supported by the support part 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. 16, the distal end portion 52 has a flat shape and is a portion that is inserted into the vagina 1400. Although it does not specifically limit as length L1 which is the full length 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 40 mm-80 mm. Further, the width W1 that is the maximum width of the distal end portion 52 is not particularly limited, but is preferably about 10 mm to 80 mm, and more preferably about 20 mm to 60 mm. Further, the thickness T1 that becomes the maximum thickness (excluding the suction port 543) of the distal end portion 52 is not particularly limited, but is preferably 5 mm to 50 mm, and more preferably 10 mm to 30 mm. In the distal end portion 52, the portion having the maximum width and the portion having the maximum thickness are the same portion, that is, the central portion in the longitudinal direction of the distal end portion 52. By setting such length (L1) × width (W1) × thickness (T1), the tip 52 has a shape and size suitable for a general vagina 1400. Therefore, the stability of the puncture device 1 in the mounted state is increased, and the burden on the patient is reduced.

  Further, the tip 523 of the tip 52 is rounded. Thereby, when inserting the front-end | tip part 52 in the vagina 1400, while being able to perform the insertion operation smoothly, it can prevent reliably damaging a vagina wall with the front-end | tip 523.

  On the other hand, the width and thickness of the portion on the proximal end side of the distal end portion 52 are gradually reduced toward the proximal direction. Thereby, when extracting the front-end | tip part 52 from the vagina 1400, the extraction operation can be performed smoothly.

  The tip portion 52 having such a shape is entirely inclined with respect to the urethra insertion portion 41 so as to be separated from the urethra insertion portion 41 toward the tip side. Thereby, compared with the case where it is not inclined, the positional relationship of the urethral insertion part 41 and the front-end | tip part 52 can be closely approached to the actual positional relationship of the urethra 1300 and the vagina 1400. Therefore, the puncture device 1 is more stably held by the patient in the wearing state, and the burden on the patient is reduced.

  Although it does not specifically limit as inclination-angle (theta) 3 with respect to the urethra insertion part 41 of the front-end | tip part 52, For example, it is preferable that it is about 0 degree-45 degrees, and it is more preferable that it is about 0 degree-30 degrees. 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 1400 and the urethra 1300 are unnatural in the wearing state depending on the individual difference of the patient, the posture during the procedure, and the like. The puncture apparatus 1 may not be stably held.

  As described above, the tip 52 is a flat portion. And this front-end | tip part 52 has the upper surface (one surface) 521a used as the surface by the side of the urethra insertion part 41, and the lower surface (other surface) 521b which is the surface of the other side. The upper surface 521a has a top surface 521c and two inclined surfaces 521d (see FIG. 17). The top surface 521c is a surface parallel to the flat lower surface 521b. Each inclined surface 521d is a surface that is disposed on both sides of the top surface 521c and is inclined with respect to the top surface 521c. Thus, the upper surface 521a has a convex shape that protrudes toward the urethral insertion portion 41 in a cross-sectional view of the distal end portion 52.

  As shown in FIGS. 16 and 17, the distal end portion 52 includes a first suction portion as a suction portion that sucks the living tissue, that is, the vagina wall 1403 in an inserted state in which the distal end portion 52 is inserted into the vagina 1400. 54a and a second suction part 54b are provided. Hereinafter, the structure of this suction part and its peripheral part will be described.

The first suction portion 54a and the second suction portion 54b, a first suction direction _{I 1} in the first suction portion 54a against the vaginal wall 1403, first in the second suction portion 54b against the vaginal wall 1403 2 of the suction direction I ₂ are arranged differently. Further, in the present embodiment, three first suction portions 54 a are provided, and two second suction portions 54 b are provided, and each suction portion has the maximum width W 1 of the distal end portion 52. It is provided in the part.

  Each of the three first suction portions 54a includes a first recess (recess) 541a and three first suction holes (suction holes) 542a formed at the bottom of the first recess 541a. Yes.

The three first suction portions 54 a are arranged in a direction orthogonal to the insertion direction in which the vaginal insertion tool 5 is inserted into the vagina 1400, that is, in the width direction of the distal end portion 52. That is, one of the three first suction portions 54a has a first recess 541a that opens to the top surface 521c of the upper surface 521a, and the remaining two first suction portions 54a. Each of the first recesses 541a is open to the inclined surface 521d of the upper surface 521a. With such a first suction part 54a, as shown in FIG. 17 (c), the first suction direction I toward the vaginal wall 1403 toward the central axis of the vaginal insertion tool 5, that is, the central side of the vaginal cavity 1400 is provided. ₁ can be aspirated. This makes it possible to efficiently and as small as possible reduce the recessed portion (also referred to as “button hole”) 1402 of the anterior vaginal wall that is the upper surface of the vaginal wall 1403. This will be described later.

  As shown in FIG. 12, the region S2 in which the first suction portion 54a in the middle of the three first suction portions 54a is provided faces the region S1 in which the suction holes 44 are formed. ing. The puncture device 1 is configured such that the needle tip of the puncture member 3 passes between these regions S1 and S2. In the region S1, the urethra wall is adsorbed by the urethral insertion portion 41, and in the region S2, the vagina wall 1403 is adsorbed by the distal end portion 52. Therefore, the urethra wall and the vaginal wall 1403 are wider and more between the regions S1 and S2. Ensure separation. By passing the puncture member 3 through such a region, the puncture member 3 can be punctured more safely.

Moreover, as shown to Fig.16 (a), adjacent 1st recessed part 541a is partitioned off by the wall part 543a. Each wall portion 543a has a thickness U1 that gradually increases toward the front and rear in the insertion direction, that is, toward the distal direction and the proximal direction. As a result, each first recess 541a has a rounded corner 544a in plan view. The corners 544a having such a shape, when aspiration of the vaginal wall 1403 to the first suction direction I _1, the suction portion of the vaginal wall 1403 to seal the first recess 541a airtightly Can do. This allows the suction force in the first recess 541a is sufficiently occur, to reliably suck the vaginal wall 1403 to the first suction direction I _1. Thus, the corner portion 544a has a shape that prevents air leakage, that is, suction leakage.

  As shown in FIG. 17, an inner space 544 that communicates with the suction port 543 is formed in the distal end portion 52 at the back side of the bottom portion of the first recess 541a. Each first suction hole 542a reaches the internal space 544, respectively. Accordingly, each first suction hole 542a communicates with the suction port 543 through the internal space 544. The suction port 543 is provided so as to be located outside the living body in the mounted state. A suction device such as a pump can be connected to the suction port 543.

  As shown in FIG. 16, in each first suction portion 54 a, three first suction holes 542 a are arranged at equal intervals along the longitudinal direction of the distal end portion 52. The arrangement form of the first suction holes 542a is not limited to this. For example, the first suction holes 542a may be arranged in the width direction of the tip portion 52, or are arranged in a matrix along the longitudinal direction and the width direction of the tip portion 52, respectively. It may be arranged or may be arranged irregularly. Further, the number of first suction holes 542a arranged in each first suction portion 54a is not limited to three, and may be one, two, four or more, for example.

In addition, the tip 52 is provided with a rib (projection) 56 that protrudes from the upper surface 521a, that is, protrudes from the upper surface 521a so as to form a step between the upper surface 521a. The rib 56, when viewed from the first suction direction _{I 1,} i.e., in a plan view of the upper surface 521a, and surrounds the entire periphery of the first recess 541a (see FIG. 16). Although it does not specifically limit as protrusion amount T2 of the rib 56, For example, it is preferable that it is 0.5 mm-5 mm, and it is more preferable that it is 1 mm-3 mm.

As shown in FIG. 17 (b), when the tip 52 is inserted into the vagina 1400, the rib 56 can be brought into close contact with the vagina front wall. As a result, the interior of each first recess 541a is hermetically sealed by the front wall of the vagina to form a closed space. Then, when the suction device connected to the suction port 543 is operated from this state, the suction force is sufficient in the first recess 541a, coupled with the above-described function at the corner portion 544a of each first recess 541a. It certainly occurs. This makes it possible to reliably sucked anterior vaginal wall (vaginal wall 1403) by a first suction direction I _1.

  Furthermore, each 1st recessed part 541a is provided with the 1st prevention part 55a which prevents the said vagina wall 1403 from reaching | attaining each 1st suction hole 542a in the state in which the vagina wall 1403 was attracted | sucked. . As shown in FIGS. 17B and 17C, the first blocking portion 55a protrudes from the bottom of the first recess 541a, and as shown in FIG. It consists of parts that make up. In the present embodiment, the wall portion 543a also has a function similar to that of the first blocking portion 55a.

  And each 1st suction hole 542a is arrange | positioned via the gap | interval 551a directly under such a 1st prevention part 55a. The gap 551a communicates with the inside of the first recess 541a. Thereby, the inside of the 1st crevice 541a and each 1st suction hole 542a can be connected via gap 551a.

  Incidentally, the suction force with respect to the vagina wall 1403 is proportional to the area where the vagina wall 1403 is actually sucked (hereinafter referred to as “suction area”). Here, the suction area when the vagina wall 1403 enters the bottom of the first recess 541a and directly contacts the first suction hole 542a to close the first suction hole 542a, and the vagina wall 1403 is the first. A comparison is made with the suction area when the first suction hole 542a is not blocked although it has entered partway through the recess 541a. The former suction area is significantly smaller than the latter suction area. For this reason, the suction force with respect to the vagina wall 1403 is lower in the former than in the latter. For this reason, there is a possibility that the suction force with respect to the vagina wall 1403 is insufficient, and the vagina wall 1403 is separated from the first suction portion 54a, that is, detached.

  Therefore, in the present embodiment, even in the suction state, the first blocking portion 55a can reliably prevent the vaginal wall 1403 from blocking the first suction hole 542a. Thereby, the fall of a suction force can be prevented reliably and the suction state can be maintained. Therefore, the vaginal wall 1403 is prevented from being detached from the first suction part 54a.

  As described above, two second suction portions 54b are provided. As shown in FIG. 17, these two second suction portions 54 b are respectively disposed on the side surface 521 e of the distal end portion 52.

  Each of the second suction portions 54b includes a second recess 541b and three second suction holes 542b formed at the bottom of the second recess 541b. The second recess 541b is open to the side surface 521e. Each of the three second suction holes 542 b reaches the internal space 544 and communicates with the suction port 543 via the internal space 544. As shown in FIG. 16, three second suction holes 542 b are arranged at equal intervals along the longitudinal direction of the distal end portion 52. The arrangement form of the second suction holes 542b is not limited to this. For example, the second suction holes 542b may be arranged in the thickness direction of the distal end portion 52, or are arranged in rows in the longitudinal direction and the thickness direction of the distal end portion 52, respectively. It may be arranged in a shape or may be arranged irregularly. Further, the number of the second suction holes 542b in each second suction portion 54b is not limited to three, and may be one, two, four or more, for example.

As shown in FIG. 17C, the second suction part 54 b as described above allows the first suction part 54 a of the vagina wall 1403 to suck, that is, a part different from the front wall of the vagina. Suction can be performed in a _second suction direction I ₂ that is in the direction toward the central axis of the insertion tool 5 and is orthogonal to the _first suction direction I ₁ . By this suction, the vagina wall 1403 can be drawn into the second recess 541b, so that the vagina wall 1403 is pulled into the second recess 541b, and thus the recessed portion 1402 of the vagina wall 1403 is made as small as possible. To contribute to.

As shown in FIG. 16B, the second concave portion 541b has a shape having a rounded corner portion 544b in a side view, similarly to the first concave portion 541a. The corner 544b, may be when the aspiration of the vaginal wall 1403 in the second suction direction _{I 2,} the suction portion of the vaginal wall 1403 seals the second recess 541b airtightly. This allows the suction force to the second recess 541b is sufficiently occur, to reliably suck the vaginal wall 1403 in the second suction direction I _2.

  Each second recess 541b is provided with a second blocking portion 55b for blocking the vagina wall 1403 from reaching each second suction hole 542b in a state where the vagina wall 1403 is sucked. . The second blocking portion 55b protrudes from the bottom of the second recess 541b as shown in FIGS. 17B and 17C, and has a ladder shape in a side view as shown in FIG. 16B. In addition, it is disposed between the second suction holes 542b.

  Such a second blocking portion 55b reliably prevents the vagina wall 1403 from reaching the second suction hole 542b and closing the second suction hole 542b even in the suction state. be able to. Thereby, the fall of a suction force can be prevented reliably and the suction state can be maintained. Therefore, the vaginal wall 1403 is prevented from being detached from the second suction part 54b.

  Note that a portion like the rib 56 described above may also be provided around the second recess 541b of each second suction portion 54b.

  Next, a suction method using the first suction unit 54a and the second suction unit 54b having the above-described configuration will be described with reference to FIG.

  As shown in FIG. 17 (a), depending on the patient, the central part 1401 of the anterior wall of the vagina hangs down into the vagina 1400, and the vagina in which concave portions (parts) 1402, also called “button holes”, exist on both sides. 1400 may be included.

  As shown in FIG. 17B, the distal end portion 52 of the vagina insertion tool 5 is inserted into the vagina 1400 with the suction device connected to the suction port 543 stopped. In this inserted state, of the three first suction portions 54 a, the two first suction portions 54 a on both sides face the recessed portion 1402, and the middle first suction portion 54 a enters the vagina 1400. The rib 56 comes into close contact with the front wall of the vagina while facing the central portion 1401 of the front wall of the vagina that has been hanging down. As a result, the interior of each first recess 541a is hermetically sealed by the front wall of the vagina to form a closed space. At this time, each recessed portion 1402 is not yet sufficiently small. Further, each side surface 521e of the distal end portion 52 is in close contact with both side portions of the anterior vaginal wall. As a result, each second suction portion 54b is hermetically sealed in the second recess 541b to become a closed space.

When the suction device is operated from this state, the suction force in the _first suction direction I1 is collectively within the first recesses 541a of the first suction portions 54a as shown in FIG. It occurs without excess and deficiency, and the suction force in the _second suction direction I2 is also generated in the second recess 541b of each second suction portion 54b.

  Then, due to the suction force in the middle first suction part 54a, a part (center part 1401) of the vagina wall 1403 enters the first recess 541a of the first suction part 54a, and each second suction part Due to the suction force at 54b, part of the vagina wall 1403 enters the second recess 541b of the second suction part 54b. As a result, the left-side depressed portion 1402 in FIG. 17C is pulled in the arrow α direction, and the right-side depressed portion 1402 is also pulled in the arrow β direction.

  Moreover, the recessed part 1402 is pulled toward the 1st recessed part 541a of the 1st suction part 54a with the suction force in the 1st suction part 54a of both sides.

  Due to the synergistic effect of such pulling, each recessed portion 1402 can be made as small as possible and away from the urethra 1300. Accordingly, when the puncture member 3 punctures the vagina wall 1403, that is, the living tissue between the vagina 1400 and the urethra 1300, it is possible to reliably prevent the puncture portion 1402 from being punctured by mistake. . That is, a sufficient puncture route X can be secured.

  The tip 52 is preferably provided with a marker that can confirm the puncture route of the puncture device 1. Such a marker is not particularly limited as long as it can be visually recognized from the outside. For example, the marker can be constituted by a colored portion, an uneven portion, or the like.

  Further, the separation distance D between the distal end portion 52 and the urethral insertion portion 41 is not particularly limited, but is about 5 to 40 mm corresponding to the separation distance between the urethral opening 1320 and the vaginal opening 1410 in a general woman. Is preferred.

  The shaft portion 53 has a thin rod shape extending substantially parallel to the urethral insertion portion 41. Although it does not specifically limit as the length (distance of the front-end | tip part 52 and the support part 50) of the axial part 53, It is preferable that it is about 100 mm or less, and it is more preferable that it is about 20-50 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.

  The urethral insertion tool 4 and the vaginal insertion tool 5 have been described above. The insertion tool 6 having the urethral insertion tool 4 and the vaginal insertion tool 5 is further maintained by the maintenance unit 61 that maintains the relative positional relationship between the urethral insertion unit 41 and the vaginal insertion unit 51, and the maintenance unit 61. It has the displacement part 62 which can make the front-end | tip part 52 of the vaginal insertion part 51 approach the urethra insertion part 41 rather than relative positional relationship.

  As shown in FIG. 12, the displacement part 62 has a hinge part 621, and the support parts 40 and 50 are rotatably connected by the hinge part 621. Thus, by connecting the support portions 40 and 50 so as to be rotatable, a displacement portion 62 having a simple configuration can be obtained, and further, an operation for bringing the distal end portion 52 closer to the urethra insertion portion 41 can be easily performed. Will be able to do.

  On the other hand, the maintenance unit 61 fixes the urethral insertion tool 4 and the vaginal insertion tool 5 to maintain the relative positional relationship between them, and releases the fixation between the urethral insertion tool 4 and the vaginal insertion tool 5. In this state, the vaginal insertion tool 5 can be rotated with respect to the urethral insertion tool 4.

  As illustrated in FIG. 12, the maintenance unit 61 includes an operation unit 611 provided in the support unit 50, and an engagement unit 612 that is provided in the support unit 40 and engages with the operation unit 611. The operation unit 611 includes a shaft portion 611a capable of bending deformation (elastic deformation), a knob 611b connected to the shaft portion 611a, and a claw portion 611c provided at the tip of the knob 611b. One engaging portion 612 includes a concave portion 612 a formed in the support portion 40.

  As shown in FIG. 18A, the support portion 50 is fixed to the support portion 40 by engaging the claw portion 611c with the recess 612a, and the relative positions of the urethral insertion device 4 and the vaginal insertion device 5 are fixed. A relationship can be maintained. On the other hand, as shown in FIG. 18B, the maintenance state is released by pulling the knob 611b downward and removing the claw portion 611c from the recess 612a, and the vaginal insert 5 is rotated with respect to the urethra insert 4 It becomes possible. And in the state which can be rotated, the vagina insertion part 51 (front-end | tip part 52) can be made to approach the urethra insertion part 41 rather than the maintenance state shown to Fig.18 (a).

  In the present embodiment, the engaging portion 612 is provided on the support portion 40, and the operation portion 611 is provided on the support portion 50. On the contrary, the engaging portion 612 is provided on the support portion 50. The operation unit 611 may be provided on the support unit 40. Moreover, the structure of the operation part 611 is not limited to this embodiment, as long as the same effect can be exhibited.

  In addition, the insertion tool 6 may further include a biasing portion (for example, a spring) that biases the vaginal insertion portion 51 toward the urethral insertion portion 41 side. Thereby, when the lock | rock of the maintenance part 61 is cancelled | released, the vagina insertion part 51 will move to the urethra insertion part 41 side automatically by the urging | biasing force of the said urging | biasing part. Therefore, the operation of the insertion tool 6 becomes easier.

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

  First, the patient is placed in a 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 device 4 is inserted into the urethra 1300 of the patient, and the vagina insertion portion 51 of the vaginal insertion device 5 is inserted into the vagina 1400 of the patient. By inserting the urethra insertion part 41 into the urethra 1300, the urethra 1300 is corrected to a predetermined shape (in this embodiment, a straight line) by the urethra insertion part 41, and by inserting the vagina insertion part 51 into the vagina 1400, 1400 is corrected to the predetermined shape by the vaginal insertion portion 51 (tip portion 52).

  Next, the balloon 42 disposed in the bladder 1310 is expanded, and urine is discharged from the bladder 1310 through the urine drainage 471 as necessary. Next, as shown in FIG. 19B, the urethral insertion portion 41 is pulled outward (base end side) until the balloon 42 comes into contact with the bladder neck, and in this state, the marker 46 is exposed from the urethral opening 1320. Check whether or not As described above, when the marker 46 is exposed from the urethral opening 1320, it is determined that the puncture apparatus 1 cannot be used, and the procedure is stopped at this point. On the other hand, when the marker 46 is not exposed from the urethral opening 1320, it is determined that the puncture apparatus 1 can be used, and the procedure is continued.

  Next, as shown in FIG. 20A, the urethral insertion portion 41 is pushed into the body to bring the marker 45 into contact with the urethral opening 1320. Thereby, the puncture member 3 is positioned with respect to the urethral opening 1320, and the puncture route X of the puncture member 3 is determined. Here, when a marker is provided at the distal end portion 52 of the vaginal insertion portion 51, a safer procedure can be performed by checking the puncture route X of the puncture member 3 using the marker.

  Next, a suction device is connected to the suction ports 433 and 543, the suction device is operated, the urethral wall is adsorbed to the suction hole 44 of the urethral insertion portion 41, and the vagina wall is attached to the first suction portion of the vaginal insertion portion 51. It is made to adsorb | suck to 54a and the 2nd suction part 54b. As described above, at this time, since the marker 45 covers and closes the urethral opening 1320 on the urethra 1300 side, the inflow of air into the urethra 1300 through the urethral opening 1320 is suppressed, and the urethra into the urethra insertion part 41 is suppressed. The wall can be more reliably adsorbed. On the other hand, on the vagina 1400 side, as described above, the first recess 541a of each first suction portion 54a and the second recess 541b of each second suction portion 54b are hermetically sealed to the vagina wall 1403. Therefore, the suction at each suction part can be reliably performed. Thus, the living tissue between the urethra 1300 and the vagina 1400 is expanded by the suction on the urethra 1300 side and the suction on the vagina 1400 side, and thus the puncture route X can be sufficiently secured. In particular, as described above, the depressed portion 1402 of the vagina wall 1403 can be made as small as possible by suction with the vaginal insertion tool 5, so that the puncture route X can be secured more reliably.

  Furthermore, in the vaginal insertion tool 5, as shown in FIG. 20 (b), first, the lock of the maintenance unit 61 is released, and the vaginal insertion unit 51 is made rotatable with respect to the urethral insertion unit 41. The insertion part 51 is moved to the urethral insertion part 41 side. Thereby, the upper surface 521a of the front-end | tip part 52 and the vagina front wall can be stuck more reliably. In this state, by operating the suction device connected to the suction port 543, the vagina wall can be more reliably adsorbed to the vagina insertion portion 51. After adsorbing the vagina wall 1403, as shown in FIG. 21A, the vagina insertion part 51 is moved away from the urethra insertion part 41, the maintenance part 61 is locked, and the vagina insertion part 51 and the urethra insertion part The relative positional relationship with 41 is fixed. This maintains the state where the urethra 1300 and the vagina 1400 are sufficiently separated from each other, thereby contributing to securing the puncture route X.

  At the time of such adsorption, for example, if the urethra wall is properly adsorbed by the urethra insertion part 41, the suction hole 44 is blocked by the urethra wall, so that the suction from the suction port 433 is stopped or weakened. Similarly, if the vagina wall 1403 is properly adsorbed to the vagina insertion portion 51, the first suction portion 54a and the second suction portion 54b are blocked by the vagina wall 1403, so that suction from the suction port 543 is stopped or Weaken. For this reason, the surgeon properly adsorbs the urethral wall and the vagina wall 1403 to the urethral insertion portion 41 and the vagina insertion portion 51 from the suction state (for example, the magnitude of sound generated by the suction) from the suction ports 433 and 543. You can check whether or not.

  In addition, the insertion tool 6 may have a confirmation part which confirms an adsorption state mechanically. Although it will not specifically limit if a suction state can be confirmed as a confirmation part, For example, based on the flow rate measurement part (negative pressure meter) which measures the flow volume from the suction port 543, and the measurement result from this flow rate measurement part It can be set as the structure which has a judgment part which judges whether adsorption | suction is performed correctly.

  As described above, after the urethral wall and the front wall of the vagina are sufficiently separated to puncture the puncture member 3, 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.

  And as shown in FIG. 23, the control part 48 is removed from the urethra insertion part 41, and the insertion tool 6 is pushed into a body inner side. As described above, the urethra wall is adsorbed to the urethra insertion part 41 and the vagina wall 1403 is adsorbed to the vagina insertion part 51. Therefore, when the insertion tool 6 is pushed into the body, the urethra 1300 and the vagina are also pushed together. 1400 is pushed in and the tissue between them is extended. Therefore, it becomes easier to puncture the tissue with the puncture member 3.

  In particular, in this embodiment, since the sliding resistance amplifying part 49 for increasing the sliding resistance with the urethra 1300 is provided in the urethra insertion part 41, the urethra 1300 can be pushed in more reliably. Further, since the rubbing (displacement) between the urethra insertion part 41 and the urethra 1300 is suppressed, damage to the urethra can be suppressed.

  At this time, since the restricting portion 48 is removed, the marker 45 slides toward the proximal end side of the urethral insertion portion 41 while abutting against the urethral opening 1320, and does not inhibit the above-described pushing of the urethral insertion portion 41.

  In the above description, the case where both the urethra 1300 and the vagina 1400 are pushed into the body is described. However, only one of the urethra 1300 and the vagina 1400 may be pushed into the body. Also by this, the same effect can be exhibited.

  Next, with the urethra 1300 and vagina 1400 pushed into the body, the puncture device 1 is positioned so that the puncture trajectory of the puncture member 3 passes through the safety zones S5 of the left and right closure holes 1101 and 1102 of the pelvis. While maintaining the state, the handle 74 is operated to rotate the operation member 7 as shown in FIG. Thereby, the needle body 35 of the puncture member 3 enters the body by puncturing the body surface H of the right buttock of the patient or the vicinity thereof, and between the one closed hole 1101, the urethra 1300 and the vagina 1400, After passing through the other closing hole 1102 in order, it protrudes outside the body from the body surface H of the left buttocks or its vicinity. 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.

  At this time, the puncture member 3 punctures the living body so as to pass between the marker 46 and the urethral opening 1320. Thereby, for example, the puncture member 3 punctures between the middle part (middle urethra) of the urethra 1300 and the vagina 1400, and more effective treatment can be performed.

  Thereby, the puncture member 3 is arrange | positioned at a biological body. 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.24 (b), only 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. 26, the central portion S4 is arranged such that its width direction (long axis J32 direction) W is substantially parallel to the urethra 1300. That is, the width direction W of the urethra 1300 that has been corrected by inserting the urethral insertion tool 4 and the central portion S4 is located substantially in parallel.

  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 disposed in parallel with the corrected urethra 1300.

  Next, as shown in FIG. 27B, 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 split piece 32 and the proximal end split piece 33 are moved in a direction along the shape thereof, and the main body 31 has an internal space in which the implant main body 91 can be moved with sufficiently low friction. Thus, an unnecessary tensile force is not applied to the implant main body 91, and the implant main 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. 28, 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. In particular, the vaginal wall 1403 can be reliably sucked without excess or deficiency, and by this suction, the vaginal wall 1403 can be expanded to ensure a sufficient puncture path X. As a result, it is possible to reliably prevent accidental puncture of the vagina 1400 and the like, which is safe.

  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, it prevents the occurrence of complications such as the exposure of the implant 9 into the vagina 1400 from the wound generated by the incision and the infection from the wound as in the case of the conventional incision of the vagina. It is very safe and can embed the implant 9 reliably.

Second Embodiment
FIG. 29 is a diagram showing a usage state of the vaginal insertion tool (biological insertion tool (second embodiment)) of the present invention, in which (a) is a cross-sectional view showing an example of the shape of the vagina wall, and (b) Sectional drawing which shows the state which inserted the vagina insertion part in the vagina shown to (a), (c) is sectional drawing which shows the state which attracted | sucked the inside of the vagina with the 2nd suction part from the state of (b), (d) It is sectional drawing which shows the state which attracted | sucked the inside of a vagina with the 1st suction part from the state of (c).

Hereinafter, the second embodiment of the living body insertion tool and suction method of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted. To do.
The present embodiment is the same as the first embodiment except that the configuration of the vaginal insertion tool is different.

  As shown in FIG. 29, in this embodiment, the internal space 544 of the distal end portion 52 of the vaginal insertion tool 5 is divided into a first space 5441 and a second space 5442 by a partition portion 544c. Each first suction hole 542a communicates with the first space 5441, and each second suction hole 542b communicates with the second space 5442. The first space 5441 and the second space 5442 are each in communication with a separate suction port (not shown).

  With such a configuration, the suction by the first suction part 54a and the suction by the second suction part 54b can be performed at different timings, that is, at different timings. This will be described below.

  As shown in FIG. 29A, the vagina 1400 has a recessed portion (part) 1402 as in the first embodiment.

  As shown in FIG. 29B, the distal end portion 52 of the vagina insertion tool 5 is inserted into the vagina 1400 with the suction device connected to the suction port 543 stopped. In this inserted state, the middle first suction part 54a faces the central part 1401 of the anterior vaginal wall, and the two first suction parts 54a on both sides face the recessed part 1402, respectively. Further, the rib 56 is in close contact with the vagina front wall, and the inside of each first recess 541a is hermetically sealed by the vagina front wall to form a closed space. At this time, each recessed portion 1402 is not yet sufficiently small. Further, the side surfaces 521e of the distal end portion 52 are in close contact with both sides of the anterior vaginal wall, and the second recesses 541b of the second suction portions 54b are also hermetically sealed to form a closed space.

When the suction device on the second space 5442 side is operated from this state, as shown in FIG. 29C, first, the second suction direction in the second recess 541b of each second suction portion 54b. A suction force of I ₂ is generated all at once. As a result, a part of the vagina wall 1403 is as much as possible and enters the second recess 541b of each second suction part 54b. Accordingly, the left recessed portion 1402 in FIG. 29C is pulled in the direction of the arrow α1, and the right recessed portion 1402 is also pulled in the direction of the arrow β1, respectively than in the case of FIG. 29B. Get smaller.

Next, when the suction device on the first space 5441 side is further operated from the state shown in FIG. 29 (c), as shown in FIG. in the recess 541a, a first suction force of the suction direction _{I 1} occurs collectively. Then, due to the suction force in the middle first suction part 54a, a part (center part 1401) of the vagina wall 1403 enters the first recess 541a of the first suction part 54a. Accordingly, the left recessed portion 1402 in FIG. 29C is pulled in the direction of arrow α2, and the right recessed portion 1402 is also pulled in the direction of arrow β2. Along with this, each recessed portion 1402 is pulled toward the first concave portion 541a of the first suction portion 54a by the suction force of the first suction portions 54a on both sides.

  By performing the suction in the first suction part 54a and the suction in the second suction part 54b with a time difference in this way, as shown in FIG. In effect, it will disappear. This disappearance and the puncture route X can be more sufficiently secured, and thus erroneous puncture can be more reliably prevented.

  Note that the present invention is not limited to the structure in which the internal space 544 is divided into the first space 5441 and the second space 5442. For example, by making the hole diameter of the first suction hole larger than the hole diameter of the second suction hole without dividing the internal space 544, a suction structure having the same effect can be obtained with a smaller structure.

<Third Embodiment>
FIG. 30 is a partial cross-sectional view showing a third embodiment of the vaginal insert (biological insert) of the present invention.

Hereinafter, the third embodiment of the living body insertion tool and suction method of the present invention will be described with reference to these drawings, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.
The present embodiment is the same as the first embodiment except that the configuration of the vaginal insertion tool is different.

  As shown in FIG. 30, in this embodiment, the vaginal insertion tool 5 includes an auxiliary portion 57 that assists the insertion operation when the vaginal insertion tool 5 is inserted into the vaginal cavity. The auxiliary portion 57 is a coat layer 571 formed on a portion where the distal end portion 52 of the vaginal insertion tool 5 is expected to contact the vaginal wall 1403 during the insertion operation, that is, on at least a part of the outer surface. The outer surface includes the upper surface 521a and the rib 56 of the front end portion 52, the lower surface 521b, the side surface 521e, and the other front end 523. The formation of the coat layer 571 on the rib 56 may be omitted. In this case, the slidability with respect to the vagina wall 1403 can be improved, and the vagina wall 1403 can be prevented from slipping when the vagina wall 1403 is sucked.

  The coat layer 571 is a layer coated with a hydrophilic material. As a result, the hydrophilic material is wetted to produce lubricity, the friction between the tip 52 and the vagina wall 1403 is reduced, and the slidability is improved. Therefore, the operability during the insertion operation is improved.

  Examples of hydrophilic materials include cellulose-based polymer materials, polyethylene oxide-based polymer materials, and maleic anhydride-based polymer materials (for example, maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymer). Acrylamide polymer substances (for example, polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymer), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone and the like.

<Fourth embodiment>
FIG. 31 is a partial cross-sectional view showing a fourth embodiment of the vaginal insert (biological insert) of the present invention.

  Hereinafter, the fourth embodiment of the living body insertion tool and suction method of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted. To do.

  The present embodiment is the same as the third embodiment except that the configuration of the auxiliary portion that assists the insertion operation of the vaginal insertion tool is different.

  As shown in FIG. 31, in this embodiment, the auxiliary | assistant part 57 is comprised by the several spherical body 572 supported by the front-end | tip part 52 so that rotation was possible. Some of these spheres 572 are unevenly distributed on the lower surface 521b of the distal end portion 52 and others are unevenly distributed on the side surface 521e. In addition, a part of each sphere 572 protrudes from the lower surface 521b or the side surface 521e.

  Each of the spheres 572 arranged in this manner can rotate when it comes into contact with the vagina wall 1403 during the insertion operation. Thereby, the operativity at the time of insertion operation improves.

<Fifth Embodiment>
FIG. 32 is a view of the fifth embodiment of the vaginal insertion tool (biological insertion tool) of the present invention viewed from the distal end side.

  Hereinafter, the fifth embodiment of the living body insertion tool and the suction method of the present invention will be described with reference to these drawings. However, the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.

  The present embodiment is the same as the third embodiment except that the configuration of the auxiliary portion that assists the insertion operation of the vaginal insertion tool is different.

  As shown in FIG. 32, in the present embodiment, the auxiliary portion 57 has a recess 573 in which a portion between the lower surface 521b and the side surface 521e of the distal end portion 52 is recessed toward the central axis side of the distal end portion 52. ing. Thereby, the contact area with the vagina wall 1403 on the lower surface 521b and the side surface 521e can be reduced, and thus the operability during the insertion operation is improved.

<Sixth Embodiment>
FIG. 33 is a view showing a sixth embodiment of the vaginal insertion tool (biological insertion tool) of the present invention, in which (a) is a side view and (b) is a front view.

  Hereinafter, the sixth embodiment of the living body insertion tool and suction method of the present invention will be described with reference to these drawings, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.

  The present embodiment is the same as the third embodiment except that the configuration of the auxiliary portion that assists the insertion operation of the vaginal insertion tool is different.

  As shown in FIG. 33, in the present embodiment, the auxiliary portion 57 includes a plurality of ridges 574 that are formed to protrude from the distal end portion 52 along the longitudinal direction of the vaginal insertion tool 5. These ridges 574 include those that are unevenly distributed on the lower surface 521b of the distal end portion 52 and those that are unevenly distributed on the side surface 521e. Moreover, the top part of any protrusion 574 is rounded.

  When the vagina 1400 is inserted into the distal end portion 52, each ridge 574 comes into contact with each other more preferentially than the lower surface 521b and the side surface 521e. Thereby, the contact area with the vagina wall 1403 on the lower surface 521b and the side surface 521e can be reduced, and thus the operability during the insertion operation is improved.

<Seventh embodiment>
FIG. 34 is a view showing a seventh embodiment of the vaginal insert (biological insert) of the present invention, in which (a) is a plan view and (b) is a side view.

  Hereinafter, the seventh embodiment of the living body insertion tool and suction method of the present invention will be described with reference to these drawings, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.

  The present embodiment is the same as the first embodiment except that the arrangement of the first suction part in the vaginal insertion tool is different.

  As shown in FIG. 34, in the present embodiment, the three first suction portions 54a are arranged along the insertion direction in which the vaginal insert 5 is inserted into the vagina 1400, that is, the longitudinal direction of the vaginal insert 5. ing. This arrangement direction is a direction orthogonal to the direction of the puncture path X.

  When the first suction portion 54a is arranged in the first embodiment, depending on the degree of suction force, the puncture path X has a waveform in the vicinity of the first suction portion 54a along the formation direction. That is, a wavy shape. In this case, the implant main body 91 placed in the living body also has the shape.

  On the other hand, in the present embodiment, the puncture route X is preferably prevented from forming a waveform, and thus the implant body 91 placed in the living body also follows its shape. Thereby, the urethra 1300 can be favorably supported.

<Eighth Embodiment>
FIG. 35 is a side view showing the operation process of the eighth embodiment of the vaginal insert (biological insert) of the present invention.

  Hereinafter, an eighth embodiment of the living body insertion tool and suction method of the present invention will be described with reference to these drawings. However, the difference from the above-described embodiment will be mainly described, and description of similar matters will be omitted. To do.

  This embodiment is the same as the first embodiment except that the configuration of the ribs in the vaginal insertion tool is different.

  As shown in FIG. 35, in the present embodiment, the rib 56 is formed of balloons 561 and 562 that are formed over the entire circumference of the distal end portion 52 (vaginal insertion tool 5) and can be expanded and contracted. The balloon 561 is disposed on the distal end side with respect to the first suction portion 54a, and the balloon 562 is disposed on the proximal end side with respect to the first suction portion 54a. In other words, the balloon 561 is disposed in front of the first suction part 54a in the insertion direction in which the vaginal insertion tool 5 is inserted into the vagina 1400, and the balloon 561 is inserted in the insertion direction with respect to the first suction part 54a. It is arranged at the rear. As described above, the balloon 561 and the balloon 562 are spaced apart from each other in the longitudinal direction of the vaginal insertion tool 5 via the first suction portion 54a.

  The balloons 561 and 562 communicate with the balloon port 524 via a lumen (not shown) provided at the distal end portion 52. A balloon expansion device such as a syringe can be connected to the balloon port 524. When a working fluid (liquid such as physiological saline, gas, etc.) is supplied from the balloon dilator to the balloons 561 and 562, the balloons 561 and 562 are inserted in the insertion direction of the vaginal insert 5, that is, the vaginal insert 5 (See FIGS. 35B to 35D). Further, when the working fluid is extracted from the balloons 561 and 562 by the balloon expanding device, the balloons 561 and 562 contract in the opposite direction (see FIG. 35A).

  In addition, a lid 58 is detachably attached to the distal end portion 52 at a portion closer to the proximal end than the balloon 562. The lid body 58 has a flat plate shape, and a through hole 581 is formed at the center thereof. The lid body 58 is attached to the distal end portion 52 by inserting and fitting the distal end portion 52 into the through hole 581.

Next, a method for using the vaginal insertion tool 5 will be described.
First, as shown in FIG. 35A, a predetermined amount of the vagina insertion tool 5 is inserted into the vagina 1400 with the balloons 561 and 562 deflated. This insertion operation is facilitated since the balloons 561 and 562 can be performed in a deflated state.

  Next, as shown in FIG. 35 (b), a lid body 58 is attached to the distal end portion 52, and the vaginal opening 1410 is hermetically sealed by the lid body 58. Thereby, the inside of the vagina 1400 becomes a closed space.

  In addition, the balloons 561 and 562 are expanded together with the mounting operation of the lid 58. The expanded balloons 561 and 562 do not reach the vaginal wall 1403.

  Next, as shown in FIG. 35C, the inside of the vagina 1400 is sucked by the first suction part 54a. As described above, since the inside of the vagina 1400 is a closed space, the vagina wall 1403 is drawn toward the balloons 561 and 562 by suction, and finally comes into contact. As a result, a closed space is formed between the balloons 561 and 562 and the vaginal wall 1403.

  Then, as shown in FIG. 35 (d), when the suction by the first suction part 54a is continued, the vagina wall 1403 between the balloon 561 and the balloon 562 further moves toward the first suction part 54a. Gravitate. As a result, the living tissue between the vagina 1400 and the urethra 1300 is expanded, and thus the puncture route X for the living tissue can be sufficiently secured. Note that the lid 58 may be removed in the state shown in FIG.

<Ninth Embodiment>
FIG. 36 is a partial vertical cross-sectional side view showing a ninth embodiment of the vaginal insert (biological insert) of the present invention.

  Hereinafter, the ninth embodiment of the living body insertion tool and suction method of the present invention will be described with reference to these drawings. However, the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.

  The present embodiment is the same as the eighth embodiment except that the configuration of the ribs in the vaginal insertion tool is different.

  As shown in FIG. 36, in this embodiment, the rib 56 is configured by elastic rings 563 and 564 formed over the entire circumference of the distal end portion 52 (vaginal insertion tool 5). The ring 563 and the ring 564 are spaced apart from each other in the longitudinal direction of the vaginal insertion tool 5 via the first suction part 54a.

  The ring 563 is inclined toward the proximal end side, and the ring 564 is inclined toward the distal end side.

  Also with the rings 563 and 564 having such a configuration, a closed space can be defined between the vaginal wall 1403 and the vaginal insertion tool 5 being inserted. Therefore, suction by the first suction portion 54a is possible. Can be performed reliably.

<Tenth Embodiment>
FIG. 37 to FIG. 39 are longitudinal sectional views showing the operation process of the tenth embodiment of the vaginal insertion tool (biological insertion tool) of the present invention. 40 is a cross-sectional view of the vaginal insertion tool (biological insertion tool) shown in FIG. 41 is a cross-sectional view of the vaginal insertion tool (biological insertion tool) shown in FIG.

  Hereinafter, the tenth embodiment of the living body insertion tool and suction method of the present invention will be described with reference to these drawings. However, the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.

  The present embodiment is the same as the first embodiment except that the configuration of the vaginal insertion tool is different. The configuration of the vaginal insertion tool can also be applied to the urethral insertion tool.

  As shown in FIGS. 37 to 41, in this embodiment, the vaginal insertion tool 5 </ b> A includes a main body portion 81 configured by a hollow body, and ten plate pieces (projections) 82 that can be moved into and out of the main body portion 81. And an operation portion 83 that collectively operates each plate piece 82 and a connecting portion 84 that connects each plate piece 82 and the operation portion 83.

  The main body 81 has a cylindrical shape with both ends closed, that is, a distal end wall portion 811 on the distal end side, a proximal end wall portion 812 on the proximal end side, and a side wall 813 between these wall portions. It has.

  As shown in FIGS. 40 and 41, the side wall 813 is formed with ten slits 814 penetrating in the thickness direction and extending in the longitudinal direction. A plate piece 82 is inserted into each slit 814. Accordingly, the ten plate pieces 82 are arranged radially and can move in the radial direction with respect to the main body portion 81, but are restricted from moving in the longitudinal direction and the circumferential direction.

  The side wall 813 is formed with a suction hole 815 formed of a through hole in a portion between adjacent slits 814. The number of the suction holes 815 formed is not particularly limited and may be one or more.

  Further, a suction port 816 that communicates with the internal space 817 of the main body 81 is formed on the side wall 813 so as to protrude. Thereby, the suction hole 815 communicates with the suction port 816 via the internal space 817. Note that a suction device such as a pump can be connected to the suction port 816. By operating this suction device, a suction force is generated in the suction hole 815, and the vagina wall 1403 can be sucked (see FIG. 41).

  On the distal end wall portion 811 of the main body portion 81, an elongated support portion 85 is formed so as to protrude toward the proximal end side and penetrate through the proximal end wall portion 812. The support portion 85 is a portion that supports the operation portion 83 so as to be movable. In addition, although the cross-sectional shape of the support part 85 is circular in the structure of FIG. 40, FIG. 41, it is not limited to this, For example, you may change according to the installation number of the board pieces 82. FIG.

  The operation portion 83 includes a cylindrical portion 831 concentrically disposed on the outer peripheral side of the support portion 85, an operation piece 832 provided on the proximal end side of the cylindrical portion 831, and the cylindrical portion 831 and the operation piece. 832 and a connecting plate 833 for connecting the H.

The cylindrical portion 831 is supported so as to be slidable along the longitudinal direction with respect to the support portion 85.
The connecting plate 833 extends from the cylindrical portion 831 toward the proximal direction.

  The operation piece 832 protrudes from the base end portion of the connecting plate 833 toward the upper side in FIG. 37 (the same applies to FIGS. 38 and 39).

  Each plate piece 82 can take the first state shown in FIG. 40 and the second state shown in FIG. 41 by operating the operation unit 83. The thickness of the inner edge portion of each plate piece 82 is increased to form a thickness increasing portion 821. In the state shown in FIG. 41, the protrusion limit is regulated by the thickness increasing portion 821 coming into contact with the slit 814.

  Further, elastic films 861 and 862 are disposed on the distal end side and the proximal end side of the plate piece 82. The elastic film 861 is connected between the outer edges of each plate piece 82. The elastic film 862 is connected between the outer edge of each plate piece 82 and the outer periphery of the side wall 813 of the main body 81. In the state shown in FIG. 37, the elastic films 861 and 862 are contracted, and in the state shown in FIGS. 38 and 39, the elastic films 861 and 862 are expanded. As a result, a closed space can be defined by the elastic film 861, the elastic film 862, the plate piece 82, and the vagina wall 1403 (see FIGS. 38 and 41). Can be aspirated.

  The connecting portion 84 includes a plurality of links 841 that connect each plate piece 82 and the cylindrical portion 831 of the operation portion 83. The end of the link 841 on the plate piece 82 side is supported so as to be rotatable with respect to the plate piece 82. Similarly, the end portion on the cylindrical portion 831 side of the link 841 is also supported so as to be rotatable with respect to the cylindrical portion 831. Then, when the operation piece 832 is picked with a fingertip and operated in the front-rear direction, the operation force is transmitted to each plate piece 82 via the link 841, and the plate piece 82 protrudes or is immersed. it can.

Next, a method for using the vaginal insertion tool 5A will be described.
First, as shown in FIGS. 37 and 40, the vaginal insertion tool 5A is inserted into the vagina 1400 with each plate piece 82 in the first state. This first state is a state in which the maximum outer diameter of the vaginal insertion tool 5A itself is the smallest, and the insertion operation into the vagina 1400 can be easily performed.

  Next, as shown in FIG. 38, the operation piece 832 of the operation unit 83 is picked up with a fingertip, and the operation unit 83 is advanced in the distal direction. As a result, as shown in FIG. 41, the respective plate pieces 82 are collectively brought into the second state, the plate pieces 82 approach the vagina wall 1403, and the outer edge portion is brought into contact with the vagina wall 1403. Abut. Note that the pressing operation in the distal direction of the operation unit 83 is performed until the engagement piece 851 provided in the support unit 85 is engaged with the concave portion 834 in which the cylindrical portion 831 of the operation unit 83 is formed. Thereby, the second state can be maintained.

  Further, as the plate piece 82 enters the second state, the elastic films 861 and 862 expand. Thus, a closed space is defined by the adjacent plate pieces 82, the elastic film 861, the elastic film 862, and the vagina wall 1403.

  And the suction device connected to the suction port 816 is operated in this state. Thereby, as shown in FIG. 41, the vaginal wall 1403 between the adjacent plate pieces 82 is pulled toward the center side of the vaginal insertion tool 5A.

  Next, as shown in FIG. 39, the operation piece 832 of the operation unit 83 is picked up with a fingertip, and the operation unit 83 is slightly retracted toward the proximal direction. Accordingly, each plate piece 82 is still in the second state and is in contact with the vagina wall 1403, but the degree of contact is weakened.

  At this time, the operation piece 832 engages with a recess 852 provided in the support portion 85. Accordingly, it is possible to maintain a state where the degree of contact is weak, and it is also possible to narrow the vagina 1400 and widen the space between the urethra 1300 and the vagina 1400.

  Then, the puncture member 3 is operated to puncture a living tissue between the urethra 1300 and the vagina 1400. Since this living tissue is pulled in a direction away from the urethra 1300 by the vaginal insertion tool 5A, it is expanded. Thereby, the puncture path | route X is fully ensured.

  Further, when the vaginal insertion tool 5A is removed from the vagina 1400 after the implant 9 is placed, the operation portion 83 is retracted toward the proximal end toward the limit position. Thereby, each board piece 82 returns to a 1st state (refer FIG. 37) collectively, Therefore, the said board piece 82 spaces apart with respect to the vagina wall 1403. FIG. And extraction operation of 5 A of vagina insertion tools is performed.

  Note that the vaginal insertion tool 5 is configured to collectively operate the ten plate pieces 82 in the present embodiment, but is not limited to this. For example, a desired plate piece out of the ten plate pieces 82 is used. Only 82 may be configured to be operable.

  Moreover, although the installation number of the board pieces 82 was 10 sheets in this embodiment, it is not limited to this, For example, 1-9 sheets may be sufficient and 10 sheets or more may be sufficient.

  In addition, although the ten plate pieces 82 are arranged radially in the configuration shown in FIG. 40, the present invention is not limited to this, and may be unevenly distributed on the upper side or the lower side in FIG. 40, for example. In the case of the vaginal insertion tool 5, it is preferable to use the side where the plate piece 82 is unevenly located on the urethra 1300 side, that is, the side to be sucked.

  In addition, in the present embodiment, the ten plate pieces 82 are configured to be able to appear and disappear collectively, but are not limited thereto, and may be configured to be able to appear and appear independently, for example. In this case, each plate piece 82 can be made to appear and disappear according to the shape of the vagina wall 1403.

<Eleventh embodiment>
FIG. 42 is a longitudinal sectional view showing an operation process of the eleventh embodiment of the vaginal insertion tool (biological insertion tool) of the present invention.

  Hereinafter, the eleventh embodiment of the living body insertion tool and suction method of the present invention will be described with reference to these drawings, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted. To do.

  The present embodiment is the same as the tenth embodiment except that the configuration of the operation unit of the vaginal insertion tool is different.

  As shown in FIG. 42, in this embodiment, the vaginal insertion tool 5A includes a coil spring 87 as a biasing member that biases the operation portion 83 toward the distal direction. The coil spring 87 is disposed between the operation piece 832 of the operation unit 83 and the projecting piece 853 provided at the base end portion of the support unit 85.

  When each plate piece 82 is in the first state, the operation piece 832 is engaged with the concave portion 852 of the support portion 85 (see FIG. 42A). As a result, the operating portion 83 is prevented from being erroneously moved in the distal direction by the urging force of the coil spring 87.

  If the engagement of the operation piece 832 with respect to the recess 852 is released from this state, the operation portion 83 can be moved in the distal direction by the urging force of the coil spring 87. Thereby, each board piece 82 will be in a 2nd state.

  As described above, the coil spring 87 assists the operation of the operation unit 83, and the operation can be easily performed.

  As mentioned above, although the biological insertion tool and suction method of this invention were demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a biological insertion tool can exhibit the same function. Any configuration can be substituted. Moreover, arbitrary components may be added. In addition, the steps constituting the suction method can be replaced with those having any constitution that can exhibit the same function. Moreover, arbitrary processes may be added.

  In addition, the living body insertion tool and suction method of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  In the above-described embodiment, the configuration in which the main body is separable into the distal end split piece and the proximal end split piece has been described. The structure which cannot be used may be sufficient. That is, the main body may have a single tube shape. In this case, the state maintaining unit is also omitted.

  In the above-described embodiment, the sheath is configured as a part of the puncture member, but is not limited thereto. That is, a sheath may be inserted into a through-hole formed in a living body using some means first. Specifically, in correspondence with the first embodiment described above, a puncture device 1 is prepared in which the puncture member 3 is omitted, and the insertion portion 71 is used as a puncture member, and the distal end portion 711 is punctured into the right hip of the patient. Then, after passing through one obturator hole, between the urethra and the vagina, and the other obturator hole in order, it is projected from the left buttocks. Next, the insertion portion 71 is inserted into the interior, the sheath 30 (main body 31) is advanced into the body along the insertion portion 71, and both ends protrude from the body surface H. Next, the insertion portion 71 is removed from the body. Thereby, the sheath 30 is arrange | positioned in the biological body. And if the implant main body 91 is arrange | positioned in the sheath 30 and the sheath 30 is extracted from a body, the implant main body 91 can be detained in the living body like embodiment mentioned above.

  In addition, for example, the distal end portion 711 of the insertion portion 71 is punctured into the right hip of the patient, passes through one obturator hole, between the urethra and the vagina, and the other obturator hole in order, and then from the left hip to the outside of the body. Then, the distal end portion of the sheath 30 is fixed to the distal end portion 711. Next, the insertion portion 71 is rotated in the reverse direction to remove the insertion portion 71 from the body, and the sheath 30 is placed in the living body. And if the implant main body 91 is arrange | positioned in the sheath 30 and the sheath 30 is extracted from a body, leaving the implant main body 91, the implant main body 91 can be detained in the living body similarly to embodiment mentioned above.

  In the above-described embodiment, three first suction units and two second suction units are provided. However, each of the first suction unit and the second suction unit includes one or more. For example, the number of installations is not limited.

  Moreover, the structure of the 1st suction part with which a vaginal insertion tool is equipped, and the 2nd suction part is applicable also to a urethral insertion tool.

  Moreover, the structure of the protrusions (ribs or plate pieces) provided in the vaginal insertion tool can also be applied to the urethral insertion tool.

  In the above-described embodiment, the configuration in which the main body of the puncture member is placed in the living body and then the implant main body is inserted into the main body has been described. However, the present invention is not limited thereto, and the implant main body is the puncture member (main body) from the beginning. It may be housed inside. In this case, for example, it is preferable to fix the thread located on the needle tip side of the two threads of the implant body to the needle tip. Thereby, when the needle tip is removed from the main body, the thread can be protruded out of the main body. Therefore, subsequent fine adjustment of the arrangement of the implant body can be performed smoothly.

  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.

DESCRIPTION OF SYMBOLS 1 Puncture apparatus 10 Medical tube assembly 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 side Opening 33 Base end split piece 331 Tip side opening 332 Base end opening 34 State maintaining portion 341 Thread 342a, 342b, 342c Hole 345, 346 Exposed hole 347 Slit 347a, 347b Part 348 Hole 35 Needle body 351 Needle tip 352 Base end 353 Engagement section 4 Urethral insertion tool 40 Support section 41 Urethral insertion section 42 Balloon 431 Balloon port 432 Urine discharge port 433 Suction port 44 Suction hole 45 Marker (positioning section)
450 Inflow reduction part 46 Marker (detection part)
47 Urine discharge part 471 Urine discharge hole 48 Restriction part 481 Main body 482 Knob 49 Sliding resistance amplification part 5, 5A Vaginal insertion tool 50 Support part 51 Vaginal insertion part 52 Tip part 521a Upper surface (one surface)
521b Lower surface (the other surface)
521c Top surface 521d Inclined surface 521e Side surface 523 Tip 524 Balloon port 53 Shaft portion 54a First suction portion 541a First recess (recess)
542a First suction hole 543a Wall portion 544a Corner portion 54b Second suction portion 541b Second recess 542b Second suction hole 544b Corner portion 543 Suction port 544 Internal space 5441 First space 5442 Second space 544c Partition Portion 55a first blocking portion 551a gap 55b second blocking portion 56 rib (protrusion)
561, 562 Balloon 563, 564 Ring 57 Auxiliary part 571 Coat layer 572 Sphere 573 Recess 574 Projection 58 Lid 581 Through hole 6 Insertion tool 61 Maintenance part 611 Operation part 611a Shaft part 611b Knob 611c Claw part 612 Engagement part 612a Recess 62 Displacement part 621 Hinge part 7 Operation member 71 Insertion part 711 Tip part 72 Connection part 73 Shaft part 81 Main part 811 Tip wall part 812 Base end wall part 813 Side wall 814 Slit 815 Suction hole 816 Suction port 817 Internal space 82 Plate piece ( Protrusion)
821 Thickness increasing portion 83 Operation portion 831 Cylindrical portion 832 Operation piece 833 Connection plate 834 Recess 84 Connection portion 841 Link 85 Support portion 851 Engagement piece 852 Recess 853 Projection piece 861, 862 Elastic film 87 Coil spring 74 Handle 9 Implant 90 Packaging material 91 Implant body 92 Band 1100 Pelvis 1101, 1102 Closure hole 1200 Pubic joint 1300 Urethra 1310 Bladder 1320 Urethra mouth 1400 Vagina 1401 Central part 1402 Recessed part 1403 Vaginal wall 1410 Vagina mouth A1 Inner periphery A2 Outer part A3 Surface A4 Back face D Distance H Body surface I ₁ First suction direction I ₂ Second suction direction J1, J2 Axis J31 Short axis J32 Long axis J32 ′ Extension line J5 Center axis L1 Length O Center P Intersection S1, S2 Region S4 Center S5 Safety zone T1 Thickness T2 Projection amount U1 Thickness W Width direction W Maximum width X puncture route f1, f2, f9 plane r1 minimum curvature radius r2 maximum curvature radius θ1, θ2, θ3 inclination angle θ4 central angle θ5 angle

Claims (8)

A biological insertion tool used in an inserted state inserted into a biological lumen,
A suction section for sucking the living tissue in the inserted state;
A living body insertion tool comprising: a protrusion provided to protrude so as to surround at least a part of the suction part.   The living body insertion tool according to claim 1, wherein the protrusion is arranged so as to surround the entire circumference of the suction part. The living body insertion tool has a long overall shape,
The protrusions are arranged at the front and rear in the insertion direction in which the living body insertion tool is inserted into the living body lumen with respect to the suction section, and ribs formed along the circumferential direction of the living body insertion tool. The living body insertion tool according to claim 1 or 2.   The living body insertion tool according to claim 3, wherein each of the ribs is expandable and contractible in a direction orthogonal to the insertion direction.   The living body insertion tool according to claim 1, wherein at least a part of the protrusion is supported so as to be able to approach and separate from the living tissue in the inserted state.   The living body insertion tool according to claim 5, further comprising an operation section that performs an operation of moving the protrusion closer to and away from the living tissue.   The living body insertion tool according to any one of claims 1 to 6, further comprising an auxiliary unit that assists the insertion operation when the living body insertion tool is inserted into the living body lumen. A suction method for suctioning a living tissue in a living body lumen,
A living body insertion tool having a protrusion is inserted into the living body lumen, and a part of the closed space is defined in the living body lumen by at least a part of the protrusion and the portion where the living tissue is sucked. In this state, the suction is performed by sucking the inside of the closed space.

Images