JP2015061557A - Puncture device and puncture method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a puncture device and a puncture method which reduce a burden on a patient, exhibit high safety of the patient, and are capable of easily embedding an indwelling object for supporting a biological tissue into a living body.SOLUTION: A puncture device 1 comprises curved puncture needles 71 and 81 and a supporting part 26 for turnably supporting the puncture needles 71 and 81 so that the base ends of the puncture needles 71 and 81 do not interfere with each other. Then, the puncture needles 71 and 81 are turned together to the distal end side to cause the distal end parts of the puncture needles 71 and 81 to engage with each other. The supporting part 26 comprises guide holes 261 and 262 for guiding turning of the puncture needles 71 and 81.

Description

  The present invention relates to a puncture device and a puncture method.

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

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

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

JP 2010-99499 A

  An object of the present invention is to provide a puncture device and a puncture method that can reduce the burden on a patient, have high patient safety, and can easily embed a living tissue supporting indwelling object in a living body.

Such an object is achieved by the present inventions (1) to (11) below.
(1) a curved first puncture needle;
A curved second puncture needle;
And a support portion that rotatably supports the first puncture needle and the second puncture needle so that the proximal end portion of the first puncture needle and the proximal end portion of the second puncture needle do not interfere with each other. A puncture device characterized by that.

  (2) By rotating both the first puncture needle and the second puncture needle toward the distal end side, the distal end portion of the first puncture needle and the distal end portion of the second puncture needle are engaged with each other (1 ) The puncture device according to the above.

  (3) The puncture device according to (1) or (2), wherein the support portion includes a guide portion that guides rotation of the first puncture needle and the second puncture needle.

  (4) The puncture device according to any one of (1) to (3), wherein the support portion includes a contact portion that contacts a living tissue.

  (5) The puncture device according to any one of (1) to (4), wherein a rotation axis of the first puncture needle and a rotation axis of the second puncture needle substantially coincide with each other.

  (6) The puncture device according to any one of (1) to (5), wherein the distal end of the first puncture needle and the distal end of the second puncture needle move in substantially the same plane.

(7) In the initial state before puncturing,
The puncture device according to any one of (1) to (6), wherein the proximal end portion of the first puncture needle and the proximal end portion of the second puncture needle are arranged so as not to interfere with each other.

  (8) One of the first puncture needle and the second puncture needle is tubular, and the other is inserted inside the one of the above (1) to (6) Puncture device.

  (9) The puncture apparatus according to any one of (1) to (8), further including a rotation operation unit that rotates the first puncture needle and the second puncture needle.

(10) a longitudinal urethral insertion portion that is inserted into the urethra;
When the first puncture needle and the second puncture needle are rotated to the distal end side, at least one tip of the first puncture needle and the second puncture needle is located above the urethra insertion portion and the first puncture needle and the The above-mentioned (1) having a first puncture needle and a regulating portion that regulates the positional relationship between the second puncture needle and the urethral insertion portion so as to pass the distal side from the rotation center of the second puncture needle. The puncture device according to any one of (9) to (9).

(11) By operating the rotation operation unit, the first puncture needle is rotated by the guide unit to puncture from the first part of the living body, and the second puncture needle is oriented in a direction different from the first puncture needle. Puncture from a second part different from the first part of the living body by rotating by the guide part,
A puncture method comprising engaging a distal end portion of the first puncture needle and a distal end portion of the second puncture needle in the living body.

  According to the present invention, since the penetration hole can be formed in the living body using the first puncture needle and the second puncture needle, the lengths of the first puncture needle and the second puncture needle can be shortened. It is possible to suppress deformation (bending, twisting, etc.) during puncturing of the first puncture needle and the second puncture needle. Therefore, accurate puncture of the puncture needle can be performed. Furthermore, the burden on the patient is small, the safety of the patient is high, and the living tissue supporting indwelling object can be easily embedded in the living body.

It is a perspective view which shows an example of an implant. It is a perspective view which shows the puncture apparatus which concerns on 1st Embodiment of this invention. It is a side view of the puncture device shown in FIG. It is a top view which shows the puncture member which the puncture apparatus shown in FIG. 2 has. It is a top view explaining the connection method of the two division pieces covered on the puncture member shown in FIG. It is the BB sectional view taken on the line in Fig.5 (a). It is a figure which shows the sheath which the puncture apparatus shown in FIG. 2 has, (a) is a perspective view, (b) is the sectional view on the AA line in (a). It is a top view which shows the fixing | fixed part of the flame | frame with which the puncture apparatus shown in FIG. 2 is provided. It is sectional drawing which shows the rotation operation part provided in the flame | frame with which the puncture apparatus shown in FIG. 2 is provided. It is a side view of the insertion tool which the puncture apparatus shown in FIG. 2 has. It is a figure which shows the positional relationship of a puncture member and a closing hole (pelvis), (a) is a side view, (b) is a front view. It is the elements on larger scale of the vaginal insertion tool which the insertion tool shown in FIG. 10 has. (A) is sectional drawing which shows an example of the shape of a vagina wall, (b) is sectional drawing which shows the state which inserted the vagina insertion part in the vagina shown to (a). (A) And (b) is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. 2, respectively. (A) And (b) is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. 2, respectively. FIG. 16 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. (A) And (b) is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. 2, respectively. It is a side view which shows the relationship between the puncture apparatus in the state shown to Fig.17 (a), and a pelvis. It is sectional drawing which shows the attitude | position of the sheath with respect to the urethra at the time of the state shown in FIG.17 (b). (A) And (b) is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. 2, respectively. It is sectional drawing which shows the 1st, 2nd puncture needle which the puncture apparatus which concerns on 2nd Embodiment of this invention has, and has shown the state which the 1st, 2nd puncture needle engaged. It is a perspective view which shows the puncture apparatus which concerns on 3rd Embodiment of this invention. It is sectional drawing which shows the 1st, 2nd puncture needle which the puncture apparatus shown in FIG. 22 has, and has shown the state which the 1st, 2nd puncture needle engaged. (A) And (b) is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. 22, respectively. It is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. It is a perspective view which shows the puncture apparatus which concerns on 4th Embodiment of this invention. (A) is a perspective view which shows the front-end | tip part of a 1st puncture needle, (b) is a perspective view which shows the front-end | tip part of a 2nd puncture needle. (A) And (b) is sectional drawing for demonstrating delivery of the implant from a 1st puncture needle to a 2nd puncture needle, respectively. (A) And (b) is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. 26, respectively. (A) is sectional drawing which shows the 1st, 2nd puncture needle which the puncture apparatus which concerns on 5th Embodiment of this invention has, (b) and (c) are respectively from a 1st puncture needle to a 2nd puncture needle. It is sectional drawing for demonstrating delivery of the implant of this. It is a perspective view which shows the puncture apparatus which concerns on 6th Embodiment of this invention. It is a perspective view which shows the puncture member which the puncture apparatus shown in FIG. 31 has. It is a top view of the puncture member shown in FIG. It is a top view explaining rotation of the puncture member shown in FIG. 32, (a) has shown the initial state, (b) has shown the puncture state. It is a top view which shows the puncture member which the puncture apparatus which concerns on 7th Embodiment of this invention has. It is a perspective view which shows the puncture member which the puncture apparatus which concerns on 8th Embodiment of this invention has. It is sectional drawing which shows the rotation operation part which the puncture apparatus which concerns on 8th Embodiment of this invention has. It is a top view which shows the puncture member which the puncture apparatus which concerns on 9th Embodiment of this invention has, (a) has shown the initial state, (b) has shown the puncture state. It is a top view of the puncture member shown in FIG. It is a top view which shows the puncture member which the puncture apparatus which concerns on 10th Embodiment of this invention has, (a) has shown the initial state, (b) has shown the puncture state. (A) And (b) is a top view which shows the modification of the puncture member shown in FIG. 40, respectively. It is a top view which shows the puncture member which the puncture apparatus which concerns on 11th Embodiment of this invention has, (a) shows an initial state, (b) has shown the puncture state. It is a top view which shows the puncture member which the puncture apparatus which concerns on 12th Embodiment of this invention has. (A) And (b) is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. 43, respectively. It is a figure which shows the initial state of the puncture apparatus which concerns on 13th Embodiment of this invention, (a) is a front view, (b) is a top view, (c) is a bottom view. (A) And (b) is a figure for demonstrating the operation procedure of the puncture apparatus shown in FIG. 45, respectively. It is a perspective view which shows the puncture apparatus which concerns on 14th Embodiment of this invention. It is a top view which shows the structure of the rotation operation part which the puncture apparatus shown in FIG. 47 has. It is a figure which shows the initial state of the puncture apparatus which concerns on 15th Embodiment of this invention, (a) is sectional drawing seen from the front side, (b) is a rear view. It is a perspective view which shows the puncture apparatus which concerns on 16th Embodiment of this invention. It is a figure which shows the structure of the rotation operation part which the puncture apparatus shown in FIG. 50 has, (a) is a top view, (b) is a front view. It is a figure which shows the initial state of the puncture apparatus which concerns on 17th Embodiment of this invention, (a) is sectional drawing seen from the front side, (b) is a rear view.

  Hereinafter, the puncture apparatus and puncture 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 the puncture device according to the 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 a puncture member included in the puncture apparatus shown in FIG. FIG. 5 is a plan view for explaining a method of connecting two divided pieces placed on the puncture member shown in FIG. FIG. 6 is a cross-sectional view taken along line BB in FIG. 7 is a view showing a sheath of the puncture device shown in FIG. 2, in which (a) is a perspective view and (b) is a cross-sectional view taken along line AA in (a). FIG. 8 is a plan view showing a frame fixing portion provided in the puncture device shown in FIG. 2. FIG. 9 is a cross-sectional view showing a rotation operation unit provided in a frame included in the puncture device shown in FIG. FIG. 10 is a side view of an insertion tool included in the puncture device shown in FIG. FIG. 11 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. 12 is a partially enlarged view of the vaginal insertion tool of the insertion tool shown in FIG. 13A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 13B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. 14 (a) and 14 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIGS. 15A and 15B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 16 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIGS. 17A and 17B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 18 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 19 is a cross-sectional view showing the posture of the sheath relative to the urethra in the state shown in FIG. 20 (a) and 20 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.

  In the following, for convenience of explanation, the left side in FIG. 3 is also referred to as “tip”, the right side is also referred to as “base end”, the upper side is also referred to as “upper”, and the lower side is also referred to as “lower”. 2 to 4 show states that have not yet been used, and 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”.

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

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

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

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

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

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

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

  As shown in FIG. 2, the puncture device 1 includes a frame (restricting portion) 2, an insertion tool 6, two puncture members 7 and 8, and a sheath (medical tube) 3. The insertion tool 6 and the puncture members 7 and 8 are supported, and the sheath 3 is supported by the puncture members 7 and 8. 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. Puncture member The puncture members 7 and 8 are members for puncturing a living body. These puncture members 7 and 8 are provided substantially symmetrically with respect to the center of the frame 2.

  As shown in FIGS. 2 to 5, the puncture member (first puncture member) 7 includes a puncture needle (first puncture needle) 71, a shaft portion (first shaft portion) 73, a puncture needle 71 and a shaft portion 73. And a connecting portion 72 for connecting the two. The puncture needle 71 is a part that punctures a living body, is solid, is curved in a substantially arc shape, and has a blade surface 711 at its tip (needle tip). The shaft 73 intersects the center of the puncture needle 71 and extends on an axis J1 orthogonal to the plane f1 including the extension axis of the puncture needle 71. Further, the connecting portion 72 connects the proximal end portion of the puncture needle 71 and the distal end portion of the shaft portion 73, and has a substantially L shape that is bent at a substantially right angle in the middle. In addition, these puncture needle 71, the connection part 72, and the axial part 73 may be formed integrally, and at least 1 site | part may be formed separately with respect to the other site | part.

  Similarly, the puncture member (second puncture member) 8 includes a puncture needle (second puncture needle) 81, a shaft portion 83, and a connecting portion 82 that connects the puncture needle 81 and the shaft portion (second shaft portion) 83. And have. The puncture needle 81 is a part that punctures a living body, is solid, is curved in a substantially arc shape, and has a blade surface 811 at the tip thereof. The puncture needle 81 has a radius of curvature and a central angle substantially equal to those of the puncture needle 71. Further, the extending axis of the puncture needle 81 is located in the same plane f1 as the puncture needle 71. Further, the shaft portion 83 intersects with the center of the puncture needle 81 and extends on an axis J2 orthogonal to the plane f1. The connecting portion 82 connects the proximal end portion of the puncture needle 81 and the distal end portion of the shaft portion 83, and has a substantially L shape that is bent at a substantially right angle. The puncture needle 81, the connecting portion 82, and the shaft portion 83 may be integrally formed, or at least one portion may be formed separately from other portions.

  As shown in FIG. 2 and FIG. 4, the puncture needles 71 and 81 are arranged so that their proximal ends are butted at the center, and their distal ends are facing the opposite side. Therefore, the puncture needle 71 is punctured into the living body by rotating clockwise from the initial state in FIG. 4 (first direction), and the puncture needle 81 is counterclockwise in FIG. 4 from the initial state (second direction). It is punctured into the living body by rotating in the direction. And finally, the front-end | tip parts of the puncture needles 71 and 81 contact | abut, and the blade surfaces 711 and 811 face and overlap. On the other hand, the puncture needle 71 is removed from the living body by rotating counterclockwise in FIG. 4 from the puncture state, and the puncture needle 81 is removed from the living body by rotating clockwise in FIG. 4 from the puncture state. Is done. In particular, since the puncture needles 71 and 81 are both curved in an arc shape, puncture and removal from the living body as described above can be performed more smoothly.

  In addition, the axes J1 and J2 are provided substantially parallel to each other and close to each other. Thereby, the front-end | tip of the puncture members 7 and 8 can be moved along the circumference of substantially the same circle. Therefore, the puncture needles 71 and 81 can be punctured more smoothly, and the puncture route of the puncture needles 71 and 81 can be shortened. Further, since both puncture needles 71 and 81 move in the plane f1, the puncture needles 71 and 81 can be punctured more smoothly from this point, and the blade surfaces 711 and 811 can be easily overlapped. Become.

  The separation distance between the axes J1 and J2 is preferably shorter as long as the rotation of the puncture members 7 and 8 is not hindered. Specifically, the distance is preferably about 10 mm or less, for example, about 5 mm or less. Is more preferable.

  Further, the central angle θ6 of the puncture needles 71 and 81 is not particularly limited and is appropriately set according to various conditions. The tip of the puncture needle 71 enters the body from one of the patient's buttocks. Can pass through one obturator and reach between the urethra and vagina, and the tip of the puncture needle 81 enters the body from the other buttocks of the patient and passes through the other obturator and between the urethra and vagina Set to be reachable. Specifically, the central angle θ6 of the puncture needles 71 and 81 is preferably, for example, about 80 ° to 180 °, and more preferably about 100 ° to 160 °. Thereby, while being able to exhibit said effect, it can prevent that the puncture needles 71 and 81 become excessively long.

  As will be described later, the puncture needle 71 is covered with the divided piece 31, and the puncture needle 81 is covered with the divided piece 32. Therefore, the shape of the puncture needles 71 and 81 is designed according to the shape of the internal space of the divided pieces 31 and 32. More specifically, the puncture needles 71 and 81 are designed such that the cross-sectional shape thereof is substantially equal to or slightly smaller than the cross-sectional shape of the internal space of the segment pieces 31 and 32. Thereby, the puncture needles 71 and 81 function as a stylet that reinforces the divided pieces 31 and 32, and the deformation of the divided pieces 31 and 32 can be suppressed. However, the shape of the puncture needles 71 and 81 may not be designed according to the internal space of the divided pieces 31 and 32 as long as it can be inserted into the divided pieces 31 and 32. It may have a cross-sectional shape such as.

  The constituent material of the puncture members 7 and 8 having such a configuration 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.

2-2. Sheath The sheath 3 is a member that has a tube shape and is used to place the implant 9 in the living body using the internal space.

  In the initial state shown in FIG. 4, the sheath 3 is divided into two tubular segment pieces 31 and 32 that can be connected. The divided piece (first medical tube) 31 is detachably covered with the puncture needle 71, and the divided piece (second medical tube) 32 is detachably covered with the puncture needle 81. Further, the tip of the split piece 32 is configured to be narrower than the tip of the split piece 31, and the split pieces 31 and 32 are connected by inserting the tip of the split piece 32 into the tip of the split piece 31. Can be done.

  In the initial state shown in FIG. 4, the distal end portion of the puncture needle 71 protrudes from the distal end opening of the segment piece 31 and the proximal end of the segment piece 31 is in contact with the connecting portion 72. Thereby, the division | segmentation piece 31 does not shift | deviate to the extension direction of the puncture needle 71 at the time of puncture, without inhibiting the puncture to the biological body of the puncture needle 71. FIG. Similarly, the distal end portion of the puncture needle 81 is exposed from the distal end opening of the divided piece 32, and the proximal end of the divided piece 32 is in contact with the connecting portion 82. Thereby, the divided piece 32 does not disturb the puncture of the puncture needle 81 into the living body, and does not shift in the extending direction of the puncture needle 81 during puncture. Therefore, the puncture needles 71 and 81 can be punctured into the living body and the divided pieces 31 and 32 can be smoothly introduced into the living body.

  As shown in FIG. 5A, the puncture needles 71 and 81 are punctured into the living body, and the divided pieces 31 and 32 are connected only by overlapping the blade surfaces 711 and 811 facing each other in the living body. Then, as shown in FIG. 5 (b), the split pieces 31, 32 (at least the split piece 31) are pushed into the tip side (the other side) to connect the split pieces 31, 32. can do. According to such a method, the divided pieces 31 and 32 can be easily connected. Further, the surgeon can determine whether or not the divided pieces 31 and 32 are connected with a sense obtained from the hand.

  In the present embodiment, blade surfaces 711 and 811 that are substantially flat surfaces are provided at the distal ends of the puncture needles 71 and 81, and these blade surfaces 711 and 811 are configured to face each other and overlap each other. Unnecessary gaps or steps are hardly formed at the boundary between the puncture needles 71 and 81. Therefore, the connection of the division pieces 31 and 32 as described above can be performed smoothly.

  As shown in the figure, in a state where the split pieces 31 and 32 are connected, the base end portions of the split pieces 31 and 32 are respectively exposed to the outside of the body. Thereby, the insertion of the implant 9 into the sheath 3 can be easily performed as described in the explanation of the procedure described later. In particular, as shown in FIG. 6, since the cross-sectional shape of the split piece 32 and the cross-sectional shape of the puncture needle 71 are substantially equal, it is difficult for the split piece 32 and the puncture needle 71 to be caught. The connection of the pieces 31 and 32 can be performed smoothly.

  The central angle θ4 (see FIG. 5B) of the sheath 3 in a state where the split pieces 31 and 32 are connected is not particularly limited and is appropriately set according to various conditions. It is set so that it can pass through and protrude outside the body from both 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 °.

  In the present embodiment, the divided pieces 31 and 32 have substantially the same length, and in a state where the divided pieces 31 and 32 are connected, the boundary portion (the central portion of the sheath 3) is located between the urethra and the vagina. It will be.

  Here, as described above, in this embodiment, the shape of the puncture needle 71 is designed according to the shape of the internal space of the divided piece 31, and the shape of the puncture needle 81 is matched to the shape of the internal space of the divided piece 32. Designed. Therefore, rotation of the split pieces 31 and 32 with respect to the puncture needles 71 and 81 can be prevented, and the split pieces 31 and 32 can be placed in the living body in a predetermined posture. Further, since the puncture needle 71 closes the distal end side opening of the divided piece 31, it is possible to suppress the invasion of living tissue from the distal end side opening of the divided piece 31 into the internal space when the puncture needle 71 is punctured. Furthermore, since the puncture needle 81 closes the distal end side opening of the divided piece 32, it is possible to suppress the invasion of living tissue from the distal end side opening of the divided piece 32 into the internal space when the puncture needle 81 is punctured. Therefore, it is possible to prevent the internal space of the sheath 3 from becoming dirty or clogged with living tissue, and the implant 9 can be placed smoothly.

  Each of the divided pieces 31 and 32 as described above preferably has a light transmission property so that the inside can be visually recognized from the outside. Thereby, the state (for example, the presence or absence of damage) of the puncture needles 71 and 81 inserted therein can be confirmed, and the safety of the puncture apparatus 1 is further improved.

Next, the shape of the sheath 3 in a state where the split pieces 31 and 32 are connected will be described in detail.
As shown in FIG. 7A, the sheath 3 has a curved shape that is curved in an arc shape. As shown in FIG. 7B, the sheath 3 has a flat cross-sectional shape having a short axis J31 and a long axis J32. By making the sheath 3 into a flat shape, the implant body 91 can be controlled in a desired posture within the sheath 3.

  The flat shape of the sheath 3 is not particularly limited. For example, an elliptical shape, a cross-sectional convex lens shape, 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 sheath 3 (the length in the direction of the long axis J32) is designed to be substantially the same as the width of the implant body 91. Thereby, the frictional resistance between the implant 9 and the sheath 3 is lowered, and unnecessary force is not applied to the implant 9, and the implant body 91 can be disposed in the sheath 3 in a sufficiently deployed state. However, the width of the internal space of the sheath 3 may be shorter than the width of the implant body 91. In this case, since the width of the sheath 3 can be suppressed, the invasiveness is further reduced.

  In the following, for convenience of explanation, as shown in FIG. 7B, the end portion of the sheath 3 located on the inner side in the long axis J32 direction is also referred to as “inner peripheral portion A1”, The positioned end 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. 7B, a surface including both the center point of the arc of the central portion S4 of the sheath 3 and the center point of the cross-sectional shape with respect to the longitudinal direction of the sheath 3 (surface including the center axis of the sheath 3). When the plane f9 is the plane and the angle between the plane f9 and the short axis J31 at the central portion S4 is the tilt angle θ1, the tilt angle θ1 is preferably an acute angle. By setting the inclination angle θ1 to an acute angle, the implant body 91 can be disposed substantially parallel to the urethra, as will be described later. Therefore, the urethra can be supported more effectively.

  The inclination angle θ1 is not particularly limited as long as it is an acute angle, but for example, it is preferably about 20 ° to 60 °, more preferably 30 ° to 45 °, and about 35 ° to 40 °. Is more preferable. Thereby, the above-mentioned effect improves further. The inclination angle θ1 preferably satisfies the above numerical range over the entire extending direction of the sheath 3, but it is only necessary to satisfy the above numerical range at least at the central portion S4. Here, the “central portion S4” refers to a region including at least a portion located between the urethra and the vagina in a state where the sheath 3 is disposed in the living body.

  The configuration of the sheath 3 can be paraphrased as follows. That is, as shown in FIG. 7B, the sheath 3 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.

  Moreover, the structure of the sheath 3 can also be paraphrased as follows. As shown in FIG. 7 (b), the sheath 3 has an inner peripheral portion A1 having a minimum radius of curvature r1 located on the inner peripheral edge and a peripheral edge in the plan view when viewed from the central axis J5 direction of the sheath 3. It can be said that the outer peripheral portion A2 is located and has the maximum radius of curvature r2, and the inner peripheral portion A1 and the outer peripheral portion A2 are configured to be shifted in the direction of the central axis J5.

  As the constituent material of the sheath 3 as described above, a hard material that maintains the shape and the internal space when inserted into the body is preferable. 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 sheath 3, 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 sheath 3, it becomes possible to provide flexibility while maintaining the internal space to the extent that the insert can slide.

  Moreover, the marker may be provided in the both ends of the sheath 3 in the part which is the same position from the center part S4, and protrudes out of the living body in the state where the sheath 3 is arranged in the living body. Thereby, the position in the living body of center part S4 can be confirmed by comparing the position of both markers.

2-3. Frame The frame 2 includes a frame main body (supporting portion) 20 and a rotation operation unit 25 built in the frame main body 20.

  The frame main body 20 rotatably holds the puncture members 7 and 8 to which the divided pieces 31 and 32 are attached, and fixes the insertion tool 6 in a detachable manner.

  The frame body 20 has a function of determining a puncture route of the puncture needles 71 and 81 when the puncture members 7 and 8 puncture a living tissue. Specifically, the frame body 20 includes the puncture members 7 and 8 and the urethra so that the puncture needles 71 and 81 are brought into contact with the urethra insertion tool 4 and the vaginal insertion tool 5 without colliding with each other. The positional relationship between the insertion tool 4 and the vaginal insertion tool 5 is determined. That is, in the frame body 20, when the puncture needles 71, 81 are rotated to the distal end side, at least one tip of the puncture needles 71, 81 (extension line in the puncture direction of the puncture needles 71, 81) is from the urethra insertion device 4. In addition, the positional relationship between the puncture members 7 and 8 and the urethral insertion device 4 is regulated so that the distal ends of the puncture needles 71 and 81 are engaged with each other through the distal side from the axes J1 and J2.

  As shown in FIGS. 2 and 3, the frame body 20 includes a bearing portion 21 for bearing the shaft portions 73 and 83 of the puncture members 7 and 8, a guide portion 22 for guiding the puncture members 7 and 8, and a bearing portion 21. And a guide part 22 and a fixing part 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 axes J1 and J2. A through hole is formed on the shaft J1 of the bearing portion 21, and the shaft portion 73 is rotatably inserted into the through hole. A through hole is also formed on the shaft J2 of the bearing portion 21, and the shaft portion 83 is rotatably inserted into the through hole. Thereby, the puncture members 7 and 8 are supported by the frame main body 20 in a state of being rotatable around the axes J1 and J2.

  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. The guide part 22 is located inside the puncture members 7 and 8, has an arc shape extending along the puncture members 7 and 8, and is configured to support the puncture members 7 and 8 from the inside. Each of the split pieces 31 and 32 is disposed on 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. The connecting portion 23 has a rod shape extending substantially parallel to the axes J1 and J2. 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 axes J1 and J2. As shown in FIG. 8, the fixing portion 24 includes a concave portion 243 into which a later-described support portion 40 or 50 included in the insertion tool 6 is 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.

  The frame main body 20 as described above incorporates a rotation operation unit 25. The rotation operation unit 25 is a mechanism for interlocking the puncture needles 71 and 81 and simultaneously rotating them in the opposite direction (different directions) with the same rotation angle. By providing such a rotation operation unit 25, the puncture needles 71 and 81 can be interlocked to puncture the living body at the same time, so that the puncture apparatus 1 can be easily operated and a procedure is required. Time can be shortened. In addition, since the movement of the puncture needles 71 and 81 can be controlled to be constant, the puncture apparatus 1 can be used correctly and safely.

  The configuration of the rotation operation unit 25 is not particularly limited as long as the above function can be exhibited. However, as shown in FIG. 9, the rotation operation unit 25 of the present embodiment is arranged on the rear side of the bearing unit 21. The handle 251 is provided, and the shaft portion 73 of the puncture member 7 is fixed to the handle 251. The rotation operation unit 25 includes a conversion unit 252 built in the bearing unit 21, and the conversion unit 252 allows the rotation of the handle 251 to rotate the puncture needle 71 and the rotation of the puncture needle 81. Converted to dynamic. The conversion part 252 has two gears 252a and 252b, the gear 252a is fixed to the shaft part 73, and the gear 252b is fixed to the shaft part 83 in a state of meshing with the gear 252a. The gear ratio of the gears 252a and 252b is approximately 1: 1, and the rotation angles of the gears 252a and 252b are equal. Thus, the rotation operation part 25 becomes a simple structure by setting it as the structure using a gearwheel.

  When the handle 251 is rotated clockwise, the puncture needle 71 rotates clockwise, and the puncture needle 81 rotates counterclockwise by the same angle as the puncture needle 71. On the contrary, the handle 251 is rotated counterclockwise. When turned, the puncture needle 71 rotates counterclockwise, and the puncture needle 81 rotates clockwise by the same angle as the puncture needle 71. As described above, according to the rotation operation unit 25, the puncture needles 71 and 81 can be punctured simultaneously by simply turning the handle 251. Therefore, the puncture apparatus 1 can be used easily. In particular, since the puncture needles 71 and 81 rotate at the same rotation angle, the movement of the puncture needles 71 and 81 can be easily predicted, and the puncture apparatus 1 can be used more safely. In addition, since the puncture needles 71 and 81 rotate at the same rotation angle, the lengths of the puncture needles 71 and 81 can be made relatively short, and a decrease in rigidity of the puncture needles 71 and 81 can be suppressed.

  In this embodiment, the handle 251 is provided to manually operate the puncture members 7 and 8, but the handle 251 may be omitted when the handle 251 is operated using a drive source such as a motor. it can. In this case, for example, a button (forward rotation button, reverse rotation button, or the like) for controlling the driving of the motor may be disposed on the connecting portion 23.

2-4. Insertion Tool As shown in FIG. 10, the insertion tool 6 includes a urethral insertion tool 4 and a vaginal insertion tool 5.

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

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

  The urethral insertion portion 41 has a straight tubular shape. The distal end portion of the urethra insertion portion 41 is provided with a balloon 42 which is an expandable and expandable / contractable expandable body, and a urine discharge portion 47.

  The balloon 42 is disposed so as to be positioned in the bladder when the urethral insertion portion 41 is inserted into the urethra. 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. 10, 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 with the urethral insertion unit 41 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 marker 46 for confirming the insertion depth of the urethra insertion part 41 into the urethra is provided in the middle of the urethra insertion part 41. The marker 46 is located at the urethral opening when the urethra insertion part 41 is inserted into the urethra and the balloon 42 is located in the bladder. Thereby, the insertion depth to the urethra of the urethra insertion part 41 can be confirmed easily. Note that the marker 46 only needs to be visible from the outside, and can be configured by, for example, a colored portion, an uneven portion, or the like. Further, instead of the marker 46, a scale on which the distance from the tip of the urethral insertion portion 41 is written may be provided.

  A plurality of suction holes 44 are formed in the middle of the urethral insertion portion 41 (at the tip side from the marker 46). 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, the urethral wall can be adsorbed and fixed to the suction hole 44. In particular, as in the present embodiment, by providing the 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.

  When the urethral wall is adsorbed and fixed to the urethra insertion part 41, the urethra insertion part 41 is pushed into the body (the distal side of the urethra insertion part 41), and the urethra and the bladder are pushed into the body along with this, and the bladder is punctured. It can be shifted to a position that does not overlap the puncture path of the needles 71 and 81. Therefore, a larger puncture path for the puncture needles 71 and 81 can be secured, and the puncture needles 71 and 81 can be punctured accurately and safely.

  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.

  Next, the inclination between the urethral insertion portion 41 and the puncture needles 71 and 81 will be described. As shown in FIG. 3, the rotation axes J1 and J2 of the piercing members 71 and 81 are arranged so that the separation distance from the axis J3 of the urethral insertion portion 41 increases toward the distal end side. Inclined with respect to the axis. The angle formed by the axes J1, J2 and J3, in other words, the inclination angle θ2 of the plane f9 (plane f1) with respect to the plane f2 orthogonal to the axis J3 of the urethral insertion portion 41 is not particularly limited, but is about 20 ° to 60 °. Preferably, it is about 30 ° to 45 °, more preferably about 35 ° to 40 °. Thereby, the puncture needles 71 and 81 can be easily punctured, and the puncture distance by the puncture needles 71 and 81 can be further shortened.

  Specifically, by setting the inclination angle θ2 within the above range, as shown in FIG. 11A, the puncture needle 71 can widely grasp one closing hole 1101 of the pelvis 1100 in a plane, A wide puncture space for the puncture needle 71 can be secured. Similarly, the puncture needle 81 can grasp the other closing hole 1102 of the pelvis 1100 widely in a plane, and a puncture space for the puncture needle 81 can be secured widely. That is, the puncture needles 71 and 81 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 needles 71 and 81 can be punctured easily.

  Since the puncture needles 71 and 81 pass through a shallow portion of the tissue by puncturing the puncture needles 71 and 81 in a relatively vertical direction with respect to the closure holes 1101 and 1102, the distal ends of the puncture needles 71 and 81 are closed. 1102 is passed at a shorter distance. Therefore, as shown in FIG. 11B, the puncture needles 71 and 81 can be moved closer to the pubic joint 1200 of the closing holes 1101 and 1102, preferably through the safety zone S5. Since the safety zone S5 is a site with few nerves and blood vessels to avoid damage, the puncture needles 71 and 81 can be safely punctured by passing through the safety zone S5. Therefore, it becomes less invasive and can reduce the burden on the patient.

  Thus, by setting the inclination angle θ2 in the above range, the patient can puncture the puncture needles 71 and 81 more appropriately. In addition, puncturing at the above-described angle makes it easy to target the tissue between the middle urethra and the vagina that indicate the middle portion in the length direction of the urethra. Here, since the position between the middle urethra and the vagina is suitable as a site for implanting the implant 9 and treating urinary incontinence, targeting the tissue between the middle urethra and the vagina is more effective. Can be treated.

  When the inclination angle θ2 is less than the above lower limit value or exceeds the above upper limit value, the puncture needles 71 and 81 may widen the closure holes 1101 and 1102 in a planar manner depending on individual differences of patients, posture during the procedure, and the like. In some cases, the puncture path of the puncture needles 71 and 81 cannot be shortened sufficiently.

  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. Further, the rotation axes J1 and J2 of the piercing members 71 and 81 are inclined with respect to the axis of the urethra insertion part 41 so that the separation distance from the axis J3 of the urethra insertion part 41 decreases toward the distal end side. You may do it.

-Vaginal insertion tool-
As shown in FIG. 10, the vaginal insertion tool 5 includes a long vaginal insertion portion 51 that is inserted into the vagina partway and a support portion 50 that supports the vaginal insertion portion 51. The vaginal insertion portion 51 has a distal end portion 52 located on the distal end side and a shaft portion 53 connected to the proximal end portion of the distal end portion 52, and the shaft portion 53 is supported by the support portion 50.

  Further, the support portion 50 is provided with a male screw 501, and the vaginal insert 5 is fixed to the urethral insert 4 by tightening the male screw 501 into a female screw (not shown) of the support 40. be able to.

  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.

  The distal end portion 52 has a long shape. Further, the upper surface 52 (the surface on the urethral insertion portion 41 side) 52a is inclined with respect to the urethral insertion portion 41 so that the distal end portion 52 is separated from the urethral insertion portion 41 toward the distal end. Thereby, the positional relationship between the urethral insertion portion 41 and the distal end portion 52 can be brought close to the actual positional relationship between the urethra and the vagina. Therefore, the puncture device 1 is more stably held by the patient in the wearing state, and the burden on the patient is reduced. Moreover, since a space for puncturing the puncture needles 71 and 81 can be secured between the distal end portion 52 and the urethral insertion portion 41, the puncture needles 71 and 81 can be safely punctured.

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

  The distal end portion 52 has a flat shape that is crushed in the vertical direction of the puncture device 1 (the arrangement direction of the urethra and vagina). Moreover, as shown in FIG. 12, the front-end | tip part 52 has the center part with the substantially constant width | variety, and the rounded front-end | tip part. Although it does not specifically limit as length L2 of the front-end | tip part 52, It is preferable that it is about 20-100 mm, and it is more preferable that it is about 30-60 mm. Further, the width W1 of the distal end portion 52 is not particularly limited, but is preferably about 10 to 50 mm, and more preferably about 20 to 40 mm. Further, the thickness of the tip portion 52 is not particularly limited, but is preferably about 5 to 25 mm, and more preferably about 10 to 20 mm. By having such length × width × thickness, the distal end portion 52 has a shape and size suitable for a general vagina. Therefore, the stability of the puncture device 1 in the mounted state is increased, and the burden on the patient is reduced.

  In addition, as shown in FIG. 12, a plurality of bottomed recesses 55 are formed on the upper surface 52 a of the distal end portion 52. A suction hole 59 is provided in the bottom surface of each recess 55, and each suction hole 59 passes through the distal end portion 52 and is connected to a suction port 54 provided at the base end portion. The suction port 54 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 54. When the suction device is operated with the tip 52 inserted into the vagina, the front wall of the vagina is adsorbed and fixed to the tip 52. When the vaginal insertion part 51 is pushed into the body (the distal end side of the vaginal insertion part 51) in a state where the front wall of the vagina is adsorbed and fixed to the tip part 52, the vagina can be pushed together with this. Therefore, the arrangement and shape of the vagina can be adjusted, and the puncture route of the puncture needles 71 and 81 can be sufficiently secured. As a result, the puncture needles 71 and 81 can be punctured accurately and safely.

  The number of recesses 55 is not particularly limited and may be one.

  As shown in FIG. 10, the region S2 where the recess 55 is formed is opposed to the region S1 where the suction hole 44 is formed. And the puncture apparatus 1 is comprised so that the front-end | tip of the puncture needles 71 and 81 may pass between these area | regions S1 and S2. As described above, since the urethral wall is adsorbed by the urethral insertion portion 41 in the region S1 and the vagina wall is adsorbed by the distal end portion 52 in the region S2, the urethral wall and the vagina wall are more closely spaced between the regions S1 and S2. Wide and more reliably spaced. By passing the puncture needles 71 and 81 through such a region, the puncture needles 71 and 81 can be punctured more safely.

  In addition, as shown in FIG. 12, it is preferable that area | region S2 covers substantially the whole area of the width direction of the upper surface 52a. Although it does not specifically limit as width W2 of area | region S2, It is preferable that it is about 9-49 mm, and it is more preferable that it is about 19-39 mm. Accordingly, the vaginal wall can be more reliably adsorbed to the distal end portion 52 without being affected by the shape of the vaginal wall of each patient.

  In particular, depending on the patient, as shown in FIG. 13 (a), the central portion 1401 of the anterior vagina hangs down into the vagina, and the vagina 1400 has portions (parts also referred to as “button holes”) 1402 on both sides. May have. Even in such a case, as shown in FIG. 13B, not only the central portion 1401 but also the recessed portion 1402 can be more reliably adsorbed. In this way, by reliably adsorbing the recessed portion 1402 by the distal end portion 52, the recessed portion 1402 can be moved away from the urethra 1300, and the puncture needles 71 and 81 are punctured into the recessed portion 1402. It can be effectively prevented.

  The tip 52 is provided with a marker 57 that can confirm the puncture route of the puncture needles 71 and 81. Since the marker 57 is provided so that the puncture needles 71 and 81 puncture between the vagina wall and the urethral wall located above, the puncture of the puncture needles 71 and 81 is confirmed by confirming the position of the marker 57. The route can be easily confirmed, and the operability and safety of the puncture device 1 are improved. The marker 57 is preferably provided at least on the lower surface of the distal end portion 52. Since the lower surface is a surface that faces the vaginal opening side and is visible to the operator through the vaginal opening in the inserted state, by providing the marker 57 on the lower surface, the puncture path of the puncture needles 71 and 81 is more reliably performed. Can be confirmed. The marker 57 is only required to be visible from the outside, and can be constituted by, for example, a colored portion, an uneven portion, or the like.

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

  The shaft portion 53 has a thin rod shape extending substantially parallel to the urethral insertion portion 41. 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 insertion tool 6 has been described above. In the insertion tool 6 of the present embodiment, the urethral insertion tool 4 and the vaginal insertion tool 5 are configured to be detachable. However, the present invention is not limited to this, and the urethral insertion tool 4 and the vagina insertion tool 5 are not removable. It may be. Further, although the urethral insertion portion 41 is fixed to the support portion 40, the present invention is not limited to this, and the urethral insertion portion 41 may be slidable in the axial direction with respect to the support portion 40. In this case, for example, if a predetermined male screw provided in the support part 40 is loosened, the urethra insertion part 41 is slidable with respect to the support part 40, and if the screw is tightened, the urethra insertion part 41 is supported. It may be configured to be fixed to the portion 40. According to this configuration, since the length of the urethral insertion portion 41 (the length on the distal end side with respect to the support portion 40) can be adjusted, the insertion tool 6 is more user-friendly. The same applies to the vaginal insertion part 51.

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

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

  Specifically, first, the urethral insertion portion 41 of the urethral insertion tool 4 is inserted into the urethra 1300. At this time, the insertion depth is confirmed by the marker 46, and the balloon 42 is placed in the bladder 1310. The urethra 1300 is corrected to a predetermined shape (linear shape) by the urethra insertion part 41. Next, the balloon 42 is expanded, and urine is discharged from the bladder 1310 through the urine drain 471 as necessary. On the other hand, the vaginal insertion part 51 of the vaginal insertion tool 5 is inserted into the vagina 1400. And after confirming the puncture route of the puncture needles 71 and 81 using the marker 57, the support part 50 is fixed to the support part 40. FIG. Thereby, mounting | wearing of the insertion tool 6 to a patient is completed.

  Next, a suction device is connected to the suction ports 433 and 54, the suction device is operated, the urethral wall is adsorbed to the urethral insertion portion 41, and the vagina front wall is adsorbed to the vaginal insertion portion 51. 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 suction from the suction port 433 is stopped or weakened. Similarly, if the anterior vagina wall is properly adsorbed by the vagina insertion portion 51, the suction hole 59 is blocked by the vagina wall, so that suction from the suction port 54 is stopped or weakened. For this reason, the surgeon properly adsorbs the urethral wall and the vagina front wall to the urethral insertion part 41 and the vagina insertion part 51 from the suction conditions (for example, the magnitude of sound generated by suction) from the suction ports 433 and 54. You can check whether or not.

  The insertion tool 6 may have a confirmation mechanism that mechanically confirms the suction state. The confirmation mechanism is not particularly limited as long as the adsorption state can be confirmed. For example, a flow rate measurement unit (negative pressure gauge) that measures the flow rate from the suction ports 433 and 54 and a measurement result from the flow rate measurement unit are used. It can be set as the structure which has a judgment part which judges whether adsorption | suction is performed properly based on.

  Next, liquid peeling is performed as necessary. Specifically, as shown in FIG. 14B, the puncture needle of the syringe 2000 is punctured into the anterior wall of the vagina from between the urethra insertion part 41 and the vagina insertion part 51, and between the urethra 1300 and the vagina 1400 ( A liquid such as physiological saline or a local anesthetic is injected into the living tissue between the regions S1 and S2. As a result, the living tissue between the regions S1 and S2 expands, whereby the urethra wall is pressed against the urethral insertion portion 41 and the vagina front wall is pressed against the vagina insertion portion 51.

  Here, it is preferable to continue the suction from the suction holes 44 and 59 even during liquid peeling. When the urethra wall is pressed against the urethra insertion part 41 by liquid peeling, the suction from the suction port 433 is stopped or weakened. Similarly, when the anterior vaginal wall is pressed against the vaginal insertion part 51, the suction from the suction port 45 is stopped or weakened. Therefore, the surgeon can confirm whether or not the liquid separation has been properly performed based on the suction conditions from the suction ports 433 and 54.

  Liquid separation is performed so that the urethral wall and the vaginal front wall are sufficiently separated, and then 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.15 (b), the puncture apparatus 1 is pushed inside a body. As described above, the urethra wall is adsorbed to the urethra insertion part 41 and the vagina wall is adsorbed to the vagina insertion part 51. Therefore, when the puncture device 1 is pushed into the body, the urethra 1300 and the vagina 1400 are simultaneously pushed. Is pushed in and the tissue between them is extended. Therefore, sagging of the tissue is reduced, and puncture of the puncture needles 71 and 81 into the tissue becomes easier.

  Next, with the puncture device 1 pushed into the body, the puncture device 1 is positioned so that the puncture paths of the puncture needles 71 and 81 pass through the safety zones S5 of the left and right closure holes 1101 and 1102 of the pelvis. The handle 251 is rotated while maintaining the state.

  As a result, as shown in FIG. 17A, the puncture needle 71 punctures the body surface H (first part) of the patient's right buttock or in the vicinity thereof and enters the body, thereby closing the closure hole 1101. Passing through and reaching between the urethra 1300 and the vagina 1400, together with this, the puncture needle 81 punctures the body surface H (second part) of the patient's left buttocks or in the vicinity thereof into the body. Enters, passes through the obturator 1102 and reaches between the urethra 1300 and the vagina 1400. And the front-end | tip parts of the puncture needles 71 and 81 contact | abut in the predetermined position of the vicinity between the urethra 1300 and the vagina 1400, and the blade surfaces 711 and 811 face and overlap. At this time, as described above, the puncture needles 71 and 81 are punctured substantially perpendicularly to the closing holes 1101 and 1102, whereby a passage can be formed at a position suitable for placement of the implant 9. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.

  Next, the divided pieces 31 and 32 are both pushed into the living body and connected. Thereby, the sheath 3 is arrange | positioned in the biological body. Next, the handle 251 is operated to rotate the puncture needles 71 and 81 in the direction opposite to that during puncture, and only the puncture needles 71 and 81 are removed from the living body while the sheath 3 is placed in the living body. Next, the frame 2 is removed from the insertion tool 6. As a result, as shown in FIG. 17B, only the sheath 3 is placed in the living body. The sheath 3 is arranged in the living body with both end openings exposed to the outside of the living body.

  Next, the position of the sheath 3 is adjusted as necessary. Specifically, the left and right protruding lengths of the sheath 3 are aligned, and the central portion S4 of the sheath 3 is positioned between the urethra 1300 and the vagina 1400. In this state, as shown in FIG. 19, the central portion S <b> 4 of the sheath 3 is arranged such that the width direction (long axis J <b> 32 direction) W is substantially parallel to the urethra 1300. That is, the urethra 1300 that has been corrected by inserting the urethral insertion portion 41 and the width direction W of the central portion S4 of the sheath 3 are substantially parallel to each other.

  Next, the implant 9 is inserted into the sheath 3 while being taken out from the packaging material 90, and the implant body 91 is protruded from the openings at both ends of the sheath 3 as shown in FIG. 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 sheath 3. As described above, since the sheath 3 has a flat shape, the posture of the implant body 91 follows the flat shape, and the implant body 91 has a sheath direction so that the width direction thereof coincides with the width direction of the sheath 3. 3 is arranged. From the relationship with the urethra 1300, the implant body 91 is arranged in parallel with the corrected urethra 1300.

  Next, the divided pieces 31 and 32 are both pulled toward the proximal end to release the connection of the divided pieces 31 and 32, and the divided pieces 31 and 32 are pulled out from the living body. At this time, the divided pieces 31 and 32 are moved almost simultaneously in the opposite directions, and the divided pieces 31 and 32 are moved in an arc shape along the respective shapes. Thereby, the sheath 3 can be smoothly removed from the living body.

  When the divided pieces 31 and 32 are removed from the living body as described above, the surrounding tissue that has been spread by the sheath 3 returns to the original position, and gradually moves from the center of the implant body 91 toward both ends. The tissue comes into contact with the implant body 91. As described above, since the split pieces 31 and 32 are moved in the direction along the shape thereof, and the sheath 3 has an internal space in which the implant body 91 can be moved with sufficiently low friction, the implant body 91 is provided. In this case, an unnecessary tensile force is not applied, and it can be left as it is. Thereby, adjustment of the tension of the implant main body 91 becomes unnecessary. By the above, as shown in FIG.20 (b), the implant main body 91 will be in the state embedded by the biological 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 sheath 3 from the living body by dividing it, the sheath 3 can be easily removed from the living body. Further, since the segment pieces 31 and 32 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.

  In addition, since the split pieces 31 and 32 are removed from the living body with the urethra insertion part 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, the puncture needles 71 and 81 can be handled only by a minimally invasive technique such as puncture, without performing a invasive incision or the like. Therefore, the burden on the patient is small and the safety of the patient is high. In particular, by puncturing from both sides of the living body using the two puncture needles 71 and 81, for example, the length of the puncture needles 71 and 81 compared to the case of puncturing from one side using one puncture needle Can be shortened. Therefore, it is possible to suppress bending and twisting of the puncture needles 71 and 81 due to the resistance received during puncture. Therefore, the puncture needles 71 and 81 can be punctured more accurately, and the safety becomes higher.

  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, since the puncture needles 71 and 81 can puncture a living body while avoiding the urethra 1300 and the vagina 1400, the puncture needles 71 and 81 can be prevented from puncturing the urethra 1300 and the vagina 1400, and safety is ensured. It is. Further, it is possible to prevent the occurrence of complications such as the exposure of the implant 9 into the vagina from the wound created by the incision and the infection from the wound as in the case of the conventional incision of the vagina. It is possible to embed the implant 9 reliably.

Second Embodiment
FIG. 21 is a cross-sectional view showing the first and second puncture needles of the puncture apparatus according to the second embodiment of the present invention, and shows a state in which the first and second puncture needles are engaged. FIG. 21 is a cross-sectional view corresponding to FIG. 6 of the first embodiment described above.

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

  This embodiment is the same as the first embodiment described above except that the configuration of the first puncture needle is different.

  As shown in FIG. 21, the puncture needle 71 of this embodiment has a tubular shape and has a through-hole 713 that opens to the distal end (blade surface 711) and the proximal end. When both puncture needles 71 and 81 are rotated to the distal end side, the distal end portion of puncture needle 81 is inserted into through-hole 713 from the distal end side opening of puncture needle 71 as shown in FIG. In this way, by inserting the distal end portion of the puncture needle 81 into the distal end portion of the puncture needle 71, the puncture needles 71 and 81 can be engaged with each other in a stable state with no displacement. Therefore, the connection work of the split pieces 31 and 32 can be performed more smoothly.

  In particular, in this embodiment, the blade surfaces 711 and 811 of the puncture needles 71 and 81 are both oriented in the same direction (upper side in FIG. 21). Therefore, since the puncture needle 81 is gradually inserted into the puncture needle 71 from the tip, for example, as compared with the case where the blade surfaces 711 and 811 face each other as in the first embodiment described above, the puncture needle 81 is easily inserted into the puncture needle 71. Therefore, the puncture device 1 has better operability.

  In the present embodiment, the puncture needle 71 has a tubular shape, but the configuration of the puncture needle 71 is not limited to this as long as the puncture needle 81 can be inserted into the distal end thereof. Only the distal end portion may be tubular, and the proximal end portion may be solid.

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

<Third Embodiment>
FIG. 22 is a perspective view showing a puncture device according to a third embodiment of the present invention. FIG. 23 is a cross-sectional view showing the first and second puncture needles of the puncture device shown in FIG. 22, and shows a state in which the first and second puncture needles are engaged. 24 (a) and 24 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 22, respectively. FIG. 25 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 23 is a cross-sectional view corresponding to FIG. 6 of the first embodiment described above.

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

  The present embodiment is the same as the first embodiment described above except that the configurations of the first and second puncture needles are different and the sheath is omitted.

  As shown in FIG. 22, in the puncture device 1 of the present embodiment, the sheath 3, that is, the divided pieces 31 and 32 are omitted.

  Moreover, as shown in FIG. 23, the puncture needles 71 and 81 each have a tubular shape. Therefore, a through-hole (internal space) 713 that opens to the distal end (blade surface 711) and the proximal end is formed in the puncture needle 71, and the distal end (blade surface 811) and the proximal end are formed in the puncture needle 81. A through-hole (internal space) 813 is formed to open. When the puncture needles 71 and 81 are rotated to the distal end side, the distal end portion of the puncture needle 81 is inserted into the through hole 713 from the distal end side opening of the puncture needle 71. In this way, by inserting the distal end portion of the puncture needle 81 into the puncture needle 71, the puncture needles 71 and 81 can be engaged in a stable state with no deviation.

  In particular, in this embodiment, the blade surfaces 711 and 811 of the puncture needles 71 and 81 are both oriented in the same direction (upper side in FIG. 23). Therefore, the puncture needle 81 is gradually inserted into the puncture needle 71 from the tip thereof, and, for example, as compared with the case where the blade surfaces 711 and 811 face each other as in the first embodiment described above, the puncture needle 81. Is easily inserted into the puncture needle 71. Therefore, the puncture device 1 has better operability.

  When the puncture needles 71 and 81 are engaged as described above, the through holes 713 and 813 communicate with each other and a space for inserting the implant 9 is formed. That is, in this embodiment, the puncture needles 71 and 81 also serve as the sheath 3 of the first and second embodiments described above. Thus, since the puncture needles 71 and 81 also serve as the sheath 3, the implant 9 can be more smoothly embedded in the living body.

Next, a method for embedding the implant 9 using the puncture device 1 of the present embodiment will be described.
First, the puncture needles 71 and 81 are punctured into the living body through the same steps as in the first embodiment described above, and the distal end portion of the puncture needle 81 is inserted into the distal end portion of the puncture needle 71 as shown in FIG. Then, the puncture needles 71 and 81 are engaged. Thereby, the through holes 713 and 813 communicate with each other. Next, the implant 9 is inserted into the puncture needles 71 and 81, and as shown in FIG. 24 (b), the implant body 91 is in a state of protruding from both end openings of the puncture needles 71 and 81. Next, with the implant body 91 left, the puncture needles 71 and 81 are rotated to the proximal end side, and both the puncture needles 71 and 81 are removed from the living body. As described above, as shown in FIG. 25, the implant body 91 is embedded in the living body.

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

<Fourth embodiment>
FIG. 26 is a perspective view showing a puncture device according to a fourth embodiment of the present invention. FIG. 27A is a perspective view showing the distal end portion of the first puncture needle, and FIG. 27B is a perspective view showing the distal end portion of the second puncture needle. FIGS. 28A and 28B are cross-sectional views for explaining delivery of the implant from the first puncture needle to the second puncture needle, respectively. FIGS. 29A and 29B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.

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

  The present embodiment is the same as the first embodiment described above except that the configurations of the first and second puncture needles are different and the sheath is omitted.

  As shown in FIG. 26, in the puncture device 1 of the present embodiment, the sheath 3, that is, the divided pieces 31 and 32 are omitted.

  In addition, as shown in FIGS. 27A and 27B, the puncture needles 71 and 81 each have a tubular shape. Therefore, a through hole 713 that opens to the distal end (blade surface 711) and the proximal end is formed in the puncture needle 71, and a penetration that opens to the distal end (blade surface 811) and the proximal end is formed in the puncture needle 81. A hole 813 is formed. When the puncture needles 71 and 81 are rotated to the distal end side, the distal end portion of the puncture needle 81 is inserted into the through hole 713 from the distal end side opening of the puncture needle 71. In this way, by inserting the distal end portion of the puncture needle 81 into the puncture needle 71, the puncture needles 71 and 81 can be engaged with each other with less displacement.

  In particular, in this embodiment, the blade surfaces 711 and 811 of the puncture needles 71 and 81 are both oriented in the same direction. Therefore, the puncture needle 81 is gradually inserted into the puncture needle 71 from the tip thereof, and, for example, as compared with the case where the blade surfaces 711 and 811 face each other as in the first embodiment described above, the puncture needle 81. Is easily inserted into the puncture needle 71.

  In addition, as shown in FIG. 27A, an implant holding portion 76 that holds the implant 9 is provided at the distal end portion of the puncture needle 71. The implant holding part 76 has a groove 763 that crosses the distal end side opening 713a of the through hole 713. The implant 9 can be held by the puncture needle 71 by hooking the band 92 of the implant 9 in the groove 763. In this case, it is preferable to tie the band 92 to form a loop 921 and hook the loop 921 into the groove 763. This makes it difficult for the implant 9 to be detached from the puncture needle 71. Further, since the loop 921 is disposed across the distal end opening 713a, the delivery of the implant 9 to the puncture needle 81 described later can be performed more reliably.

  On the other hand, as shown in FIG. 27 (b), an implant receiving portion 86 for receiving the implant 9 held by the puncture needle 71 is provided at the distal end portion of the puncture needle 81. The implant receiving portion 86 has a groove 863 that traverses the distal end side opening 813 a of the through-hole 813 and a claw portion 862 that protrudes into the groove 863. The nail | claw part 862 inclines and protrudes in the base end side, and has become what is called a "bark". Further, the claw portion 862 is formed as a part of the blade surface 811.

  When the distal end portion of the puncture needle 81 is inserted into the puncture needle 71, the claw portion 862 passes through the loop 921 and the loop 921 enters the groove 863, as shown in FIG. Thereafter, when the puncture needle 81 is pulled out from the puncture needle 71, a ring 921 is caught on the claw portion 862, and the implant 9 is delivered to the puncture needle 81 as shown in FIG. That is, when the distal end portions of the puncture needles 71 and 81 are engaged (connected), the implant receiving portion 86 is connected to the implant 9 by the engagement, and the implant holding portion 76 and the implant receiving portion 86 are separated from each other. The implant 9 is detached from the implant holding portion 76. According to such a configuration, since the implant 9 is automatically transferred from the puncture needle 71 to the puncture needle 81 in the step of puncturing / removing the puncture needles 71 and 81, a procedure using the puncture device 1 is performed. Can be done more easily and smoothly.

Next, a method for embedding the implant 9 using the puncture device 1 of the present embodiment will be described.
First, the puncture needles 71 and 81 are brought into a state before puncturing the living body through the same steps as in the first embodiment described above. Next, after the implant 9 is hooked in the groove 763 of the puncture needle 71, as shown in FIG. 29 (a), the puncture needles 71 and 81 are respectively rotated toward the distal end to puncture the living body. The tip is inserted into the tip of the puncture needle 71. At that time, the implant 9 is guided into the living body from the distal end side together with the puncture needle 71 and delivered to the puncture needle 81. Next, the puncture needles 71 and 81 are respectively rotated to the proximal end side and removed from the living body. At this time, the implant 9 is discharged out of the living body together with the puncture needle 81 from the distal end side. Therefore, as described above, as shown in FIG. 29B, the implant body 91 is embedded in the living body. According to such a method, for example, the implant 9 can be embedded in the living body with fewer steps compared to the method using the sheath as in the first embodiment described above.

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

  Note that the outer shape of the puncture needles 71 and 81 of the present embodiment may be the same as the outer shape of the first to third embodiments described above. Thereby, in the state which expanded the implant 9, it can embed in a living body with a more correct attitude | position. The implant 9 may be disposed in the through hole 713 of the puncture needle 71 while being held by the puncture needle 71. Further, in this embodiment, the puncture needle 71 has the implant holding portion 76 and the puncture needle 81 has the implant receiving portion 86. Conversely, the puncture needle 71 has the implant receiving portion 86 and the puncture needle The needle 81 may have an implant holding part 76.

<Fifth Embodiment>
30A is a cross-sectional view showing the first and second puncture needles included in the puncture apparatus according to the fifth embodiment of the present invention, and FIGS. 30B and 30C are views from the first puncture needle, respectively. It is sectional drawing for demonstrating delivery of the implant to 2 puncture needles.

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

  The present embodiment is the same as the fourth embodiment described above except that the configurations of the first and second puncture needles are different.

  As shown in FIG. 30A, in the puncture device 1 of the present embodiment, the implant holding portion 76 is detachably provided at the distal end portion of the puncture needle 71. A convex portion 761 is provided on the inner peripheral surface of the implant holding portion 76. On the other hand, an implant receiving portion 86 is provided at the distal end portion of the puncture needle 81, and the implant receiving portion 86 includes a recess 861 provided on the outer periphery of the puncture needle 81.

  As shown in FIG. 30 (b), the convex portion 761 and the concave portion 861 are formed by inserting the distal end portion (implant receiving portion 86) of the puncture needle 81 into the distal end portion (implant holding portion 76) of the puncture needle 71. Engage. When the convex portion 761 and the concave portion 861 are engaged, the implant holding portion 76 is fixed to the implant receiving portion 86, and the implant 9 is delivered to the puncture needle 81 together with the implant holding portion 76.

  Then, as shown in FIG. 30 (c), when the puncture needle 81 is pulled out from the puncture needle 71, the distal end portion of the implant 9 is discharged out of the living body together with the puncture needle 81. According to such a configuration, since the implant 9 is automatically transferred from the puncture needle 71 to the puncture needle 81 in the step of puncturing / removing the puncture needles 71 and 81, a procedure using the puncture device 1 is performed. Can be done more easily and smoothly.

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

  In the present embodiment, the implant holding portion 76 and the implant receiving portion 86 are fixed by uneven fitting. However, these fixing methods are not limited to this, and for example, means such as press-fitting and adhesion are used. It may be used.

<Sixth Embodiment>
FIG. 31 is a perspective view showing a puncture apparatus according to a sixth embodiment of the present invention. FIG. 32 is a perspective view showing a puncture member included in the puncture apparatus shown in FIG. FIG. 33 is a top view of the puncture member shown in FIG. FIG. 34 is a plan view for explaining the rotation of the puncture member shown in FIG. 32, where (a) shows the initial state and (b) shows the puncture state.

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

  The present embodiment is the same as the fourth embodiment described above except that the configurations of the first and second puncture needles are different.

  31, FIG. 32 and FIG. 33 are diagrams each showing an initial state of the puncture apparatus 1 of the present embodiment. As shown in these drawings, in the puncture device 1 of the present embodiment, in the initial state, the proximal end portion 79 of the puncture needle 71 and the proximal end portion 89 of the puncture needle 81 are in the directions of the axes J1 and J2 (on the plane f1). (Normal direction). Further, the first puncture needles 71 and 81 are arranged so as not to interfere with the respective rotations.

  Then, by rotating both the puncture needles 71 and 81 from the initial state shown in FIG. 34A to the distal end side, the puncture needle 81 is placed at the distal end of the puncture needle 71 as shown in FIG. The distal end portion is inserted, and the puncture needles 71 and 81 are engaged. In the puncture device 1 of the present embodiment, it is necessary to cross the puncture members 7 and 8 during such movement, so that the puncture member 8 moves so as to dive inside the puncture member 7. It has become.

  Thus, by arranging the proximal end portions 79 and 89 of the puncture needles 71 and 81 in the directions of the axes J1 and J2, the puncture needle 71, The central angle θ6 of 81 can be increased. Therefore, the puncture needles 71 and 81 can be punctured deeper into the living body, and as shown in FIG. 34 (b), the puncture device 1 can be sufficiently applied to, for example, a thick patient with thick subcutaneous fat. it can.

  In the present embodiment, the proximal end portion 79 of the puncture needle 71 is located on the front side of the proximal end portion 89 of the puncture needle 81. Thereby, the 1st puncture needles 71 and 81 will be arrange | positioned so that each rotation may not be interfered.

  Further, as shown in FIG. 33, the puncture needle 71 has a spiral shape toward the rear side of the axis J1, and conversely, the puncture needle 81 has a spiral shape toward the front of the axis J2. The puncture needle 81 is provided substantially parallel to the puncture needle 71. And both the front-end | tip of the puncture needle 71 and the front-end | tip of the puncture needle 81 are located in the plane f1, and it rotates within this plane f1. In this way, since the tips of the puncture needles 71 and 81 both move in the plane f1, the puncture needles 71 and 81 can be smoothly punctured, and the tips of the puncture needles 71 and 81 can be more reliably connected to each other. Can be engaged. In particular, by making the puncture needles 71 and 81 spiral, the puncture needles 71 and 81 can be punctured with lower resistance.

  The center angle θ6 of the puncture needles 71 and 81 is not particularly limited, but is preferably about 90 ° to 170 °, and more preferably about 120 ° to 150 °, respectively. Thereby, as described above, the puncture needles 71 and 81 can be punctured deeper into the living body. In addition, the puncture needles 71 and 81 can be prevented from becoming excessively long, and the puncture needles 71 and 81 that are difficult to be deformed (twisted deformation or bending deformation) can be obtained. Therefore, the puncture needles 71 and 81 can be accurately punctured.

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

<Seventh embodiment>
FIG. 35 is a top view showing a puncture member included in the puncture apparatus according to the seventh embodiment of the present invention.

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

  This embodiment is the same as the sixth embodiment described above except that the configurations of the first and second puncture needles are different.

  As shown in FIG. 35, in the puncture device 1 of the present embodiment, in the initial state, the proximal end portion 79 of the puncture needle 71 and the proximal end portion 89 of the puncture needle 81 are in the directions of the axes J1 and J2 (the method of the plane f1). (Over the line direction). A dent (recessed portion) 791 that is recessed with respect to the distal end portion 78 is formed on the rear surface of the proximal end portion 79 of the puncture needle 71, and a front surface of the proximal end portion 89 of the puncture needle 81 is opposed to the distal end portion 88. An indented recess (recess) 891 is formed. In the initial state, the proximal end portion 89 of the puncture needle 81 is positioned in the recess 791 of the puncture needle 71, and the proximal end portion 79 of the puncture needle 71 is positioned in the recess 891 of the puncture needle 81. That is, the recess 791 functions as a relief portion that prevents interference with the puncture needle 81, and the recess 891 functions as a relief portion that prevents interference with the puncture needle 71. By setting it as such a structure, the puncture needles 71 and 81 can be arrange | positioned with a simple structure. Further, the entire puncture needles 71 and 81 can be positioned within the plane f1 and can be rotated within the plane f1. For this reason, the puncture needles 71 and 81 can be punctured more smoothly.

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

<Eighth Embodiment>
FIG. 36 is a perspective view showing a puncture member included in the puncture apparatus according to the eighth embodiment of the present invention. FIG. 37 is a cross-sectional view showing a rotation operation unit included in the puncture device according to the eighth embodiment of the present invention.

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

  This embodiment is the same as the sixth embodiment described above except that the configurations of the first and second puncture needles are different.

  As shown in FIG. 36, in the puncture device 1 of the present embodiment, the shaft portion 73 of the puncture member 7 has a tubular shape, and the shaft portion 83 of the puncture member 8 is inserted inside the shaft portion 73. Therefore, the rotation axis J1 of the puncture member 7 and the rotation axis J2 of the puncture member 8 coincide. Thereby, since the puncture members 7 and 8 can be rotated concentrically, the puncture needles 71 and 81 can be punctured into the living body more smoothly. Moreover, the front-end | tip parts of the puncture needles 71 and 81 can be engaged more reliably.

  As shown in FIG. 37, the rotation operation unit 25 of the present embodiment has a handle 251 provided on the rear side of the bearing unit 21, and the shaft 83 of the puncture member 8 is fixed to the handle 251. Has been. The rotation operation unit 25 includes a conversion unit 252 built in the bearing unit 21, and the conversion unit 252 allows the rotation of the handle 251 to rotate the puncture needle 71 and the rotation of the puncture needle 81. Converted to dynamic. The conversion unit 252 includes four gears 252c, 252d, 252e, 252f and a belt 253. The gear 252c is fixed to the shaft portion 83, and the gear 252d is fixed to a shaft 256 provided in parallel with the shaft portion 83. These gears 252 c and 252 d are connected by a belt 253. Further, the gear 252e is fixed to the shaft 256, and the gear 252f is fixed to the shaft portion 73 in a state of being engaged with the gear 252e. The gear ratios of these four gears 252c to 252f are set so that the shaft portions 73 and 83 rotate at the same rotation angle.

  With such a configuration, when the handle 251 is rotated clockwise, the puncture needle 81 rotates clockwise, and the puncture needle 71 rotates counterclockwise by the same angle as the puncture needle 81, on the contrary. When the handle 251 is rotated counterclockwise, the puncture needle 81 rotates counterclockwise and the puncture needle 71 rotates clockwise by the same angle as the puncture needle 81. According to the rotating operation unit 25 having such a configuration, the puncture needles 71 and 81 can be punctured simultaneously by simply turning the handle 251, so that the puncture apparatus 1 can be used easily. In particular, since the puncture needles 71 and 81 rotate at the same rotation angle, it is easy to determine (predict) the movement of the puncture needles 71 and 81, and the puncture apparatus 1 can be used more safely.

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

  In place of this embodiment, the gears 252c and 252d may be pulleys and the belt 253 may be a flat belt. Thereby, the shaft portion 83 (handle 251) can idle with respect to the shaft portion 73. Therefore, for example, when the handle 251 is operated and receives an excessive (predetermined or greater) load even though the puncture needle 71 is in contact with the pelvis and cannot be punctured further, the handle 251 is pivoted. It is possible to prevent the puncture needle 71 from being punctured further by spinning around the portion 73. Therefore, erroneous puncture can be prevented and the puncture apparatus 1 can be used more safely.

<Ninth Embodiment>
FIG. 38 is a plan view showing a puncture member included in the puncture apparatus according to the ninth embodiment of the present invention, where (a) shows an initial state and (b) shows a puncture state. FIG. 39 is a top view of the puncture member shown in FIG.

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

  This embodiment is the same as the sixth embodiment described above except that the configurations of the first and second puncture needles are different.

  As shown in FIG. 38A, in the puncture device 1 of the present embodiment, the proximal end 79 of the puncture needle 71 and the proximal end 89 of the puncture needle 81 are orthogonal to the axes J1 and J2 in the initial state. It is provided so as to overlap the direction (in-plane direction of the plane f1). Then, by rotating the puncture needles 71 and 81 toward each other from the initial state shown in FIG. 38A, the puncture needle 81 is placed at the distal end portion of the puncture needle 71 as shown in FIG. The tip is inserted. Thus, by arranging the base end portions 79 and 89 so as to overlap each other, it is possible to increase the center angle of the puncture needles 71 and 81 while suppressing the protruding amount of the puncture needles 71 and 81 in the initial state. Therefore, the puncture needles 71 and 81 can be punctured deeper into the living body, and the puncture apparatus 1 can be sufficiently applied to, for example, a thick patient with thick subcutaneous fat.

  In the puncture device 1, a recess (recess) 791 that is recessed with respect to the distal end side is formed on the inner peripheral side of the proximal end portion 79 of the puncture needle 71, and the outer peripheral side of the proximal end portion 89 of the puncture needle 81. In addition, a recess (recess) 891 that is recessed with respect to the distal end side is formed. In the initial state, the proximal end portion 89 of the puncture needle 81 is positioned in the recess 791 of the puncture needle 71, and the proximal end portion 79 of the puncture needle 71 is positioned in the recess 891 of the puncture needle 81. That is, the recess 791 functions as a relief portion that prevents interference with the puncture needle 81, and the recess 891 functions as a relief portion that prevents interference with the puncture needle 71. By setting it as such a structure, the puncture needles 71 and 81 can be arrange | positioned with a simple structure.

  As shown in FIG. 39, both puncture needles 71 and 81 are located in the plane f1 and rotate in the plane f1. For this reason, while being able to puncture puncture needles 71 and 81 more smoothly, the front-end | tip parts of puncture needles 71 and 81 can be engaged more reliably.

  In the present embodiment, the base end portion 79 is located outside the base end portion 89, but on the contrary, the base end portion 89 may be located outside the base end portion 79.

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

<Tenth Embodiment>
FIG. 40 is a plan view showing a puncture member included in the puncture apparatus according to the tenth embodiment of the present invention, where (a) shows an initial state and (b) shows a puncture state. 41 (a) and 41 (b) are plan views showing modifications of the puncture member shown in FIG.

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

  The present embodiment is the same as the ninth embodiment described above except that the configurations of the first and second puncture needles are different.

  As shown in FIG. 40A, in the puncture device 1 of the present embodiment, the proximal end 79 of the puncture needle 71 and the proximal end 89 of the puncture needle 81 are orthogonal to the axes J1 and J2 in the initial state. It is provided so as to overlap the direction (in-plane direction of the plane f1). Then, by rotating the puncture needles 71 and 81 toward the distal end from the initial state shown in FIG. 40 (a), the puncture needle 81 is placed at the distal end of the puncture needle 71 as shown in FIG. 40 (b). The tip is inserted. Thus, by arranging the base end portions 79 and 89 so as to overlap each other, it is possible to increase the center angle of the puncture needles 71 and 81 while suppressing the protruding amount of the puncture needles 71 and 81 in the initial state. Therefore, the puncture needles 71 and 81 can be punctured deeper into the living body, and the puncture apparatus 1 can be sufficiently applied to, for example, a thick patient with thick subcutaneous fat.

  The puncture needles 71 and 81 are both disposed in the plane f1, and rotate in the plane f1.

  The puncture needle 71 has an arc shape, and has a substantially constant radius of curvature over the entire region in the extending direction. In contrast, the puncture needle 81 is curved in an arc shape as a whole, but the curvature radius is different between the proximal end portion 89 and the distal end portion 88. Specifically, the puncture needle 81 has an arc shape and a distal end portion 88 having a radius of curvature substantially equal to that of the puncture needle 71, and a proximal end portion 89 having an arc shape and a smaller radius of curvature than the puncture needle 71. These are connected by a connecting portion that is gently curved (inclined). In the initial state, the proximal end portion 89 of the puncture needle 81 is located inside the proximal end portion 79 of the puncture needle 71. That is, a space formed by shifting the proximal end portion 89 inward from the distal end portion 88 functions as an escape portion that prevents interference between the puncture needles 71 and 81. By setting it as such a structure, the puncture needles 71 and 81 can be arrange | positioned with a simple structure.

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

  As a modification of the present embodiment, the configuration shown in FIGS. 41A and 41B may be employed.

  In the modification shown in FIG. 41 (a), the puncture needle 81 has an arc shape and has a substantially constant radius of curvature over the entire region in the extending direction. In contrast, the puncture needle 71 has an arc shape and a distal end portion 78 having a radius of curvature substantially equal to the puncture needle 81, and a proximal end portion 79 having an arc shape and a radius of curvature larger than that of the puncture needle 81. These are connected by a gently curved (inclined) connecting portion. In the initial state, the proximal end portion 79 of the puncture needle 71 is located outside the proximal end portion 89 of the puncture needle 81.

  In the modification shown in FIG. 41 (b), the puncture needle 71 has an arc shape and a distal end portion 78 having a predetermined radius of curvature, and a proximal end portion 79 having an arc shape and a larger radius of curvature than the distal end portion 78. These are connected by a connecting portion that is gently curved (inclined). On the other hand, the puncture needle 81 has an arc shape and has a distal end portion 88 having substantially the same radius of curvature as the distal end portion 78 of the puncture needle 71, and a proximal end portion 89 having an arc shape and a smaller radius of curvature than the distal end portion 88. These are connected by a gently curved (inclined) connecting portion. Further, the radius of curvature of the base end portion 89 is larger than that of the base end portion 79, and the difference in curvature radius between the tip end portion 78 and the base end portion 79 and the difference in curvature radius between the tip end portion 88 and the base end portion 89 are substantially equal. It has become. In the initial state, the proximal end portion 79 of the puncture needle 71 is located outside the proximal end portion 89 of the puncture needle 81.

<Eleventh embodiment>
FIG. 42 is a plan view showing a puncture member included in the puncture apparatus according to the eleventh embodiment of the present invention, where (a) shows an initial state and (b) shows a puncture state.

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

  The present embodiment is the same as the ninth embodiment described above except that the configurations of the first and second puncture needles are different.

  As shown in FIG. 42A, in the puncture device 1 of the present embodiment, the puncture needle 71 is designed to have a larger central angle θ6 than the puncture needle 81. Further, the rotation operation unit 25 is configured so that the puncture needle 71 rotates at a larger rotation angle than the puncture needle 81 in accordance with the rotation operation of the handle 251. Note that the rotation angles of the puncture needles 71 and 81 can be appropriately changed by adjusting the gear ratio of the gears 252a and 252b.

  Therefore, when the puncture needles 71 and 81 are rotated toward the distal end from the initial state shown in FIG. 42A, the position shifted from between the urethra 1300 and the vagina 1400 as shown in FIG. Thus, the puncture needles 71 and 81 are engaged. Thus, by engaging the puncture needles 71 and 81 at positions away from the urethra 1300 and the vagina 1400, erroneous puncture into the urethra 1300 and the vagina 1400 can be more effectively prevented, and the procedure can be performed more safely. Can do.

  In particular, in the present embodiment, the puncture needle 71 that is thicker and more rigid than the puncture needle 81 is lengthened to prevent further reduction in rigidity of the puncture needle 81 that originally has low rigidity. Therefore, both the puncture needles 71 and 81 can be sufficiently maintained in rigidity, and the puncture needles 71 and 81 can be punctured more accurately. In contrast to this embodiment, the puncture needle 81 may be lengthened and the puncture needle 71 may be shortened. In this case, the length of the puncture needle 81 that is thinner than the puncture needle 71 is made less invasive.

  The central angle θ6 of the puncture needle 71 is not particularly limited as long as it can pass between the urethra 1300 and the vagina 1400, but is preferably about 120 ° to 200 °, for example, 140 ° to 170 It is more preferable that the angle is about 0 °. On the other hand, the center angle θ6 of the puncture needle 81 is not particularly limited, but is preferably about 50 ° to 100 °, and more preferably about 60 ° to 80 °.

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

<Twelfth embodiment>
FIG. 43 is a plan view showing a puncture member included in the puncture apparatus according to the twelfth embodiment of the present invention. 44 (a) and 44 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 43, respectively.

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

  The present embodiment is the same as the fourth embodiment described above except that the configurations of the first and second puncture needles are different.

  As shown in FIG. 43, in the puncture device 1 of the present embodiment, the puncture needle 71 is not provided with the implant holding portion 76, and the puncture needle 81 is not provided with the implant receiving portion 86. Therefore, in the puncture device 1 of this embodiment, the implant 9 cannot be delivered from the puncture needle 71 to the puncture needle 81. That is, the puncture needles 71 and 81 exhibit only the function of puncturing a living body, which is the original function. Thus, the puncture needles 71 and 81 are solid and do not have the through holes 713 and 813 because the implant holding portion 76 and the implant receiving portion 86 are omitted.

Next, a method for embedding the implant 9 using the puncture device 1 of the present embodiment will be described.
First, as shown in FIG. 44 (a), the puncture needles 71 and 81 are punctured into the living body through the same steps as in the first embodiment described above, and the tips of the puncture needles 71 and 81 are brought into contact with each other in the living body. . Next, as shown in FIG. 44 (b), the puncture needles 71 and 81 are pivoted toward each other and removed. Thereby, the piercing hole 1500 for embedding the implant 9 in the living body is formed. Thereafter, by placing the implant 9 in the piercing hole 1500, the implant 9 can be embedded in the living body. The method of arranging the implant 9 in the piercing hole 1500 is not particularly limited. For example, first, a guide wire is introduced into the piercing hole 1500 so that both ends are exposed, and the implant is inserted into one end of the guide wire. By connecting 9 and pulling the other end of the guide wire, the implant can be placed in the piercing hole 1500.

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

<13th Embodiment>
FIG. 45 is a diagram showing an initial state of the puncture device according to the thirteenth embodiment of the present invention, where (a) is a front view, (b) is a top view, and (c) is a bottom view. 46 (a) and 46 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.

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

  As shown in FIG. 45 (a), the puncture device 1 of the present embodiment includes a frame 2 having a frame body 20 and a rotation operation unit 25, and puncture needles 71 and 81. The frame body 20 includes a support portion 26 that rotatably supports and accommodates the puncture needles 71 and 81. The support portion 26 is substantially U-shaped along the shape of the puncture needles 71 and 81, and the lower surface thereof is a contact portion that comes into contact with the living tissue when the puncture device 1 is used. . The rotation operation unit 25 has a knob 259a connected to the proximal end portion of the puncture needle 71 and a knob 259b connected to the proximal end portion of the puncture needle 81. The knobs 259a and 259b are connected to the knob 259a. The puncture needles 71 and 81 can be easily operated by manually operating.

  In addition, as shown in FIG. 45 (c), a guide hole (guide portion) 261 for guiding the rotation of the puncture needle 71 and a guide hole (guide for guiding the rotation of the puncture needle 81) are provided in the support portion 26. Part) 262. Further, both ends of the guide hole 261 are opened on the lower surface of the support portion 26, and the puncture needle 71 can be projected out of the support portion 26 and retracted into the support portion 26 through the opening. Similarly, both ends of the guide hole 262 are open on the lower surface of the support portion 26, and through this opening, the puncture needle 81 can be projected out of the support portion 26 and retracted into the support portion 26. . By providing such guide holes 261 and 262, the puncture needles 71 and 81 can be rotated more smoothly.

  As shown in FIG. 45B, a long hole 263 communicating with the guide hole 261 is formed on the outer peripheral surface of the support portion 26, and a knob 259 a projects from the long hole 263. A long hole 264 that communicates with the guide hole 262 is formed on the outer peripheral surface of the support portion 26, and a knob 259 b projects from the long hole 264. The long hole 263 is a hole with an end, and the knob 259a abuts on the tip of the long hole 263, so that further rotation of the puncture needle 71 can be prevented. Similarly, the long hole 264 is a hole with an end, and the knob 259b abuts on the tip of the long hole 264, so that the puncture needle 81 can be prevented from further rotating. That is, the long holes 263 and 264 also function as a restricting portion that restricts the rotation range of the puncture needles 71 and 81 (particularly, the protruding amount of the puncture needles 71 and 81). By providing such a restricting portion, excessive protrusion of the puncture needles 71 and 81 can be prevented, and the tip portions of the puncture needles 71 and 81 can be safely engaged with each other.

  The puncture needles 71 and 81 accommodated in the support portion 26 having the above configuration are both curved in a substantially spiral shape. Further, the puncture needles 71 and 81 are supported and accommodated in the support portion 26 in a state in which the tips are directed to the opposite sides and are rotatable about the rotation axis J7. In this way, since the puncture needles 71 and 81 can be rotated concentrically by matching the rotation axes of the puncture needles 71 and 81, the puncture needles 71 and 81 can be smoothly punctured into the living body. It can be carried out. The rotation axis J7 coincides with the central axis of the puncture needles 71 and 81.

  Further, the puncture needles 71 and 81 have substantially the same central angle and substantially the same radius of curvature. Moreover, the puncture needles 71 and 81 are arranged substantially in parallel so as to overlap in the direction of the rotation axis J7 so that the base ends of each other do not interfere with each other. By providing the puncture needles 71 and 81 in the direction of the rotation axis J7 in this manner, the central angle of the puncture needles 71 and 81 can be increased while suppressing the amount of protrusion of the puncture needles 71 and 81 in the initial state. it can. Therefore, the puncture needles 71 and 81 can be punctured deeper into the living body, and the puncture apparatus 1 can be sufficiently applied to, for example, a thick patient with thick subcutaneous fat.

  The central angles of the puncture needles 71 and 81 are not particularly limited, but are preferably about 90 ° to 180 °, and more preferably about 120 ° to 150 °, respectively. Thereby, the puncture needles 71 and 81 can be sufficiently punctured into the living body, and the tip portions of the puncture needles 71 and 81 can be engaged with each other in the living body. In addition, the puncture needles 71 and 81 can be prevented from becoming excessively long, and the puncture needles 71 and 81 that are difficult to be deformed (twisted deformation or bending deformation) can be obtained. Therefore, the puncture needles 71 and 81 can be accurately punctured.

  In addition, both the tip of the puncture needle 71 and the puncture needle 81 move on the same spiral trajectory. Thereby, the puncture needles 71 and 81 can be smoothly punctured, and the distal ends of the puncture needles 71 and 81 can be more reliably engaged. In particular, by making the puncture needles 71 and 81 substantially spiral, the puncture needles 71 and 81 can be punctured with low resistance.

  The puncture needle 71 has a tubular shape, and an implant holding portion 76 (groove 763) is provided at the distal end portion thereof. On the other hand, the puncture needle 81 has a tubular shape that is thinner than the puncture needle 71, and its tip can be inserted into the puncture needle 71. In addition, an implant receiving portion 86 (a groove 863 and a claw portion 862) is provided at the distal end portion of the puncture needle 81. Therefore, the implant 9 can be transferred from the puncture needle 71 to the puncture needle 81 by rotating the puncture needles 71 and 81 toward the distal end to engage the distal ends.

Next, a method for embedding the implant 9 using the puncture device 1 of the present embodiment will be described.
First, as shown in FIG. 46A, the puncture device 1 is positioned so that the tip of the puncture needle 71 is positioned on the closing hole 1101 and the tip of the puncture needle 81 is positioned on the closing hole 1102. In the positioned state, the lower surface of the support portion 26 is in contact with the living tissue. Next, after the implant 9 is hooked in the groove 763 of the puncture needle 71, as shown in FIG. 46B, the knobs 259a and 259b are operated to rotate the puncture needles 71 and 81 counterclockwise (in different directions). It is moved to puncture the living body, and the distal end portion of the puncture needle 81 is inserted into the distal end portion of the puncture needle 71. At that time, the implant 9 is guided into the living body from the distal end side together with the puncture needle 71 and delivered to the puncture needle 81. The puncture order of the puncture needles 71 and 81 is not particularly limited, and the puncture needle 81 may be punctured after the puncture needle 71 has been punctured first. The needle 81 may be punctured. Further, the puncture needles 71 and 81 may be punctured simultaneously. However, among the above three cases, it is preferable to puncture the puncture needle 81 after the puncture needle 71 has been punctured first. Thus, it becomes easy to engage the puncture needles 71 and 81 in the living body by puncturing the thicker puncture needle first.

  Next, the puncture needles 71 and 81 are removed from the living body by operating the knobs 259a and 259b. At this time, the implant 9 is discharged from the living body together with the puncture needle 81 from the distal end side. As described above, the implant body 91 is embedded in the living body.

  As described above, according to the puncture device 1, when the implant 9 is placed, the puncture needles 71 and 81 can be handled only by a minimally invasive technique such as puncture, without performing a invasive incision or the like. Therefore, the burden on the patient is small and the safety of the patient is high. In particular, by puncturing from both sides of the living body using the two puncture needles 71 and 81, for example, the length of the puncture needles 71 and 81 compared to the case of puncturing from one side using one puncture needle Can be shortened. Therefore, the bending and twisting of the puncture needles 71 and 81 due to the resistance received at the time of puncture can be suppressed accordingly. Therefore, the puncture needles 71 and 81 can be punctured more accurately, and the safety becomes higher.

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

  In the present embodiment, the tips of the puncture needles 71 and 81 protrude from the support portion 26 in the initial state. However, the present invention is not limited to this, and the puncture needles 71 and 81 retract in the support portion 26 in the initial state. You may do it. Although not shown, the above procedure is performed with the insertion tool 6 attached to the living body, that is, with the urethra insertion part 41 inserted into the urethra 1300 and the vagina insertion part 51 inserted into the vagina 1400. Is more preferable. Thereby, the puncture needles 71 and 81 can be punctured more safely.

<Fourteenth embodiment>
FIG. 47 is a perspective view showing a puncture device according to a fourteenth embodiment of the present invention. FIG. 48 is a plan view showing a configuration of a rotation operation unit included in the puncture device shown in FIG.

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

  The present embodiment is the same as the thirteenth embodiment described above except that the configuration of the frame and the rotation operation unit is different.

  As shown in FIG. 47, in the puncture device 1 of this embodiment, the frame body 20 includes a support portion 26, a fixing portion 24 that fixes the insertion tool 6, and a connecting portion that connects the support portion 26 and the fixing portion 24. 23. In addition, an insertion tool 6 (the urethral insertion tool 4 and the vaginal insertion tool 5) is fixed to the frame body 20.

  The frame body 20 has the puncture needles 71 and 81, the urethral insertion device 4 and the vagina so that the puncture needles 71 and 81 are brought into contact with the urethral insertion device 4 and the vagina insertion device 5 without colliding with them. The positional relationship of the insertion tool 5 is defined. That is, in the frame body 20, when the puncture needles 71, 81 are rotated to the distal end side, at least one tip of the puncture needles 71, 81 (extension line in the puncture direction of the puncture needles 71, 81) is from the urethra insertion device 4. The positional relationship between the puncture needles 71 and 81 and the urethral insertion tool 4 and the vaginal insertion tool 5 is such that the distal ends of the puncture needles 71 and 81 are engaged with each other through the distal side from the rotation axis J7. It is regulated.

  Further, the frame body 20 is provided with a rotation operation unit 25 for interlocking the puncture needles 71 and 81 and simultaneously rotating them in the opposite direction at an equal angle. By providing such a rotation operation unit 25, for example, the puncture device 1 is easily operated as compared with the case where the puncture needles 71 and 81 are each manually operated as in the thirteenth embodiment described above, for example. And the time taken for the procedure can be shortened. In addition, since the movement of the puncture needles 71 and 81 can be controlled to be constant, the puncture apparatus 1 can be used correctly and safely.

  As shown in FIG. 48, the rotation operation unit 25 is provided on the rear side of the connection unit 23, and the handle 251 rotatably supported by the connection unit 23 and the rotation of the handle 251 rotate the puncture needle 71. A conversion unit 252 that converts the movement and rotation of the puncture needle 81. The conversion unit 252 includes a bevel gear 254a fixed to the shaft of the handle 251, a bevel gear 254b meshing with the bevel gear 254a, and a substantially columnar rotating body 254c fixed to the shaft of the bevel gear 254b. doing. The handle 251 is rotated 90 ° by the bevel gears 254a and 254b. When the handle 251 is rotated, the rotating body 254c is rotated about the axis J8.

  The rotating body 254c is made of a material having a relatively high frictional resistance, such as a rubber material, and is disposed between the puncture needles 71 and 81 and is in contact with both the puncture needles 71 and 81. Therefore, when the rotating body 254c is rotated by the operation of the handle 251, along with the rotation, the puncture needles 71 and 81 are interlocked and simultaneously rotate in the opposite direction with substantially the same rotation angle. Thus, the rotation operation part 25 becomes a simple structure by setting it as the structure using a gearwheel.

  In particular, in the present embodiment, the rotating body 254c can idle with respect to the puncture needles 71 and 81. Therefore, for example, when the handle 251 is operated and an excessive (predetermined or greater) load is applied even though the puncture needles 71 and 81 are in contact with the pelvis and cannot be punctured further, the rotating body 254c Is idle with respect to the puncture needles 71 and 81, and further puncture of the puncture needles 71 and 81 can be prevented. Therefore, erroneous puncture can be prevented and the puncture apparatus 1 can be used more safely.

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

  In the present embodiment, the frame body 20 includes the connecting portion 23 and the fixing portion 24, but these may be omitted. In this case, for example, the handle 251 may be disposed on the back side or the top side of the support portion 26. Further, the insertion tool 6 may be omitted.

<Fifteenth embodiment>
49A and 49B are views showing an initial state of the puncture device according to the fifteenth embodiment of the present invention, wherein FIG. 49A is a cross-sectional view seen from the front side, and FIG. 49B is a rear view.

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

  This embodiment is the same as the thirteenth embodiment described above except that the configuration of the puncture needle is different.

  As shown in FIG. 49, the puncture apparatus 1 of the present embodiment includes a support portion 26, puncture needles 71 and 81, and knobs 259a and 259b. By manually operating the knobs 259a and 259b, puncture is performed. The needles 71 and 81 can be operated.

  As shown in FIG. 49, the puncture needles 71 and 81 are supported and accommodated in the support portion 26 so that the tips thereof are directed to the opposite sides and are rotatable about the rotation axis J7. The puncture needles 71 and 81 have substantially the same central angle. The puncture needles 71 and 81 are both provided in the same plane with the rotation axis J7 as a normal, and rotate in the plane. Further, the puncture needles 71 and 81 are arranged so that their base end portions 79 and 89 overlap each other in the in-plane direction of the plane (a direction perpendicular to the rotation axis J7).

  The puncture needle 71 is curved in an arc shape and has a substantially constant radius of curvature over the entire region in the extending direction. In contrast, the puncture needle 81 is curved in an arc shape and has a distal end portion 88 having a radius of curvature substantially equal to that of the puncture needle 71, and a proximal end portion that is curved in an arc shape and has a smaller radius of curvature than the puncture needle 71. 89, and these are connected by a gently curved (inclined) connecting portion. In the initial state, the proximal end portion 89 of the puncture needle 81 is located inside the proximal end portion 79 of the puncture needle 71.

  The support portion 26 is substantially U-shaped along the shape of the puncture needles 71 and 81. Further, a guide hole 261 for guiding the rotation of the puncture needles 71 and 81 is provided in the support portion 26, and the puncture needles 71 and 81 are further individually guided inside the guide hole 261. A partition 261a is provided.

  Further, long holes 263 and 264 communicating with the guide hole 261 are formed on the back surface of the support portion 26, and a knob 259 a protrudes from the long hole 263, and a knob 259 b protrudes from the long hole 264. The long holes 263 and 264 are end-holes, and when the knobs 259a and 259b are brought into contact with the tip portions, further rotation of the puncture needles 71 and 81 can be prevented.

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

<Sixteenth Embodiment>
FIG. 50 is a perspective view showing a puncture apparatus according to the sixteenth embodiment of the present invention. 51 is a diagram showing a configuration of a rotation operation unit included in the puncture device shown in FIG. 50, wherein (a) is a top view and (b) is a front view.

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

  The present embodiment is the same as the fifteenth embodiment described above except that the configuration of the rotation operation unit is different.

  As shown in FIG. 50, in the puncture device 1 of the present embodiment, the frame body 20 has a support portion 26 and a grip portion 27 connected to the rear of the housing portion. The frame main body 20 is provided with a rotation operation unit 25 for interlocking the puncture needles 71 and 81 and simultaneously rotating them in the opposite direction at the same rotation angle. By providing such a rotation operation unit 25, for example, the puncture apparatus 1 can be operated more easily than when manually operating the puncture needles 71 and 81 as in the fifteenth embodiment described above. And the time taken for the procedure can be shortened. In addition, since the movement of the puncture needles 71 and 81 can be controlled to be constant, the puncture apparatus 1 can be used correctly and safely.

  As shown in FIGS. 51 (a) and 51 (b), the rotation operation unit 25 is provided on the rear side of the gripping unit 27 and is rotatably supported by the gripping unit 27, and the rotation of the handle 251. A conversion unit 252 that converts the movement into rotation of the puncture needle 71 and rotation of the puncture needle 81 is provided. The conversion unit 252 includes a bevel gear 255a fixed to the shaft of the handle 251; a bevel gear 255b meshing with the bevel gear 255a; and a pair of rotating belts 255c and 255d connected to the shaft of the bevel gear 255b. doing.

  Each of the rotating belts 255c and 255d has a pair of pulleys and a belt suspended on the pulleys, and one pulley is fixed to the shaft of the bevel gear 255b. The rotating belts 255c and 255d rotate in the same direction and at the same speed as the bevel gear 255b rotates. The rotating belt 255 c is provided in contact with the puncture needle 71, and the rotating belt 255 d is provided in contact with the puncture needle 81. Therefore, when the rotating belts 255c and 255d are rotated by the operation of the handle 251, the puncture needles 71 and 81 are simultaneously rotated at the same angle in the opposite direction along with the rotation. Thus, the rotation operation part 25 becomes a simple structure by using a gearwheel.

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

  In the present embodiment, the frame 2 has the grip portion 27, but the grip portion 27 may be omitted. In this case, for example, the handle 251 may be disposed on the back side or the top side of the support portion 26.

<Seventeenth Embodiment>
52A and 52B are views showing an initial state of the puncture device according to the seventeenth embodiment of the present invention, wherein FIG. 52A is a cross-sectional view seen from the front side, and FIG. 52B is a rear view.

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

  This embodiment is the same as the thirteenth embodiment described above except that the configuration of the puncture needle is different.

  As shown in FIGS. 52 (a) and 52 (b), the puncture device 1 of the present embodiment includes a support portion 26, puncture needles 71 and 81, and knobs 259a and 259b, and the knobs 259a and 259b are manually operated. The puncture needles 71 and 81 can be operated by operating with.

  Further, the puncture needles 71 and 81 are supported and accommodated in the support portion 26 in a state in which the tips are directed to the opposite side and both can rotate around the rotation axis J7. The puncture needles 71 and 81 have substantially the same central angle. The puncture needles 71 and 81 are provided in a plane with the rotation axis J7 as a normal line, and rotate in the plane.

  The puncture needles 71 and 81 are both tubular, and the proximal end portion 89 of the puncture needle 81 is inserted into the proximal end portion 79 of the puncture needle 71. The puncture needle 71 is formed with a slit 77 for sliding the knob 259b connected to the puncture needle 81.

  The support portion 26 is substantially U-shaped along the shape of the puncture needles 71 and 81. A guide hole 261 for guiding the rotation of the puncture needles 71 and 81 is provided in the support portion 26. A long hole 264 communicating with the guide hole 261 is formed on the outer peripheral surface of the support portion 26, and a knob 259 b projects from the long hole 264. The long hole 264 is a hole with an end, and when the knob 259b comes into contact with the tip, the puncture needle 81 can be prevented from further rotating. A long hole 263 communicating with the guide hole 261 is formed on the back surface of the support portion 26, and a knob 259 a protrudes from the long hole 263. The long hole 263 is a hole with an end, and the knob 259a abuts on the tip of the long hole 263, so that further rotation of the puncture needle 71 can be prevented.

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

  The puncture device and the puncture method of the present invention have been described based on the illustrated embodiment. However, the present invention is not limited to this, and the configuration of each part is an arbitrary configuration having the same function. Can be substituted. In addition, any other component may be added to the present invention. Moreover, you may combine each embodiment suitably.

  In the first to twelfth embodiments described above, the puncture needles 71 and 81 are configured to rotate to the opposite side by turning the handle of the rotation operation unit, but the rotation operation unit is omitted. The puncture needles 71 and 81 may be moved manually. In this case, by providing a handle fixed to the shaft portion 73 of the puncture needle 71 and a handle fixed to the shaft portion 83 of the puncture needle 81, and operating these handles independently, the puncture needles 71, 81 are provided. Can be operated. In addition, the puncture needles 71 and 81 can be operated by holding the connecting portions 72 and 83. Thus, when manually operating the puncture needles 71 and 81, the puncture needle 81 may be punctured after puncturing the puncture needle 71, and conversely, the puncture needle 71 is punctured after puncturing the puncture needle 81. May be. Further, the puncture needles 71 and 81 may be punctured simultaneously. Among these cases, it is preferable to puncture the puncture needle 81 after puncturing the puncture needle 71. By first puncturing the thicker puncture needle 71, the distal end portions of the puncture needles 71 and 81 can be more reliably engaged with each other in the living body.

  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 2 Frame 20 Frame main body 21 Bearing part 22 Guide part 23 Connecting part 24 Fixing part 243 Recessed part 244 Male screw 25 Rotating operation part 251 Handle 252 Conversion part 252a Gear 252b Gear 252c Gear 252d Gear 252e Gear 252f Gear 253 Belt 254a Bevel gear 254b Bevel gear 254c Rotating body 255a Bevel gear 255b Bevel gear 255c Rotating belt 255d Rotating belt 256 Shaft 259a Knob 259b Knob 26 Supporting portion 261 Guide hole 261a Partition 262 Guide hole 263 Long hole 264 Long hole 27 Holding portion 3 Sheath 31 Dividing Piece 32 Divided Piece 4 Urethral Insertion Tool 40 Support Portion 41 Urethral Insertion Portion 42 Balloon 431 Balloon Port 432 Urine Discharge Port 433 Aspiration Port 44 Aspiration Hole 45 Aspiration Port 46 Marker 47 Urine Discharge Portion 471 Vaginal insertion tool 50 Support part 501 Male screw 51 Vaginal insertion part 52 Tip part 52a Upper surface 53 Shaft part 54 Suction port 55 Recess 57 Marker 59 Suction hole 6 Insertion tool 7 Puncture member 71 Puncture needle 711 Blade surface 713 Through hole 713a Tip side opening 72 connecting portion 73 shaft portion 76 implant holding portion 761 convex portion 763 groove 77 slit 78 distal end portion 79 base end portion 791 recess 8 puncture member 81 puncture needle 811 blade surface 813 through hole 813a distal end side opening 82 coupling portion 83 shaft portion 86 implant Receiving portion 861 Recess 862 Claw portion 863 Groove 88 Tip portion 88 Tip side 89 Base end portion 891 Depression 9 Implant 90 Packaging material 91 Implant body 92 Band (connecting portion)
1100 Pelvis 1101 Closing hole 1102 Closing hole 1200 Pubic joint 1300 Urethra 1310 Bladder 1400 Vagina 1401 Central part 1402 Part 1500 Puncture hole 2000 Syringe A1 Inner peripheral part A2 Outer peripheral part A3 Surface A4 Back face D Separation distance H Body surface J1 Axis axis)
J2 axis (rotating axis)
J31 short axis J32 long axis J32 ′ extension line J5 central axis J7 rotation axis J8 axis P intersection S1 area S2 area S4 center S5 safety zone W width direction f1 plane f2 plane f9 plane r1 minimum curvature radius r2 maximum curvature radius θ1 inclination Angle θ2 Tilt angle θ3 Tilt angle θ4 Center angle θ5 Angle θ6 Center angle

Claims (11)

A curved first puncture needle;
A curved second puncture needle;
And a support portion that rotatably supports the first puncture needle and the second puncture needle so that the proximal end portion of the first puncture needle and the proximal end portion of the second puncture needle do not interfere with each other. A puncture device characterized by that.   2. The distal end portion of the first puncture needle and the distal end portion of the second puncture needle are engaged with each other by rotating both the first puncture needle and the second puncture needle toward the distal end side. Puncture device.   The puncture apparatus according to claim 1, wherein the support portion includes a guide portion that guides rotation of the first puncture needle and the second puncture needle.   The puncture apparatus according to any one of claims 1 to 3, wherein the support portion includes a contact portion that contacts a living tissue.   The puncture device according to any one of claims 1 to 4, wherein a rotation axis of the first puncture needle and a rotation axis of the second puncture needle substantially coincide with each other.   The puncture device according to any one of claims 1 to 5, wherein a distal end of the first puncture needle and a distal end of the second puncture needle move in substantially the same plane. In the initial state before puncturing,
The puncture device according to any one of claims 1 to 6, wherein a proximal end portion of the first puncture needle and a proximal end portion of the second puncture needle are arranged so as not to interfere with each other.   The puncture device according to any one of claims 1 to 6, wherein one of the first puncture needle and the second puncture needle is tubular, and the other is inserted into the one.   The puncture device according to any one of claims 1 to 8, further comprising a rotation operation unit configured to rotate the first puncture needle and the second puncture needle. A longitudinal urethra insertion part to be inserted into the urethra;
When the first puncture needle and the second puncture needle are rotated to the distal end side, at least one tip of the first puncture needle and the second puncture needle is located above the urethra insertion portion and the first puncture needle and the The first puncture needle and a restricting portion that restricts a positional relationship between the second puncture needle and the urethral insertion portion so as to pass the distal side from the rotation center of the second puncture needle. The puncture device according to any one of Items 9 to 9. By operating the rotation operation unit, the first puncture needle is rotated by the guide unit to puncture from the first part of the living body, and the second puncture needle is moved by the guide unit in a direction different from that of the first puncture needle. Rotate and puncture from a second part different from the first part of the living body,
A puncture method comprising engaging a distal end portion of the first puncture needle and a distal end portion of the second puncture needle in the living body.

Images