WO2015041140A1

WO2015041140A1 - Puncturing device and puncturing method

Info

Publication number: WO2015041140A1
Application number: PCT/JP2014/074096
Authority: WO
Inventors: 政克川浦; 奈央横井
Original assignee: テルモ株式会社
Priority date: 2013-09-20
Filing date: 2014-09-11
Publication date: 2015-03-26

Abstract

This puncturing device (1) has a puncturing section and an operation section. The puncturing section has: a curved section (713) curved in an arc; and a needle tip (351) that punctures in vivo tissue. The operation section has: a shaft section (73) provided on a rotating shaft (J1); and a coupling section (72) that couples the tip end of the shaft section (73) to the back end of the curved section (713). The arc center of the curved section (713) is on the rotating shaft (J1). The coupling section (72) and shaft section (73) are thicker than the curved section (713), and so the rigidity of the coupling section (72) and the shaft section (73) is greater than the rigidity of the curved section (713). When the shaft section (73) rotates by means of a handle (74), the curved section (713) rotates over a puncturing pathway (X) such that the curved section (713) has the rotating shaft (J1) as the center thereof, and the needle tip (351) punctures in vivo tissue. As such a time, although external force resulting from puncturing resistance is applied to the coupling section (72) and the shaft section (73), the coupling section (72) and shaft section (73) do not deform due to having high rigidity.

Description

Puncture device and puncture method

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

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

Surgical therapy is effective for treating urinary incontinence. For example, a band-like implant called a “sling” is used, and the sling is placed in the body, and the urethra is supported by the sling (see, for example, Patent Document 1). . 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 a puncture needle or the like to connect the peeled portion and the outside through a closed hole ( Hereinafter, this operation is referred to as “puncture operation”). In such a state, the sling is left in the body.

However, during the puncture operation, there is a possibility that the puncture needle is bent or twisted and deformed due to puncture resistance. In this case, there is a risk of puncturing a site different from the target site.

JP 2010-99499 A

An object of the present invention is to provide a puncture device and a puncture method that can reliably puncture a target site.

Such an object is achieved by the present inventions (1) to (8) below.
(1) A puncture portion that is elongated, is curved at least partially in the longitudinal direction, is supported so as to be rotatable about a rotation axis, and punctures a living tissue;
An operation unit that is connected to the puncture unit and rotates the puncture unit about the rotation axis;
The puncture apparatus, wherein the operation unit includes a high-rigidity part having higher rigidity than the puncture part.

(2) The operation unit has a long shape,
The puncture apparatus according to (1), wherein the high-rigidity portion is a portion where the thickness of the operation portion is larger than the thickness of the puncture portion.

(3) The puncture portion has an arc shape, and the center of the arc coincides with the rotation axis,
The operation portion includes a shaft portion disposed on the rotation shaft, and a connecting portion that connects the shaft portion and the puncture portion,
The puncture apparatus according to (1) or (2), wherein at least the connecting portion is the high-rigidity portion.

(4) The puncture device according to (3), wherein the connecting portion has a long shape, and the middle is curved or bent.

(5) The puncture device according to the above (3) or (4), wherein the connecting portion has a linear shape and has a portion inclined with respect to the rotation axis.

(6) The puncture device according to any one of (2) to (5), wherein the shaft portion is the high-rigidity portion.

(7) having a boundary portion located between the operation portion and the puncture portion;
The puncture apparatus according to any one of (1) to (6), wherein the boundary portion gradually increases in thickness toward the operation portion side.

(8) It has a long shape, is curved at least partly in the longitudinal direction, is supported so as to be rotatable around a rotation axis, is connected to the puncture unit, and is connected to the puncture unit. A puncture method for puncturing a living body with a puncture device having a highly rigid portion with higher rigidity and an operation portion for rotating the puncture portion about the rotation axis,
When the puncture unit punctures a living body, deformation of the operation unit is prevented or suppressed by the high-rigidity unit.

According to the present invention, since the operation portion is a highly rigid portion having higher rigidity than the puncture portion, it is possible to prevent the operation portion from being deformed by puncture resistance when the puncture portion punctures a living body. Thereby, the puncture part can puncture a target site reliably.

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. 4 is a side view of the insertion tool of the puncture device shown in FIG. FIG. 5 is a cross-sectional view for explaining the function of the marker provided in the urethral insertion portion, in which (a) shows an inappropriate case, and (b) shows an appropriate case. FIG. 6 is a cross-sectional view for explaining the function of the marker provided in the urethra insertion part. FIG. 7 is a view 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. FIG. 8 is a partially enlarged view of the vaginal insertion tool included in the insertion tool shown in FIG. 2, wherein (a) is a top view and (b) is a cross-sectional view. 9A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 9B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. FIG. 10 is a cross-sectional view showing a state where the vaginal insertion portion shown in FIG. 2 is inserted into the vagina. FIGS. 11A and 11B are diagrams for explaining the maintenance mechanism and the displacement mechanism of the insertion tool shown in FIG. 2, in which FIG. 11A shows a locked state, and FIG. 11B shows a released state. . 12 is a view showing a puncture member included in the puncture apparatus shown in FIG. 2, wherein (a) is a perspective view and (b) is a cross-sectional view taken along line AA in (a). 13 is a cross-sectional view of the puncture member shown in FIG. FIG. 14 is a view showing a state maintaining mechanism of the puncture member shown in FIG. 2, wherein (a) is a top view, and (b) and (c) are cross-sectional views. 15 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 2, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. is there. 16 is a cross-sectional view of the guide portion shown in FIG. FIG. 17 is a perspective view showing an operation member included in the puncture device shown in FIG. 18 is a view as seen from the direction of arrow A in FIG. FIG. 19 is a view as seen from the direction of arrow B in FIG. FIG. 20 is a plan view showing a frame fixing portion provided in the puncture device shown in FIG. 2. FIG. 21 is a view of the puncture device shown in FIG. 2 as viewed from the distal end side. FIG. 22 is a view showing a pelvis and a closing hole. 23A and 23B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 24A and 24B are diagrams for explaining the operation procedure of the puncture device shown in FIG. FIGS. 25A and 25B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2. FIG. 26 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 27 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. FIGS. 28A and 28B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2. FIGS. 29A and 29B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2. FIG. 30 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 31 is a cross-sectional view showing the posture of the puncture member relative to the urethra in the state shown in FIG. 32A and 32B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 33 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. FIG. 34 is a perspective view of an operation member included in the puncture device according to the second embodiment of the present invention. FIG. 35 is a perspective view of an operation member included in the puncture device according to the third embodiment of the present invention. FIG. 36 is a perspective view of an operation member included in the puncture device according to the fourth embodiment of the present invention. FIG. 37 is a view showing a guide part provided in the puncture device according to the fifth embodiment of the present invention, where (a) is a view seen from the distal end side, and (b) is an arrow C in (a). It is the figure seen from the direction. FIGS. 38A and 38B are views showing a guide part provided in the puncture device according to the sixth embodiment of the present invention, wherein FIG. 38A is a view seen from the distal end side, and FIG. 38B is an arrow D in FIG. It is the figure seen from the direction. FIG. 39 is a side view showing an insertion tool included in the puncture device according to the seventh embodiment of the present invention. FIG. 40 is a side view showing an insertion tool included in the puncture device according to the eighth embodiment of the present invention. FIG. 41 is a side view showing an insertion tool included in the puncture device according to the ninth embodiment of the present invention. FIG. 42 is a cross-sectional view showing a state where the urethral insertion tool of the insertion tool shown in FIG. 41 is inserted into the urethra. FIG. 43 is a side view of the insertion tool included in the puncture device according to the tenth embodiment of the present invention, in which (a) shows a state locked by the maintenance mechanism, and (b) shows a state in which the maintenance mechanism is released. FIG. 44 (a) is a side view of an insertion tool included in the puncture device according to the eleventh embodiment of the present invention, FIG. 44 (b) is a side view showing a state locked by the maintenance mechanism, and FIG. 44 (c) is the maintenance mechanism. It is a side view which shows the state released | released. FIG. 45 is a side view of an insertion tool included in the puncture device according to the twelfth embodiment of the present invention. FIG. 46 is a cross-sectional view showing a state in which the vaginal insertion tool shown in FIG. 45 is inserted into the vagina. FIG. 47 is a side view of an insertion tool included in the puncture device according to the thirteenth embodiment of the present invention. 48 is a view showing the distal end portion of the vaginal insertion tool shown in FIG. 47, in which (a) is a top view and (b) is a cross-sectional view taken along line BB in (a). 49 is a diagram showing a state in which the distal end portion shown in FIG. 48 is inserted into the vagina, in which (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed. FIG. FIG. 50 is a cross-sectional view showing the distal end portion of the vaginal insertion tool included in the puncture device according to the fourteenth embodiment of the present invention. 51 is a diagram showing a state in which the distal end portion shown in FIG. 50 is inserted into the vagina, in which (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed. FIG. FIG. 52 is a cross-sectional view showing the distal end portion of the vaginal insertion tool included in the puncture device according to the fifteenth embodiment of the present invention. FIGS. 53A and 53B are views showing the distal end portion of the vaginal insertion tool included in the puncture device according to the sixteenth embodiment of the present invention, wherein FIG. 53A is a side view, FIG. 53B is a top view, and FIG. is there. 54 is a diagram showing a state in which the distal end portion shown in FIG. 53 is inserted into the vagina, where (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed. FIG. FIG. 55 is a view showing a distal end portion of a vaginal insertion tool included in a puncture device according to a seventeenth embodiment of the present invention. 56A and 56B are views showing the distal end portion of the vaginal insertion tool included in the puncture device according to the eighteenth embodiment of the present invention, wherein FIG. 56A is a side view and FIG. 56B is a cross-sectional view. FIGS. 57A and 57B are diagrams for explaining the function of the tip shown in FIG. 56, respectively. FIG. 58 is a side view showing a urethra insertion tool included in the puncture device according to the nineteenth embodiment of the present invention. FIG. 59 is a side view showing a urethra insertion part included in the puncture device according to the twentieth embodiment of the present invention. 60 (a) and 60 (b) are partial cross-sectional views showing a urethra insertion part included in the puncture device according to the twenty-first embodiment of the present invention. FIG. 61 is a perspective view showing a puncture member included in the puncture apparatus according to the twenty-second embodiment of the present invention. 62 is a cross-sectional view showing a modification of the puncture member shown in FIG. FIG. 63 is a cross-sectional view showing an operation member included in the puncture device according to the twenty-third embodiment of the present invention.

Hereinafter, a puncture apparatus and a 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. 4 is a side view of the insertion tool of the puncture device shown in FIG. FIG. 5 is a cross-sectional view for explaining the function of the marker provided in the urethral insertion portion, in which (a) shows an inappropriate case, and (b) shows an appropriate case. FIG. 6 is a cross-sectional view for explaining the function of the marker provided in the urethra insertion part. FIG. 7 is a view 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. FIG. 8 is a partially enlarged view of the vaginal insertion tool included in the insertion tool shown in FIG. 2, wherein (a) is a top view and (b) is a cross-sectional view. 9A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 9B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. FIG. 10 is a cross-sectional view showing a state where the vaginal insertion portion shown in FIG. 2 is inserted into the vagina. FIGS. 11A and 11B are diagrams for explaining the maintenance mechanism and the displacement mechanism of the insertion tool shown in FIG. 2, in which FIG. 11A shows a locked state, and FIG. 11B shows a released state. . 12 is a view showing a puncture member included in the puncture apparatus shown in FIG. 2, wherein (a) is a perspective view and (b) is a cross-sectional view taken along line AA in (a). 13 is a cross-sectional view of the puncture member shown in FIG. FIG. 14 is a view showing a state maintaining mechanism of the puncture member shown in FIG. 2, wherein (a) is a top view, and (b) and (c) are cross-sectional views. 15 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 2, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. is there. 16 is a cross-sectional view of the guide portion shown in FIG. FIG. 17 is a perspective view showing an operation member included in the puncture device shown in FIG. 18 is a view as seen from the direction of arrow A in FIG. FIG. 19 is a view as seen from the direction of arrow B in FIG. FIG. 20 is a plan view showing a frame fixing portion provided in the puncture device shown in FIG. 2. FIG. 21 is a view of the puncture device shown in FIG. 2 as viewed from the distal end side. FIG. 22 is a view showing a pelvis and a closing hole. 23A and 23B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 24A and 24B are diagrams for explaining the operation procedure of the puncture device shown in FIG. FIGS. 25A and 25B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2. FIG. 26 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 27 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. FIGS. 28A and 28B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2. FIGS. 29A and 29B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2. FIG. 30 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 31 is a cross-sectional view showing the posture of the puncture member relative to the urethra in the state shown in FIG. 32A and 32B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 33 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.

In the following, for convenience of explanation, the left side in FIG. 3 is also referred to as “tip”, the right side is also referred to as “base end”, the upper side is also referred to as “upper”, and the lower side is also referred to as “lower”. FIG. 3 shows a state that is not yet used. Hereinafter, for convenience of explanation, this state is also referred to as an “initial state”. For convenience of explanation, the state where the puncture device (insertion tool) shown in FIG. 3 is attached to the patient is also referred to as “wearing state”. Moreover, in FIG. 13 and FIG. 14, the puncture member currently extended in circular arc shape is linearly extended and shown for convenience of explanation, respectively.

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

1 is an instrument 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 has an implant body 91 and a band 92 connected to one end of the implant 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 shape as long as the same effect can be exhibited.

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

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

As shown in FIG. 2, the puncture device 1 includes a frame (support portion) (support member) 2, an insertion tool 6, an operation member 7, and a puncture member 3. The insertion tool 6 and the operation member 7 are supported, and the puncture member 3 is supported by the operation member 7.

Hereinafter, each of these units will be described in order.
2-1. Insertion Tool As shown in FIG. 4, the insertion tool 6 includes a urethral insertion tool 4 and a vaginal insertion tool 5.

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

Further, the length of the urethral insertion portion 41 (portion on the 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 mm to 100 mm.

The urethral insertion portion 41 has a straight tubular shape. A distal end portion of the urethra insertion portion 41 is provided with a balloon (engagement portion) 42 that has extensibility and can be expanded / contracted, and a urine discharge portion 47.

The balloon 42 is disposed so as to be located 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. 4, 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 discharge part 47 is used to discharge urine in the bladder with the urethra insertion part 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.

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

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

The plurality of suction holes 44 are arranged over the entire 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 portion 41 inserted into the urethra, the urethra wall can be adsorbed and fixed to the suction hole 44. In particular, as in the present embodiment, by providing a plurality of suction holes 44 over the entire area in the circumferential direction of the urethra insertion part 41, a wide range of the urethra wall can be adsorbed and fixed to the urethra insertion part 41.

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

When the urethra insertion part 41 is pushed into the body inside (the distal end side of the urethra insertion part 41) with the urethra wall adsorbed and fixed to the urethra insertion part 41 in this way, the urethra and bladder are pushed into the body along with this, The bladder can be shifted to a position that does not overlap the puncture route (puncture target site) X of the puncture member 3. Therefore, a larger puncture path X of the puncture member 3 can be ensured, and the puncture member 3 can be punctured accurately and safely.

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

Specifically, as shown in FIG. 5 (a), when the separation distance between the bladder 1310 and the urethral orifice 1320 is less than a predetermined distance, the urethral insertion portion 41 is inserted into the urethra 1300, and the balloon 42 is expanded. In the state of being engaged with the bladder neck, the marker 46 is exposed from the urethral opening 1320. On the other hand, as shown in FIG. 5B, when the separation distance between the bladder 1310 and the urethral orifice 1320 is equal to or greater than a predetermined distance, the urethra insertion part 41 is inserted into the urethra 1300 and the balloon 42 is expanded to expand the bladder neck In the state of being engaged with the part, the marker 46 is located in the urethra 1300 and is not exposed from the urethral opening 1320.

As shown in FIG. 5A, if the marker 46 is exposed from the urethral opening 1320, the distance between the bladder 1310 and the urethral opening 1320 is short, and there is sufficient space between them to puncture the puncture member 3. Expected not to exist. Therefore, in this case, it is determined that the puncture member 3 cannot be punctured.

On the other hand, as shown in FIG. 5B, if the marker 46 is not exposed from the urethral orifice 1320, the distance between the bladder 1310 and the urethral orifice 1320 is sufficiently long, and the puncture member 3 is punctured between them. It is expected that there will be sufficient space for Therefore, in this case, it is determined that the puncture member 3 can be punctured.

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

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

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

As shown in FIGS. 4 and 5, a sliding resistance amplifying section 49 is provided at the distal end of the urethra insertion portion 41 to increase the sliding resistance against the urethra by contacting the urethra wall (tissue in the urethra). Is provided. As described above, during the procedure using the puncture device 1, the urethra wall is adsorbed and fixed to the urethra insertion part 41, and the urethra insertion part 41 is pushed into the body, whereby the bladder 1310 is punctured by the puncture member 3. However, if the suction hole 44 does not sufficiently adsorb the urethral wall, the urethral wall may come off from the suction hole 44, and the bladder 1310 may not be pushed in sufficiently. Therefore, as in the present embodiment, the sliding resistance amplifying portion 49 is provided in the urethra insertion portion 41 so that the urethral insertion portion 41 is not easily slid with respect to the urethra wall. Even in such a case, if the suction through the suction hole 44 is sufficient, the bladder 1310 can be pushed into the body more reliably by a synergistic effect therewith. Therefore, the puncture member 3 can be punctured more safely.

The configuration of the sliding resistance amplifying unit 49 is not particularly limited as long as the above effects can be exhibited. In this embodiment, it is composed of fine irregularities (rough surface) formed on the surface of the urethral insertion portion 41. Thereby, the structure of the sliding resistance amplification part 49 becomes simple. The sliding resistance amplifying unit 49 is provided over the entire circumferential direction of the urethral insertion unit 41. Thereby, since the area of the sliding resistance amplification part 49 can be enlarged more, the sliding resistance with respect to the urethra 1300 can be raised more. The sliding resistance amplifier 49 can be formed by embossing, sandblasting, laser processing, or the like.

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

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

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

The marker 45 is in contact with the restricting portion 48 and in a state where further sliding toward the proximal end is restricted (the state shown in FIG. 4), the puncture route of the puncture member 3 and a predetermined relative positional relationship It is positioned so that Therefore, as shown in FIG. 6, the puncture route X of the puncture member 3 can be positioned with respect to the urethral opening 1320 by inserting the urethral insertion portion 41 into the urethra 1300 and positioning the marker 45 at the urethral opening 1320. it can. Thus, by positioning the puncture route X with respect to the urethral opening 1320, for example, compared with the case of positioning with respect to the bladder 1310, positioning accuracy is increased, and the puncture member 3 is accurately punctured. Can do. Here, the “predetermined relative positional relationship” means, for example, a positional relationship in which the puncture route X of the puncture member 3 does not overlap the bladder 1310 in a state where the marker 45 is positioned at the urethral opening 1320. Can do.

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

Such a marker 45 has a function of positioning the puncture route of the puncture member 3 with respect to the urethral opening 1320 as described above, and the urethral insertion portion 41 is inserted into the urethra 1300 via the urethral opening 1320. It has a function as an inflow reduction unit 450 that suppresses the inflow of air into the urethra 1300. More specifically, as shown in FIG. 6, when the urethral insertion portion 41 is inserted into the urethra 1300 and the marker 45 is in contact with the urethral opening 1320, the urethral opening 1320 is covered with the marker 45. ing. Therefore, it is difficult for air to flow into the urethra 1300 from the urethral opening 1320, and the inflow of air into the urethra 1300 (suction hole 44) via the urethral opening 1320 can be suppressed. As a result, the suction of the urethra wall by the suction hole 44 can be performed more reliably and effectively.

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

Next, the inclination between the urethra insertion part 41 and the puncture member 3 will be described. As shown in FIG. 3, the inclination angle of the plane f9 (plane f1) with respect to the plane f2 orthogonal to the axis J2 of the urethra insertion portion 41 (in other words, the angle formed by the axes (rotation axes) J1 and J2) θ2 is particularly Although not limited, it is preferably about 20 ° to 60 °, more preferably about 30 ° to 45 °, and further preferably about 35 ° to 40 °. Thereby, the puncture of the puncture member 3 can be performed easily, and the puncture distance by the puncture member 3 can be further shortened.

More specifically, by setting the inclination angle θ2 within the above range, the puncture member 3 can widely grasp the left and right closure holes 1101 and 1102 of the pelvis 1100 in a plane as shown in FIG. It is possible to secure a wide puncture space for the puncture member 3. That is, the puncture member 3 can be punctured in a relatively vertical direction with respect to the closing holes 1101 and 1102 in a state where the patient is in a predetermined body position (crushed stone position). Therefore, the puncture member 3 can be punctured easily.

In addition, since the puncture member 3 passes through a shallow portion of the tissue by puncturing the puncture member 3 in a relatively vertical direction with respect to the closure holes 1101 and 1102, the needle body 35 of the puncture member 3 is closed to the left and right closure holes. It passes between 1101 and 1102 at a shorter distance. Therefore, as shown in FIG. 7B, the puncture member 3 can pass through the closure holes 1101 and 1102 near the pubic joint 1200, preferably through the safety zone S5. Since the safety zone S5 is a region where there are few nerves and blood vessels to avoid damage, the puncture member 3 can be punctured safely by passing through the safety zone S5. Therefore, it becomes less invasive and can reduce the burden on the patient.

Thus, by setting the inclination angle θ2 within the above range, it is possible to more appropriately puncture the patient with the puncture member 3. 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.

On the other hand, when the inclination angle θ2 is less than the lower limit value or exceeds the upper limit value, the puncture member 3 planarly closes the closing holes 1101 and 1102 depending on individual differences in the patient, the posture during the procedure, and the like. There are cases where it is not possible to capture widely or the puncture route cannot be shortened sufficiently.

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

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

-Vaginal insertion tool-
As shown in FIGS. 4 and 8, the vaginal insertion tool 5 includes a long vagina insertion portion 51 inserted into the vagina partway and a support portion (vaginal insertion portion support portion) that supports the vagina insertion portion 51. 50. The vaginal insertion portion 51 has a distal end portion 52 located on the distal end side and a shaft portion 53 connected to the proximal end portion of the distal end portion 52, and the shaft portion 53 is supported by the support portion 50.

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

The tip 52 is a part that is inserted into the vagina. The length L2 from the distal end to the proximal end of the distal end portion 52 is not particularly limited, but is preferably about 20 mm to 100 mm, and more preferably about 30 mm to 60 mm. The width W1 of the tip 52 is not particularly limited, but is preferably about 10 mm to 50 mm, and more preferably about 20 mm to 40 mm. By setting such length (L2) × width (W1), the tip 52 has a shape and size suitable for a general vagina. Therefore, the stability of the puncture device 1 in the mounted state is increased, and the burden on the patient is reduced.

Also, the tip 52 has a generally constant width as a whole, and the tip is rounded. The distal end portion 52 is located on the distal end side, and the tapered portion 521 whose height gradually increases toward the proximal end side, and the inflow reduction portion 522 located on the proximal end side of the tapered portion 521 and having a substantially constant height. And have. As will be described later, the inflow reduction unit 522 has a function of suppressing the inflow of air into the vagina via the vaginal opening with the tip 52 inserted into the vagina.

In the taper portion 521, the upper surface (the surface on the urethral insertion portion 41 side) 521a is inclined with respect to the urethral insertion portion 41 so as to move away from the urethral insertion portion 41 toward the distal end. Thereby, compared with the case where it does not incline, the positional relationship of the urethra insertion part 41 and the front-end | tip part 52 can be closely approached to the actual positional relationship of the urethra and the vagina. Therefore, the puncture device 1 is more stably held by the patient in the wearing state, and the burden on the patient is reduced.

The inclination angle θ3 of the upper surface 521a 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.

Further, a suction hole 54 is provided in the distal end portion 52 as a suction portion for adsorbing the vagina wall to the distal end portion 52.

The suction hole 54 has a bottomed recess 541 that opens to the upper surface 521a of the tapered portion 521. Thereby, as will be described later, the front wall of the vagina can be adsorbed to the tip portion 52. The suction hole 54 is provided in the distal end portion 52 and has a connection hole 542 that connects the bottom surface of the concave portion 541 and the suction port 543 provided in the proximal end portion of the distal end portion 52.

The suction port 543 is provided so as to be located outside the living body in the mounted state. A suction device such as a pump can be connected to the suction port 543. When the suction device is operated with the distal end portion 52 inserted into the vagina, the vaginal front wall, which is the upper surface of the vagina wall, is adsorbed to the recess 541. Fixed. When the vaginal insertion part 51 is pushed into the body (the distal end side of the vaginal insertion part 51) with the front wall of the vagina adsorbed and fixed to the concave part 541, the vaginal wall can be pushed together. Therefore, the arrangement and shape of the vagina wall can be adjusted, and the puncture route of the puncture member 3 can be sufficiently secured. As a result, the puncture member 3 can be punctured accurately and safely.

Note that the number of suction holes 54 is not limited to one, and a plurality of suction holes 54 may be provided. When a plurality of suction holes 54 are provided, the arrangement of the recesses 541 is not particularly limited, and may be arranged side by side in the length direction, may be arranged side by side in the width direction, or may be long. They may be arranged in rows and columns in the horizontal direction and in the width direction, or may be arranged irregularly.

As shown in FIG. 4, the region S2 where the recess 541 is formed is opposed to the region S1 where the suction hole 44 is formed. The puncture device 1 is configured such that the needle tip of the puncture member 3 passes between these regions S1 and S2. As described above, since the urethral wall is adsorbed by the urethral insertion portion 41 in the region S1 and the vagina wall is adsorbed by the 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 member 3 through such a region, the puncture member 3 can be punctured more safely.

In addition, as shown to Fig.8 (a), it is preferable that area | region S2 covers substantially the whole area of the width direction of the upper surface 521a. The width W2 of the region S2 is not particularly limited, but is preferably about 9 to 49 mm, and more preferably about 19 to 39 mm. Thereby, the vaginal wall can be more reliably adsorbed to the distal end portion 52 without being greatly affected by the shape of the vaginal wall.

In particular, depending on the patient, as shown in FIG. 9A, the central part 1401 of the anterior wall of the vagina hangs down into the vagina and dents (parts called “button holes”) 1402 exist on both sides thereof. May have. Even in such a case, as shown in FIG. 9B, 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 it is effective that the puncture member 3 is punctured into the recessed portion 1402. Can be prevented.

Here, as shown in FIG. 10, in a state where the distal end portion 52 is inserted into the vagina 1400, the vicinity of the vagina opening 1410 of the vagina 1400 (the base end side from the portion where the recess 541 of the vagina 1400 is located) and the vagina opening 1410. The inflow reduction part 522 is located in the position. The inflow reducing portion 522 is higher than the tapered portion 521 on the distal end side, and its entire circumference (cross-sectional area) is also longer than the tapered portion 521. Therefore, the vicinity of the vaginal opening 1410 and the vaginal opening 1410 of the vagina 1400 extend greatly, and the contraction force strongly adheres to the outer periphery of the inflow reduction unit 522. Therefore, the inflow of air into the vagina 1400 (recessed portion 541) through the vaginal opening 1410 is suppressed, and the suction of the vagina wall by the suction hole 54 can be performed more reliably and effectively.

In addition, as a shape of the inflow reduction part 522, if the above-mentioned effect can be exhibited, it will not be limited to the shape of this embodiment, For example, height H1 may increase gradually toward the base end side. In this case, the upper surface of the inflow reducing portion 522 may be a continuous surface having the same inclination as the upper surface 521a of the tapered portion 521, or may be a discontinuous surface having a different inclination.

Further, a marker 57 that can confirm the puncture route of the puncture device 1 is provided at the distal end portion 52. Since the marker 57 is provided so that the puncture member 3 punctures between the vagina wall and the urethra wall located above, the puncture route of the puncture member 3 can be easily confirmed by confirming the position of the marker 57. As a result, the operability and safety of the puncture apparatus 1 are improved. It is preferable that the marker 57 is provided on at least one of the lower surface and the side surface of the distal end portion 52. Since the lower surface and the side surface are easily visible to the operator even when the distal end 52 is inserted into the vagina, the puncture route of the puncture member 3 can be easily confirmed by providing the marker 57 at such a position. can do. Further, the insertion depth of the distal end portion 52 into the vagina can also be confirmed. Such a 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 10 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. The length of the shaft portion 53 (the distance between the tip portion 52 and the support portion 50) is not particularly limited, but is preferably about 100 mm or less, and more preferably about 20 to 50 mm. Thereby, the axial part 53 can be made into appropriate length and the operativity of the puncture apparatus 1 improves. If the length of the shaft portion 53 exceeds the above upper limit value, the center of gravity of the puncture device 1 is greatly separated from the patient depending on the configuration of the frame 2 and the stability of the puncture device 1 in the mounted state is lowered. There is a case.

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

As shown in FIG. 4, the displacement mechanism 62 has a hinge portion 621, and the

support portions

40 and 50 are rotatably connected by the hinge portion 621. Thus, by connecting the

support portions

40 and 50 so as to be rotatable, a displacement mechanism 62 having a simple configuration can be obtained, and further, an operation of bringing the distal end portion 52 closer to the urethra insertion portion 41 can be easily performed. Will be able to do.

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

As illustrated in FIG. 4, the maintenance mechanism 61 includes an operation unit 611 provided in the support unit 50 and an engagement unit 612 provided in the support unit 40 and engaged with the operation unit 611. The operation unit 611 includes a shaft portion 611a capable of bending deformation (elastic deformation), a knob 611b connected to the shaft portion 611a, and a claw portion 611c provided at the tip of the knob 611b. One engaging portion 612 includes a concave portion 612 a formed in the support portion 40.

As shown in FIG. 11 (a), the nail | claw part 611c is made into the state engaged with the recessed part 612a, the support part 50 is fixed to the support part 40, and the relative position of the urethral insertion tool 4 and the vaginal insertion tool 5 is shown. A relationship can be maintained. On the other hand, as shown in FIG. 11B, the maintenance state is released by pulling the knob 611b downward and removing the claw portion 611c from the recess 612a, and the vaginal insert 5 is rotated with respect to the urethra insert 4 It becomes possible. And in the state which can be rotated, the vagina insertion part 51 (front-end | tip part 52) can be made to approach the urethra insertion part 41 rather than the maintenance state shown to Fig.11 (a).

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

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

2-2. Puncture member The puncture member (puncture needle) 3 is a member for puncturing a living body. As shown in FIG. 12A, the puncture member 3 has a long sheath (medical tube) 30 and a needle body 35 provided at the distal end of the sheath 30. The sheath 30 includes a tubular main body 31 and a state maintaining mechanism 34.

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

The main body 31 has a curved shape that is curved in an arc shape. Further, as shown in FIG. 12B, the main body 31 has a flat cross-sectional shape having a short axis J31 and a long axis J32. By making the main body 31 into a flat shape, the implant main body 91 can be controlled in a desired posture within the main body 31.

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

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

In the following, for convenience of explanation, as shown in FIG. 12B, the end located on the inner side in the major axis J32 direction is also referred to as “inner peripheral portion A1”, and the end located on the outer side in the major axis J32 direction. The portion is also referred to as “outer peripheral portion A2”, the surface facing upward is also referred to as “front surface A3”, and the surface facing downward is also referred to as “back surface A4”.

As shown in FIG. 12B, a plane (plane including the central axis of the main body 31) including both the central point of the arc of the central portion S4 and the central point of the cross-sectional shape with respect to the longitudinal direction of the main body 31 is defined as a plane f9. When the angle formed between the plane f9 and the short axis J31 at the central portion S4 is defined as an inclination angle θ1, the inclination angle θ1 is preferably an acute angle. By setting the inclination angle θ1 to an acute angle, the implant body 91 can be disposed substantially parallel to the urethra, as will be described later. Therefore, the urethra can be supported more effectively.

The inclination angle θ1 is not particularly limited as long as it is an acute angle. 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.

In addition, although it is preferable that the inclination angle θ1 satisfies the numerical range in the entire extending direction of the main body 31, it is only necessary to satisfy the numerical range at least in the central portion S4. Here, the “central portion S4” means at least a region including a portion located between the urethra and the vagina in a state where the puncture member 3 is punctured into the living body (a state where the main body 31 is disposed in the living body). .

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

The configuration of the main body 31 can be rephrased as follows. That is, as shown in FIG. 12B, the main body 31 is formed such that the long axis J32 is inclined with respect to the central axis J5 of the arc, and an extension line J32 ′ between the central axis J5 and the long axis J32 is formed. It can also be said that it is configured to have an intersection P. In this case, the angle θ5 formed by the central axis J5 and the extension line J32 ′ is equal to the inclination angle θ1.

In other words, as shown in FIG. 21, the main body 31 has an inner peripheral portion that is located at the inner peripheral edge and has a minimum radius of curvature r1 in a plan view when viewed from the direction of the central axis J5 of the main body 31. A1 and an outer peripheral portion A2 located at the outer peripheral edge and having a maximum radius of curvature r2, as shown in FIG. 12B, the inner peripheral portion A1 and the outer peripheral portion A2 are shifted from each other in the direction of the central axis J5. It can be said that it is configured as follows.

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

As shown in FIG. 13, the distal end divided piece 32 has a tube shape and has a distal end side opening 321 and a proximal end side opening 322. Further, the base end split piece 33 also has a tube shape and has a front end side opening 331 and a base end side opening 332. And the front-end | tip part of the base end split piece 33 is inserted in the base end part of the front end split piece 32, and, thereby, the front end split piece 32 and the base end split piece 33 are connected. By inserting the proximal end divided piece 33 into the distal divided piece 32, a step that may occur at the boundary between the divided

pieces

32 and 33 becomes difficult to be caught by the living tissue when the puncture member 3 is punctured, and the puncture member 3 is punctured into the living body. Can be performed smoothly. However, contrary to the present embodiment, the

split pieces

32 and 33 may be connected by inserting the base end of the tip split piece 32 into the base split piece 33.

The state where the divided

pieces

32 and 33 are connected (connected state) is maintained by the state maintaining mechanism 34. As shown in FIG. 14A, the state maintaining mechanism 34 includes

holes

342a, 342b, and 342c, an endless thread 341 inserted through the

holes

342a, 342b, and 342c, and an exposure hole 345 that exposes the thread 341. 346 and a slit 347 that connects the exposure holes 345 and 346.

The hole 342a is a base end portion of the base end split piece 33 and is provided near the inner peripheral portion A1 of the surface A3. On the other hand, the

holes

342b and 342c are the base end portions of the tip split piece 32, and are provided facing the inner peripheral portion A1 of the front surface A3 and the back surface A4.

The yarn 341 is disposed in the main body 31 and is routed outside the main body 31 between the hole 342b and the hole 342c and between the hole 342a and the proximal end opening 332, respectively. Thereby, the connection state of the division |

segmentation pieces

32 and 33 can be maintained easily. Further, the exposure of the thread 341 to the outside of the main body 31 can be suppressed, and the thread 341 is hardly caught on the living tissue. Further, since the entire length of the thread 341 can be shortened as much as possible, the thread 341 is hardly caught by the implant 9 when the implant 9 is inserted into the main body 31. In particular, as described above, since the

holes

342a, 342b, and 342c are respectively disposed closer to the inner peripheral portion A1, the yarn 341 is also biased toward the inner peripheral portion A1. Therefore, the thread 341 is hardly caught by the implant 9.

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

Here, as shown in FIG. 14C, the axis of the hole 342a is inclined so that the outer opening is located closer to the base end side than the inner opening. On the other hand, the axes of the

holes

342b and 342c are inclined so that the outer opening is positioned at the tip of the inner opening as shown in FIG. 14 (b). Thereby, each

hole

342a, 342b, 342c can be extended along the path | route of the thread | yarn 341, and the thread | yarn 341 becomes difficult to be caught in each

hole

342a, 342b, 342c.

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

holes

342b and 342c. Further, the thread 341 includes a string, a band, and the like that can be used in the same manner as the thread 341.

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

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

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

Thus, in this embodiment, the slit 347 is used as the blade passage. Accordingly, the thread 341 can be easily cut as described above, and deformation of the main body 31 due to the tension of the thread 341 is prevented. For example, as illustrated in FIG. 15A, the passage path of the blade may be configured by a hole 348 instead of the slit 347. However, in this case, depending on the hardness of the main body 31, as shown in FIG. 15B, the hole 348 may buckle and collapse due to the tension of the thread 341, and the main body 31 may be deformed. On the other hand, in the slit 347, as shown in FIG. 15C, the

portions

347a and 347b sandwiching the slit 347 are in contact with each other and are stretched. Is prevented.

A needle body 35 is provided at the tip of the main body 31 as described above. As shown in FIG. 13, the needle body 35 has a tapered needle tip 351 and a proximal end portion 352 provided on the proximal end side of the needle tip 351. Then, the base end portion 352 is inserted into the main body 31, whereby the needle body 35 is detachably held on the main body 31. The proximal end portion 352 is fitted into the main body 31 with a force that can prevent unintentional detachment of the needle body 35 from the main body 31.

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

Further, the base end portion 352 is provided with an engaging portion 353 that engages with the distal end portion 711 of the insertion portion 71. The engaging portion 353 is configured by a concave portion, and the distal end portion 711 is positioned in the engaging portion 353 in the inserted state in which the puncture member 3 is inserted into the inserting portion 71. Thereby, the displacement of the puncture member 3 with respect to the insertion part 71 is suppressed, and puncture of the puncture member 3 to a living body can be performed more smoothly.

Note that when the cross-sectional shape of at least the tip end portion 711 of the insertion portion 71 is flat, the cross-sectional shape of the engaging portion 353 is formed in accordance with the cross-sectional shape of the tip end portion 711. That is, it is preferable that the cross-sectional shape of the tip portion 711 is also flat. Thereby, in the state where the engaging portion 353 and the tip portion 711 are engaged, the flat shapes of the engaging portion 353 and the tip portion 711 overlap each other. By this overlap, the sheath 30 is restricted from rotating around the axis with respect to the insertion portion 71.

In addition, the flat shape is not particularly limited. For example, an ellipse, a rhombus with rounded corners, a rectangle with rounded corners (flat shape), and a central portion wider than both ends. It can also be made into a spindle shape with expanded (expanded diameter).

The puncture member 3 has been described above. The central angle θ4 (see FIG. 21) of the puncture member 3 is not particularly limited and is appropriately set according to various conditions. However, the needle body 35 enters the body from one buttock of the patient, and the urethra It is set so that it can pass between the vagina and protrude from the other buttocks. Specifically, the central angle θ4 is preferably about 150 ° to 270 °, more preferably about 170 ° to 250 °, and further preferably about 190 ° to 230 °.

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

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

As shown in FIG. 21, the puncture member 3 is arranged on the guide portion 22 of the frame 2 so that the back surface A4 of the puncture member 3 is located on the distal end side and the front surface A3 is located on the proximal end side. .

In the puncture device 1, the medical tube assembly 10 is configured by the puncture member 3 (main body 31) as described above and the insertion portion 71 of the operation member 7 inserted into the main body 31, and these are the medical tube assembly. Use starts in the state of the solid 10.

2-3. Operation Member The operation member 7 shown in FIG. 17 is a member for rotating the puncture member 3 about the rotation axis J1. The operation member 7 has a long shape and a circular cross section. The operation member 7 can be divided into an insertion portion 71, a shaft portion 73, and a connection portion 72 that connects the insertion portion 71 and the shaft portion 73. The boundary portion between the insertion portion 71 and the connecting portion 72 is a first bent portion 75 bent substantially at a right angle, and the boundary portion between the shaft portion 73 and the connecting portion 72 is bent at a substantially right angle. Two bent portions 76 are formed.

The insertion portion 71 is a part that is inserted into the puncture member 3 and functions as a stylet that reinforces the puncture member 3 from the inside. As shown in FIG. 3, the insertion portion 71 is provided on a plane f1 having the rotation axis J1 as a normal line, and is configured to rotate on the plane f1. By inserting the insertion portion 71 into the puncture member 3, the puncture member 3 is connected to the operation member 7, and the operation member 7 can be operated by the operation member 7.

Further, the insertion portion 71 has a long shape, is curved in an arc shape, and has a bending portion 713 whose center coincides with the rotation axis J1, and a distal end portion 711 provided on the distal end side of the bending portion 713. Can be divided into The central angle of the bending portion 713 is set according to the central angle of the puncture member 3.

The thickness of the curved portion 713 is constant over the entire length in the longitudinal direction of the curved portion 713. Further, as shown in FIG. 18, the diameter D1 of the curved portion 713 is preferably 1 to 10 mm, and more preferably 2 to 5 mm. Thereby, the bending rigidity and the torsional rigidity at the curved portion 713 can be sufficiently secured, and the function as a stylet can be sufficiently exhibited. Hereinafter, the bending rigidity and the torsional rigidity are collectively referred to as “stiffness”.

The tip portion 711 has a tapered shape in which the outer diameter gradually decreases in the tip direction. Thereby, when inserting the insertion part 71 in the puncture member 3, the operation can be performed smoothly.

The shaft portion 73 has a long shape and is provided on the rotation shaft J1. Further, the shaft portion 73 rotates around the rotation axis J1 during the rotation operation. The diameter D2 of the shaft portion 73 is constant over the entire length in the longitudinal direction of the shaft portion 73 and is larger than the diameter D1 of the curved portion 713. That is, the shaft portion 73 is thicker than the curved portion 713.
Such a curved portion 713 and the needle tip 351 of the sheath 30 constitute a puncture portion.

The connecting portion 72 connects the proximal end portion of the insertion portion 71 and the distal end portion of the shaft portion 73. In addition, the connecting portion 72 has an L-shape that is bent at a substantially right angle, and the bent portion is a third bent portion 77. The diameter D3 of the connecting portion 72 is the same as the diameter D2 of the shaft portion 73 and is thicker than the diameter D1 of the bending portion 713. The diameter D3 of the connecting portion 72 and the diameter D2 of the shaft portion 73 are preferably 2 to 20 mm, and more preferably 7 to 15 mm.

The connecting portion 72 and the shaft portion 73 as described above constitute an operation portion that rotates the bending portion 713.

Thus, in the operation member 7, the thickness of the connecting portion 72 and the shaft portion 73 is larger than the thickness of the insertion portion 71. Therefore, the connecting portion 72 and the shaft portion 73 are high-rigidity portions having higher rigidity than the insertion portion 71.

A handle 74 is fixed to the base end portion of the shaft portion 73. By rotating the handle 74, the operation member 7 can be rotated around the rotation axis J1. Yes. When the living body is punctured by operating the handle 74, the handle 74 corresponds to a force point, the shaft portion 73 corresponds to a fulcrum, and the needle tip 351 of the puncture member 3 corresponds to an action point.

Here, when the puncture member 3 punctures a living body, an external force is applied to the puncture member 3 due to the puncture resistance received from the living tissue. Due to the external force, in the operation member 7, the portion between them is easily deformed because the needle tip 351 corresponding to the action point is far from the handle 74 corresponding to the force point. Specifically, as shown in FIG. 19, the connecting portion 72 and the shaft portion 73 are likely to be deformed by bending or twisting like the connecting portion 72 ′ and the shaft portion 73 ′ indicated by a two-dot chain line in the drawing. become. However, as described above, in the puncture device 1, since the connecting portion 72 and the shaft portion 73 are high-rigidity portions, deformation or deformation like the connecting portion 72 ′ and the shaft portion 73 ′ is prevented or suppressed. Can do. Therefore, the needle tip 351 can reliably pass through the puncture route X, and can puncture the target site with certainty.

In particular, since stress concentrates on the first bent portion 75, the second bent portion 76, and the third bent portion 77, these are portions that are relatively easily deformed. The bent portion 75, the second bent portion 76, and the third bent portion 77 are also included in the high-rigidity portion. Thereby, the deformation | transformation in the 1st bending part 75, the 2nd bending part 76, and the 3rd bending part 77 can be prevented or suppressed effectively.

In addition, the insertion part 71, the connection part 72, and the axial part 73 are comprised with the same material. The constituent material is not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like can be used.

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

As shown in FIGS. 2 and 3, the frame 2 includes a bearing portion 21 that supports the shaft portion 73 of the operation member 7, a guide portion (contact member) 22 that guides the puncture member 3, and the bearing portion 21 and the guide. It has the connection part 23 which connects the part 22, and the fixing | fixed part 24 which fixes the insertion tool 6. FIG.

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 rotation axis J1. A through hole 211 is formed on the rotation shaft J1 of the bearing portion 21, and the shaft portion 73 is rotatably inserted into the through hole 211. Thereby, the operation member 7 is supported by the frame 2 in a state in which the operation member 7 can rotate about the rotation axis J1.

The fixed portion 24 is disposed to face the connecting portion 23 via the rotation axis J1. As shown in FIG. 20, the fixing portion 24 includes a concave portion 243 into which the

support portions

40 and 50 of the insertion tool 6 described above are fitted, and a male screw 244. In such a fixing part 24, the insertion tool 6 can be fixed to the fixing part 24 by fitting the supporting

parts

40 and 50 into the recessed part 243 and further tightening the male screw 244 into the supporting part 40.

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

As shown in FIGS. 2 and 3, the guide portion 22 is provided at the distal end portion of the puncture device 1 and is disposed to face the bearing portion 21. The guide portion 22 has a long shape and is configured by a plate member curved in a substantially arc shape. In addition, the guide portion 22 is provided along the puncture member 3 inside the puncture member 3. The guide portion 22 has a function of guiding the puncture member 3 when the puncture member 3 rotates. Moreover, the cross-sectional shape of the guide part 22 is curving toward the rotation axis J1 over the entire length of the guide part 22 in the longitudinal direction.

As shown in FIG. 21, both end portions of the guide portion 22 are contact portions (pressing portions) 221 and 222 that are portions that contact the body surface H when the living body is punctured by the puncture device 1. . A pair of the

contact portions

221 and 222 are provided via the rotation axis J1, and the left side in FIG. 21 is the contact portion 221 and the right side in FIG. The

contact portions

221 and 222 have a fixed positional relationship with respect to the puncture route X of the needle tip 351.

The distance L1 between the contact portion 221 and the rotation axis J1 (the rotation center of the puncture member 3) in the direction orthogonal to the rotation axis J1 is the rotation axis J1 between the contact portion 222 and the rotation axis J1. This is the same as the distance L3 in the orthogonal direction (see FIG. 21). The distance L1 between the contact portion 221 and the rotation axis J1 and the distance L3 between the contact portion 222 and the rotation axis J1 are in a direction orthogonal to the rotation axis J1 between the puncture member 3 and the rotation axis J1. It is shorter than the distance L6. The positional relationship between the

contact portions

221 and 222 and the needle tip 351 (puncture member 3) is regulated by the frame 2 so as to satisfy the above conditions regardless of the rotation angle of the puncture member 3. Yes. Furthermore, the positional relationship between the

contact portions

221 and 222 and the urethral insertion device 4 is regulated by the frame 2 so that the distance between them is constant.

Further, each of the

contact portions

221 and 222 can function as a positioning portion that positions the puncture path X (the position of the needle tip 351) with respect to the living body in a contact state in contact with the body surface H. Each

contact part

221, 222 has a closed hole (one closed hole) 1102, between the urethral cavity and the vaginal cavity, and the closed hole (the other closed hole) after the needle tip 351 passes through the body surface H. ) It positions with respect to each

closing hole

1101 and 1102 so that it may pass in order of 1101. This will be described below.

As shown in FIG. 28, the abutting part 221 is brought into contact with a part corresponding to the closing hole 1101 of the body surface H, and the abutting part 222 is brought into contact with a part corresponding to the closing hole 1102 on the body surface H, Press toward the living body.

At this time, as shown in FIG. 22 and FIG. 28, the abutting portion 221 passes through the biological tissue covering the pelvis 1100 from the body surface H, and is on the midline 1500 side of the edge of the closing hole 1101 of the pelvis 1100. The portion 1103 is pressed. In the present specification, the “midline” refers to a line passing through the center of the front and back of the human body and along the spine.

On the other hand, the contact portion 222 presses the portion 1104 on the midline 1500 side of the edge of the closed hole 1102 of the pelvis 1100 through the body tissue covering the pelvis 1100 from the body surface H.

Further, as shown in FIG. 22, the contact portion 221 presses the portion 1103 in the direction of arrow A (toward the median line 1500), and the contact portion 222 presses the portion 1104 in the direction of arrow B (median point). (Toward the line 1500). Thereby, each

contact part

221 and 222 will be in the state which pinches | interposes the part between the closing hole 1101 and the closing hole 1102 of the pelvis 1100. In this state, the

contact portions

221 and 222 are restricted from moving in the left-right direction and the up-down direction in FIG. As a result, in the puncture device 1, the

contact portions

221 and 222 are positioned with respect to the closing holes 1101 and 1102.

Depending on the patient's body shape and the like, there is an individual difference in the size of the pelvis 1100, but the interval L5 between the closing hole 1101 and the closing hole 1102 is relatively small (see FIG. 22). Therefore, the

contact portions

221 and 222 can be positioned so that the needle tip 351 passes through the closing holes 1101 and 1102 regardless of the patient's body shape and the like. That is, the puncture device 1 is excellent in versatility.

Further, as shown in FIG. 21, the distance L4 between the

contact portions

221 and 222 is preferably 50 to 200 mm, and more preferably 80 to 100 mm. By setting the separation distance L4 between the

contact portions

221 and 222 within the above range, the contact portion 221 can press the portion 1103 and the contact portion 222 can press the portion 1104.

Further, as described above, each of the

contact portions

221 and 222 has a cross-sectional shape curved toward the rotation axis J1. Thereby, as shown in FIG. 22, each contact part 221,222 can be made into the shape along the curved shape of the

part

1103,1104. For this reason, the

contact parts

221 and 222 can hold the positioning state more stably.

The distance L1 between the contact part 221 and the rotation axis J1 and the distance L3 between the contact part 221 and the rotation axis J1 are 50 to 100% of the distance L6 between the puncture member 3 and the rotation axis J1. Preferably, it is 90 to 100%. Thereby, the needle tip 351 can pass outside the

contact portions

221 and 222 and in the vicinity of the

contact portions

221 and 222. Therefore, the

contact portions

221 and 222 are positioned, and the needle tip 351 can pass through the safety zone S5 of the closing holes 1101 and 1102 (see FIG. 22).

Thus, the positional relationship between the

contact portions

221 and 222 with respect to the puncture member 3 is regulated by the frame 2. For this reason, the surgeon can detect the puncture route X with respect to the living body by the

contact portions

221 and 222. In addition, since the abutting

portions

221 and 222 are configured to position the puncture member 3 with respect to the closure holes 1101 and 1102, the puncture member 3 defines the closure hole 1102 between the closure hole 1101 and the urethra and the vagina. It can pass reliably. Combined with these, the puncture device 1 can puncture the target site more reliably.

Furthermore, as described above, since the

contact portions

221 and 222 are also restricted in positional relationship with respect to the urethral insertion tool 4 and the vagina insertion tool 5 supported by the frame 2, the puncture member 3 is more reliably Can pass between the urethra 1300 and the vagina 1400. That is, the puncture member 3 can pass through the rotation axis J <b> 1 on the distal side of the urethral insertion tool 4 and on the proximal side of the vaginal insertion tool 5. Thereby, the puncture apparatus 1 can puncture a target site reliably.

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

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

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

vagina

1400, 1400 is corrected to the predetermined shape by the vaginal insertion portion 51 (tip portion 52).

Next, the balloon 42 arranged in the bladder 1310 is expanded, and urine is discharged from the bladder 1310 through the urine drainage hole 471 as necessary. Next, as shown in FIG. 23 (b), the urethral insertion portion 41 is pulled to the outside of the body (base end side) until the balloon 42 comes into contact with the bladder neck, and in this state, the marker 46 is exposed from the urethral opening 1320. Check whether or not As described above, when the marker 46 is exposed from the urethral opening 1320, it is determined that the puncture apparatus 1 cannot be used, and the procedure is stopped at this point. On the other hand, when the marker 46 is not exposed from the urethral opening 1320, it is determined that the puncture apparatus 1 can be used, and the procedure is continued.

Next, as shown in FIG. 24 (a), the urethra insertion part 41 is pushed into the body to bring the marker 45 into contact with the urethral opening 1320. Thereby, the puncture member 3 is positioned with respect to the urethral opening 1320, and the puncture route of the puncture member 3 is determined. Here, further, a safer procedure can be performed by confirming the puncture route of the puncture member 3 using the marker 57 provided at the distal end portion 52 of the vaginal insertion portion 51.

Next, a suction device is connected to the

suction ports

433 and 543, the suction device is operated, the urethral wall is adsorbed to the suction hole 44 of the urethral insertion portion 41, and the vagina wall is adsorbed to the suction hole 54 of the vaginal insertion portion 51. Let As described above, at this time, since the marker 45 covers and closes the urethral opening 1320 on the urethra 1300 side, the inflow of air into the urethra 1300 through the urethral opening 1320 is suppressed, and the urethra into the urethra insertion part 41 is suppressed. The wall can be more reliably adsorbed. On the other hand, since the vaginal opening 1410 is in close contact with the inflow reduction portion 522 on the vagina 1400 side, the inflow of air into the vagina 1400 through the vaginal opening 1410 is suppressed, and the vaginal wall 51 is adsorbed to the vaginal insertion portion 51. This can be done more reliably.

In particular, in the vaginal insertion tool 5, as shown in FIG. 24 (b), first, the lock of the maintenance mechanism 61 is released so that the vaginal insertion part 51 can rotate with respect to the urethral insertion part 41, The insertion part 51 is moved to the urethral insertion part 41 side. Thereby, the upper surface 521a of the front-end | tip part 52 and the vagina front wall can be stuck more reliably. In this state, by operating the suction device connected to the suction port 543, the vagina wall can be more reliably adsorbed to the vagina insertion portion 51. After adsorbing the vagina wall, as shown in FIG. 25 (a), the vagina insertion portion 51 is moved away from the urethra insertion portion 41, the maintenance mechanism 61 is locked, and the vagina insertion portion 51 and the urethral insertion portion 41 are moved. The relative positional relationship with is fixed. Thereby, the state where the urethra 1300 and the vagina 1400 are sufficiently separated can be maintained.

In such adsorption, for example, if the urethra wall is properly adsorbed by the urethra insertion portion 41, the suction hole 44 is blocked by the urethra wall, so that the suction from the suction port 433 is stopped or weakened. Similarly, if the vagina wall is properly adsorbed by the vagina insertion portion 51, the suction hole 54 is blocked by the vagina wall, and thus suction from the suction port 543 is stopped or weakened. Therefore, the surgeon determines whether or not the urethral wall and the vagina wall are properly adsorbed to the urethra insertion part 41 and the vagina insertion part 51 based on the suction state from the suction ports 433 and 543 (for example, the magnitude of the sound generated by the suction). Can be confirmed.

Note that 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, the confirmation mechanism is based on a flow rate measurement unit (negative pressure gauge) that measures a flow rate from the suction port 543 and a measurement result from the flow rate measurement unit. It can be set as the structure which has a judgment part which judges whether adsorption | suction is performed correctly.

After the urethral wall and the vagina wall are sufficiently separated to puncture the puncture member 3 as described above, the frame 2 is fixed to the insertion tool 6 as shown in FIG. To do. Thereby, the puncture apparatus 1 will be in the state with which the patient was mounted | worn. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.

Then, as shown in FIG. 27, the restriction portion 48 is removed from the urethral insertion portion 41, and the insertion tool 6 is pushed into the body. As described above, the urethra wall is adsorbed to the urethra insertion part 41 and the vagina wall is adsorbed to the vagina insertion part 51. Therefore, when the insertion tool 6 is pushed into the body, the urethra 1300 and the vagina 1400 are simultaneously inserted. Is pushed in. Therefore, it becomes easier to puncture the tissue with the puncture member 3. Moreover, the puncture target site can be punctured more reliably.

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

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

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

Next, the abutting

portions

221 and 222 are brought into contact with the body surface H while the urethra 1300 and the vagina 1400 are pushed into the body. Further, the

contact portions

221 and 222 are pressed toward the pelvis 1100 side. At this time, the contact portion 221 presses the portion 1103 via the biological tissue covering the pelvis 1100, and the contact portion 222 presses the portion 1104 via the biological tissue covering the pelvis 1100. Thereby, the puncture apparatus 1 will be in a positioning state (refer Fig.28 (a)).

It should be noted that when the

contact portions

221 and 222 are pressed toward the living body, the

contact portions

221 and 222 may press portions other than the

closed holes

1101 and 1102 of the pelvis 1100. In such a case, the

contact portions

221 and 222 are moved toward the pelvis 1100 while moving in the left-right direction and the up-down direction in FIG. By this moving operation, the

contact portions

221 and 222 are moved to the positions shown in FIG. In addition, when it will be in a positioning state by moving operation, the

contact parts

221 and 222 will move from the pelvis 1100 (hard part) to the closing holes 1101 and 1102 (soft part). The surgeon can recognize that the puncture device 1 is in the positioning state due to the change of the touch transmitted to the finger through the puncture device 1.

Further, in this positioning state, as described above, the

contact portions

221 and 222 sandwich the portion between the closing hole 1101 and the closing hole 1102 of the pelvis 1100. Thereby, the operator can hold | maintain the positioning state stably.
After setting the positioning state in this way, puncture of the living body by the puncture member 3 is started.

First, the handle 74 is operated to rotate the operation member 7 as shown in FIG. Thereby, the needle body 35 of the puncture member 3 punctures the body surface H of the right buttocks of the patient or a portion in the vicinity thereof, enters the body, and between the obturator hole 1101, the urethra 1300 and the vagina 1400, the obturator hole 1102. , And then protrudes from the body surface H of the left buttock or the vicinity thereof (see FIG. 29A). At this time, when the puncture member 3 rotates and punctures the living body, the connection portion 72 and the shaft portion 73 are connected to each other by the puncture resistance received from the living tissue. It seems to be deformed by bending or twisting. However, since the connecting portion 72 and the shaft portion 73 are high-rigidity portions, deformation like the connecting portion 72 ′ and the shaft portion 73 ′ can be prevented or suppressed. Therefore, the needle tip 351 can reliably pass through the puncture route X, and can puncture the target site with certainty.

It should be noted that a passage can be formed at a position suitable for placement of the implant 9 by puncturing the puncture member 3 substantially perpendicularly to the left and right closure holes 1101 and 1102 of the pelvis. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.

Thereby, the puncture member 3 is arranged in the living body. Next, the handle 74 is operated to rotate the operation member 7 in the opposite direction, and only the operation member 7 is removed from the living body while the puncture member 3 is placed in the living body. Next, the frame 2 is removed from the insertion tool 6, and the needle body 35 is removed from the main body 31. Thereby, as shown in FIG. 29B, only the main body 31 is placed in the living body. The main body 31 is disposed in the living body with both the distal end side opening and the proximal end side opening exposed to the outside of the living body.

Next, the position of the main body 31 is adjusted as necessary. Specifically, the left and right protruding lengths of the main body 31 are aligned, and the central portion S4 of the main body 31 is positioned between the urethra 1300 and the vagina 1400. In this state, as shown in FIG. 31, the central portion S4 is arranged such that the width direction (long axis J32 direction) W is substantially parallel to the urethra 1300. That is, the width direction W of the urethra 1300 that has been corrected by inserting the urethral insertion tool 4 and the central portion S4 is located substantially in parallel.

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

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

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

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

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

Thus, the main body 31 can be easily removed from the living body by dividing the main body 31 and removing it from the living body. In addition, since the divided

pieces

32 and 33 being removed hardly affect the posture of the implant body 91 in the region between the urethra 1300 and the vagina 1400, the implant body 91 can be embedded in a desired posture.

Further, since the

split pieces

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

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

In this way, the position of the needle tip 351 is positioned with respect to the closing hole 1101 and the closing hole 1102 so that the needle tip 351 passes through the closing hole 1101, the urethra 1300 and the vagina 1400, and the closing hole 1102 in this order. Thus, the puncture apparatus 1 can puncture a living body easily and accurately.

Furthermore, since the living body is punctured in a state where the positional relationship between the contact portion 221 and the puncture member 3 is regulated, the puncture apparatus 1 can puncture the living body more reliably.

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

Second Embodiment
FIG. 34 is a perspective view showing an operation member included in the puncture apparatus according to the second embodiment of the present invention.

Hereinafter, the second 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 first embodiment described above except that the configuration of the operation member is different.

34, in the operation member 7A of the present embodiment, the thickness of the shaft portion 73 is the same as that of the curved portion 713, and is thinner than the thickness of the connecting portion 72. Since the shaft portion 73 is supported by the bearing portion 21 of the frame 2, even if it has the same rigidity as the curved portion 713, it is a portion that is relatively difficult to deform.

Thus, in the operation member 7A, the same effect as that of the first embodiment can be obtained by making only the connecting portion 72 that is relatively easily deformed into a high-rigidity portion.

<Third Embodiment>
FIG. 35 is a perspective view showing an operation member included in the puncture apparatus according to the third embodiment of the present invention.

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.

As shown in FIG. 35, in the operation member 7B of the present embodiment, the connecting portion 72 has a linear shape and is inclined with respect to the rotation axis J1. Thereby, in the connection part 72, the 3rd bending part 77 can be abbreviate | omitted. Therefore, it can prevent or reduce more reliably that connecting part 72 changes.

<Fourth embodiment>
FIG. 36 is a perspective view showing an operation member included in the puncture device according to the fourth embodiment of the present invention.

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.

36, the operation member 7C of the present embodiment has a boundary portion 722 located between the bending portion 713 and the connecting portion 72. The boundary portion 722 is provided on the proximal end side extension line of the bending portion 713. Further, at the boundary portion 722, the thickness gradually increases toward the connecting portion 72 side. According to the boundary portion 722, the stress applied from the curved portion 713 to the first bent portion can be relaxed. Therefore, it can prevent or reduce more reliably that the 1st bending part 75 deform | transforms.

<Fifth Embodiment>
FIG. 37 is a view showing a guide part provided in the puncture device according to the fifth embodiment of the present invention, where (a) is a view seen from the distal end side, and (b) is an arrow C in (a). It is the figure seen from the direction.

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.

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

As shown in FIG. 37 (a), the guide portion 22A of the present embodiment has a tube shape curved in an arc shape. A sheath 30 is inserted into the guide portion 22A. Further, a slit 223 penetrating from the inner periphery to the outer periphery is formed in the guide portion 22A. The slit 223 is formed over the entire length of the guide portion 22A in the longitudinal direction. Thereby, it is possible to prevent the guide portion 22 </ b> A from interfering with the connecting portion 72 of the operation member 7 when the sheath 30 is rotated.

Also, as shown in FIG. 37 (b), the

contact portions

221 and 222 are ring-shaped when viewed from the direction of arrow C in FIG. 37 (a). Thereby, the contact area of each

contact part

221 and 222 and the body surface H can be made larger, and thus positioning can be performed more stably.

<Sixth Embodiment>
FIGS. 38A and 38B are views showing a guide part provided in the puncture device according to the sixth embodiment of the present invention, wherein FIG. 38A is a view seen from the distal end side, and FIG. 38B is an arrow D in FIG. It is the figure seen from the direction.

Hereinafter, the thirtieth 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.

38 (a) and 38 (b), the guide portion 22B of the present embodiment is composed of a rod-like member that is curved in an arc shape. Further, a pair of guide portions 22B are provided via the sheath 30, and each guide portion 22B is provided side by side along the rotation axis J1.

According to such a configuration, the puncture member 3 passes between the contact portions 221 and passes between the contact portions 222. Therefore, in the positioning state, the operator can easily predict the position through which the puncture member 3 passes using each contact portion 221 and each contact portion 222 as a guide. Furthermore, since the sheath 30 is relatively easy to visually recognize, the prediction can be easily performed.

<Seventh embodiment>
FIG. 39 is a side view showing an insertion tool included in the puncture device according to the seventh embodiment of the present invention.

Hereinafter, the seventh embodiment of the puncture device 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 first embodiment described above except that the configuration of the urethral insertion tool is different.

As shown in FIG. 39, in the urethra insertion tool 4 of the present embodiment, a marker 45 is provided on the surface of the urethra insertion part 41. Further, the marker 45 does not substantially protrude from the surface of the urethral insertion portion 41. Therefore, the marker 45 can enter the urethra 1300 together with the urethra insertion part 41. Further, the marker 45 is fixed on the surface of the urethral insertion portion 41 and cannot move with respect to the urethral insertion portion 41. Such a marker 45 does not have a function as the inflow reduction unit 450.

By configuring the marker 45 with such a configuration, for example, the configuration of the puncture apparatus 1 can be simplified as compared with the first embodiment. In addition, the puncture apparatus 1 can be easily operated at a predetermined stage. Specifically, for example, in the first embodiment described above, since the marker 45 protrudes from the urethra insertion part 41 and cannot enter the urethra 1300, the restriction part 48 is removed and the marker 45 slides with respect to the urethra insertion part 41. It had to be possible. On the other hand, in the present embodiment, since the marker 45 can enter the urethra 1300, the above-described operation is not necessary, and the operation can be smoothly performed correspondingly.

The configuration of the marker 45 is not particularly limited as long as the operator can visually recognize from the outside. For example, the marker 45 may be configured by a colored portion colored in a color different from the surroundings, or may be configured by a concave portion or a convex portion. May be.

In the present embodiment, the marker 45 does not substantially protrude from the outer periphery of the urethra insertion portion 41, but the marker 45 may protrude slightly from the outer periphery of the urethra insertion portion 41 as long as it can enter the urethra 1300. Good.

Further, in the urethral insertion tool 4 of the present embodiment, the sliding resistance amplifying part 49 is configured by a ring-shaped protrusion (protruding part) protruding from the outer periphery of the urethral insertion part 41. Even when the sliding resistance amplifying section 49 is configured as described above, the sliding resistance of the urethral insertion section 41 with respect to the urethra 1300 can be effectively increased. In the present embodiment, one ring-shaped protrusion is provided, but the number of protrusions is not particularly limited, and for example, a plurality of protrusions may be provided side by side in the length direction of the urethral insertion portion 41. . In addition, the protrusions do not have to be ring-shaped. For example, a plurality of hook-shaped protrusions may be arranged along the circumferential direction of the urethra insertion part 41, or the length of the urethra insertion part 41 may be long. It may be a spiral protrusion extending in the direction.

Furthermore, in this embodiment, the sliding resistance amplifying unit 49 also serves as the marker 46. Therefore, the configuration of the urethral insertion tool 4 is further simplified. In order to make the function as the marker 46 easier, the sliding resistance amplifying portion 49 is preferably colored in a color different from the surroundings (the distal end side and the proximal end side).

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

<Eighth Embodiment>
FIG. 40 is a side view showing an insertion tool included in the puncture device according to the eighth embodiment of the present invention.

Hereinafter, the sixth 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.

As shown in FIG. 40, the balloon 42 and the urine discharge part 47 are omitted in the urethral insertion device 4 of the present embodiment. According to such a configuration, the configuration of the urethral insertion tool 4 can be simplified. In the puncture device 1, as described above, in order to position the puncture position of the puncture member 3 with respect to the urethral opening 1320, the urethra insertion portion 41 is mainly aligned by being engaged with the bladder neck. Even if the balloon 42 to be used is omitted, the operability of the puncture device 1 at the time of puncturing the puncture member 3 is hardly lowered.

Also in the eighth embodiment, the same effects as those of the first embodiment described above can be obtained.

<Ninth Embodiment>
FIG. 41 is a side view showing an insertion tool included in the puncture device according to the ninth embodiment of the present invention. FIG. 42 is a cross-sectional view showing a state where the urethral insertion tool of the insertion tool shown in FIG. 41 is inserted into the urethra.

As shown in FIG. 41, in the urethral insertion device 4 of the present embodiment, the balloon 42 and the urine discharge part 47 are omitted.

Further, in the urethral insertion device 4 of the present embodiment, the marker 45 is provided on the surface of the urethral insertion portion 41 and does not substantially protrude from the surface of the urethral insertion portion 41. Therefore, the marker 45 can enter the urethra 1300. Further, the marker 45 is fixed on the surface of the urethral insertion portion 41 and cannot move with respect to the urethral insertion portion 41. The configuration of such a marker 45 is the same as that of the second embodiment described above.

Since such a marker 45 cannot serve as the inflow reduction unit 450 as in the first embodiment, the inflow reduction unit 450 is provided separately from the marker 45 in the present embodiment.

The inflow reduction part 450 is provided between the marker 45 and the region S1, and is located in the urethra 1300 when the urethra insertion part 41 is inserted into the urethra 1300 and the marker 45 is located at the urethral opening 1320. The inflow reduction part 450 is configured by a ring-shaped protrusion (protrusion part) provided so as to protrude from the outer periphery of the urethral insertion part 41.

Further, the outer diameter of the inflow reducing portion 450 is gradually reduced from the central portion toward both ends (the distal end and the proximal end), and the outer diameters at both ends substantially coincide with the outer diameter of the urethral insertion portion 41. Therefore, a step is not substantially formed between the inflow reducing portion 450 and the urethral insertion portion 41, and the urethral insertion portion 41 can be inserted into the urethra 1300 with less invasiveness.

As shown in FIG. 42, the inflow reduction portion 450 is located in the urethra 1300 in a state where the urethra insertion portion 41 is inserted into the urethra 1300. Since the inflow reduction part 450 has a larger outer diameter than the other part of the urethral insertion part 41 (the front end side and the base end side part of the inflow reduction part 450), the inflow reduction part 450 is more than the other part. Even the urethral wall is more closely attached. Therefore, the urethra 1300 can be sealed in the inflow reduction portion 450, and the inflow of air from the urethral opening 1320 to the back side of the inflow reduction portion 450 of the urethra 1300, that is, the portion where the suction hole 44 is located. Can be suppressed. As a result, the suction of the urethra wall by the suction hole 44 can be performed more reliably and effectively.

Further, in the urethra insertion tool 4 of the present embodiment, the sliding resistance amplifying part 49 has a groove 491 extending in the circumferential direction of the urethra insertion part 41. A plurality of the grooves 491 are provided along the longitudinal direction of the urethral insertion portion 41. Note that the number of grooves 491 disposed along the circumferential direction of the urethral insertion portion 41 is not particularly limited, and may be one or may be two or more. Such a sliding resistance amplifying section 49 can also increase the sliding resistance of the urethral insertion section 41 with respect to the urethra 1300 with a simple configuration.

In particular, since the groove 491 is a groove extending in the circumferential direction of the urethral insertion portion 41, for example, compared with a case where the groove 491 is a circular groove, a groove extending in the longitudinal direction of the urethral insertion portion 41, The sliding resistance with the urethra 1300 when the urethral insertion part 41 is pushed into the body can be increased. Also, by providing a plurality of grooves 491 in the longitudinal direction of the urethral insertion portion 41, the sliding resistance with the urethra 1300 when the urethral insertion portion 41 is pushed into the body can be increased. Therefore, according to this embodiment, the above-mentioned effect is further enhanced.

In the present embodiment, at least one groove 491 also serves as the suction hole 44. That is, the groove 491 that also serves as the suction hole 44 passes through the urethral insertion portion 41 and is connected to the suction port 433. By setting it as such a structure, the structure of the urethral insertion tool 4 becomes a simpler thing. In addition, since the groove 491 also serves as the suction hole 44, the urethral wall and the groove 491 are more strongly caught when the urethral wall is adsorbed. Therefore, the sliding resistance of the urethra insertion part 41 with respect to the urethra can be further increased.

Further, the urethral insertion tool 4 of the present embodiment has a suction hole 440 facing the tip of the urethral insertion portion 41. As shown in FIG. 42, the suction hole 440 is positioned in the bladder 1310 when the urethral insertion portion 41 is inserted into the urethra 1300 and the marker 45 is positioned at the urethral opening 1320. Therefore, the bladder wall can be adsorbed by the suction hole 440. Thereby, the bladder 1310 can be pushed into the body more effectively together with the urethral insertion portion 41. The suction hole 440 may also serve as the urine discharge part 47 for discharging urine in the bladder 1310.

Also in the ninth embodiment, the same effects as those of the first embodiment described above can be obtained.

<Tenth Embodiment>
FIG. 43 is a side view of the insertion tool included in the puncture device according to the tenth embodiment of the present invention, in which (a) shows a state locked by the maintenance mechanism, and (b) shows a state in which the maintenance mechanism is released. FIG.

Hereinafter, the tenth 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 first embodiment described above except that the configuration of the urethral insertion tool, specifically, the configuration of the displacement mechanism and the maintenance mechanism is different.

As shown in FIG. 43 (a), the displacement mechanism 62 included in the insertion tool 6 of the present embodiment connects the urethral insertion portion 41 and the vaginal insertion portion 51 so that they can approach and separate. Specifically, the displacement mechanism 62 has a slide shaft 622 protruding downward from the support portion 40, and the support portion 50 is slidably connected to the slide shaft 622. The support portion 50 is provided so as not to rotate with respect to the slide shaft 622. In addition, a flange (engaging portion) 614 is provided at the distal end portion of the slide shaft 622, and the flange 614 prevents the support portion 50 from being detached from the slide shaft 622. Thus, by enabling the vagina insertion tool 5 to be slidable with respect to the slide shaft 622, the urethral insertion portion 41 and the vagina insertion portion 51 can be approached and separated by a simple operation.

On the other hand, the maintenance mechanism 61 can take a state in which the relative positional relationship between the urethral insertion tool 4 and the vaginal insertion tool 5 is maintained, and a state in which the vaginal insertion tool 5 can slide with respect to the urethral insertion tool 4. . Such a maintenance mechanism 61 includes the flange 614 described above and an operation unit 613 provided on the support unit 50. Further, the operation unit 613 includes a shaft portion 613a that can be bent and deformed, a knob 613b that is connected to the shaft portion 613a, and a claw portion 613c that is provided at the tip of the tab 613b. Engageable.

As shown in FIG. 43 (a), the claw portion 613c is engaged with the flange 614, whereby the support portion 40 and the support portion 50 are fixed, and the relative relationship between the urethral insert 4 and the vaginal insert 5 is relative. The positional relationship can be maintained. On the other hand, as shown in FIG. 43 (b), the lock (maintenance state) is released by pulling the knob 613 b upward and detaching the claw portion 613 c from the flange 614, and the vaginal insert 5 is moved relative to the urethra insert 4. To be slidable. And in the slidable state, the front-end | tip part 52 (vagina insertion part 51) can be made to approach the urethra insertion part 41 rather than the maintenance state shown to Fig.43 (a).

In this embodiment, the slide shaft 622 is provided on the support portion 40 and the operation portion 613 is provided on the support portion 50. On the contrary, the slide shaft 622 is provided on the support portion 50 and the operation portion 613 is operated. The part 613 may be provided on the support part 40. Moreover, the structure of the operation part 613 is not limited to this embodiment, as long as the same effect can be exhibited.

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

<Eleventh embodiment>
44 (a) is a side view of an insertion tool included in the puncture device according to the eleventh embodiment of the present invention, FIG. 44 (b) is a side view showing a state locked by the maintenance mechanism, and FIG. 44 (c) is the maintenance mechanism. It is a side view which shows the state released | released.

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.

As shown in FIG. 44 (a), the

support portions

40 and 50 are fixed in the insertion tool 6 of the present embodiment.

Moreover, in the insertion tool 6 of this embodiment, the shaft part 53 of the vagina insertion part 51 can be bent and deformed in the middle by the displacement mechanism 62. Specifically, the shaft portion 53 is divided into a distal end side shaft portion 531 located on the distal end side and a proximal end side shaft portion 532 located on the proximal end side, and these can be rotated by a hinge portion 625. It is connected to. Then, by rotating the distal end side shaft portion 531 relative to the proximal end side shaft portion 532, the distal end portion 52 can be easily approached and separated from the urethral insertion portion 41.

On the other hand, the maintenance mechanism 61 can maintain the distal end side shaft portion 531 and the proximal end side shaft portion 532 in a linear posture, and can rotate the distal end side shaft portion 531 with respect to the proximal end side shaft portion 532. The state to perform can be taken. Such a maintenance mechanism 61 has a cylindrical slider (operation unit) 615 provided on the outer periphery of the shaft portion 53 and slidable (movable) in the longitudinal direction with respect to the shaft portion 53. Yes.

As shown in FIG. 44 (b), when the hinge 625 is covered with the slider 615, the distal end side shaft portion 531 and the proximal end side shaft portion 532 are maintained in a linear posture, and the urethral insertion portion The relative positional relationship between 41 and the tip 52 is maintained. On the other hand, as shown in FIG. 44 (c), when the slider 615 is slid to expose the hinge portion 625, the lock (maintenance state) is released, and the distal end portion 52 moves relative to the urethra insertion portion 41. In a rotatable state. In the rotatable state, the distal end portion 52 can be brought closer to the urethral insertion portion 41 than in the maintenance state shown in FIG. Such a maintenance mechanism 61 can be easily operated.

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

<Twelfth embodiment>
FIG. 45 is a side view of an insertion tool included in the puncture device according to the twelfth embodiment of the present invention. FIG. 46 is a cross-sectional view showing a state in which the vaginal insertion tool shown in FIG. 45 is inserted into the vagina.

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

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

45, in the vaginal insertion tool 5 of the present embodiment, the distal end portion 52 has a flat shape that is crushed in the height direction. Therefore, for example, the front-end | tip part 52 can be easily inserted in a vagina compared with 1st Embodiment mentioned above.

A ring-shaped inflow reducing portion 59 that protrudes from the outer periphery of the distal end portion 52 is provided on the proximal end portion of the distal end portion 52, more specifically, on the proximal end side of the recessed portion 541. Such an inflow reducing portion 59 is not inserted into the vagina 1400 together with the distal end portion 52. Furthermore, it protrudes sufficiently so that the vaginal opening 1410 can be covered. The inflow reducing portion 59 preferably has airtightness and flexibility, and is made of, for example, a rubber material.

As shown in FIG. 46, such an inflow reduction unit 59 abuts against the vaginal opening 1410 with the tip 52 inserted into the vagina 1400 to cover and close the vaginal opening 1410, and the vagina 1400 through the vaginal opening 1410. Suppresses the inflow of air into the inside. Thereby, the suction of the vaginal wall by the suction hole 54 can be performed more reliably and effectively.

Even in the twelfth embodiment, the same effects as those of the first embodiment described above can be obtained.

<13th Embodiment>
FIG. 47 is a side view of an insertion tool included in the puncture device according to the thirteenth embodiment of the present invention. 48 is a view showing the distal end portion of the vaginal insertion tool shown in FIG. 47, in which (a) is a top view and (b) is a cross-sectional view taken along line BB in (a). 49 is a diagram showing a state in which the distal end portion shown in FIG. 48 is inserted into the vagina, in which (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed. FIG.

Hereinafter, the thirteenth 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.

As shown in FIG. 47, the vaginal insertion tool 5 of this embodiment has a flat shape in which the distal end portion 52 is crushed in the height direction as in the twelfth embodiment. Therefore, for example, the front-end | tip part 52 can be easily inserted in a vagina compared with 1st Embodiment mentioned above. As shown in FIGS. 48 (a) and 48 (b), the tip portion 52 connects the upper surface (first surface) 52a and the lower surface 52d, the upper surface 52a and the lower surface 52d, and the upper surface 52a. Side surfaces (second surfaces) 52b and 52c, and the cross-sectional shape is substantially trapezoidal.

Further, the tip portion 52 includes a suction hole (first suction hole) 54A that opens to the upper surface 52a, a suction hole (second suction hole) 54B that opens to the side surface 52b, and a suction hole (first suction hole) that opens to the side surface 52c. 2 suction holes) 54C. That is, the distal end portion 52 of the present embodiment has a configuration in which a pair of

suction holes

54B and 54C are arranged on both sides of the suction hole 54A. These three

suction holes

54A, 54B, and 54C are connected to the suction port 543 through the distal end portion 52, respectively.

The suction hole 54A has a recess 541A that opens to a wide range on the upper surface 52a, the suction hole 54B has a recess 541B that opens to a wide range on the side surface 52b, and the suction hole 54C opens to a wide range on the side surface 52c. A recess 541C is provided. The depth of the recess 541A is deeper than the depth of the

recesses

541B and 541C, and the width of the recess 541A is wider than the width of the

recesses

541B and 541C.

Also, the suction directions of these three

suction holes

54A, 54B, 54C are different from each other. The suction hole 54A has the normal of the upper surface 52a as the suction direction (first suction direction) Ia, the suction hole 54B has the normal of the side surface 52b as the suction direction (second suction direction) Ib, and the suction hole 54C has The normal line of the side surface 52c is the suction direction (second suction direction) Ic. By adopting such a configuration, the vagina 1400 having the recessed portion 1402 as shown in FIG. 9 described above can be more effectively adsorbed.

More specifically, as shown in FIG. 49 (a), when the tip 52 is inserted into the vagina 1400, the concave portion 541A faces the central portion 1401 (hanging portion) of the front wall of the vagina and the concave portion 541B is in the center. The concave portion 541C faces the concave portion 1402 ′ adjacent to the portion 1401, and the concave portion 541C faces the concave portion 1402 ″ adjacent to the central portion 1401. Therefore, when the suction of the vaginal wall by the suction holes 54A, 54B, 54C is performed, FIG. As shown in (b), the central portion 1401 is adsorbed to the concave portion 541A, the concave portion 1402 ′ (1402) is adsorbed to the concave portion 541B, and the concave portion 1402 ″ (1402) is adsorbed to the concave portion 541C. As described above, according to the distal end portion 52 of the present embodiment, not only the central portion 1401 but also the recessed portions 1402 ′ and 1402 ″ can be adsorbed, and the entire vaginal front wall can be adsorbed more reliably. Can do.

In particular, as in the present embodiment, the depth of the concave portion 541A is made deeper than the depth of the

concave portions

541B and 541C, and the width of the concave portion 541A is made wider than the width of the

concave portions

541B and 541C, thereby making the central portion 1401 deeper. Can be adsorbed. Therefore, the recessed portions 1402 ′ and 1402 ″ on both sides of the center portion 1401 approach the recessed

portions

541B and 541C, and as a result, the recessed portions 1402 ′ and 1402 ″ are more reliably secured by the recessed

portions

541B and 541C. Can be adsorbed.

Here, the angle θ6 formed by the suction direction Ia of the suction hole 54A and the suction direction Ib of the suction hole 54B is not particularly limited, but is preferably about 20 ° to 70 °, for example, 30 ° to 50 °. It is preferable that it is about. Accordingly, the

concave portions

541B and 541C can be more accurately directed to the recessed portions 1402 'and 1402 ".

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

<Fourteenth embodiment>
FIG. 50 is a cross-sectional view showing the distal end portion of the vaginal insertion tool included in the puncture device according to the fourteenth embodiment of the present invention. 51 is a diagram showing a state in which the distal end portion shown in FIG. 50 is inserted into the vagina, in which (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed. FIG. FIG. 50 is a cross-sectional view corresponding to FIG.

Hereinafter, the fourteenth 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 vaginal insertion tool, specifically, the shape of the tip is different.

As shown in FIG. 50, the vaginal insertion tool 5 of the present embodiment has a substantially trapezoidal cross-sectional shape, and the upper surface 52a is recessed inwardly (lower surface 52d side). Since the upper surface 52a has a concave shape in this way, the tip 52 has

suction holes

54B and 54C that open to the side surfaces 52b and 52c, rather than the suction holes 54A that open to the upper surface 52a. The shape protrudes toward the outer periphery.

Thus, as shown in FIG. 51 (a), when the distal end portion 52 is inserted into the vagina 1400, the

concave portions

541B and 541C can be disposed close to the recessed portions 1402 ′ and 1402 ″. As shown in 51 (b), at the time of suction, the portions 1402 ′ and 1402 ″ recessed in the

recesses

541B and 541C can be sucked more reliably.

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

<Fifteenth embodiment>
FIG. 52 is a cross-sectional view showing the distal end portion of the vaginal insertion tool included in the puncture device according to the fifteenth embodiment of the present invention. FIG. 52 is a cross-sectional view corresponding to FIG.

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 eleventh embodiment described above except that the configuration of the vaginal insertion tool, specifically, the shape of the tip is different.

As shown in FIG. 52, the vaginal insertion tool 5 of the present embodiment is provided with a suction hole 54 having a recess 541 that opens across the upper surface 52a and the side surfaces 52b and 52c. In such a suction hole 54, the suction direction is different between a portion 541a that opens to the upper surface 52a of the recess 541, a portion 541b that opens to the side surface 52b, and a portion 541c that opens to the side surface 52c.

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

In the present embodiment, the upper surface 52a and the side surfaces 52b and 52c are each configured as a flat surface, and the side surfaces 52b and 52c are inclined with respect to the upper surface 52a. However, the shape of the distal end portion 52 is not limited to this. For example, the upper surface 52a and the side surfaces 52b and 52c may be formed of curved surfaces that are continuous with each other. Even with such a shape, the same effect as the present embodiment can be exhibited.

<Sixteenth Embodiment>
FIGS. 53A and 53B are views showing the distal end portion of the vaginal insertion tool included in the puncture device according to the sixteenth embodiment of the present invention, wherein FIG. 53A is a side view, FIG. 53B is a top view, and FIG. is there. 54 is a diagram showing a state in which the distal end portion shown in FIG. 53 is inserted into the vagina, where (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed. FIG.

Hereinafter, the sixteenth 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.

53, in the vaginal insertion tool 5 of the present embodiment, a plurality of suction holes 54 are provided over the entire area in the circumferential direction of the tapered portion 521 of the distal end portion 52. As a result, as shown in FIG. 54B, not only the front wall of the vagina but also the entire circumference of the vagina wall can be adsorbed. Therefore, the vaginal wall can be adsorbed to the distal end portion 52 more effectively.

In particular, in the present embodiment, a plurality of suction holes 54 are provided along the circumferential direction of the tip portion 52, and a plurality of suction holes 54 are provided along the longitudinal direction of the tip portion 52, and are arranged over the entire taper portion 521. Has been. Accordingly, the suction holes 54 can be arranged in a wider range while suppressing the size of each suction hole 54 to an appropriate size, so that the vagina wall can be more effectively prevented while preventing damage to the vagina wall during suction. Can be adsorbed.

In the present embodiment, the concave portion 541 of each suction hole 54 has a substantially circular opening shape, but the opening shape of the concave portion 541 is not particularly limited and, for example, extends in the circumferential direction of the distal end portion 52. A longitudinal shape may be sufficient and the longitudinal shape extended in the longitudinal direction of the front-end | tip part 52 may be sufficient. Further, for example, the recesses 541 may have opening shapes having different shapes or sizes.

In this embodiment, since the inflow reduction part 522 is provided on the proximal end side of the taper part 521 in which the suction hole 54 is provided, the above-described effect is more remarkably exhibited in combination with the effect of the inflow reduction part 522. can do.

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

<Seventeenth Embodiment>
FIG. 55 is a view showing a distal end portion of a vaginal insertion tool included in a puncture device according to a seventeenth embodiment of the present invention.

Hereinafter, the seventeenth 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 sixteenth embodiment described above except that the configuration of the vaginal insertion tool is different.

As shown in FIG. 55, the vaginal insertion tool 5 of the present embodiment has a flat shape in which the tip 52 is crushed in the height direction. Similar to the eleventh embodiment described above, a plurality of suction holes 54 are also provided in such a tip portion 52 over the entire area in the circumferential direction. Further, an inflow reduction portion 59 protruding from the distal end portion 52 is provided on the proximal end side of the region where the suction hole 54 of the distal end portion 52 is formed.

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

<Eighteenth embodiment>
56A and 56B are views showing the distal end portion of the vaginal insertion tool included in the puncture device according to the eighteenth embodiment of the present invention, wherein FIG. 56A is a side view and FIG. 56B is a cross-sectional view. 57 (a) and 57 (b) are diagrams for explaining the function of the tip shown in FIG.

This embodiment is the same as the fourteenth embodiment described above except that the distal end portion of the vaginal insertion tool is deformable.

As shown in FIG. 56 (a), in the vaginal insertion tool 5 of the present embodiment, the distal end portion 52 is divided into a base portion 52A and a movable portion 52B. The base portion 52A is connected to the shaft portion 53, and the movable portion 52B can be displaced vertically (the arrangement direction of the urethral insertion portion 41 and the vaginal insertion portion 51) with respect to the base portion 52A.

The displacement mechanism 58 for displacing the movable part 52B with respect to the base part 52A is not particularly limited. For example, as shown in FIG. 56 (b), the movable part 52B is located above (distant from) the base part 52A. ) And a string (operation part) 582 that is connected to the movable part 52B and is hooked on the base part 52A. The string 582 is preferably pulled out to the vicinity of the support portion 50 through, for example, the shaft portion 53 so that the operator can easily hold it. In the displacement mechanism 58 having such a configuration, the movable portion 52B can be displaced toward the base 52A against the urging force of the spring 581 by pulling the string 582. After the displacement of the movable portion 52B, the tip portion 52 is thinner than before the displacement.

The tip 52 having such a configuration is used as follows, for example. First, as shown in FIG. 57 (a), the distal end portion 52 is inserted into the vagina 1400. Next, the vaginal wall is adsorbed by the suction hole 54. Next, as shown in FIG. 57 (b), the string 582 is pulled to displace the movable portion 52B downward. At this time, since the front wall of the vagina adsorbed by the movable portion 52B is displaced downward together with the movable portion 52B, the space between the vagina 1400 and the urethra 1300 is widened. Thereby, the puncture space of the puncture member 3 can be ensured more widely, and the puncture of the puncture member 3 can be performed more safely.

In particular, in this embodiment, since the movable portion 52B is pressed against the vagina front wall by the spring 581, the movable portion 52B and the vagina front wall can be brought into close contact with each other, and the vagina front wall is adsorbed to the movable portion 52B. Can be performed more reliably.

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

<Nineteenth embodiment>
FIG. 58 is a side view showing a urethra insertion tool included in the puncture device according to the nineteenth embodiment of the present invention.

Hereinafter, the nineteenth 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 embodiments, and the description of the same matters will be omitted.

As shown in FIG. 58, in the urethra insertion device 4 of the present embodiment, the middle of the urethra insertion portion 41 (portion located in the urethra in the mounted state) is curved in a convex shape, and this convex curved portion Constitutes the sliding resistance amplifying section 49.

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

As a modification of the present embodiment, for example, the middle of the urethra insertion part 41 (the part located in the urethra in the attached state) is curved a plurality of times in a wave shape, and this curved part is the sliding resistance amplifying part 49. May be configured.

<20th Embodiment>
FIG. 59 is a side view showing a urethra insertion part included in the puncture device according to the twentieth embodiment of the present invention.

Hereinafter, the twentieth 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. 59, in the urethra insertion device 4 of the present embodiment, a coating layer 492 that covers the urethra insertion part 41 is provided in the middle of the urethra insertion part 41 (portion located in the urethra in a mounted state). Yes. The coating layer 492 has a higher sliding resistance with respect to the urethra than the surface of the urethral insertion portion 41, and the sliding resistance amplification unit 49 is configured by the coating layer 492. In this embodiment, since the coating layer 492 is provided so as to overlap the region S1, the suction hole 44 is formed so as to penetrate the coating layer 492.

The constituent material of the covering layer 492 is not particularly limited, and for example, materials having a high coefficient of friction such as various rubber materials such as natural rubber, acrylic rubber, styrene-butadiene rubber, urethane rubber, and silicone rubber can be used. .

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

In the present embodiment, a step due to the thickness of the covering layer 492 occurs at the boundary between the covering layer 492 and the urethral insertion portion 41. In order to eliminate this step, that is, the urethral insertion portion 41 and the covering portion are covered. A concave portion corresponding to the thickness of the covering layer 492 may be formed in advance in a region where the covering layer 492 of the urethral insertion portion 41 is provided so that the outer peripheral surfaces of the layer 492 are flush with each other. Thereby, the urethral insertion part 41 can be more smoothly inserted into the urethra.

<Twenty-first embodiment>
60 (a) and 60 (b) are partial cross-sectional views showing a urethra insertion part included in the puncture device according to the twenty-first embodiment of the present invention.

Hereinafter, the twenty-first 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. 60 (a), the sliding resistance amplifying unit 49 provided in the urethral insertion device 4 of the present embodiment is provided in the middle of the urethra insertion unit 41 (portion located in the urethra when attached). And a protrusion 493 protruding from the urethral insertion portion 41 and a cylindrical slider 494 slidably provided on the outer periphery of the urethral insertion portion 41. The protrusion 493 is inclined toward the tip side and is a “barbed”. Further, the slider 494 can move between a state where the protrusion 493 is covered and a state where the protrusion 493 is exposed. In the state where the protrusion 493 is covered, the protrusion 493 is tilted.

The protrusion 493 can be elastically deformed, and is made of various rubber materials such as natural rubber, acrylic rubber, styrene-butadiene rubber, urethane rubber, and silicone rubber.

As shown in FIG. 60B, the sliding resistance amplifying unit 49 configured as described above is in a state in which the protrusion 493 is covered with the slider 494 until the urethra insertion portion 41 is inserted into the urethra. After the portion 41 is inserted into the urethra and positioned by the marker 45, as shown in FIG. 60A, the slider 494 is slid to the proximal end side so that the projection 493 is exposed.

According to such a method of use, since the urethral insertion portion 41 is inserted into the urethra without the function of the sliding resistance amplifying portion 49 being exhibited, the insertion can be performed smoothly. On the other hand, when the urethra insertion part 41 is pushed into the body with the urethra wall adsorbed and fixed to the urethra insertion part 41, the function of the sliding resistance amplifying part 49 is exhibited. It can be pushed in more reliably.

In particular, in this embodiment, since the protrusion 493 is “barbed”, the sliding resistance at the time of pushing can be further increased.

Also according to the twenty-first embodiment, the same effects as those of the first embodiment described above can be obtained.

In the present embodiment, only one protrusion 493 is provided, but the number of protrusions 493 is not particularly limited.

<Twenty-second embodiment>
FIG. 61 is a perspective view showing a puncture member included in the puncture apparatus according to the twenty-second embodiment of the present invention. 62 is a cross-sectional view showing a modification of the puncture member shown in FIG.

Hereinafter, the 22nd 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. 61, the puncture member 3 of the present embodiment is configured with a sheath 30. That is, the puncture member 3 has a configuration in which the needle body 35 is omitted from the puncture member 3 of the first embodiment described above. Further, in a state (initial state) in which the insertion portion 71 is inserted into the puncture member 3, the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31. The tip 711 protruding from the main body 31 also serves as the needle tip of the puncture member 3.

Thus, since the distal end portion 711 of the insertion portion 71 also serves as the needle body of the puncture member 3, for example, the number of members can be reduced as compared with the first embodiment described above. Moreover, if the puncture member 3 is punctured into a living body and the insertion portion 71 is removed from the puncture member 3, the distal end side opening of the main body 31 can be opened. In other words, according to the present embodiment, unlike the first embodiment described above, it is not necessary to remove the needle body 35 in order to open the distal end side opening of the main body 31, so that surgery can be performed more smoothly. . Further, since the outer diameter of the insertion portion 71 and the inner diameter of the opening on the distal end side of the main body 31 are set to be substantially the same, the displacement of the insertion portion 71 with respect to the main body 31 is prevented, and the operability is improved.

Further, a tapered portion 319 in which the outer diameter from the distal end side opening gradually increases toward the proximal end is provided at the distal end of the main body 31. The tapered portion 319 functions as a peeling portion that peels off the living body gradually so as to gradually expand following the distal end portion 711 as the distal end portion 711 of the insertion portion 71 punctures the living body.

In addition, the taper angle of the taper portion 319 and the taper angle of the tip portion 711 may be the same, but are preferably different. In this case, it is preferable that the taper angle of the taper portion 319 is smaller than the taper angle of the tip portion 711. Thereby, smooth puncture can be performed.

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

Further, as a modification of the present embodiment, the following configuration can be given. As shown in FIG. 62, the puncture member 3 is configured with a sheath 30. That is, the puncture member 3 has a configuration in which the needle body 35 is omitted from the puncture member 3 of the first embodiment described above. Further, in a state (initial state) in which the insertion portion 71 is inserted into the puncture member 3, the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31.

The tip portion 711 is provided so as to be removable from the insertion portion 71 by screwing, fitting, or the like. Further, the distal end portion 711 has a needle tip 712 protruding from the distal end of the sheath 30. The needle tip 712 has a flat shape following the sheath 30. Further, the needle tip 712 has an area gradually increasing portion 712a where the cross-sectional area gradually increases toward the tip, and an area gradually decreasing portion 712b which is provided on the tip side of the area gradually increasing portion 712a and whose cross-sectional area gradually decreases toward the tip. ing. The short axis of the boundary portion 712c between the area gradually increasing portion 712a and the area gradually decreasing portion 712b is longer than the short axis of the distal end of the sheath 30, and the long axis of the boundary portion 712c is longer than the long axis of the distal end of the sheath 30. Thereby, the living body can be punctured substantially only with the needle tip 712. Therefore, puncture resistance can be reduced and puncture into a living body can be performed more smoothly. Note that the short axis of the boundary portion 712c may be equal to the short axis of the distal end of the sheath 30, and the long axis of the boundary portion 712c may be equal to the long axis of the sheath 30 distal end.

<23rd Embodiment>
FIG. 63 is a cross-sectional view showing an operation member included in the puncture device according to the twenty-third embodiment of the present invention.

Hereinafter, the 23rd 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.

63, in the operation member 7D of the present embodiment, the bending portion 713, the coupling portion 72, and the shaft portion 73 have a constant thickness. Further, the material constituting the bending portion 713 is different from the material constituting the connecting portion 72 and the shaft portion 73. The rigidity of the material constituting the coupling part 72 and the shaft part 73 is higher than the rigidity of the material constituting the bending part 713. Thereby, the rigidity of the connection part 72 and the axial part 73 can be made into a highly rigid part.

The combination of these materials is not particularly limited, and examples thereof include a combination of stainless steel and titanium, a combination of stainless steel and tungsten, and a combination of stainless steel and alumina.

In addition, the thickness of the bending part 713, the connection part 72, and the axial part 73 may be constant, and the bending part 713, the connection part 72, and the axial part 73 may be comprised with the same material. In this case, the connecting portion 72 and the shaft portion 73 are processed so as to have higher rigidity than the bending portion 713. Although it does not specifically limit as this processing method, For example, the method etc. which set the temperature conditions suitably in the heat processing process in the process (process) which manufactures an operation member are mentioned. Moreover, when the operation member is comprised with various alloys, the operation member which has a highly rigid part can be obtained by setting (adjusting) the mixing ratio of the composition which comprises it suitably.

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 above-described embodiment, each contact portion is positioned with respect to each closing hole. However, the present invention is not limited to this, and when the puncture member punctures a living body, the abutment portion passes through the closing hole. Positioning may be performed with respect to this. In this case, the contact part on the side of the closed hole that passes through later can be omitted.

In the embodiment, the connecting portion of the operation member has a bent shape, but the present invention is not limited to this, and may have a curved shape.

In the above-described embodiment, the configuration in which the main body is separable into the distal end divided piece and the proximal end divided piece has been described. However, the configuration of the main body is not limited to this, and is separated into the distal end side and the proximal end side. The structure which cannot be used may be sufficient. That is, the main body may have a single tube shape. In this case, the state maintaining mechanism is also omitted.

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

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

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

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

For example, the present invention relates to excretion disorder (urinary urgency, frequent urination, urinary incontinence, stool incontinence, urinary retention, difficulty in urination, etc.), pelvic organ prolapse, vesicovaginal fistula, urethral vagina, as the pelvic floor muscles weaken Pelvic floor diseases including epilepsy, pelvic pain, etc. are included in the target of application. 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.

In addition, the hypermovable tissue includes 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, proximal ligament, sacral uterine ligament, sacrospinous ligament, and the like.

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

The puncture device according to the present invention has an elongated shape, is curved at least partially in the longitudinal direction, is supported so as to be rotatable around a rotation axis, and is connected to the puncture unit and a puncture unit that punctures a living tissue. And an operation portion that rotates the puncture portion about the rotation axis, and the operation portion includes a highly rigid portion that is higher in rigidity than the puncture portion. Thereby, when the puncture part punctures a living body, it can prevent that an operation part deform | transforms by puncture resistance. Therefore, the puncture unit can reliably puncture the target site.

DESCRIPTION OF SYMBOLS 1 Puncture apparatus 10 Medical tube assembly 2 Frame 21 Bearing part 211 Through-

hole

22, 22A,

22B Guide part

221, 222 Contact part 223 Slit 23 Connection part 24 Fixing part 243 Recess 244 Male screw 3 Puncture member 30 Sheath 31 Main body 319 Tapered portion 32 Tip split piece 321 Tip side opening 322 Base end side opening 33 Base end split piece 331 Tip side opening 332 Base end side opening 34 State maintaining mechanism 341 Threads 342a to 342c

Holes

345, 346 Exposed holes 347

Slits

347a, 347b Portion 348 Hole 35 Needle body 351 Needle tip 352 Engagement part 4 Urethral insertion tool 40 Support part 41 Urethral insertion part 42

Balloon

44, 440 Suction hole 431 Balloon port 432 Urine discharge port 433 suction port 45 markers (positioning portion)
450 Inflow reduction part 46 Marker (detection part)
47 Urine discharge part 471 Urine discharge hole 48 Restriction part 481 Main body 482 Knob 49 Sliding resistance amplification part 491 Groove 492 Cover layer 493 Projection 494 Slider 5 Vaginal insert 50 Support part 51 Vaginal insertion part 52 Tip part 52A Base part 52B Movable part

52a Upper surface

52b, 52c Side surface 52d Lower surface 521 Tapered portion 521a Upper surface 522 Inflow reduction portion 53 Shaft portion 531 Tip side shaft portion 532 Base end

side shaft portions

54, 54A, 54B, 54C Suction holes 541, 541A, 541B,

541C Recesses

541a, 541b , 541c Portion 543 Suction port 57 Marker 58 Displacement mechanism 581 Spring (biasing portion)
582 String (operation part)
59 Inflow reduction part 6 Insertion tool 61 Maintenance mechanism 611 Operation part 611a Shaft part 611b Knob part 611c Claw part 612 Engagement part 612a Recessed part 613 Operation part 613a Shaft part 613b Knob part 613c Claw part 614 Flange 62 Displacement mechanism 621 Hinge part 622 Slide shaft 625 Hinge part 7, 7A, 7B, 7C, 7D Operation member 71 Insertion part 711 Tip part 712 Needle tip 713 Curved part 712a Area gradually increasing part 712b Area gradually decreasing part 712c Boundary part 72, 72 'Connecting part 722 Boundary part 73, 73' shaft Part 74 Handle 75 First bent part 76 Second bent part 77 Third bent part 9 Implant 90 Packaging material 91 Implant body 92 Band 615 Slider 1100 Pelvis 1101, 1102 Closure hole 11 3, 1104 portion 1200 pubic joint 1300 urethra 1310 bladder 1320 urethral opening 1400 vagina 1401 central portion 1402, 1402 ′, 1402 ”recessed portion 1410 vaginal opening 1500 midline A1 inner periphery A2 outer periphery A3 surface A4 back surface D separation distance D1 , D2, D3 Diameter H Body surface H1 Height Ia, Ib, Ic Suction direction J1 Rotating axis J2 Axis J31 Short axis J32 Long axis J32 'Extension line J5 Central axis O Center P Intersection S1, S2 Area S4 Central part S5 Safety Zone W Width direction W1, W2 Width X Puncture path f1, f2, f9 Plane r1 Minimum curvature radius r2 Maximum curvature radius θ1, θ2, θ3 Inclination angle θ4 Center angles θ5, θ6 Angles L1, L3, L4, L6 Distance L2 Length L5 interval

Claims

A puncture part that is elongated, is curved at least partially in the longitudinal direction, is supported so as to be rotatable about a rotation axis, and punctures a living tissue;
An operation unit that is connected to the puncture unit and rotates the puncture unit about the rotation axis;
The puncture apparatus, wherein the operation unit includes a high-rigidity part having higher rigidity than the puncture part.
The operation part has a long shape,
The puncture apparatus according to claim 1, wherein the high-rigidity portion is a portion where the thickness of the operation portion is larger than the thickness of the puncture portion.
The puncture portion has an arc shape, and the center of the arc coincides with the rotation axis,
The operation portion includes a shaft portion disposed on the rotation shaft, and a connecting portion that connects the shaft portion and the puncture portion,
The puncture device according to claim 1 or 2, wherein at least the connecting portion is the high-rigidity portion.
The puncture device according to claim 3, wherein the connecting portion has an elongated shape, and the middle thereof is curved or bent.
The puncture device according to claim 3 or 4, wherein the connecting portion has a linear shape and has a portion inclined with respect to the rotation axis.
The puncture device according to any one of claims 2 to 5, wherein the shaft portion is the high-rigidity portion.
Having a boundary portion located between the operation portion and the puncture portion;
The puncture device according to any one of claims 1 to 6, wherein a thickness of the boundary portion gradually increases toward the operation portion side.
It has a long shape, is curved at least partly in the longitudinal direction, is supported so as to be pivotable about a pivot axis, and is connected to the puncture section and is more rigid than the puncture section. A puncture method for puncturing a living body with a puncture device having a high-rigidity portion and an operation portion for rotating the puncture portion about the rotation axis,
When the puncture unit punctures a living body, deformation of the operation unit is prevented or suppressed by the high-rigidity unit.