JP2015061568A - Organism insertion apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an organism insertion apparatus capable of making a puncture portion for a biological tissue constant irrespective of an individual difference.SOLUTION: An insertion tool 6 comprises: a urinary tract insertion member 4; a vagina insertion member 5; and a support part 60 for supporting those members in a manner to approach-leave each other. The support part 60 includes: a connection part 602 for connecting an injection tool; and a position regulation part 603 having a function to regulate the positional relations among the urinary tract insertion member 4, the vagina insertion member 5 and the connection part 602 such that the ratio between the distance between the injection tool and the urinary tract insertion member 4, and the distance between the injection tool and the vagina insertion member 5 may be constant.

Description

  The present invention relates to a living body insertion device.

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

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

  However, there are individual differences in the thickness of the living tissue between the urethra and the vagina. For this reason, depending on the patient, the puncture site of the injection needle when performing liquid exfoliation, or the communication between the exfoliated site and the outside There were problems such as variations in the puncture location of the puncture needle.

JP 2010-99499 A

  An object of the present invention is to provide a living body insertion device capable of making a puncture site for a living tissue constant regardless of individual differences.

Such an object is achieved by the present inventions (1) to (6) below.
(1) an elongated urethral insertion device inserted into the urethral cavity;
An elongated vaginal insertion tool inserted into the vaginal cavity;
A support for supporting the urethral insertion tool and the vaginal insertion tool in an approachable and / or detachable manner,
The support includes at least one connection for connecting an infusion device for injecting liquid into the living tissue between the urethral cavity and the vaginal cavity;
The urethral insertion tool and the vagina so that the ratio of the distance between the connection part and the urethral insertion tool and the distance between the connection part and the vagina insertion tool is constant in the approached and / or spaced state. A living body insertion device having a position restricting portion for restricting a positional relationship between an insertion tool and the connecting portion.

(2) The living body insertion device according to (1), wherein a plurality of the connection portions are provided.
(3) The living body insertion device according to (2), wherein the plurality of connection portions are arranged so that connection directions of the injection devices are different.

(4) It further comprises an injection device having a needle tip for puncturing the living tissue,
When the needle tip passes between the urethral insertion tool and the vaginal insertion tool, the position restricting unit is configured to move at least a part of the injection tool and the urethral insertion tool in the approaching and / or separating state. And the positional relationship between the urethral insertion tool, the vaginal insertion tool and at least a part of the injection tool so that the ratio of the distance between the urethra insertion tool, the vaginal insertion tool and the injection tool is constant. The living body insertion device according to any one of (1) to (3), which is regulated.

(5) an elongated urethral insertion device inserted into the urethral cavity;
An elongated vaginal insertion tool inserted into the vaginal cavity;
A puncture needle having a needle tip for puncturing a living tissue between the urethral cavity and the vaginal cavity;
A support body that supports the urethral insertion tool and the vaginal insertion tool so as to be able to approach and / or separate from each other and supports the puncture needle so as to be movable in a puncturing direction,
The support includes a distance between the needle tip and the urethral insertion tool in a state in which the needle tip passes between the urethral insertion tool and the vaginal insertion tool in the approach and / or separation state, and Biological insertion having a position restricting portion having a function of restricting the positional relationship between the urethral insertion tool, the vaginal insertion tool, and the puncture needle so that the ratio of the distance between the needle tip and the vaginal insertion tool is constant. apparatus.

(6) an elongated urethral insertion tool inserted into the urethral cavity;
An elongated vaginal insertion tool inserted into the vaginal cavity;
A support for supporting the urethral insertion tool and the vaginal insertion tool in an approachable and / or detachable manner,
The support includes at least one connection for connecting an infusion device for injecting liquid into the living tissue between the urethral cavity and the vaginal cavity;
With the infusion device connected to the connecting portion, in the approached and / or separated state, the distance between the at least part of the infusion device and the urethral insertion device, the at least part of the infusion device, and the A living body insertion device having a position restriction unit having a function of regulating a positional relationship between the urethral insertion tool and the vaginal insertion tool and the connecting portion so that a ratio to a distance from the vaginal insertion tool is constant.

  There are individual differences in the thickness of the living tissue between the urethral cavity and the vaginal cavity, which may be relatively thick or relatively thin. For patients with relatively thick biological tissue, the urethral insertion tool and the vaginal insertion tool are used in a separated state. On the other hand, for a patient having a relatively thin living tissue, the urethral insertion tool and the vaginal insertion tool are used in close proximity. According to the present invention, the ratio between the distance between the needle and the urethral insertion part and the distance between the needle and the vaginal insertion part is constant due to the action of the position restricting part in both the former and the latter states. Thereby, when puncturing a biological tissue with a needle, the puncture location can be made constant regardless of individual differences.

FIG. 1 is a perspective view showing a puncture device to which a living body insertion device (first embodiment) of the present invention is applied. FIG. 2 is a side view of the puncture device shown in FIG. FIG. 3 is a plan view showing an operation member of the puncture apparatus shown in FIG. 4A and 4B are diagrams showing a puncture member included in the puncture apparatus shown in FIG. 1, wherein FIG. 4A is a perspective view and FIG. 4B is a cross-sectional view taken along line AA in FIG. FIG. 5 is a cross-sectional view of the puncture member shown in FIG. 6A and 6B are diagrams showing a state maintaining mechanism included in the puncture member shown in FIG. 4A, wherein FIG. 6A is a top view, and FIGS. 6B and 6C are cross-sectional views. . FIG. 7 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 3, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. It is. 8A and 8B are diagrams showing a second anchor included in the puncture device shown in FIG. 1, wherein FIG. 8A is a cross-sectional view and FIG. 8B is a cross-sectional view showing a state where the puncture member is engaged. FIG. 9 is a view showing a first anchor of the puncture device shown in FIG. 1, wherein (a) is a cross-sectional view and (b) is a cross-sectional view showing a state where the puncture member is engaged. FIG. 10 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 11 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 12 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 13 is a plan view showing a frame fixing portion provided in the puncture apparatus shown in FIG. 1. FIG. 14 is a side view of an insertion tool included in the puncture device shown in FIG. 1. FIG. 15 is a diagram showing the positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view. 16 is a partially enlarged view of a vaginal insertion member included in the insertion tool shown in FIG. 17A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 17B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. FIG. 18 is a view showing an implant used together with the puncture device shown in FIG. FIG. 19 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG. 20A and 20B are diagrams for explaining the operation procedure of the puncture device shown in FIG. 1, in which FIG. 20A is a diagram when the operation is appropriate, and FIG. 20B is a diagram when the operation is inappropriate. FIG. 21 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 1. 22 (a) and 22 (b) are diagrams for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 23 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. 24 (a) and 24 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 25 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 26 is a cross-sectional view showing the posture of the puncture member relative to the urethra in the state shown in FIG. FIGS. 27A and 27B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 28 (a) and 28 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIGS. 29A and 29B are side views for explaining an operation method for the vaginal insertion member of the living body insertion device (second embodiment) of the present invention. FIG. 30 is a side view of a vaginal insertion member included in the living body insertion device (third embodiment) of the present invention. FIG. 31 is a diagram for explaining an operation procedure of the living body insertion device (fourth embodiment) of the present invention. FIG. 32 is a diagram for explaining an operation procedure of the living body insertion device (fourth embodiment) of the present invention. FIG. 33 is a diagram for explaining the operation procedure of the living body insertion device (fourth embodiment) according to the present invention, where (a) shows a case where the operation is proper, and (b) shows a case where the operation is inappropriate. FIG. FIG. 34 is a side view of a urethral insertion member included in the living body insertion device (fifth embodiment) of the present invention. 35 is a cross-sectional view taken along line BB in FIG. FIG. 36 is a cross-sectional view of a urethral insertion member included in the living body insertion device (sixth embodiment) of the present invention. FIG. 37 is a side view of a urethral insertion member included in the living body insertion device (seventh embodiment) of the present invention. 38 is a cross-sectional view taken along line CC in FIG. FIG. 39 is a plan view of a vaginal insertion member included in the living body insertion device (eighth embodiment) of the present invention. 40 is a cross-sectional view taken along line DD in FIG. FIG. 41 is a plan view of a vaginal insertion member included in the living body insertion device (9th embodiment) of the present invention. 42 is a cross-sectional view taken along line EE in FIG. FIG. 43 is a longitudinal sectional view of a vaginal insertion member included in the living body insertion device (tenth embodiment) of the present invention. FIG. 44 is a plan view of a vaginal insertion member included in the living body insertion device (eleventh embodiment) of the present invention. FIG. 45 is a diagram for explaining an operation procedure of the vaginal insertion member shown in FIG. 44. FIG. 46 is a diagram for explaining an operation procedure of the vaginal insertion member shown in FIG. 44. FIG. 47 is a plan view of a vaginal insertion member included in the living body insertion device (the twelfth embodiment) of the present invention. 48 is a longitudinal sectional view of the vaginal insertion member shown in FIG. FIG. 49 is a plan view of a vaginal insertion member included in the living body insertion device (the thirteenth embodiment) of the present invention. 50 is a cross-sectional view taken along line FF in FIG. FIG. 51 is a plan view of a vaginal insertion member included in the living body insertion device (fourteenth embodiment) of the present invention. 52 is a cross-sectional view taken along the line GG in FIG. FIG. 53 is an enlarged view of the protrusion of the vaginal insertion member included in the living body insertion device (fifteenth embodiment) of the present invention. FIG. 54 is an enlarged view of the protrusion of the vaginal insertion member included in the living body insertion device (sixteenth embodiment) of the present invention. FIG. 55 is a view for explaining an operation procedure of the living body insertion device (seventeenth embodiment) of the present invention. FIG. 56 is a view for explaining an operation procedure of the living body insertion device (seventeenth embodiment) of the present invention. FIG. 57 is a view for explaining the operation procedure of the living body insertion device (eighteenth embodiment) of the present invention. FIG. 58 is a view for explaining the operation procedure of the living body insertion device (eighteenth embodiment) of the present invention. 59 is an enlarged cross-sectional view of a region [H] surrounded by a two-dot chain line in FIG. 60 is an enlarged cross-sectional view of a region [I] surrounded by a two-dot chain line in FIG. FIG. 61 is a view for explaining the operation procedure of the living body insertion device (19th embodiment) of the present invention. FIG. 62 is a view for explaining an operation procedure of the living body insertion device (19th embodiment) of the present invention. FIG. 63 is a diagram for explaining an operation procedure of the living body insertion device (twentieth embodiment) of the present invention. FIG. 64 is a diagram for explaining an operation procedure of the living body insertion device (20th embodiment) of the present invention. FIG. 65 is a front view of the support of the living body insertion device (twentieth embodiment) of the present invention. FIG. 66 is a front view of a support of the living body insertion device (21st embodiment) of the present invention. FIG. 67 is a front view of the support of the living body insertion device (22nd embodiment) of the present invention. FIG. 68 is a front view of a support of the living body insertion device (23rd embodiment) of the present invention. FIG. 69 is a front view of a support of the living body insertion device (24th embodiment) of the present invention. 70 is a view seen from the direction of arrow J in FIG. FIG. 71 is a side view of the living body insertion device (25th embodiment) of the present invention. FIG. 72 is a side view of the living body insertion device (26th embodiment) of the present invention. FIG. 73 is a side view of the living body insertion device (27th embodiment) of the present invention.

  Hereinafter, a living body insertion device of the present invention is explained in detail based on a suitable embodiment shown in an accompanying drawing.

<First Embodiment>
FIG. 1 is a perspective view showing a puncture device to which a living body insertion device (first embodiment) of the present invention is applied. FIG. 2 is a side view of the puncture device shown in FIG. FIG. 3 is a plan view showing an operation member of the puncture apparatus shown in FIG. 4A and 4B are diagrams showing a puncture member included in the puncture apparatus shown in FIG. 1, wherein FIG. 4A is a perspective view and FIG. 4B is a cross-sectional view taken along line AA in FIG. FIG. 5 is a cross-sectional view of the puncture member shown in FIG. 6A and 6B are diagrams showing a state maintaining mechanism included in the puncture member shown in FIG. 4A, wherein FIG. 6A is a top view, and FIGS. 6B and 6C are cross-sectional views. FIG. 7 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 3, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. It is. 8A and 8B are diagrams showing a second anchor included in the puncture device shown in FIG. 1, wherein FIG. 8A is a cross-sectional view and FIG. 8B is a cross-sectional view showing a state where the puncture member is engaged. FIG. 9 is a view showing a first anchor of the puncture device shown in FIG. 1, wherein (a) is a cross-sectional view and (b) is a cross-sectional view showing a state where the puncture member is engaged. FIG. 10 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 11 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 12 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 13 is a plan view showing a frame fixing portion provided in the puncture apparatus shown in FIG. 1. FIG. 14 is a side view of an insertion tool included in the puncture device shown in FIG. 1. FIG. 15 is a diagram showing a positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view. 16 is a partially enlarged view of a vaginal insertion member included in the insertion tool shown in FIG. 17A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 17B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. FIG. 18 is a view showing an implant used together with the puncture device shown in FIG. FIG. 19 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG. 20A and 20B are diagrams for explaining the operation procedure of the puncture device shown in FIG. 1, in which FIG. 20A is a diagram when the operation is appropriate, and FIG. 20B is a diagram when the operation is inappropriate. FIG. 21 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 1. 22 (a) and 22 (b) are diagrams for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 23 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. 24 (a) and 24 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 25 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 26 is a cross-sectional view showing the posture of the puncture member relative to the urethra in the state shown in FIG. FIGS. 27A and 27B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 28 (a) and 28 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.

  In the following, for convenience of explanation, the left side in FIG. 2 is referred to as “tip”, the right side is referred to as “base end”, the upper side is referred to as “upper”, and the lower side is referred to as “lower”. FIG. 2 shows a state that is not yet used. Hereinafter, for convenience of explanation, this state is also referred to as an “initial state”. The state where the puncture device (insertion tool) shown in FIG. 2 is attached to the patient is also referred to as “attached state”. In FIGS. 5 and 6, the puncture member extending in an arc shape is illustrated as being linearly extended for convenience of explanation.

1. Puncture device First, the puncture device 1 will be described.

  A puncture device 1 shown in FIGS. 1 and 2 is a device used when a living tissue supporting indwelling material for treatment of female urinary incontinence, that is, treatment of urinary incontinence is embedded in a living body.

  This puncture device 1 includes a frame (support) 2, a puncture member (puncture needle) 3, a urethral insertion member (urethral insertion tool) 4, a vaginal insertion member (urethral insertion tool) 5, an operation member 7, and anchors 81 and 82. The puncture member 3, the urethral insertion member 4, the vaginal insertion member 5, the operation member 7 and the anchors 81 and 82 are supported on the frame 2, respectively. In the puncture device 1, the urethral insertion member 4 and the vagina insertion member 5 constitute an insertion tool (biological insertion device) 6. Hereinafter, these will be described in order.

(Operation member)
The operation member 7 is a member for operating the puncture member 3. As shown in FIGS. 1 to 3, the operation member 7 has an insertion portion 71, a shaft portion 73, and a connecting portion 72 that connects the insertion portion 71 and the shaft portion 73. The insertion portion 71, the coupling portion 72, and the shaft portion 73 may be integrally formed, or at least one portion may be formed as a separate body from other portions.

  The insertion portion 71 is a part that is inserted into the puncture member 3 and functions as a stylet that reinforces the puncture member 3 from the inside. By inserting the insertion portion 71 into the puncture member 3, the puncture member 3 is connected to the operation member 7, whereby the operation member 7 can be operated by the operation member 7. Such an insertion portion 71 has an arc shape corresponding to the shape of the puncture member 3. The central angle of the insertion portion 71 is set according to the central angle of the puncture member 3. Further, the distal end portion 711 of the insertion portion 71 is tapered. By having the tapered tip end portion 711, the puncture member 3 can be smoothly inserted into the insertion portion 71.

  The shaft portion 73 intersects the center O of the insertion portion 71 and extends along an axis J1 orthogonal to the plane f1 including the insertion portion 71.

  The connecting portion 72 connects the proximal end portion of the insertion portion 71 and the distal end portion of the shaft portion 73. Moreover, the connection part 72 has comprised the substantially L shape bent in the substantially right angle in the middle. The connecting portion 72 also functions as a grasping portion that the operator grasps when operating the operation member 7.

  Such an operation member 7 is configured to have higher rigidity than the puncture member 3 (main body 31). The constituent material of the operation member 7 is not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy can be used.

(Puncture member)
The puncture member 3 is a member for puncturing a living body. 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 as shown in FIG. 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. Such a main body 31 has an internal space into which the implant main body 91 can be inserted. The main body 31 has a curved shape curved in an arc shape, and has a flat cross-sectional shape as shown in FIG. In particular, the cross-sectional shape at the central portion S4 in the longitudinal direction of the main body 31 is a flat shape including the short axis J31 and the long axis J32. As will be described later, an implant main body 91 is disposed in the main body 31. Therefore, the posture within the main body 31 of the implant main body 91 can be controlled by making the main body 31 into a flat shape.

  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 a main body portion 911 described later of the implant main body 91. Thereby, even if the implant main body 91 is moved, the frictional resistance with the internal space of the main body 31 is lowered, and unnecessary force is not applied to the implant main body 91, and the main body portion 911 is disposed in the main body 31 in a sufficiently expanded state. can do. However, the width of the internal space of the main body 31 (the length in the direction of the long axis J32) may be shorter than the width of the main body portion 911. Thereby, since the width | variety of the main body 31 can be restrained, it can be set as the less invasive puncture member 3. FIG.

  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 It can also be a spindle shape that is larger (expanded) than the portion.

  In the following, for convenience of explanation, as shown in FIG. 4B, the end located on the inner side (one end) in the direction of the long axis J32 is also referred to as “inner peripheral portion A1”, and is located on the outer side (the other end). The end portion to be performed 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. 4B, a plane including both the center point of the arc of the central portion S4 and the center point of the cross-sectional shape with respect to the longitudinal direction of the main body 31 (the plane including the central axis of the main body 31) is defined as a plane f9. When the angle formed between the plane f9 and the short axis J31 at the central portion S4 is defined as an inclination angle θ1, the inclination angle θ1 is preferably an acute angle. By setting the inclination angle θ1 to an acute angle, an implant 9, which will be described later, can be disposed substantially parallel to the urethra (urethral cavity) 1300, which is one of the body lumens, and the urethra 1300 can be supported more effectively. it can. This effect will be described in detail later.

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

  The inclination angle θ1 preferably satisfies the above numerical range over the entire extending direction of the main body 31, but at least satisfies the above numerical range at the central portion S4 in the extending direction of the main body 31. The above effects can be exhibited. The “central portion S4” means at least one of the urethra 1300 and one of the living body lumens in the same manner as the urethra 1300 in a state where the puncture member 3 is punctured into the living body (a state where the main body 31 is disposed in the living body). The area | region containing the site | part located between vagina (vaginal cavity) 1400 which is is said. Moreover, in this embodiment, it can be said that the center part (center and the vicinity of both sides) between the anchors 81 and 82 is the center part S4 in a state where the anchors 81 and 82 are engaged with the puncture member 3 as described later. .

  It should be noted that markers are provided at both ends of the main body 31 at positions that are equal from the central portion S4 and project outside the living body when the main body 31 is disposed on the living body (state shown in FIG. 24). Also good. Thereby, the position in the living body of center part S4 can be confirmed by comparing the position of both markers.

  The configuration of the main body 31 can be paraphrased as follows. That is, as shown in FIG. 4B, the main body 31 is formed such that the major axis J32 is inclined with respect to the arc central axis J5, and an extension line J32 between the arc central axis J5 and the major axis J32. It can be said that '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. 10, the main body 31 is an inner peripheral portion having a minimum radius of curvature r <b> 1 located at the inner peripheral edge in a plan view when viewed from the central axis J <b> 5 direction 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. 4B, the inner peripheral portion A1 and the outer peripheral portion A2 are separated in the direction of the central axis J5 ( It can be said that it is configured to be positioned.

  The main body 31 having such a shape is composed of two divided pieces so that it can be divided in the middle. That is, the main body 31 is divided into a distal end divided piece 32 and a proximal end divided piece 33. The distal end divided piece 32 and the proximal end divided piece 33 have substantially the same length, and their boundary is located at the central portion S4.

  As shown in FIG. 5, 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. As described above, 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 is less likely to be caught on the living tissue, and the puncture member 3 can be smoothly punctured into the living body. Can be done. However, contrary to the present embodiment, the split pieces 32 and 33 may be connected by inserting the tip split piece 32 into the base end split piece 33.

  The connection state in which the divided pieces 32 and 33 are connected is maintained by the state maintaining mechanism 34. As shown in FIG. 6A, the state maintaining mechanism 34 exposes the holes 342a, 342b, 342c, an endless thread (connecting member) 341 inserted through the holes 342a, 342b, 342c, and the thread 341. Exposure holes (through holes) 345 and 346 to be exposed, and slits 347 connecting the exposure holes 345 and 346.

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

  The thread 341 is disposed in the main body 31, and is exposed to the outside of the main body 31 between the hole 342b and the hole 342c and between the hole 342a and the proximal end opening 332, respectively. By drawing the yarn 341 in this way, the connection state of the divided pieces 32 and 33 can be reliably maintained. 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, the overall length of the yarn 341 can be shortened as much as possible while allowing the yarn 341 to be cut as will be described later. Therefore, it is difficult for the thread 341 to be caught by the implant body 91 when the implant body 91 is inserted into the body 31. Further, as described above, since the holes 342a, 342b, and 342c are respectively disposed closer to the inner peripheral portion A1, the thread 341 is also disposed closer to the inner peripheral portion A1. Therefore, when the implant main body 91 is inserted into the main body 31, the thread 341 is hardly caught on the implant main body 91.

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

  Here, as shown in FIG. 6C, the hole 342 a has an axis inclined so that the outer opening is positioned closer to the base end side than the inner opening. On the other hand, as shown in FIG. 6B, the holes 342b and 342c each have an inclined axis so that the outer opening is located at the tip of the inner opening. Thereby, each hole 342a, 342b, 342c can be extended along the path | route of the thread | yarn 341, and the thread | yarn 341 becomes difficult to be caught in each hole 342a, 342b, 342c.

  The 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, respectively. The site | part in which the exposure holes 345 and 346 are provided protrudes from the body surface H in the state which has arrange | positioned the main body 31 in the biological body. The exposure holes 345 and 346 are located on the path of the yarn 341. Therefore, the thread 341 is exposed outside the main body 31 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, the distal end split piece 32 and the proximal end split piece 33 are separable by cutting the thread 341. By setting it as such a structure, the front end division | segmentation piece 32 and the base end division | segmentation piece 33 can be made into the state which can be isolate | separated by simple operation. Moreover, since the cutting | disconnection of the thread | yarn 341 is visible, it can confirm easily that the front end division | segmentation piece 32 and the base end division | segmentation piece 33 became a state which can be isolate | separated.

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

  Thus, in this embodiment, the slit 347 is provided, and this slit 347 is used as the passage path of the blade. Thereby, the deformation of the main body 31 due to the tension of the yarn 341 is prevented. Specifically, as shown in FIG. 7A, the passage route of the blade may be replaced by a slit 347 and configured by a hole 348. However, in this case, depending on the hardness of the main body 31, as shown in FIG. 7B, the hole 348 may be buckled and crushed by the tension of the thread 341, and the main body 31 may be deformed. On the other hand, in the slit 347, since the portions 347a and 347b sandwiching the slit 347 are in contact and stretched, as shown in FIG. Is prevented.

  As shown in FIG. 5, a pair of engagement holes 315 and 316 that engage with the anchor 81 are provided at the distal end portion of the main body 31. On the other hand, a pair of engagement holes 317 and 318 that engage with the anchor 82 are provided at the base end portion of the main body 31. Of these four engagement holes, the engagement holes 315 and 317 are provided in the inner peripheral portion A1, and the engagement holes 316 and 318 are provided in the outer peripheral portion A2.

  As described above, the main body 31 has a flat shape and is not easily crushed in the major axis direction, so that the separation distance between the inner peripheral portion A1 and the outer peripheral portion A2 is difficult to change. Further, the inner peripheral portion A1 and the outer peripheral portion A2 have large curvatures and are not easily deformed compared to the front surface A3 and the rear surface A4. Therefore, by providing the engagement holes 315 and 317 in the inner peripheral portion A1 and the engagement holes 316 and 318 in the outer peripheral portion A2, the engagement between the anchors 81 and 82 and the main body 31 is difficult to be released.

  Further, the separation distance between the engagement holes 315 and 316 and the central portion S4 and the separation distance between the engagement holes 317 and 318 and the central portion S4 are substantially equal. Thereby, the anchors 81 and 82 serve as markers, and the position of the central portion S4 of the main body 31 in the living body can be easily grasped.

  A needle body 35 is provided at the tip of the main body 31 as described above. As shown in FIG. 5, 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. Note that the base end portion 352 is fitted into the main body 31 with a force that can prevent unintentional detachment of the needle body 35 from the main body 31. The needle body 35 may be configured integrally with the main body 31.

  In addition, the proximal end portion 352 is provided with an engaging portion 353 that engages with the distal end portion 711 of the insertion portion 71. The engaging portion 353 is configured by a concave portion, and the distal end portion 711 is positioned in the engaging portion 353 in the inserted state in which the puncture member 3 is inserted into the inserting portion 71. By providing the engagement portion 353, the displacement of the needle body 35 with respect to the insertion portion 71 is suppressed, and the puncture member 3 can be punctured into the living body more smoothly.

  The puncture member 3 has been described above. The center angle θ4 of the puncture member 3 is not particularly limited and is appropriately set according to various conditions. As will be described later, the needle body 35 enters the body from one of the buttocks of the patient, and the urethra It is set so that it can pass between 1300 and the vagina 1400 and project outside the body from the other buttocks. Specifically, the central angle θ4 is preferably 150 to 270 °, more preferably 170 to 250 °, and further preferably 190 to 230 °.

  Moreover, as a constituent material of the main body 31 and the needle body 35, a hard material which maintains a shape and internal space in the state inserted in the body is preferable. Examples of such a hard material include various resin materials such as polyethylene, polyimide, polyamide, polyester elastomer, and polypropylene, and various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like. . In addition to employing a hard material as the configuration of the main body 31 and the needle body 35, when a material other than the hard material is employed, the wall can be reinforced by a reinforcing member. For example, by embedding a high-strength braided body in the wall, the shape and the internal space can be maintained while being inserted into the body. As another example of the reinforcing member, by embedding a spiral object in the wall of the main body 31, it is possible to provide flexibility while maintaining the internal space to the extent that the insert can slide.

  It is preferable that the main body 31 has light transmittance and the inside can be visually recognized from the outside. Thereby, for example, it is possible to confirm 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 cut.

  The puncture member 3 (main body 31) described above and the insertion portion 71 inserted into the main body 31 constitute the medical tube assembly 10, and in the puncture device 1, these are in the state of the medical tube assembly 10. Use begins.

  The number and arrangement of the holes (342a, 342b, 342c) 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.

(anchor)
As shown in FIG. 8A, the anchor (second anchor) 81 protrudes from the base 811 having an insertion hole 812 through which the main body 31 is inserted, and engages with the pair of engagement holes 315 and 316. A pair of claw portions 813 and 814 is provided. The cross-sectional shape of the insertion hole 812 corresponds to the cross-sectional shape of the main body 31. Therefore, in a state where the puncture member 3 is inserted through the insertion hole 812, the rotation of the anchor 81 with respect to the puncture member 3 is restricted, and these positional relationships are appropriately maintained. When the puncture member 3 is inserted into the insertion hole 812 and the puncture member 3 is pushed forward with respect to the anchor 81, the claw portions 813 and 814 engage with the engagement holes 315 and 316 as shown in FIG. As a result, the anchor 81 is engaged with the tip split piece 32. In the engaged state, the base portion 811 is located on the proximal end side with respect to the claw portions 813 and 814. As described above, when the puncture member 3 is inserted through the insertion hole 812, the rotation of the anchor 81 with respect to the puncture member 3 is restricted, so that the engagement between the claw portions 813 and 814 and the engagement holes 315 and 316 is ensured. Can be expressed.

  Similarly, as shown in FIG. 9A, the anchor (first anchor) 82 includes a base portion 821 having an insertion hole 822 through which the main body 31 is inserted, a base portion 821, and a pair of engagement holes 317, 318. It has a pair of claw parts 823 and 824 to be engaged. The cross-sectional shape of the insertion hole 822 corresponds to the cross-sectional shape of the main body 31. Therefore, in a state where the puncture member 3 is inserted through the insertion hole 822, the rotation of the anchor 82 with respect to the puncture member 3 is restricted, and these positional relationships are appropriately maintained. When the puncture member 3 is inserted into the insertion hole 812 and the puncture member 3 is pushed forward against the anchor 82, the claws 823 and 824 engage with the engagement holes 317 and 318 as shown in FIG. 9B. As a result, the anchor 82 is engaged with the base end split piece 33. In the engaged state, the base portion 821 is located on the tip side of the claw portions 823 and 824. As described above, when the puncture member 3 is inserted into the insertion hole 822, the rotation of the anchor 82 with respect to the puncture member 3 is restricted, so that the engagement between the claw portions 823 and 824 and the engagement holes 317 and 318 is ensured. Can be expressed.

  The constituent materials of the anchors 81 and 82 are not particularly limited, and for example, various resin materials can be used.

(flame)
The frame 2 rotatably holds the operation member 7 to which the puncture member 3 is attached, and fixes the insertion tool 6 and the anchors 81 and 82 in a detachable manner. The frame 2 has a function of determining a puncture route of the needle body 35 when the puncture member 3 punctures a living tissue. Specifically, the frame 2 is configured so that when the puncture member 3 punctures a living tissue, the needle body 35 passes between the urethra insertion member 4 and the vagina insertion member 5 without colliding with them. 3. The positional relationship between the urethral insertion member 4 and the vaginal insertion member 5 is defined.

  As shown in FIGS. 1 and 2, the frame 2 guides the bearing portion 21 that supports the shaft portion 73 of the operation member 7 and the puncture member 3 and detachably holds the first and second anchors 81 and 82. A guide portion (holding portion) 22, a connecting portion 23 that connects the bearing portion 21 and the guide portion 22, and a fixing portion 24 to which the insertion tool 6 is fixed.

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

  The guide portion 22 is located on the distal end side of the puncture device 1 and is disposed to face the bearing portion 21. As shown in FIG. 10, the guide portion 22 is formed with a substantially C-shaped guide groove 221 that accommodates the puncture member 3 and guides the puncture member 3. Further, as shown in FIG. 11, in the state of being placed in the guide groove 221, the puncture member 3 has the back surface A4 positioned on the distal end side and the surface A3 positioned on the proximal end side.

  Moreover, the guide part 22 is holding the anchors 81 and 82 so that attachment or detachment is possible. The anchor 82 is held facing the front end side opening 222 so that the insertion hole 822 is continuous with the guide groove 221, and the anchor 81 is guided by the guide groove 221 so that the insertion hole 812 is continuous with the guide groove 221. Is held opposite to the base end side opening 223.

  In the initial state, the main body 31 is inserted into the insertion hole 822 of the anchor 82, and the needle body 35 protrudes from the guide portion 22. When the operation member 7 is rotated, the puncture member 3 gradually protrudes from the guide portion 22, and finally, the needle body 35 enters the guide portion 22 through the proximal end opening 223 as shown in FIG. . In this process, the puncture member 3 passes through the insertion hole 812 of the anchor 81 on the distal end side of the puncture member 3, and the claw portions 813 and 814 engage with the engagement holes 315 and 316. On the other hand, the claw portions 823 and 824 are engaged with the engagement holes 317 and 318 on the proximal end side of the puncture member 3. Thereby, the anchors 81 and 82 are engaged with the puncture member 3.

  The connecting portion 23 connects the bearing portion 21 and the guide portion 22. Further, the connecting portion 23 has a rod shape extending substantially parallel to the axis J1. The connecting portion 23 also functions as a grasping portion, and an operator can use the puncture apparatus 1 by grasping the connecting portion 23.

  The fixed portion 24 is disposed to face the connecting portion 23 via the axis J1. As shown in FIG. 13, the fixing portion 24 has a concave portion 243 into which a support portion 60 described later of the insertion tool 6 is fitted, and a male screw 244. The insertion tool 6 can be fixed to the fixing portion 24 by fitting the supporting portion 60 into the recess 243 and further tightening the male screw 244 into a female screw (not shown) of the supporting portion 60.

(Insert tool)
As shown in FIGS. 1 and 14, the insertion tool 6 includes a urethral insertion part (second insertion part) 41 inserted into the urethra 1300 and a vaginal insertion part (first insertion part) inserted into the vagina 1400. 51 and a support portion 60 that arranges and supports the urethral insertion portion 41 and the vagina insertion portion 51 side by side. As described above, the insertion tool 6 includes two living body insertion tools, that is, the urethral insertion member 4 and the vaginal insertion member 5, and the urethral insertion member 4 includes the urethral insertion portion 41, and the vaginal insertion member 5 is A vaginal insertion part 51 is provided. The support portion 60 includes a support portion 40 that is provided in the urethral insertion member 4 and supports the urethral insertion portion 41, and a support portion 50 that is provided in the vaginal insertion member 5 and supports the vaginal insertion portion 51. In the insertion tool 6, the urethral insertion member 4 and the vagina insertion member 5 are detachable via the support portions 40 and 50. Hereinafter, the urethral insertion member 4 and the vaginal insertion member 5 will be described in order.

-Urethral insertion member-
The urethral insertion member 4 includes a long urethral insertion portion 41 that is inserted into the urethra 1300 halfway and a support portion 40 that supports the urethral insertion portion 41. Hereinafter, for convenience of explanation, a portion located in the urethra 1300 (including the bladder 1310) in the wearing state is also referred to as an “insertion portion 411”, and is a portion exposed from the urethral opening to the outside in the wearing state. The portion up to the support portion 40 is also referred to as a “non-insertion portion 412”.

  The urethral insertion portion 41 has a straight tubular shape with a rounded tip. In addition, a balloon 42 that can be expanded and contracted and a urine discharge portion 47 are provided at the distal end portion of the insertion portion 411. As shown in FIG. 19, the balloon 42 is in contact with the bladder neck 1320 by expanding in a state where the urethral insertion portion 41 is inserted into the urethra 1300 until the urine drainage portion 47 reaches the bladder 1310. It functions as a restricting portion (or may be referred to as “contact portion”) for restricting the axial position of the urethral insertion member 4 in the urethra 1300. Specifically, when the puncture device 1 is used, the balloon 42 is expanded after being inserted into the bladder 1320 of the patient. Then, when the expanded balloon 42 is hooked on the bladder neck 1320, the position of the urethra insertion member 4 with respect to the bladder 1310 and the urethra 1300 is fixed. On the other hand, the urine discharge unit 47 has a function of discharging urine in the bladder 1310 and also has a function of supplying a liquid such as water into the bladder 1310.

  The balloon 42 passes through the urethral insertion portion 41 and is connected to a balloon port 43 provided at the proximal end portion thereof. A balloon expansion device such as a syringe can be connected to the balloon port 43. When the working fluid (liquid such as physiological saline, gas, etc.) is supplied from the balloon expanding device to the balloon 42, the balloon 42 expands. Conversely, when the working fluid is extracted from the balloon 42 by the balloon expanding device, the balloon 42 contracts. To do. In FIG. 14, the state in which the balloon 42 is deflated is indicated by a two-dot chain line, and the state in which the balloon 42 is expanded is indicated by a solid line.

  On the other hand, the urine discharge part 47 is provided with a discharge hole 471 that communicates the inside and outside of the urine discharge part 47. The urine discharge part 47 passes through the urethra insertion part 41 and is connected to a urine discharge port 48 provided at the base end part thereof. By connecting a suction device such as a syringe to the urine discharge port 48 and operating the suction device, urine introduced from the discharge hole 471 can be discharged from the urine discharge port 48. Further, for example, a syringe filled with water in advance can be connected to the urine discharge port 48. In this case, water can be supplied into the bladder 1310 from the discharge hole 471 by pressing the plunger of the syringe.

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

  A plurality of suction holes (suction ports) 44 opened in the outer peripheral surface are formed in the middle of the insertion portion 411. The plurality of suction holes 44 are arranged over the entire area in the circumferential direction of the urethral insertion portion 41. Each suction hole 44 is connected to a suction port 45 provided at the base end portion through the urethra insertion portion 41. A suction device such as a pump can be connected to the suction port 45. When the urethra insertion part 41 is inserted into the urethra 1300, the outer peripheral surface of the insertion part 411 of the urethra insertion part 41 abuts (or approaches) the living tissue between the urethra 1300 and the vagina 1400, that is, the urethra wall. When the suction device is operated in this state, the urethral wall is sucked to the outer peripheral surface side of the insertion portion 411. Thereby, the adhesiveness of a urethra wall and the outer peripheral surface of the insertion part 411 which is a contact surface with respect to the said urethra wall can be improved. In this state, when the urethra insertion part 41 is pushed into the distal end side (inside the body), the urethra 1300 is also pushed together, and for example, the bladder 1310 can be shifted to a position that does not overlap with the puncture path of the puncture member 3. The puncture route can be secured. Therefore, the puncture member 3 can be punctured accurately and safely.

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

  In the puncture device 1, a line from each suction hole 44 to the suction device such as a pump through the suction port 45 may be referred to as a “suction line 49”.

  As shown in FIG. 14, a ring member 46 that divides the insertion portion 411 and the non-insertion portion 412 is attached to the urethral insertion portion 41. The ring member 46 is movable along the longitudinal direction of the urethral insertion portion 41, and is supported so as to be fixed at the movement destination. For example, the ring member 46 functions as a marker for confirming the insertion depth of the urethra insertion part 41 into the urethra 1300 or seals the urethral opening in a state where the urethra insertion part 41 is inserted into the urethra 1300. Also functions as a cap.

  The length of the insertion portion 411 is not particularly limited, and is appropriately set depending on the length of the patient's urethra 1300, the shape of the bladder 1310, and the like. Since the length of a general female urethra is about 30 to 50 mm, it is more preferably about 50 to 100 mm.

  The length of the non-insertion portion 412 (the separation distance between the urethral opening and the support portion 40) is not particularly limited, but is preferably about 100 mm or less, and more preferably about 20 to 50 mm. Thereby, the non-insertion part 412 can be made into appropriate length, and operativity improves. If the length of the non-insertion portion 412 exceeds the upper limit, depending on the configuration of the frame 2, the center of gravity of the puncture device 1 is greatly separated from the patient, and the stability of the puncture device 1 in the worn state is reduced. There is a case.

  The constituent material of the urethral insertion member 4 is not particularly limited. For example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials can be used.

  Here, the inclination angle θ2 of the plane f9 (plane f1) with respect to the plane f2 orthogonal to the axis J2 of the urethra insertion part 41 is preferably about 20 to 60 °, more preferably about 30 to 45 °, More preferably, it is about 35-40 degrees. In other words, the main body 31 is preferably placed in the body so that the angle formed by the plane f9 and the plane orthogonal to the axis of the urethra 1300 is about 20 to 60 °, and is about 30 to 45 °. It is more preferable to be left in the body, and it is still more preferable to be left in the body so as to be about 35 to 40 °. Thereby, the puncture of the puncture member 3 can be easily performed, and the puncture distance by the puncture member 3 can be further shortened.

  More specifically, by setting the inclination angle θ2 within the above range, the puncture member 3 can broadly grasp the left and right closure holes 1101 and 1102 of the pelvis 1100 in a plane as shown in FIG. It is possible to secure a wide puncture space for the puncture member 3. That is, the puncture member 3 can be punctured in a relatively vertical direction with respect to the closing holes 1101 and 1102 in a state where the patient is in a predetermined body position (crushed stone position). Therefore, the puncture member 3 can be punctured easily. In addition, since the puncture member 3 is punctured in a relatively vertical direction with respect to the closure holes 1101 and 1102, the needle body 35 of the puncture member 3 passes through the shallow portion of the tissue. You can pass between them at a shorter distance. Therefore, as shown in FIG. 15 (b), the puncture member 3 can pass through the closure holes 1101 and 1102 near the pubic joint 1200, preferably through the safety zone S5. Since the safety zone S5 is a site where there are few nerves and blood vessels to avoid damage, the puncture member 3 can be punctured safely. Therefore, it becomes less invasive and can reduce the burden on the patient. As described above, by setting the inclination angle θ2 within the above range, the patient can be punctured with the puncture member 3 more appropriately. In addition, puncturing at the above-described angle makes it easy to target the tissue between the middle urethra that points to the middle portion in the length direction of the urethra 1300 and the vagina 1400. Between the middle urethra and the vagina 1400 is a position suitable as a site for implanting the implant 9 and treating urinary incontinence.

  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.

  More preferably, the puncture between the middle urethra and the vagina 1400 is facilitated by puncturing the urethra 1300 or the vagina 1400, and both the urethra 1300 and the vagina 1400 while being shifted in position. The method of pushing one of the urethra 1300 and the vagina 1400 into the body is, for example, in a state in which the urethra insertion member 4 and / or the vagina insertion member 5 are inserted at appropriate positions, and suction holes described later provided for them. After the urethra 1300 and / or the vagina 1400 are adsorbed by 44 and 59, the urethra insertion member 4 and / or the vagina insertion member 5 are further moved to the inside of the body along their respective axes to a predetermined position. Can do. In this manner, the main body 31 is vertically punctured with respect to the left and right closing holes 1101 and 1102 of the pelvis with the position shifted so as to push at least one of the urethra 1300 and the vagina 1400 to the inside of the body. The passage can be formed at a position suitable for the detention.

  Set so that the trajectory of the main body 31 passes through the safety zone S5 of the left and right closure holes 1101 and 1102 of the pelvis, and at least one of the urethra 1300 and the vagina 1400 is positioned so that the trajectory is located between the middle urethra and the vagina 1400. It is preferable to shift to the inside of the body and puncture the main body 31 along the track to form a passage.

-Vaginal insertion member-
As shown in FIG. 1 and FIG. 14, the vaginal insertion member 5 is a long vaginal insertion portion (first insertion portion) 51 that is inserted into the vagina 1300 halfway, and a support that supports the vaginal insertion portion 51. Part 50. In the following, for convenience of explanation, a portion located in the vagina 1400 in the mounted state is also referred to as an “insertion portion 511”, and is a portion exposed from the vagina mouth to the outside of the body in the mounted state up to the support portion 50. This portion is also referred to as “non-insertion portion 512”.

  The insertion part 511 has a long shape. Further, the insertion portion 511 extends with an inclination with respect to the insertion portion 411 so that the distal end side is separated from the insertion portion 411. By tilting the insertion portion 511 with respect to the insertion portion 411, the positional relationship between the insertion portions 411 and 511 can be made closer to the positional relationship between the urethra 1300 and the vagina 1400 as compared to the case where the insertion portion 511 is not tilted. Therefore, the puncture device 1 is more stably held by the patient in the wearing state, and the burden on the patient is reduced. Although it does not specifically limit as inclination-angle (theta) 3 with respect to the insertion part 411 of the insertion part 511, For example, it is preferable that it is about 0-45 degrees, and it is more preferable that it is about 0-30 degrees. Thereby, the said effect can be exhibited more notably. On the other hand, when the inclination angle θ3 is less than the above lower limit value or exceeds the above upper limit value, the vagina 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.

  As shown in FIG. 16, the insertion portion 511 has a flat shape that is crushed in the vertical direction of the puncture device 1 (the arrangement direction of the urethra 1300 and the vagina 1400). Further, the insertion portion 511 has a central portion having a substantially constant width and a rounded tip portion. Although it does not specifically limit as length L2 of the insertion part 511, It is preferable that it is about 20-100 mm, and it is more preferable that it is about 30-60 mm. Further, the width W1 of the insertion portion 511 is not particularly limited, but is preferably about 10 to 50 mm, and more preferably about 20 to 40 mm. Further, the thickness of the insertion portion 511 is not particularly limited, but is preferably about 5 to 25 mm, and more preferably about 10 to 20 mm. By adopting such length × width × thickness, the insertion portion 511 has a shape and size suitable for a general vagina 1400. Therefore, the stability of the puncture device 1 in the mounted state is increased, and the burden on the patient is reduced.

  A plurality of bottomed recesses 53 arranged in a matrix are formed on the upper surface (surface on the urethral insertion portion 41 side) 511a of the insertion portion 511. In addition, the number of the recessed parts 53 is not specifically limited, For example, one may be sufficient. In addition, one suction hole 59 is provided on the bottom surface of each recess 53, and each suction hole 59 passes through the insertion portion 511 and is connected to a suction port 54 provided at the base end portion thereof. . The suction port 54 is provided so as to be located outside the living body in the mounted state. A suction device such as a pump can be connected to the suction port 54. When the vaginal insertion part 51 is inserted into the vagina 1400, the upper surface 511a of the insertion part 511 of the vaginal insertion part 51 abuts (or approaches) the living tissue between the urethra 1300 and the vagina 1400, that is, the vagina wall. When the suction device is operated in this state, the vagina wall is sucked to the upper surface 511a side of the insertion portion 511. Thereby, the adhesiveness of a vagina wall and the upper surface 511a of the insertion part 511 which is a contact surface with respect to the said vagina wall can be improved. In this state, when the vagina insertion part 51 is pushed into the distal end side (inside the body), the vagina wall can be pushed together. Therefore, the arrangement and shape of the vagina wall can be adjusted, the puncture route of the puncture member 3 can be secured, and the puncture of the puncture member 3 can be performed accurately and safely.

  In the present embodiment, one suction hole 59 is formed in one recess 53, but the present invention is not limited to this, and a plurality of suction holes 59 may be formed in one recess 53. The total number of suction holes 59 is not limited to a plurality, and may be one.

  In the puncture device 1, the line from each suction hole 59 to the suction device such as a pump through the suction port 54 may be referred to as a “suction line 58”.

  As shown in FIG. 14, the region S2 in which the plurality of recesses 53 are formed is disposed opposite to the region S1. The needle tip 351 of the puncture member 3 passes between these areas S1 and S2. As described above, the urethra 1300 that is the lower surface of the urethral wall is adsorbed by the insertion portion 411 in the region S1, and the vagina wall is adsorbed by the insertion portion 511 in the region S2, so that the urethral wall is between the regions S1 and S2. And the vaginal wall are more widely separated. Therefore, the puncture member 3 can be punctured more safely by passing the puncture member 3 through such a region.

  The region S2 extends over substantially the entire width direction of the upper surface 511a. Although it does not specifically limit as width W2 of area | region S2, It is preferable that it is about 9-49 mm, and it is more preferable that it is about 19-39 mm. Thereby, the vaginal wall can be more reliably adsorbed to the insertion portion 511 without being greatly affected by the shape of the vagina wall. In particular, some patients may have a vagina 1400 shaped such that a portion of the anterior vaginal wall 1410 hangs into the vagina 1400 as shown in FIG. Even in such a case, if the width W2 is set as described above, as shown in FIG. 17B, not only the sagging portion but also the portions on both sides of the sagging portion can be reliably sucked. Therefore, the front wall of the vagina can be more reliably separated from the urethra 1300 without being affected by the shape of the vagina 1400. In particular, in this embodiment, since the insertion portion 511 has a flat shape, the front wall of the vagina can be adsorbed so as to be further away from the urethra 1300, and the living tissue between the urethra wall and the vagina wall can be more widely spread. Can be spread.

  As shown in FIGS. 14 and 16, the protrusion 11 is disposed in the immediate vicinity of the distal end side of the region S <b> 2, i. The protrusion 11 protrudes toward the urethral insertion member 5 side, and functions as a contact detection unit that detects whether or not the expanded balloon 11 of the urethral insertion member 5 is in contact with the bladder neck 1320. Note that the top 111 of the protrusion 11 is preferably rounded.

  By the way, in a state where the urethra insertion member 5 is inserted into the urethra 1300, the balloon 42 is expanded, and the balloon 42 is brought into contact with the bladder neck 1320 in order to position the urethra insertion member 5, It may be pulled in the proximal direction. In this case, for example, for an elderly woman whose bladder neck 1320 is relatively weak, the balloon 42 pushes the bladder neck 1320 and expands into the urethra 1300 as shown in FIG. It goes into excess. The state shown in FIG. 20 (b) is a state in which the puncture path M with respect to the living tissue of the puncture member 3 and the urethra 1300 (bladder neck 1320) interfere with each other. Is not preferred. Such a state is difficult for the surgeon to grasp.

  Therefore, the protrusion 11 can detect whether or not the balloon 11 expanded from the urethral insertion member 5 is in contact with the bladder neck 1320, that is, whether the balloon 11 has not excessively entered the urethra 1300. This will be described below.

  First, as shown in FIG. 19, the urethral insertion member 5 is inserted into the urethra 1300, and the balloon 42 is expanded in the bladder 1310. Next, as shown in FIG. 20A, the urethral insertion member 5 is inserted into the urethra 1300, the vaginal insertion member 5 is inserted into the vagina 1400, and the urethral insertion member 5 is pulled toward the proximal end side.

  The insertion depth of the vagina insertion member 5 into the vagina 1400 is preferably set to a depth at which the marker 57 is located, for example, about 15 mm away from the urethral orifice. At this time, the protrusion 11 is in a state where the vicinity of the bladder neck 1320 is pressed toward the urethral insertion member 5 side.

  As described above, when the urethral insertion member 5 is pulled to the proximal end side, the balloon 42 expanded to the protruding portion 11 side does not excessively enter the urethra 1300 and is only slightly in contact with the bladder neck 1320. The vibration is transmitted to the protrusion 11 through the bladder neck 1320 (biological tissue). According to the detection result by the protrusion 11, the surgeon is in a state in which the balloon 42 is in contact with the bladder neck 1320, and thus the puncture path M is positioned on the urethral opening side of the bladder neck 1320. That is, it can be determined and grasped that the protrusion 11 as the detection unit is located on the distal end side with respect to the puncture path M of the puncture member 3. If puncturing is performed in this state, it is possible to reliably prevent the needle body 35 of the puncture member 3 from puncturing the urethra 1300 or the bladder 1310, that is, erroneous puncture. In other words, when a surgical procedure such as puncture is performed on a living tissue located between the urethra 1300 and the vagina 1400, the procedure can be reliably performed.

  As shown in FIG. 16, the protrusion 11 extends along a direction orthogonal to the longitudinal direction of the vaginal insertion member 5, that is, along the width direction. This makes it possible to secure a large area for detecting whether or not the balloon 11 is in contact with the bladder neck 1320 as compared to, for example, a case where the protrusion 11 has a pin shape. Can be done.

  In addition, the insertion unit 511 is provided with a marker (puncture position confirmation unit) 57 that can confirm the puncture route of the puncture device 1, that is, the vaginal wall present on the upper surface of the position where the marker 57 exists. The puncture device can be fixed to puncture between the urethral walls. Therefore, the operability and safety of the insertion tool 6 are improved. The marker 57 is provided at least on the lower surface 511b of the insertion portion 511. Since the lower surface 511b is a surface that faces the vaginal opening side and is visible to the operator through the vaginal opening in the inserted state, by providing the marker 57 on the lower surface 511b, the puncture route of the puncture apparatus 1 can be more reliably performed. Can be confirmed. Further, the insertion depth of the insertion portion 511 into the vagina 1400 can also be confirmed. Note that the marker 57 only needs to be visible from the outside, and can be configured by, for example, a colored portion, an uneven portion, or the like.

  The non-insertion portion 512 has a thin rod shape extending substantially parallel to the urethral insertion portion 41. The separation distance D between the non-insertion portion 512 and the urethral insertion portion 41 is not particularly limited, but is preferably about 5 to 40 mm in accordance with the separation distance between the urethral opening and the vaginal opening in a general woman. .

  The length of the non-insertion portion 512 (the distance between the vaginal opening and the support portion 50) is not particularly limited, but is preferably about 100 mm or less, more preferably about 20 to 50 mm. Thereby, the non-insertion part 512 can be made into suitable length, and operativity improves. If the length of the non-insertion portion 512 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 worn state is lowered. There is a case.

  The support portion 50 is provided with a male screw 501, and the support portions 40 and 50 are fixed to each other by tightening the male screw 501 into a female screw (not shown) of the support portion 40.

  The constituent material of the vaginal insertion member 5 is not particularly limited. For example, as with the urethra insertion member 4, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials are used. Can do.

Further, the support portion 40 supports the urethral insertion portion 41 so as to be movable in the longitudinal direction thereof. Thus, when the support portion 40 and the support portion 50 are connected, the protrusion 11 and the balloon 42 are connected to each other. Approach and separation (approach and / or separation) are possible.
The configuration of the puncture device 1 has been described above.

  In the puncture device 1, the urethral insertion member 4 and the vagina insertion member 5 constituting the insertion tool 6 are configured to be detachable. However, the present invention is not limited to this, and the urethral insertion member 4 and the vagina insertion member 5 are detachable. It may be impossible.

  Further, in the puncture device 1, the urethral insertion portion 41 is fixed to the support portion 40, but the present invention is not limited to this, and the urethral insertion portion 41 is fixed to the support portion 40 and the support portion 40. It may be possible to select a state in which it can slide in the axial direction. Specifically, for example, if the screw provided in the support part 40 is loosened, the urethra insertion part 41 becomes slidable with respect to the support part 40, and if the screw is tightened, the urethra insertion part 41 becomes the support part. 40 may be in a fixed state. According to this configuration, since the length of the non-insertion portion 412 can be adjusted, the insertion tool 6 is more convenient to use. The same applies to the vaginal insertion part 51. Further, by moving the urethra insertion part 41 back and forth in the urethra 1300, the balloon 42 in contact with the bladder 1310 comes into contact with the protrusion 11 of the vaginal insertion part 41 via the living tissue and the position of the balloon 42 in the bladder 1310. Can be surely grasped.

  In the puncture apparatus 1, each part 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.

2. Next, a method of using the puncture device 1 will be described. Prior to that, an implant 9 used with the puncture device 1 will be described.

  The implant (living tissue support indwelling product) 9 shown in FIG. 18 is an implantable device for treating female urinary incontinence, that is, a device that supports the urethra, for example, the urethra is about to move to the vaginal wall side. Sometimes it is a device that supports the urethra so as to restrict its movement away from the vaginal wall. As this implant 9, for example, a long object having flexibility can be used.

  The implant 9 includes an implant main body (strip-shaped elongated object) 91 and a bag-shaped packaging material 92 that accommodates the implant main body 91. The implant body 91 has a body portion 911 and a band 912 connected to one end of the body portion 911. By providing the implant 9 with the packaging material 92, contamination of the implant body 91 can be effectively prevented. Note that a guide wire, string, thread, or the like may be used instead of the band 912.

  The main body portion 911 has a net shape, and the entire shape thereof is a belt shape. In addition, the main-body part 911 can be comprised, for example by what crossed the linear body and knit in the net shape, ie, a net-like braided body. Examples of the linear body include a circular cross section, a flat cross section, that is, a strip.

  The constituent materials of the main body 911, the band 912, and the packaging material 92 are not particularly limited. For example, various resin materials, fibers, and the like having biocompatibility such as polypropylene, polyester, and nylon can be used. .

  The implant 9 is not limited to the net-like one as long as the same effect can be exhibited. The implant 9 and the sheath 30 constitute the pelvic treatment kit of the present invention.

  Next, an operation procedure (puncture method) of the puncture device 1, that is, a procedure hand when the implant 9 is embedded in a living body will be described.

  First, the patient is crushed on the operating table, and the urethral insertion portion 41 of the urethral insertion member 4 is inserted into the urethra 1300 of the patient as shown in FIG. At this time, the insertion depth is confirmed by the ring member 46 disposed in advance at a predetermined position, and the balloon 42 is disposed in the bladder 1310. The urethra 1300 is corrected to the predetermined shape by the urethra insertion part 41 having a predetermined shape. In the case of the present embodiment, the urethra is straightened by the straight urethra insertion part 41.

  Next, the balloon 42 is expanded, and urine is discharged from the bladder 1310 through the discharge hole 471 as necessary.

  Next, as shown in FIG. 20, the vaginal insertion part 51 of the vaginal insertion member 5 is inserted into the vagina 1400 of the patient. At this time, the puncture position is confirmed with the marker 57 and inserted to an appropriate depth.

  Then, the urethral insertion member 4 is pulled toward the proximal end side. At this time, the urethral insertion member 4 is in the state shown in FIG. 20A or the state shown in FIG.

  In the state shown in FIG. 20 (a), as described above, the balloon 42 does not excessively enter the urethra 1300, but lightly contacts the bladder neck 1320, and the vibration is projected through the bladder neck 1320. 11 is transmitted. As a result, the surgeon is in a state where the balloon 42 is in contact with the bladder neck 1320 and the puncture path M is located closer to the urethral orifice than the bladder neck 1320, that is, a preferable state for puncture. Can be grasped.

  On the other hand, in the state shown in FIG. 20B, the vibration is not transmitted to the surgeon, and the surgeon has excessively penetrated the urethra 1300, which is not preferable for puncture. You can expect that. In this case, the urethral insertion member 4 is pushed or pulled to the state shown in FIG.

Next, as shown in FIG. 21, the male screws 501 are operated to fix the support portions 40 and 50. Thereby, mounting | wearing of the insertion tool 6 to a patient is completed. In this state, the non-insertion parts 412 and 512 are separated from each other, and the support part 60 is separated from the body surface between the urethral opening and the vaginal opening, and the body surface is exposed. In addition, when the insertion portion 511 and the anterior wall of the vagina are separated from each other and a gap (space) is formed between them, from the body surface between the urethral opening and the vagina opening, the urethra 1300 and the vagina 1400 A space S3 for puncturing the syringe (injection tool) 2000 into the living tissue between them is formed. The syringe 2000 is previously filled with a liquid such as physiological saline or local anesthesia, and a syringe needle 2001 is attached to the tip.
Further, the ring member 46 of the urethral insertion member 4 is brought into close contact with the urethral opening and fixed.

  Next, a suction device is connected to the suction ports 45 and 54, the suction device is operated, the urethra 1300 is adsorbed to the urethra insertion portion 41, and the vagina front wall is adsorbed to the vaginal insertion portion 51. For example, if the urethra 1300 is properly adsorbed by the urethra insertion portion 41, the suction hole 44 is blocked by the urethra wall, and thus suction from the suction port 45 is stopped or weakened. Similarly, if the anterior vagina wall is properly adsorbed by the vagina insertion portion 51, the suction hole 59 is blocked by the vagina wall, so that suction from the suction port 54 is stopped or weakened. For this reason, the surgeon properly adsorbs the urethra 1300 and the anterior wall of the vagina to the urethra insertion part 41 and the vagina insertion part 51 from the state of suction from the suction ports 45 and 54 (for example, the magnitude of sound generated by suction). You can check whether or not. The insertion tool 6 may have a confirmation mechanism that mechanically confirms the suction state. The confirmation mechanism is not particularly limited as long as the adsorption state can be confirmed. For example, the confirmation mechanism is based on a flow rate measurement unit (negative pressure gauge) that measures a flow rate from the suction port 54 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.

  Next, liquid peeling is performed. Specifically, as shown in FIG. 21, the injection needle 2001 of the syringe 2000 is punctured from the proximal end to the anterior vaginal wall 1410 through a space (space S3) between the insertion portion 511 and the anterior vaginal wall 1410. Then, physiological saline, local anesthesia, or the like is injected into the living tissue between the urethra 1300 and the vagina 1400 (between the regions S1 and S2). As a result, the living tissue between the regions S1 and S2 expands, the urethra 1300 is pressed against the urethral insertion portion 41, and the vaginal front wall 1410 is pressed against the vaginal insertion portion 51.

  Here, it is preferable to continue the suction from the suction holes 44 and 59 even during liquid peeling. When the urethra 1300 is pressed against the urethra insertion part 41 by liquid separation, the urethra 1300 is further adsorbed by the urethra insertion part 41, and thus suction from the suction port 45 is stopped or weakened. Similarly, when the anterior vagina wall is pressed against the vagina insertion portion 51, the anterior vagina wall is further adsorbed by the vagina insertion portion 51, so that suction from the suction port 45 is stopped or weakened. Therefore, the operator can confirm whether or not the liquid separation has been properly performed based on the suction state from the suction ports 45 and 54.

  Liquid separation is performed so that the urethra 1300 and the anterior wall of the vagina are sufficiently separated from each other, and then the frame 2 is fixed to the insertion tool 6 as shown in FIG. Thereby, the puncture apparatus 1 will be in the state with which the patient was mounted | worn. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.

  Next, for example, while holding the connecting portion 23 of the frame 2 with one hand, the connecting portion 72 of the operating member 7 is held with the other hand, and the operating member 7 is turned as shown in FIG. Rotate clockwise. Thereby, the needle body 35 of the puncture member 3 enters the body from a different direction from the injection needle 2001, that is, punctures the body surface H of the right buttock of the patient or a portion in the vicinity thereof (first portion), After passing through one closing hole 1101, between the urethra 1300 and the vagina 1400 and the other closing hole 1102 in order, it protrudes from the body surface H of the left buttocks or its vicinity (second part) to the outside, and finally Therefore, it retracts into the guide unit 22 (see FIG. 25).

  Thereby, the puncture member 3 is disposed in the living body, and the anchors 81 and 82 are engaged with the main body 31 according to the principle described above. Therefore, when the anchor 82 abuts on the body surface H, further insertion of the proximal end portion of the main body 31 into the living body is restricted. In other words, it is possible to ensure that the base end of the main body 31 is exposed to the outside of the living body.

  Next, the operation member 7 is rotated clockwise in FIG. At this time, the puncture member 3 also tries to rotate counterclockwise together with the operation member 7, but when the anchor 81 comes into contact with the body surface H, further rotation (movement) is prevented. Therefore, the insertion portion 71 is removed from the puncture member 3 and the living body while maintaining the state where the tip of the main body 31 is exposed to the outside of the living body. Next, puncture device 1 (member other than puncture member 3) is removed from the patient, and needle body 35 is removed from main body 31. Thereby, as shown in FIG.24 (b), only the main body 31 will be in the state arrange | positioned in the biological body. The main body 31 is disposed in the living body with both the distal end side opening and the proximal end side opening exposed to the outside of the living body.

  Next, the position of the main body 31 is adjusted as necessary. Specifically, the main body 31 is shifted to the proximal end side or the distal end side, and the positions of the anchors 81 and 82 with respect to the living body are symmetrical. Thereby, the center part S4 of the main body 31 can be positioned between the urethra 1300 and the vagina 1400 more reliably. In this state, as shown in FIG. 26, the central portion S4 is arranged such that its width direction (long axis J32 direction) W is substantially parallel to the urethra 1300. That is, the width direction W of the urethra 1300, which is corrected by inserting the urethra insertion member 4 and the central portion S4, is located substantially in parallel.

  Next, the implant body 91 is inserted into the body 31 while being taken out from the packaging material 92, and as shown in FIG. 27A, the band 912 is projected from the proximal end opening and the distal end opening of the body 31; To do. Thus, contamination of the implant main body 91 can be prevented by accommodating the implant main body 91 in the packaging material 92 until immediately before being disposed in the main body 31. As described above, since the main body 31 has a flat shape, the posture of the main body portion 911 follows this flat shape. That is, as shown in FIG. 27B, the main body portion 911 is disposed in the main body 31 so 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. 28A, 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. Since the exposure holes 345 and 346 are located on the proximal end side with respect to the anchor 82, the exposure holes 345 and 346 are surely exposed to the outside of the living body. Therefore, the yarn 341 can be easily cut.

  Next, the adsorption of the urethra 1300 by the urethral insertion part 41 and the adsorption of the vaginal front wall 1410 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. By the above, as shown in FIG.28 (b), the implant main body 91 will be in the state embedded in the biological body.

  In a state where the implant main body 91 is embedded in the living body, the main body portion 911 is disposed substantially parallel to the urethra 1300 in a region between the urethra 1300 and the vagina 1400. Therefore, the urethra 1300 can be supported in a wider area by the implant body 91.

  Thus, by removing the main body 31 from the living body by dividing it, the main body 31 can be easily removed from the living body. Further, since the main body 31 can be removed from the living body without removing the anchors 81 and 82 from the main body 31, the main body 31 can be easily removed. Further, according to such an extraction method, the divided pieces 32 and 33 being extracted hardly affect the posture of the main body 911 in the region between the urethra 1300 and the vagina 1400.

  Further, since the split pieces 32 and 33 are removed from the living body in a state where the urethra insertion member 4 is 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 urethral insertion member 4 is removed from the urethra 1300, and the vagina insertion member 5 is removed from the vagina 1400. After the urethral insertion member 4 is removed, the urethra 1300 returns to the natural shape, but the main body portion 911 is embedded in the tissue, so that the urethra 1300 in the natural state and the main body portion 911 are maintained in a parallel state. Can do.
Thereafter, unnecessary portions of the implant body 91 are excised, and the procedure is finished.

  As described above, according to the puncture device 1, it is possible to detect that the puncture route M is in a state of interfering with the urethra 1300, for example, prior to the puncture by the puncture member 3. It can be done safely. Further, 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 make a large invasive incision or the like. High safety. 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
FIGS. 29A and 29B are side views for explaining an operation method for the vaginal insertion member of the living body insertion device (second embodiment) of the present invention.

Hereinafter, the second embodiment of the living body insertion device of the present invention will be described with reference to this figure, but the description will focus on 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 except that the configuration of the vaginal insertion member is different.

  As shown in FIG. 29, in this embodiment, the protrusion 11 of the vaginal insertion member 5 is formed of a plate piece, and the top 111 is supported so as to be able to appear and retract with respect to the upper surface 511 a of the vaginal insertion part 51. As a result, the protrusion 11 is retracted from the urethra insertion member 4 (see FIG. 29 (a)) and the urethra insertion member 4 side, that is, the second state protruding toward the upper side in FIG. The state (see FIG. 29B) can be taken.

When the vaginal insertion member 5 is inserted into the vagina 1400, it is preferable that the protrusion 11 is in the first state. Thereby, when inserting into the vagina 1400, it can prevent that the protrusion 11 becomes obstructive, Therefore, the insertion becomes easy. Further, even when the upper surface 511a of the vagina insertion portion 51 is desired to be directed to the vagina wall after the insertion, the protrusion 11 can be prevented from becoming an obstacle.
And the protrusion 11 in a 1st state can be changed to a 2nd state.

  In the first state, the portion 112 on the opposite side of the top portion 111 of the protrusion 11 protrudes from the lower surface 511 b of the vagina insertion portion 51. By pressing the protruding portion 112, the protruding portion 11 can be easily and reliably brought into the second state.

<Third Embodiment>
FIG. 30 is a side view of a vaginal insertion member included in the living body insertion device (third embodiment) of the present invention.

Hereinafter, the third embodiment of the living body insertion device of the present invention will be described with reference to this figure, but the description will focus on differences from the above-described embodiment, and description of similar matters will be omitted.
This embodiment is the same as the first embodiment except that the shape of the vaginal insertion member is different.

  As shown in FIG. 30, in the present embodiment, a recess 511 c is formed on the upper surface 511 a of the vagina insertion portion 51. The puncture path M can pass away from the recess 511c.

  Moreover, the longitudinal cross-sectional shape of the recessed part 511c makes a wedge shape. By forming such a recess 511 c, the tip end side of the recess 511 c protrudes, and the protruding portion functions as the protrusion 11.

  In such a configuration, protrusion of the protrusion 11 from the upper surface 511a can be suppressed. Thereby, when inserting the vagina insertion member 5 in the vagina 1400, it can prevent that the protrusion 11 becomes obstructive, Therefore, the insertion becomes easy.

<Fourth embodiment>
FIG. 31 is a diagram for explaining an operation procedure of the living body insertion device (fourth embodiment) of the present invention. FIG. 32 is a diagram for explaining an operation procedure of the living body insertion device (fourth embodiment) of the present invention. FIG. 33 is a diagram for explaining the operation procedure of the living body insertion device (fourth embodiment) according to the present invention, where (a) shows a case where the operation is proper, and (b) shows a case where the operation is inappropriate. FIG.

Hereinafter, the fourth embodiment of the living body insertion device of the present invention will be described with reference to these drawings. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
The present embodiment is the same as the first embodiment except that the configuration of the urethral insertion member is different.

  As shown in FIGS. 31 to 33, in this embodiment, the urethral insertion member 4 has at least one detection lumen that functions as a positioning detection unit that detects that the balloon 42 is in contact with the bladder neck 1320. (Flow path) 12 is provided. The detection lumen 12 is formed along the longitudinal direction of the urethral insertion portion 41 of the urethral insertion member 4. Based on the detection result (detection method), it can be determined whether or not the positioning state is correct in the positioning state in which the balloon 42 is positioned in contact with the bladder neck 1320.

  The detection lumen 12 has an inflow port 121 through which the liquid in the bladder 1310 can flow. The inflow port 121 is provided on the outer peripheral surface of the urethral insertion portion 41 in the vicinity of the proximal end side of the balloon 42, and opens sideways into the bladder 1310 in a state where the balloon 42 is inserted and disposed in the bladder 1310. It is formed as follows. The inflow port 121 is formed between the balloon 42 and the suction hole 44. Further, the inflow port 121 is disposed so as to open into the bladder 1310, but is not limited thereto. For example, the inflow port 121 may open into both the bladder 1310 and the urethra 1300, or open into the urethra 1300. Also good.

  In the case where a plurality of inflow ports 121 are formed, it is preferable that the inflow ports 121 are arranged at equal intervals along the circumferential direction of the urethral insertion portion 41.

  As described above, with the urethra insertion member 5 inserted into the urethra 1300, the balloon 42 is expanded, and the balloon 42 is placed in contact with the bladder neck 1320 to position the urethra insertion member 5 to insert the urethra. The member 5 may be pulled in the proximal direction. If this tension is insufficient, the balloon 42 does not come into contact with the bladder neck 1320 and is not positioned as shown in FIG. The state shown in FIG. 33 (b) may be in a state where the puncture path M and the urethra 1300 (bladder neck 1320) interfere with each other, which is not preferable for the treatment of urinary incontinence in women. Such a state is difficult for the surgeon to grasp.

  Therefore, the detection lumen 12 can detect whether or not the balloon 11 expanded by the urethral insertion member 5 is in contact with the bladder neck 1320 to be positioned. This will be described below.

  First, as shown in FIG. 31, the urethral insertion member 5 is inserted into the urethra 1300, and the balloon 42 is expanded in the bladder 1310. Thereafter, the urine in the bladder 1310 is discharged (outflow) through the urine discharge unit 47.

  Next, as shown in FIG. 32, the urethra insertion member 5 is pulled toward the proximal end, the urethra wall is sucked by the suction hole 44, and water N is supplied through the urine discharge part 47. Thereby, the inside of the bladder 1310 is once filled with water N.

  Next, if the tension of the urethral insertion member 5 is appropriate, the balloon 11 comes into contact with the bladder neck 1320 as shown in FIG. On the other hand, if the tension is inappropriate, that is, if the tension is insufficient, the balloon 11 does not contact the bladder neck 1320 as shown in FIG. 33 (b), and the balloon 11 and the bladder neck 1320 are not contacted. A gap 1330 is formed therebetween.

  Then, as shown in FIG. 33 (a), when the positioning state is correct, the balloon 42 is in contact with the bladder neck 1320 and seals the periphery thereof. That is, water N does not flow down the detection lumen 12. In addition, as shown in FIG. 33 (b), when the positioning state is negative, the water N flows into the inflow port 121 through the gap 1330. As a result, the water N flows down the detection lumen 12. The operator can confirm the water N flowing down the detection lumen 12, that is, confirm the flashback.

  Thus, in the urethra insertion member 5, the presence or absence of flashback can be confirmed, that is, the detection result by the detection lumen 12 can be confirmed. Thereby, the surgeon can judge and grasp that the positioning state is correct, and therefore the puncture route M is located on the urethral opening side of the bladder neck 1320.

  If puncture (puncture method) is performed by the puncture member 3, the puncture route M passes through a target site with respect to the living tissue, so that safe puncture can be performed reliably.

  Further, the diameter of the portion of the urethral insertion portion 41 where the inflow port 121 is disposed is a reduced diameter portion 413 which is thinner than the thickness of the portion where the suction hole 44 is disposed. When the urethral wall is sucked by the suction hole 44, the urethral wall is pulled toward the urethral insertion portion 41 and is in close contact with the outer peripheral surface of the urethral insertion portion 41. The tensioned urethra wall may extend to the inflow port 121, but it is prevented from coming into close contact with the reduced diameter portion 413. This reliably prevents the inflow port 121 from being blocked by the urethra wall, so that the presence or absence of flashback can be confirmed with certainty.

<Fifth Embodiment>
FIG. 34 is a side view of a urethral insertion member included in the living body insertion device (fifth embodiment) of the present invention. 35 is a cross-sectional view taken along line BB in FIG.

  Hereinafter, the fifth embodiment of the living body insertion device of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.

  This embodiment is the same as the fourth embodiment except that the configuration of the urethral insertion member is different.

  As shown in FIG. 34, in this embodiment, the inflow port 121 is provided at a boundary portion 415 between the reduced diameter portion 413 of the urethral insertion portion 41 and the large diameter portion 414 on the proximal end side with respect to the reduced diameter portion 413. Facing the tip. Since the inlet 121 is arranged in this way, the inlet 121 is more reliably prevented from being blocked by the suctioned urethra wall, and thus the presence or absence of flashback can be more reliably confirmed. it can.

<Sixth Embodiment>
FIG. 36 is a cross-sectional view of a urethral insertion member included in the living body insertion device (sixth embodiment) of the present invention.

Hereinafter, the sixth embodiment of the living body insertion device of the present invention will be described with reference to this drawing. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
This embodiment is the same as the fifth embodiment except that the configuration of the urethral insertion member is different.

  As shown in FIG. 36, in this embodiment, the inflow port 121 is unevenly distributed on the reduced diameter portion 413 side. When the urethral insertion portion 41 has a structure assembled by inserting the reduced diameter portion 413 into the large diameter portion 414, if the inflow port 121 is arranged unevenly on the reduced diameter portion 413 side, Formation can be performed easily. Further, the size of the inlet 121 can be set larger than the size of the inlet 121 in the sixth embodiment.

<Seventh embodiment>
FIG. 37 is a side view of a urethral insertion member included in the living body insertion device (seventh embodiment) of the present invention. 38 is a cross-sectional view taken along line CC in FIG.

Hereinafter, the seventh embodiment of the living body insertion device of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the fourth embodiment except that the configuration of the urethral insertion member is different.

  As shown in FIGS. 37 and 38, in this embodiment, the inflow port 121 is provided at a boundary portion 416 with the balloon 42 of the urethral insertion portion 41 and faces the distal direction. Further, the urethra insertion portion 41 is formed with a groove 417 that extends from the outer peripheral surface of the urethra insertion portion 41 to the inflow port 121. Thereby, the liquid in the bladder 1310 can flow into the inflow port 121 through the groove 417 when the positioning state is not possible.

<Eighth Embodiment>
FIG. 39 is a plan view of a vaginal insertion member included in the living body insertion device (eighth embodiment) of the present invention. 40 is a cross-sectional view taken along line DD in FIG.

Hereinafter, the eighth embodiment of the living body insertion device of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the vaginal insertion member is different.

  As shown in FIGS. 39 and 40, in this embodiment, the vaginal insertion member 5 is formed to be recessed in the living tissue between the urethra 1300 and the vagina 1400, that is, the upper surface 511 a that can contact the vagina wall. It has only one recess 53. A plurality of suction holes 59 are arranged in a matrix at the bottom 531 of the recess 53.

  As shown in FIG. 40, the recess 53 of the vaginal insertion member 5 is provided with a blocking portion 13 that prevents the vaginal wall from reaching each suction hole 59 in a state where the vaginal wall is sucked. The blocking portion 13 is composed of a plurality of linear bodies 131 in which at least one portion forms a linear shape, and these linear bodies 131 are crossed to form a lattice shape. Each linear body is provided between the side walls 532 opposed to each other that are erected from the bottom portion 531 of the recess 53, that is, are connected to each other.

  In addition, as for the arrangement | positioning location with respect to the recessed part 53 of the prevention part 13, as much as possible, ie, the position away as much as possible from the bottom part 531 of the recessed part 53 is more preferable.

  Moreover, it is preferable that the space | interval of the linear bodies 131 of the left-right direction in FIG. 39 and the space | interval of the linear bodies 131 of an up-down direction are each 5 mm or more, for example.

  Moreover, the space | interval of the linear bodies 131 of the left-right direction and the space | interval of the linear bodies 131 of an up-down direction may be the same, and may differ. If they are different, the latter is preferably larger than the former.

  Further, in the present embodiment, the blocking unit 13 is formed by crossing a plurality of linear bodies 131 into a lattice shape, but is not limited thereto. It may be arranged parallel to the direction.

  Moreover, it does not specifically limit as a cross-sectional shape of each linear body 131, For example, polygonal shape, circular shape, elliptical shape etc. are mentioned.

  Moreover, the wire diameter of each linear body 131 may be smaller than the opening diameter of the suction hole 59, may be the same, or may be larger.

  Moreover, it does not specifically limit as a constituent material of the linear body 131, For example, various metal materials and various resin materials can be used.

  By the way, the suction force with respect to the vagina wall is proportional to the area where the vagina wall is actually sucked (hereinafter referred to as “suction area”). Here, the suction area when the vagina wall enters the bottom portion 531 of the recess 53 and directly contacts each suction hole 59 to close the suction hole 59, and the vagina wall enters the middle of the recess 53. The suction area when the suction hole 59 is not blocked will be compared. The former suction area is significantly smaller than the latter suction area. For this reason, the suction force with respect to the vagina wall is lower in the former than in the latter. For this reason, there is a possibility that the suction force against the vagina wall is insufficient and the vagina wall is separated from the upper surface 511a of the vagina insertion member 5, that is, detached.

  Therefore, in the present embodiment, as shown in FIG. 40, the blocking portion 13 can surely prevent the vaginal wall from blocking the suction hole 59 even in the suction state. With this (suction method), it is possible to reliably prevent a reduction in suction force and maintain the suction state. Therefore, the vaginal wall is prevented from being detached from the upper surface 511a of the vaginal insertion member 5.

  As shown in FIG. 40, the vaginal wall reaches each suction hole 59, that is, when the contact portion is blocked by the blocking portion 13, the vaginal wall sinks between adjacent linear bodies 131. In this state, the vagina wall follows the moving direction of the vagina insertion member 5 by moving the vagina insertion member 5 back and forth. Thereby, the position adjustment of the puncture route M can be performed.

  As shown in FIG. 39, each suction hole 59 overlaps the intersecting portion 132 of the linear bodies 131 in a plan view of the upper surface 511a. That is, the linear body 131 overlaps the suction direction of the suction hole 59. With such an arrangement relationship, even if the sucked vagina wall enters the vicinity of the bottom 531 of the recess 53, the suction hole 59 can be reliably prevented from being blocked by the vagina wall.

  The configuration of the blocking unit 13 can be applied to the urethral insertion member 4 in addition to the vaginal insertion member 5.

<Ninth Embodiment>
FIG. 41 is a plan view of a vaginal insertion member included in the living body insertion device (9th embodiment) of the present invention. 42 is a cross-sectional view taken along line EE in FIG.

Hereinafter, the ninth embodiment of the living body insertion device of the present invention will be described with reference to these drawings. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
The present embodiment is the same as the eighth embodiment except that the configuration of the vaginal insertion member is different.

  As shown in FIGS. 41 and 42, in this embodiment, each linear body 131 constituting the blocking portion 13 has a strip shape, and the width direction thereof is arranged to coincide with the depth direction of the concave portion 53. That is, the bottoms of the respective linear bodies 131 are arranged so as to coincide with the bottoms of the recesses 53.

  Further, as shown in FIG. 42, the blocking portion 13 is supported by the bottom portion 531 of the recessed portion 53 via the spacer 133. Thereby, a clearance gap exists between the prevention part 13 and the bottom part 531, and it connects. When the blocking portion 13 is arranged in the vicinity of the bottom portion 531 of the recess 53 as described above, the linear body 131 has a belt shape whose width direction matches the depth direction of the recess 53 as described above. Preferably there is. Thereby, the sucked vagina wall can be prevented from reaching each suction hole 59.

  Further, when the blocking portion 13 is disposed in the vicinity of the bottom portion 531 of the recessed portion 53, the vagina wall enters more deeply into the recessed portion 53 than in the eighth embodiment. Therefore, it is preferable that a protrusion 533 protrudes from the side wall 532 of the recess 53. This protrusion 533 can be bitten into the vagina wall that has penetrated to the back side of the recess 53. In this state, the vagina wall follows the moving direction of the vagina insertion member 5 by moving the vagina insertion member 5 back and forth. Thereby, the position adjustment of the puncture route M can be performed.

<Tenth Embodiment>
FIG. 43 is a longitudinal sectional view of a vaginal insertion member included in the living body insertion device (tenth embodiment) of the present invention.

Hereinafter, the tenth embodiment of the living body insertion device of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
The present embodiment is the same as the ninth embodiment except that the configuration of the vaginal insertion member is different.

  As shown in FIG. 43, in the present embodiment, at least one linear body 131 of the plurality of linear bodies 131 constituting the blocking portion 13 is opposite to the bottom portion 531, that is, upward. A protruding protrusion 134 is formed. In addition, it is preferable that the protrusion 134 is extended toward the paper surface back | inner side in FIG. Such a protrusion 134 can bite into the vaginal wall that has entered the back side of the recess 53 together with the protrusion 533 of the recess 53. In this state, by moving the vaginal insertion member 5 back and forth, the vaginal wall also reliably follows the moving direction of the vaginal insertion member 5. Thereby, the position adjustment of the puncture path | route M can be performed reliably.

<Eleventh embodiment>
FIG. 44 is a plan view of a vaginal insertion member included in the living body insertion device (eleventh embodiment) of the present invention. FIG. 45 is a diagram for explaining an operation procedure of the vaginal insertion member shown in FIG. 44. FIG. 46 is a diagram for explaining an operation procedure of the vaginal insertion member shown in FIG. 44.

Hereinafter, the eleventh embodiment of the living body insertion device of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the vaginal insertion member is different.

  As shown in FIGS. 44 to 46, in this embodiment, the vaginal insertion member 5 has a holding portion 52. In the suction state, the sucked portion 1420 enters the recess 53. The holding portion 52 is a portion that holds the sucked portion 1420 that has entered the concave portion 53.

  The holding portion 52 includes a holding piece 521 that is supported so as to be movable in the surface direction of the upper surface 511 a inside the concave portion 53, that is, forward and backward in the insertion direction of the vaginal insertion member 5. The sandwiching piece 521 includes a plate piece, and has a bent portion 522 whose base end portion is bent twice in one direction, that is, bent in a “U” shape. The bent portion 522 functions as a pressing portion that is pressed when the holding piece 521 is moved. The portion opposite to the bent portion 522 functions as a holding portion 523 that holds the sucked portion 1420 at the destination of the holding piece 521.

  Such a sandwiching piece 521 is inserted into a groove 511 d formed in the insertion portion 511 of the vaginal insertion portion 51. The groove 511 d is formed in parallel with the upper surface 511 a and opens directly below the protrusion 533 of the recess 53. Thereby, the sandwiching piece 521 can protrude into the recess 53. And this protrusion amount is adjusted when the clamping piece 521 moves. In the first state shown in FIG. 45, the sandwiching piece 521 is retracted most with respect to the recess 53, and in the second state shown in FIG. 46, the sandwiching piece 521 protrudes most with respect to the recess 53. Naturally, the sandwiching piece 521 can take an intermediate state (third state) between the first state and the second state during the movement.

  As shown in FIG. 45, the holding piece 521 is in the first state until the suction is started. In this state, a part of the vagina wall is sucked into the concave portion 53 by the suction force, and the sucked portion 1420 enters the concave portion 53.

  Thereafter, as shown in FIG. 46, the clamping piece 521 is in the second state by pressing the bent portion 522 toward the distal end. In this state, the sucked portion 1420 is sandwiched between the sandwiching portion 523 and the protruding portion 533 of the side wall 532 that is positioned forward in the movement direction of the sandwiching piece 521.

  For example, the suction force may be reduced due to a malfunction of the suction device connected to the suction port 54 of the vaginal insertion member 5, and the suction state with respect to the suctioned portion 1420 may be released. Moreover, it may come off because the contact surface of the vagina surface and the suction part shifts. However, even if the suction state is released by the sandwiching piece 521 (suction method) in the second state as described above, the force similar to that in the suction state, that is, the suctioned portion 1420 is set to the concave portion 54 (vaginal insertion). A tensile force can be reliably applied to the attracted portion 1420 on the member 5) side. And it can change to subsequent puncture operation rapidly.

  In addition, it does not specifically limit as a constituent material of the clamping piece 521, For example, various resin materials and various metal materials can be used.

  Further, the vaginal insertion member 5 has a movement limit restricting portion 55 that restricts the movement limit of the sandwiching piece 521. As shown in FIG. 46, the bent portion 522 of the holding piece 521 in the second state can abut on the movement limit restricting portion 55, thereby restricting the movement limit in the distal direction. Thereby, it is possible to prevent an excessive clamping force from acting on the suctioned portion 1420.

  Further, the movement limit restricting portion 55 can be inserted into and engaged with the bent portion 522 bent in the “U” shape as described above. By this engagement, the second state can be maintained. Therefore, even if the pressing force against the bent portion 522 of the holding piece 521 is released, the holding piece 521 can continue to hold the suctioned portion 1420. .

  Note that the configuration of the holding portion 52 can be applied to the urethral insertion member 4 in addition to the vaginal insertion member 5.

<Twelfth embodiment>
FIG. 47 is a plan view of a vaginal insertion member included in the living body insertion device (the twelfth embodiment) of the present invention. 48 is a longitudinal sectional view of the vaginal insertion member shown in FIG.

Hereinafter, the twelfth embodiment of the living body insertion device of the present invention will be described with reference to these drawings. The description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
The present embodiment is the same as the eleventh embodiment except that the configuration of the vaginal insertion member is different.

  As shown in FIGS. 47 and 48, in the present embodiment, the holding piece 521 has the holding portion 523 bent once, and a plurality of irregularities 524 are formed in the bent holding portion 523. Thereby, the unevenness 524 can be caught in the sucked portion 1420 held in the second state, and the sucked portion 1420 can be reliably prevented from unintentionally coming out of the recess 53.

  As shown in FIG. 47, in the plan view of the upper surface 511a, the suction hole 59 is disposed at a position that does not overlap with the clamping piece 521 at the movement limit, that is, the clamping piece 521 in the second state. As a result, the pinching piece 521 does not cover the suction direction of the suction hole 59. On the other hand, in the twelfth embodiment, the suction port 59 located on the proximal end side of the plurality of suction ports 59 is disposed at a position overlapping the sandwiching piece 521 in the second state.

  As described in the twelfth embodiment, the sucked portion 1420 drawn into the recess 53 in the first state is pressed toward the distal end in the second state. In this case, the sucked portion 1420 is somewhat released from the suction force by the suction port 59 located on the base end side. For this reason, you may abbreviate | omit the suction port 59 located in the said base end side. Thereby, simplification of the structure of the vaginal insertion member 5 can be achieved.

<13th Embodiment>
FIG. 49 is a plan view of a vaginal insertion member included in the living body insertion device (the thirteenth embodiment) of the present invention. 50 is a cross-sectional view taken along line FF in FIG.

Hereinafter, the thirteenth embodiment of the living body insertion device of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the vaginal insertion member is different.

  As shown in FIGS. 49 and 50, in the present embodiment, the vaginal insertion member 5 has a misalignment prevention portion 56. When the vagina wall is punctured by the puncture member 3 in the suction state, the position deviation prevention unit 56 is displaced in the puncture direction of the puncture member 3 (the direction of the white arrow in the figure) with respect to the upper surface 511a. The part that prevents or suppresses movement.

  Such a misregistration prevention portion 56 has a plurality of (three in the present embodiment) ribs (first protrusions) 561 that are formed so as to protrude from the bottom 531 of the recess 53. One of the three ribs 561 is disposed at the center in the width direction of the vaginal insertion member 5, and the remaining two are disposed at equal intervals with respect to the rib 561 at the center.

  Each rib 561 extends in the longitudinal direction of the vaginal insertion member 5, that is, in the direction orthogonal to the puncture direction of the puncture member 3. The ribs 561 have the same height and may have the same height as the side wall 532 of the recess 53, but are preferably lower than the side wall 532.

  The number of ribs 561 is plural in this embodiment, but is not limited to this, and may be one, for example.

  When performing puncture with the puncture member 3, first, the adhesion between the upper surface 511a of the vaginal insertion member 5 and the vagina wall is enhanced as an adsorbed state, and the puncture is performed as it is. It will be pulled. If this tensile force is excessive, the vaginal wall is detached from the upper surface 511a of the vaginal insertion member 5 and released from the suction state.

  However, as shown in FIG. 50, in the vaginal insertion member 5, each rib 561 sinks into the suctioned portion 1420 that has entered the recess 53 in the suction state. Even if the vagina wall is excessively pulled in the puncture direction, the rib 561 (suction method) can reliably prevent or suppress the vagina wall from shifting in the puncture direction. Thereby, it is possible to reliably prevent the vaginal wall from being unintentionally released from the suction state during puncturing.

<Fourteenth embodiment>
FIG. 51 is a plan view of a vaginal insertion member included in the living body insertion device (fourteenth embodiment) of the present invention. 52 is a cross-sectional view taken along the line GG in FIG.

Hereinafter, the fourteenth embodiment of the living body insertion device of the present invention will be described with reference to these drawings. However, differences from the above-described embodiments will be mainly described, and description of similar matters will be omitted.
This embodiment is the same as the thirteenth embodiment except that the configuration of the vaginal insertion member is different.

  As shown in FIGS. 51 and 52, in this embodiment, the blocking portion 53 has a plurality of small protrusions (second protrusions) 562 that are formed to protrude from the upper surface 511a in addition to the ribs 561. . These small protrusions 562 are arranged so as to surround the recess 53. Thereby, in the vaginal insertion member 5, a total of three or more ribs 561 and small projections 562 are arranged along the puncture direction.

  Each small protrusion 562 has the same height, width, and length, but is smaller than the rib 561. Note that the rib 561 located at the center of the three ribs 561 is lower than the ribs 561 on both sides thereof.

  As shown in FIG. 52, in the blocking portion 53, a virtual line 563 connecting the tops of three or more ribs 561 and small protrusions 562 along the puncture direction is the same as the puncture route M of the puncture member 3. A curved shape curved in an arc shape.

  While the puncture member 3 is performing puncture, the vagina wall is excessively pulled in the puncture direction as described above, but is also pressed against the vagina insertion member 5 side. The ribs 561 and the small protrusions 562 are arranged so that the imaginary line 563 follows the arc shape, and therefore, the pressing force against the vagina wall becomes uniform.

  The number of small protrusions 562 formed is plural in the present embodiment, but is not limited thereto, and may be one, for example.

<Fifteenth embodiment>
FIG. 53 is an enlarged view of the protrusion of the vaginal insertion member included in the living body insertion device (fifteenth embodiment) of the present invention.

Hereinafter, the fifteenth embodiment of the living body insertion device of the present invention 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 except that the configuration of the vaginal insertion member is different.

  As shown in FIG. 53, in the present embodiment, the small protrusion 562 is inclined toward the puncture direction. As a result, when the sucked portion 1420 (vagina wall) is pulled in the puncture direction in the sucked state, each small protrusion 562 surely sinks into the sucked portion 1420, and thus the sucked portion 1420 is unintentionally removed from the sucked state. Can be more reliably prevented from being released.

<Sixteenth Embodiment>
FIG. 54 is an enlarged view of the protrusion of the vaginal insertion member included in the living body insertion device (sixteenth embodiment) of the present invention.

  Hereinafter, the sixteenth embodiment of the living body insertion device of the present invention 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 except that the configuration of the vaginal insertion member is different.

  As shown in FIG. 54, in the present embodiment, the small protrusion 562 is formed with a claw 564 that protrudes in the puncturing direction. As a result, when the sucked portion 1420 is pulled in the puncture direction in the sucked state, the claw 564 of each small protrusion 562 surely sinks into the sucked portion 1420 and prevents the sucked portion 1420 from moving, thereby It is possible to more reliably prevent the portion 1420 from being unintentionally released from the suction state.

  Note that the thickness of the small protrusion 562 is preferably thicker toward the root side, that is, toward the upper surface 511a.

<Seventeenth Embodiment>
FIG. 55 is a view for explaining an operation procedure of the living body insertion device (seventeenth embodiment) of the present invention. FIG. 56 is a view for explaining an operation procedure of the living body insertion device (seventeenth embodiment) of the present invention.

Hereinafter, the seventeenth embodiment of the living body insertion device of the present invention will be described with reference to these drawings. However, differences from the above-described embodiments will be mainly described, and description of similar matters will be omitted.
The present embodiment is the same as the first embodiment except that the configuration of the living body insertion device is different.

  As shown in FIGS. 55 and 56, in this embodiment, the suction line 49 of the urethral insertion member 4 (one biological insertion tool) and the suction line 58 of the vaginal insertion member 5 (the other biological insertion tool) are: In the middle, they merge at the junction 61. And the alerting | reporting part comprised with the balloon 14 which can be expanded-contracted is arrange | positioned on the line 62 downstream from this confluence | merging part 61. FIG. The expansion and contraction of the balloon 14 can be regarded as at least one of the following two notifications.

  The first notification is a notification of whether or not the suction is in a predetermined suction state when the urethral insertion member 4 sucks the urethral wall (living tissue), specifically, whether or not the suction is successful.

  The second notification is a notification as to whether or not the suction is in a predetermined suction state when the vaginal insertion member 5 sucks the vaginal wall (living tissue), specifically, whether or not the suction is successful.

  The structure of the balloon 14 is a film-like, elastic elastic body formed into a bag shape, and the internal space communicates with the line 62. In addition, it does not specifically limit as a constituent material of an elastic film, For example, various rubber materials like a silicone rubber can be used.

  Such a balloon 14 is exposed from the living body in a mounted state. Thereby, the balloon 14 can be visually recognized with certainty.

  In addition, it is preferable that a cock for communicating / blocking between the balloon 14 and the line 62 is provided at the boundary between the balloon 14 and the line 62. When performing suction with each insertion member, the cock 14 is operated to keep the balloon 14 and the line 62 in communication.

  As shown in FIG. 55, the balloon 14 is expanded by an elastic force in an initial state, that is, in a state where suction by the urethral insertion member 4 and the vaginal insertion member 5 has not been performed yet.

  Then, as shown in FIG. 56, when suction is started with the urethra insertion member 4 and the vagina insertion member 5 and either suction is successful, that is, the urethra wall is adsorbed by the urethra insertion member 4, and the vaginal wall Is adsorbed by the vaginal insertion member 5, the inside of the balloon 14 is also sucked through the line 62, and it is recognized that the balloon 14 is contracted and its size is remarkably reduced.

  On the other hand, when one or both of the suctions at the urethral insertion member 4 and the vaginal insertion member 5 have failed, the balloon 14 is hardly changed or slightly changed. In order to confirm which suction has failed, for example, a clamp can be attached to the suction line 49 or the suction line 58 on the upstream side of the junction 61 and the confirmation can be performed. As an example, when the suction with the urethral insertion member 4 is successful and the suction with the vaginal insertion member 5 is unsuccessful, there is almost no change in the balloon 14 even if the clamp line is attached to the suction line 49. When the clamp is attached to the suction line 58, the balloon 14 is deflated. Thereby, it turns out that the suction with the urethral insertion member 4 succeeds and the suction with the vaginal insertion member 5 fails. Instead of the clamp, a three-way stopcock may be installed at the junction 61 so that the junction 61 can be opened and closed.

  Since the balloon 14 has a function of notifying the success or failure of the suction in this way, when the suction to the living body is performed, the success or failure of the suction can be grasped easily and surely only by visually checking the state of the balloon 14. can do.

  According to the above configuration, prior to performing puncturing (puncturing method) with the puncture member 3, the direction in which the living tissue between the urethra 1300 and the vagina 1400 is expanded, that is, the urethra 1300 and the vagina 1400 are separated from each other. Puncturing can be performed while confirming whether or not the suction has succeeded while sucking in the direction to be performed.

  Moreover, it is preferable that the line 62 in which the balloon 14 is provided is comprised with the tube which has flexibility. Thereby, the balloon 14 can be moved to a position where it is easy to visually recognize or a position that does not interfere with the procedure.

  The balloon 14 is deflated by suction, but is not limited to this, and may be inflated or other deformations.

  In addition, although the alerting | reporting part is comprised by the bag-shaped balloon 14 in this embodiment, it is not limited to this, For example, the elastic film may be stretched by the frame. In addition, as a notification form, a notification by voice, a notification by light emission, or a notification by a pressure gauge that notifies a change in internal pressure may be used.

<Eighteenth embodiment>
FIG. 57 is a view for explaining the operation procedure of the living body insertion device (eighteenth embodiment) of the present invention. FIG. 58 is a view for explaining the operation procedure of the living body insertion device (eighteenth embodiment) of the present invention. 59 is an enlarged cross-sectional view of a region [H] surrounded by a two-dot chain line in FIG. 60 is an enlarged cross-sectional view of a region [I] surrounded by a two-dot chain line in FIG.

Hereinafter, an eighteenth embodiment of the living body insertion device of the present invention will be described with reference to these drawings, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
The present embodiment is the same as the first embodiment except that the configuration of the living body insertion device is different.

  As shown in FIGS. 57 and 58, in the present embodiment, the support portion 60 (connecting portion) of the insertion tool 6 is configured to be connected to the urethral insertion member 4 and the vaginal insertion member 5 so as to be able to approach and separate. . Specifically, the support portion 60 includes the support portion 40 on the urethral insertion member 4 side and the support portion 50 on the vagina insertion member 5 side as described above, and further includes the support portion 40 and the support portion. 50 has a rotation support portion 63 that supports the rotation 50 in a rotatable manner. The configuration of the rotation support portion 63 is not particularly limited, and can be, for example, a portion composed of a shaft and a bearing. When one of the urethra insertion member 4 and the vagina insertion member 5 is rotated in a predetermined direction with respect to the other by the rotation support portion 63, the urethra insertion member 4 and the vagina insertion member 5 approach each other. 57, the urethral insertion member 4 and the vagina insertion member 5 are separated from each other when rotated in the opposite direction to that shown in FIG.

  As shown in FIGS. 59 and 60, the support portion 60 includes a first lock portion 64 that maintains the approaching state and a second lock portion 65 that maintains the separated state. The first lock portion 64 has a first engagement portion 502 that is configured by a recess that is opened in the base end surface of the support portion 40. The second lock portion 65 includes a second engagement portion 503 configured by a recess that is opened at the base end surface of the support portion 40 at a position different from that of the first engagement portion 502.

  Further, the first lock portion 64 and the second lock portion 65 have one common engaging member 66. The engaging member 66 includes an arm portion 661 supported and fixed to the support portion 50, and an engaging piece 662 provided at an end portion of the arm portion 661. The engagement piece 662 can be engaged with the first engagement portion 502 and the second engagement portion 503 at different timings. As shown in FIG. 60, in the approaching state, the engaging piece 662 can engage with the first engaging portion 502, and the approaching state is reliably maintained by this engagement. As shown in FIG. 59, in the separated state, the engagement piece 662 can be engaged with the second engagement portion 503, and the separated state is reliably maintained by this engagement.

  Note that an inclined surface 663 is formed at the tip of the engagement piece 662. With the inclined surface 663, the engagement piece 662 can be easily moved over the first engagement portion 502 when shifting from the approaching state to the separating state.

  As shown in FIGS. 57 and 58, in this embodiment, the vaginal insertion portion 51 of the vaginal insertion member 5 is not supported by the support portion 50 and is halfway in the longitudinal direction of the urethral insertion portion 41 of the urethral insertion member 4. It is supported by. What is supported by the support portion 50 instead of the vagina insertion portion 51 is the auxiliary vagina insertion portion 15 provided in the vagina insertion member 5 and inserted into the vagina 1400 together with the vagina insertion portion 51. The auxiliary vaginal insertion portion 15 is formed in a long shape and is a curved portion that is curved in an overall arch shape in a direction away from the urethral insertion member 4, that is, across the vaginal insertion portion 51. . Further, the auxiliary vagina insertion portion 15 is longer than the vagina insertion portion 51, and the distal end portion 151 of the auxiliary vagina insertion portion 15 is located on the distal end side of 511 of the vagina insertion portion 51. A protruding portion 152 that protrudes from the urethra insertion member 4 side and is rounded is formed at the distal end portion 151. The protrusion 152 can press directly below the bladder 1310 in the approaching state. Thereby, clamping to the biological tissue mentioned later can be performed reliably.

  In the present embodiment, the balloon 42 is omitted from the urethra insertion member 4. Instead, a deformable portion 418 that can be bent and deformed at the distal end portion of the urethral insert portion 41, and an operation for deforming the deformable portion 418. And a wire 419. The deforming portion 418 is linear in a natural state where no external force is applied, and has a curved shape curved toward the vaginal insertion member 5 in the deformed state. The operation wire 419 has a distal end portion fixed to the distal end portion of the deformable portion 418, and can grip the proximal end portion and pull it in the proximal direction. By this pulling, the deformable portion 418 is curved and deformed, and thus can be brought into contact with the bladder neck 1320 in this deformed state.

  In the insertion tool 6 configured as described above, first, as shown in FIG. 57, the urethral insertion member 4 and the vagina insertion member 5 are placed in a separated state and attached to a living body. As described above, the separated state is reliably maintained by the second lock portion 65. Thereby, the mounting | wearing state with respect to a biological body can be performed easily.

  Next, as shown in FIG. 58, the urethral insertion member 4 and the vaginal insertion member 5 are brought into an approaching state. This approaching state is also reliably maintained by the first lock portion 64 as described above. In this approaching state, the living tissue between the urethra 1300 and the vagina 1400 can be pinched, and if it is pushed in the distal direction as it is, the pinned living tissue can also be moved in that direction. Thereby, the position where the puncture route M should be formed can be adjusted.

  Thus, prior to performing puncture (puncture method) with the puncture member 3, the position can be adjusted by moving it back and forth between the urethra 1300 and the vagina 1400, and after the adjustment, A surgical procedure for a living tissue can be performed accurately and reliably.

<Nineteenth embodiment>
FIG. 61 is a view for explaining the operation procedure of the living body insertion device (19th embodiment) of the present invention. FIG. 62 is a view for explaining an operation procedure of the living body insertion device (19th embodiment) of the present invention.

Hereinafter, the nineteenth embodiment of the living body insertion device of the present invention will be described with reference to these drawings. However, differences from the above-described embodiment will be mainly described, and description of similar matters will be omitted.
The present embodiment is the same as the eighteenth embodiment except that the configuration of the living body insertion device is different.

  As shown in FIGS. 61 and 62, in this embodiment, the vaginal insertion member 5 has a configuration in which the vaginal insertion portion 51 is omitted and the auxiliary vaginal insertion portion 15 is provided. In this case, the auxiliary vagina insertion part 15 becomes the main body part of the vagina insertion member 5, and the vagina insertion member 5 can have a simple structure.

  Further, as shown in FIG. 61, when the vaginal insertion portion 51 is omitted, the state of the vagina wall can be easily confirmed when the auxiliary vaginal insertion portion 15 is inserted into the vagina 1400, which is preferable.

  Further, as shown in FIG. 62, when the living tissue is clamped in the approaching state, the auxiliary vagina insertion portion 15 confirms how far the vagina 1400 is inserted and at which position the vagina 1400 is clamped with respect to the living tissue. can do.

<20th Embodiment>
FIG. 63 is a diagram for explaining an operation procedure of the living body insertion device (twentieth embodiment) of the present invention. FIG. 64 is a diagram for explaining an operation procedure of the living body insertion device (20th embodiment) of the present invention. FIG. 65 is a front view of the support of the living body insertion device (twentieth embodiment) of the present invention.

Hereinafter, the twentieth embodiment of the living body insertion device of the present invention will be described with reference to these drawings. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
The present embodiment is the same as the first embodiment except that the configuration of the living body insertion device is different.

  As shown in FIGS. 63 and 64, in the present embodiment, the support portion 60 is configured to support the urethral insertion member 4 and the vaginal insertion member 5 so as to be able to approach and separate from each other. Specifically, as shown in FIG. 65, the support part 60 further includes a frame body 601, a connection part 602, and a position restriction part 603 in addition to the support parts 40 and 50.

  The frame body 601 supports the support portion 40, the connection portion 602, and the support portion 50 in order from the upper side in FIG. The support portion 40 and the connection portion 602 are supported so as to be movable in the vertical direction in FIG. 65 with respect to the frame body 601. The moving mechanism is not particularly limited, and can be constituted by, for example, a groove and a protrusion that is inserted into the groove and moves along the groove. The support portion 50 is fixedly supported with respect to the frame body 601.

  The connection part 602 has a plate shape and has a connection port 602a to which the syringe 2000 is connected at the center part in the longitudinal direction. As shown in FIG. 64, in a state where the syringe 2000 is connected to the connection port 602a, the injection needle 2001 attached to the syringe 2000 protrudes in the distal direction. The connecting portion 602 includes a support plate 602b having an arc shape that supports the syringe 2000 from the vagina insertion member 5 side in a state where the syringe 2000 is connected. Thereby, the syringe 2000 is stably connected to the connection portion 602.

  The position restricting unit 603 is a link mechanism that includes two first links 603a and two second links 603b. Each first link 603a intersects each other, connects the support portion 40 and the connection portion 602, and is supported by a support point that can rotate with respect to these. The second links 603b intersect each other, connect the connection portion 602 and the support portion 50, and are supported by support points that can rotate with respect to these. With the position restricting portion 603 having such a configuration, the support portion 40 and the connection portion 602 can move in the same direction in conjunction with the support portion 50, that is, can approach and separate. As a result, as shown in FIG. 65, the distance Q1 between the injection needle 2001 and the urethral insertion member 4, the injection needle 2001, and the vagina, regardless of whether the syringe 2000 is connected to the connection portion 602 or not. The ratio of the insertion member 5 to the distance Q2 is constant. In the position restriction part 603, the support part 40 (urethral insertion member 4), the support part 50 (vagina insertion member 5), and the connection part 602 are restricted so as to maintain such a positional relationship.

  The frame 601 is provided with a lock member 601a that temporarily restricts re-movement at the destination when the support portion 40 and the connection portion 602 move in conjunction with each other. The lock member 601a can be engaged with the support portion 40, re-movement is restricted by this engagement, and re-movement is possible by releasing the engagement.

  As shown in FIGS. 63 and 64, there are individual differences in the thickness of the living tissue between the urethra 1300 and the vagina 1400, which is relatively thick (see FIG. 63) and relatively thin (see FIG. 64). See).

  As shown in FIG. 63, for a patient having a relatively thick biological tissue, the urethral insertion member 4 and the vaginal insertion member 5 are mounted in a separated state. On the other hand, as shown in FIG. 64, the urethral insertion member 4 and the vaginal insertion member 5 are attached to a patient with relatively thin living tissue. In both the state shown in FIG. 63 and the state shown in FIG. 64, the distance Q1 between the injection needle 2001 and the urethral insertion member 4, the injection needle 2001, and the vaginal insertion member due to the action of the position restricting unit 603 described above. The ratio of 5 to the distance Q2 is surely constant. As a result, when the living tissue is punctured with the injection needle 2001, the puncture location R can be made constant regardless of individual differences, that is, the central portion in the thickness direction of the living tissue can be made. If puncture is performed in this state, liquid is injected, and liquid detachment (injection method) is performed, in this case as well, the living tissue is sucked into the urethral insertion member 4 and the vagina insertion member 5 regardless of individual differences. It can expand quickly to the state. Further, the puncture site R can be set to a position shifted from the portion of the living tissue that is actually sucked by the vaginal insertion member 5 (see FIG. 64). As a result, it is possible to prevent the liquid used for the corner liquid separation from being sucked from the living tissue by the vaginal insertion member 5.

  Further, as described above, the biological tissue expands due to liquid detachment. As shown in FIG. 64, in the insertion tool 6, it is preferable that the connecting portion 602 is configured to be rotatable with respect to the frame body 601, and the rotation of the living tissue in which the injection needle 2001 expands by this rotation is preferable. Can follow. Thereby, it is possible to prevent an excessive force from the injection needle 2001 from acting on the living tissue.

<Twenty-first embodiment>
FIG. 66 is a front view of a support of the living body insertion device (21st embodiment) of the present invention.

Hereinafter, the twenty-first embodiment of the living body insertion device of the present invention will be described with reference to this figure. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
The present embodiment is the same as the twentieth embodiment except that the configuration of the living body inserting apparatus is different.

  As shown in FIG. 66, in this embodiment, the support part 60 is supported so that the support part 40 and the support part 50 can move in the vertical direction in the figure relative to the frame body 601, and the connection part 602 is attached to the frame body 601. It is supported in a fixed manner.

  The position restricting portion 603 allows the support portion 40 and the support portion 50 to move in the opposite direction in conjunction with the connection portion 602, that is, approach / separate. As a result, the ratio between the distance Q1 between the injection needle 2001 (connection portion 602) and the urethral insertion member 4 and the distance Q2 between the injection needle 2001 (connection portion 602) and the vaginal insertion member 5 is constant in a state of approaching / separating. It becomes. Therefore, when the living tissue is punctured with the injection needle 2001, the puncture location R can be made constant regardless of individual differences.

  Note that the frame 601 is provided with a lock member 601a and a lock member 601b that temporarily restrict re-movement at the movement destination when the support portion 40 and the support portion 50 move together. . The lock member 601a can be engaged with the support portion 40, re-movement is restricted by this engagement, and re-movement is possible by releasing the engagement. The lock member 601b can be engaged with the support portion 50, re-movement is restricted by this engagement, and re-movement is possible by releasing the engagement.

<Twenty-second embodiment>
FIG. 67 is a front view of the support of the living body insertion device (22nd embodiment) of the present invention.

Hereinafter, the twenty-second embodiment of the living body insertion device of the present invention will be described with reference to this drawing. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
This embodiment is the same as the twenty-first embodiment except that the configuration of the living body insertion device is different.

  As shown in FIG. 67, in the present embodiment, the support portion 40 has an engaging portion 401 that engages with the lock member 601a at the position where the support portion 40 and the support portion 50 are farthest from each other. Has an engaging portion 504 that engages with the lock member 601b.

  The engaging portion 401 can be elastically deformed and is elastically deformed by being pressed by the lock member 601a in a state of being engaged with the lock member 601a. Thereby, the state which engaged with the engaging part 401 and the lock member 601a is reliably maintained. Further, by pulling the lock member 601a from this engaged state, the engagement between the engagement portion 401 and the lock member 601a is released.

  The engaging portion 504 is also elastically deformable, and is elastically deformed by being pressed by the lock member 601b in a state of being engaged with the lock member 601b. Thereby, the state which engaged with the engaging part 504 and the lock member 601b is reliably maintained. Further, by pulling the lock member 601b from this engaged state, the engagement between the engaging portion 504 and the lock member 601b is released.

<23rd Embodiment>
FIG. 68 is a front view of a support of the living body insertion device (23rd embodiment) of the present invention.

Hereinafter, the twenty-third embodiment of the living body insertion device of the present invention will be described with reference to this drawing. However, 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 twenty-first embodiment except that the configuration of the living body insertion device is different.

  As shown in FIG. 68, in this embodiment, the position restricting portion 603 includes a pinion gear 603c that is rotatably supported by the connection portion 602, a rack 603d that is fixedly supported by the support portion 40, and the support portion 50. And a rack 603e fixedly supported on the rack. The rack 603d and the rack 603e are arranged via a pinion gear 603c and mesh with the pinion gear 603c. With the position restricting portion 603 having such a configuration, the ratio between the distance Q1 between the injection needle 2001 and the urethral insertion member 4 and the distance Q2 between the injection needle 2001 and the vagina insertion member 5 becomes constant. Thereby, when puncturing a living tissue with the injection needle 2001, the puncture location R can be made constant regardless of individual differences.

  Further, the support portion 40 is provided with a stopper 402 protruding toward the support portion 50 side, and the support portion 50 is provided with a stopper 505 protruding toward the support portion 40 side. And when the support part 40 and the support part 50 approach most, the stopper 402 and the stopper 505 contact | abut, and the closest approach distance can be controlled.

  In the present embodiment, the connection port 602a is preferably configured to be slidable in the left-right direction in FIG.

<24th Embodiment>
FIG. 69 is a front view of a support of the living body insertion device (24th embodiment) of the present invention. 70 is a view seen from the direction of arrow J in FIG.

Hereinafter, a twenty-fourth embodiment of the living body insertion device of the present invention will be described with reference to these drawings, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
This embodiment is the same as the twenty-first embodiment except that the configuration of the living body insertion device is different.

  As shown in FIGS. 69 and 70, in the present embodiment, two connecting portions 602 having a cylindrical shape are provided. As shown in FIG. 70, the two connection portions 602 are arranged via the frame body 601 so that the central shafts 602c approach each other toward the distal direction. With such an arrangement, the connection directions of the syringes 200 are different between the connection portions 602. Thereby, if the two connection parts 602 are selected and used, the living tissue can be punctured from different directions to inject the liquid, and thus the time required for the liquid separation can be shortened.

<25th Embodiment>
FIG. 71 is a side view of the living body insertion device (25th embodiment) of the present invention.

Hereinafter, the twenty-fifth embodiment of the living body insertion device of the present invention will be described with reference to this drawing. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
This embodiment is the same as the twenty-fourth embodiment except that the configuration of the living body insertion device is different.

  As shown in FIG. 71, in this embodiment, a plurality of connection ports 602a are provided. These connection portions 602 are arranged along the longitudinal direction of the frame body 601, that is, along the vertical direction in FIG. 71. Further, these connection ports 602a are arranged so as to draw a circular orbit around a predetermined position. The “predetermined position” here is a point where the tip of the syringe 2000 is reached. It is set so as to reach above the protruding portion existing at the tip of the vaginal insertion portion 51. However, the present invention is not limited to this, and the “predetermined position” may be determined from the marker positions of the urethral insertion part 41 and the vagina insertion part 51. Thereby, the connection directions of the syringe 200 at the connection portions 602 are different from each other, and thus it is possible to puncture the living tissue from different directions and inject the liquid.

  Thus, in this embodiment, the upper and lower frames of the support portion 60 and the engaging portion 504 as described in the twenty-second embodiment may be used as the stoppers of the support portions 40 and 50.

<Twenty-sixth embodiment>
FIG. 72 is a side view of the living body insertion device (26th embodiment) of the present invention.

Hereinafter, the twenty-sixth embodiment of the living body insertion device of the present invention 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.
The present embodiment is the same as the twentieth embodiment except that the configuration of the living body inserting apparatus is different.

  As shown in FIG. 72, in this embodiment, the frame 2 and the support portion 60 are connected, and the frame 2 in this connected state is the position of the urethral insertion member 4, the vaginal insertion member 5, and the puncture member 3. It functions as a position control unit that controls the relationship. Specifically, the frame 2 allows the urethral insertion member 4 and the vaginal insertion member 5 to approach and separate when the needle body 35 (needle tip 351) passes between the urethral insertion member 4 and the vagina insertion member 5. Regardless, the positioning is performed such that the ratio between the distance Q3 between the needle body 35 and the urethral insertion member 4 and the distance Q4 between the needle body 35 and the vagina insertion member 5 is constant. Thereby, it is possible to accurately perform puncture (puncture method) with the puncture member 3 with the puncture location of the needle body 35 with respect to the living tissue being constant regardless of individual differences. The ratio between the distance Q3 and the distance Q4 and the ratio between the distance Q1 and the distance Q2 described above are the same.

  In the treatment of female urinary incontinence, it is preferable that the location where the puncture member 3 is actually punctured and the location where the puncture member 2001 is actually punctured are the same in the living tissue. Therefore, the configuration in which the two ratios described above are the same is effective.

<Twenty-seventh embodiment>
FIG. 73 is a side view of the living body insertion device (27th embodiment) of the present invention.

Hereinafter, the twenty-seventh embodiment of the living body insertion device of the present invention will be described with reference to this drawing. However, the difference from the above-described embodiment will be mainly described, and the description of the same matters will be omitted.
The present embodiment is the same as the twentieth embodiment except that the configuration of the living body inserting apparatus is different.

  As shown in FIG. 73, in the present embodiment, the connecting portion 602 (a) and the support plate (b) are omitted, and the configuration is simplified accordingly.

  In this embodiment, the puncture member 3 is arranged so that the puncture hole by the puncture member 3 is formed in a direction orthogonal to the longitudinal direction of the insertion tool 6.

  As mentioned above, although the biological insertion apparatus of this invention was demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a biological insertion apparatus is arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.

  Moreover, the living body insertion device of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  In the above-described embodiment, the needle body is detachably held on the main body. However, the present invention is not limited thereto, and the needle body is fixed to the main body, for example, the main body and the needle body are integrally formed. May be. In this case, the distal end side opening of the main body can be opened by puncturing the living body with the puncture member and projecting the needle body out of the living body, and then cutting the needle body with a scissors or the like.

  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 to this. It may be accommodated in. 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.

  Further, 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. However, the use of the puncture device is limited thereto. Is not to be done.

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

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

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

DESCRIPTION OF SYMBOLS 1 Puncture apparatus 10 Medical tube assembly 11 Protrusion part 111 Top part 12 Lumen (flow path)
121 Inlet 13 Blocking portion 131 Linear body 132 Crossing portion 133 Spacer 134 Protruding portion 14 Balloon 15 Auxiliary vagina inserting portion 151 Tip portion 152 Protruding portion 2 Frame 21 Bearing portion 211 Through hole 22 Guide portion 221 Guide groove 222 Tip side opening 223 Proximal opening 23 Connecting portion 24 Fixing portion 243 Recess 244 Male screw 3 Puncture member 30 Sheath 31 Main body 315 Engaging hole 316 Engaging hole 317 Engaging hole 318 Engaging hole 319 Tapered portion 32 Tip split piece 321 Tip side opening 322 Base end opening 33 Base end split piece 331 Tip end opening 332 Base end opening 34 State maintaining mechanism 341 Thread 342a Hole 342b Hole 342c Hole 345 Exposed hole 346 Exposed hole 347 Slit 347a Part 347b Part 348 Hole 35 Needle body 351 Needle tip 352 Base end portion 353 Engagement portion 4 Urethral insertion member 40 Support portion 401 Engagement 402 stopper 41 urethra insertion part 411 insertion part 412 non-insertion part 413 reduced diameter part 414 large diameter part 415 boundary part 416 boundary part 417 groove 418 deformation part 419 operation wire 42 balloon 43 balloon port 44 suction hole 45 suction port 46 ring member 47 Urine discharge part 471 Drain hole 48 Urine discharge port 49 Suction line 5 Vaginal insertion member 50 Support part 501 Male screw 502 First engagement part 503 Second engagement part 504 Engagement part 505 Stopper 51 Vaginal insertion part 511 Insertion part 511a Upper surface 511b Lower surface 511c Recessed portion 511d Groove 512 Non-insertion portion 52 Holding portion 521 Holding piece 522 Bending portion 523 Holding portion 524 Concavity and convexity 53 Recessed portion 531 Bottom portion 532 Side wall 533 Protruding portion 54 Suction port 55 Movement limit restricting portion 56 Position shift prevention portion 561 Rib (First protrusion)
562 Small protrusion (second protrusion)
563 Virtual line 564 Claw 57 Marker 58 Suction line 59 Suction hole 6 Insertion tool 60 Support portion 601 Frame 601a Lock member 601b Lock member 602 Connection portion 602a Connection port 602b Support plate 602c Center shaft 603 Position restriction portion 603a First link 603b Second link 603c Pinion gear 603d Rack 603e Rack 61 Junction part 62 Line 63 Rotation support part 64 First lock part 65 Second lock part 66 Engagement member 661 Arm part 662 Engagement piece 663 Inclined surface 7 Operation member 71 Insertion part 711 Tip part 712 Needle tip 712a Area gradually increasing part 712b Area gradually decreasing part 712c Boundary part 72 Connecting part 73 Shaft part 81 Anchor (second anchor)
811 Base portion 812 Insertion hole 813 Claw portion 814 Claw portion 82 Anchor (first anchor)
821 Base part 822 Insertion hole 823 Claw part 824 Claw part 9 Implant 91 Implant body 911 Body part 912 Band 92 Packaging material 1100 Pelvis 1101 Closure hole 1102 Closure hole 1200 Pubic joint 1300 Urethra 1310 Bladder 1320 Bladder neck 1330 Gap 1400 Vaginal 1410 Vaginal 1410 Wall 1420 Suctioned portion 2000 Syringe 2001 Injection needle A1 Inner peripheral portion A2 Outer peripheral portion A3 Front surface A4 Back surface D Separation distance H Body surface J1 Axis J2 Axis J31 Short axis J32 Long axis J32 'Extension line J5 Central axis f1 Plane f2 Plane f9 Plane L2 Length M Puncture path N Water O Center P Intersection Q1 Distance Q2 Distance Q3 Distance Q4 Distance R Puncture location S1 Region S2 Space S4 Center S5 Safety zone r1 Minimum curvature radius r2 Maximum curvature radius W Width W1 Width W2 Width θ1 Inclination angle θ2 Inclination angle θ3 Inclination angle θ4 Medium Heart angle θ5 angle

Claims (6)

An elongated urethral insertion device inserted into the urethral cavity;
An elongated vaginal insertion tool inserted into the vaginal cavity;
A support for supporting the urethral insertion tool and the vaginal insertion tool in an approachable and / or detachable manner,
The support includes at least one connection for connecting an infusion device for injecting liquid into the living tissue between the urethral cavity and the vaginal cavity;
The urethral insertion tool and the vagina so that the ratio of the distance between the connection part and the urethral insertion tool and the distance between the connection part and the vagina insertion tool is constant in the approached and / or spaced state. A living body insertion device having a position restricting portion for restricting a positional relationship between an insertion tool and the connecting portion.   The living body insertion device according to claim 1, wherein a plurality of the connection portions are provided.   The living body insertion device according to claim 2, wherein the plurality of connection portions are arranged so that connection directions of the injection devices are different. An injection device having a needle tip for puncturing the living tissue;
When the needle tip passes between the urethral insertion tool and the vaginal insertion tool, the position restricting unit is configured to move at least a part of the injection tool and the urethral insertion tool in the approaching and / or separating state. And the positional relationship between the urethral insertion tool, the vaginal insertion tool and at least a part of the injection tool so that the ratio of the distance between the urethra insertion tool, the vaginal insertion tool and the injection tool is constant. The living body insertion device according to any one of claims 1 to 3, wherein the living body insertion device is regulated. An elongated urethral insertion device inserted into the urethral cavity;
An elongated vaginal insertion tool inserted into the vaginal cavity;
A puncture needle having a needle tip for puncturing a living tissue between the urethral cavity and the vaginal cavity;
A support body that supports the urethral insertion tool and the vaginal insertion tool so as to be able to approach and / or separate from each other and supports the puncture needle so as to be movable in a puncturing direction,
The support includes a distance between the needle tip and the urethral insertion tool in a state in which the needle tip passes between the urethral insertion tool and the vaginal insertion tool in the approach and / or separation state, and Biological insertion having a position restricting portion having a function of restricting the positional relationship between the urethral insertion tool, the vaginal insertion tool, and the puncture needle so that the ratio of the distance between the needle tip and the vaginal insertion tool is constant. apparatus. An elongated urethral insertion device inserted into the urethral cavity;
An elongated vaginal insertion tool inserted into the vaginal cavity;
A support for supporting the urethral insertion tool and the vaginal insertion tool in an approachable and / or detachable manner,
The support includes at least one connection for connecting an infusion device for injecting liquid into the living tissue between the urethral cavity and the vaginal cavity;
With the infusion device connected to the connecting portion, in the approached and / or separated state, the distance between the at least part of the infusion device and the urethral insertion device, the at least part of the infusion device, and the A living body insertion device having a position restriction unit having a function of regulating a positional relationship between the urethral insertion tool and the vaginal insertion tool and the connecting portion so that a ratio to a distance from the vaginal insertion tool is constant.

Images