JP2015058074A - Paracentesis device and paracentesis method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a paracentesis device and a paracentesis needle capable of realizing accurate paracentesis when a living tissue is subjected to the paracentesis.SOLUTION: A paracentesis device 1 comprises a paracentesis needle which has a bow-shaped curve and punctures a living tissue by its rotation, a paracentesis member 3E which is connected to the paracentesis needle and comprises a rotational shaft to be rotational center of the paracentesis needle, and a supporting part 17 which rotatably supports the paracentesis member 3E on the rotational shaft and movably supports the paracentesis member 3E in a direction orthogonal to the rotational shaft. The supporting part 17 is so constructed that first paracentesis onto the paracentesis member 3E and second paracentesis in which curvature is larger than that of the first paracentesis are sequentially operated.

Description

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

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

  Surgical therapy is effective for 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 space between the urethra and the vagina, and closes the peeled area and the outside using, for example, an arc-shaped puncture needle Communication is made through a hole (hereinafter, this operation is referred to as “puncture operation”). In such a state, the sling is left in the body.

  However, when a puncture operation is performed with a puncture needle having a relatively large radius of curvature, it can be punctured deeply from the surface of the living body, but blood vessels such as the common iliac arteriovenous, femoral arteriovenous, closed arteriovenous, closed nerves, etc. May accidentally puncture your nerve. When a puncture operation is performed on a relatively thick patient with a long distance from the body surface to the tissue between the urethral cavity and the vaginal cavity using a puncture needle with a relatively small radius of curvature, the length of the puncture needle Depending on the situation, the puncture needle may not reach the target site sufficiently.

JP 2010-99499 A

  An object of the present invention is to provide a puncture apparatus and a puncture method that can accurately and sufficiently perform puncture on a living tissue.

Such an object is achieved by the present inventions (1) to (8) below.
(1) a puncture member having a puncture needle that punctures a living tissue by bending and rotating, and a rotation shaft that is connected to the puncture needle and serves as a rotation center of the puncture needle;
A puncture apparatus comprising: a support portion that supports the puncture member so as to be rotatable about the rotation axis and supports the movement in a direction orthogonal to the rotation axis.

  (2) The puncture device according to (1), wherein in the use state of the puncture device, a direction orthogonal to the rotation axis is a horizontal direction or a vertical direction.

  (3) The above-described (1) or (2), wherein the support portion includes at least one pinion gear that is provided on the rotation shaft and rotates together with the rotation shaft, and at least one rack that meshes with the pinion gear. ) The puncture device according to the above.

(4) The support portion is configured such that, in a use state of the puncture device, a direction orthogonal to the rotation axis is a vertical direction, and the puncture needle is reciprocated in the vertical direction.
The rack includes a first rack and a second rack disposed to face the first rack via the pinion gear,
The pinion gear according to (3), wherein the pinion gear meshes with one of the first rack and the second rack in the forward path and meshes with the other rack in the return path.

(5) The pinion gear includes a first pinion gear and a second pinion gear disposed adjacent to the first pinion gear along the rotation axis.
The rack includes a first rack that meshes with the first pinion gear, and a second rack that meshes with the second pinion gear;
The puncture apparatus according to (4), wherein a gear ratio between the first pinion gear and the first rack and a gear ratio between the second pinion gear and the second rack are different.

  (6) The support unit is configured to sequentially perform a first puncture and a second puncture having a larger curvature than the first puncture on the puncture member. The puncture device according to any one of 5).

(7) The puncture device is used to place an implant between the urethral cavity and the vaginal cavity and to form a puncture hole for placing the implant in the living tissue prior to the placement. Yes,
The first puncture is performed until the needle tip of the puncture needle extends from the surface of the living body to the front of the one closed hole, and the needle tip of the puncture needle passes between the urethral cavity and the vaginal cavity from the front of the one closed hole. The puncture device according to (6), wherein the second puncture is performed until the second closed hole is passed over the other closed hole.

(8) A puncturing method for puncturing a living tissue and forming an arcuate puncture hole in the living tissue,
A puncturing method, wherein puncturing is performed so that the curvature of the puncture hole changes along the longitudinal direction of the puncture hole in the process of puncturing the living tissue.

  According to the present invention, in the process of puncturing a biological tissue to form a puncture hole, the curvature of the locus drawn by the needle tip of the puncture needle can be appropriately changed according to the puncture depth. Then, along with the change, the formed puncture hole has a curvature that changes along its longitudinal direction, like the locus. As a result, the puncture hole is in a state that reliably avoids living body lumens such as arteries, urethral cavities, and vaginal cavities. Thus, in the puncture device, when puncturing a living tissue, the puncture can be performed accurately.

FIG. 1 is a perspective view showing a first embodiment of the puncture apparatus of the present invention. FIG. 2 is a side view of the puncture device shown in FIG. FIG. 3 is a plan view showing a frame fixing portion provided in the puncture apparatus shown in FIG. 1. FIG. 4 is a side view of the insertion tool provided in the puncture device shown in FIG. 1. FIG. 5 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. 6 is a partially enlarged view of the vaginal insertion member of the insertion tool shown in FIG. 7A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 7B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. 8A and 8B are diagrams showing a puncture member provided in the puncture device shown in FIG. 1, wherein FIG. 8A is a perspective view, and FIG. 8B is a cross-sectional view taken along line AA in FIG. FIG. 9 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 10 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 11 is a side view showing the relationship between the puncture apparatus and the pelvis in the state shown in FIG. FIG. 12 is a diagram for explaining the operation procedure of the puncture device shown in FIG. 1 (view from the patient's leg side). FIG. 13 is a diagram (a diagram seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus shown in FIG. 1. FIG. 14 is a view for explaining the operation procedure of the puncture device shown in FIG. 1 (view from the patient's leg side). FIG. 15 is a diagram (a diagram viewed from the patient's leg side) for explaining an operation procedure of the puncture apparatus shown in FIG. 1. FIG. 16 is a diagram (a diagram viewed from the patient's leg side) for explaining the operation procedure of the puncture apparatus shown in FIG. 1. FIG. 17 is a diagram for explaining the operation procedure of the puncture device shown in FIG. 1 (viewed from the patient's leg side). 18 is a cross-sectional view taken along line BB in FIG. 19 is a cross-sectional view taken along the line CC in FIG. 20 is a cross-sectional view taken along the line DD in FIG. FIG. 21 is a diagram for explaining an operation procedure of the puncture apparatus (second embodiment) according to the present invention. FIG. 22 is a diagram for explaining an operation procedure of the puncture device of the present invention (second embodiment). FIG. 23 is a side view showing a third embodiment of the puncture apparatus of the present invention. FIG. 24 is a side view showing a fourth embodiment of the puncture device of the present invention. FIG. 25 is a perspective view showing a fifth embodiment of the puncture device of the present invention. FIG. 26 is a plan view showing a puncture member provided in the puncture device shown in FIG. 27 is a perspective view showing a puncture member provided in the puncture apparatus shown in FIG. 28 is a cross-sectional view of the puncture member shown in FIG. 29 is a diagram showing a state maintaining mechanism of the puncture member shown in FIG. 27, in which (a) is a top view and (b) and (c) are cross-sectional views. 30 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 26, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing the present embodiment. It is. FIG. 31 is a view for explaining the operation procedure of the puncture device shown in FIG. 25 (view from the patient's leg side). FIG. 32 is a diagram (a diagram viewed from the patient's leg side) for explaining the operation procedure of the puncture device shown in FIG. 25. FIG. 33 is a view for explaining the operation procedure of the puncture device shown in FIG. 25 (view from the patient's leg side). FIG. 34 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 35 is a view for explaining the operation procedure of the puncture device shown in FIG. 25 (view from the patient's leg side). FIG. 36 is a view for explaining the operation procedure of the puncture device shown in FIG. 25 (view from the patient's leg side). FIG. 37 is a diagram showing an operating state of a support portion provided in the puncture device shown in FIG. FIGS. 38A and 38B are diagrams showing a support portion provided in the puncture device of the present invention (sixth embodiment), where FIG. 38A is a plan view and FIG. 38B is a cross-sectional view. FIG. 39 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus of the present invention (seventh embodiment). FIG. 40 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus (seventh embodiment) of the present invention. FIG. 41 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus of the present invention (seventh embodiment). FIG. 42 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus (seventh embodiment) of the present invention. FIG. 43 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus of the present invention (seventh embodiment). FIG. 44 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus of the present invention (seventh embodiment). FIG. 45 is a diagram (a diagram viewed from the patient's leg side) for explaining the operation procedure of the puncture device of the present invention (seventh embodiment). FIG. 46 is a view for explaining the operation procedure of the puncture apparatus (seventh embodiment) of the present invention (viewed from the patient's leg side). FIG. 47 is a diagram showing an operating state of the support portion provided in the puncture device (seventh embodiment) of the present invention. FIG. 48 is a cross-sectional view showing an eighth embodiment of the puncture device of the present invention. FIG. 49 is a perspective view showing a puncture member provided in the puncture apparatus (9th embodiment) of the present invention. FIG. 50 is a cross-sectional view showing a modification of the puncture member shown in FIG.

  Hereinafter, the puncture apparatus and puncture method of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

<First Embodiment>
FIG. 1 is a perspective view showing a first embodiment of the puncture apparatus of the present invention. FIG. 2 is a side view of the puncture device shown in FIG. FIG. 3 is a plan view showing a frame fixing portion provided in the puncture apparatus shown in FIG. 1. FIG. 4 is a side view of the insertion tool provided in the puncture device shown in FIG. 1. FIG. 5 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. 6 is a partially enlarged view of the vaginal insertion member of the insertion tool shown in FIG. 7A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 7B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. 8A and 8B are diagrams showing a puncture member provided in the puncture device shown in FIG. 1, wherein FIG. 8A is a perspective view, and FIG. 8B is a cross-sectional view taken along line AA in FIG. FIG. 9 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 10 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG. FIG. 11 is a side view showing the relationship between the puncture apparatus and the pelvis in the state shown in FIG. FIG. 12 is a diagram for explaining the operation procedure of the puncture device shown in FIG. 1 (view from the patient's leg side). FIG. 13 is a diagram (a diagram seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus shown in FIG. 1. FIG. 14 is a view for explaining the operation procedure of the puncture device shown in FIG. 1 (view from the patient's leg side). FIG. 15 is a diagram (a diagram viewed from the patient's leg side) for explaining an operation procedure of the puncture apparatus shown in FIG. 1. FIG. 16 is a diagram (a diagram viewed from the patient's leg side) for explaining the operation procedure of the puncture apparatus shown in FIG. 1. FIG. 17 is a diagram for explaining the operation procedure of the puncture device shown in FIG. 1 (viewed from the patient's leg side). 18 is a cross-sectional view taken along line BB in FIG. 19 is a cross-sectional view taken along the line CC in FIG. 20 is a cross-sectional view taken along the line DD 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”.

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

  The puncture device 1 is a device that is 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.

  As shown in FIGS. 1 and 13, the puncture device 1 includes a frame (support portion) 2, a puncture member 3 </ b> A, a urethral insertion member 4, and a vaginal insertion member 5, and the puncture member 3 </ b> A and urethral insertion are attached to the frame 2. The member 4 and the vaginal insertion member 5 are supported. In the puncture device 1, the urethral insertion member 4 and the vagina insertion member 5 constitute an insertion tool 6. Hereinafter, these will be described in order.

(flame)
As shown in FIGS. 1 and 2, the frame 2 connects the grip portion 21 gripped in the mounted state, the guide portion (holding portion) 22 that guides the puncture member 3 </ b> A, and the grip portion 21 and the guide portion 22. And a fixing portion 24 to which the insertion tool 6 is fixed.

  The gripping part 21 is located on the proximal end side of the puncture device 1 and extends in a direction substantially orthogonal to the axis J1. The “axis J1” is an axis that becomes the center of rotation when the puncture member 3A rotates.

  The guide part 22 is located on the distal end side of the puncture device 1 and is arranged to face the grip part 21. The guide portion 22 has an arch shape, and an engaging portion 224 is provided on the outer peripheral portion of the lower end thereof. The engaging portion 224 is configured by a protruding portion that protrudes outward.

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

  The fixed portion 24 is disposed to face the connecting portion 23 via the axis J1. As shown in FIG. 3, 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.

(Puncture member)
The puncture member 3A punctures a living body (living tissue). As shown in FIGS. 13 to 16, the puncture member 3 </ b> A includes a puncture needle 11, a sheath (medical tube) 30, a connection member 12, and a regulation member 13, and these are assemblies.

-Puncture needle-
The puncture needle 11 is composed of a long wire and has elasticity. Thereby, the puncture needle 11 can be curved and deformed elastically. The puncture needle 11 is linear in a natural state where no external force is applied.

  As the constituent material of the puncture needle 11, a metal material can be used, and the metal material is not particularly limited. For example, a super-material such as a Ni—Ti alloy, a Ni—Al alloy, a Cu—Zn alloy, etc. Examples include elastic alloys.

  The distal end portion of the puncture needle 11 has a taper shape whose outer diameter gradually decreases in the distal direction. Thereby, a sharp needle tip 111 is formed at the tip of the puncture needle 11. The needle tip 111 is a part mainly responsible for puncturing the living body.

  Note that the outer peripheral portion of the puncture needle 11 is preferably subjected to a low friction process by applying a lubricant, for example. Thereby, the operation of inserting the puncture needle 11 into the sheath 30 can be easily performed.

-Sheath-
The sheath 30 has a tubular main body 31 and a mounting portion 37 provided at the base end portion of the main body 31.

  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 puncture needle 11 and the implant 9 can be inserted. As shown in FIG. 14, the main body 31 can pierce (puncture) the living body together with the puncture needle 11 in the inserted state where the puncture needle 11 is inserted. In addition, it is preferable that the edge part of the front-end | tip opening part of the main body 31 has comprised the taper shape which the outer diameter decreased gradually toward the front-end | tip direction. Thereby, in the insertion state, the edge part of the main body 31 and the front-end | tip part of the puncture needle 11 will form the taper surface, and, thereby, the penetration | piercing with respect to a biological body becomes easy. The full length of the puncture needle 11 and the implant 9 is sufficiently longer than the full length of the main body 31.

  As shown in FIG. 8A, the main body 31 has a curved portion 314 at least at a portion from the tip to a predetermined distance. The curved portion 314 is a portion shaped in a curved state curved in an arc shape (bow shape) in a natural state where no external force is applied.

  The central angle of the bending portion 314 is not particularly limited and is appropriately set according to various conditions. As will be described later, the bending portion 314 and the puncture needle 11 together with the puncture needle 11 from the patient's buttocks Is set so that it can pass between the urethra 1300 and the vagina 1400 and reach the vicinity of the other buttocks. Specifically, the central angle is preferably 150 to 270 °, more preferably 170 to 250 °, and still more preferably 190 to 230 °.

  The main body 31 has at least a curved portion 314 having elasticity. Thereby, as shown in FIG. 13, the bending portion 314 is regulated linearly by the regulating member 13.

  As shown in FIG. 8B, the main body 31 has a flat cross-sectional shape. In particular, the cross-sectional shape at the central portion S4 in the longitudinal direction of the curved portion 314 is a flat shape including the short axis J31 and the long axis J32. As will be described later, an implant body 91 is disposed in the body 31 in place of the puncture needle 11. In this case, by making the main body 31 into a flat shape, the posture of the implant main body 91 in the main body 31 can be controlled.

  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 (see FIG. 19). 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 invasive puncture member 3A.

  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. 8B, 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. 8B, a plane including both the center point of the arc of the central portion S4 and the center point of the cross-sectional shape with respect to the longitudinal direction of the main body 31 (surface including the central axis of the main body 31) is defined as a plane f9. When the angle formed between the plane f9 and the short axis J31 at the central portion S4 is defined as an inclination angle θ1, the inclination angle θ1 is preferably an acute angle. By setting the inclination angle θ1 to an acute angle, an implant 9 described later can be disposed substantially parallel to the urethra (urethral cavity) 1300, and the urethra 1300 can be supported more effectively. 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 bending portion 314, but at least satisfies the above numerical range at the central portion S4 in the extending direction of the bending portion 314. If it is, the said effect can be exhibited. The “central portion S4” is located between the urethra 1300 and the vagina (vaginal cavity) 1400 at least when the puncture member 3A is punctured into the living body (the main body 31 is disposed in the living body). The area including the part is said.

  The configuration of the main body 31 can be paraphrased as follows. That is, as shown in FIG. 8B, 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. 8B, the main body 31 is located at the inner periphery of the main body 31 as viewed in the direction of the central axis J5 of the main body 31 and has a minimum radius of curvature r1. An inner peripheral portion A1 and an outer peripheral portion A2 having a maximum radius of curvature r2 located at the outer peripheral edge are provided, and the inner peripheral portion A1 and the outer peripheral portion A2 are spaced apart (shifted) in the direction of the central axis J5. It can be said that it is composed.

  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.

  The mounting portion 37 is provided on the base end outer peripheral portion (upper end portion) of the main body 31. The mounting portion 37 is formed in a ring shape along the circumferential direction of the main body 31, and can be fitted to the proximal end portion of the connecting member 12 from the outer peripheral side (see FIGS. 14 to 16). Thereby, the sheath 30 is detachably attached to the connection member 12 via the attachment portion 37.

  The constituent material of the sheath 30 is preferably a material that has elasticity and maintains its shape and internal space when inserted into the body. As such a material, for example, various resin materials such as polyethylene, polyimide, polyamide, polyester elastomer, and polypropylene can be used.

  It is preferable that the sheath 30 has light permeability and is visible from the outside. Thereby, for example, the state of the inserted puncture needle 11 and implant 9 can be confirmed.

  Further, it is preferable that the outer peripheral portion of the sheath 30 is subjected to a low friction process, for example, by applying a lubricant. Thereby, operation which inserts the sheath 30 in the connection member 12 or the control member 13 can be performed easily.

-Connection member-
As shown in FIG. 13, the connection member 12 is formed of a cylinder that is harder than the sheath 30. The cylindrical body has a linear center axis. Further, the inner diameter of the connecting member 12 is slightly larger than the outer diameter of the main body 31 of the sheath 30. As a result, as shown in FIG. 13, when the bending portion 314 of the sheath 30 is inserted into the connection member 12, the bending portion 314 is linearly restricted by the connection member 12, and can be easily applied to the restriction member 13 as it is. Will be introduced.

  Moreover, the connection member 12 has the enlarged diameter part 121 which the internal diameter expanded at the front-end | tip part (lower end part). The enlarged diameter portion 121 can be fitted to the proximal end portion of the regulating member 13 from the outer peripheral side (see FIGS. 13 to 16). Thereby, the connecting member 12 is detachably connected to the regulating member 13 via the enlarged diameter portion 121.

  A groove 122 is formed in the inner peripheral portion of the enlarged diameter portion 121 along the circumferential direction. In the groove 122, the protrusion 133 of the restriction member 13 is inserted in a state where the connection member 12 is connected to the restriction member 13. Thereby, the enlarged diameter part 121 and the regulating member 13 are engaged, and coupled with the fitting, the connection state between the connecting member 12 and the regulating member 13 is reliably maintained.

  The constituent material of the connecting member 12 is not particularly limited, and for example, the same constituent material as that of the sheath 30 can be used. In addition, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like. Can also be used.

-Restriction member-
As shown in FIG. 12, the regulating member 13 is used in a state where it is placed on the body surface H by puncturing the body surface (biological surface) H prior to puncturing with the puncture needle 11. Similar to the connection member 12, the restriction member 13 is formed of a cylindrical body that is harder than the sheath 30. The cylindrical body has a linear center axis. The regulating member 13 has a sharp puncture portion 131 at the tip thereof. With this puncture portion 131, the body surface H can be punctured easily and reliably toward one of the left and right closure holes 1101 and 1102 (the closure hole 1101 in this embodiment). The total length of the restricting member 13 is preferably the same as or longer than the total length of the connecting member 12.

  The inner diameter of the regulating member 13 is also slightly larger than the outer diameter of the main body 31 of the sheath 30, similarly to the connecting member 12. Accordingly, as shown in FIG. 13, the curved portion 314 is regulated (corrected) linearly by the regulating member 13 after being regulated linearly by the connecting member 12. Then, the bending portion 314 returns to the curved state when the restriction by the restriction member 13 is released at the portion protruding from the tip opening of the restriction member 13 (see FIGS. 14 to 16).

  In the middle of the regulating member 13 in the longitudinal direction, a flange portion 132 is provided on the outer periphery thereof. The flange portion 132 is configured by an enlarged diameter portion in which the outer diameter of the regulating member 13 is increased. As shown in FIG. 12, the flange portion 132 comes into contact with the body surface H when the regulating member 13 punctures the body surface H. Thereby, the puncture depth with respect to the body surface H of the regulating member 13 is regulated. Further, the flange portion 132 is pressed against the body surface H by engaging with the engaging portion 224 of the guide portion 22 of the frame 2 in a puncture state where the regulating member 13 punctures the body surface H. This prevents the regulating member 13 from being unintentionally removed from the body surface H, so that the puncture state, that is, the indwelling state is reliably maintained.

  Further, a protrusion 133 is formed on the outer peripheral portion of the base end of the restricting member 13 along the circumferential direction. As described above, the protrusion 133 is inserted into the groove 122 formed in the enlarged diameter portion 121 of the connection member 12 and contributes to reliably maintaining the connection state between the connection member 12 and the regulating member 13.

  The constituent material of the regulating member 13 is not particularly limited, and for example, the same constituent material as that of the connecting member 12 can be used.

  In addition, although the regulating member 13 has the puncture part 131 in this embodiment, it is not limited to this, The puncture part 131 may be abbreviate | omitted.

  In the puncture member 3 </ b> A, the curvature changing unit 14 is configured by the sheath 30, the connecting member 12, and the regulating member 13. The curvature changing unit 14 is a mechanism that changes the curvature of the puncture needle 11 in the process in which the puncture needle 11 punctures a living body. A plurality of types of punctures are obtained in accordance with the curvature. In this embodiment, a first puncture with substantially zero curvature and a second puncture with a larger curvature than the first puncture are possible. is there.

  When treating urinary incontinence in women, the first puncture is performed until the needle tip 111 of the puncture needle 11 extends from the body surface H to the front of the closure hole 1101 (see FIGS. 12 and 13). In this first puncture, the puncture needle 11 is in a state in which the needle tip 111 protrudes through the sheath 30, and in this state passes through the regulating member 13 through the connection member 12. At this time, the puncture needle 11 is straightened by the regulating member 13 together with the curved portion 314 of the sheath 30. Thereby, the living body can be punctured linearly, that is, the first puncture can be performed.

  Then, the second puncture is performed until the needle tip 111 of the puncture needle 11 passes through the urethra 1300 and the vagina 1400 and passes (passes) the closure hole 1102 (the other closure hole) after passing through the closure hole 1101 ( (See FIG. 14). In this second puncture, the puncture needle 11 gradually protrudes from the regulating member 13 together with the curved portion 314 of the sheath 30. At this time, the restriction by the restriction member 13 is released, and the bending portion 314 returns to the bending state. As a result, the puncture needle 11 follows the bending state of the bending portion 314, that is, follows the bending shape of the bending portion 314. . Thereby, the living body can be punctured in an arc shape, that is, the second puncture can be performed.

  Furthermore, after the needle tip 111 of the puncture needle 11 passes through the closing hole 1102, the first puncture is performed again until it protrudes from the body surface H (see FIG. 15). In this first puncture, the attachment portion 37 of the sheath 30 is attached to the connecting member 12, and the movement of the sheath 30 is stopped, and only the puncture needle 11 moves. At this time, the puncture needle 11 is also released from the restriction by the bending portion 314, and moves straight as it is, that is, toward the tangential direction of the bending portion 314. Thereby, the living body can be punctured linearly, that is, the first puncture can be performed.

  In this way, the curvature changing unit 14 can operate the puncture needle 11 so that puncture is performed in the order of first puncture → second puncture → first puncture.

  By the way, depending on the patient's body shape, for example, in the case of a relatively thick patient, if the puncture needle 11 is curved in an arc shape immediately after puncture, the urethra 1300 exists in the direction in which the needle tip 111 is aimed, that is, in the forward direction. It will be in the state. If the puncture operation is continued in this state, the urethra 1300 will be punctured by mistake. However, in the puncture device 1, the curvature changing unit 14 can perform the first puncture to a position where the urethra 1300 is avoided, and thus the erroneous puncture can be reliably prevented.

  In addition, as above-mentioned, the curvature change part 14 is comprised by the sheath 30, the connection member 12, and the control member 13 in this embodiment, However, It is not limited to this, The connection member 12 can also be abbreviate | omitted.

(Insert tool)
As shown in FIGS. 1 and 4, the insertion tool 6 includes a urethral insertion part (second insertion part) 41 to be inserted into the urethra 1300 and a vaginal insertion part (first insertion part) to be inserted into the vagina 1400. 51 and a support portion 60 that supports the urethral insertion portion 41 and the vaginal insertion portion 51. As described above, the insertion tool 6 includes the urethral insertion member 4 and the vaginal insertion member 5, the urethral insertion member 4 includes the urethral insertion portion 41, and the vaginal insertion member 5 includes the vaginal insertion portion 51. 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 / contracted and a urine discharge portion 47 are provided at the distal end portion of the insertion portion 411. The balloon 42 functions as a restricting portion that restricts 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 1310 of the patient. Then, when the expanded balloon 42 is caught on the bladder neck, the position of the urethral insertion member 4 with respect to the bladder 1310 and the urethra 1300 is fixed. On the other hand, the urine discharge unit 47 is used to discharge urine in 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. 4, a state where the balloon 42 is deflated is indicated by a two-dot chain line, and a state where the balloon 42 is expanded is indicated by a solid line.

  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. Therefore, urine introduced from the discharge hole 471 can be discharged from the urine discharge port 48.

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

  A plurality of suction holes 44 are formed in the middle of the 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 suction device is operated with the urethra insertion part 41 inserted into the urethra 1300, the urethra wall can be adsorbed and fixed to the urethra insertion part 41. In this state, when the urethra insertion part 41 is pushed into the distal end (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 route of the puncture member 3A. A puncture route for the member 3A can be secured. Therefore, the puncture member 3A 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.

  Further, a marker 46 for confirming the insertion depth of the urethra insertion part 41 into the urethra 1300 is provided at the boundary between the insertion part 411 and the non-insertion part 412. The marker 46 is located at the urethral opening when the urethra insertion part 41 is inserted into the urethra 1300 and the balloon 42 is located within the bladder 1310. Thereby, the insertion depth to the urethra 1300 of the insertion part 411 can be confirmed easily. The marker 46 only needs to be visually recognized from the outside, and can be constituted by, for example, a colored portion, an uneven portion, or the like. In addition, it may replace with the marker 46 and may provide the scale in which the distance from the front-end | tip of the urethral insertion part 41 was described.

  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 1300 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 3A can be easily performed, and the puncture distance by the puncture member 3A can be further shortened.

  Specifically, by setting the inclination angle θ2 within the above range, the puncture member 3A can widely grasp the left and right closing 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 3A. That is, the puncture member 3A 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 3A can be punctured easily. In addition, since the puncture member 3A passes through a shallow portion of the tissue by puncturing the puncture member 3A in a relatively vertical direction with respect to the closure holes 1101 and 1102, the puncture member 3A is shorter between the left and right closure holes 1101 and 1102. Can pass by distance. Therefore, as shown in FIG. 5 (b), the puncture member 3A can pass through the closure holes 1101, 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 3A can be punctured safely. Therefore, it becomes less invasive and can reduce the burden on the patient. Thus, by setting the inclination angle θ2 within the above range, the patient can be more appropriately punctured with the puncture member 3A. 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 3A planarly closes the closing holes 1101 and 1102 depending on individual differences in the patient, 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 FIGS. 1 and 4, the vaginal insertion member 5 includes a long vaginal insertion portion (first insertion portion) 51 that is inserted into the vagina 1400 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 lower limit value or exceeds the upper limit value, the urethra 1300 and the vagina 1400 are unnatural in the wearing state depending on individual differences of patients, posture during the procedure, and the like. The puncture apparatus 1 may not be stably held.

  As shown in FIG. 6, 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 40 mm, and more preferably about 20 to 30 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. 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 are formed on the upper surface (surface on the urethra 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 suction device is operated in a state where the insertion portion 511 is inserted into the vagina 1400, the front portion of the vagina that is the upper surface of the vagina wall is inserted into the insertion portion 511. 1410 is adsorbed and fixed. When the vagina insertion portion 51 is pushed into the distal end (inside the body) with the vagina wall being adsorbed and fixed, the vagina wall can be pushed together with this. Therefore, the arrangement and shape of the vagina wall can be adjusted, the puncture path of the puncture member 3A can be secured, and the puncture of the puncture member 3A can be performed accurately and safely.

  The region S2 in which the plurality of recesses 53 are formed is disposed to face the region S1. The needle tip 111 of the puncture member 3A passes between these areas S1 and S2. As described above, the urethra 1300 which is the lower surface of the urethral wall is adsorbed by the insertion portion 411 in the region S1, and the vagina front wall 1410 is adsorbed by the insertion portion 511 in the region S2, so that the urethra is between the regions S1 and S2. The wall and vaginal wall are more widely separated. Therefore, the puncture member 3A can be punctured more safely by passing the puncture member 3A 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 9-39 mm, and it is more preferable that it is about 19-29 mm. Thereby, the vaginal front wall 1410 can be more reliably adsorbed to the insertion portion 511 without being greatly affected by the shape of the vagina wall. In particular, as shown in FIG. 7A, some patients may have a vagina 1400 shaped such that a part of the anterior vaginal wall 1410 hangs into the vagina 1400. Even in such a case, if the width W2 is set as described above, as shown in FIG. 7B, not only the sagging portion but also the portions on both sides of the sagging portion can be reliably sucked. Therefore, the vaginal front wall 1410 can be more reliably separated from the urethra 1300 without being affected by the shape of the vagina 1400. In particular, in the present embodiment, since the insertion portion 511 has a flat shape, the anterior vaginal wall 1410 can be adsorbed so as to be further away from the urethra 1300, and the living tissue between the urethral wall and the vagina wall can be more Can be widely spread.

  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 1 can be fixed so as 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 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.

  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. This also applies to the vaginal insertion portion 51.

  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. Implant Next, the implant 9 used with the puncture device 1 will be described.

  As shown in FIG. 15, an implant (living tissue support indwelling) 9 is an implantable device for treating female urinary incontinence, that is, a device that supports the urethra 1300, for example, the urethra 1300 is located on the vaginal wall side. This is a device that supports the urethra 1300 so as to restrict movement in a direction away from the vagina wall when it is about to move to the vagina. 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 911 is a net-like band. 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 those having a circular cross section and a flat cross section.

  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.

3. Method of Using Puncture Device 1 Next, a method of using the puncture device 1 (operation procedure) will be described with reference to FIGS. By using this puncture device 1 (puncture method), when the implant 9 is placed between the urethra 1300 and the vagina 1400, an arch-like puncture for placing the implant 9 in the living tissue prior to the placement. Holes can be formed.

  First, the patient is placed in the crushed position on the operating table, and the insertion tool 6 is attached to the patient as shown in FIG. Specifically, first, the urethral insertion portion 41 of the urethral insertion member 4 is inserted into the urethra 1300 of the patient. At this time, the insertion depth is confirmed by the marker 46, and the balloon 42 is placed in the bladder 1310. The urethra 1300 is corrected to the predetermined shape by the urethra insertion part 41 having a predetermined shape. In the present embodiment, the urethra 1300 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. Further, the vaginal insertion part 51 of the vaginal insertion member 5 is inserted into the patient's vagina 1400. At this time, the puncture position is confirmed with the marker 57 and inserted to an appropriate depth. Then, the support portions 40 and 50 are fixed by operating the male screw 501. 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 vaginal wall 1410 are separated and a gap (space) is formed between them, the body surface between the urethra mouth and the vagina mouth is A space S3 for piercing the living tissue with the syringe is formed.

  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 urethral insertion portion 41, and the vaginal front wall 1410 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 vaginal wall 1410 is properly adsorbed by the vaginal insertion portion 51, the suction hole 59 is blocked by the vagina wall, and thus suction from the suction port 54 is stopped or weakened. Therefore, the surgeon properly adsorbs the urethra 1300 and the vaginal front wall 1410 to the urethra insertion part 41 and the vagina insertion part 51 from the suction state (for example, the magnitude of sound generated by suction) from the suction ports 45 and 54. It can be confirmed 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. 9 (b), the puncture needle of the syringe 2000 is punctured into the vaginal front wall 1410 through the space (space S3) between the insertion portion 511 and the vaginal front wall 1410, and the urethra. A liquid such as physiological saline or a local anesthetic is injected into the living tissue between 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 vaginal wall is pressed against the vaginal insertion part 51, the anterior vaginal wall 1410 is further adsorbed by the vaginal insertion part 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 1410 are sufficiently separated, and then the regulating member 13 is placed on the body surface H of the right buttock of the patient or in the vicinity thereof. Then, as shown in FIG. 10, the insertion tool 6 is fixed to the frame 2. 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. As shown in FIG. 12, the restricting member 13 has the flange portion 132 engaged with the engaging portion 224 of the guide portion 22 of the frame 2. Thereby, the regulating member 13 is pressed against the body surface H and fixed. Further, the connecting member 12 is connected to the restricting member 13.

  Next, for example, while holding the grasping portion 21 or the connecting portion 23 of the frame 2 with one hand, the puncture needle 11 inserted through the sheath 30 with the other hand is connected to the connecting member 12 as shown in FIG. Through the restricting member 13. At this time, the needle tip 111 of the puncture needle 11 slightly protrudes from the distal end opening of the sheath 30.

  When the puncture needle 11 is pushed together with the sheath 30, the first puncture is performed as described above.

  Further, when the pushing operation for pushing the puncture needle 11 together with the sheath 30 is continued, the second puncture is performed as described above. As shown in FIG. 14, in the second puncture, the puncture path of puncture needle 11 is a path that passes between closure hole 1101, urethra 1300, and vagina 1400 through closure hole 1102. At this time, between the urethra 1300 and the vagina 1400, the puncture needle 11 and the sheath 30 are in the state shown in FIG. The second puncture is performed until the attachment portion 37 of the sheath 30 is attached to the connecting member 12 and the movement of the sheath 30 is stopped.

  Next, as shown in FIG. 15, when only the puncture needle 11 is pushed in, the first puncture is performed again as described above. By this puncture, the needle tip 111 protrudes from the body surface H of the left buttock or its vicinity. Thereafter, while removing the implant body 91 from the packaging material 92, the band 912 is passed through a through hole (not shown) provided in the vicinity of the needle tip 111 of the puncture needle 11. Thereby, the implant main body 91 and the puncture needle 11 are connected.

  Next, as shown in FIG. 16, the puncture needle 11 is pulled in the direction opposite to the above while the sheath 30 is indwelled in the living body, and is removed from the sheath 30. As a result, the implant body 91 is pulled together with the puncture needle 11 and is inserted through the sheath 30 in place of the puncture needle 11. 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 sheath 30.

  Moreover, it is preferable to arrange the position of the sheath 30 as needed. Specifically, it is preferable that the sheath 30 is shifted to the proximal end side or the distal end side so that the central portion S4 of the main body 31 is positioned between the urethra 1300 and the vagina 1400 as much as possible. Accordingly, as shown in FIG. 19, the central portion S4 is arranged so that the width direction (long axis J32 direction) is substantially parallel to the urethra 1300. That is, the width direction of the urethra 1300, which is corrected by inserting the urethra insertion member 4 and the central portion S4, is substantially parallel. Furthermore, since the central portion S4 has a flat shape, the posture of the main body portion 911 of the implant main body 91 follows this flat shape, which is preferable. That is, as shown in FIG. 19, the main body portion 911 is disposed in the sheath 30 so that the width direction thereof coincides with the width direction of the central portion S4. 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. 17, the puncture needle 11 is removed from the implant body 91 and the frame 2 is removed from the patient. Further, the suction of the urethra 1300 by the urethral insertion part 41 and the suction 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.

  Thereafter, the sheath 30, the regulating member 13, and the connecting member 12 are collectively pulled out from the living body. When the sheath 30 is removed from the living body, the surrounding tissue that has been spread by the sheath 30 returns to the original position, and the tissue gradually contacts the implant body 91 from one end side to the other end side of the implant body 91. I will do it. Thereby, an unnecessary tensile force is not applied to the implant body 91 and the implant body 91 can be left as it is, so that adjustment of the tension of the implant body 91 becomes unnecessary. As described above, as shown in FIG. 20, the implant main body 91 is embedded in the living body. In a state where the implant body 91 is embedded in the living body, the 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.

  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. In addition, since the sheath 30 is removed from the living body in a state where the urethral insertion member 4 is inserted into the urethra 1300, it is possible to prevent an excessive tension from being applied to the urethra 1300 by the implant body 91 placed in the living body.

  As described above, according to the puncture device 1, the curvature of the puncture needle 11 can be appropriately changed according to the puncture depth in the process of puncturing a living tissue to form a puncture hole. As the curvature of the puncture needle 11 changes, the curvature of the formed puncture hole also changes along its longitudinal direction. This ensures that the puncture hole has passed between the urethra 1300 and the vagina 1400. Thus, the puncture device 1 can accurately perform puncture when puncturing a living tissue.

  Further, according to the puncture device 1, when the implant 9 is placed, it can be handled only by a minimally invasive technique such as puncture of the puncture member 3A, and it is not necessary to perform a large invasive incision or the like. There is little burden and patient safety is high. 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.

  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.

  In the series of procedures from FIG. 14 to FIG. 16, as described above, the sheath 30 and the puncture needle 11 are assembled and inserted into the restricting member 13. It is possible to simply insert into the regulating member 13 and puncture. In this case, the bending portion 314 can be advanced to a portion beyond the closing hole 1102, and then the puncture needle 11 can be inserted into the sheath 30 to advance the puncture. In this case, it is preferable that the distal end of the sheath 30 has a structure capable of puncturing a living body.

Second Embodiment
FIG. 21 is a diagram for explaining an operation procedure of the puncture apparatus (second embodiment) according to the present invention. FIG. 22 is a diagram for explaining an operation procedure of the puncture device of the present invention (second embodiment).

Hereinafter, the second embodiment of the puncture device and the puncture method of the present invention will be described with reference to these drawings. However, the description will focus on differences from the above-described embodiments, and description of similar matters will be omitted. .
This embodiment is the same as the first embodiment except that the configuration of the puncture member is different.

  As shown in FIGS. 21 and 22, in the puncture member 3 </ b> B, the puncture needle 11 includes a small piece connecting portion 113 to which a plurality of small pieces 112 are connected, and a linear portion 114 extending from the small piece connecting portion 113 in the proximal direction. It consists of and.

In the small piece connecting portion 113, adjacent small pieces 112 are connected by a concave portion and a convex portion, are in a straight line shape in a natural state (see FIG. 21), and are elastically deformed when an external force is applied ( (See FIG. 22). Further, a sharp needle tip 111 is provided on the small piece 112a located at the most distal end.
The linear part 114 has higher rigidity than the small piece connecting part 113.

  In addition, the puncture member 3B is provided with an operation wire 15 as an operation portion for bending and deforming the puncture needle 11. The operation wire 15 is inserted through the puncture needle 11, and the tip is connected to the small piece 112 a of the puncture needle 11. In addition, a grip portion 151 that is gripped when operating the operation wire 15 is provided at the proximal end portion of the operation wire 15. The puncture needle 11 is bent and deformed by gripping the gripping portion 151 and pulling the operation wire 15 (puncture needle 11) toward the proximal direction. Note that the curvature of the puncture needle 11 also changes proportionally according to the amount of tension of the operation wire 15. In this way, the operation wire 15 functions as a curvature changing unit 14 that changes the curvature of the puncture needle 11.

  In this embodiment, the puncture member 3B can perform the first puncture and the second puncture. As shown in FIG. 21, when performing the first puncture, the puncture needle 11 is regulated by the regulating member 13 and is in a linear state. Thereby, the 1st puncture is performed reliably. As shown in FIG. 22, when performing the second puncture, the puncture needle 11 is bent and deformed by performing a pulling operation with the operation wire 15 in a state where the restriction by the restriction member 13 is released. As a result, the second puncture is performed reliably, so that the puncture between the urethra 1300 and the vagina 1400 can be performed. Further, by loosening the operation wire 15 after the second puncture, the puncture needle 11 returns to a straight line, and the first puncture can be performed.

  As shown in FIG. 21, the puncture needle 11 is provided with a marker 115 on the linear portion 114. When the marker 115 is overlapped with the body surface H, if the operation wire 15 is operated, the puncture needle 11 is curved and deformed, and a transition to the second puncture can be made.

  Thus, also in this embodiment, when puncturing a living body, the puncturing can be performed accurately, and a puncture hole similar to the first embodiment can be formed in the living body.

<Third Embodiment>
FIG. 23 is a side view showing a third embodiment of the puncture apparatus of the present invention.

Hereinafter, the third embodiment of the puncture device and the puncture method 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 description of similar matters will be omitted.
This embodiment is the same as the second embodiment except that the configuration of the puncture member is different.

  As shown in FIG. 23, the puncture member 3C is provided with a lock mechanism 16 that maintains the curved state of the puncture needle 11. The lock mechanism 16 is a mechanism that bears a part of the curvature changing unit 14 and includes a compression coil spring 161. The compression coil spring 161 is disposed in a compressed state between a flange portion 116 provided at the proximal end portion of the puncture needle 11 and a flange portion 152 provided at the proximal end portion of the operation wire 15.

  When performing the first puncture, the flange portion 152 of the operation wire 15 is pressed toward the direction in which the compression coil spring 161 contracts to perform the puncture.

  On the other hand, when performing the second puncture, the pressure on the flange portion 152 is released and the puncture is performed. When the pressure on the flange portion 152 is released, the operating wire 15 is pulled toward the proximal direction by the restoring force of the compression coil spring 161, and the puncture needle 11 is bent and maintained. By maintaining this state, the second puncture can be performed easily.

<Fourth embodiment>
FIG. 24 is a side view showing a fourth embodiment of the puncture device of the present invention.

Hereinafter, the fourth embodiment of the puncture device and the puncture method 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 second embodiment except that the configuration of the puncture member is different.

  As shown in FIG. 24, in the puncture member 3D, the puncture needle 11 extends in a proximal direction from a winding portion 117 in which a band-like body (or a linear body) is spirally wound, and from the winding portion 117. It is comprised with the linear part 114. FIG.

  The winding part 117 is linear in a natural state (see FIG. 24). Further, the winding portion 117 can be elastically deformed by applying an external force, that is, by operating the operation wire 15. Thereby, the curvature of the winding part 117 changes, and therefore the first puncture and the second puncture can be performed in order.

<Fifth Embodiment>
FIG. 25 is a perspective view showing a fifth embodiment of the puncture device of the present invention. FIG. 26 is a plan view showing a puncture member provided in the puncture device shown in FIG. 27 is a perspective view showing a puncture member provided in the puncture apparatus shown in FIG. 28 is a cross-sectional view of the puncture member shown in FIG. 29 is a diagram showing a state maintaining mechanism of the puncture member shown in FIG. 27, in which (a) is a top view and (b) and (c) are cross-sectional views. 30 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 26, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing the present embodiment. It is. FIG. 31 is a view for explaining the operation procedure of the puncture device shown in FIG. 25 (view from the patient's leg side). FIG. 32 is a diagram (a diagram viewed from the patient's leg side) for explaining the operation procedure of the puncture device shown in FIG. 25. FIG. 33 is a view for explaining the operation procedure of the puncture device shown in FIG. 25 (view from the patient's leg side). FIG. 34 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 35 is a view for explaining the operation procedure of the puncture device shown in FIG. 25 (view from the patient's leg side). FIG. 36 is a view for explaining the operation procedure of the puncture device shown in FIG. 25 (view from the patient's leg side). FIG. 37 is a diagram showing an operating state of a support portion provided in the puncture device shown in FIG.

  In FIG. 28 and FIG. 29, for convenience of explanation, the puncture member extending in an arc shape is linearly extended and illustrated.

Hereinafter, the fifth embodiment of the puncture device and puncture method of the present invention will be described with reference to these drawings. However, the description will focus on the differences from the above-described embodiments, 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 puncture device is different.

  As shown in FIG. 25, the puncture device 1 includes a frame 2, a puncture member 3E, a urethral insertion member 4, a vaginal insertion member 5, and an operation member 7. The puncture member 3E, the urethral insertion member 4, Each vaginal insertion member 5 is supported. The puncture device 1 of the present embodiment is mainly different from the puncture device 1 of the first embodiment in the puncture member 3E.

1. Puncture device (puncture member)
As shown in FIGS. 31 to 36, the puncture member 3E punctures a living body while securing the target puncture route R to form a puncture hole. As shown in FIG. 28, the puncture member 3E has a sheath 30, a needle body 35 provided at the distal end of the sheath 30, and an operation member 7 (insertion portion 71) for operating the sheath 30. The sheath 30 and the needle body 35 constitute a puncture needle. The sheath 30 includes a tubular main body 31 and a state maintaining mechanism 34.

-Operation member-
The operation member 7 is a member for operating the sheath 30. As shown in FIG. 26, 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 sheath 30 and functions as a stylet that reinforces the sheath 30 from the inside. By inserting the insertion portion 71 into the sheath 30, the sheath 30 is coupled to the operation member 7, and thereby the sheath 30 can be rotated by the operation member 7. Such an insertion portion 71 has an arc shape corresponding to the shape of the sheath 30. The central angle of the insertion portion 71 is set according to the central angle of the sheath 30. Further, the distal end portion 711 of the insertion portion 71 is tapered. By having the tapered tip end portion 711, the insertion portion 71 can be smoothly inserted into the sheath 30.

  The shaft portion 73 is a rotation shaft that intersects with the center O of the insertion portion 71 and serves as the rotation center of the sheath 30 (needle body 35). The shaft portion 73 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 sheath 30. 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.

-Sheath-
As shown in FIGS. 27 and 28, in this embodiment, the main body 31 of the sheath 30 is a hard one curved in an arcuate shape, and is constituted by two divided pieces so that it can be divided in the middle thereof. ing. 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. 28, the distal end split 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. In this way, by inserting the proximal end divided piece 33 into the distal divided piece 32, a step that may occur at the boundary between the divided pieces 32 and 33 becomes difficult to be caught on the living tissue, and the puncture member 3E smoothly punctures 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 constituent material of the main body 31 is preferably a hard material that maintains its shape and internal space when inserted into the body. Examples of such a hard material include various resin materials such as polyethylene, polyimide, polyamide, polyester elastomer, and polypropylene, and various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like. . In addition to adopting a hard material as the configuration of the main body 31, when a material other than the hard material is employed, it is also achieved by reinforcing the wall with a reinforcing member. For example, by embedding a high-strength braided body in the wall, the shape and the internal space can be maintained while being inserted into the body. As another example of the reinforcing member, by embedding a spiral object in the wall of the main body 31, it is possible to provide flexibility while maintaining the internal space to the extent that the insert can slide.

  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. 29A, the state maintaining mechanism 34 exposes the holes 342a, 342b, and 342c, an endless thread (connecting member) 341 inserted through the holes 342a, 342b, and 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. 29C, the hole 342a has an axis inclined such that the outer opening is located closer to the base end side than the inner opening. On the other hand, as shown in FIG. 29 (b), the holes 342b and 342c each have an inclined axis so that the outer opening is positioned closer to the tip than the inner opening. Thereby, each hole 342a, 342b, 342c can be extended along the path | route of the thread | yarn 341, and the thread | yarn 341 becomes difficult to be caught in each hole 342a, 342b, 342c.

  The 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. 30A, the passage route of the blade may be configured by a hole 348 instead of the slit 347. However, in this case, depending on the hardness of the main body 31, as shown in FIG. 30B, 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, the portions 347a and 347b sandwiching the slit 347 are in contact with each other and are stretched. Therefore, as shown in FIG. Is prevented.

  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.

  As shown in FIG. 28, a pair of engagement holes 315 and 316 used for other purposes, for example, for facilitating the operation of the sheath 30 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 are similarly used for other purposes 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.

  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 position of the center part 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. 28, 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 insertion state in which the puncture member 3E is inserted into the insertion 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 3E can be smoothly punctured into the living body.

  Note that when the cross-sectional shape of at least the tip end portion 711 of the insertion portion 71 is flat, the cross-sectional shape of the engaging portion 353 is formed in accordance with the cross-sectional shape of the tip end portion 711. That is, it is preferable that the cross-sectional shape of the tip portion 711 is also flat. Thereby, in the state where the engaging portion 353 and the tip portion 711 are engaged, the flat shapes of the engaging portion 353 and the tip portion 711 overlap each other. By this overlapping, the sheath 30 is restricted from rotating around the axis of the insertion portion 71, that is, around the axis along the puncture direction. Thereby, the curved puncture path | route which passes between the urethra 1300 and the vagina 1400 reliably can be ensured.

  The constituent material of the needle body 35 is not particularly limited, and for example, the same constituent material as that of the main body 31 can be used.

(Support part)
As shown in FIG. 25, a support portion 17 that supports the puncture member 3 </ b> E (operation member 7) is built in and disposed in the grip portion 21 of the frame 2. The support portion 17 can support the puncture member 3E so as to be rotatable around the shaft portion 73. Further, the support portion 17 rotates the puncture member 3E around the shaft portion 73 and also in a direction orthogonal to the shaft portion 73, that is, in the horizontal direction in the use state (mounted state) of the puncture device 1 in this embodiment. It can be movably supported.

  As shown in FIG. 37, the support portion 17 is fixedly provided on the shaft portion 73, and a pinion gear 171 that rotates together with the shaft portion 73, and a rack that is fixedly provided on the grip portion 21 and meshes with the pinion gear 171. 172.

  The pinion gear 171 has teeth 1711 formed in a region of a half circumference in the circumferential direction of the shaft portion 73. The rack 172 is formed so that the total length of the tooth portion is equal to the total length of the teeth 1711 of the pinion gear 171. As a result, as shown in FIGS. 37 (a) to 37 (c), the pinion gear 171 is engaged with the rack 172, and as shown in FIG. However, it can be in a state where it can move in the left-right direction in the figure.

  By the support portion 17 having such a configuration, the puncture member 3E can perform the first puncture (puncture in FIG. 31 → FIG. 32) and the second puncture (puncture in FIG. 32 → FIG. 33 → FIG. 34 → FIG. 35). The first puncture (puncture in FIG. 36) is sequentially performed. Thereby, the locus drawn by the needle tip 351 of the puncture member 3E becomes the target puncture route R, and as a result, the puncture member 3E punctures the living body along the target puncture route R.

2. Method of Using Puncture Device 1 Next, a method of use (operation procedure) of the puncture device 1 of this embodiment will be described with reference to FIGS.

  As shown in FIG. 31, with the puncture device 1 attached, the needle tip 351 is applied to the body surface H of the right buttocks on the right side of the patient or a part (first part) in the vicinity thereof. At this time, the support part 17 is in the state 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 rotated clockwise as shown in FIG. Let As a result, the needle tip 351 of the puncture member 3E enters the body by puncturing the body surface H of the right buttocks of the patient or a portion in the vicinity thereof (first portion) with the first puncture. This first puncture is performed up to the closing hole 1101.

  As shown in FIG. 33, when the rotation operation for the operation member 7 is further performed, the second puncture is started, and the puncture by the second puncture is started.

  As shown in FIG. 34, when the rotation angle of the operation member 7 becomes 90 degrees from the state shown in FIG. 31, the needle tip 351 passes between the urethra 1300 and the vagina 1400. At this time, the support part 17 is in the state shown in FIG.

  Thereafter, as shown in FIG. 35, the living body can be punctured by the second puncture until immediately before passing through the closing hole 1102.

  As shown in FIG. 36, when the rotation angle of the operation member 7 is 180 degrees from the state shown in FIG. 31, the needle tip 351 passes through the closing hole 1102, and further, the left heel part or its hook It reaches directly below the body surface H in the vicinity. At this time, the support portion 17 is in the state shown in FIG.

  As the operation member 7 is further rotated, as shown in FIG. 37 (d), the pinion gear 171 is disengaged from the rack 172, and the shaft 73 is idle. As a result, the needle tip 351 protrudes from the body surface H to the outside of the body.

  By the puncturing operation as described above, an arched puncture hole as close as possible to the target puncture route R is formed in the living body. Similarly to the first embodiment, this puncture hole is in a state of reliably passing between the urethra 1300 and the vagina 1400. Thus, also in the puncture apparatus 1 of this embodiment, when puncturing a living tissue, the puncture can be performed accurately.

  Next, the needle body 35 is removed from the sheath 30, and the operation member 7 is rotated in the opposite direction to the above. Thereby, the insertion portion 71 of the operation member 7 is removed from the sheath 30 while the sheath 30 remains in the living body.

  Next, the implant body 91 is inserted into the sheath 30 while being taken out from the packaging material 92, and the band 912 is projected from the proximal end opening and the distal end opening of the sheath 30.

  Next, the thread 341 exposed from the exposure holes 345 and 346 is cut. As a result, the sheath 30 can be divided into the distal split piece 32 and the proximal split piece 33. The exposure holes 345 and 346 are exposed to the outside of the living body, so that the thread 341 can be easily cut.

  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 sheath 30 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 sheath 30 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 sheath 30 has an internal space in which the implant body 91 can move with a sufficiently low sliding. As a result, an unnecessary tensile force is not applied to the implant body 91, and the implant body 91 can be placed as it is. Thereby, adjustment of the tension of the implant main body 91 becomes unnecessary. As described above, the implant body 91 is embedded in the living body.

  Further, by removing the sheath 30 from the living body by dividing the sheath 30 as described above, the sheath 30 can be easily removed from the living body. 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.

<Sixth Embodiment>
FIGS. 38A and 38B are diagrams showing a support portion provided in the puncture device of the present invention (sixth embodiment), where FIG. 38A is a plan view and FIG. 38B is a cross-sectional view.

  Hereinafter, the sixth embodiment of the puncture device and the puncture method of the present invention will be described with reference to these drawings. However, the difference from the above-described embodiment will be mainly described, and description of similar matters will be omitted. .

  This embodiment is the same as the fifth embodiment except that the configuration of the support portion that supports the puncture member is different.

  As shown in FIG. 38, in the present embodiment, the support portion 17 includes a first pinion gear 171A and a second pinion gear 171B that are fixedly provided on the shaft portion 73 of the operation member 7, and the grip of the frame 2. The first rack 172 </ b> A and the second rack 172 </ b> B are fixedly provided on the portion 21.

  As shown in FIG. 38A, the first pinion gear 171 </ b> A and the second pinion gear 171 </ b> B are disposed adjacent to each other along the shaft portion 73. The first rack 172A is disposed so as to mesh with the first pinion gear 171A, and the second rack 172B is disposed so as to mesh with the second pinion gear 171B.

  As shown in FIG. 38B, the first pinion gear 171A has teeth 1712 and 1714, and the second pinion gear 171B has teeth 1713.

  In the support portion 17, when the shaft portion 73 rotates, the teeth 1712, 1713, and 1714 mesh with each other along with the rotation. When the shaft portion 73 rotates, first, the first pinion gear 171A is disengaged by engaging the teeth 1712 with the first rack 172A while rotating by a predetermined angle α1 (for example, 45 degrees). Next, while the second pinion gear 171B rotates by a predetermined angle α2 (for example, 90 degrees), the teeth 1713 engage with the second rack 172B and are disengaged. Next, while the first pinion gear 171A rotates by a predetermined angle α3 (for example, 45 degrees), the teeth 1714 engage with the first rack 172A and are disengaged.

  The gear ratio between the first pinion gear 171A and the first rack 172A is different from the gear ratio between the second pinion gear 171B and the second rack 172B. That is, the former gear ratio is smaller than the latter gear ratio.

  When the first first puncture is performed by the support portion 17 having such a configuration, the teeth 1712 of the first pinion gear 171 mesh with the first rack 172A, and when the second puncture is performed, the second puncture is performed. When the teeth 1713 of the pinion gear 171B are engaged with the second rack 172B and the final first puncture is performed, the teeth 1714 of the first pinion gear 171A are engaged with the first rack 172A. Thereby, the moving speed of the needle tip 351 in the horizontal direction can be changed, that is, the speed is low in the first puncture and the speed is high in the second puncture. Therefore, it is possible to form a puncture hole in the target puncture route R as much as possible.

  In the support portion 17, unlike the configuration of FIG. 38 (b), “tooth” is provided in the first pinion gear 171A in the range of the predetermined angle α2, and the second pinion gear in the range of the predetermined angles α1 and α3. “Tooth” may be provided in 171B.

<Seventh embodiment>
FIG. 39 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus of the present invention (seventh embodiment). FIG. 40 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus (seventh embodiment) of the present invention. FIG. 41 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus of the present invention (seventh embodiment). FIG. 42 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus (seventh embodiment) of the present invention. FIG. 43 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus of the present invention (seventh embodiment). FIG. 44 is a view (a view seen from the patient's leg side) for explaining the operation procedure of the puncture apparatus of the present invention (seventh embodiment). FIG. 45 is a diagram (a diagram viewed from the patient's leg side) for explaining the operation procedure of the puncture device of the present invention (seventh embodiment). FIG. 46 is a view for explaining the operation procedure of the puncture apparatus (seventh embodiment) of the present invention (viewed from the patient's leg side). FIG. 47 is a diagram showing an operating state of the support portion provided in the puncture device (seventh embodiment) of the present invention.

  Hereinafter, the seventh embodiment of the puncture device and puncture method of the present invention will be described with reference to these drawings, but the description will focus on the differences from the above-described embodiments, 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 support portion that supports the puncture member is different.

  As shown in FIGS. 39 to 40, in the present embodiment, the support portion 17 supports the puncture member 3 </ b> E so as to reciprocate in the vertical direction while the puncture device 1 is being used while rotating around the shaft portion 73. can do.

  As shown in FIG. 47, the support portion 17 is fixedly provided on the shaft portion 73, is fixedly provided on the pinion gear 171 that rotates together with the shaft portion 73, and the gripping portion 21 of the frame 2, and the pinion gear 171 is attached. The first rack 172C and the second rack 172D are arranged to face each other. The first rack 172C and the second rack 172D are arranged slightly shifted in the moving direction of the pinion gear 171. Further, the first rack 172C and the second rack 172D are formed so that the total length of the tooth portions thereof is equal to the total length of the teeth 1711 of the pinion gear 171. 47 (a), 47 (b) and 47 (e), the state where the pinion gear 171 is engaged with the first rack 172C, and the pinion as shown in FIGS. 47 (c) and 47 (d). The state where the gear 171 meshes with the second rack 172D can be taken.

  By the support portion 17 having such a configuration, the puncture member 3E can be used for the first puncture (puncture in FIG. 39 → FIG. 40) and the second puncture (FIG. 40 → FIG. 41 → FIG. 42 → FIG. 43 → FIG. 44). Puncture) and first puncture (puncture in FIG. 44 → FIG. 45) are operated in order. Thereby, the locus drawn by the needle tip 351 of the puncture member 3E becomes the target puncture route R, and as a result, the puncture member 3E punctures the living body along the target puncture route R.

  The usage method (operation procedure) of the puncture apparatus 1 of this embodiment is demonstrated referring FIG. 39-FIG.

  As shown in FIG. 39, with the puncture device 1 in the wearing state, the needle tip 351 is applied to the body surface H of the right buttocks of the patient or a portion (first portion) in the vicinity thereof. At this time, the support portion 17 is in the state 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 rotated clockwise as shown in FIG. Let Thereby, the needle tip 351 of the puncture member 3E enters the body by puncturing the body surface H of the right buttocks on the right side of the patient or a portion in the vicinity thereof (first portion) with the first puncture, and reaches the closing hole 1101. .

  As shown in FIG. 41, when the rotation operation is further performed on the operation member 7, the second puncture is performed, and the puncture by the second puncture is performed. At this time, the support portion 17 is in the state shown in FIG.

As shown in FIG. 42, when the rotation angle of the operation member 7 is 45 degrees from the state shown in FIG. 39, the needle tip 351 passes between the urethra 1300 and the vagina 1400. At this time, the support portion 17 is in the state shown in FIG. 47C, and the pinion gear 171 is disengaged from the first rack 172C and meshes with the second rack 172D.
This is the puncture route obtained in the forward path.

  Thereafter, when the rotation operation is continued, the living body can be punctured by the second puncture until immediately before passing through the closing hole 1102, as shown in FIGS. At this time, the support portion 17 is in the state shown in FIG.

  Note that as the shaft portion 73 moves vertically upward, the puncture member 3E also moves in the same direction. Thereby, as shown in FIG. 44, the puncture member 3E lifts the urethra 1300 together with the urethra insertion member 4.

  As shown in FIG. 45, when the rotation angle of the operating member 7 reaches 90 degrees from the state shown in FIG. 39, the needle tip 351 passes through the closing hole 1102, and further, the left brim or its It reaches directly below the body surface H in the vicinity.

Then, when the rotation operation is further performed on the operation member 7, the needle tip 351 protrudes from the body surface H to the outside as shown in FIG. At this time, the support portion 17 is in the state shown in FIG.
This is the puncture route obtained on the return path.

  By the puncturing operation as described above, an arched puncture hole as close as possible to the target puncture route R is formed in the living body. Similarly to the first embodiment, this puncture hole is in a state of reliably passing between the urethra 1300 and the vagina 1400. Thus, also in the puncture apparatus 1 of this embodiment, when puncturing a living tissue, the puncture can be performed accurately.

<Eighth Embodiment>
FIG. 48 is a cross-sectional view showing an eighth embodiment of the puncture device of the present invention.

Hereinafter, an eighth embodiment of the puncture apparatus and puncture method 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 description of similar matters will be omitted.
This embodiment is the same as the first embodiment except that the configuration of the regulating member is different.

  As shown in FIG. 48, in the present embodiment, the restriction member 13 is provided such that the flange portion 132 moves along the axial direction of the restriction member 13 by screwing and can be stopped at that position. Thereby, according to a patient's body shape, the puncture depth made into the biological body of the control member 13 can be adjusted, and the distance of the said 1st puncture at the time of performing 1st puncture can be changed. For example, when the patient is thick, the first puncture can be performed as shown in FIG. On the other hand, when the patient is lean, the first puncture can be performed as shown in FIG.

  The flange portion 132 moves along the axial direction of the restricting member 13 by screwing as described above, and can be stopped at that position. However, a nut 134 is provided for more reliably maintaining the stop. Is preferred. After the flange portion 132 is stopped, the stop of the flange portion 132 can be more reliably maintained by tightening the nut 134 from above the flange portion 132. Further, if the nut 134 is loosened, the flange portion 132 can be moved.

<Ninth Embodiment>
FIG. 49 is a perspective view showing a puncture member provided in the puncture apparatus (9th embodiment) of the present invention. FIG. 50 is a cross-sectional view showing a modification of the puncture member shown in FIG.

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

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

  As shown in FIG. 49, in this embodiment, the needle body 35 is omitted from the puncture member 3A of the fifth embodiment described above. In a state where the insertion portion 71 is inserted into the puncture member 3 </ b> F (initial state), the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31. The tip 711 protruding from the main body 31 also serves as the needle tip of the puncture member 3F. Thus, when the distal end portion 711 of the insertion portion 71 also serves as the needle body of the puncture member 3F, for example, the number of members can be reduced as compared with the second embodiment described above. Further, if the puncture member 3F is punctured into the living body and the insertion portion 71 is removed from the puncture member 3F, the distal end side opening of the main body 31 can be opened. That is, according to the present embodiment, unlike the fifth embodiment described above, it is not necessary to remove the needle body 35 in order to open the distal end side opening of the main body 31, so that the surgery can be performed more smoothly. . Further, since the outer diameter of the insertion portion 71 and the inner diameter of the opening on the distal end side of the main body 31 are set to be substantially the same, the displacement of the insertion portion 71 with respect to the main body 31 is prevented, and the operability is improved.

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

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

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

  Moreover, the following structures are mentioned as a modification of this embodiment. As shown in FIG. 50, the puncture member 3F has a configuration in which the needle body 35 is omitted from the puncture member 3A of the fifth embodiment described above. In a state where the insertion portion 71 is inserted into the puncture member 3 </ b> F (initial state), the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31.

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

  The puncture device and puncture method of the present invention have been described above with respect to the illustrated embodiment. However, the present invention is not limited to this, and each part constituting the puncture device can be any arbitrary one that can exhibit the same function. It can be replaced with that of the configuration. The puncture device may be added with an arbitrary component, and the puncture method may be added with an optional step.

  Moreover, the puncture device and puncture method of the present invention may be a combination of any two or more configurations (features) of the above-described embodiments.

  In the fifth embodiment, the needle body is detachably held on the main body. However, the present invention is not limited to this, 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.

  Further, in the fifth embodiment, the configuration in which the main body is separable into the front end split piece and the base end split piece has been described. The structure which cannot be isolate | separated may be sufficient. That is, the main body may have a single tube shape. In this case, the state maintaining mechanism is also omitted.

  Further, in each of the embodiments described above, the configuration in which the implant body is inserted into the puncture member after the puncture member is disposed in the living body has been described. It may be. In this case, for example, it is preferable to fix the implant body to the needle tip.

  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 11 Puncture needle 111 Needle tip 112 Small piece 112a Small piece 113 Small piece connection part 114 Linear part 115 Marker 116 Flange part 117 Winding part 12 Connection member 121 Expanded part 122 Groove 13 Restriction member 131 Puncture part 132 Flange part 133 Projection Part 134 nut 14 curvature changing part 15 operation wire 151 gripping part 152 flange part 16 locking mechanism 161 compression coil spring 17 support part 171 pinion gear 171A first pinion gear 171B second pinion gear 1711 tooth 1712 tooth 1713 tooth 1714 tooth 172 rack 172A 1st rack 172B 2nd rack 172C 1st rack 172D 2nd rack 2 Frame 21 Grasping part 22 Guide part 224 Engaging part 23 Connecting part 24 Fixing part 243 Recessed part 244 Male screw 3A Puncturing member 3B Puncturing member 3C Puncture part 3D Puncture member 3E Puncture member 3F Puncture member 30 Sheath 31 Main body 314 Bending portion 315 Engagement hole 316 Engagement hole 317 Engagement hole 319 Taper portion 32 Tip split piece 321 Tip side opening 322 Base end side opening 33 Base End split piece 331 Front end side opening 332 Base end side 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 353 Engagement Joint part 37 Mounting part 4 Urethral insertion member 40 Support part 41 Urethral insertion part 411 Insertion part 412 Non-insertion part 42 Balloon 43 Balloon port 44 Aspiration hole 45 Aspiration port 46 Marker 47 Urine discharge part 471 Drainage hole 48 Urine discharge port 5 Vaginal insertion Member 50 Supporting part 501 Male screw 51 Vaginal insertion part 511 Insertion part 511 Upper surface 511b Lower surface 512 Non-insertion portion 53 Recessed portion 54 Suction port 57 Marker 59 Suction hole 6 Insertion tool 60 Support portion 7 Operating member 71 Insertion portion 711 Tip portion 712 Needle tip 712a Area gradually increasing portion 712b Area gradually decreasing portion 712c Boundary portion 72 Connecting portion 73 Shaft portion 9 Implant 91 Implant body 911 Body portion 912 Band 92 Wrapping material 1100 Pelvis 1101 Closure hole 1102 Closure hole 1200 Pubic joint 1300 Urethra 1310 Bladder 1400 Vagina 1410 Vaginal front wall 2000 Syringe A1 Inner periphery A2 Outer periphery A3 Surface A4 Back surface D Separation distance H Body surface J1 axis J2 axis J31 minor axis J32 major axis J32 ′ extension line J5 central axis f1 plane f2 plane f9 plane L2 length O center P intersection R target puncture path S1 area S2 area S3 space S4 center S5 safety Zone r1 Minimum radius of curvature r2 Maximum Rate radius W1 width W2 width θ1 inclination angle θ2 inclination angle θ3 inclination angle θ5 angle α1 angle α2 angle α3 angle

Claims (8)

A puncture member having a puncture needle that punctures a living tissue by bending and rotating, and a rotation shaft that is connected to the puncture needle and that serves as a rotation center of the puncture needle;
A puncture apparatus comprising: a support portion that supports the puncture member so as to be rotatable about the rotation axis and supports the movement in a direction orthogonal to the rotation axis.   2. The puncture device according to claim 1, wherein in the support portion, a direction orthogonal to the rotation axis is a horizontal direction or a vertical direction when the puncture device is in use.   The puncture device according to claim 1 or 2, wherein the support portion includes at least one pinion gear that is provided on the rotation shaft and rotates together with the rotation shaft, and at least one rack that meshes with the pinion gear. . In the support portion, in a use state of the puncture device, a direction orthogonal to the rotation axis is a vertical direction, and the puncture needle is reciprocated in the vertical direction.
The rack includes a first rack and a second rack disposed to face the first rack via the pinion gear,
The puncture apparatus according to claim 3, wherein the pinion gear meshes with one of the first rack and the second rack in the forward path and meshes with the other rack in the backward path. The pinion gear includes a first pinion gear and a second pinion gear disposed adjacent to the first pinion gear along the rotation axis.
The rack includes a first rack that meshes with the first pinion gear, and a second rack that meshes with the second pinion gear;
The puncture device according to claim 4, wherein a gear ratio between the first pinion gear and the first rack and a gear ratio between the second pinion gear and the second rack are different.   The said support part is comprised so that the 1st puncture with respect to the said puncture member and the 2nd puncture with a curvature larger than this 1st puncture may be performed in order. The puncture device according to item. The puncture device is used to place an implant between the urethral cavity and the vaginal cavity and to form a puncture hole for placing the implant in the living tissue prior to the placement,
The first puncture is performed until the needle tip of the puncture needle extends from the surface of the living body to the front of the one closed hole, and the needle tip of the puncture needle passes between the urethral cavity and the vaginal cavity from the front of the one closed hole. The puncture device according to claim 6, wherein the second puncture is performed until the second closed hole is passed through. A puncturing method for puncturing a biological tissue to form an arched puncture hole in the biological tissue,
A puncturing method, wherein puncturing is performed so that the curvature of the puncture hole changes along the longitudinal direction of the puncture hole in the process of puncturing the living tissue.

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