WO2014162434A1 - Puncture device - Google Patents

Puncture device Download PDF

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Publication number
WO2014162434A1
WO2014162434A1 PCT/JP2013/059899 JP2013059899W WO2014162434A1 WO 2014162434 A1 WO2014162434 A1 WO 2014162434A1 JP 2013059899 W JP2013059899 W JP 2013059899W WO 2014162434 A1 WO2014162434 A1 WO 2014162434A1
Authority
WO
WIPO (PCT)
Prior art keywords
puncture
anchor
main body
urethra
puncture member
Prior art date
Application number
PCT/JP2013/059899
Other languages
French (fr)
Japanese (ja)
Inventor
政克 川浦
奈央 横井
有浦　茂樹
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2013/059899 priority Critical patent/WO2014162434A1/en
Publication of WO2014162434A1 publication Critical patent/WO2014162434A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B17/06109—Big needles, either gripped by hand or connectable to a handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06042—Means for attaching suture to needle located close to needle tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06047—Means for attaching suture to needle located at the middle of the needle

Definitions

  • the present invention relates to a puncture device.
  • Urinary incontinence particularly stress urinary incontinence, urine leakage occurs due to abdominal pressure applied during normal exercise, laughing, coughing, sneezing, etc.
  • the cause of this is, for example, that the pelvic floor muscle, which is a muscle that supports the urethra, is loosened due to childbirth and the like.
  • Surgical therapy is effective for the treatment of urinary incontinence.
  • a band-like tissue-supporting indwelling material called a “sling”
  • the sling is placed in the body, and the sling supports the urethra (for example, Patent Document 1).
  • the operator incises the vagina with a scalpel, peels off the space between the urethra and the vagina, and uses the puncture needle or the like to connect the peeled portion and the outside through a closed hole. In such a state, the sling is left in the body.
  • vagina is incised, there is a risk that a sling may be exposed in the vagina from the wound generated by the incision, and there may be complications such as infection from the wound.
  • vagina since the vagina is incised, there is a disadvantage that the invasion is large and the burden on the patient is large.
  • the urethra or the like may be damaged during the procedure by the surgeon, and the surgeon himself may also damage the fingertip.
  • An object of the present invention is to provide a puncture device that can stably place an implant in a living body.
  • a puncture member having a long tubular body and a needle body provided at the distal end of the tubular body; A first anchor and a second anchor engageable with the tube; A holding portion for detachably holding the first anchor and the second anchor, When the puncture member punctures the first part of the living body and causes the needle tip to protrude out of the living body from a second part different from the first part, in this process, the first part of the tubular body is ex vivo.
  • a puncture device wherein the first anchor is engaged with a portion protruding to the outside, and the second anchor is engaged with a portion protruding from the second portion to the outside of the living body.
  • the second anchor has a claw portion that engages with the tubular body, and is held by the holding portion so that the claw portion faces a front side in a moving direction of the puncture member ( The puncture device according to 1).
  • the puncture member has a first engagement portion that engages with the first anchor, and a second engagement portion that engages with the second anchor, In an initial state where the puncture member is not punctured into the first part of the living body, the first anchor and the second engagement portion are engaged, When the puncture member punctures the first portion and causes the needle tip to protrude from the second portion to the outside of the living body, the engagement between the first anchor and the second engagement portion is released in this process.
  • the puncture device according to (1) or (2), wherein the first anchor and the first engaging portion are engaged, and the second anchor and the second engaging portion are engaged.
  • the puncture member is punctured into the living body from the first part, passes through one obturator hole, between the urethra and the vagina, and sequentially through the other obturator hole, and protrudes out of the living body from the second part.
  • the puncture device according to any one of (1) to (4).
  • the tube has at least a flat cross-sectional shape at the center in the longitudinal direction, When the puncture member is punctured into the living body, the central portion is located between the urethra and the vagina, and the long axis direction of the central portion is substantially parallel to the urethra (5
  • the puncture device according to any one of (8) to (8).
  • the tubular body includes a tip split piece for engaging the first anchor, and a base split piece connected to the base end side of the tip split piece for engaging the second anchor.
  • the puncture device according to any one of (1) to (9) above.
  • the puncture device according to any one of the above.
  • the first and second anchors engaged with the tubular body come into contact with the body surface with the puncture member punctured into the living body, so that the distal end and the proximal end of the tubular body are buried in the living body. Can be prevented.
  • both the distal end side opening and the proximal end side opening of the tubular body can be kept exposed to the outside of the living body. Therefore, the implant can be easily inserted into the tubular body, and the implant can be easily embedded in the living body by removing only the tubular body from the living body while the implant is placed in the tubular body. it can.
  • FIG. 1 is a perspective view showing a puncture apparatus according to a first embodiment of the present invention.
  • FIG. 2 is a side view of the puncture device shown in FIG.
  • FIG. 3 is a plan view showing an operation member of the puncture apparatus shown in FIG. 4A and 4B are diagrams showing a puncture member included in the puncture apparatus shown in FIG. 1, wherein FIG. 4A is a perspective view, and FIG. 4B is a cross-sectional view taken along line AA in FIG.
  • FIG. 5 is a cross-sectional view of the puncture member shown in FIG. 6A and 6B are diagrams showing a state maintaining mechanism included in the puncture member shown in FIG. 4A, wherein FIG. 6A is a top view, and FIGS.
  • FIG. 6B and 6C are cross-sectional views.
  • FIG. 7 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 3, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment.
  • It is. 8A and 8B are diagrams showing a second anchor included in the puncture device shown in FIG. 1, wherein FIG. 8A is a cross-sectional view and FIG. 8B is a cross-sectional view showing a state where the puncture member is engaged.
  • FIG. 9 is a view showing a first anchor of the puncture device shown in FIG. 1, wherein (a) is a cross-sectional view and (b) is a cross-sectional view showing a state where the puncture member is engaged.
  • FIG. 10 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG.
  • FIG. 11 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG.
  • FIG. 12 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG.
  • FIG. 13 is a cross-sectional view showing a modification of the puncture apparatus shown in FIG.
  • FIG. 14 is a plan view showing a frame fixing portion provided in the puncture apparatus shown in FIG. 1.
  • FIG. 15 is a side view of the insertion tool of the puncture device shown in FIG. FIG.
  • FIG. 16 is a diagram showing the positional relationship between the puncture member and the closing hole (pelvis), where (a) is a side view and (b) is a front view.
  • 17 is a partially enlarged view of a vaginal insertion member included in the insertion tool shown in FIG. 18A is a cross-sectional view showing an example of the shape of the vagina wall
  • FIG. 18B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG.
  • FIG. 19 is a view showing an implant used together with the puncture device shown in FIG. 20 (a) and 20 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIGS.
  • FIGS. 21A and 21B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • FIG. 22 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG.
  • FIGS. 23A and 23B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • FIG. 24 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG.
  • FIG. 25 is a cross-sectional view showing the posture of the puncture member with respect to the urethra in the state shown in FIG.
  • FIGS. 26A and 26B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • FIGS. 27A and 27B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG.
  • FIG. 28 is a perspective view showing a puncture member included in the puncture apparatus according to the second embodiment of the present invention.
  • FIG. 29 is a cross-sectional view showing a modification of the puncture member shown in FIG.
  • FIG. 30 is a perspective view showing a puncture member included in the puncture apparatus according to the third embodiment of the present invention.
  • FIG. 31 is a perspective view showing a puncture member included in the puncture apparatus according to the fourth embodiment of the present invention.
  • FIG. 32 is a perspective view showing a puncture member included in the puncture apparatus according to the fifth embodiment of the present invention.
  • FIG. 33 is a cross-sectional view showing a puncture member included in the puncture apparatus according to the sixth embodiment of the present invention.
  • FIG. 29 is a cross-sectional view showing a modification of the puncture member shown in FIG.
  • FIG. 30 is a perspective view showing a puncture member included in the puncture apparatus according to the third embodiment of the present invention.
  • FIG. 31 is a perspective
  • FIG. 34 is a view showing a puncture member included in the puncture apparatus according to the seventh embodiment of the present invention, in which (a) is a plan view and (b) and (c) are sectional views.
  • FIG. 35 is a cross-sectional view showing a puncture member included in the puncture apparatus according to the eighth embodiment of the present invention.
  • 36 is a cross-sectional view showing a modification of the puncture member shown in FIG.
  • FIG. 37 is a view showing a puncture member included in the puncture apparatus according to the ninth embodiment of the present invention, in which (a) is a plan view and (b) and (c) are sectional views.
  • FIG. 1 is a perspective view showing a puncture apparatus according to a first embodiment of the present invention.
  • FIG. 2 is a side view of the puncture device shown in FIG.
  • FIG. 3 is a plan view showing an operation member of the puncture apparatus shown in FIG. 4A and 4B are diagrams showing a puncture member included in the puncture apparatus shown in FIG. 1, wherein FIG. 4A is a perspective view, and FIG. 4B is a cross-sectional view taken along line AA in FIG.
  • FIG. 5 is a cross-sectional view of the puncture member shown in FIG.
  • FIGS. 6A and 6B are diagrams showing a state maintaining mechanism included in the puncture member shown in FIG. 4A, wherein FIG. 6A is a top view, and FIGS. 6B and 6C are cross-sectional views.
  • FIG. 7 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 3, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment.
  • It is. 8A and 8B are diagrams showing a second anchor included in the puncture device shown in FIG. 1, wherein FIG. 8A is a cross-sectional view and FIG. 8B is a cross-sectional view showing a state where the puncture member is engaged.
  • FIG. 8A is a cross-sectional view
  • FIG. 8B is a cross-sectional view showing a state where the puncture member is engaged.
  • FIG. 9 is a view showing a first anchor of the puncture device shown in FIG. 1, wherein (a) is a cross-sectional view and (b) is a cross-sectional view showing a state where the puncture member is engaged.
  • FIG. 10 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG.
  • FIG. 11 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG.
  • FIG. 12 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG.
  • FIG. 13 is a cross-sectional view showing a modification of the puncture apparatus shown in FIG. FIG.
  • FIG. 14 is a plan view showing a frame fixing portion provided in the puncture apparatus shown in FIG. 1.
  • FIG. 15 is a side view of the insertion tool of the puncture device shown in FIG.
  • FIG. 16 is a diagram showing a positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view.
  • 17 is a partially enlarged view of a vaginal insertion member included in the insertion tool shown in FIG. 18A is a cross-sectional view showing an example of the shape of the vagina wall
  • FIG. 18B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG.
  • FIG. 19 is a view showing an implant used together with the puncture device shown in FIG. 20 (a) and 20 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • FIGS. 21A and 21B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • FIG. 22 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG.
  • FIGS. 23A and 23B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • FIG. 24 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG.
  • FIG. 25 is a cross-sectional view showing the posture of the puncture member with respect to the urethra in the state shown in FIG.
  • FIGS. 26A and 26B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • FIGS. 27A and 27B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • 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”.
  • the puncture member extending in an arc shape is illustrated as being linearly extended for convenience of explanation.
  • Puncture device 1 shown in FIG. 1 and FIG. 2 is a device used when embedding a living tissue supporting indwelling material for treatment of female urinary incontinence, that is, treatment of urinary incontinence.
  • the puncture device 1 includes a frame (support portion) 2, a puncture member 3, a urethral insertion member 4, a vaginal insertion member 5, an operation member 7, and anchors 81 and 82.
  • the member 4, the vaginal insertion member 5, the operation member 7, and the anchors 81 and 82 are supported.
  • the urethral insertion member 4 and the vagina insertion member 5 constitute an insertion tool 6.
  • the operation member 7 is a member for operating the puncture member 3. As shown in FIGS. 1 to 3, the operation member 7 has an insertion portion 71, a shaft portion 73, and a connecting portion 72 that connects the insertion portion 71 and the shaft portion 73.
  • the insertion portion 71, the coupling portion 72, and the shaft portion 73 may be integrally formed, or at least one portion may be formed as a separate body from other portions.
  • the insertion portion 71 is a part that is inserted into the puncture member 3 and functions as a stylet that reinforces the puncture member 3 from the inside.
  • the puncture member 3 is connected to the operation member 7, whereby the operation member 7 can be operated by the operation member 7.
  • Such an insertion portion 71 has an arc shape corresponding to the shape of the puncture member 3.
  • the central angle of the insertion portion 71 is set according to the central angle of the puncture member 3.
  • the distal end portion 711 of the insertion portion 71 is tapered. By having the tapered tip end portion 711, the puncture member 3 can be smoothly inserted into the insertion portion 71.
  • the shaft portion 73 intersects the center O of the insertion portion 71 and extends along an axis J1 orthogonal to the plane f1 including the insertion portion 71.
  • the connecting portion 72 connects the proximal end portion of the insertion portion 71 and the distal end portion of the shaft portion 73. Moreover, the connection part 72 has comprised the substantially L shape bent in the substantially right angle in the middle. Such a connecting portion 72 also functions as a gripping portion that the operator grips when operating the operation member 7.
  • Such an operation member 7 is configured to have higher rigidity than the puncture member 3 (main body 31).
  • the constituent material of the operation member 7 is not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy can be used.
  • the puncture member 3 is a member for puncturing a living body.
  • the puncture member 3 has a long main body (tubular body) 31 and a needle body 35 provided at the tip of the main body 31, as shown in FIG.
  • 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 an implant main body (strip-shaped elongated object) 91 can be inserted.
  • the main body 31 has a curved shape curved in an arc shape, and has a flat cross-sectional shape as shown in FIG.
  • the cross-sectional shape at the central portion S4 in the longitudinal direction of the main body 31 is a flat shape including the short axis J31 and the long axis J32.
  • an implant main body 91 is disposed in the main body 31.
  • the posture within the main body 31 of the implant main body 91 can be controlled by making the main body 31 into a flat shape.
  • the width of the internal space of the main body 31 is designed to be substantially the same as the width of a main body portion 911 described later of the implant main body 91.
  • 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.
  • the end located on the inner side in the long axis direction is also referred to as “inner peripheral part A1”, and the end located on the outer side is also referred to as “outer peripheral part 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”.
  • 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 is defined as a plane f9.
  • the angle formed between the plane f9 and the short axis J31 at the central portion S4 is defined as an inclination angle ⁇ 1
  • the inclination angle ⁇ 1 is preferably an acute angle.
  • the inclination angle ⁇ 1 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 ⁇ 1 preferably satisfies the above numerical range over the entire extending direction of the main body 31, but at least satisfies the above numerical range at the central portion S4 in the extending direction of the main body 31.
  • the “central portion S4” refers to a region including at least a portion located between the urethra and the vagina in a state where the puncture member 3 is punctured into a living body.
  • the center part (center and the vicinity of both sides) between the anchors 81 and 82 is the center part S4 in a state where the anchors 81 and 82 are engaged with the puncture member 3 as described later. .
  • markers are provided at both ends of the main body 31 at positions that are equal from the central portion S4 and project outside the living body when the main body 31 is disposed on the living body (state shown in FIG. 23). Also good. Thereby, the position in the living body of center part S4 can be confirmed by comparing the position of both markers.
  • the configuration of the main body 31 can be rephrased as follows. That is, as shown in FIG. 4B, the main body 31 is formed such that the major axis J32 is inclined with respect to the arc central axis J5, and an extension line J32 between the arc central axis J5 and the major axis J32. It can be said that 'is configured to have an intersection P. In this case, the angle ⁇ 5 formed by the central axis J5 and the extension line J32 ′ is equal to the inclination angle ⁇ 1. In other words, as shown in FIG.
  • the main body 31 is an inner peripheral portion having a minimum radius of curvature r ⁇ b> 1 located at the inner peripheral edge in a plan view when viewed from the central axis J ⁇ b> 5 direction of the main body 31.
  • Such a main body 31 is composed of two divided pieces so that it can be divided along the way. 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.
  • the distal end split piece 32 has a tubular shape and has a distal end side opening 321 and a proximal end side opening 322.
  • the base end split piece 33 also has a tubular shape, and has a front end side opening 331 and a base end side opening 332. And the front-end
  • the split pieces 32 and 33 may be connected by inserting the tip split piece 32 into the base end split piece 33.
  • the main body 31 is provided with a state maintaining mechanism 34 for maintaining the state where the divided pieces 32 and 33 are connected.
  • the state maintaining mechanism 34 exposes the holes 342a, 342b, 342c, an endless thread (connecting member) 341 inserted through the holes 342a, 342b, 342c, and the thread 341. Exposure holes 345 and 346 to be exposed, and slits 347 connecting the exposure holes 345 and 346.
  • the hole 342a is a base end portion of the base end split piece 33 and is provided near the inner peripheral portion A1 of the surface A3.
  • the holes 342b and 342c are the base end portions of the tip split piece 32, and are provided facing the inner peripheral portion A1 of the front surface A3 and the back surface A4.
  • the yarn 341 is disposed in the main body 31 and is 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.
  • the yarn 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.
  • 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 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.
  • the position of the knot is not limited.
  • the hole 342a has an axis inclined so that the outer opening is located closer to the base end side than the inner opening.
  • the holes 342b and 342c each have an inclined axis so that the outer opening is located at the tip of the inner opening.
  • 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.
  • part in which the exposure holes 345 and 346 are provided protrudes from the body surface in the state which has arrange
  • 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.
  • the exposure holes 345 and 346 are connected by a slit 347 provided in the inner peripheral portion A1.
  • the thread 341 can be easily cut by providing the exposure holes 345 and 346 and the slit 347 as in the present embodiment.
  • a scissors having a pair of blades first blade and second blade
  • the first blade is inserted into the exposure holes 345 and 346
  • the thread 341 is positioned between the pair of blades.
  • 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.
  • the thread 341 can be easily cut.
  • the slit 347 is provided, and the slit 347 is used as a passage path of the blade. Thereby, the deformation of the main body 31 due to the tension of the yarn 341 is prevented.
  • the passage route of the blade may be replaced by a slit 347 and configured by a hole 348.
  • the hole 348 may be buckled and crushed by the tension of the thread 341, and the main body 31 may be deformed.
  • the slit 347 since the portions 347a and 347b sandwiching the slit 347 are in contact and stretched, as shown in FIG. 7C, the above-described deformation does not occur and the main body 31 is not deformed. Is prevented.
  • a pair of engagement holes 315 and 316 that engage with the anchor 81 are provided at the distal end portion of the main body 31.
  • a pair of engagement holes 317 and 318 that engage with the anchor 82 are provided at the base end portion of the main body 31.
  • the engagement holes 315 and 317 are provided in the inner peripheral portion A1
  • the engagement holes 316 and 318 are provided in the outer peripheral portion A2.
  • the main body 31 has a flat shape and is not easily crushed in the long axis direction, so that the separation distance between the inner peripheral portion A1 and the outer peripheral portion A2 is difficult to change. Further, the inner peripheral portion A1 and the outer peripheral portion A2 have large curvatures and are not easily deformed compared to the front surface A3 and the rear surface A4. Therefore, by providing the engagement holes 315 and 317 in the inner peripheral portion A1 and the engagement holes 316 and 318 in the outer peripheral portion A2, the engagement between the anchors 81 and 82 and the main body 31 is difficult to be released.
  • the separation distance between the engagement holes 315 and 316 and the central portion S4 is substantially equal to the separation distance between the engagement holes 317 and 318 and the central portion S4.
  • a needle body 35 is provided at the tip of the main body 31 as described above.
  • 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.
  • the base end portion 352 is provided with an engaging portion 353 that engages with the distal end portion 711 of the insertion portion 71.
  • the engaging portion 353 is configured by a concave portion, and the distal end portion 711 is positioned in the engaging portion 353 in the inserted state in which the puncture member 3 is inserted into the inserting portion 71.
  • the puncture member 3 has been described above.
  • the central angle ⁇ 4 of the puncture member 3 is not particularly limited and is appropriately set according to various conditions.
  • the needle body 35 enters the body from one of the buttocks of the patient, and the urethra It is set so that it can pass between the vagina and protrude from the other buttocks.
  • the central angle ⁇ 4 is preferably 150 to 270 °, more preferably 170 to 250 °, and further preferably 190 to 230 °.
  • a hard material that maintains the shape and internal space in a state of being inserted into the body is preferable.
  • 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.
  • the wall can be reinforced by a reinforcing member.
  • the shape and the internal space can be maintained while being inserted into the body.
  • 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 main body 31 has light permeability and the inside can be visually recognized from the outside. Thereby, for example, it is possible to confirm whether the distal end portion 711 of the insertion portion 71 inserted inside is engaged with the engagement portion 353 or whether the thread 341 is not cut.
  • the 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 tip split piece 32 and the base end split piece 33 can be maintained by the thread 341.
  • 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.
  • 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.
  • the thread 341 includes a string, a band, and the like that can be used in the same manner as the thread 341.
  • an anchor (second anchor) 81 includes a base portion 811 having an insertion hole 812 through which the puncture member 3 (main body 31) is inserted, a base portion 811 and a pair of engagement holes 315, A pair of claw portions 813 and 814 that engage with 316 are provided.
  • the cross-sectional shape of the insertion hole 812 corresponds to the cross-sectional shape of the puncture member 3 (main body 31). Therefore, in a state where the puncture member 3 is inserted through the insertion hole 812, the rotation of the anchor 81 with respect to the puncture member 3 is restricted, and these positional relationships are appropriately maintained.
  • the claw portions 813 and 814 engage with the engagement holes 315 and 316 as shown in FIG.
  • the anchor 81 is engaged with the puncture member 3 (the tip split piece 32).
  • the base portion 811 is located on the proximal end side with respect to the claw portions 813 and 814.
  • the rotation of the anchor 81 with respect to the puncture member 3 is restricted, so that the engagement between the claw portions 813 and 814 and the engagement holes 315 and 316 is ensured. Can be expressed.
  • the anchor (first anchor) 82 has a base portion 821 having an insertion hole 822 through which the puncture member 3 is inserted, and protrudes from the base portion 821, and a pair of engagement holes 317 and 318. And a pair of claw portions 823 and 824 that engage with each other.
  • the cross-sectional shape of the insertion hole 822 corresponds to the cross-sectional shape of the puncture member 3. Therefore, in a state where the puncture member 3 is inserted through the insertion hole 822, the rotation of the anchor 82 with respect to the puncture member 3 is restricted, and these positional relationships are appropriately maintained.
  • the puncture member 3 When the puncture member 3 is inserted into the insertion hole 812 and the puncture member 3 is pushed forward against the anchor 82, the claws 823 and 824 engage with the engagement holes 317 and 318 as shown in FIG. 9B. As a result, the anchor 82 is engaged with the puncture member 3 (base end split piece 33). In the engaged state, the base portion 821 is located on the tip side of the claw portions 823 and 824. As described above, when the puncture member 3 is inserted into the insertion hole 822, the rotation of the anchor 82 with respect to the puncture member 3 is restricted, so that the engagement between the claw portions 823 and 824 and the engagement holes 317 and 318 is ensured. Can be expressed.
  • the constituent materials of the anchors 81 and 82 are not particularly limited, and various resin materials can be used, for example.
  • the frame 2 rotatably holds the operation member 7 to which the puncture member 3 is attached, and fixes the insertion tool 6 and the anchors 81 and 82 in a detachable manner.
  • the frame 2 has a function of determining a puncture route of the needle body 35 when the puncture member 3 punctures a living tissue.
  • the frame 2 is configured so that when the puncture member 3 punctures a living tissue, the needle body 35 passes between the urethra insertion member 4 and the vagina insertion member 5 without colliding with them. 3.
  • the positional relationship between the urethral insertion member 4 and the vaginal insertion member 5 is defined.
  • the frame 2 guides the bearing portion 21 that supports the shaft portion 73 of the operation member 7 and the puncture member 3 and detachably holds the first and second anchors 81 and 82.
  • a guide portion (holding portion) 22 a connecting portion 23 that connects the bearing portion 21 and the guide portion 22, and a fixing portion 24 to which the insertion tool 6 is fixed.
  • the bearing portion 21 is located on the proximal end side of the puncture device 1 and extends in a direction substantially orthogonal to the axis J1.
  • a through hole 211 is formed on the shaft J1 of the bearing portion 21, and the shaft portion 73 is rotatably inserted into the through hole 211.
  • the operation member 7 is supported on the frame 2 in a state of being rotatable about the axis J1.
  • the guide portion 22 is located on the distal end side of the puncture device 1 and is disposed to face the bearing portion 21. As shown in FIG. 10, the guide portion 22 is formed with a substantially C-shaped (arc-shaped) guide groove 221 that accommodates the puncture member 3 and guides the puncture member 3. Further, as shown in FIG. 11, in the state of being placed in the guide groove 221, the puncture member 3 has the back surface A4 positioned on the distal end side and the surface A3 positioned on the proximal end side.
  • the guide part 22 is holding the anchors 81 and 82 so that attachment or detachment is possible.
  • the anchor 82 is held facing the front end side opening 222 so that the insertion hole 822 is continuous with the guide groove 221, and the anchor 81 is guided by the guide groove 221 so that the insertion hole 812 is continuous with the guide groove 221. Is held opposite to the base end side opening 223.
  • the main body 31 is inserted into the insertion hole 822 of the anchor 82, and the needle body 35 projects from the guide portion 22.
  • the puncture member 3 gradually protrudes from the guide portion 22, and finally, the needle body 35 enters the guide portion 22 through the proximal end opening 223 as shown in FIG. .
  • the puncture member 3 passes through the insertion hole 812 of the anchor 81 on the distal end side of the puncture member 3, and the claw portions 813 and 814 engage with the engagement holes 315 and 316.
  • the claw portions 823 and 824 are engaged with the engagement holes 317 and 318 on the proximal end side of the puncture member 3.
  • the anchors 81 and 82 are engaged with the puncture member 3.
  • the claw portions 813 and 814 of the anchor 81 are inclined toward the front side in the moving direction of the puncture member 3. Therefore, when the puncture member 3 is inserted into the anchor 81, the claw portions 813 and 814 and the puncture member 3 are prevented from being caught, and the puncture member 3 slides between the claw portions 813 and 814 while smoothly moving between them. Can be moved to.
  • the direction of the anchor 82 is not particularly limited, and the claw portions 813 and 814 may face the rear side in the moving direction of the puncture member 3, contrary to the present embodiment.
  • the puncture member 3 has already been inserted into the anchor 82 in the initial state and is positioned on the proximal end side of the engagement holes 315 and 316. That is, the claw portions 823 and 824 of the anchor 82 are in an expanded state (the claw portions 823 and 824 are elastically deformed), the claw portions 823 and 824 are distorted, and the elastic force (restoration) of the claw portions 823 and 824 is restored. May decrease. Therefore, as shown in FIG. 13, the claws 823 and 824 of the anchor 82 may be engaged with the engagement holes 315 and 316 of the puncture member 3 in the initial state. By doing in this way, the deformation amount of the nail
  • the claws of the anchor 81 when the state shown in FIG. The engagement between the portions 813 and 824 and the engagement holes 315 and 316 can be performed firmly.
  • the connecting portion 23 connects the bearing portion 21 and the guide portion 22. Further, the connecting portion 23 has a rod shape extending substantially parallel to the axis J1. The connecting portion 23 also functions as a grasping portion, and an operator can use the puncture apparatus 1 by grasping the connecting portion 23.
  • the fixing part 24 is arranged to face the connecting part 23 via the axis J1.
  • 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.
  • the insertion tool 6 includes a urethral insertion portion (second insertion portion) 41 to be inserted into the urethra, and a vaginal insertion portion (first insertion portion) 51 to be inserted into the vagina. And a support portion 60 that supports the urethral insertion portion 41 and the vaginal insertion portion 51.
  • 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.
  • the urethral insertion member 4 and the vagina insertion member 5 are detachable via the support portions 40 and 50.
  • the urethral insertion member 4 and the vaginal insertion member 5 will be described in order.
  • the urethral insertion member 4 has a long urethral insertion portion 41 that is inserted into the urethra halfway and a support portion 40 that supports the urethral insertion portion 41.
  • a portion located in the urethra (including the bladder) in the attached state is also referred to as an “insertion portion 411”, and is a portion exposed outside the body from the urethral opening in the attached state.
  • a portion up to the support portion 40 is also referred to as a “non-insertion portion 412”.
  • the urethra insertion part 41 has a straight tubular shape with a rounded tip.
  • 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.
  • the puncture device 1 when used, the balloon 42 is expanded after being inserted into the patient's bladder. And the position of the urethral insertion member 4 with respect to a bladder and a urethra is fixed by the expanded balloon 42 being caught in a bladder neck.
  • the urine discharge unit 47 is used to discharge urine in the bladder.
  • the balloon 42 passes through the urethra insertion part 41 and is connected to a balloon port 43 provided at the base end thereof.
  • a balloon expansion device such as a syringe can be connected to the balloon port 43.
  • the working fluid liquid such as physiological saline, gas, etc.
  • the balloon 42 expands.
  • the working fluid is extracted from the balloon 42 by the balloon expanding device, the balloon 42 contracts.
  • FIG. 15 the state in which the balloon 42 is deflated is indicated by a two-dot chain line, and the state in which the balloon 42 is expanded is indicated by a solid line.
  • 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.
  • These balloon 42 and urine discharge part 47 can be constituted by a double lumen, for example.
  • a plurality of suction holes 44 are formed in the middle of the 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 urethral insertion portion 41.
  • a suction device such as a pump can be connected to the suction port 45.
  • 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.
  • a marker 46 for confirming the insertion depth of the urethra insertion part 41 into the urethra 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 urethral insertion portion 41 is inserted into the urethra and the balloon 42 is located in the bladder. Thereby, the insertion depth to the urethra 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
  • the length of the insertion portion 411 is not particularly limited, and is appropriately set depending on the length of the patient's urethra, the shape of the bladder, and the like. Since the length of a typical female urethra is about 30 to 50 mm, it is more preferably about 50 to 100 mm.
  • the length of the non-insertion portion 412 (the separation distance between the urethral opening and the support portion 40) is not particularly limited, but is preferably about 100 mm or less, and more preferably about 20 to 50 mm. Thereby, the non-insertion part 412 can be made into appropriate length, and operativity improves. If the length of the non-insertion portion 412 exceeds the upper limit, depending on the configuration of the frame 2, the center of gravity of the puncture device 1 is greatly separated from the patient, and the stability of the puncture device 1 in the worn state is reduced. There is a case.
  • the constituent material of the urethral insertion member 4 is not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials can be used.
  • the inclination angle ⁇ 2 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 to 40 °.
  • the main body 31 is preferably placed in the body so that the angle between the plane f9 and the plane orthogonal to the axis of the urethra is about 20 to 60 °, and the body 31 is about 30 to 45 °. It is more preferable to be indwelled in the body, and it is more preferable to be indwelled in the body so as to be about 35 to 40 °. Thereby, the puncture of the puncture member 3 can be easily performed, and the puncture distance by the puncture member 3 can be further shortened.
  • the puncture member 3 can widely grasp the left and right closure holes 1101 and 1102 of the pelvis 1100 in a plane as shown in FIG. It is possible to secure a wide puncture space for the puncture member 3. That is, the puncture member 3 can be punctured in a relatively vertical direction with respect to the closing holes 1101 and 1102 in a state where the patient is in a predetermined body position (crushed stone position). Therefore, the puncture member 3 can be punctured easily. In addition, since the puncture member 3 is punctured in a relatively vertical direction with respect to the closure holes 1101 and 1102, the needle body 35 of the puncture member 3 passes through the shallow portion of the tissue.
  • the puncture member 3 can pass through the closure holes 1101 and 1102 near the pubic joint 1200, preferably through the safety zone S5. Since the safety zone S5 is a site where there are few nerves and blood vessels to avoid damage, the puncture member 3 can be punctured safely. Therefore, it becomes less invasive and can reduce the burden on the patient. As described above, by setting the inclination angle ⁇ 2 within the above range, the patient can puncture the puncture member 3 more appropriately. In addition, puncturing at the above-described angle makes it easy to target the tissue between the middle urethra and the vagina that indicate the middle portion in the length direction of the urethra. Between the middle urethra and the vagina is a position suitable as a site for implanting the implant 9 and treating urinary incontinence.
  • the puncture member 3 planarly closes the closing holes 1101 and 1102 depending on individual differences in the patient, the posture during the procedure, and the like. There are cases where it is not possible to capture widely or the puncture route cannot be shortened sufficiently.
  • the puncture between the middle urethra and the vagina is facilitated by puncturing the urethra or the vagina, and both the urethra and the vagina in a position shifted so as to be pushed into the body.
  • the urethra insertion member 4 and / or the vagina insertion member 5 is inserted in an appropriate position, and a suction hole 44, which will be described later, is provided in the urethra and the vagina.
  • the urethral insertion member 4 and / or the vagina insertion member 5 can be further moved to the inside of the body along the respective axes to a predetermined position.
  • the main body 31 is punctured perpendicularly to the left and right closure holes 1101 and 1102 of the pelvis in a state where the position is shifted so as to push at least one of the urethra and the vagina into the inside of the body.
  • the passage can be formed at a position suitable for the above.
  • the trajectory of the main body 31 is set so as to pass through the safety zones S5 of the left and right closure holes 1101 and 1102 of the pelvis, and at least one of the urethra and vagina is inward of the body so that the trajectory is located between the middle urethra and the vagina. It is preferable to shift and puncture the main body 31 along the track to form a passage.
  • the vaginal insertion member 5 includes a long vaginal insertion portion (first insertion portion) 51 that is inserted into the vagina partway and a support portion that supports the vaginal insertion portion 51. 50.
  • first insertion portion a portion located in the vagina in the wearing state
  • insertion portion 511 a portion located in the vagina in the wearing state
  • non-insertion portion 512 a portion exposed from the vaginal opening to the outside of the body in the wearing state up to the support portion 50. This portion is also referred to as “non-insertion portion 512”.
  • the insertion portion 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 and the vagina than when 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.
  • the inclination angle ⁇ 3 of the insertion portion 511 with respect to the insertion portion 411 is not particularly limited, but is preferably about 0 to 45 °, and more preferably about 0 to 30 °. Thereby, the said effect can be exhibited more notably.
  • the inclination angle ⁇ 3 is less than the above lower limit value or exceeds the above upper limit value, the vagina and urethra deform unnaturally in the wearing state depending on individual differences of patients, posture during the procedure, etc.
  • the puncture device 1 may not be stably held.
  • 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 and vagina). Further, the insertion portion 511 has a central portion having a substantially constant width and a rounded tip portion.
  • the length L2 of the insertion portion 511 is not particularly limited, but is preferably about 20 to 100 mm, and more preferably about 30 to 60 mm.
  • the width W1 of the insertion portion 511 is not particularly limited, but is preferably about 10 to 40 mm, more preferably about 20 to 30 mm.
  • 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 urethral insertion portion 41 side) 511a of the insertion portion 511.
  • the number of the recessed parts 53 is not specifically limited, For example, one may be sufficient.
  • 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.
  • the vaginal front wall which is the upper side of the vagina wall, is inserted into the insertion portion 511. Adsorbed and fixed.
  • 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 route of the puncture member 3 can be secured, and the puncture of the puncture member 3 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. And the needle point of the puncture member 3 passes between these area
  • the urethral posterior wall which is the lower side of the urethral wall, is adsorbed by the insertion portion 411.
  • the vagina front wall is adsorbed by the insertion portion 511.
  • the urethral wall and vaginal wall are more widely separated. Therefore, the puncture member 3 can be punctured more safely by passing the puncture member 3 through such a region.
  • the region S2 extends over substantially the entire width direction of the upper surface 511a.
  • the width W2 of the region S2 is not particularly limited, but is preferably about 9 to 39 mm, and more preferably about 19 to 29 mm.
  • the vaginal wall can be more reliably adsorbed to the insertion portion 511 without being greatly affected by the shape of the vagina wall.
  • some patients may have a vagina 1400 having a shape in which a part of the anterior vaginal wall 1410 hangs into the vagina. Even in such a case, if the width W2 is as described above, as shown in FIG.
  • the vaginal front wall 1410 can be more reliably separated from the urethra without being affected by the shape of the vagina 1400.
  • the vaginal anterior wall 1410 can be adsorbed so as to be further away from the urethra, and the living tissue between the urethral wall and the vagina wall can be broadened. Can be spread.
  • the insertion unit 511 is provided with a marker (puncture position confirmation unit) 57 that can confirm the puncture route of the puncture device 1, that is, the vaginal wall present on the upper surface of the position where the marker 57 exists.
  • the puncture device can be fixed to puncture between the urethral walls. Therefore, the operability and safety of the insertion tool 6 are improved.
  • the marker 57 is provided at least on the lower surface 511b of the insertion portion 511. Since the lower surface 511b is a surface that faces the vaginal opening side and is visible to the operator through the vaginal opening in the inserted state, by providing the marker 57 on the lower surface 511b, the puncture route of the puncture apparatus 1 can be more reliably performed. Can be confirmed. Further, the insertion depth of the insertion portion 511 into the vagina can also be confirmed.
  • 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 10 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, and 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.
  • various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials are used. Can do.
  • the configuration of the puncture device 1 has been described above.
  • the urethral insertion member 4 and the vagina insertion member 5 constituting the insertion tool 6 are configured to be detachable.
  • 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.
  • 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.
  • each part is fixed to the frame 2 so that the inclination angle ⁇ 2 is constant, but the present invention is not limited to this, and the inclination angle ⁇ 2 may be variable.
  • inclination-angle (theta) 2 can be adjusted according to a patient, it becomes the puncture apparatus 1 which is more convenient.
  • 19 is an implantable device for treating female urinary incontinence, that is, a device that supports the urethra, for example, the urethra is about to move to the vaginal wall side. Sometimes it is a device that supports the urethra so as to restrict its movement away from the vaginal wall. As this implant 9, for example, a long object having flexibility can be used.
  • the implant 9 has an implant main body 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.
  • contamination of the implant body 91 can be effectively prevented.
  • a guide wire, string, thread, or the like may be used instead of the band 912.
  • the main body portion 911 has a net shape, and the entire shape is a belt shape.
  • the main-body part 911 can be comprised, for example by what crossed the linear body and knit in the net shape, ie, a net-like braided body.
  • Examples of the linear body include a circular cross section, a flat cross section, that is, a strip.
  • the constituent materials of the main body 911, the band 912, and the packaging material 92 are not particularly limited.
  • various resin materials, fibers, and the like having biocompatibility such as polypropylene, polyester, and nylon can be used. .
  • the implant 9 is not limited to the net-like one as long as the same effect can be exhibited.
  • the patient is crushed on the operating table, and the insertion tool 6 is attached to the patient as shown in FIG. Specifically, first, the urethral insertion portion 41 of the urethral insertion 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 case of the present embodiment, the urethra is straightened by the straight urethra insertion part 41.
  • 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
  • the living body between the urethra and the vagina is determined from the body surface between the urethra and the vagina.
  • a space S3 for piercing the tissue with the syringe is formed.
  • a suction device is connected to the suction ports 45 and 54, the suction device is operated, the rear wall of the urethra is adsorbed to the urethral insertion portion 41, and the front wall of the vagina is adsorbed to the vaginal insertion portion 51.
  • the suction hole 44 is blocked by the urethra wall, so that suction from the suction port 45 is stopped or weakened.
  • the suction hole 59 is blocked by the vagina wall, so that suction from the suction port 54 is stopped or weakened.
  • 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.
  • 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
  • liquid peeling is performed. Specifically, as shown in FIG. 20B, the puncture needle of the syringe 2000 is punctured through the space (space S3) between the insertion portion 511 and the anterior wall of the vagina, and the urethra 1300 and the vagina 1400 are A liquid such as physiological saline or a local anesthetic is injected into the living tissue between the regions (between the regions S1 and S2). As a result, the living tissue between the regions S1 and S2 expands, the urethral posterior wall is pressed against the urethral insertion portion 41, and the vagina front wall is pressed against the vagina insertion portion 51.
  • space S3 space between the insertion portion 511 and the anterior wall of the vagina
  • a liquid such as physiological saline or a local anesthetic
  • the suction from the suction holes 44 and 59 it is preferable to continue the suction from the suction holes 44 and 59 even during the liquid peeling.
  • the rear wall of the urethra is pressed against the urethra insertion part 41 by liquid peeling, the rear wall of the urethra is further adsorbed by the urethra insertion part 41, so that suction from the suction port 45 is stopped or weakened.
  • the anterior vagina wall is pressed against the vagina insertion portion 51, the anterior vagina wall is further adsorbed by the vagina insertion portion 51, so that suction from the suction port 45 is stopped or weakened. Therefore, the operator can confirm whether or not the liquid separation has been properly performed based on the suction state from the suction ports 45 and 54.
  • the puncture apparatus 1 After liquid separation, the urethra posterior wall and the vagina anterior wall are sufficiently separated from each other, and then the frame 2 is fixed to the insertion tool 6 as shown in FIG. Thereby, the puncture apparatus 1 will be in the state with which the patient was mounted
  • the connecting portion 72 of the operating member 7 is held with the other hand, and the operating member 7 is held back as shown in FIG. Rotate clockwise.
  • the needle body 35 of the puncture member 3 punctures the body surface H of the right buttocks of the patient or a portion in the vicinity thereof (first portion) and enters the body, and the one closed hole 1101, the urethra 1300 and the vagina After passing through the other closing hole 1102 in order with the 1400, it projects out of the body surface H of the left buttocks or its vicinity (second part) and finally retracts into the guide part 22. (See FIG. 24).
  • the puncture member 3 is disposed in the living body, and the anchors 81 and 82 are engaged with the main body 31 according to the principle described above. Therefore, when the anchor 82 abuts on the body surface H, further insertion of the proximal end portion of the main body 31 into the living body is restricted. In other words, it is possible to ensure that the base end of the main body 31 is exposed to the outside of the living body.
  • the operation member 7 is rotated clockwise in FIG.
  • the puncture member 3 also tries to rotate counterclockwise together with the operation member 7, but when the anchor 81 comes into contact with the body surface H, further rotation (movement) is prevented. Therefore, the insertion portion 71 is removed from the puncture member 3 and the living body while maintaining the state where the tip of the main body 31 is exposed to the outside of the living body.
  • puncture device 1 member other than puncture member 3
  • needle body 35 is removed from main body 31.
  • FIG. 23B only the main body 31 is placed in the living body.
  • the main body 31 is disposed in the living body with both the distal end side opening and the proximal end side opening exposed to the outside of the living body.
  • the position of the main body 31 is adjusted as necessary. Specifically, the main body 31 is shifted to the proximal end side or the distal end side, and the positions of the anchors 81 and 82 with respect to the living body are symmetrical. Thereby, the center part S4 of the main body 31 can be positioned between the urethra 1300 and the vagina 1400 more reliably.
  • the central portion S4 is arranged such that its width direction (long axis direction of the transverse section) W is substantially parallel to the urethra 1300. That is, the width direction W of the urethra 1300, which is corrected by inserting the urethra insertion member 4 and the central portion S4, is located substantially in parallel.
  • the implant body 91 is inserted into the body 31 while being taken out from the packaging material 92, and as shown in FIG. 26 (a), the band 912 projects from the proximal end opening and the distal end opening of the body 31; To do.
  • contamination of the implant main body 91 can be prevented by accommodating the implant main body 91 in the packaging material 92 until immediately before being disposed in the main body 31.
  • the main body 31 has a flat shape
  • the posture of the main body portion 911 follows this flat shape. That is, as shown in FIG. 26B, the main body portion 911 is disposed in the main body 31 such that the width direction thereof matches the width direction of the main body 31. From the relationship with the urethra 1300, the implant body 91 is disposed in parallel with the corrected urethra 1300.
  • the thread 341 exposed from the exposure holes 345 and 346 is cut.
  • the main body 31 can be divided into the tip split piece 32 and the base split piece 33. Since the exposure holes 345 and 346 are located on the proximal end side with respect to the anchor 82, the exposure holes 345 and 346 are surely exposed to the outside of the living body. Therefore, the yarn 341 can be easily cut.
  • 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.
  • the tip split piece 32 and the base end split piece 33 are moved substantially simultaneously in opposite directions, and the tip split piece 32 and the base end split piece 33 are each moved in an arc shape along the shape thereof. Thereby, the main body 31 is smoothly removed from the living body.
  • the distal-end divided piece 32 and the proximal-end divided piece 33 are removed from the living body as described above, the surrounding tissue that has been spread by the main body 31 returns to the original position, and both end portions from the central portion of the implant main body 91 are restored.
  • the tissue gradually comes into contact with the implant body 91 toward the end.
  • the distal end divided piece 32 and the proximal end divided piece 33 are moved in the direction along the shape thereof, and the main body 31 has an internal space in which the implant main body 91 can move with a sufficiently low sliding.
  • 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.
  • 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.
  • the main body 31 can be easily removed from the living body by dividing the main body 31 and removing it from the living body. Further, since the main body 31 can be removed from the living body without removing the anchors 81 and 82 from the main body 31, the main body 31 can be easily removed. Further, according to such an extraction method, the divided pieces 32 and 33 being extracted hardly affect the posture of the main body 911 in the region between the urethra 1300 and the vagina 1400.
  • the urethra insertion member 4 is removed from the urethra 1300.
  • 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.
  • the puncture device 1 when the implant 9 is placed, it can be handled only by a minimally invasive technique such as puncture of the puncture member 3, and it is not necessary to perform a highly invasive incision or the like. Therefore, the burden on the patient is small and the safety of the patient is high. Further, since the implant body 91 can be embedded in parallel with the urethra 1300, the urethra 1300 can be supported in a wider area. Further, the puncture member 3 can puncture the living body while avoiding the urethra 1300 and the vagina 1400, and the puncture member 3 can be prevented from puncturing the urethra 1300 and the vagina 1400, which is safe. Further, it is possible to prevent the occurrence of complications such as the exposure of the implant 9 into the vagina from the wound created by the incision and the infection from the wound as in the case of the conventional incision of the vagina. It is possible to embed the implant 9 reliably.
  • FIG. 28 is a perspective view showing a puncture member included in the puncture apparatus according to the second embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
  • the puncture member 3A of the present embodiment is composed of a main body 31. That is, the puncture member 3A has a configuration in which the needle body 35 is omitted from the puncture member 3 of the first embodiment described above. Further, in a state (initial state) in which the insertion portion 71 is inserted into the puncture member 3, the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31. The tip 711 protruding from the main body 31 also serves as the needle tip of the puncture member 3A.
  • the distal end portion 711 of the insertion portion 71 also serves as the needle body of the puncture member 3A, for example, the number of members can be reduced as compared with the first embodiment described above.
  • the puncture member 3 is punctured into a living body and the insertion portion 71 is removed from the puncture member 3, the distal end side opening of the main body 31 can be opened.
  • 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.
  • 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.
  • 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.
  • the puncture member 3 ⁇ / b> A includes a sheath 30. That is, the puncture member 3A has a configuration in which the needle body 35 is omitted from the puncture member 3 of the first embodiment described above. Further, in a state (initial state) in which the insertion portion 71 is inserted into the puncture member 3, the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31.
  • the tip portion 711 is provided so as to be removable from the insertion portion 71 by screwing, fitting, or the like. Further, the distal end portion 711 has a needle tip 712 protruding from the distal end of the sheath 30.
  • the needle tip 712 has a flat shape following the sheath 30. Further, the needle tip 712 has an area gradually increasing portion 712a 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.
  • 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.
  • 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.
  • FIG. 30 is a perspective view showing a puncture member included in the puncture apparatus according to the third embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
  • the main body 31B of the puncture member 3B has a configuration in which a distal end divided piece 32 and a proximal end divided piece 33 are connected via a fragile portion.
  • the distal end divided piece 32, the proximal end divided piece 33, and the weakened portion 36 are integrally formed.
  • the configuration of the fragile portion 36 is not particularly limited as long as it is more brittle than the front end split piece 32 and the base end split piece 33 and can be easily broken.
  • it has a perforation 361 provided so as to go around the main body 31. It can be configured.
  • the fragile portion 36 is broken, and the distal divided piece 32 and the proximal divided piece are separated.
  • the piece 33 is separated. According to such a configuration, there is no overlap between the tip split piece 32 and the base end split piece 33 as in the first embodiment described above, and therefore there is a step at the boundary between the tip split piece 32 and the base end split piece 33. Therefore, the puncture of the puncture member 3B and the insertion of the implant main body 91 into the main body 31 can be performed smoothly.
  • the fragile portion 36 also serves as a state maintaining mechanism for maintaining the connection state between the distal end divided piece 32 and the proximal end divided piece 33, the state maintaining mechanism 34 as in the first embodiment described above may be omitted. it can. Therefore, the configuration of the puncture member 3B can be simplified.
  • FIG. 31 is a perspective view showing a puncture member included in the puncture apparatus according to the fourth embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
  • the state maintaining mechanism 34C included in the puncture member 3C of the present embodiment is further inserted into the state maintaining mechanism 34 of the first embodiment described above through holes 342d and 342e and holes 342d and 342e. And an endless thread (connecting member) 349.
  • the hole 342d is provided at the distal end portion of the base end split piece 33 and closer to the inner peripheral portion A1 of the surface A3.
  • the hole 342e is a proximal end portion of the distal end split piece 32 and is provided from the outer peripheral portion A2 of the surface A3.
  • the thread 349 is prepared, for example, as a thread with ends, and one end of the thread 349 is inserted into the main body 31 from the proximal end opening 332, pulled out of the main body 31 from the hole 342d, and inserted into the main body 31 from the hole 342e. 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.
  • the position of the knot is not limited.
  • the thread 349 is exposed to the outside of the main body 31 through the exposure holes 345 and 346 in the same manner as the thread 341. Therefore, similarly to the thread 341, it can be cut through the exposure holes 345 and 346.
  • the thread 349 By drawing the thread 349 in this way, the following effects can be exhibited. That is, in the first embodiment described above, the holes 342a, 342b, and 342c are all formed closer to the inner peripheral portion A1, and the yarn 341 is also drawn around from the inner peripheral portion A1. Therefore, contraction force is applied to the inner peripheral portion A1 side, and the main body 31 may be deformed so that the outer peripheral portion A2 side of the split pieces 32 and 33 is separated from each other.
  • a gap may be formed at the boundary between the divided pieces 32 and 33, or a large step may be formed, which may affect the puncture of the living body. Therefore, as in this embodiment, a hole 342d near the inner peripheral portion A1 of the base end split piece 33 and a hole 342e near the outer peripheral portion A2 of the tip split piece 32 are formed, and the thread 349 is drawn around them.
  • the deformation as described above can be suppressed, and the main body 31 can be maintained in a predetermined shape.
  • the state maintaining mechanism 34C uses the two yarns 341 and 349, but these yarns may be combined into one (yarn 341).
  • 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 342d, and inserted into the main body 31 from the hole 342e. It is obtained by pulling out from the hole 342b to the outside of the main body 31, inserting into the main body 31 from the hole 342c, pulling out from the hole 342a to the outside of the main body 31, and finally connecting to the other end in the vicinity of the proximal end opening 332.
  • FIG. 32 is a perspective view showing a puncture member included in the puncture apparatus according to the fifth embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
  • the state maintaining mechanism 34D included in the puncture member 3D omits the hole 342c from the state maintaining mechanism 34 according to the first embodiment described above, and uses an end-threaded thread 341.
  • the thread 341 is disposed in the main body 31. One end of the thread 341 protrudes from the hole 342a, and a knot 341a is formed at the protruding portion. The knot 341a has such a size that it cannot pass through the hole 342a.
  • the other end of the thread 341 protrudes from the hole 342b, and a knot 341b is formed at the protruding portion.
  • the knot 341b has such a size that it cannot pass through the hole 342b.
  • the state maintaining mechanism 34D maintains the connection state of the distal end divided piece 32 and the proximal end divided piece 33 by arranging the thread 341 in this way.
  • FIG. 33 is a cross-sectional view showing a puncture member included in the puncture apparatus according to the sixth embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
  • the state maintaining mechanism 34E of the puncture member 3E of the present embodiment is inserted into the holes 342f, 342g, 342h, 342i and the respective wires 342f, 342g, 342h, 342i, and has an elastic wire (line ) 39.
  • the holes 342f and 342g are provided in the axial direction at the distal end portion of the inner peripheral portion A1 of the proximal end split piece 33, and the holes 342h and 342i are axially provided at the proximal end portion of the inner peripheral portion A1 of the distal end split piece 32. It is provided side by side. Further, the holes 342f and 342h are overlapped, and the holes 342g and 342i are overlapped.
  • the wire 39 is drawn out of the main body 31 through the holes 342f and 342h and introduced into the main body 31 through the holes 342g and 342i. Thereby, the connection state of the division
  • the wire 39 is not particularly limited, and for example, a wire made of various metal materials such as stainless steel, a cobalt alloy, a nickel alloy, or a wire made of a piano wire can be used.
  • FIG. 34 is a view showing a puncture member included in the puncture apparatus according to the seventh embodiment of the present invention, in which (a) is a plan view, and (b) and (c) are sectional views.
  • the puncture member extending in an arc shape is linearly extended and illustrated.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
  • the state maintaining mechanism 34F included in the puncture member 3F of the present embodiment includes a hole 342a, a hole 352a provided in the proximal end portion 352 of the needle body 35, and a thread 341.
  • the thread 341 is disposed in the main body 31, is engaged with the needle body 35 by being inserted through the hole 352a, and is engaged with the proximal end split piece 33 by being inserted through the hole 342a.
  • the divided pieces 32 and 33 can be divided by cutting the yarn 341.
  • 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 through the base end side opening 332, pulled out of the main body 31 from the hole 342a through the hole 352a, and finally. It is obtained by tying the other end in the vicinity of the base end side opening 332.
  • FIG. 35 is a cross-sectional view showing a puncture member included in the puncture apparatus according to the eighth embodiment of the present invention.
  • 36 is a cross-sectional view showing a modification of the puncture member shown in FIG.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
  • the state maintaining mechanism 34G included in the puncture member 3G of the present embodiment includes holes 342j and 342k provided in the distal end divided piece 32, and protrusions 343a and 343b provided in the proximal end divided piece 33. , And a stylet (tube body) 344 inserted into the main body 31.
  • the holes 342j and 342k are formed to be divided into a front surface A3 and a back surface A4 of the base end portion of the tip split piece 32.
  • the protrusions 343a and 343b are formed separately on the front surface A3 and the back surface A4 of the distal end portion of the base end split piece 33.
  • the protrusion 343a is engaged with the hole 342j, and the protrusion 343b is engaged with the hole 342k.
  • the stylet 344 is inserted into the main body 31, and the stylet 344 regulates the inward displacement of the protrusions 343a and 343b. Even with such a configuration, the connection state of the split pieces 32 and 33 can be maintained. In the state maintaining mechanism 34G, the divided pieces 32 and 33 can be divided by pulling out the stylet 344 from the main body 31 so that the protrusions 343a and 343b can be displaced inward.
  • a hard material that can regulate the displacement of the protrusions 343a and 343b.
  • 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.
  • the wall can be reinforced with a reinforcing member.
  • the state maintaining mechanism 34G has the stylet 344, but the insertion portion 71 inserted into the main body 31 may also serve as the stylet 344 as shown in FIG. That is, the insertion portion 71 may be configured to restrict the inward displacement of the protrusions 343a and 343b.
  • FIG. 37 is a view showing a puncture member included in the puncture apparatus according to the ninth embodiment of the present invention, in which (a) is a plan view and (b) and (c) are sectional views.
  • the puncture member extending in an arc shape is linearly extended and illustrated.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
  • the state maintaining mechanism 34H included in the puncture member 3H includes a hole 342l provided in the tip split piece 32 and a wire 38 having elasticity.
  • the wire 38 has a distal end hook (claw portion) 381 hooked in the hole 342l at the distal end portion, and a proximal end hook (claw) hooked on the proximal end of the proximal end split piece 33 at the proximal end portion. Part) 382. Then, by hooking the tip hook 381 and the base end hook 382 to the hole 342l and the base end split piece 33, the connection state of the split pieces 32 and 33 can be maintained.
  • the divided pieces 32 and 33 are divided by pushing the wire 38 toward the distal end, retracting the distal hook 381 into the main body 31, and releasing the engagement between the distal hook 381 and the hole 342l. It will be in a state that can be.
  • the puncture apparatus according to the present invention has been described based on the illustrated embodiment. However, the present invention is not limited to this, and the configuration of each part may be replaced with an arbitrary configuration having the same function. Can do. In addition, any other component may be added to the present invention.
  • the needle body is detachably hold
  • a main body (tube body) and a needle body are integrally formed, etc.
  • the needle body may be fixed to the main body (tube body).
  • the puncture member is punctured into the living body, the needle body is protruded outside the living body, and then the needle body is cut using a scissors or the like to open the distal end side opening of the main body (tubular body). Can do.
  • the said embodiment demonstrated the case where the puncture apparatus of this invention was applied to the apparatus used when implanting the implantable implant for the treatment of female urinary incontinence in the living body, the puncture apparatus of this invention was demonstrated.
  • the use of is not limited thereto.
  • the present invention relates to excretion disorder (urinary urgency, frequent urination, urinary incontinence, stool incontinence, urinary retention, difficulty in urination, etc.), pelvic organ prolapse, cystovaginal fistula, urethral vagina Pelvic floor diseases including epilepsy, pelvic pain, etc. are included in the target of application.
  • Pelvic organ prolapse includes diseases such as cystocele, small intestinal aneurysm, rectal aneurysm, and uterine prolapse.
  • 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 bladder, vagina, uterus, intestine and the like.
  • Micro-movable tissues include bones, muscles, fascia, ligaments and the like.
  • pelvic floor disease it includes obturator fascia, coccyx fascia, proximal ligament, sacral uterine ligament, sacrospinous ligament, and the like.
  • procedures to connect hypermovable tissue to micromovable tissue include retropubic sling surgery, transobturator sling surgery (transobturator sling surgery, transobturator tape; TOT), transvaginal mesh surgery (Tension-free Vaginal Mesh; TVM), elevation using sacral uterine ligament (Uterosacral Ligament Suspension; USLS), fusion using sacrospinous ligament (Sacrospinous Ligament Fixation; SSLF), fusion using iliac coccyx fascia, tailbone Includes fusion using the fascia.
  • the puncture device of the present invention includes a puncture member having a tubular body having a long tubular shape, a needle body provided at a distal end portion of the tubular body, and a first anchor and a second anchor that can be engaged with the tubular body. And a holding part that detachably holds the first anchor and the second anchor, the puncture member punctures a first part of a living body, and the needle tip is a second part different from the first part
  • the first anchor engages with a portion of the tubular body protruding from the first portion to the outside of the living body, and the second portion protrudes from the second portion to the outside of the living body.
  • An anchor is configured to engage.
  • the puncture device of the present invention has industrial applicability.

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Abstract

This puncture device (1) is provided with: a puncture member (3) having an arcuate main body (31) and a needle body (35) disposed at the tip of the main body (35); a first and second anchor (81, 82) which can engage with the main body (31); and a guide unit (holding unit) (22) which detachably holds the first and second anchors (81, 82). This puncture device is configured such that the puncture member (31) punctures a first site of the body, and when the needle tip (35) protrudes to outside of the body from a second site different from the first site, the first anchor (81) engages with the portion of the main body (31) protruding from the first site to outside of the body, and the second anchor (82) engages with the portion that protrudes to outside of the body from the second site.

Description

穿刺装置Puncture device
　本発明は、穿刺装置に関するものである。 The present invention relates to a puncture device.
　尿失禁、特に、腹圧性尿失禁になると、通常の運動中や、笑い、咳、くしゃみ等により腹圧がかかることで、尿漏れが生じる。この原因は、例えば、出産等により、尿道を支える筋肉である骨盤底筋が緩むこと等が挙げられる。 Urinary incontinence, particularly stress urinary incontinence, urine leakage occurs due to abdominal pressure applied during normal exercise, laughing, coughing, sneezing, etc. The cause of this is, for example, that the pelvic floor muscle, which is a muscle that supports the urethra, is loosened due to childbirth and the like.
　尿失禁の治療には、外科的療法が有効であり、例えば、「スリング」と呼ばれる帯状の生体組織支持用留置物を用い、スリングを体内に留置し、そのスリングで尿道を支持する（例えば、特許文献１参照）。スリングを体内に留置するには、術者がメスで膣を切開し、尿道と膣の間を剥離し、穿刺針等を用いて、その剥離した部位と外部とを閉鎖孔を介し連通させる。そして、このような状態で、スリングを体内に留置する。 Surgical therapy is effective for the treatment of urinary incontinence. For example, using a band-like tissue-supporting indwelling material called a “sling”, the sling is placed in the body, and the sling supports the urethra (for example, Patent Document 1). In order to place the sling in the body, the operator incises the vagina with a scalpel, peels off the space between the urethra and the vagina, and uses the puncture needle or the like to connect the peeled portion and the outside through a closed hole. In such a state, the sling is left in the body.
　しかしながら、膣を切開してしまうと、その切開により生じた傷口からスリングが膣内に露出してしまう虞や、前記傷口から感染してしまう等の合併症が生じる虞がある。また、膣を切開するので、侵襲が大きく、患者への負担が大きいという欠点がある。また、術者による手技の最中に尿道等を損傷する虞があり、また、術者自身も指先を損傷する虞がある。 However, if the vagina is incised, there is a risk that a sling may be exposed in the vagina from the wound generated by the incision, and there may be complications such as infection from the wound. In addition, since the vagina is incised, there is a disadvantage that the invasion is large and the burden on the patient is large. In addition, there is a risk that the urethra or the like may be damaged during the procedure by the surgeon, and the surgeon himself may also damage the fingertip.
特開２０１０－９９４９９号公報JP 2010-99499 A
　本発明の目的は、生体内にインプラントを安定して留置することができる穿刺装置を提供することにある。 An object of the present invention is to provide a puncture device that can stably place an implant in a living body.
　このような目的は、下記（１）～（１５）の本発明により達成される。
　（１）　長尺管状をなす管体と、前記管体の先端部に設けられた針体とを有する穿刺部材と、
　前記管体に係合可能な第１アンカーおよび第２アンカーと、
　前記第１アンカーおよび前記第２アンカーを着脱自在に保持する保持部と、を備え、
　前記穿刺部材が生体の第１部位を穿刺し、前記針先を前記第１部位と異なる第２部位から生体外へ突出させると、この過程にて、前記管体の前記第１部位から生体外へ突出している部分に前記第１アンカーが係合し、前記第２部位から生体外へ突出している部分に前記第２アンカーが係合するよう構成されていることを特徴とする穿刺装置。 Such an object is achieved by the present inventions (1) to (15) below.
(1) a puncture member having a long tubular body and a needle body provided at the distal end of the tubular body;
A first anchor and a second anchor engageable with the tube;
A holding portion for detachably holding the first anchor and the second anchor,
When the puncture member punctures the first part of the living body and causes the needle tip to protrude out of the living body from a second part different from the first part, in this process, the first part of the tubular body is ex vivo. A puncture device, wherein the first anchor is engaged with a portion protruding to the outside, and the second anchor is engaged with a portion protruding from the second portion to the outside of the living body.
　（２）　前記第２アンカーは、前記管体に係合する爪部を有し、前記爪部が前記穿刺部材の移動方向の前方側に向くように、前記保持部に保持されている上記（１）に記載の穿刺装置。 (2) The second anchor has a claw portion that engages with the tubular body, and is held by the holding portion so that the claw portion faces a front side in a moving direction of the puncture member ( The puncture device according to 1).
　（３）　前記穿刺部材は、前記第１アンカーと係合する第１係合部と、前記第２アンカーと係合する第２係合部と、を有し、
　前記穿刺部材が生体の第１部位に穿刺されていない初期状態では、前記１アンカーと前記第２係合部が係合しており、
　前記穿刺部材が前記第１部位を穿刺し、前記針先を前記第２部位から生体外へ突出させると、この過程にて、前記第１アンカーと前記第２係合部との係合が解除され、前記第１アンカーと前記１係合部とが係合し、前記第２アンカーと前記第２係合部とが係合する上記（１）または（２）に記載の穿刺装置。 (3) The puncture member has a first engagement portion that engages with the first anchor, and a second engagement portion that engages with the second anchor,
In an initial state where the puncture member is not punctured into the first part of the living body, the first anchor and the second engagement portion are engaged,
When the puncture member punctures the first portion and causes the needle tip to protrude from the second portion to the outside of the living body, the engagement between the first anchor and the second engagement portion is released in this process. The puncture device according to (1) or (2), wherein the first anchor and the first engaging portion are engaged, and the second anchor and the second engaging portion are engaged.
　（４）　前記針体は、前記管体に対して離脱可能である上記（１）ないし（３）のいずれか１項に記載の穿刺装置。 (4) The puncture device according to any one of (1) to (3), wherein the needle body is detachable from the tube body.
　（５）　前記穿刺部材は、前記第１部位から生体に穿刺され、一方の閉鎖孔、尿道と膣との間、他方の閉鎖孔を順に通過し、前記第２部位から生体外へ突出する上記（１）ないし（４）のいずれか１項に記載の穿刺装置。 (5) The puncture member is punctured into the living body from the first part, passes through one obturator hole, between the urethra and the vagina, and sequentially through the other obturator hole, and protrudes out of the living body from the second part. The puncture device according to any one of (1) to (4).
　（６）　前記管体は、円弧状に湾曲する部分を有している上記（５）に記載の穿刺装置。 (6) The puncture device according to (5), wherein the tubular body has a curved portion.
　（７）　前記針体の移動経路を含む平面は、女性の尿道の軸を法線とする平面に対して２０°～６０°傾斜している上記（５）または（６）に記載の穿刺装置。 (7) The puncture device according to (5) or (6), wherein the plane including the moving path of the needle body is inclined 20 ° to 60 ° with respect to a plane having the normal axis of the female urethra as a normal line .
　（８）　前記尿道に挿入する尿道挿入部を有し、
　前記針体の移動経路を含む平面は、前記尿道挿入部の中心軸を法線とする平面に対して２０°～６０°傾斜している上記（５）または（６）に記載の穿刺装置。 (8) having a urethral insertion portion to be inserted into the urethra,
The puncture apparatus according to (5) or (6), wherein a plane including a movement path of the needle body is inclined by 20 ° to 60 ° with respect to a plane having a central axis of the urethral insertion portion as a normal line.
　（９）　前記管体は、少なくとも、長手方向の中央部での横断面形状が偏平形状であり、
　前記穿刺部材が生体へ穿刺された状態では、前記中央部が前記尿道と前記膣との間に位置し、かつ、前記中央部の長軸方向が前記尿道とほぼ平行となっている上記（５）ないし（８）のいずれか１項に記載の穿刺装置。 (9) The tube has at least a flat cross-sectional shape at the center in the longitudinal direction,
When the puncture member is punctured into the living body, the central portion is located between the urethra and the vagina, and the long axis direction of the central portion is substantially parallel to the urethra (5 The puncture device according to any one of (8) to (8).
　（１０）　前記管体は、前記第１アンカーを係合させる先端分割片と、前記先端分割片の基端側に接続され、前記第２アンカーを係合させる基端分割片とを有している上記（１）ないし（９）のいずれか１項に記載の穿刺装置。 (10) The tubular body includes a tip split piece for engaging the first anchor, and a base split piece connected to the base end side of the tip split piece for engaging the second anchor. The puncture device according to any one of (1) to (9) above.
　（１１）　前記穿刺部材は、前記先端分割片と前記基端分割片との接続状態を維持する状態維持機構を有している上記（１０）に記載の穿刺装置。 (11) The puncture device according to (10), wherein the puncture member has a state maintaining mechanism that maintains a connection state between the distal end divided piece and the proximal end divided piece.
　（１２）　前記状態維持機構は、前記管体に配置され、前記先端分割片と前記基端分割片とを接続する接続部材を有している上記（１１）に記載の穿刺装置。 (12) The puncture device according to (11), wherein the state maintaining mechanism includes a connecting member that is disposed on the tubular body and connects the distal end divided piece and the proximal end divided piece.
　（１３）　前記管体に挿入可能な長尺状をなし、前記管体よりも剛性が高い挿入部を備え、前記管体に前記挿入部を挿入した状態で用いられる上記（１）ないし（１２）のいずれか１項に記載の穿刺装置。 (13) The above-described (1) to (12), which has an elongated shape that can be inserted into the tubular body, has an insertion portion that is higher in rigidity than the tubular body, and is used in a state where the insertion portion is inserted into the tubular body ) The puncture device according to any one of the above.
　（１４）　前記挿入部の先端部は、前記針体と係合している上記（１３）に記載の穿刺装置。 (14) The puncture device according to (13), wherein a distal end portion of the insertion portion is engaged with the needle body.
　（１５）　尿道と膣との間にインプラントを留置して、骨盤内臓器における疾患の治療に用いられる上記（１）ないし（１４）のいずれか１項に記載の穿刺装置。 (15) The puncture device according to any one of (1) to (14), wherein an implant is placed between the urethra and the vagina to be used for treatment of a disease in an organ in the pelvis.
　本発明によれば、穿刺部材を生体に穿刺した状態で、管体に係合した第１、第２アンカーが体表面に当接するため、管体の先端および基端が生体内へ埋没することを防止することができる。言い換えると、管体の先端側開口および基端側開口が共に、生体外に露出した状態を維持することができる。そのため、管体内へのインプラントの挿入を容易に行うことができ、管体内にインプラントを配置した状態で、管体のみを生体から抜去することで、簡単に、インプラントを生体内に埋設することができる。 According to the present invention, the first and second anchors engaged with the tubular body come into contact with the body surface with the puncture member punctured into the living body, so that the distal end and the proximal end of the tubular body are buried in the living body. Can be prevented. In other words, both the distal end side opening and the proximal end side opening of the tubular body can be kept exposed to the outside of the living body. Therefore, the implant can be easily inserted into the tubular body, and the implant can be easily embedded in the living body by removing only the tubular body from the living body while the implant is placed in the tubular body. it can.
図１は、本発明の第１実施形態に係る穿刺装置を示す斜視図である。FIG. 1 is a perspective view showing a puncture apparatus according to a first embodiment of the present invention. 図２は、図１に示す穿刺装置の側面図である。FIG. 2 is a side view of the puncture device shown in FIG. 図３は、図１に示す穿刺装置が有する操作部材を示す平面図である。FIG. 3 is a plan view showing an operation member of the puncture apparatus shown in FIG. 図４は、図１に示す穿刺装置が有する穿刺部材を示す図であり、（ａ）が斜視図、（ｂ）が（ａ）中のＡ－Ａ線断面図である。4A and 4B are diagrams showing a puncture member included in the puncture apparatus shown in FIG. 1, wherein FIG. 4A is a perspective view, and FIG. 4B is a cross-sectional view taken along line AA in FIG. 図５は、図４（ａ）に示す穿刺部材の断面図である。FIG. 5 is a cross-sectional view of the puncture member shown in FIG. 図６は、図４（ａ）に示す穿刺部材が有する状態維持機構を示す図であり、（ａ）が上面図、（ｂ）および（ｃ）が断面図である。6A and 6B are diagrams showing a state maintaining mechanism included in the puncture member shown in FIG. 4A, wherein FIG. 6A is a top view, and FIGS. 6B and 6C are cross-sectional views. 図７は、図３に示す穿刺部材が有する状態維持機構を示す部分拡大図であり、（ａ）および（ｂ）がそれぞれ変形例を示す平面図、（ｃ）が本実施形態を示す平面図である。FIG. 7 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 3, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. It is. 図８は、図１に示す穿刺装置が有する第２アンカーを示す図であり、（ａ）が断面図、（ｂ）が穿刺部材に係合した状態を示す断面図である。8A and 8B are diagrams showing a second anchor included in the puncture device shown in FIG. 1, wherein FIG. 8A is a cross-sectional view and FIG. 8B is a cross-sectional view showing a state where the puncture member is engaged. 図９は、図１に示す穿刺装置が有する第１アンカーを示す図であり、（ａ）が断面図、（ｂ）が穿刺部材に係合した状態を示す断面図である。FIG. 9 is a view showing a first anchor of the puncture device shown in FIG. 1, wherein (a) is a cross-sectional view and (b) is a cross-sectional view showing a state where the puncture member is engaged. 図１０は、図１に示す穿刺装置が備えるフレームの案内部を示す断面図である。FIG. 10 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. 図１１は、図１に示す穿刺装置が備えるフレームの案内部を示す断面図である。FIG. 11 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. 図１２は、図１に示す穿刺装置が備えるフレームの案内部を示す断面図である。FIG. 12 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. 図１３は、図１に示す穿刺装置の変形例を示す断面図。FIG. 13 is a cross-sectional view showing a modification of the puncture apparatus shown in FIG. 図１４は、図１に示す穿刺装置が備えるフレームの固定部を示す平面図である。FIG. 14 is a plan view showing a frame fixing portion provided in the puncture apparatus shown in FIG. 1. 図１５は、図１に示す穿刺装置が有する挿入具の側面図である。FIG. 15 is a side view of the insertion tool of the puncture device shown in FIG. 図１６は、穿刺部材と閉鎖孔（骨盤）との位置関係を示す図であり、（ａ）が側面図、（ｂ）が正面図である。FIG. 16 is a diagram showing the positional relationship between the puncture member and the closing hole (pelvis), where (a) is a side view and (b) is a front view. 図１７は、図１５に示す挿入具が有する膣挿入部材の部分拡大図である。17 is a partially enlarged view of a vaginal insertion member included in the insertion tool shown in FIG. 図１８は、（ａ）が膣壁の形状の一例を示す断面図、（ｂ）が（ａ）に示す膣内に膣挿入部を挿入した状態を示す断面図である。18A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 18B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. 図１９は、図１に示す穿刺装置と共に用いられるインプラントを示す図である。FIG. 19 is a view showing an implant used together with the puncture device shown in FIG. 図２０（ａ）および（ｂ）は、それぞれ、図１に示す穿刺装置の操作手順を説明するための図である。20 (a) and 20 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 図２１（ａ）および（ｂ）は、それぞれ、図１に示す穿刺装置の操作手順を説明するための図である。FIGS. 21A and 21B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 図２２は、図２１（ａ）に示す状態の時の穿刺装置と骨盤との関係を示す側面図である。FIG. 22 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. 図２３（ａ）および（ｂ）は、それぞれ、図１に示す穿刺装置の操作手順を説明するための図である。FIGS. 23A and 23B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 図２４は、図２３（ａ）に示す状態の時の穿刺装置と骨盤との関係を示す側面図である。FIG. 24 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. 図２５は、図２３（ｂ）に示す状態の時の尿道に対する穿刺部材の姿勢を示す断面図である。FIG. 25 is a cross-sectional view showing the posture of the puncture member with respect to the urethra in the state shown in FIG. 図２６（ａ）および（ｂ）は、それぞれ、図１に示す穿刺装置の操作手順を説明するための図である。FIGS. 26A and 26B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 図２７（ａ）および（ｂ）は、それぞれ、図１に示す穿刺装置の操作手順を説明するための図である。FIGS. 27A and 27B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 図２８は、本発明の第２実施形態に係る穿刺装置が有する穿刺部材を示す斜視図である。FIG. 28 is a perspective view showing a puncture member included in the puncture apparatus according to the second embodiment of the present invention. 図２９は、図２８に示す穿刺部材の変形例を示す断面図である。FIG. 29 is a cross-sectional view showing a modification of the puncture member shown in FIG. 図３０は、本発明の第３実施形態に係る穿刺装置が有する穿刺部材を示す斜視図である。FIG. 30 is a perspective view showing a puncture member included in the puncture apparatus according to the third embodiment of the present invention. 図３１は、本発明の第４実施形態に係る穿刺装置が有する穿刺部材を示す斜視図である。FIG. 31 is a perspective view showing a puncture member included in the puncture apparatus according to the fourth embodiment of the present invention. 図３２は、本発明の第５実施形態に係る穿刺装置が有する穿刺部材を示す斜視図である。FIG. 32 is a perspective view showing a puncture member included in the puncture apparatus according to the fifth embodiment of the present invention. 図３３は、本発明の第６実施形態に係る穿刺装置が有する穿刺部材を示す断面図である。FIG. 33 is a cross-sectional view showing a puncture member included in the puncture apparatus according to the sixth embodiment of the present invention. 図３４は、本発明の第７実施形態に係る穿刺装置が有する穿刺部材を示す図であり、（ａ）が平面図、（ｂ）および（ｃ）がそれぞれ断面図である。FIG. 34 is a view showing a puncture member included in the puncture apparatus according to the seventh embodiment of the present invention, in which (a) is a plan view and (b) and (c) are sectional views. 図３５は、本発明の第８実施形態に係る穿刺装置が有する穿刺部材を示す断面図である。FIG. 35 is a cross-sectional view showing a puncture member included in the puncture apparatus according to the eighth embodiment of the present invention. 図３６は、図３５に示す穿刺部材の変形例を示す断面図である。36 is a cross-sectional view showing a modification of the puncture member shown in FIG. 図３７は、本発明の第９実施形態に係る穿刺装置が有する穿刺部材を示す図であり、（ａ）が平面図、（ｂ）および（ｃ）がそれぞれ断面図である。FIG. 37 is a view showing a puncture member included in the puncture apparatus according to the ninth embodiment of the present invention, in which (a) is a plan view and (b) and (c) are sectional views.
　以下、本発明の穿刺装置を添付図面に示す好適な実施形態に基づいて詳細に説明する。
　＜第１実施形態＞
　図１は、本発明の第１実施形態に係る穿刺装置を示す斜視図である。図２は、図１に示す穿刺装置の側面図である。図３は、図１に示す穿刺装置が有する操作部材を示す平面図である。図４は、図１に示す穿刺装置が有する穿刺部材を示す図であり、（ａ）が斜視図、（ｂ）が（ａ）中のＡ－Ａ線断面図である。図５は、図４（ａ）に示す穿刺部材の断面図である。図６は、図４（ａ）に示す穿刺部材が有する状態維持機構を示す図であり、（ａ）が上面図、（ｂ）および（ｃ）が断面図である。図７は、図３に示す穿刺部材が有する状態維持機構を示す部分拡大図であり、（ａ）および（ｂ）がそれぞれ変形例を示す平面図、（ｃ）が本実施形態を示す平面図である。図８は、図１に示す穿刺装置が有する第２アンカーを示す図であり、（ａ）が断面図、（ｂ）が穿刺部材に係合した状態を示す断面図である。図９は、図１に示す穿刺装置が有する第１アンカーを示す図であり、（ａ）が断面図、（ｂ）が穿刺部材に係合した状態を示す断面図である。図１０は、図１に示す穿刺装置が備えるフレームの案内部を示す断面図である。図１１は、図１に示す穿刺装置が備えるフレームの案内部を示す断面図である。図１２は、図１に示す穿刺装置が備えるフレームの案内部を示す断面図である。図１３は、図１に示す穿刺装置の変形例を示す断面図。図１４は、図１に示す穿刺装置が備えるフレームの固定部を示す平面図である。図１５は、図１に示す穿刺装置が有する挿入具の側面図である。図１６は、穿刺部材と閉鎖孔（骨盤）との位置関係を示す図であり、（ａ）が側面図、（ｂ）が正面図である。図１７は、図１５に示す挿入具が有する膣挿入部材の部分拡大図である。図１８は、（ａ）が膣壁の形状の一例を示す断面図、（ｂ）が（ａ）に示す膣内に膣挿入部を挿入した状態を示す断面図である。図１９は、図１に示す穿刺装置と共に用いられるインプラントを示す図である。図２０（ａ）および（ｂ）は、それぞれ、図１に示す穿刺装置の操作手順を説明するための図である。図２１（ａ）および（ｂ）は、それぞれ、図１に示す穿刺装置の操作手順を説明するための図である。図２２は、図２１（ａ）に示す状態の時の穿刺装置と骨盤との関係を示す側面図である。図２３（ａ）および（ｂ）は、それぞれ、図１に示す穿刺装置の操作手順を説明するための図である。図２４は、図２３（ａ）に示す状態の時の穿刺装置と骨盤との関係を示す側面図である。図２５は、図２３（ｂ）に示す状態の時の尿道に対する穿刺部材の姿勢を示す断面図である。図２６（ａ）および（ｂ）は、それぞれ、図１に示す穿刺装置の操作手順を説明するための図である。図２７（ａ）および（ｂ）は、それぞれ、図１に示す穿刺装置の操作手順を説明するための図である。 Hereinafter, the puncture device 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 puncture apparatus according to a first embodiment of the present invention. FIG. 2 is a side view of the puncture device shown in FIG. FIG. 3 is a plan view showing an operation member of the puncture apparatus shown in FIG. 4A and 4B are diagrams showing a puncture member included in the puncture apparatus shown in FIG. 1, wherein FIG. 4A is a perspective view, and FIG. 4B is a cross-sectional view taken along line AA in FIG. FIG. 5 is a cross-sectional view of the puncture member shown in FIG. 6A and 6B are diagrams showing a state maintaining mechanism included in the puncture member shown in FIG. 4A, wherein FIG. 6A is a top view, and FIGS. 6B and 6C are cross-sectional views. FIG. 7 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 3, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. It is. 8A and 8B are diagrams showing a second anchor included in the puncture device shown in FIG. 1, wherein FIG. 8A is a cross-sectional view and FIG. 8B is a cross-sectional view showing a state where the puncture member is engaged. FIG. 9 is a view showing a first anchor of the puncture device shown in FIG. 1, wherein (a) is a cross-sectional view and (b) is a cross-sectional view showing a state where the puncture member is engaged. FIG. 10 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 11 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 12 is a cross-sectional view showing a guide portion of a frame provided in the puncture apparatus shown in FIG. FIG. 13 is a cross-sectional view showing a modification of the puncture apparatus shown in FIG. FIG. 14 is a plan view showing a frame fixing portion provided in the puncture apparatus shown in FIG. 1. FIG. 15 is a side view of the insertion tool of the puncture device shown in FIG. FIG. 16 is a diagram showing a positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view. 17 is a partially enlarged view of a vaginal insertion member included in the insertion tool shown in FIG. 18A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 18B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. FIG. 19 is a view showing an implant used together with the puncture device shown in FIG. 20 (a) and 20 (b) are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIGS. 21A and 21B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 22 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIGS. 23A and 23B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIG. 24 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG. FIG. 25 is a cross-sectional view showing the posture of the puncture member with respect to the urethra in the state shown in FIG. FIGS. 26A and 26B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. FIGS. 27A and 27B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
　なお、以下では、説明の便宜上、図２中の左側を「先端」、右側を「基端」、上側を「上」、下側を「下」と言う。また、図２は、まだ使用されていない状態を示し、以下では、説明の便宜上、この状態を「初期状態」とも言う。また、図２に示す穿刺装置（挿入具）が患者に装着された状態を「装着状態」とも言う。また、図５および図６では、それぞれ、説明の便宜上、円弧状に延在している穿刺部材を直線的に伸ばして図示している。 In the following, for convenience of explanation, the left side in FIG. 2 is referred to as “tip”, the right side is referred to as “base end”, the upper side is referred to as “upper”, and the lower side is referred to as “lower”. FIG. 2 shows a state that is not yet used. Hereinafter, for convenience of explanation, this state is also referred to as an “initial state”. The state where the puncture device (insertion tool) shown in FIG. 2 is attached to the patient is also referred to as “attached state”. In FIGS. 5 and 6, the puncture member extending in an arc shape is illustrated as being linearly extended for convenience of explanation.
　１．穿刺装置
　図１および図２に示す穿刺装置１は、女性の尿失禁の治療、すなわち、尿失禁の治療用の生体組織支持用留置物を生体内に埋設する際に用いる装置である。 1. Puncture device The puncture device 1 shown in FIG. 1 and FIG. 2 is a device used when embedding a living tissue supporting indwelling material for treatment of female urinary incontinence, that is, treatment of urinary incontinence.
　この穿刺装置１は、フレーム（支持部）２、穿刺部材３、尿道挿入部材４、膣挿入部材５、操作部材７およびアンカー８１、８２を備えており、フレーム２に、穿刺部材３、尿道挿入部材４、膣挿入部材５、操作部材７およびアンカー８１、８２がそれぞれ支持されている。また、穿刺装置１では、尿道挿入部材４と膣挿入部材５とで挿入具６を構成している。以下、これらについて順に説明する。 The puncture device 1 includes a frame (support portion) 2, a puncture member 3, a urethral insertion member 4, a vaginal insertion member 5, an operation member 7, and anchors 81 and 82. The member 4, the vaginal insertion member 5, the operation member 7, and the anchors 81 and 82 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.
　（操作部材）
　操作部材７は、穿刺部材３を操作するための部材である。このような操作部材７は、図１ないし図３に示すように、挿入部７１と、軸部７３と、挿入部７１および軸部７３を連結する連結部７２とを有している。これら挿入部７１、連結部７２および軸部７３は、一体的に形成されていてもよいし、少なくとも１つの部位が他の部位に対して別体として形成されていてもよい。 (Operation member)
The operation member 7 is a member for operating the puncture member 3. As shown in FIGS. 1 to 3, the operation member 7 has an insertion portion 71, a shaft portion 73, and a connecting portion 72 that connects the insertion portion 71 and the shaft portion 73. The insertion portion 71, the coupling portion 72, and the shaft portion 73 may be integrally formed, or at least one portion may be formed as a separate body from other portions.
　挿入部７１は、穿刺部材３に挿入される部位であり、穿刺部材３を内側から補強するスタイレットとして機能する。挿入部７１を穿刺部材３に挿入することで、穿刺部材３が操作部材７に接続され、これにより、操作部材７による穿刺部材３の操作が可能となる。このような挿入部７１は、穿刺部材３の形状に対応した円弧状をなしている。挿入部７１の中心角は、穿刺部材３の中心角に合わせて設定される。また、挿入部７１の先端部７１１は、先細りしている。先細りした先端部７１１を有することで、挿入部７１への穿刺部材３の挿入を円滑に行うことができる。 The insertion portion 71 is a part that is inserted into the puncture member 3 and functions as a stylet that reinforces the puncture member 3 from the inside. By inserting the insertion portion 71 into the puncture member 3, the puncture member 3 is connected to the operation member 7, whereby the operation member 7 can be operated by the operation member 7. Such an insertion portion 71 has an arc shape corresponding to the shape of the puncture member 3. The central angle of the insertion portion 71 is set according to the central angle of the puncture member 3. Further, the distal end portion 711 of the insertion portion 71 is tapered. By having the tapered tip end portion 711, the puncture member 3 can be smoothly inserted into the insertion portion 71.
　軸部７３は、挿入部７１の中心Ｏと交わり、挿入部７１を含む平面ｆ１と直交する軸Ｊ１に沿って延在している。 The shaft portion 73 intersects the center O of the insertion portion 71 and extends along an axis J1 orthogonal to the plane f1 including the insertion portion 71.
　連結部７２は、挿入部７１の基端部と軸部７３の先端部とを連結している。また、連結部７２は、途中でほぼ直角に屈曲したほぼＬ字状をなしている。このような連結部７２は、操作部材７を操作する際に術者が把持する把持部としても機能する。 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. Such a connecting portion 72 also functions as a gripping portion that the operator grips when operating the operation member 7.
　このような操作部材７は、穿刺部材３（本体３１）よりも剛性が高くなるように構成されている。操作部材７の構成材料としては、特に限定されず、例えば、ステンレス鋼、アルミニウムまたはアルミニウム合金、チタンまたはチタン合金のような各種金属材料等を用いることができる。 Such an operation member 7 is configured to have higher rigidity than the puncture member 3 (main body 31). The constituent material of the operation member 7 is not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy can be used.
　（穿刺部材）
　穿刺部材３は、生体を穿刺するための部材である。このような穿刺部材３は、図４（ａ）に示すように、長尺な本体（管体）３１と、本体３１の先端に設けられた針体３５とを有している。 (Puncture member)
The puncture member 3 is a member for puncturing a living body. The puncture member 3 has a long main body (tubular body) 31 and a needle body 35 provided at the tip of the main body 31, as shown in FIG.
　本体３１は、長尺な管体（チューブ）で構成されており、先端と基端とがそれぞれ開口している。このような本体３１は、インプラント本体（帯状長尺物）９１を挿入可能な内部空間を有している。また、本体３１は、円弧状に湾曲した湾曲形状をなし、図４（ｂ）に示すように、扁平形状の横断面形状を有している。特に、本体３１の長手方向の中央部Ｓ４での横断面形状は、短軸Ｊ３１と長軸Ｊ３２とを含む扁平形状である。後述するように、本体３１内には、インプラント本体９１が配置される。そのため、本体３１を扁平形状とすることで、インプラント本体９１の本体３１内での姿勢を制御することができる。また、本体３１の内部空間の幅は、インプラント本体９１の後述する本体部９１１の幅とほぼ同じに設計されている。これにより、インプラント本体９１を移動させても本体３１の内部空間との摩擦抵抗が低くなり、インプラント本体９１に不要な力が掛からず、十分に展開した状態で本体部９１１を本体３１内に配置することができる。 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 an implant main body (strip-shaped elongated object) 91 can be inserted. The main body 31 has a curved shape curved in an arc shape, and has a flat cross-sectional shape as shown in FIG. In particular, the cross-sectional shape at the central portion S4 in the longitudinal direction of the main body 31 is a flat shape including the short axis J31 and the long axis J32. As will be described later, an implant main body 91 is disposed in the main body 31. Therefore, the posture within the main body 31 of the implant main body 91 can be controlled by making the main body 31 into a flat shape. Further, the width of the internal space of the main body 31 is designed to be substantially the same as the width of a main body portion 911 described later of the implant main body 91. Thereby, even if the implant main body 91 is moved, the frictional resistance with the internal space of the main body 31 is lowered, and unnecessary force is not applied to the implant main body 91, and the main body portion 911 is disposed in the main body 31 in a sufficiently expanded state. can do.
　なお、本体３１の扁平形状としては、特に限定されず、例えば、楕円形、断面凸レンズ形状、角部が丸みを帯びたひし形、角部が丸みを帯びた長方形（平ら形状）、中央部が両端部よりも拡大した（拡径した）紡錘形とすることもできる。 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.
　以下では、説明の便宜上、図４（ｂ）に示すように、長軸方向の内側に位置する端部を「内周部Ａ１」とも言い、外側に位置する端部を「外周部Ａ２」とも言い、上側に向く面を「表面Ａ３」とも言い、下側に向く面を「裏面Ａ４」とも言う。 In the following, for convenience of explanation, as shown in FIG. 4B, the end located on the inner side in the long axis direction is also referred to as “inner peripheral part A1”, and the end located on the outer side is also referred to as “outer peripheral part 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”.
　図４（ｂ）に示すように、中央部Ｓ４の円弧の中心点と本体３１の長手方向に対する横断面形状の中心点の両方を含む面（本体３１の中心軸を含む面）を平面ｆ９とし、平面ｆ９と中央部Ｓ４での短軸Ｊ３１とのなす角を傾斜角θ１としたとき、傾斜角θ１は、鋭角であるのが好ましい。傾斜角θ１を鋭角とすることで、後述するインプラント９を尿道とほぼ平行に配置することができ、尿道をより効果的に支持することができる。この効果については、後に詳述する。なお、傾斜角θ１としては、鋭角であれば特に限定されないが、２０～６０°程度であるのが好ましく、３０～４５°であるのがより好ましく、３５～４０°程度であるのがさらに好ましい。これにより、上述した効果がより一層向上する。 As shown in FIG. 4B, a plane including both the center point of the arc of the central portion S4 and the center point of the cross-sectional shape with respect to the longitudinal direction of the main body 31 (the plane including the central axis of the main body 31) is defined as a plane f9. When the angle formed between the plane f9 and the short axis J31 at the central portion S4 is defined as an inclination angle θ1, the inclination angle θ1 is preferably an acute angle. By setting the inclination angle θ1 to an acute angle, an implant 9 described later can be disposed substantially parallel to the urethra, and the urethra can be more effectively supported. 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.
　傾斜角θ１は、本体３１の延在方向全域で上記数値範囲を満足しているのが好ましいが、少なくとも、本体３１の延在方向の中央部Ｓ４にて上記数値範囲を満足していれば、上記効果を発揮することができる。なお、前記「中央部Ｓ４」とは、少なくとも、穿刺部材３を生体に穿刺した状態で、尿道と膣との間に位置する部位を含む領域を言う。また、本実施形態では、後述するように穿刺部材３にアンカー８１、８２が係合された状態で、アンカー８１、８２間の中央部（中央およびその両側近傍）が中央部Ｓ４であるとも言える。 The inclination angle θ1 preferably satisfies the above numerical range over the entire extending direction of the main body 31, but at least satisfies the above numerical range at the central portion S4 in the extending direction of the main body 31. The above effects can be exhibited. The “central portion S4” refers to a region including at least a portion located between the urethra and the vagina in a state where the puncture member 3 is punctured into a living body. Moreover, in this embodiment, it can be said that the center part (center and the vicinity of both sides) between the anchors 81 and 82 is the center part S4 in a state where the anchors 81 and 82 are engaged with the puncture member 3 as described later. .
　なお、本体３１の両端部には、中央部Ｓ４から等しい位置であって、本体３１が生体に配置された状態（図２３の状態）で生体外へ突出している部分にマーカーが設けられていてもよい。これにより、両マーカーの位置を比べることによって、中央部Ｓ４の生体内での位置を確認することができる。 It should be noted that markers are provided at both ends of the main body 31 at positions that are equal from the central portion S4 and project outside the living body when the main body 31 is disposed on the living body (state shown in FIG. 23). Also good. Thereby, the position in the living body of center part S4 can be confirmed by comparing the position of both markers.
　本体３１の構成は、次のように言い換えることもできる。すなわち、本体３１は、図４（ｂ）に示すように、円弧の中心軸Ｊ５に対して長軸Ｊ３２が傾斜するように形成されており、円弧の中心軸Ｊ５と長軸Ｊ３２の延長線Ｊ３２’が交点Ｐを有するように構成されているとも言える。この場合、中心軸Ｊ５と延長線Ｊ３２’とのなす角θ５が傾斜角θ１と等しい。また、別の言い方をすれば、本体３１は、図１０に示すように、本体３１の中心軸Ｊ５方向から見た平面視にて、その内周縁に位置し最少曲率半径ｒ１を有する内周部Ａ１と、外周縁に位置し最大曲率半径ｒ２を有する外周部Ａ２とを備え、図４（ｂ）に示すように、内周部Ａ１と外周部Ａ２とが中心軸Ｊ５方向に離間して（ずれて）位置するように構成されているとも言える。 The configuration of the main body 31 can be rephrased as follows. That is, as shown in FIG. 4B, the main body 31 is formed such that the major axis J32 is inclined with respect to the arc central axis J5, and an extension line J32 between the arc central axis J5 and the major axis J32. It can be said that 'is configured to have an intersection P. In this case, the angle θ5 formed by the central axis J5 and the extension line J32 ′ is equal to the inclination angle θ1. In other words, as shown in FIG. 10, the main body 31 is an inner peripheral portion having a minimum radius of curvature r <b> 1 located at the inner peripheral edge in a plan view when viewed from the central axis J <b> 5 direction of the main body 31. A1 and an outer peripheral portion A2 located at the outer peripheral edge and having a maximum radius of curvature r2, as shown in FIG. 4B, the inner peripheral portion A1 and the outer peripheral portion A2 are separated in the direction of the central axis J5 ( It can be said that it is configured to be positioned.
　このような本体３１は、途中にて分割できるように、２つの分割片にて構成されている。すなわち、本体３１は、先端分割片３２と、基端分割片３３とに分かれている。先端分割片３２と基端分割片３３とは、ほぼ同じ長さであり、これらの境界は、中央部Ｓ４に位置している。 Such a main body 31 is composed of two divided pieces so that it can be divided along the way. 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.
　図５に示すように、先端分割片３２は、管状をなし、先端側開口３２１と基端側開口３２２とを有している。また、基端分割片３３も、管状をなし、先端側開口３３１と基端側開口３３２とを有している。そして、基端分割片３３の先端部が基端側開口３２２から先端分割片３２内へ挿入されており、これにより、先端分割片３２と基端分割片３３とが接続されている。このように、基端分割片３３を先端分割片３２内へ挿入することで、分割片３２、３３の境界に生じ得る段差が生体組織に引っ掛かり難くなり、穿刺部材３の生体への穿刺を円滑に行うことができる。ただし、本実施形態とは逆に、先端分割片３２を基端分割片３３内へ挿入することで、分割片３２、３３を接続してもよい。 As shown in FIG. 5, the distal end split piece 32 has a tubular 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 tubular 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 division piece 33 is inserted in the front end division piece 32 from the base end side opening 322, and, thereby, the front end division piece 32 and the base end division piece 33 are connected. As described above, by inserting the proximal end divided piece 33 into the distal divided piece 32, a step that may occur at the boundary between the divided pieces 32 and 33 is less likely to be caught on the living tissue, and the puncture member 3 can be smoothly punctured into the living body. Can be done. However, contrary to the present embodiment, the split pieces 32 and 33 may be connected by inserting the tip split piece 32 into the base end split piece 33.
　また、本体３１には、分割片３２、３３が接続された状態を維持するための状態維持機構３４が設けられている。図６（ａ）に示すように、状態維持機構３４は、孔３４２ａ、３４２ｂ、３４２ｃと、各孔３４２ａ、３４２ｂ、３４２ｃに挿通された無端状の糸（接続部材）３４１と、糸３４１を露出させる露出孔３４５、３４６と、露出孔３４５、３４６を繋ぐスリット３４７とを有している。 Further, the main body 31 is provided with a state maintaining mechanism 34 for maintaining the state where the divided pieces 32 and 33 are connected. As shown in FIG. 6A, the state maintaining mechanism 34 exposes the holes 342a, 342b, 342c, an endless thread (connecting member) 341 inserted through the holes 342a, 342b, 342c, and the thread 341. Exposure holes 345 and 346 to be exposed, and slits 347 connecting the exposure holes 345 and 346.
　孔３４２ａは、基端分割片３３の基端部であって、表面Ａ３の内周部Ａ１寄りに設けられている。一方、孔３４２ｂ、３４２ｃは、先端分割片３２の基端部であって、表面Ａ３と裏面Ａ４の内周部Ａ１寄りに対向して設けられている。 The hole 342a is a base end portion of the base end split piece 33 and is provided near the inner peripheral portion A1 of the surface A3. On the other hand, the holes 342b and 342c are the base end portions of the tip split piece 32, and are provided facing the inner peripheral portion A1 of the front surface A3 and the back surface A4.
　糸３４１は、本体３１内に配置されており、孔３４２ｂと孔３４２ｃの間、孔３４２ａと基端側開口３３２の間でそれぞれ本体３１外に露出している。糸３４１をこのように引き回すことで、分割片３２、３３の接続状態を確実に維持することができる。また、糸３４１の本体３１外への露出を抑えることができ、糸３４１が生体組織に引っ掛かり難くなる。また、後述するような糸３４１の切断を可能としつつ、糸３４１の全長を成るべく短くすることができる。そのため、インプラント本体９１を本体３１内に挿通する際に糸３４１がインプラント本体９１に引っ掛かり難くなる。また、前述したように、孔３４２ａ、３４２ｂ、３４２ｃがそれぞれ内周部Ａ１寄りに配置されているため、糸３４１も内周部Ａ１寄りに配置される。そのため、インプラント本体９１を本体３１内へ挿入する際に、糸３４１がインプラント本体９１に引っ掛かり難くなる。 The yarn 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. 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 made as short 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.
　なお、糸３４１は、例えば、有端の糸を用意し、その一端を、基端側開口３３２から本体３１内に挿入し、孔３４２ｂから本体３１外に引き出し、孔３４２ｃから本体３１内に挿入し、孔３４２ａから本体３１外へ引き出し、最後に、基端側開口３３２付近で他端と結ぶことで得られる。ただし、結び目の位置は限定されない。 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 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.
　ここで、孔３４２ａは、図６（ｃ）に示すように、外側開口が内側開口よりも基端側へ位置するように軸が傾斜している。一方、孔３４２ｂ、３４２ｃは、それぞれ、図６（ｂ）に示すように、外側開口が内側開口よりも先端へ位置するように軸が傾斜している。これにより、各孔３４２ａ、３４２ｂ、３４２ｃを糸３４１の経路に沿って延在させることができ、各孔３４２ａ、３４２ｂ、３４２ｃに糸３４１が引っ掛かり難くなる。 Here, as shown in FIG. 6 (c), the hole 342a has an axis inclined so that the outer opening is located closer to the base end side than the inner opening. On the other hand, as shown in FIG. 6B, the holes 342b and 342c each have an inclined axis so that the outer opening is located at the tip of the inner opening. Thereby, each hole 342a, 342b, 342c can be extended along the path | route of the thread | yarn 341, and the thread | yarn 341 becomes difficult to be caught in each hole 342a, 342b, 342c.
　露出孔３４５、３４６は、基端分割片３３の基端部の表面Ａ３と裏面Ａ４に、対向して設けられている。露出孔３４５、３４６が設けられている部位は、本体３１を生体内に配置した状態で、体表面から突出する。また、露出孔３４５、３４６は、糸３４１の経路上に位置している。そのため、露出孔３４５、３４６から糸３４１が本体３１外へ露出する。また、これら露出孔３４５、３４６は、内周部Ａ１に設けられたスリット３４７によって繋がっている。 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 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. The exposure holes 345 and 346 are connected by a slit 347 provided in the inner peripheral portion A1.
　このような状態維持機構３４では、糸３４１を切断することにより、先端分割片３２と基端分割片３３とが分離可能な状態となる。このような構成とすることで、先端分割片３２と基端分割片３３とを簡単な操作で分離可能な状態とすることができる。また、糸３４１の切断は、目視可能であるため、先端分割片３２と基端分割片３３とが分離可能な状態となったことを簡単に確認することができる。 In such a state maintaining mechanism 34, by cutting the thread 341, the distal end divided piece 32 and the proximal end divided piece 33 can be separated. By setting it as such a structure, the front end division | segmentation piece 32 and the base end division | segmentation piece 33 can be made into the state which can be isolate | separated by simple operation. Moreover, since the cutting | disconnection of the thread | yarn 341 is visible, it can confirm easily that the front end division | segmentation piece 32 and the base end division | segmentation piece 33 became a state which can be isolate | separated.
　本実施形態のように、露出孔３４５、３４６およびスリット３４７を設けることで、糸３４１を簡単に切断することができる。一例を挙げて説明すると、一対の刃（第１刃および第２刃）を有する鋏を用意し、第１刃を露出孔３４５、３４６に挿通し、一対の刃の間に糸３４１を位置させる。そして、鋏を閉操作すると、第１、第２刃の少なくとも一方がスリット３４７を通過し、第１、第２刃が互いに重なり合い、その過程で糸３４１が切断される。このように、露出孔３４５、３４６およびスリット３４７を設けることで、糸３４１を簡単に切断することができる。 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.
　このように、本実施形態では、スリット３４７を設け、このスリット３４７を刃の通過経路として用いている。これにより、糸３４１の張力による本体３１の変形が防止される。具体的には、図７（ａ）に示すように、刃の通過経路をスリット３４７に替えて孔３４８で構成してもよい。しかしながら、この場合は、本体３１の硬さ等によっては、図７（ｂ）に示すように、糸３４１の張力によって孔３４８が座屈して潰れ、本体３１が変形するおそれがある。これに対してスリット３４７では、スリット３４７を挟んだ部分３４７ａ、３４７ｂが当接して突っ張っているため、図７（ｃ）に示すように、上記のような変形が起きず、本体３１の変形が防止される。 As described above, in this embodiment, the slit 347 is provided, and the slit 347 is used as a passage path of the blade. Thereby, the deformation of the main body 31 due to the tension of the yarn 341 is prevented. Specifically, as shown in FIG. 7A, the passage route of the blade may be replaced by a slit 347 and configured by a hole 348. However, in this case, depending on the hardness of the main body 31, as shown in FIG. 7B, the hole 348 may be buckled and crushed by the tension of the thread 341, and the main body 31 may be deformed. On the other hand, in the slit 347, since the portions 347a and 347b sandwiching the slit 347 are in contact and stretched, as shown in FIG. 7C, the above-described deformation does not occur and the main body 31 is not deformed. Is prevented.
　また、図５に示すように、本体３１の先端部には、アンカー８１に係合する一対の係合孔３１５、３１６が設けられている。一方、本体３１の基端部には、アンカー８２に係合する一対の係合孔３１７、３１８が設けられている。これら４つの係合孔のうち、係合孔３１５、３１７は、内周部Ａ１に設けられ、係合孔３１６、３１８は、外周部Ａ２に設けられている。 Further, as shown in FIG. 5, a pair of engagement holes 315 and 316 that engage with the anchor 81 are provided at the distal end portion of the main body 31. On the other hand, a pair of engagement holes 317 and 318 that engage with the anchor 82 are provided at the base end portion of the main body 31. Of these four engagement holes, the engagement holes 315 and 317 are provided in the inner peripheral portion A1, and the engagement holes 316 and 318 are provided in the outer peripheral portion A2.
　前述したように、本体３１は、扁平形状であり、長軸方向に潰れ難いため、内周部Ａ１と外周部Ａ２の離間距離が変化し難い。また、内周部Ａ１および外周部Ａ２は、表面Ａ３および裏面Ａ４に比べて曲率が大きく変形し難い。そのため、内周部Ａ１に係合孔３１５、３１７を設け、外周部Ａ２に係合孔３１６、３１８を設けることで、アンカー８１、８２と本体３１との係合が解除され難くなる。 As described above, the main body 31 has a flat shape and is not easily crushed in the long axis direction, so that the separation distance between the inner peripheral portion A1 and the outer peripheral portion A2 is difficult to change. Further, the inner peripheral portion A1 and the outer peripheral portion A2 have large curvatures and are not easily deformed compared to the front surface A3 and the rear surface A4. Therefore, by providing the engagement holes 315 and 317 in the inner peripheral portion A1 and the engagement holes 316 and 318 in the outer peripheral portion A2, the engagement between the anchors 81 and 82 and the main body 31 is difficult to be released.
　また、係合孔３１５、３１６と中央部Ｓ４との離間距離と、係合孔３１７、３１８と中央部Ｓ４との離間距離とがほぼ等しくなっている。これにより、アンカー８１、８２がマーカーの役目をなし、生体内での本体３１の中央部Ｓ４の位置を簡単に把握することができる。 Further, the separation distance between the engagement holes 315 and 316 and the central portion S4 is substantially equal to the separation distance between the engagement holes 317 and 318 and the central portion S4. Thereby, the anchors 81 and 82 serve as markers, and the position of the central portion S4 of the main body 31 in the living body can be easily grasped.
　以上のような本体３１の先端には、針体３５が設けられている。図５に示すように、針体３５は、先細りした針先３５１と、針先３５１の基端側に設けられた基端部３５２とを有している。そして、基端部３５２が本体３１内に挿入され、これにより、針体３５が本体３１に着脱自在に保持されている。なお、基端部３５２は、針体３５の本体３１からの意図しない離脱を防止できる程度の力で本体３１に嵌入されている。なお、針体３５は、本体３１と一体的に構成されていてもよい。 A needle body 35 is provided at the tip of the main body 31 as described above. As shown in FIG. 5, the needle body 35 has a tapered needle tip 351 and a proximal end portion 352 provided on the proximal end side of the needle tip 351. Then, the base end portion 352 is inserted into the main body 31, whereby the needle body 35 is detachably held on the main body 31. Note that the base end portion 352 is fitted into the main body 31 with a force that can prevent unintentional detachment of the needle body 35 from the main body 31. The needle body 35 may be configured integrally with the main body 31.
　また、基端部３５２には、挿入部７１の先端部７１１と係合する係合部３５３が設けられている。係合部３５３は、凹部で構成され、挿入部７１に穿刺部材３を挿入した挿入状態では、係合部３５３内に先端部７１１が位置している。係合部３５３を設けることで、挿入部７１に対する針体３５の変位が抑制され、生体への穿刺部材３の穿刺をより円滑に行うことができる。 Further, the base end portion 352 is provided with an engaging portion 353 that engages with the distal end portion 711 of the insertion portion 71. The engaging portion 353 is configured by a concave portion, and the distal end portion 711 is positioned in the engaging portion 353 in the inserted state in which the puncture member 3 is inserted into the inserting portion 71. By providing the engagement portion 353, the displacement of the needle body 35 with respect to the insertion portion 71 is suppressed, and the puncture member 3 can be punctured into the living body more smoothly.
　以上、穿刺部材３について説明した。穿刺部材３の中心角θ４は、特に限定されず、諸条件に応じて適宜設定されるものであるが、後述するように、針体３５が、患者の一方の鼠蹊部から体内に入り、尿道と膣の間を通過して、他方の鼠蹊部から体外に突出することができるように設定される。具体的には、中心角θ４は、１５０～２７０°であることが好ましく、１７０～２５０°であることがより好ましく、１９０～２３０°であることがさらに好ましい。 The puncture member 3 has been described above. The central angle θ4 of the puncture member 3 is not particularly limited and is appropriately set according to various conditions. As will be described later, the needle body 35 enters the body from one of the buttocks of the patient, and the urethra It is set so that it can pass between the vagina and protrude from the other buttocks. Specifically, the central angle θ4 is preferably 150 to 270 °, more preferably 170 to 250 °, and further preferably 190 to 230 °.
　また、本体３１および針体３５の構成材料としては、体内に挿入された状態で形状や内部空間を維持するような硬質材料が好ましい。このような硬質材料としては、例えば、ポリエチレン、ポリイミド、ポリアミド、ポリエステルエラストマー、ポリプロピレン等の各種樹脂材料やステンレス鋼、アルミニウムまたはアルミニウム合金、チタンまたはチタン合金のような各種金属材料等を用いることができる。なお、本体３１および針体３５の構成として硬質材料を採用する他に、硬質材料以外の材料を採用する場合は、壁を補強部材で補強することでも達成される。例えば、高強度の編組体を壁内に埋め込むことにより、体内に挿入された状態で形状や内部空間を維持することができる。また、補強部材の他の例としては、本体３１の壁に螺旋状物を埋め込むことにより挿入物の摺動可能な程度に内部空間を保持しつつ可撓性を備えることが可能となる。 Further, as the constituent material of the main body 31 and the needle body 35, a hard material that maintains the shape and internal space in a state of being inserted into the body is preferable. Examples of such a hard material include various resin materials such as polyethylene, polyimide, polyamide, polyester elastomer, and polypropylene, and various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like. . In addition to employing a hard material as the configuration of the main body 31 and the needle body 35, when a material other than the hard material is employed, the wall can be reinforced by a reinforcing member. For example, by embedding a high-strength braided body in the wall, the shape and the internal space can be maintained while being inserted into the body. As another example of the reinforcing member, by embedding a spiral object in the wall of the main body 31, it is possible to provide flexibility while maintaining the internal space to the extent that the insert can slide.
　本体３１は、光透過性を有しており、外部から内部が視認可能になっているのが好ましい。これにより、例えば、内部に挿入された挿入部７１の先端部７１１が係合部３５３に係合しているか、糸３４１が切れていないか等を確認することができる。 It is preferable that the main body 31 has light permeability and the inside can be visually recognized from the outside. Thereby, for example, it is possible to confirm whether the distal end portion 711 of the insertion portion 71 inserted inside is engaged with the engagement portion 353 or whether the thread 341 is not cut.
　なお、糸３４１を通す孔（３４２ａ、３４２ｂ、３４２ｃ）の数および配置は、糸３４１によって先端分割片３２と基端分割片３３との接続状態を維持できる限り、特に限定されない。また、糸３４１は、無端状である必要はなく、一端と他端とを有する有端状であってもよい。例えば、有端状の糸を用意し、その一端を孔３４２ａおよび基端側開口３３２に通した輪っかとし、他端を孔３４２ｂ、３４２ｃに通した輪っかとしてもよい。また、糸３４１には、糸３４１と同様に用いることができる紐や帯等も含まれる。 In addition, 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 tip split piece 32 and the base end split piece 33 can be maintained by the thread 341. Moreover, the thread | yarn 341 does not need to be endless shape, and the end shape which has one end and the other end may be sufficient as it. For example, an end-shaped thread may be prepared, and one end thereof may be a loop that passes through the hole 342a and the proximal end opening 332, and the other end may be a loop that passes through the holes 342b and 342c. Further, the thread 341 includes a string, a band, and the like that can be used in the same manner as the thread 341.
　（アンカー）
　図８（ａ）に示すように、アンカー（第２アンカー）８１は、穿刺部材３（本体３１）を挿通する挿通孔８１２を有する基部８１１と、基部８１１から突出し、一対の係合孔３１５、３１６と係合する一対の爪部８１３、８１４とを有している。挿通孔８１２の横断面形状は、穿刺部材３（本体３１）の横断面形状に対応している。そのため、挿通孔８１２に穿刺部材３が挿通された状態では、穿刺部材３に対するアンカー８１の回転が規制され、これらの位置関係が適切に維持される。挿通孔８１２に穿刺部材３を挿入し、穿刺部材３をアンカー８１に対して押し進めると、図８（ｂ）に示すように、爪部８１３、８１４が係合孔３１５、３１６に係合する。これにより、穿刺部材３（先端分割片３２）にアンカー８１が係合する。係合した状態では、基部８１１が爪部８１３、８１４よりも基端側に位置している。前述したように、穿刺部材３を挿通孔８１２に挿通した状態では、穿刺部材３に対するアンカー８１の回転が規制されるため、爪部８１３、８１４と係合孔３１５、３１６との係合を確実に発現させることができる。 (anchor)
As shown in FIG. 8A, an anchor (second anchor) 81 includes a base portion 811 having an insertion hole 812 through which the puncture member 3 (main body 31) is inserted, a base portion 811 and a pair of engagement holes 315, A pair of claw portions 813 and 814 that engage with 316 are provided. The cross-sectional shape of the insertion hole 812 corresponds to the cross-sectional shape of the puncture member 3 (main body 31). Therefore, in a state where the puncture member 3 is inserted through the insertion hole 812, the rotation of the anchor 81 with respect to the puncture member 3 is restricted, and these positional relationships are appropriately maintained. When the puncture member 3 is inserted into the insertion hole 812 and the puncture member 3 is pushed forward with respect to the anchor 81, the claw portions 813 and 814 engage with the engagement holes 315 and 316 as shown in FIG. Thereby, the anchor 81 is engaged with the puncture member 3 (the tip split piece 32). In the engaged state, the base portion 811 is located on the proximal end side with respect to the claw portions 813 and 814. As described above, when the puncture member 3 is inserted through the insertion hole 812, the rotation of the anchor 81 with respect to the puncture member 3 is restricted, so that the engagement between the claw portions 813 and 814 and the engagement holes 315 and 316 is ensured. Can be expressed.
　同様に、図９（ａ）に示すように、アンカー（第１アンカー）８２は、穿刺部材３を挿通する挿通孔８２２を有する基部８２１と、基部８２１から突出し、一対の係合孔３１７、３１８と係合する一対の爪部８２３、８２４とを有している。挿通孔８２２の横断面形状は、穿刺部材３の横断面形状に対応している。そのため、挿通孔８２２に穿刺部材３が挿通された状態では、穿刺部材３に対するアンカー８２の回転が規制され、これらの位置関係が適切に維持される。挿通孔８１２に穿刺部材３を挿入し、穿刺部材３をアンカー８２に対して押し進めると、図９（ｂ）に示すように、爪部８２３、８２４が係合孔３１７、３１８に係合する。これにより、穿刺部材３（基端分割片３３）にアンカー８２が係合する。係合した状態では、基部８２１が爪部８２３、８２４よりも先端側に位置している。前述したように、穿刺部材３を挿通孔８２２に挿通した状態では、穿刺部材３に対するアンカー８２の回転が規制されるため、爪部８２３、８２４と係合孔３１７、３１８との係合を確実に発現させることができる。 Similarly, as shown in FIG. 9A, the anchor (first anchor) 82 has a base portion 821 having an insertion hole 822 through which the puncture member 3 is inserted, and protrudes from the base portion 821, and a pair of engagement holes 317 and 318. And a pair of claw portions 823 and 824 that engage with each other. The cross-sectional shape of the insertion hole 822 corresponds to the cross-sectional shape of the puncture member 3. Therefore, in a state where the puncture member 3 is inserted through the insertion hole 822, the rotation of the anchor 82 with respect to the puncture member 3 is restricted, and these positional relationships are appropriately maintained. When the puncture member 3 is inserted into the insertion hole 812 and the puncture member 3 is pushed forward against the anchor 82, the claws 823 and 824 engage with the engagement holes 317 and 318 as shown in FIG. 9B. As a result, the anchor 82 is engaged with the puncture member 3 (base end split piece 33). In the engaged state, the base portion 821 is located on the tip side of the claw portions 823 and 824. As described above, when the puncture member 3 is inserted into the insertion hole 822, the rotation of the anchor 82 with respect to the puncture member 3 is restricted, so that the engagement between the claw portions 823 and 824 and the engagement holes 317 and 318 is ensured. Can be expressed.
　アンカー８１、８２の構成材料としては、それぞれ、特に限定されず、例えば、各種樹脂材料を用いることができる。 The constituent materials of the anchors 81 and 82 are not particularly limited, and various resin materials can be used, for example.
　（フレーム）
　フレーム２は、穿刺部材３が装着された操作部材７を回動自在に保持し、また、挿入具６およびアンカー８１、８２を着脱自在に固定する。フレーム２は、穿刺部材３が生体組織を穿刺する際に、針体３５の穿刺経路を定める機能を有している。具体的には、フレーム２は、穿刺部材３が生体組織を穿刺したとき、針体３５が尿道挿入部材４と膣挿入部材５との間をこれらに衝突せずに通過するように、穿刺部材３、尿道挿入部材４および膣挿入部材５の位置関係を定めている。 (flame)
The frame 2 rotatably holds the operation member 7 to which the puncture member 3 is attached, and fixes the insertion tool 6 and the anchors 81 and 82 in a detachable manner. The frame 2 has a function of determining a puncture route of the needle body 35 when the puncture member 3 punctures a living tissue. Specifically, the frame 2 is configured so that when the puncture member 3 punctures a living tissue, the needle body 35 passes between the urethra insertion member 4 and the vagina insertion member 5 without colliding with them. 3. The positional relationship between the urethral insertion member 4 and the vaginal insertion member 5 is defined.
　図１および図２に示すように、フレーム２は、操作部材７の軸部７３を軸受する軸受部２１と、穿刺部材３を案内するとともに第１、第２アンカー８１、８２を着脱自在に保持する案内部（保持部）２２と、軸受部２１と案内部２２とを連結する連結部２３と、挿入具６が固定される固定部２４とを有している。 As shown in FIGS. 1 and 2, the frame 2 guides the bearing portion 21 that supports the shaft portion 73 of the operation member 7 and the puncture member 3 and detachably holds the first and second anchors 81 and 82. A guide portion (holding portion) 22, a connecting portion 23 that connects the bearing portion 21 and the guide portion 22, and a fixing portion 24 to which the insertion tool 6 is fixed.
　軸受部２１は、穿刺装置１の基端側に位置し、軸Ｊ１に対してほぼ直交する方向に延在している。軸受部２１の軸Ｊ１上には、貫通孔２１１が形成されており、この貫通孔２１１に軸部７３が回動自在に挿入されている。これにより、フレーム２に操作部材７が軸Ｊ１まわりに回動可能な状態で支持される。 The bearing portion 21 is located on the proximal end side of the puncture device 1 and extends in a direction substantially orthogonal to the axis J1. A through hole 211 is formed on the shaft J1 of the bearing portion 21, and the shaft portion 73 is rotatably inserted into the through hole 211. As a result, the operation member 7 is supported on the frame 2 in a state of being rotatable about the axis J1.
　案内部２２は、穿刺装置１の先端側に位置し、軸受部２１と対向配置されている。図１０に示すように、案内部２２には、穿刺部材３を収容し、穿刺部材３を案内する略Ｃ字状（円弧状）の案内溝２２１が形成されている。また、図１１に示すように、案内溝２２１内に配置された状態では、穿刺部材３は、裏面Ａ４を先端側が位置し、表面Ａ３が基端側に位置している。 The guide portion 22 is located on the distal end side of the puncture device 1 and is disposed to face the bearing portion 21. As shown in FIG. 10, the guide portion 22 is formed with a substantially C-shaped (arc-shaped) guide groove 221 that accommodates the puncture member 3 and guides the puncture member 3. Further, as shown in FIG. 11, in the state of being placed in the guide groove 221, the puncture member 3 has the back surface A4 positioned on the distal end side and the surface A3 positioned on the proximal end side.
　また、案内部２２は、アンカー８１、８２を着脱自在に保持している。アンカー８２は、挿通孔８２２が案内溝２２１と連続するように、先端側開口２２２と対向して保持されており、アンカー８１は、挿通孔８１２が案内溝２２１と連続するように、案内溝２２１の基端側開口２２３と対向して保持されている。 Moreover, the guide part 22 is holding the anchors 81 and 82 so that attachment or detachment is possible. The anchor 82 is held facing the front end side opening 222 so that the insertion hole 822 is continuous with the guide groove 221, and the anchor 81 is guided by the guide groove 221 so that the insertion hole 812 is continuous with the guide groove 221. Is held opposite to the base end side opening 223.
　初期状態では、アンカー８２の挿通孔８２２に本体３１が挿通され、かつ、案内部２２から針体３５が突出している。そして、操作部材７を回転操作すると、案内部２２から穿刺部材３が徐々に突出し、最終的に、図１２に示すように、針体３５が基端側開口２２３から案内部２２内に侵入する。この過程にて、穿刺部材３の先端側では、穿刺部材３がアンカー８１の挿通孔８１２内を通過し、係合孔３１５、３１６に爪部８１３、８１４が係合する。一方、穿刺部材３の基端側では、係合孔３１７、３１８に爪部８２３、８２４が係合する。これにより、アンカー８１、８２が穿刺部材３に係合する。ここで、本実施形態では、アンカー８１の爪部８１３、８１４が穿刺部材３の移動方向の前方側に向いて傾斜している。そのため、穿刺部材３がアンカー８１に挿入される際の、爪部８１３、８１４と穿刺部材３との引っ掛かりが防止され、穿刺部材３が爪部８１３、８１４と摺動しながらこれらの間をスムーズに移動することができる。ただし、アンカー８２の向きは、特に限定されず、本実施形態とは反対に、爪部８１３、８１４が穿刺部材３の移動方向の後方側に向いていてもよい。 In the initial state, the main body 31 is inserted into the insertion hole 822 of the anchor 82, and the needle body 35 projects from the guide portion 22. When the operation member 7 is rotated, the puncture member 3 gradually protrudes from the guide portion 22, and finally, the needle body 35 enters the guide portion 22 through the proximal end opening 223 as shown in FIG. . In this process, the puncture member 3 passes through the insertion hole 812 of the anchor 81 on the distal end side of the puncture member 3, and the claw portions 813 and 814 engage with the engagement holes 315 and 316. On the other hand, the claw portions 823 and 824 are engaged with the engagement holes 317 and 318 on the proximal end side of the puncture member 3. Thereby, the anchors 81 and 82 are engaged with the puncture member 3. Here, in this embodiment, the claw portions 813 and 814 of the anchor 81 are inclined toward the front side in the moving direction of the puncture member 3. Therefore, when the puncture member 3 is inserted into the anchor 81, the claw portions 813 and 814 and the puncture member 3 are prevented from being caught, and the puncture member 3 slides between the claw portions 813 and 814 while smoothly moving between them. Can be moved to. However, the direction of the anchor 82 is not particularly limited, and the claw portions 813 and 814 may face the rear side in the moving direction of the puncture member 3, contrary to the present embodiment.
　なお、図１０に示すように、本実施形態では、初期状態にてすでに穿刺部材３がアンカー８２に挿入され、かつ、係合孔３１５、３１６の基端側に位置している。すなわち、アンカー８２の爪部８２３、８２４が広がった状態（爪部８２３、８２４が弾性変形した状態）となっており、爪部８２３、８２４が歪んで、爪部８２３、８２４の弾性力（復元力）が低下するおそれがある。そこで、図１３に示すように、初期状態にて、アンカー８２の爪部８２３、８２４が穿刺部材３の係合孔３１５、３１６に係合していてもよい。このようにすることで、本実施形態よりも爪部８２３、８２４の変形量が少なくなり、爪部８２３、８２４の歪みを抑えることができる。 As shown in FIG. 10, in this embodiment, the puncture member 3 has already been inserted into the anchor 82 in the initial state and is positioned on the proximal end side of the engagement holes 315 and 316. That is, the claw portions 823 and 824 of the anchor 82 are in an expanded state (the claw portions 823 and 824 are elastically deformed), the claw portions 823 and 824 are distorted, and the elastic force (restoration) of the claw portions 823 and 824 is restored. May decrease. Therefore, as shown in FIG. 13, the claws 823 and 824 of the anchor 82 may be engaged with the engagement holes 315 and 316 of the puncture member 3 in the initial state. By doing in this way, the deformation amount of the nail | claw parts 823 and 824 becomes smaller than this embodiment, and distortion of the nail | claw parts 823 and 824 can be suppressed.
　なお、図１３の構成とすると、穿刺部材３を案内部２２から突出させる際（図１０の状態から図１２の状態とする際）に、爪部８２３、８２４と係合孔３１５、３１６との係合を解除する必要がある。そのため、係合孔３１５、３１６の基端側の輪郭（外縁）３１５ａ、３１６ａの傾斜を、先端側の輪郭３１５ｂ、３１６ｂの傾斜よりもなだらかにするのが好ましい。これにより、爪部８２３、８２４と係合孔３１５、３１６との係合を解除し易くなる。また、先端側の輪郭３１５ｂ、３１６ｂの傾斜を係合孔３１５、３１６の基端側の輪郭３１５ａ、３１６ａの傾斜よりも急にすることで、図１２の状態となったときのアンカー８１の爪部８１３、８２４と係合孔３１５、３１６との係合を強固に行うことができる。 13, when the puncture member 3 is projected from the guide portion 22 (from the state of FIG. 10 to the state of FIG. 12), the claw portions 823, 824 and the engagement holes 315, 316 It is necessary to release the engagement. For this reason, it is preferable to make the slopes of the contours (outer edges) 315a and 316a on the proximal end side of the engagement holes 315 and 316 gentler than the slopes of the contours 315b and 316b on the distal end side. As a result, the engagement between the claw portions 823 and 824 and the engagement holes 315 and 316 can be easily released. Further, by making the inclination of the contours 315b and 316b on the distal end side steeper than the inclinations of the contours 315a and 316a on the proximal end side of the engagement holes 315 and 316, the claws of the anchor 81 when the state shown in FIG. The engagement between the portions 813 and 824 and the engagement holes 315 and 316 can be performed firmly.
　連結部２３は、軸受部２１と案内部２２とを連結している。また、連結部２３は、軸Ｊ１とほぼ平行に延在する棒状をなしている。連結部２３は、把持部としても機能し、術者は、連結部２３を把持して穿刺装置１を使用することができる。 The connecting portion 23 connects the bearing portion 21 and the guide portion 22. Further, the connecting portion 23 has a rod shape extending substantially parallel to the axis J1. The connecting portion 23 also functions as a grasping portion, and an operator can use the puncture apparatus 1 by grasping the connecting portion 23.
　固定部２４は、軸Ｊ１を介して連結部２３と対向配置されている。図１４に示すように、固定部２４は、挿入具６の後述する支持部６０を嵌め込む凹部２４３と、雄ネジ２４４とを有している。支持部６０を凹部２４３へ嵌め込み、さらに、雄ネジ２４４を支持部６０の雌ネジ（図示せず）に締め込むことにより、挿入具６を固定部２４に固定することができる。 The fixing part 24 is arranged to face the connecting part 23 via the axis J1. As shown in FIG. 14, 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.
　（挿入具）
　図１および図１５に示すように、挿入具６は、尿道に挿入される尿道挿入部（第２の挿入部）４１と、膣に挿入される膣挿入部（第１の挿入部）５１と、尿道挿入部４１および膣挿入部５１を支持する支持部６０とを有している。前述したように、挿入具６は、尿道挿入部材４と膣挿入部材５とで構成され、尿道挿入部材４が尿道挿入部４１を備え、膣挿入部材５が膣挿入部５１を備えている。また、支持部６０は、尿道挿入部材４が備え、尿道挿入部４１を支持する支持部４０と、膣挿入部材５が備え、膣挿入部５１を支持する支持部５０とを有している。挿入具６では、支持部４０、５０を介して、尿道挿入部材４と膣挿入部材５とが着脱自在となっている。以下、尿道挿入部材４および膣挿入部材５について順に説明する。 (Insert tool)
As shown in FIGS. 1 and 15, the insertion tool 6 includes a urethral insertion portion (second insertion portion) 41 to be inserted into the urethra, and a vaginal insertion portion (first insertion portion) 51 to be inserted into the vagina. 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.
　－尿道挿入部材－
　尿道挿入部材４は、途中まで尿道内に挿入される長尺状の尿道挿入部４１と、尿道挿入部４１を支持する支持部４０とを有している。なお、以下では、説明の便宜上、装着状態にて尿道（膀胱を含む）内に位置する部位を「挿入部４１１」とも言い、装着状態にて尿道口から体外に露出している部分であって支持部４０までの部分を「非挿入部４１２」とも言う。 -Urethral insertion member-
The urethral insertion member 4 has a long urethral insertion portion 41 that is inserted into the urethra halfway and a support portion 40 that supports the urethral insertion portion 41. In the following description, for convenience of explanation, a portion located in the urethra (including the bladder) in the attached state is also referred to as an “insertion portion 411”, and is a portion exposed outside the body from the urethral opening in the attached state. A portion up to the support portion 40 is also referred to as a “non-insertion portion 412”.
　尿道挿入部４１は、先端が丸みを帯びた真っ直ぐな管状をなしている。また、挿入部４１１の先端部には、拡張／収縮自在なバルーン４２と、尿排出部４７とが設けられている。バルーン４２は、尿道内における尿道挿入部材４の軸方向の位置を規制する規制部として機能する。具体的には、穿刺装置１の使用時には、バルーン４２を患者の膀胱内に挿入した後に拡張させる。そして、拡張させたバルーン４２が膀胱頚部に引っ掛かることにより、膀胱および尿道に対する尿道挿入部材４の位置が固定される。一方、尿排出部４７は、膀胱内の尿を排出するために用いられる。 The urethra insertion part 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. Specifically, when the puncture device 1 is used, the balloon 42 is expanded after being inserted into the patient's bladder. And the position of the urethral insertion member 4 with respect to a bladder and a urethra is fixed by the expanded balloon 42 being caught in a bladder neck. On the other hand, the urine discharge unit 47 is used to discharge urine in the bladder.
　バルーン４２は、尿道挿入部４１内を通ってその基端部に設けられたバルーンポート４３に接続されている。バルーンポート４３には、シリンジ等のバルーン拡張器具を接続することができる。バルーン拡張器具からバルーン４２に作動流体（生理食塩水等のような液体、気体等）を供給するとバルーン４２が拡張し、反対に、バルーン拡張器具によってバルーン４２から作動流体を抜き取るとバルーン４２が収縮する。なお、図１５では、バルーン４２が収縮した状態を二点鎖線で示し、バルーン４２が拡張した状態を実線で示している。 The balloon 42 passes through the urethra insertion part 41 and is connected to a balloon port 43 provided at the base end 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. 15, the state in which the balloon 42 is deflated is indicated by a two-dot chain line, and the state in which the balloon 42 is expanded is indicated by a solid line.
　一方、尿排出部４７には、尿排出部４７の内外を連通する排出孔４７１が設けられている。また、尿排出部４７は、尿道挿入部４１内を通ってその基端部に設けられた尿排出ポート４８に接続されている。そのため、排出孔４７１から導入した尿を尿排出ポート４８から排出することができる。 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.
　これらバルーン４２および尿排出部４７は、例えば、ダブルルーメンによって構成することができる。 These balloon 42 and urine discharge part 47 can be constituted by a double lumen, for example.
　また、挿入部４１１の途中には、複数の吸引孔４４が形成されている。複数の吸引孔４４は、尿道挿入部４１の周方向の全域にわたって配置されている。各吸引孔４４は、尿道挿入部４１を通って基端部に設けられた吸引ポート４５に接続されている。吸引ポート４５には、ポンプ等の吸引装置を接続することができる。尿道挿入部４１を尿道に挿入した状態で吸引装置を作動させると、尿道挿入部４１に尿道壁を吸着・固定することができる。そして、この状態で、尿道挿入部４１を先端側（体内）へ押し込むと、これとともに尿道も押し込まれ、例えば、膀胱を穿刺部材３の穿刺経路と重ならない位置にずらすことができ、穿刺部材３の穿刺経路を確保することができる。そのため、穿刺部材３の穿刺を正確かつ安全に行うことができる。なお、吸引孔４４の数は、特に限定されず、例えば、１つであってもよい。また、吸引孔４４の配置は、特に限定されず、例えば、尿道挿入部４１の周方向の一部にのみ形成されていてもよい。 Also, 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 urethral 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, 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 side (inside the body), the urethra is also pushed together, and for example, the bladder can be shifted to a position that does not overlap the puncture path of the puncture member 3. The puncture route can be secured. Therefore, the puncture member 3 can be punctured accurately and safely. The number of suction holes 44 is not particularly limited, and may be one, for example. The arrangement of the suction holes 44 is not particularly limited, and may be formed only in a part of the circumferential direction of the urethral insertion portion 41, for example.
　また、挿入部４１１と非挿入部４１２との境界部には、尿道挿入部４１の尿道への挿入深さを確認するためのマーカー４６が設けられている。マーカー４６は、尿道挿入部４１を尿道内に挿入し、バルーン４２が膀胱内に位置するとき、尿道口に位置する。これにより、簡単に、挿入部４１１の尿道への挿入深さを確認することができる。マーカー４６としては、外部から視認できれば良く、例えば、着色部、凹凸部等により構成することができる。なお、マーカー４６に替えて、尿道挿入部４１の先端からの距離が記された目盛を設けてもよい。 Also, a marker 46 for confirming the insertion depth of the urethra insertion part 41 into the urethra 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 urethral insertion portion 41 is inserted into the urethra and the balloon 42 is located in the bladder. Thereby, the insertion depth to the urethra 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.
　挿入部４１１の長さとしては、特に限定されず、患者の尿道の長さおよび膀胱の形状等によって適宜設定される。一般的な女性の尿道の長さが３０～５０ｍｍ程度であるため、５０～１００ｍｍ程度であるのがより好ましい。 The length of the insertion portion 411 is not particularly limited, and is appropriately set depending on the length of the patient's urethra, the shape of the bladder, and the like. Since the length of a typical female urethra is about 30 to 50 mm, it is more preferably about 50 to 100 mm.
　非挿入部４１２の長さ（尿道口と支持部４０の離間距離）としては、特に限定されないが、１００ｍｍ以下程度であるのが好ましく、２０～５０ｍｍ程度であるのがより好ましい。これにより、非挿入部４１２を適切な長さとすることができ、操作性が向上する。仮に、非挿入部４１２の長さが上記上限値を超えると、フレーム２の構成等によっては、穿刺装置１の重心が患者から大きく離れてしまい、装着状態での穿刺装置１の安定性が低下する場合がある。 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.
　尿道挿入部材４の構成材料としては、特に限定されず、例えば、ステンレス鋼、アルミニウムまたはアルミニウム合金、チタンまたはチタン合金のような各種金属材料、各種樹脂材料を用いることができる。 The constituent material of the urethral insertion member 4 is not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials can be used.
　ここで、尿道挿入部４１の軸Ｊ２に直交する平面ｆ２に対する平面ｆ９（平面ｆ１）の傾斜角θ２は、２０～６０°程度であるの好ましく、３０～４５°程度であるのがより好ましく、３５～４０°程度であるのがさらに好ましい。言い換えると、本体３１は、平面ｆ９と尿道の軸に直交する平面とのなす角が２０～６０°程度となるように体内に留置されるのが好ましく、３０～４５°程度となるように体内に留置されるのがより好ましく、３５～４０°程度となるように体内に留置されるのがさらに好ましい。これにより、穿刺部材３の穿刺を容易に行うことができるとともに、穿刺部材３による穿刺距離をより短くすることができる。 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 to 40 °. In other words, the main body 31 is preferably placed in the body so that the angle between the plane f9 and the plane orthogonal to the axis of the urethra is about 20 to 60 °, and the body 31 is about 30 to 45 °. It is more preferable to be indwelled in the body, and it is more preferable to be indwelled in the body so as to be about 35 to 40 °. Thereby, the puncture of the puncture member 3 can be easily performed, and the puncture distance by the puncture member 3 can be further shortened.
　具体的に説明すると、傾斜角θ２を上記範囲内とすることによって、図１６（ａ）に示すように、穿刺部材３が骨盤１１００の左右の閉鎖孔１１０１、１１０２を平面的に広く捉えることができ、穿刺部材３の穿刺スペースを広く確保することができる。すなわち、患者を所定の***（砕石位）にした状態で、閉鎖孔１１０１、１１０２に対して穿刺部材３を比較的垂直方向に穿刺することができる。そのため、穿刺部材３の穿刺を容易に行うことができる。加えて、閉鎖孔１１０１、１１０２に対して穿刺部材３を比較的垂直方向に穿刺することで、組織の浅い部分を通過するため、穿刺部材３の針体３５が左右の閉鎖孔１１０１、１１０２の間をより短い距離で通過することができる。そのため、図１６（ｂ）に示すように、穿刺部材３を閉鎖孔１１０１、１１０２の恥骨結合１２００寄り、好ましくはセーフティゾーンＳ５を通過させることができる。セーフティゾーンＳ５は、損傷を避けたい神経や血管が少ない部位であるため、穿刺部材３を安全に穿刺することができる。そのため、より低侵襲となり、患者の負担を小さく抑えることができる。このように、傾斜角θ２を上記範囲とすることによって、患者への穿刺部材３の穿刺をより適切に行うことができる。また、上述の角度にて穿刺することにより、尿道の長さ方向における中位部を指す中部尿道と膣の間の組織を目標にし易くなる。中部尿道と膣の間は、インプラント９を埋設して尿失禁の治療を行う部位として適した位置である。 More specifically, by setting the inclination angle θ2 within the above range, the puncture member 3 can widely grasp the left and right closure holes 1101 and 1102 of the pelvis 1100 in a plane as shown in FIG. It is possible to secure a wide puncture space for the puncture member 3. That is, the puncture member 3 can be punctured in a relatively vertical direction with respect to the closing holes 1101 and 1102 in a state where the patient is in a predetermined body position (crushed stone position). Therefore, the puncture member 3 can be punctured easily. In addition, since the puncture member 3 is punctured in a relatively vertical direction with respect to the closure holes 1101 and 1102, the needle body 35 of the puncture member 3 passes through the shallow portion of the tissue. You can pass between them at a shorter distance. Therefore, as shown in FIG. 16B, the puncture member 3 can pass through the closure holes 1101 and 1102 near the pubic joint 1200, preferably through the safety zone S5. Since the safety zone S5 is a site where there are few nerves and blood vessels to avoid damage, the puncture member 3 can be punctured safely. Therefore, it becomes less invasive and can reduce the burden on the patient. As described above, by setting the inclination angle θ2 within the above range, the patient can puncture the puncture member 3 more appropriately. In addition, puncturing at the above-described angle makes it easy to target the tissue between the middle urethra and the vagina that indicate the middle portion in the length direction of the urethra. Between the middle urethra and the vagina is a position suitable as a site for implanting the implant 9 and treating urinary incontinence.
　これに対して、傾斜角θ２が上記下限値未満の場合または上記上限値を超える場合は、患者の個体差、手技中の姿勢等によっては、穿刺部材３が閉鎖孔１１０１、１１０２を平面的に広く捉えることができなかったり、穿刺経路を十分に短くすることができなかったりする場合がある。 On the other hand, when the inclination angle θ2 is less than the lower limit value or exceeds the upper limit value, the puncture member 3 planarly closes the closing holes 1101 and 1102 depending on individual differences in the patient, the posture during the procedure, and the like. There are cases where it is not possible to capture widely or the puncture route cannot be shortened sufficiently.
　より好ましくは、尿道または膣、尿道および膣の両方を体内側へ押し込むように位置をずらした状態で穿刺すると中部尿道と膣の間を穿刺しやすい。尿道および膣のいずれか一方を体内側へ押し込む方法は、例えば、尿道挿入部材４および／または膣挿入部材５を適切な位置に挿入した状態にし、これらに備えられている後述する吸引孔４４、５９によって、尿道および／または膣を吸着させた後、尿道挿入部材４および／または膣挿入部材５をさらに所定の位置まで各々の軸線に沿って体内側へ移動させる方法とすることができる。このようにして尿道と膣の少なくとも一方を体内側へ押し込むように位置をずらした状態で、本体３１を骨盤の左右の閉鎖孔１１０１、１１０２に対して垂直に穿刺することにより、インプラント９の留置に適した位置に通路を形成することができる。 More preferably, the puncture between the middle urethra and the vagina is facilitated by puncturing the urethra or the vagina, and both the urethra and the vagina in a position shifted so as to be pushed into the body. For example, the urethra insertion member 4 and / or the vagina insertion member 5 is inserted in an appropriate position, and a suction hole 44, which will be described later, is provided in the urethra and the vagina. 59, after the urethra and / or vagina is adsorbed, the urethral insertion member 4 and / or the vagina insertion member 5 can be further moved to the inside of the body along the respective axes to a predetermined position. In this manner, the main body 31 is punctured perpendicularly to the left and right closure holes 1101 and 1102 of the pelvis in a state where the position is shifted so as to push at least one of the urethra and the vagina into the inside of the body. The passage can be formed at a position suitable for the above.
　本体３１の軌道が骨盤の左右の閉鎖孔１１０１、１１０２のセーフティゾーンＳ５を通過するようにセットし、該軌道が中部尿道と膣の間に位置するように尿道と膣の少なくとも一方を体内側へずらし、本体３１を軌道に沿って穿刺して通路を形成することが好ましい。 The trajectory of the main body 31 is set so as to pass through the safety zones S5 of the left and right closure holes 1101 and 1102 of the pelvis, and at least one of the urethra and vagina is inward of the body so that the trajectory is located between the middle urethra and the vagina. It is preferable to shift and puncture the main body 31 along the track to form a passage.
　－膣挿入部材－
　図１および図１５に示すように、膣挿入部材５は、途中まで膣内に挿入される長尺状の膣挿入部（第１の挿入部）５１と、膣挿入部５１を支持する支持部５０とを有している。なお、以下では、説明の便宜上、装着状態にて膣内に位置する部位を「挿入部５１１」とも言い、装着状態にて膣口から体外に露出している部分であって支持部５０までの部分を「非挿入部５１２」とも言う。 -Vaginal insertion member-
As shown in FIG. 1 and FIG. 15, the vaginal insertion member 5 includes a long vaginal insertion portion (first insertion portion) 51 that is inserted into the vagina partway and a support portion that supports the vaginal insertion portion 51. 50. In the following, for convenience of explanation, a portion located in the vagina in the wearing state is also referred to as an “insertion portion 511”, and is a portion exposed from the vaginal opening to the outside of the body in the wearing state up to the support portion 50. This portion is also referred to as “non-insertion portion 512”.
　挿入部５１１は、長尺状をなしている。また、挿入部５１１は、先端側が挿入部４１１から離間するように、挿入部４１１に対して傾斜して延在している。挿入部５１１を挿入部４１１に対して傾斜させることにより、傾斜していない場合と比較して、挿入部４１１、５１１の位置関係を尿道と膣の位置関係に近づけることができる。そのため、装着状態にて、穿刺装置１がより安定して患者に保持されるとともに、患者への負担が軽減される。挿入部５１１の挿入部４１１に対する傾斜角θ３としては、特に限定されないが、例えば、０～４５°程度であるのが好ましく、０～３０°程度であるのがより好ましい。これにより、上記効果をより顕著に発揮することができる。これに対して、傾斜角θ３が上記下限値未満の場合や上記上限値を超えた場合は、患者の個体差、手技中の姿勢等によっては、装着状態にて膣や尿道が不自然に変形し、穿刺装置１が安定して保持されない場合がある。 The insertion portion 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 and the vagina than when 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. The inclination angle θ3 of the insertion portion 511 with respect to the insertion portion 411 is not particularly limited, but is preferably about 0 to 45 °, and more preferably about 0 to 30 °. Thereby, the said effect can be exhibited more notably. On the other hand, when the inclination angle θ3 is less than the above lower limit value or exceeds the above upper limit value, the vagina and urethra deform unnaturally in the wearing state depending on individual differences of patients, posture during the procedure, etc. However, the puncture device 1 may not be stably held.
　図１７に示すように、挿入部５１１は、穿刺装置１の上下方向（尿道および膣の配列方向）に潰れた扁平形状をなしている。また、挿入部５１１は、その幅がほぼ一定な中央部と、丸みを帯びた先端部とを有している。挿入部５１１の長さＬ２としては、特に限定されないが、２０～１００ｍｍ程度であるのが好ましく、３０～６０ｍｍ程度であるのがより好ましい。また、挿入部５１１の幅Ｗ１としては、特に限定されないが、１０～４０ｍｍ程度であるのが好ましく、２０～３０ｍｍ程度であるのがより好ましい。また、挿入部５１１の厚みとしては、特に限定されないが、５～２５ｍｍ程度であるのが好ましく、１０～２０ｍｍ程度であるのがより好ましい。このような長さ×幅×厚みとすることにとり、挿入部５１１が一般的な膣に適した形状、大きさとなる。そのため、装着状態における穿刺装置１の安定性が増すとともに、患者への負担が低減される。 As shown in FIG. 17, 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 and vagina). Further, the insertion portion 511 has a central portion having a substantially constant width and a rounded tip portion. The length L2 of the insertion portion 511 is not particularly limited, but is preferably about 20 to 100 mm, and more preferably about 30 to 60 mm. The width W1 of the insertion portion 511 is not particularly limited, but is preferably about 10 to 40 mm, 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.
　また、挿入部５１１の上面（尿道挿入部４１側の面）５１１ａには、複数の有底の凹部５３が形成されている。なお、凹部５３の数は、特に限定されず、例えば、１つであってもよい。また、各凹部５３の底面には、１つの吸引孔５９が設けられており、各吸引孔５９は、挿入部５１１内を通ってその基端部に設けられた吸引ポート５４に接続されている。吸引ポート５４は、装着状態において生体外に位置するように設けられている。吸引ポート５４には、ポンプ等の吸引装置を接続することができ、挿入部５１１を膣内に挿入した状態で吸引装置を作動させると、挿入部５１１に膣壁の上側である膣前壁が吸着固定される。そして、膣壁を吸着固定させた状態で、膣挿入部５１を先端側（体内）へ押し込むと、これとともに膣壁を押し込むことができる。そのため、膣壁の配置や形状を整えることができ、穿刺部材３の穿刺経路を確保することができ、穿刺部材３の穿刺を正確かつ安全に行うことができる。 Also, a plurality of bottomed recesses 53 are formed on the upper surface (surface on the urethral insertion portion 41 side) 511a of the insertion portion 511. In addition, the number of the recessed parts 53 is not specifically limited, For example, one may be sufficient. In addition, one suction hole 59 is provided on the bottom surface of each recess 53, and each suction hole 59 passes through the insertion portion 511 and is connected to a suction port 54 provided at the base end portion thereof. . The suction port 54 is provided so as to be located outside the living body in the mounted state. A suction device such as a pump can be connected to the suction port 54. When the suction device is operated with the insertion portion 511 inserted into the vagina, the vaginal front wall, which is the upper side of the vagina wall, is inserted into the insertion portion 511. 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 route of the puncture member 3 can be secured, and the puncture of the puncture member 3 can be performed accurately and safely.
　複数の凹部５３が形成されている領域Ｓ２は、領域Ｓ１と対向配置されている。そして、これら領域Ｓ１、Ｓ２の間を穿刺部材３の針先が通過する。前述したように、領域Ｓ１では尿道壁の下側である尿道後壁が挿入部４１１に吸着され、領域Ｓ２では膣前壁が挿入部５１１に吸着されているため、領域Ｓ１、Ｓ２の間では尿道壁と膣壁とがより広く離間している。そのため、このような領域に穿刺部材３を通過させることによって、穿刺部材３をより安全に穿刺することができる。 The region S2 in which the plurality of recesses 53 are formed is disposed to face the region S1. And the needle point of the puncture member 3 passes between these area | regions S1 and S2. As described above, in the region S1, the urethral posterior wall, which is the lower side of the urethral wall, is adsorbed by the insertion portion 411. In the region S2, the vagina front wall is adsorbed by the insertion portion 511. The urethral wall and vaginal wall are more widely separated. Therefore, the puncture member 3 can be punctured more safely by passing the puncture member 3 through such a region.
　領域Ｓ２は、上面５１１ａの幅方向のほぼ全域にわたっている。領域Ｓ２の幅Ｗ２としては、特に限定されないが、９～３９ｍｍ程度であるのが好ましく、１９～２９ｍｍ程度であるのがより好ましい。これにより、膣壁の形状にあまり影響を受けずに、膣前壁をより確実に挿入部５１１に吸着させることができる。特に、患者によっては、図１８（ａ）に示すように、膣前壁１４１０の一部が膣内へ垂れ下がったような形状の膣１４００を有している場合がある。このような場合でも、上記のような幅Ｗ２とすれば、図１８（ｂ）に示すように、垂れ下がった部分のみならず、垂れ下がった部分の両側の部分も確実に吸引することができる。そのため、膣１４００の形状に影響を受けずに、より確実に膣前壁１４１０を尿道から離間させることができる。特に、本実施形態では、挿入部５１１が扁平形状をなしているため、膣前壁１４１０をより尿道から遠ざけるように吸着することができ、尿道壁と膣壁との間の生体組織をより広く広げることができる。 The region S2 extends over substantially the entire width direction of the upper surface 511a. The width W2 of the region S2 is not particularly limited, but is preferably about 9 to 39 mm, and more preferably about 19 to 29 mm. Thereby, the vaginal wall can be more reliably adsorbed to the insertion portion 511 without being greatly affected by the shape of the vagina wall. In particular, as shown in FIG. 18A, some patients may have a vagina 1400 having a shape in which a part of the anterior vaginal wall 1410 hangs into the vagina. Even in such a case, if the width W2 is as described above, as shown in FIG. 18 (b), 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 without being affected by the shape of the vagina 1400. In particular, in this embodiment, since the insertion portion 511 has a flat shape, the vaginal anterior wall 1410 can be adsorbed so as to be further away from the urethra, and the living tissue between the urethral wall and the vagina wall can be broadened. Can be spread.
　また、挿入部５１１には、穿刺装置１の穿刺ルートを確認することのできるマーカー（穿刺位置確認部）５７が設けられている、つまり、マーカー５７の存在する位置の上面に存在する膣壁と尿道壁の間を穿刺するように穿刺装置を固定することができる。そのため、挿入具６の操作性および安全性が向上する。マーカー５７は、少なくとも、挿入部５１１の下面５１１ｂに設けられている。下面５１１ｂは、挿入状態にて、膣口側を向き、膣口を介して術者が視認できる面であるため、下面５１１ｂにマーカー５７を設けることによって、より確実に、穿刺装置１の穿刺ルートを確認することができる。また、挿入部５１１の膣への挿入深さを確認することもできる。なお、マーカー５７としては、外部から視認できれば良く、例えば、着色部、凹凸部等により構成することができる。 In addition, the insertion unit 511 is provided with a marker (puncture position confirmation unit) 57 that can confirm the puncture route of the puncture device 1, that is, the vaginal wall present on the upper surface of the position where the marker 57 exists. The puncture device can be fixed to puncture between the urethral walls. Therefore, the operability and safety of the insertion tool 6 are improved. The marker 57 is provided at least on the lower surface 511b of the insertion portion 511. Since the lower surface 511b is a surface that faces the vaginal opening side and is visible to the operator through the vaginal opening in the inserted state, by providing the marker 57 on the lower surface 511b, the puncture route of the puncture apparatus 1 can be more reliably performed. Can be confirmed. Further, the insertion depth of the insertion portion 511 into the vagina 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.
　非挿入部５１２は、尿道挿入部４１とほぼ平行に延在する細い棒状をなしている。非挿入部５１２と尿道挿入部４１との離間距離Ｄとしては、特に限定されないが、一般的な女性における尿道口と膣口との離間距離に対応させて、１０～４０ｍｍ程度であるのが好ましい。 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 10 to 40 mm in accordance with the separation distance between the urethral opening and the vaginal opening in a general woman. .
　非挿入部５１２の長さ（膣口と支持部５０の離間距離）としては、特に限定されないが、１００ｍｍ以下程度であるのが好ましく、２０～５０ｍｍ程度であるのがより好ましい。これにより、非挿入部５１２を適切な長さとすることができ、操作性が向上する。仮に、非挿入部５１２の長さが上記上限値を超えると、フレーム２の構成等によっては、穿刺装置１の重心が患者から大きく離れてしまい、装着状態での穿刺装置１の安定性が低下する場合がある。 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, and 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.
　支持部５０には、雄ネジ５０１が設けられており、この雄ネジ５０１を支持部４０の雌ネジ（図示せず）に締め込むことにより、支持部４０、５０同士が固定される。 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.
　膣挿入部材５の構成材料としては、特に限定されず、例えば、尿道挿入部材４と同様に、ステンレス鋼、アルミニウムまたはアルミニウム合金、チタンまたはチタン合金のような各種金属材料、各種樹脂材料を用いることができる。
　以上、穿刺装置１の構成について説明した。 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.
The configuration of the puncture device 1 has been described above.
　なお、穿刺装置１では、挿入具６を構成する尿道挿入部材４と膣挿入部材５とが着脱自在に構成されていたが、これに限定されず、尿道挿入部材４と膣挿入部材５が着脱不可となっていてもよい。 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.
　また、穿刺装置１では、尿道挿入部４１が支持部４０に対して固定されているが、これに限定されず、尿道挿入部４１が支持部４０に対して固定される状態と、支持部４０に対して軸方向にスライド可能な状態とを選択できるようになっていてもよい。具体的には、例えば、支持部４０に設けられたネジを緩めれば、尿道挿入部４１が支持部４０に対してスライド可能な状態となり、ネジを締め込めば、尿道挿入部４１が支持部４０に固定された状態となる構成となっていてもよい。この構成によれば、非挿入部４１２の長さを調節することができるため、より使い勝手のよい挿入具６となる。なお、このことは、膣挿入部５１についても同様である。 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.
　また、穿刺装置１では、傾斜角θ２が一定となるように各部がフレーム２に固定されているが、これに限定されず、傾斜角θ２が可変となっていてもよい。これにより、患者に合わせて傾斜角θ２を調節することができるため、より使い勝手のよい穿刺装置１となる。 In the puncture device 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．穿刺装置１の使用方法
　次に、穿刺装置１の使用方法について説明するが、それに先立って、穿刺装置１と共に使用されるインプラント９について説明する。 2. Next, a method of using the puncture device 1 will be described. Prior to that, an implant 9 used with the puncture device 1 will be described.
　図１９に示すインプラント（生体組織支持用留置物）９は、女性の尿失禁の治療のための埋設可能な器具、すなわち、尿道を支持する器具、例えば、尿道が膣壁側に移動しようとしたときに、その尿道を膣壁から離間する方向への移動を規制するように支持する器具である。このインプラント９としては、例えば、可撓性を有する長尺物を用いることができる。 19 is an implantable device for treating female urinary incontinence, that is, a device that supports the urethra, for example, the urethra is about to move to the vaginal wall side. Sometimes it is a device that supports the urethra so as to restrict its movement away from the vaginal wall. As this implant 9, for example, a long object having flexibility can be used.
　インプラント９は、インプラント本体９１と、インプラント本体９１を収容する袋状の包材９２とを有している。また、インプラント本体９１は、本体部９１１と、本体部９１１の片端に連結された帯９１２とを有している。インプラント９が包材９２を備えることによって、インプラント本体９１の汚染を効果的に防止することができる。なお、帯９１２に替えて、ガイドワイヤ、紐、糸等を用いてもよい。 The implant 9 has an implant main body 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.
　本体部９１１は、網状をなしており、その全体形状は、帯状をなしている。なお、本体部９１１は、例えば、線状体を交差させて網状に編んだもの、すなわち、網状の編組体で構成することができる。線状体としては、例えば、その横断面形状が円形のものや、横断面形状が扁平形状のもの、すなわち帯状のもの等が挙げられる。 The main body portion 911 has a net shape, and the entire shape is a belt shape. In addition, the main-body part 911 can be comprised, for example by what crossed the linear body and knit in the net shape, ie, a net-like braided body. Examples of the linear body include a circular cross section, a flat cross section, that is, a strip.
　本体部９１１、帯９１２および包材９２の構成材料としては、それぞれ、特に限定されず、例えば、ポリプロピレン、ポリエステル、ナイロン等のような生体適合性を有する各種樹脂材料、繊維等を用いることができる。 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. .
　なお、インプラント９としては、同様の効果を発揮することができれば、前記網状のものに限定されない。 The implant 9 is not limited to the net-like one as long as the same effect can be exhibited.
　次に、穿刺装置１の操作手順、すなわち、インプラント９を生体内に埋設する際の手順手について説明する。 Next, an operation procedure of the puncture device 1, that is, a procedure hand when the implant 9 is embedded in the living body will be described.
　まず、患者を手術台上で砕石位とし、図２０（ａ）に示すように、挿入具６を患者に装着する。具体的には、まず、尿道挿入部材４の尿道挿入部４１を患者の尿道１３００内に挿入する。この際、マーカー４６で挿入深さを確認し、バルーン４２を膀胱１３１０内に配置する。尿道１３００は、所定形状の尿道挿入部４１によりその所定形状に矯正される。本実施形態の場合は、直線状の尿道挿入部４１によって直線状に尿道が矯正されている。 First, the patient is crushed on the operating table, and the insertion tool 6 is attached to the patient as shown in FIG. Specifically, first, the urethral insertion portion 41 of the urethral insertion 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 case of the present embodiment, the urethra is straightened by the straight urethra insertion part 41.
　次に、バルーン４２を拡張させるとともに、必要に応じて排出孔４７１を介して膀胱１３１０内から尿を排出する。また、膣挿入部材５の膣挿入部５１を患者の膣１４００内に挿入する。この際、マーカー５７で穿刺位置を確認し、適切な深さまで挿入する。そして、雄ネジ５０１を操作して、支持部４０、５０を固定する。これにより、患者への挿入具６の装着が完了する。この状態では、非挿入部４１２、５１２同士が離間し、さらに、支持部６０が尿道口と膣口の間の体表と離間しており、前記体表が露出している。加えて、挿入部５１１と膣前壁とが離間し、これらの間に隙間（空間）が形成されている場合は、尿道口と膣口と間の体表から、尿道と膣の間の生体組織へ注射器を穿刺するための空間Ｓ３が形成される。 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 wall of the vagina are separated from each other and a gap (space) is formed between them, the living body between the urethra and the vagina is determined from the body surface between the urethra and the vagina. A space S3 for piercing the tissue with the syringe is formed.
　次に、吸引ポート４５、５４に吸引装置を接続し、吸引装置を作動させ、尿道後壁を尿道挿入部４１に吸着させるとともに、膣前壁を膣挿入部５１に吸着させる。例えば、尿道後壁が尿道挿入部４１にきちんと吸着されれば、吸引孔４４が尿道壁によって塞がれるため、吸引ポート４５からの吸引が停止または弱まる。同様に、膣前壁が膣挿入部５１にきちんと吸着されれば、吸引孔５９が膣壁によって塞がれるため、吸引ポート５４からの吸引が停止または弱まる。そのため、術者は、吸引ポート４５、５４からの吸引具合（例えば、吸引により発生する音の大小）から、尿道後壁、膣前壁が尿道挿入部４１、膣挿入部５１にきちんと吸着されているか否かを確認することができる。なお、挿入具６は、機械的に吸着状態を確認する確認機構を有していてもよい。確認機構としては、吸着状態を確認することができれば、特に限定されないが、例えば、吸引ポート５４からの流量を測定する流量測定部（負圧計）と、この流量測定部からの測定結果に基づいて吸着がきちんと行われているか否かを判断する判断部とを有する構成とすることができる。 Next, a suction device is connected to the suction ports 45 and 54, the suction device is operated, the rear wall of the urethra is adsorbed to the urethral insertion portion 41, and the front wall of the vagina is adsorbed to the vaginal insertion portion 51. For example, if the rear wall of the urethra is properly adsorbed by the urethra insertion portion 41, the suction hole 44 is blocked by the urethra wall, so that suction from the suction port 45 is stopped or weakened. Similarly, if the anterior vagina wall is properly adsorbed by the vagina insertion portion 51, the suction hole 59 is blocked by the vagina wall, so that suction from the suction port 54 is stopped or weakened. Therefore, the surgeon properly adsorbs the rear wall of the urethra and the front wall of the vagina to the urethra insertion part 41 and the vagina insertion part 51 from the suction state (for example, the magnitude of the sound generated by the 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.
　次に、液性剥離を行う。具体的には、図２０（ｂ）に示すように、挿入部５１１と膣前壁との間の空間（空間Ｓ３）を介して注射器２０００の穿刺針を穿刺し、尿道１３００と膣１４００との間（領域Ｓ１、Ｓ２の間）の生体組織へ、生理食塩水、局所麻酔薬等の液体を注入する。これにより、領域Ｓ１、Ｓ２の間の生体組織が膨張し、尿道後壁が尿道挿入部４１に押し付けられ、膣前壁が膣挿入部５１へ押し付けられる。 Next, liquid peeling is performed. Specifically, as shown in FIG. 20B, the puncture needle of the syringe 2000 is punctured through the space (space S3) between the insertion portion 511 and the anterior wall of the vagina, and the urethra 1300 and the vagina 1400 are A liquid such as physiological saline or a local anesthetic is injected into the living tissue between the regions (between the regions S1 and S2). As a result, the living tissue between the regions S1 and S2 expands, the urethral posterior wall is pressed against the urethral insertion portion 41, and the vagina front wall is pressed against the vagina insertion portion 51.
　ここで、液性剥離中も吸引孔４４、５９からの吸引を継続して行うのが好ましい。液性剥離によって、尿道後壁が尿道挿入部４１に押し付けられると、尿道後壁が尿道挿入部４１にさらに吸着されるため、吸引ポート４５からの吸引が停止または弱まる。同様に、膣前壁が膣挿入部５１に押し付けられると、膣前壁が膣挿入部５１にさらに吸着されるため、吸引ポート４５からの吸引が停止または弱まる。したがって、術者は、吸引ポート４５、５４からの吸引具合から、きちんと液性剥離が行われたか否かを確認することができる。 Here, it is preferable to continue the suction from the suction holes 44 and 59 even during the liquid peeling. When the rear wall of the urethra is pressed against the urethra insertion part 41 by liquid peeling, the rear wall of the urethra is further adsorbed by the urethra insertion part 41, so that suction from the suction port 45 is stopped or weakened. Similarly, when the anterior vagina wall is pressed against the vagina insertion portion 51, the anterior vagina wall is further adsorbed by the vagina insertion portion 51, so that suction from the suction port 45 is stopped or weakened. Therefore, the operator can confirm whether or not the liquid separation has been properly performed based on the suction state from the suction ports 45 and 54.
　液性剥離を行い、尿道後壁と膣前壁とが十分に離間した状態とした後、図２１に示すように、挿入具６にフレーム２を固定する。これにより、穿刺装置１が患者に装着された状態となる。この状態では、骨盤１１００と穿刺装置１との位置関係が、図２２に示すような状態となる。 After liquid separation, the urethra posterior wall and the vagina anterior wall are sufficiently separated from each other, and then the frame 2 is fixed to the insertion tool 6 as shown in FIG. Thereby, the puncture apparatus 1 will be in the state with which the patient was mounted | worn. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.
　次に、例えば、一方の手でフレーム２の連結部２３を把持しつつ、他方の手で操作部材７の連結部７２を把持し、図２３（ａ）に示すように、操作部材７を反時計回りに回転させる。これにより、穿刺部材３の針体３５は、患者の右側の鼠蹊部またはその近傍の部位（第１部位）の体表面Ｈを穿刺して体内に入り、一方の閉鎖孔１１０１、尿道１３００と膣１４００との間、他方の閉鎖孔１１０２を順に通過した後、左側の鼠蹊部またはその近傍の部位（第２部位）の体表面Ｈから体外に突出し、最終的に、案内部２２内に退避する（図２４参照）。 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 held back as shown in FIG. Rotate clockwise. Thereby, the needle body 35 of the puncture member 3 punctures the body surface H of the right buttocks of the patient or a portion in the vicinity thereof (first portion) and enters the body, and the one closed hole 1101, the urethra 1300 and the vagina After passing through the other closing hole 1102 in order with the 1400, it projects out of the body surface H of the left buttocks or its vicinity (second part) and finally retracts into the guide part 22. (See FIG. 24).
　これにより、生体に穿刺部材３が配置されるとともに、前述した原理によって、本体３１にアンカー８１、８２が係合する。そのため、アンカー８２が体表面Ｈに当接することで、本体３１の基端部のそれ以上の生体内への挿入が規制される。言い換えれば、本体３１の基端が生体外へ露出した状態を確保することができる。 Thereby, the puncture member 3 is disposed in the living body, and the anchors 81 and 82 are engaged with the main body 31 according to the principle described above. Therefore, when the anchor 82 abuts on the body surface H, further insertion of the proximal end portion of the main body 31 into the living body is restricted. In other words, it is possible to ensure that the base end of the main body 31 is exposed to the outside of the living body.
　次に、操作部材７を図２３（ａ）中時計回りに回転させる。この際、穿刺部材３も操作部材７とともに反時計回りに回転しようとするが、アンカー８１が体表面Ｈに当接することによって、それ以上の回転（移動）が防止される。そのため、本体３１の先端が生体外へ露出した状態が維持されつつ、挿入部７１が穿刺部材３および生体から抜去される。次に、穿刺装置１（穿刺部材３以外の部材）を患者から取り外し、さらに、本体３１から針体３５を取り外す。これにより、図２３（ｂ）に示すように、本体３１のみが生体内に配置された状態となる。本体３１は、先端側開口および基端側開口が共に生体外に露出した状態で生体内に配置される。 Next, the operation member 7 is rotated clockwise in FIG. At this time, the puncture member 3 also tries to rotate counterclockwise together with the operation member 7, but when the anchor 81 comes into contact with the body surface H, further rotation (movement) is prevented. Therefore, the insertion portion 71 is removed from the puncture member 3 and the living body while maintaining the state where the tip of the main body 31 is exposed to the outside of the living body. Next, puncture device 1 (member other than puncture member 3) is removed from the patient, and needle body 35 is removed from main body 31. As a result, as shown in FIG. 23B, only the main body 31 is placed in the living body. The main body 31 is disposed in the living body with both the distal end side opening and the proximal end side opening exposed to the outside of the living body.
　次に、必要に応じて、本体３１の位置を整える。具体的には、本体３１を基端側または先端側へずらし、アンカー８１、８２の生体との位置を左右対称とする。これにより、本体３１の中央部Ｓ４を、より確実に、尿道１３００と膣１４００との間に位置させることができる。この状態では、図２５に示すように、中央部Ｓ４は、その幅方向（横断面の長軸方向）Ｗが尿道１３００とほぼ平行に配置されている。すなわち、尿道挿入部材４が挿入されて矯正された尿道１３００と中央部Ｓ４の幅方向Ｗは、実質的に平行に位置している。 Next, the position of the main body 31 is adjusted as necessary. Specifically, the main body 31 is shifted to the proximal end side or the distal end side, and the positions of the anchors 81 and 82 with respect to the living body are symmetrical. Thereby, the center part S4 of the main body 31 can be positioned between the urethra 1300 and the vagina 1400 more reliably. In this state, as shown in FIG. 25, the central portion S4 is arranged such that its width direction (long axis direction of the transverse section) W is substantially parallel to the urethra 1300. That is, the width direction W of the urethra 1300, which is corrected by inserting the urethra insertion member 4 and the central portion S4, is located substantially in parallel.
　次に、インプラント本体９１を包材９２から取り出しつつ本体３１内に挿入し、図２６（ａ）に示すように、帯９１２を本体３１の基端側開口および先端側開口から突出させた状態とする。このように、本体３１内に配設する直前まで、インプラント本体９１を包材９２に収容することで、インプラント本体９１の汚染を防止することができる。なお、前述したように、本体３１が扁平形状なしているため、この扁平形状に本体部９１１の姿勢が倣う。すなわち、図２６（ｂ）に示すように、本体部９１１は、その幅方向が本体３１の幅方向と一致するように、本体３１内に配置される。尿道１３００との関係からは、インプラント本体９１は矯正された尿道１３００と平行に配置されている。 Next, the implant body 91 is inserted into the body 31 while being taken out from the packaging material 92, and as shown in FIG. 26 (a), the band 912 projects from the proximal end opening and the distal end opening of the body 31; To do. Thus, contamination of the implant main body 91 can be prevented by accommodating the implant main body 91 in the packaging material 92 until immediately before being disposed in the main body 31. As described above, since the main body 31 has a flat shape, the posture of the main body portion 911 follows this flat shape. That is, as shown in FIG. 26B, the main body portion 911 is disposed in the main body 31 such that the width direction thereof matches the width direction of the main body 31. From the relationship with the urethra 1300, the implant body 91 is disposed in parallel with the corrected urethra 1300.
　次に、図２７（ａ）に示すように、露出孔３４５、３４６から露出する糸３４１を切断する。これにより、本体３１を先端分割片３２と基端分割片３３とに分割できる状態となる。なお、露出孔３４５、３４６は、アンカー８２よりも基端側に位置するため、確実に生体外へ露出するようになっている。そのため、糸３４１の切断を容易に行うことができる。 Next, as shown in FIG. 27A, the thread 341 exposed from the exposure holes 345 and 346 is cut. As a result, the main body 31 can be divided into the tip split piece 32 and the base split piece 33. Since the exposure holes 345 and 346 are located on the proximal end side with respect to the anchor 82, the exposure holes 345 and 346 are surely exposed to the outside of the living body. Therefore, the yarn 341 can be easily cut.
　次に、尿道挿入部４１による尿道後壁の吸着と膣挿入部５１による膣前壁１４１０の吸着を停止する。これにより、尿道１３００と膣１４００の位置や形状が元の自然状態に戻る。 Next, the adsorption of the rear wall of the urethra by the urethra insertion part 41 and the adsorption of the 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.
　次に、先端分割片３２と基端分割片３３の接続を解除し、先端分割片３２を先端側へ向けて生体から引き抜くとともに、基端分割片３３を基端側へ向けて生体から引き抜く。この際、先端分割片３２と基端分割片３３を反対方向にほぼ同時に移動させ、先端分割片３２および基端分割片３３をそれぞれその形状に沿うように円弧状に移動させる。これにより、本体３１が生体からスムーズに取り除かれる。先端分割片３２および基端分割片３３を前述のようにして生体から取り除いていくと、本体３１により押し広げられていた周囲の組織が元の位置に戻り、インプラント本体９１の中央部から両端部に向けて徐々に組織がインプラント本体９１に接触していく。前述のように、先端分割片３２および基端分割片３３をその形状に沿った方向に移動させていることと、本体３１がインプラント本体９１を十分に低摺動で移動可能な内部空間を備えることにより、インプラント本体９１に不要な引張力が掛からずそのままの状態で留置することができる。これにより、インプラント本体９１のテンションの調節が不要になる。以上によって、図２６（ｂ）に示すように、インプラント本体９１が生体に埋設された状態となる。 Next, the connection between the distal end split piece 32 and the proximal end split piece 33 is released, the distal end split piece 32 is pulled out from the living body toward the distal end side, and the proximal end split piece 33 is pulled out from the living body toward the proximal end side. At this time, the tip split piece 32 and the base end split piece 33 are moved substantially simultaneously in opposite directions, and the tip split piece 32 and the base end split piece 33 are each moved in an arc shape along the shape thereof. Thereby, the main body 31 is smoothly removed from the living body. When the distal-end divided piece 32 and the proximal-end divided piece 33 are removed from the living body as described above, the surrounding tissue that has been spread by the main body 31 returns to the original position, and both end portions from the central portion of the implant main body 91 are restored. The tissue gradually comes into contact with the implant body 91 toward the end. As described above, the distal end divided piece 32 and the proximal end divided piece 33 are moved in the direction along the shape thereof, and the main body 31 has an internal space in which the implant main body 91 can move with a sufficiently low sliding. As a result, an unnecessary tensile force is not applied to the implant body 91, and the implant body 91 can be placed as it is. Thereby, adjustment of the tension of the implant main body 91 becomes unnecessary. As described above, as shown in FIG. 26B, the implant body 91 is embedded in the living body.
　インプラント本体９１が生体に埋設された状態では、本体部９１１は、尿道１３００と膣１４００の間の領域にて、尿道１３００とほぼ平行に配置される。そのため、インプラント本体９１によって、尿道１３００をより広域で支持することができる。 In the 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.
　このように、本体３１を分割して生体から取り除くことによって、本体３１の生体からの抜去を容易に行うことができる。また、アンカー８１、８２を本体３１から除去しなくても、本体３１を生体から抜去することができるため、本体３１の抜去を容易に行うことができる。また、このような抜去方法によれば、抜去中の分割片３２、３３が、尿道１３００と膣１４００の間の領域での本体部９１１の姿勢にほとんど影響を及ぼさない。 Thus, the main body 31 can be easily removed from the living body by dividing the main body 31 and removing it from the living body. Further, since the main body 31 can be removed from the living body without removing the anchors 81 and 82 from the main body 31, the main body 31 can be easily removed. Further, according to such an extraction method, the divided pieces 32 and 33 being extracted hardly affect the posture of the main body 911 in the region between the urethra 1300 and the vagina 1400.
　次に、尿道挿入部材４による尿道後壁の吸引を停止した後、尿道挿入部材４を尿道１３００から抜去する。尿道挿入部材４を抜去した後、尿道１３００は、自然状態の形状に戻るが、本体部９１１は組織に埋め込まれているため、自然状態の尿道１３００と本体部９１１と平行の状態を維持することができる。
　その後、インプラント本体９１の不要な部分を切除し、手技を終了する。 Next, after the suction of the rear wall of the urethra by the urethra insertion member 4 is stopped, the urethra insertion member 4 is removed from the urethra 1300. 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.
　以上説明したように、穿刺装置１によれば、インプラント９を留置する際、その穿刺部材３の穿刺等の低侵襲の手技のみで対応することができ、侵襲の大きい切開等を行わなくてよいので、患者の負担が少なく、また、患者の安全性も高い。また、インプラント本体９１を尿道１３００と平行に埋設することができるため、尿道１３００をより広域で支持することができる。また、穿刺部材３により尿道１３００および膣１４００を避けて生体を穿刺することができ、穿刺部材３が尿道１３００、膣１４００を穿刺してしまうことを防止することができ、安全である。また、従来の膣を切開する場合のようにその切開により生じた傷口からインプラント９が膣内に露出してしまうことや、前記傷口から感染してしまう等の合併症が生じることを防止することができ、非常に安全であり、確実にインプラント９を埋設することができる。 As described above, according to the puncture device 1, when the implant 9 is placed, it can be handled only by a minimally invasive technique such as puncture of the puncture member 3, and it is not necessary to perform a highly invasive incision or the like. Therefore, the burden on the patient is small and the safety of the patient is high. Further, since the implant body 91 can be embedded in parallel with the urethra 1300, the urethra 1300 can be supported in a wider area. Further, the puncture member 3 can puncture the living body while avoiding the urethra 1300 and the vagina 1400, and the puncture member 3 can be prevented from puncturing the urethra 1300 and the vagina 1400, which is safe. Further, it is possible to prevent the occurrence of complications such as the exposure of the implant 9 into the vagina from the wound created by the incision and the infection from the wound as in the case of the conventional incision of the vagina. It is possible to embed the implant 9 reliably.
　＜第２実施形態＞
　図２８は、本発明の第２実施形態に係る穿刺装置が有する穿刺部材を示す斜視図である。 Second Embodiment
FIG. 28 is a perspective view showing a puncture member included in the puncture apparatus according to the second embodiment of the present invention.
　以下、この図を参照して穿刺装置の第２実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the second embodiment of the puncture apparatus will be described with reference to this drawing, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
　本実施形態は、主に、穿刺部材の構成が異なること以外は前述した第１実施形態と同様である。 This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
　図２８に示すように、本実施形態の穿刺部材３Ａは、本体３１で構成されている。すなわち、穿刺部材３Ａは、前述した第１実施形態の穿刺部材３から針体３５を省略した構成となっている。また、穿刺部材３に挿入部７１を挿入した状態（初期状態）では、挿入部７１の先端部である先端部７１１が本体３１の先端側開口から突出している。本体３１から突出した先端部７１１は、穿刺部材３Ａの針先を兼ねる。このように、挿入部７１の先端部７１１が穿刺部材３Ａの針体を兼ねることにより、例えば、前述した第１実施形態と比較して、部材点数の削減を図ることができる。また、穿刺部材３を生体に穿刺し、穿刺部材３から挿入部７１を抜去すれば、本体３１の先端側開口を開放させることができる。すなわち、本実施形態によれば、前述した第１実施形態のように、本体３１の先端側開口を開放させるために、針体３５を取り外す必要がないため、より円滑に手術を行うことができる。また、挿入部７１の外径と本体３１の先端側開口の内径とがほぼ同じに設定されているため、本体３１に対する挿入部７１のずれが防止され、操作性が向上する。 As shown in FIG. 28, the puncture member 3A of the present embodiment is composed of a main body 31. That is, the puncture member 3A has a configuration in which the needle body 35 is omitted from the puncture member 3 of the first embodiment described above. Further, in a state (initial state) in which the insertion portion 71 is inserted into the puncture member 3, the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31. The tip 711 protruding from the main body 31 also serves as the needle tip of the puncture member 3A. Thus, when the distal end portion 711 of the insertion portion 71 also serves as the needle body of the puncture member 3A, for example, the number of members can be reduced as compared with the first embodiment described above. Moreover, if the puncture member 3 is punctured into a living body and the insertion portion 71 is removed from the puncture member 3, the distal end side opening of the main body 31 can be opened. In other words, according to the present embodiment, unlike the first embodiment described above, it is not necessary to remove the needle body 35 in order to open the distal end side opening of the main body 31, so that surgery can be performed more smoothly. . Further, since the outer diameter of the insertion portion 71 and the inner diameter of the opening on the distal end side of the main body 31 are set to be substantially the same, the displacement of the insertion portion 71 with respect to the main body 31 is prevented, and the operability is improved.
　また、本体３１の先端部には、その先端側開口からの外径が基端方向に向かって漸増するテーパ部３１９が設けられている。テーパ部３１９は、挿入部７１の先端部７１１が生体を穿刺するのに伴って、先端部７１１に続いて、生体を徐々に拡張するように剥離する剥離部として機能する。 Further, a tapered portion 319 in which the outer diameter from the distal end side opening gradually increases toward the proximal end is provided at the distal end of the main body 31. The tapered portion 319 functions as a peeling portion that peels off the living body gradually so as to gradually expand following the distal end portion 711 as the distal end portion 711 of the insertion portion 71 punctures the living body.
　なお、テーパ部３１９のテーパ角度と先端部７１１のテーパ角度とは、同じであってもよいが、図２８に示すように異なっているのが好ましい。この場合、テーパ部３１９のテーパ角度が先端部７１１のテーパ角度よりも小さいのが好ましい。これにより、円滑な穿刺を行うことができる。 It should be noted that 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.
　このような第２実施形態によっても、前述した第１実施形態と同様の効果を奏することができる。 Even in the second embodiment, the same effects as those of the first embodiment described above can be obtained.
　また、本実施形態の変形例として、次のような構成が挙げられる。図２９に示すように、穿刺部材３Ａは、シース３０で構成されている。すなわち、穿刺部材３Ａは、前述した第１実施形態の穿刺部材３から針体３５を省略した構成となっている。また、穿刺部材３に挿入部７１を挿入した状態（初期状態）では、挿入部７１の先端部である先端部７１１が本体３１の先端側開口から突出している。 Further, as a modification of the present embodiment, the following configuration can be given. As shown in FIG. 29, the puncture member 3 </ b> A includes a sheath 30. That is, the puncture member 3A has a configuration in which the needle body 35 is omitted from the puncture member 3 of the first embodiment described above. Further, in a state (initial state) in which the insertion portion 71 is inserted into the puncture member 3, the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31.
　先端部７１１は、螺号、嵌合等によって、挿入部７１に対して脱離可能に設けられている。また、先端部７１１は、シース３０の先端から突出している針先７１２を有している。針先７１２は、シース３０に倣った扁平形状をなしている。また、針先７１２は、先端に向かって横断面積が漸増する面積漸増部７１２ａと、面積漸増部７１２ａの先端側に設けられ、先端に向かって横断面積が漸減する面積漸減部７１２ｂとを有している。面積漸増部７１２ａと面積漸減部７１２ｂとの境界部７１２ｃの短軸は、シース３０の先端の短軸よりも長く、境界部７１２ｃの長軸は、シース３０先端の長軸よりも長い。これにより、実質的に針先７１２のみで生体内を穿刺することができる。そのため、穿刺抵抗を低減することができ、より円滑に生体への穿刺を行うことができる。なお、境界部７１２ｃの短軸は、シース３０の先端の短軸と等しくてもよく、境界部７１２ｃの長軸は、シース３０先端の長軸と等しくてもよい。 The tip portion 711 is provided so as to be removable from the insertion portion 71 by screwing, fitting, or the like. Further, the distal end portion 711 has a needle tip 712 protruding from the distal end of the sheath 30. The needle tip 712 has a flat shape following the sheath 30. Further, the needle tip 712 has an area gradually increasing portion 712a 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.
　＜第３実施形態＞
　図３０は、本発明の第３実施形態に係る穿刺装置が有する穿刺部材を示す斜視図である。 <Third Embodiment>
FIG. 30 is a perspective view showing a puncture member included in the puncture apparatus according to the third embodiment of the present invention.
　以下、この図を参照して穿刺装置の第３実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the third embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
　本実施形態は、主に、穿刺部材の構成が異なること以外は前述した第１実施形態と同様である。 This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
　図３０に示すように、穿刺部材３Ｂの本体３１Ｂは、先端分割片３２と基端分割片３３とを脆弱部３６を介して接続した構成となっている。本実施形態では、先端分割片３２、基端分割片３３および脆弱部３６は、一体的に形成されている。脆弱部３６の構成としては、先端分割片３２および基端分割片３３よりも脆くて破断し易ければ、特に限定されないが、例えば、本体３１を一周するように設けられたミシン目３６１を有する構成とすることができる。 As shown in FIG. 30, the main body 31B of the puncture member 3B has a configuration in which a distal end divided piece 32 and a proximal end divided piece 33 are connected via a fragile portion. In the present embodiment, the distal end divided piece 32, the proximal end divided piece 33, and the weakened portion 36 are integrally formed. The configuration of the fragile portion 36 is not particularly limited as long as it is more brittle than the front end split piece 32 and the base end split piece 33 and can be easily broken. For example, it has a perforation 361 provided so as to go around the main body 31. It can be configured.
　例えば、一方の手で先端分割片３２を把持するとともに他方の手で基端分割片３３を把持し、両者を引き離すように引っ張ると、脆弱部３６が破断し、先端分割片３２と基端分割片３３とが分離する。このような構成によれば、前述した第１実施形態のような先端分割片３２と基端分割片３３の重なり合いが生じないため、先端分割片３２と基端分割片３３との境界部に段差が生じず、穿刺部材３Ｂの穿刺や本体３１内へのインプラント本体９１の挿通を円滑に行うことができる。また、脆弱部３６が先端分割片３２と基端分割片３３との接続状態を維持する状態維持機構を兼ねているため、前述した第１実施形態のような状態維持機構３４を省略することができる。そのため、穿刺部材３Ｂの構成を簡易化することができる。 For example, when holding the distal end divided piece 32 with one hand and holding the proximal end divided piece 33 with the other hand and pulling them apart, the fragile portion 36 is broken, and the distal divided piece 32 and the proximal divided piece are separated. The piece 33 is separated. According to such a configuration, there is no overlap between the tip split piece 32 and the base end split piece 33 as in the first embodiment described above, and therefore there is a step at the boundary between the tip split piece 32 and the base end split piece 33. Therefore, the puncture of the puncture member 3B and the insertion of the implant main body 91 into the main body 31 can be performed smoothly. Further, since the fragile portion 36 also serves as a state maintaining mechanism for maintaining the connection state between the distal end divided piece 32 and the proximal end divided piece 33, the state maintaining mechanism 34 as in the first embodiment described above may be omitted. it can. Therefore, the configuration of the puncture member 3B can be simplified.
　このような第３実施形態によっても、前述した第１実施形態と同様の効果を奏することができる。 Even in the third embodiment, the same effects as those of the first embodiment described above can be obtained.
　＜第４実施形態＞
　図３１は、本発明の第４実施形態に係る穿刺装置が有する穿刺部材を示す斜視図である。 <Fourth embodiment>
FIG. 31 is a perspective view showing a puncture member included in the puncture apparatus according to the fourth embodiment of the present invention.
　以下、この図を参照して穿刺装置の第４実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the fourth embodiment of the puncture device will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
　本実施形態は、主に、穿刺部材の構成が異なること以外は前述した第１実施形態と同様である。 This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
　図３１に示すように、本実施形態の穿刺部材３Ｃが有する状態維持機構３４Ｃは、前述した第１実施形態の状態維持機構３４に、さらに、孔３４２ｄ、３４２ｅと、孔３４２ｄ、３４２ｅに挿通された無端状の糸（接続部材）３４９とを有している。 As shown in FIG. 31, the state maintaining mechanism 34C included in the puncture member 3C of the present embodiment is further inserted into the state maintaining mechanism 34 of the first embodiment described above through holes 342d and 342e and holes 342d and 342e. And an endless thread (connecting member) 349.
　孔３４２ｄは、基端分割片３３の先端部であって、表面Ａ３の内周部Ａ１寄りに設けられている。一方、孔３４２ｅは、先端分割片３２の基端部であって、表面Ａ３の外周部Ａ２よりに設けられている。 The hole 342d is provided at the distal 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 hole 342e is a proximal end portion of the distal end split piece 32 and is provided from the outer peripheral portion A2 of the surface A3.
　糸３４９は、大半が本体３１内に配置されており、孔３４２ｄと孔３４２ｅの間、孔３４２ａと基端側開口３３２の間でそれぞれ本体３１外に露出している。糸３４９は、例えば、有端の糸を用意し、その一端を、基端側開口３３２から本体３１内に挿入し、孔３４２ｄから本体３１外に引き出し、孔３４２ｅから本体３１内に挿入し、孔３４２ａから本体３１外へ引き出し、最後に、基端側開口３３２付近で他端と結ぶことで得られる。ただし、結び目の位置は限定されない。 Most of the yarn 349 is disposed in the main body 31 and is exposed to the outside of the main body 31 between the hole 342d and the hole 342e and between the hole 342a and the proximal end side opening 332. The thread 349 is prepared, for example, as a thread with ends, and one end of the thread 349 is inserted into the main body 31 from the proximal end opening 332, pulled out of the main body 31 from the hole 342d, and inserted into the main body 31 from the hole 342e. 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.
　また、糸３４９は、糸３４１と同様に、露出孔３４５、３４６から本体３１外へ露出している。そのため、糸３４１と同様に、露出孔３４５、３４６を介して切断することができる。糸３４９をこのように引き回すことで、以下の効果を発揮することができる。すなわち、前述した第１実施形態では、孔３４２ａ、３４２ｂ、３４２ｃが全て内周部Ａ１寄りに形成され、糸３４１も内周部Ａ１よりで引き回されている。そのため、内周部Ａ１側に収縮力が掛かり、分割片３２、３３の外周部Ａ２側が互いに離間するように本体３１が変形してしまうおそれがある。このような変形が起きると、分割片３２、３３の境界部に隙間ができたり、大きな段差が形成されたりし、生体への穿刺に影響を与える場合がある。そこで、本実施形態のように、基端分割片３３の内周部Ａ１寄りの孔３４２ｄと、先端分割片３２の外周部Ａ２寄りの孔３４２ｅとを形成し、これらに糸３４９を引き回すことによって、上述したような変形を抑制することができ、本体３１を所定の形状に維持することができる。 Further, the thread 349 is exposed to the outside of the main body 31 through the exposure holes 345 and 346 in the same manner as the thread 341. Therefore, similarly to the thread 341, it can be cut through the exposure holes 345 and 346. By drawing the thread 349 in this way, the following effects can be exhibited. That is, in the first embodiment described above, the holes 342a, 342b, and 342c are all formed closer to the inner peripheral portion A1, and the yarn 341 is also drawn around from the inner peripheral portion A1. Therefore, contraction force is applied to the inner peripheral portion A1 side, and the main body 31 may be deformed so that the outer peripheral portion A2 side of the split pieces 32 and 33 is separated from each other. When such deformation occurs, a gap may be formed at the boundary between the divided pieces 32 and 33, or a large step may be formed, which may affect the puncture of the living body. Therefore, as in this embodiment, a hole 342d near the inner peripheral portion A1 of the base end split piece 33 and a hole 342e near the outer peripheral portion A2 of the tip split piece 32 are formed, and the thread 349 is drawn around them. The deformation as described above can be suppressed, and the main body 31 can be maintained in a predetermined shape.
　このような第４実施形態によっても、前述した第１実施形態と同様の効果を奏することができる。 Also according to the fourth embodiment, the same effects as those of the first embodiment described above can be obtained.
　なお、本実施形態では、状態維持機構３４Ｃが２本の糸３４１、３４９を用いているが、これら糸を１本（糸３４１）にまとめてもよい。この場合には、糸３４１は、例えば、有端の糸の一端を、基端側開口３３２から本体３１内に挿入し、孔３４２ｄから本体３１外に引き出し、孔３４２ｅから本体３１内に挿入し、孔３４２ｂから本体３１外へ引き出し、孔３４２ｃから本体３１内に挿入し、孔３４２ａから本体３１外へ引き出し、最後に、基端側開口３３２付近で他端と結ぶことで得られる。 In this embodiment, the state maintaining mechanism 34C uses the two yarns 341 and 349, but these yarns may be combined into one (yarn 341). In this case, for example, 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 342d, and inserted into the main body 31 from the hole 342e. It is obtained by pulling out from the hole 342b to the outside of the main body 31, inserting into the main body 31 from the hole 342c, pulling out from the hole 342a to the outside of the main body 31, and finally connecting to the other end in the vicinity of the proximal end opening 332.
　＜第５実施形態＞
　図３２は、本発明の第５実施形態に係る穿刺装置が有する穿刺部材を示す斜視図である。 <Fifth Embodiment>
FIG. 32 is a perspective view showing a puncture member included in the puncture apparatus according to the fifth embodiment of the present invention.
　以下、この図を参照して穿刺装置の第５実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the fifth embodiment of the puncture apparatus will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
　本実施形態は、主に、穿刺部材の構成が異なること以外は前述した第１実施形態と同様である。 This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
　図３２に示すように、本実施形態の穿刺部材３Ｄが有する状態維持機構３４Ｄは、前述した第１実施形態の状態維持機構３４から孔３４２ｃを省略し、有端状の糸３４１を用いている。糸３４１は、本体３１内に配置されている。糸３４１の一端は、孔３４２ａから突出し、突出したところに結び目３４１ａが形成されている。結び目３４１ａは、孔３４２ａを通過することができない大きさとなっている。一方、糸３４１の他端は、孔３４２ｂから突出し、突出したところに結び目３４１ｂが形成されている。結び目３４１ｂは、孔３４２ｂを通過することができない大きさとなっている。状態維持機構３４Ｄは、このように糸３４１を配置することによって、先端分割片３２と基端分割片３３の接続状態を維持している。 As shown in FIG. 32, the state maintaining mechanism 34D included in the puncture member 3D according to the present embodiment omits the hole 342c from the state maintaining mechanism 34 according to the first embodiment described above, and uses an end-threaded thread 341. . The thread 341 is disposed in the main body 31. One end of the thread 341 protrudes from the hole 342a, and a knot 341a is formed at the protruding portion. The knot 341a has such a size that it cannot pass through the hole 342a. On the other hand, the other end of the thread 341 protrudes from the hole 342b, and a knot 341b is formed at the protruding portion. The knot 341b has such a size that it cannot pass through the hole 342b. The state maintaining mechanism 34D maintains the connection state of the distal end divided piece 32 and the proximal end divided piece 33 by arranging the thread 341 in this way.
　このような第５実施形態によっても、前述した第１実施形態と同様の効果を奏することができる。 Also according to the fifth embodiment, the same effects as those of the first embodiment described above can be obtained.
　＜第６実施形態＞
　図３３は、本発明の第６実施形態に係る穿刺装置が有する穿刺部材を示す断面図である。 <Sixth Embodiment>
FIG. 33 is a cross-sectional view showing a puncture member included in the puncture apparatus according to the sixth embodiment of the present invention.
　以下、この図を参照して穿刺装置の第６実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the sixth embodiment of the puncture apparatus will be described with reference to this drawing, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
　本実施形態は、主に、穿刺部材の構成が異なること以外は前述した第１実施形態と同様である。 This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
　図３３に示すように、本実施形態の穿刺部材３Ｅが有する状態維持機構３４Ｅは、孔３４２ｆ、３４２ｇ、３４２ｈ、３４２ｉと、各３４２ｆ、３４２ｇ、３４２ｈ、３４２ｉに挿通され、弾性を有するワイヤー（線状体）３９とを有している。 As shown in FIG. 33, the state maintaining mechanism 34E of the puncture member 3E of the present embodiment is inserted into the holes 342f, 342g, 342h, 342i and the respective wires 342f, 342g, 342h, 342i, and has an elastic wire (line ) 39.
　孔３４２ｆ、３４２ｇは、基端分割片３３の内周部Ａ１の先端部に軸方向に並んで設けられ、孔３４２ｈ、３４２ｉは、先端分割片３２の内周部Ａ１の基端部に軸方向に並んで設けられている。また、孔３４２ｆ、３４２ｈが重なり合っており、孔３４２ｇ、３４２ｉが重なり合っている。そして、ワイヤー３９が孔３４２ｆ、３４２ｈを介して本体３１外へ引き出され、孔３４２ｇ、３４２ｉを介して本体３１内へ導入されている。これにより、分割片３２、３３の接続状態が維持されている。なお、状態維持機構３４Ｅでは、ワイヤー３９を本体３１の基端側開口から引き抜くことで、分割片３２、３３を分割することのできる状態となる。 The holes 342f and 342g are provided in the axial direction at the distal end portion of the inner peripheral portion A1 of the proximal end split piece 33, and the holes 342h and 342i are axially provided at the proximal end portion of the inner peripheral portion A1 of the distal end split piece 32. It is provided side by side. Further, the holes 342f and 342h are overlapped, and the holes 342g and 342i are overlapped. The wire 39 is drawn out of the main body 31 through the holes 342f and 342h and introduced into the main body 31 through the holes 342g and 342i. Thereby, the connection state of the division | segmentation pieces 32 and 33 is maintained. In the state maintaining mechanism 34E, the split pieces 32 and 33 can be split by pulling out the wire 39 from the base end side opening of the main body 31.
　ワイヤー３９としては、特に限定されず、例えば、ステンレス鋼、コバルト系合金、ニッケル系合金等の各種金属材料で構成されたワイヤーや、ピアノ線で構成されたワイヤーを使用することができる。 The wire 39 is not particularly limited, and for example, a wire made of various metal materials such as stainless steel, a cobalt alloy, a nickel alloy, or a wire made of a piano wire can be used.
　このような第６実施形態によっても、前述した第１実施形態と同様の効果を奏することができる。 Also according to the sixth embodiment, the same effects as those of the first embodiment described above can be obtained.
　＜第７実施形態＞
　図３４は、本発明の第７実施形態に係る穿刺装置が有する穿刺部材を示す図であり、（ａ）が平面図、（ｂ）および（ｃ）がそれぞれ断面図である。なお、図３４では、説明の便宜上、円弧状に延在している穿刺部材を直線的に伸ばして図示している。 <Seventh embodiment>
FIG. 34 is a view showing a puncture member included in the puncture apparatus according to the seventh embodiment of the present invention, in which (a) is a plan view, and (b) and (c) are sectional views. In FIG. 34, for convenience of explanation, the puncture member extending in an arc shape is linearly extended and illustrated.
　以下、この図を参照して穿刺装置の第７実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the seventh embodiment of the puncture device will be described with reference to this drawing, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.
　本実施形態は、主に、穿刺部材の構成が異なること以外は前述した第１実施形態と同様である。 This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
　図３４に示すように、本実施形態の穿刺部材３Ｆが有する状態維持機構３４Ｆは、孔３４２ａと、針体３５の基端部３５２に設けられた孔３５２ａと、糸３４１とを有している。糸３４１は、本体３１内に配置されており、孔３５２ａに挿通されることで針体３５と係合しており、孔３４２ａに挿通されることで基端分割片３３と係合している。このような構成とすると、基端分割片３３と針体３５に先端分割片３２が挟まれた状態を維持することができるため、分割片３２、３３の接続状態を維持することができる。なお、状態維持機構３４Ｆでは、糸３４１を切断することで、分割片３２、３３を分割することのできる状態となる。 As shown in FIG. 34, the state maintaining mechanism 34F included in the puncture member 3F of the present embodiment includes a hole 342a, a hole 352a provided in the proximal end portion 352 of the needle body 35, and a thread 341. . The thread 341 is disposed in the main body 31, is engaged with the needle body 35 by being inserted through the hole 352a, and is engaged with the proximal end split piece 33 by being inserted through the hole 342a. . With such a configuration, it is possible to maintain the state where the distal end divided piece 32 is sandwiched between the proximal end divided piece 33 and the needle body 35, and thus the connection state of the divided pieces 32 and 33 can be maintained. In the state maintenance mechanism 34F, the divided pieces 32 and 33 can be divided by cutting the yarn 341.
　なお、糸３４１は、例えば、有端の糸を用意し、その一端を、基端側開口３３２から本体３１内に挿入し、孔３５２ａを経由し、孔３４２ａから本体３１外へ引き出し、最後に、基端側開口３３２付近で他端と結ぶことで得られる。 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 through the base end side opening 332, pulled out of the main body 31 from the hole 342a through the hole 352a, and finally. It is obtained by tying the other end in the vicinity of the base end side opening 332.
　このような第７実施形態によっても、前述した第１実施形態と同様の効果を奏することができる。 Also according to the seventh embodiment, the same effects as those of the first embodiment described above can be obtained.
　＜第８実施形態＞
　図３５は、本発明の第８実施形態に係る穿刺装置が有する穿刺部材を示す断面図である。図３６は、図３５に示す穿刺部材の変形例を示す断面図である。 <Eighth Embodiment>
FIG. 35 is a cross-sectional view showing a puncture member included in the puncture apparatus according to the eighth embodiment of the present invention. 36 is a cross-sectional view showing a modification of the puncture member shown in FIG.
　以下、この図を参照して穿刺装置の第８実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 Hereinafter, the eighth 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.
　本実施形態は、主に、穿刺部材の構成が異なること以外は前述した第１実施形態と同様である。 This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
　図３５に示すように、本実施形態の穿刺部材３Ｇが有する状態維持機構３４Ｇは、先端分割片３２に設けられた孔３４２ｊ、３４２ｋと、基端分割片３３に設けられた突起３４３ａ、３４３ｂと、本体３１内に挿入されているスタイレット（管体）３４４とを有している。孔３４２ｊ、３４２ｋは、先端分割片３２の基端部の表面Ａ３と裏面Ａ４とに分かれて形成されている。一方、突起３４３ａ、３４３ｂは、基端分割片３３の先端部の表面Ａ３と裏面Ａ４とに分かれて形成されている。そして、突起３４３ａは、孔３４２ｊに係合しており、突起３４３ｂは、孔３４２ｋに係合している。また、スタイレット３４４は、本体３１内に挿入されており、このスタイレット３４４によって、突起３４３ａ、３４３ｂの内側への変位を規制している。このような構成によっても、分割片３２、３３の接続状態を維持することができる。なお、状態維持機構３４Ｇでは、スタイレット３４４を本体３１から引き抜き、突起３４３ａ、３４３ｂが内側へ変位できる状態とすることによって、分割片３２、３３を分割することのできる状態となる。 As shown in FIG. 35, the state maintaining mechanism 34G included in the puncture member 3G of the present embodiment includes holes 342j and 342k provided in the distal end divided piece 32, and protrusions 343a and 343b provided in the proximal end divided piece 33. , And a stylet (tube body) 344 inserted into the main body 31. The holes 342j and 342k are formed to be divided into a front surface A3 and a back surface A4 of the base end portion of the tip split piece 32. On the other hand, the protrusions 343a and 343b are formed separately on the front surface A3 and the back surface A4 of the distal end portion of the base end split piece 33. The protrusion 343a is engaged with the hole 342j, and the protrusion 343b is engaged with the hole 342k. The stylet 344 is inserted into the main body 31, and the stylet 344 regulates the inward displacement of the protrusions 343a and 343b. Even with such a configuration, the connection state of the split pieces 32 and 33 can be maintained. In the state maintaining mechanism 34G, the divided pieces 32 and 33 can be divided by pulling out the stylet 344 from the main body 31 so that the protrusions 343a and 343b can be displaced inward.
　スタイレット３４４の構成材料としては、突起３４３ａ、３４３ｂの変位を規制することができるような硬質材料を用いるのが好ましい。このような硬質材料としては、例えば、ポリエチレン、ポリイミド、ポリアミド、ポリエステルエラストマー、ポリプロピレン等の各種樹脂材料やステンレス鋼、アルミニウムまたはアルミニウム合金、チタンまたはチタン合金のような各種金属材料等を用いることができる。なお、スタイレット３４４の構成として硬質材料を採用する他に、硬質材料以外の材料を採用する場合は、壁を補強部材で補強することでも達成される。 As the constituent material of the stylet 344, it is preferable to use a hard material that can regulate the displacement of the protrusions 343a and 343b. Examples of such a hard material include various resin materials such as polyethylene, polyimide, polyamide, polyester elastomer, and polypropylene, and various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like. . In addition to employing a hard material as the configuration of the stylet 344, when a material other than the hard material is employed, the wall can be reinforced with a reinforcing member.
　このような第８実施形態によっても、前述した第１実施形態と同様の効果を奏することができる。 Also in the eighth embodiment, the same effects as those of the first embodiment described above can be obtained.
　なお、本実施形態では、状態維持機構３４Ｇがスタイレット３４４を有しているが、図３６に示すように、本体３１内に挿入される挿入部７１がスタイレット３４４を兼ねていてもよい。すなわち、挿入部７１が突起３４３ａ、３４３ｂの内側への変位を規制するように構成されていてもよい。 In the present embodiment, the state maintaining mechanism 34G has the stylet 344, but the insertion portion 71 inserted into the main body 31 may also serve as the stylet 344 as shown in FIG. That is, the insertion portion 71 may be configured to restrict the inward displacement of the protrusions 343a and 343b.
　＜第９実施形態＞
　図３７は、本発明の第９実施形態に係る穿刺装置が有する穿刺部材を示す図であり、（ａ）が平面図、（ｂ）および（ｃ）がそれぞれ断面図である。なお、図３７では、説明の便宜上、円弧状に延在している穿刺部材を直線的に伸ばして図示している。 <Ninth Embodiment>
FIG. 37 is a view showing a puncture member included in the puncture apparatus according to the ninth embodiment of the present invention, in which (a) is a plan view and (b) and (c) are sectional views. In FIG. 37, for the convenience of explanation, the puncture member extending in an arc shape is linearly extended and illustrated.
　以下、この図を参照して穿刺装置の第９実施形態について説明するが、前述した実施形態との相違点を中心に説明し、同様の事項はその説明を省略する。 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.
　本実施形態は、主に、穿刺部材の構成が異なること以外は前述した第１実施形態と同様である。 This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is mainly different.
　図３７に示すように、本実施形態の穿刺部材３Ｈが有する状態維持機構３４Ｈは、先端分割片３２に設けられた孔３４２ｌと、弾性を有するワイヤー３８とを有している。ワイヤー３８は、その先端部に、孔３４２ｌに引っ掛かっている先端フック（爪部）３８１を有しており、基端部に、基端分割片３３の基端に引っ掛かっている基端フック（爪部）３８２を有している。そして、先端フック３８１および基端フック３８２を孔３４２ｌおよび基端分割片３３に引っ掛けることによって、分割片３２、３３の接続状態を維持することができる。なお、状態維持機構３４Ｈでは、ワイヤー３８を先端側へ押し込んで先端フック３８１を本体３１内に退避させ、先端フック３８１と孔３４２ｌの係合を解除することによって、分割片３２、３３を分割することのできる状態となる。 As shown in FIG. 37, the state maintaining mechanism 34H included in the puncture member 3H according to the present embodiment includes a hole 342l provided in the tip split piece 32 and a wire 38 having elasticity. The wire 38 has a distal end hook (claw portion) 381 hooked in the hole 342l at the distal end portion, and a proximal end hook (claw) hooked on the proximal end of the proximal end split piece 33 at the proximal end portion. Part) 382. Then, by hooking the tip hook 381 and the base end hook 382 to the hole 342l and the base end split piece 33, the connection state of the split pieces 32 and 33 can be maintained. In the state maintaining mechanism 34H, the divided pieces 32 and 33 are divided by pushing the wire 38 toward the distal end, retracting the distal hook 381 into the main body 31, and releasing the engagement between the distal hook 381 and the hole 342l. It will be in a state that can be.
　このような第９実施形態によっても、前述した第１実施形態と同様の効果を奏することができる。 Also in the ninth embodiment, the same effects as those of the first embodiment described above can be obtained.
　以上、本発明の穿刺装置を図示の実施形態に基づいて説明したが、本発明はこれに限定されるものではなく、各部の構成は、同様の機能を有する任意の構成のものに置換することができる。また、本発明に、他の任意の構成物が付加されていてもよい。 The puncture apparatus according to the present invention has been described based on the illustrated embodiment. However, the present invention is not limited to this, and the configuration of each part may be replaced with an arbitrary configuration having the same function. Can do. In addition, any other component may be added to the present invention.
　また、前記実施形態では、針体が本体（管体）に着脱自在に保持されているが、これに限定されず、例えば、本体（管体）と針体とが一体形成されている等、針体が本体（管体）に固定されていてもよい。この場合には、穿刺部材を生体に穿刺し、針体を生体外へ突出させた後、鋏等を用いて針体を切断することによって、本体（管体）の先端側開口を開放させることができる。 Moreover, in the said embodiment, although the needle body is detachably hold | maintained at a main body (tube body), it is not limited to this, For example, a main body (tube body) and a needle body are integrally formed, etc. The needle body may be fixed to the main body (tube body). In this case, the puncture member is punctured into the living body, the needle body is protruded outside the living body, and then the needle body is cut using a scissors or the like to open the distal end side opening of the main body (tubular body). Can do.
　また、前記実施形態では、本発明の穿刺装置を女性の尿失禁の治療のための埋設可能なインプラントを生体内に埋設する際に用いる装置に適用した場合について説明したが、本発明の穿刺装置の用途は、それに限定されるものではない。 Moreover, although the said embodiment demonstrated the case where the puncture apparatus of this invention was applied to the apparatus used when implanting the implantable implant for the treatment of female urinary incontinence in the living body, the puncture apparatus of this invention was demonstrated. The use of is not limited thereto.
　例えば、本発明は、骨盤底筋群の弱体化にともなう、***障害（尿意切迫感、頻尿、尿失禁、便失禁、尿閉、排尿困難など）、骨盤臓器脱、膀胱膣婁、尿道膣婁、骨盤痛などを含む骨盤底疾患が適用対象に含まれる。骨盤臓器脱には、膀胱瘤、小腸瘤、直腸瘤、子宮脱、などの疾患が含まれる。あるいは、脱している膣壁部位によって分類される呼び方である前方膣壁脱、後方膣壁脱、膣断端脱、膣円蓋部脱、などの疾患が含まれる。 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, cystovaginal fistula, urethral vagina Pelvic floor diseases including epilepsy, pelvic pain, etc. are included in the target of application. Pelvic organ prolapse includes diseases such as cystocele, small intestinal aneurysm, rectal aneurysm, and uterine prolapse. Alternatively, diseases such as anterior vaginal wall prolapse, posterior vaginal wall prolapse, vaginal stump prolapse, and vaginal vault prolapse are classified according to the vagina wall site being removed.
　また、過可動組織には、膀胱、膣、子宮、腸などが含まれる。微可動組織には、骨、筋肉、筋膜、靭帯などが含まれる。特に骨盤底疾患においては、閉鎖筋膜、尾骨筋膜、基靭帯、仙骨子宮靭帯、仙棘（せんきょく）靭帯、などが含まれる。 In addition, the hypermovable tissue includes bladder, vagina, uterus, intestine and the like. Micro-movable tissues include bones, muscles, fascia, ligaments and the like. In particular, in pelvic floor disease, it includes obturator fascia, coccyx fascia, proximal ligament, sacral uterine ligament, sacrospinous ligament, and the like.
　骨盤底疾患における、過可動組織を微可動組織に連結する手技には、恥骨後式スリング手術、経閉鎖孔スリング手術(transobturator sling surgery, transobturator tape; TOT)、経膣メッシュ手術(Tension-free Vaginal Mesh; TVM)、仙骨子宮靭帯を利用した挙上術（Uterosacral Ligament Suspension; USLS）、仙棘靭帯を利用した固定術(Sacrospinous Ligament Fixation; SSLF)、腸骨尾骨筋膜を利用した固定術、尾骨筋膜を利用した固定術、などが含まれる。 In pelvic floor disease, procedures to connect hypermovable tissue to micromovable tissue include retropubic sling surgery, transobturator sling surgery (transobturator sling surgery, transobturator tape; TOT), transvaginal mesh surgery (Tension-free Vaginal Mesh; TVM), elevation using sacral uterine ligament (Uterosacral Ligament Suspension; USLS), fusion using sacrospinous ligament (Sacrospinous Ligament Fixation; SSLF), fusion using iliac coccyx fascia, tailbone Includes fusion using the fascia.
　本発明の穿刺装置は、長尺管状をなす管体と、前記管体の先端部に設けられた針体とを有する穿刺部材と、前記管体に係合可能な第１アンカーおよび第２アンカーと、前記第１アンカーおよび前記第２アンカーを着脱自在に保持する保持部と、を備え、前記穿刺部材が生体の第１部位を穿刺し、前記針先を前記第１部位と異なる第２部位から生体外へ突出させると、前記管体の前記第１部位から生体外へ突出している部分に前記第１アンカーが係合し、前記第２部位から生体外へ突出している部分に前記第２アンカーが係合するよう構成されている。そのため、穿刺部材を生体に穿刺した状態で、管体に係合した第１、第２アンカーが体表面に当接するため、管体の先端および基端が生体内へ埋没することを防止することができる。言い換えると、管体の先端側開口および基端側開口が共に、生体外に露出した状態を維持することができる。そのため、管体内へのインプラントの挿入を容易に行うことができ、管体内にインプラントを配置した状態で、管体のみを生体から抜去することで、簡単に、インプラントを生体内に埋設することができる。
　したがって、本発明の穿刺装置は、産業上の利用可能性を有する。 The puncture device of the present invention includes a puncture member having a tubular body having a long tubular shape, a needle body provided at a distal end portion of the tubular body, and a first anchor and a second anchor that can be engaged with the tubular body. And a holding part that detachably holds the first anchor and the second anchor, the puncture member punctures a first part of a living body, and the needle tip is a second part different from the first part The first anchor engages with a portion of the tubular body protruding from the first portion to the outside of the living body, and the second portion protrudes from the second portion to the outside of the living body. An anchor is configured to engage. Therefore, since the first and second anchors engaged with the tubular body come into contact with the body surface while the puncture member is punctured into the living body, the distal end and the proximal end of the tubular body are prevented from being buried in the living body. Can do. In other words, both the distal end side opening and the proximal end side opening of the tubular body can be kept exposed to the outside of the living body. Therefore, the implant can be easily inserted into the tubular body, and the implant can be easily embedded in the living body by removing only the tubular body from the living body while the implant is placed in the tubular body. it can.
Therefore, the puncture device of the present invention has industrial applicability.
１　　　　穿刺装置
２　　　　フレーム
２１　　　軸受部
２１１　　貫通孔
２２　　　案内部
２２１　　案内溝
２２２　　先端側開口
２２３　　基端側開口
２３　　　連結部
２４　　　固定部
２４３　　凹部
２４４　　雄ネジ
３　　　　穿刺部材
３Ａ　　　穿刺部材
３Ｂ　　　穿刺部材
３Ｃ　　　穿刺部材
３Ｄ　　　穿刺部材
３Ｅ　　　穿刺部材
３Ｆ　　　穿刺部材
３Ｇ　　　穿刺部材
３Ｈ　　　穿刺部材
３０　　　シース
３１　　　本体
３１Ｂ　　本体
３１５　　係合孔
３１５ａ　輪郭
３１５ｂ　輪郭
３１６　　係合孔
３１６ａ　輪郭
３１６ｂ　輪郭
３１７　　係合孔
３１８　　係合孔
３１９　　テーパ部
３２　　　先端分割片
３２１　　先端側開口
３２２　　基端側開口
３３　　　基端分割片
３３１　　先端側開口
３３２　　基端側開口
３４　　　状態維持機構
３４Ｃ　　状態維持機構
３４Ｄ　　状態維持機構
３４Ｅ　　状態維持機構
３４Ｆ　　状態維持機構
３４Ｇ　　状態維持機構
３４Ｈ　　状態維持機構
３４１　　糸
３４１ａ　結び目
３４１ｂ　結び目
３４２ａ　孔
３４２ｂ　孔
３４２ｃ　孔
３４２ｄ　孔
３４２ｅ　孔
３４２ｆ　孔
３４２ｇ　孔
３４２ｈ　孔
３４２ｉ　孔
３４２ｊ　孔
３４２ｋ　孔
３４２ｌ　孔
３４３ａ　突起
３４３ｂ　突起
３４４　　スタイレット
３４５　　露出孔
３４６　　露出孔
３４７　　スリット
３４７ａ　部分
３４７ｂ　部分
３４８　　孔
３４９　　糸
３５　　　針体
３５１　　針先
３５２　　基端部
３５２ａ　孔
３５３　　係合部
３６　　　脆弱部
３６１　　ミシン目
３８　　　ワイヤー
３８１　　先端フック
３８２　　基端フック
３９　　　ワイヤー
４　　　　尿道挿入部材
４０　　　支持部
４１　　　尿道挿入部
４１１　　挿入部
４１２　　非挿入部
４２　　　バルーン
４３　　　バルーンポート
４４　　　吸引孔
４５　　　吸引ポート
４６　　　マーカー
４７　　　尿排出部
４７１　　排出孔
４８　　　尿排出ポート
５　　　　膣挿入部材
５０　　　支持部
５０１　　雄ネジ
５１　　　膣挿入部
５１１　　挿入部
５１１ａ　上面
５１１ｂ　下面
５１２　　非挿入部
５３　　　凹部
５４　　　吸引ポート
５７　　　マーカー
５９　　　吸引孔
６　　　　挿入具
６０　　　支持部
７　　　　操作部材
７１　　　挿入部
７１１　　先端部
７１２　　針先
７１２ａ　面積漸増部
７１２ｂ　面積漸減部
７１２ｃ　境界部
７２　　　連結部
７３　　　軸部
８１　　　アンカー
８１１　　基部
８１２　　挿通孔
８１３　　爪部
８１４　　爪部
８２　　　アンカー
８２１　　基部
８２２　　挿通孔
８２３　　爪部
８２４　　爪部
９　　　　インプラント
９１　　　インプラント本体
９１１　　本体部
９１２　　帯
９２　　　包材
１１００　骨盤
１１０１　閉鎖孔
１１０２　閉鎖孔
１２００　恥骨結合
１３００　尿道
１３１０　膀胱
１４００　膣
１４１０　膣前壁
２０００　注射器
Ａ１　　　内周部
Ａ２　　　外周部
Ａ３　　　表面
Ａ４　　　裏面
Ｄ　　　　離間距離
ｆ１　　　平面
ｆ２　　　平面
ｆ９　　　平面
Ｈ　　　　体表面
Ｊ１　　　軸
Ｊ２　　　軸
Ｊ３１　　短軸
Ｊ３２　　長軸
Ｊ３２’　延長線
Ｊ５　　　中心軸
Ｌ２　　　長さ
Ｏ　　　　中心
Ｐ　　　　交点
ｒ１　　　最少曲率半径
ｒ２　　　最大曲率半径
Ｓ１　　　領域
Ｓ２　　　領域
Ｓ３　　　空間
Ｓ４　　　中央部
Ｓ５　　　セーフティゾーン
Ｗ　　　　幅
Ｗ１　　　幅
Ｗ２　　　幅
θ１　　　傾斜角
θ２　　　傾斜角
θ３　　　傾斜角
θ４　　　中心角
θ５　　　角 DESCRIPTION OF SYMBOLS 1 Puncture apparatus 2 Frame 21 Bearing part 211 Through-hole 22 Guide part 221 Guide groove 222 Front end side opening 223 Base end side opening 23 Connection part 24 Fixing part 243 Recess 244 Male screw 3 Puncture member 3A Puncture member 3B Puncture member 3C Puncture member 3D Puncture member 3E Puncture member 3F Puncture member 3G Puncture member 3H Puncture member 30 Sheath 31 Main body 31B Main body 315 Engagement hole 315a Contour 315b Contour 316 Engagement hole 316a Contour 316b Contour 317 Engagement hole 318 Engagement hole 319 Taper part 32 Tip division Piece 321 distal end side opening 322 proximal end side opening 33 proximal end divided piece 331 distal end side opening 332 proximal end side opening 34 state maintaining mechanism 34C state maintaining mechanism 34D state maintaining mechanism 34E state maintaining mechanism 34F state maintaining mechanism 34G state maintaining mechanism 34H state Wei Mechanism 341 Thread 341a Knot 341b Knot 342a Hole 342b Hole 342c Hole 342d Hole 342e Hole 342f Hole 342g Hole 342h Hole 342i Hole 342j Hole 342k Hole 342l Hole 343a Projection 343 B Projection 344 Style 3 348 Hole 349 Thread 35 Needle body 351 Needle tip 352 Base end 352a Hole 353 Engaging portion 36 Weak portion 361 Perforation 38 Wire 381 Tip hook 382 Base end hook 39 Wire 4 Urethral insertion member 40 Supporting portion 41 Urethral insertion portion 411 Insertion Part 412 Non-insertion part 42 Balloon 43 Balloon port 44 Suction hole 45 Suction port 46 Marker 47 Urine discharge part 471 Drain hole 48 Urine discharge port 5 Vaginal insertion member 50 Supporting part 501 Male screw 51 Vaginal insertion part 511 Insertion part 511a Upper surface 511b Lower surface 512 Non-insertion part 53 Recessed part 54 Suction port 57 Marker 59 Suction hole 6 Insertion tool 60 Supporting part 7 Operating member 71 Insertion part 711 Tip part 712 Needle tip 712a Area Gradually increasing portion 712b Area gradually decreasing portion 712c Boundary portion 72 Connecting portion 73 Shaft portion 81 Anchor 811 Base portion 812 Inserting hole 813 Claw portion 814 Claw portion 82 Anchor 821 Base portion 822 Inserting hole 823 Claw portion 824 Claw portion 9 Implant 91 Implant 91 Implant body 911 Body portion 912 Belt 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 f1 Plane f2 plane f9 plane H body surface J1 axis J2 axis J31 minor axis J32 major axis J32 'extension line J5 central axis L2 length O center P intersection r1 minimum radius of curvature r2 maximum radius of curvature S1 area S2 area S3 space S4 center S5 Safety zone W Width W1 Width W2 Width θ1 Inclination angle θ2 Inclination angle θ3 Inclination angle θ4 Center angle θ5 Angle

Claims (15)

  1. 　長尺管状をなす管体と、前記管体の先端部に設けられた針体とを有する穿刺部材と、
    　前記管体に係合可能な第１アンカーおよび第２アンカーと、
    　前記第１アンカーおよび前記第２アンカーを着脱自在に保持する保持部と、を備え、
    　前記穿刺部材が生体の第１部位を穿刺し、前記針先を前記第１部位と異なる第２部位から生体外へ突出させると、この過程にて、前記管体の前記第１部位から生体外へ突出している部分に前記第１アンカーが係合し、前記第２部位から生体外へ突出している部分に前記第２アンカーが係合するよう構成されていることを特徴とする穿刺装置。     A puncture member having a long tubular body, and a needle body provided at the distal end of the tubular body;
    A first anchor and a second anchor engageable with the tube;
    A holding portion for detachably holding the first anchor and the second anchor,
    When the puncture member punctures the first part of the living body and causes the needle tip to protrude out of the living body from a second part different from the first part, in this process, the first part of the tubular body is ex vivo. A puncture device, wherein the first anchor is engaged with a portion protruding to the outside, and the second anchor is engaged with a portion protruding from the second portion to the outside of the living body.
  2. 　前記第２アンカーは、前記管体に係合する爪部を有し、前記爪部が前記穿刺部材の移動方向の前方側に向くように、前記保持部に保持されている請求項１に記載の穿刺装置。 The said 2nd anchor has a nail | claw part engaged with the said tubular body, The said nail | claw part is hold | maintained at the said holding | maintenance part so that it may face the front side of the moving direction of the said puncture member. Puncture device.
  3. 　前記穿刺部材は、前記第１アンカーと係合する第１係合部と、前記第２アンカーと係合する第２係合部と、を有し、
    　前記穿刺部材が生体の第１部位に穿刺されていない初期状態では、前記１アンカーと前記第２係合部が係合しており、
    　前記穿刺部材が前記第１部位を穿刺し、前記針先を前記第２部位から生体外へ突出させると、この過程にて、前記第１アンカーと前記第２係合部との係合が解除され、前記第１アンカーと前記１係合部とが係合し、前記第２アンカーと前記第２係合部とが係合する請求項１または２に記載の穿刺装置。     The puncture member has a first engagement portion that engages with the first anchor, and a second engagement portion that engages with the second anchor,
    In an initial state where the puncture member is not punctured into the first part of the living body, the first anchor and the second engagement portion are engaged,
    When the puncture member punctures the first portion and causes the needle tip to protrude from the second portion to the outside of the living body, the engagement between the first anchor and the second engagement portion is released in this process. The puncture apparatus according to claim 1, wherein the first anchor and the first engagement portion are engaged, and the second anchor and the second engagement portion are engaged.
  4. 　前記針体は、前記管体に対して離脱可能である請求項１ないし３のいずれか１項に記載の穿刺装置。 The puncture apparatus according to any one of claims 1 to 3, wherein the needle body is detachable from the tube body.
  5. 　前記穿刺部材は、前記第１部位から生体に穿刺され、一方の閉鎖孔、尿道と膣との間、他方の閉鎖孔を順に通過し、前記第２部位から生体外へ突出する請求項１ないし４のいずれか１項に記載の穿刺装置。 The puncture member is punctured into the living body from the first part, passes through one obturator hole, between the urethra and the vagina, and sequentially through the other obturator hole, and protrudes out of the living body from the second part. The puncture device according to any one of 4.
  6. 　前記管体は、円弧状に湾曲する部分を有している請求項５に記載の穿刺装置。 The puncture apparatus according to claim 5, wherein the tubular body has a portion curved in an arc shape.
  7. 　前記針体の移動経路を含む平面は、女性の尿道の軸を法線とする平面に対して２０°～６０°傾斜している請求項５または６に記載の穿刺装置。 The puncture apparatus according to claim 5 or 6, wherein a plane including the moving path of the needle body is inclined 20 ° to 60 ° with respect to a plane having a normal to the female urethra axis.
  8. 　前記尿道に挿入する尿道挿入部を有し、
    　前記針体の移動経路を含む平面は、前記尿道挿入部の中心軸を法線とする平面に対して２０°～６０°傾斜している請求項５または６に記載の穿刺装置。     Having a urethral insertion part to be inserted into the urethra,
    The puncture apparatus according to claim 5 or 6, wherein a plane including the moving path of the needle body is inclined by 20 ° to 60 ° with respect to a plane having a normal to the central axis of the urethral insertion portion.
  9. 　前記管体は、少なくとも、長手方向の中央部での横断面形状が偏平形状であり、
    　前記穿刺部材が生体へ穿刺された状態では、前記中央部が前記尿道と前記膣との間に位置し、かつ、前記中央部の長軸方向が前記尿道とほぼ平行となっている請求項５ないし８のいずれか１項に記載の穿刺装置。     The tubular body has at least a flat cross-sectional shape at the center in the longitudinal direction,
    6. The state in which the puncture member is punctured into a living body, the central portion is located between the urethra and the vagina, and the major axis direction of the central portion is substantially parallel to the urethra. 9. The puncture device according to any one of items 8 to 8.
  10. 　前記管体は、前記第１アンカーを係合させる先端分割片と、前記先端分割片の基端側に接続され、前記第２アンカーを係合させる基端分割片とを有している請求項１ないし９のいずれか１項に記載の穿刺装置。 The said pipe body has the front end division piece which engages with the said 1st anchor, and the base end division piece which is connected to the base end side of the said front end division piece and engages with the said 2nd anchor. 10. The puncture device according to any one of 1 to 9.
  11. 　前記穿刺部材は、前記先端分割片と前記基端分割片との接続状態を維持する状態維持機構を有している請求項１０に記載の穿刺装置。 The puncture device according to claim 10, wherein the puncture member has a state maintaining mechanism for maintaining a connection state between the distal end divided piece and the proximal end divided piece.
  12. 　前記状態維持機構は、前記管体に配置され、前記先端分割片と前記基端分割片とを接続する接続部材を有している請求項１１に記載の穿刺装置。 The puncture device according to claim 11, wherein the state maintaining mechanism includes a connection member that is disposed on the tube body and connects the distal end divided piece and the proximal end divided piece.
  13. 　前記管体に挿入可能な長尺状をなし、前記管体よりも剛性が高い挿入部を備え、前記管体に前記挿入部を挿入した状態で用いられる請求項１ないし１２のいずれか１項に記載の穿刺装置。 13. The device according to claim 1, wherein the tube body has an elongated shape that can be inserted into the tube body, has an insert portion that is higher in rigidity than the tube body, and is used in a state in which the insert portion is inserted into the tube body. The puncture device according to 1.
  14. 　前記挿入部の先端部は、前記針体と係合している請求項１３に記載の穿刺装置。 The puncture apparatus according to claim 13, wherein a distal end portion of the insertion portion is engaged with the needle body.
  15. 　尿道と膣との間にインプラントを留置して、骨盤内臓器における疾患の治療に用いられる請求項１ないし１４のいずれか１項に記載の穿刺装置。 15. The puncture device according to any one of claims 1 to 14, wherein the puncture device is used for treatment of a disease in a pelvic organ by placing an implant between the urethra and the vagina.
PCT/JP2013/059899 2013-04-01 2013-04-01 Puncture device WO2014162434A1 (en)

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CN108042139A (en) * 2018-01-15 2018-05-18 林新颖 Wean anus locking three-dimensional measurement punctures ruler
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US9498207B2 (en) 2012-12-13 2016-11-22 Ethicon Endo-Surgery, Llc Cartridge interface for surgical suturing device
US9357998B2 (en) 2012-12-13 2016-06-07 Ethicon Endo-Surgery, Llc Circular needle applier with articulating and rotating shaft
US9173655B2 (en) 2012-12-13 2015-11-03 Ethicon Endo-Surgery, Inc. Needle driver and pawl mechanism for circular needle applier
US9986998B2 (en) 2012-12-13 2018-06-05 Ethicon Llc Cartridge interface for surgical suturing device
US9398905B2 (en) 2012-12-13 2016-07-26 Ethicon Endo-Surgery, Llc Circular needle applier with offset needle and carrier tracks
US9427227B2 (en) 2012-12-13 2016-08-30 Ethicon Endo-Surgery, Llc Suturing device with reusable shaft and disposable cartridge
US9220496B2 (en) 2012-12-13 2015-12-29 Ethicon Endo-Surgery, Llc Packaging for surgical needle cartridge and suture
US9486209B2 (en) 2012-12-13 2016-11-08 Ethicon Endo-Surgery, Llc Transmission for driving circular needle
US10939909B2 (en) 2012-12-13 2021-03-09 Ethicon Llc Circular needle applier with articulating and rotating shaft
US9474522B2 (en) 2014-06-06 2016-10-25 Ethicon Endo-Surgery, Llc Jawed receiver for needle cartridge
US9375212B2 (en) 2014-06-06 2016-06-28 Ethicon Endo-Surgery, Llc Circular needle applier with cleats
US9788830B2 (en) 2014-06-06 2017-10-17 Ethicon Llc Needle cartridge with cage
US10004490B2 (en) 2014-06-06 2018-06-26 Ethicon Llc Force limited needle driver
US9526495B2 (en) 2014-06-06 2016-12-27 Ethicon Endo-Surgery, Llc Articulation control for surgical instruments
US10022120B2 (en) 2015-05-26 2018-07-17 Ethicon Llc Surgical needle with recessed features
USD800306S1 (en) 2015-12-10 2017-10-17 Ethicon Llc Surgical suturing device
USD861166S1 (en) 2015-12-10 2019-09-24 Ethicon Llc Surgical suturing device
CN108042139A (en) * 2018-01-15 2018-05-18 林新颖 Wean anus locking three-dimensional measurement punctures ruler

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