WO2015137116A1 - Puncturing member - Google Patents

Puncturing member Download PDF

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Publication number
WO2015137116A1
WO2015137116A1 PCT/JP2015/055359 JP2015055359W WO2015137116A1 WO 2015137116 A1 WO2015137116 A1 WO 2015137116A1 JP 2015055359 W JP2015055359 W JP 2015055359W WO 2015137116 A1 WO2015137116 A1 WO 2015137116A1
Authority
WO
WIPO (PCT)
Prior art keywords
puncture
needle body
distal end
sheath
puncture member
Prior art date
Application number
PCT/JP2015/055359
Other languages
French (fr)
Japanese (ja)
Inventor
政克 川浦
奈央 横井
侑右 高橋
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
Publication of WO2015137116A1 publication Critical patent/WO2015137116A1/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
    • A61B17/062—Needle manipulators
    • A61B17/0625—Needle manipulators the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • 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
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B2017/0608—J-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3413—Needle locating or guiding means guided by ultrasound

Definitions

  • the present invention relates to a puncture member.
  • 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 surgeon 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 the closing 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 member that can safely perform a procedure of embedding a living tissue supporting indwelling object in a living body.
  • a tubular medical tube A needle body connected to the distal end of the medical tube, The needle body has a widened portion, The puncture member according to claim 1, wherein a width of the widened portion is larger than a width of a distal end portion of the medical tube.
  • the medical tube includes an outer tube and an inner tube disposed in the outer tube and slidable with respect to the outer tube, and the medical tube is applied to at least one of the outer tube and the inner tube.
  • the puncture member according to (2) which has a contact surface.
  • the width of the widened portion is larger than the width of the distal end portion of the outer tube
  • the puncture member according to any one of (3) to (5), wherein a width of the distal end portion of the outer tube is larger than a width of the distal end portion of the inner tube.
  • the needle body has a needle portion having the widened portion and a proximal end portion located on the proximal end side of the needle portion, and the proximal end portion is inserted into the medical tube.
  • the puncture member according to any one of (1) to (6) above.
  • a needle that punctures a living body A shaft portion having a first shaft portion located on the proximal end side of the needle body and inserted into the living body together with the needle body;
  • a puncture member comprising: a connecting portion that is provided at a distal end portion of the first shaft portion and removably connects the first shaft portion and the needle body.
  • a restricting portion that restricts movement of the needle body to the proximal end side while allowing movement of the first shaft portion to the proximal end side, When the movement of the needle body to the proximal end side is restricted by the restricting portion, the needle body and the first shaft portion are separated from each other when the first shaft portion moves to the proximal end side ( The puncture member according to 14) or (15).
  • a protrusion is provided on one of the needle body and the connection portion, and a connection hole connected to the protrusion is provided on the other,
  • the puncture member according to any one of (14) to (16), wherein the first shaft portion and the needle body are connected by inserting the protrusion into the connection hole.
  • the protrusion has an elastically deformable portion that can be reduced with respect to a natural state by elastic deformation
  • the connection hole has an introduction part having a smaller width than the elastically deforming part in the natural state, and a widening part located on the back side of the introduction part and having a width larger than the introduction part
  • the shaft portion includes the first shaft portion and a second shaft portion slidable with respect to the first shaft portion, and the first shaft portion and the second shaft.
  • the puncture member according to any one of (14) to (19), wherein the puncture member can be extended by sliding with a portion.
  • the medical tube includes an outer tube and an inner tube which is disposed in the outer tube and is slidable with respect to the outer tube, and is extended by sliding the outer tube and the inner tube.
  • (23) a needle body; A first shaft portion that is positioned on the proximal end side of the needle body and is detachably coupled to the needle body; and a second shaft portion that is slidably coupled to the first shaft portion.
  • the shaft A restricting portion that restricts movement of the second shaft portion to the proximal end side while allowing movement of the first shaft portion to the proximal end side; and
  • a puncture apparatus comprising: a support portion that supports the shaft portion.
  • the medical tube has an outer tube and an inner tube that is disposed in the outer tube and is slidable with respect to the outer tube, and is extended by sliding the outer tube and the inner tube.
  • a puncture member characterized by comprising:
  • the connecting portion has at least a pair of insertion holes that are spaced apart in the extending direction of the second shaft portion, and the second shaft portion is inserted through the pair of insertion holes,
  • the puncture member according to (33) wherein a distance between the first shaft portion and the second shaft portion is maintained within the predetermined distance between the pair of insertion holes.
  • the connecting portion allows the first shaft portion to move relative to the second shaft portion toward the proximal end side after being in the extended state,
  • a contact surface provided on one of the connecting portion and the second shaft portion and facing the base end side of the second shaft portion; and provided on the other, the base end side on the contact surface.
  • a contact portion is provided in the connecting portion, The puncture member according to (37), wherein the contact surface is provided on the second shaft portion.
  • the medical tube has a flat cross-sectional shape having a short axis and a long axis, In any one of the above (32) to (40), the first shaft portion and the second shaft portion are juxtaposed along the long axis direction of the medical tube in the medical tube.
  • the puncture member as described.
  • the puncture member of the present invention since the width of the needle body is larger than the width of the medical tube, the puncture member can be smoothly punctured into the living body. Specifically, in the puncture member of the present invention, the needle body punctures the living body, and the distal end portion of the medical tube smaller than the puncture hole passes through the puncture hole formed by the puncture. The tip of the tube for use is not easily caught on the wall of the puncture hole. Therefore, the slidability of the puncture member within the puncture hole can be improved, and the formation of the puncture hole for indwelling the living tissue supporting indwelling object can be performed smoothly and with minimal invasiveness. Therefore, the procedure for embedding the living tissue supporting indwelling object in the living body can be performed smoothly and safely.
  • FIG. 1 is a perspective view showing an example of an implant.
  • FIG. 2 is a perspective view showing a puncture device according to a preferred embodiment.
  • FIG. 3 is a side view of the puncture device shown in FIG. 4 is a plan view (sectional view) of a puncture member included in the puncture apparatus shown in FIG.
  • FIG. 5 is a partially enlarged view of FIG. 6 is a view of the sheath of the puncture member shown in FIG. 4, wherein (a) is a perspective view and (b) is a cross-sectional view taken along line AA in (a). 7 is a cross-sectional view taken along the line CC in FIG.
  • FIG. 8 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG. FIG.
  • FIG. 9 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG.
  • FIG. 10 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG.
  • FIG. 11 is a plan view of a fixing portion of a frame included in the puncture device shown in FIG.
  • FIG. 12 is a side view of the insertion tool included in the puncture device shown in FIG. 2.
  • FIG. 13 is a diagram showing the positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view.
  • FIG. 14 is a top view of the distal end portion of the vaginal insertion tool shown in FIG.
  • FIG. 15A is a cross-sectional view showing an example of the shape of the vagina wall
  • FIG. 15B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG.
  • FIG. 16 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 17 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 18 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 19 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG.
  • FIG. 20 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 21 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 21 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 22 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 23 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 24 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG.
  • FIG. 25 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 1 is a perspective view showing an example of an implant.
  • FIG. 2 is a perspective view showing a puncture device according to a preferred embodiment.
  • FIG. 3 is a side view of the puncture device shown in FIG. 4 is a plan view (sectional view) of a puncture member included in the puncture apparatus shown in FIG.
  • FIG. 5 is a partially enlarged view of FIG. 6 is a view of the sheath of the puncture member shown in FIG. 4, wherein (a) is a perspective view and (b) is a cross-sectional view taken along line AA in (a). 7 is a cross-sectional view taken along the line CC in FIG.
  • FIG. 8 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG.
  • FIG. 9 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG.
  • FIG. 10 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG.
  • FIG. 11 is a plan view of a fixing portion of a frame included in the puncture device shown in FIG.
  • FIG. 12 is a side view of the insertion tool included in the puncture device shown in FIG. 2.
  • FIG. 13 is a diagram showing the positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view.
  • FIG. 14 is a top view of the distal end portion of the vaginal insertion tool shown in FIG. 15A is a cross-sectional view showing an example of the shape of the vagina wall
  • FIG. 15B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG.
  • FIG. 16 to FIG. 25 are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • the left side in FIG. 3 is also referred to as “tip”, the right side is referred to as “base end”, the upper side is also referred to as “upper”, and the lower side is also referred to as “lower”.
  • 2, 3, and 4 each show a state that is not yet used (a state when a procedure is started), and hereinafter, this state is also referred to as an “initial state” for convenience of explanation.
  • this state is also referred to as an “initial state” for convenience of explanation.
  • the state where the puncture device shown in FIGS. 2 and 3 is attached to the patient is also referred to as “attached state”.
  • Implant First an example of an implant (living tissue supporting indwelling object) 9 embedded in a living body by a puncture device will be described.
  • the implant 9 is an instrument that can be implanted in a living body for the treatment of female urinary incontinence.
  • the implant 9 is an instrument that supports the urethra, for example, an instrument that supports movement of the urethra in a direction away from the vagina wall when the urethra is about to move toward the vagina wall. It is.
  • a long object having flexibility can be used.
  • the implant 9 has an implant body 91 and a band (connecting portion) 92 connected to one end of the implant body 91.
  • a guide wire, string, thread, or the like may be used.
  • the implant body 91 has a net shape, and the entire shape thereof is a band shape.
  • the implant main body 91 can be configured by, for example, a braided body in which a linear body is crossed, that is, a braided body. Examples of the linear body include a circular cross section, a flat cross section, that is, a strip.
  • the constituent materials of the implant body 91, the band 92, and the packaging material 90 are not particularly limited, and for example, various resin materials having biocompatibility such as polypropylene, polyester, and nylon, fibers, and the like can be used. .
  • the implant 9 having such a configuration is accommodated in a packaging material 90 sterilized in an unused state. Thereby, contamination of the implant 9 can be prevented.
  • the implant 9 has been described above, the implant 9 is not limited to the net shape as long as the same effect can be exhibited.
  • Puncture device 1 shown in FIGS. 2 and 3 is a device used to embed the above-described implant 9 in a living body.
  • the puncture device 1 includes a frame 2, an insertion tool 6, and a puncture member 3, and the puncture member 3 and the insertion tool 6 are supported by the frame 2.
  • the insertion tool 6 includes a urethral insertion tool 4 and a vaginal insertion tool 5.
  • the puncture member 3 is a member that punctures a living body.
  • the puncture member 3 includes an operation member 31, a long sheath (medical tube) 30 attached to the operation member 31, a needle body 39 provided on the distal end side of the sheath 30, And a slide lock portion (regulation portion) 38 provided on the proximal end side of the sheath 30.
  • the sheath 30, the needle body 39, the operation member 31, and the slide lock portion 38 will be described in order.
  • the sheath 30 has a curved shape curved in an arc shape.
  • the sheath 30 is tubular, and the inside of the sheath 30 functions as a space for inserting the operation member 31 (a stylet 321 and a pusher shaft 33 described later) and a space for inserting the implant 9.
  • the sheath 30 includes an outer tube 301 and an inner tube 302 inserted into the outer tube 301, and the inner tube 302 is slidable with respect to the outer tube 301. Therefore, the inner tube 302 can protrude from the distal end side opening of the outer tube 301 from the initial state retracted into the outer tube 301. Thereby, the extendable sheath 30 is obtained. Further, the inner tube 302 can be detached from the opening on the distal end side of the outer tube 301. Thereby, the sheath 30 can be divided
  • a low friction process may be performed on the outer surface of the inner tube 302. Further, if the inner tube 302 can slide to the distal end side of the outer tube 301, the inner tube 302 may not slide to the proximal end side. That is, the sheath 30 may not be able to contract from the extended state as long as it can be extended from the initial state.
  • a contact portion 301 b that contacts the body surface H is provided at the proximal end portion of the outer tube 301.
  • the abutting portion 301b is constituted by a protruding piece provided to protrude from the outer tube 301.
  • the abutting portion 301b abuts on the body surface H when the puncture member 3 (sheath 30) is punctured into the living body, and functions as a stopper that prevents further insertion of the outer tube 301 into the living body. Thereby, it is possible to prevent the proximal end side opening of the outer tube 301 from being buried and hidden in the living body.
  • the distal end portion 301a of the outer tube 301 is an inclined surface that is inclined toward the inner side (center axis side), and has a tapered shape that is reduced in diameter (reduced width) toward the distal end side. I am doing. And the front-end
  • pipe 301 is closely_contact
  • the inner tube 302 can be smoothly slid with respect to the outer tube 301.
  • the tip portion 301a is tapered as in this embodiment.
  • the central angle of the sheath 30 is not particularly limited and is appropriately set according to various conditions.
  • the needle 39 enters the body from one of the buttocks of the patient, Between the urethra and the vagina, it is set so that it can pass through the other closing hole in order and protrude outside the body from the other buttocks.
  • the central angle is preferably about 150 ° to 270 ° in the extended state in which the inner tube 302 protrudes from the outer tube 301 as shown in FIG. 6A and FIG. More preferably, the angle is from about ° to 250 °, and more preferably from about 190 ° to 230 °.
  • the sheath 30 has a flat cross-sectional shape having a short axis J31 and a long axis J32.
  • the flat shape of the sheath 30 is not particularly limited, and is, for example, an oval shape, a convex lens shape in cross section, a rhombus with rounded corners, a rectangle with rounded corners (flat shape), and a central portion at both ends.
  • a spindle shape or the like that is larger (expanded) than the portion can be used.
  • the width of the internal space of the sheath 30 (the length in the direction of the long axis J32) is designed to be substantially the same as the width of the implant body 91. Thereby, the frictional resistance between the implant 9 and the sheath 30 is reduced, and unnecessary force is not applied to the implant 9, and the implant body 91 can be disposed in the sheath 30 in a sufficiently deployed state.
  • the width of the internal space of the sheath 30 may be shorter than the width of the implant body 91. In this case, since the width of the sheath 30 can be suppressed, the puncture member 3 is less invasive.
  • the end located on the inner side in the major axis J32 direction (the side proximal to the center) is also referred to as “inner peripheral part A1”.
  • An end located on the outer side (distal side with respect to the center) in the direction of the long axis J32 is also referred to as “outer peripheral part A2”, a surface facing upward in the drawing is also referred to as “surface A3”, and a surface facing downward Also referred to as “back A4”.
  • a plane including both the center point of the arc of the sheath 30 and the center point of the cross-sectional shape with respect to the longitudinal direction of the sheath 30 is defined as a plane f9.
  • 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. For example, it is preferably about 20 ° to 60 °, more preferably 30 ° to 45 °, and about 35 ° to 40 °. Is more preferable. Thereby, the above-mentioned effect improves further.
  • the numerical range of the inclination angle ⁇ 1 is satisfied at least in the central portion S4, and it is more preferable that it is satisfied in almost the entire region in the extending direction of the sheath 30.
  • the “central portion S4” refers to an area including at least a portion located between the urethra and the vagina in the state where the extended sheath 30 as shown in FIG. To tell.
  • Such a configuration of the sheath 30 can be rephrased as follows. That is, as shown in FIG. 6B, the sheath 30 is formed such that the long axis J32 is inclined with respect to the central axis J5 of the arc, and an extension line J32 ′ between the central axis J5 and the long axis J32 is formed. It can also be said that it is configured to have an intersection P. In this case, the inclination angle ⁇ 5 of the extension line J32 'with respect to the central axis J5 is equal to the inclination angle ⁇ 1. In other words, as shown in FIG.
  • the sheath 30 is located on the inner periphery of the sheath 30 when viewed from the direction of the central axis J5 (axis J1), and has a minimum radius of curvature r1.
  • An inner peripheral portion A1 and an outer peripheral portion A2 located at the outer peripheral edge and having a maximum radius of curvature r2, and the inner peripheral portion A1 and the outer peripheral portion A2 are configured to be shifted in the direction of the central axis J5. It can also be said.
  • the sheath 30 is light transmissive and visible from the outside. Thereby, for example, the state of the member inserted into the sheath 30 can be easily confirmed from the outside.
  • the constituent material of the sheath 30 (the outer tube 301 and the inner tube 302) is not particularly limited, but a hard material that can maintain the shape and the 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 shape and the internal space can be maintained while being inserted into the body.
  • the reinforcing member by embedding a spiral object in the sheath 30, it is possible to further provide flexibility while maintaining the internal space to the extent that the implant 9 can slide.
  • the needle body 39 includes a needle portion 391 having a tapered tip, a base end portion 392 provided on the base end side of the needle portion 391, and a boundary portion between the needle portion 391 and the base end portion 392. And an abutting surface 393.
  • the needle body 39 is detachably connected to the distal end portion of the sheath 30 by fitting the proximal end portion 392 into the distal end portion of the inner tube 302 of the sheath 30.
  • the needle body 39 and the sheath 30 can be connected with an appropriate force.
  • the contact surface 393 is provided on the needle body 39, and the needle body 39 is fitted into the inner tube 302 until the distal end portion of the sheath 30 contacts the contact surface 393. It can be connected properly. Further, by causing the distal end portion of the sheath 30 to contact the contact surface 393, it is possible to prevent the positional deviation between the needle body 39 and the sheath 30 when the stress F1 is applied.
  • the contact surface 393 is preferably formed of a surface substantially orthogonal to the axis of the needle body 39.
  • the needle portion 391 has a flat cross-sectional shape having a major axis and a minor axis, like the sheath 30. Further, as shown in FIG. 5, the needle portion 391 is arranged so that the major axis J42 and the minor axis J41 thereof substantially coincide with the major axis J32 and the minor axis J31 of the sheath 30. Thus, by making the needle part 391 flat, puncture resistance to the living body is reduced, and puncture of the puncture member 3 to the living body can be performed more smoothly.
  • the flat shape of the needle portion 391 is not particularly limited, and is similar to the sheath 30, for example, an oval shape, a convex lens shape in cross section, a diamond shape with rounded corners, a rectangle with rounded corners, a center A spindle shape or the like in which the portion is larger than both end portions can be used.
  • the needle portion 391 has the largest outer diameter (width) in the middle of the extending direction (axial direction), that is, the enlarged diameter portion (widened portion) having a larger outer diameter than the distal end side and the proximal end side portions. 391a. Specifically, the needle portion 391 is arranged on the proximal end side, and an outer diameter gradually increasing portion (width gradually increasing portion) 391b whose outer diameter (width) gradually increases toward the distal end side, and a distal end of the outer diameter gradually increasing portion 391b.
  • the enlarged diameter portion 391a also functions as a peeling portion that peels the living tissue when the puncture member 3 is punctured into the living body. Thereby, the biopsy of the puncture member 3 can be performed more smoothly.
  • the outer diameter of the enlarged diameter portion 391 a is larger than the outer diameter of the distal end portion of the sheath 30. That is, the width of the major axis J42 of the enlarged diameter portion 391a is larger than the width of the major axis J32 of the distal end portion of the sheath 30, and the width of the minor axis J41 of the enlarged diameter portion 391a is smaller than the minor axis J31 of the distal end portion of the sheath 30. Greater than the width of Thereby, the puncture member 3 can be punctured smoothly.
  • the needle body 39 punctures the living body, and the distal end portion of the sheath 30 smaller than the puncture hole passes through the puncture hole formed by the puncture. Is difficult to be caught on the wall of the puncture hole. Therefore, the slidability in the puncture hole of the puncture member 3 can be improved, and the puncture member 3 can be smoothly punctured into the living body.
  • the distal end portion of the sheath 30 is in contact with the contact surface 393, and the distal end portion of the sheath 30 is hidden behind the contact surface 393 when viewed from the distal end side of the needle body 39. The part is difficult to be caught by the wall of the puncture hole.
  • the needle body 39 punctures the living body and peels off the living tissue, and the sheath 30 substantially has a function of piercing the living body and a function of peeling the living tissue.
  • the puncture member 3 is punctured into the living body with the inner tube 302 retracted into the outer tube 301 until halfway, and from the outer tube 301 to the inner tube 302 from the middle. Do this while protruding. Therefore, the “outer diameter of the distal end portion” described above refers to the outer diameter of the distal end portion 301a of the outer tube 301 up to the middle, and the outer diameter of the distal end portion of the inner tube 302 from the middle.
  • the outer diameter of the enlarged diameter portion 391a is larger than the outer diameter of the distal end portion of the outer tube 301, and the outer diameter of the distal end portion of the outer tube 301 is larger than the outer diameter of the distal end portion of the inner tube 302. It can be said that it is getting bigger.
  • the outer diameter of the distal end portion of the inner tube 302 is equal to or slightly smaller than the inner diameter of the outer tube 301.
  • the sheath 30 is configured so that the distal end portion of the inner tube 302 protrudes from the outer tube 301 in the initial state, the distal end portion of the inner tube 302 is expanded, and the outer diameter of the outer tube 301 is increased. You may make it larger than the outer diameter of a front-end
  • the needle body 39 has the outer diameter gradually increasing portion 391b, the following effects can be exhibited.
  • the puncture route is shifted during puncturing of the puncture member 3, it is necessary to retract the puncture member 3 within the puncture hole.
  • the outer diameter gradually increasing portion 391b is not formed, the proximal end of the needle portion 391 becomes “barbed” and can be caught in the wall portion of the puncture hole, and the puncture member 3 can be smoothly retracted. There is a risk of disappearing.
  • the outer diameter gradually increasing portion 391b is provided in the needle portion 391, the above-described catch is reduced, and the puncture member 3 can be smoothly retracted.
  • the constituent material of the needle body 39 is not particularly limited, and for example, the same material as that of the sheath 30 described above can be used.
  • the needle body 39 may be solid or hollow.
  • the operation member 31 is a member that operates the sheath 30. As shown in FIG. 4, the operation member 31 includes a main body 32 and a pusher shaft (second shaft portion) 33.
  • the main body 32 includes a stylet (first shaft portion) 321, a shaft portion 323, and a connecting portion 322 that connects the stylet 321 and the shaft portion 323.
  • the stylet 321 and the pusher shaft 33 constitute a shaft portion 300, and the shaft portion 300 can be extended.
  • the stylet 321 is inserted into the sheath 30 together with the pusher shaft 33, and also functions as a reinforcing portion that reinforces the sheath 30 from the inside.
  • a stylet 321 has a substantially arc shape (curved shape) corresponding to the shape of the sheath 30.
  • the center angle and the radius of curvature of the stylet 321 are set according to the center angle and the radius of curvature of the sheath 30.
  • the shaft portion 323 intersects the center O of the stylet 321 and extends on an axis J1 orthogonal to the plane f1 including the stylet 321 (see FIG. 3).
  • the connecting portion 322 connects the base end portion of the stylet 321 and the distal end portion of the shaft portion 323.
  • the connecting portion 322 has a substantially L shape bent at a substantially right angle on the way.
  • the main body 32 having such a configuration is configured to have higher rigidity than the sheath 30.
  • the constituent material of the main body 32 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 stylet 321, the shaft portion 323, and the connecting portion 322 are all substantially the same thickness, but in order to sufficiently increase the rigidity of the main body 32 and suppress the bending of the main body 32, for example,
  • the connecting part 322 and the shaft part 323 may be thicker than the stylet 321.
  • a handle (operation unit) 324 is fixed to the base end portion of the shaft portion 323. Then, by rotating the handle 324, the operating member 31 can be rotated around the axis J1. Thereby, the puncture apparatus 1 can be operated smoothly.
  • the handle 324 may be omitted, and in this case, for example, the operation member 31 may be rotated by holding the connecting portion 322.
  • the rotation of the handle 324 when the stylet 321 is rotationally moved to the distal end side is also referred to as “forward rotation”
  • the rotation of the handle 324 when the stylet 321 is rotationally moved to the proximal end side is also referred to as “reverse rotation”.
  • the tip of the stylet 321 is provided with a tip (connecting portion) 34.
  • the distal tip 34 mainly includes a first function for detachably connecting the needle body 39 and the stylet 321, a second function for slidably connecting the stylet 321 and the pusher shaft 33, and a stylet. And a third function for restricting the relative positional relationship between the 321 and the pusher shaft 33.
  • the tip tip 34 has a main body 341 to which a stylet 321 is connected, and a protrusion 35 is provided at the tip of the main body 341.
  • the base end portion 392 of the needle body 39 is provided with a connecting hole 394 that opens to the end face. Then, by inserting the protrusion 35 into the connecting hole 394 and connecting them, the needle body 39 and the stylet 321 can be detachably connected via the tip tip 34.
  • the needle body 39 and the stylet 321 are connected via the needle body 39, so that the displacement of the sheath 30 with respect to the stylet 321, specifically, Rotation of the sheath 30 relative to the stylet 321 and displacement in the width direction can be suppressed. Therefore, the puncture member 3 can be punctured more smoothly into the living body.
  • an elastic deformation part 351 is provided that can be reduced in diameter (reduced width) relative to the natural state by elastic deformation.
  • the elastic deformation portion 351 includes two elastic pieces 352 and 353 that are spaced apart from each other, and a gap 354 that is provided between the elastic pieces 352 and 353.
  • Such an elastic deformation portion 351 is reduced in diameter relative to a natural state by elastic deformation of the elastic pieces 352 and 353 toward the inner side (gap 354).
  • the structure of the elastic deformation part 351 becomes simple.
  • the elastic pieces 352 and 353 are easily elastically deformed.
  • the elastic pieces 352 and 353 are provided with protrusions 352a and 353a that protrude outward, and in the natural state, the outer diameter of the elastic deformation portion 351 is larger than the outer diameter of the proximal end portion. Is also getting bigger.
  • the protrusions 352a and 353a are substantially hemispherical so that the base end side is an inclined surface inclined toward the central axis side of the protrusion 35.
  • the connecting hole 394 is positioned on the back side of the introduction portion 394a and the introduction portion 394a smaller than the outer diameter (width) of the elastic deformation portion 351 in the natural state, and is outside the elastic deformation portion 351 in the natural state. And an enlarged diameter portion (widened portion) 394b larger than the diameter (width).
  • the elastic deformation portion 351 is located in the enlarged diameter portion 394b as shown in FIG. In this state, the elastically deformable portion 351 is hooked on the boundary portion between the enlarged diameter portion 394b and the introduction portion 394a, and the connection state between the protrusion 35 and the connection hole 394 is maintained.
  • the puncture route is shifted during the puncture of the puncture member 3, it is necessary to retract the puncture member 3 to correct the puncture route. Since the puncture member 3 is retracted by rotating the handle 324 in the reverse direction, the needle body 39 and the sheath 30 connected to the stylet 321 are also retracted integrally by retracting the stylet 321. . Therefore, the connection strength between the protrusion 35 and the connection hole 394 is designed so that the connection state between the stylet 321 and the needle body 39 is maintained even when the stylet 321 is retracted.
  • the stylet 321 is moved from the needle body 39 when the puncture member 3 is pulled back. It is designed not to come off. Thereby, it is possible to prevent the stylet 321 from detaching from the needle body 39 during retraction.
  • the elastic deformation part 351 is in a natural state. Since the puncture device 1 is in the connected state shown in FIG. 5 in the initial state, the time for which the puncture device 1 is in the connected state (for example, the time from manufacture to use) is long. Therefore, by setting the elastic pieces 352 and 353 to the natural state in the connected state, the time during which the elastic pieces 352 and 353 are elastically deformed can be significantly shortened, and the shape of the elastic pieces 352 and 353 can be changed ( ⁇ And a decrease in elasticity can be prevented. As a result, it is possible to prevent an excessive decrease in force required to release the connected state, and effectively prevent unintentional detachment of the needle body 39 from the stylet 321.
  • the tip 35 is provided with the protrusion 35 and the needle body 39 is provided with the connecting hole 394.
  • the arrangement of the protrusion 35 and the connecting hole 394 is not limited to this, and for example, the tip tip 34 is provided.
  • a connecting hole 394 may be provided on the needle body 39, and the protrusion 35 may be provided on the needle body 39.
  • the distal tip 34 is formed thin so that it can be disposed in the sheath 30, it may be difficult to secure a space for forming the connection hole 394 depending on the size of the sheath 30. Therefore, from the viewpoint of the degree of freedom of arrangement, it is preferable to provide the protrusion 35 on the tip tip 34 and provide the connection hole 394 in the needle body 39 as in this embodiment.
  • the main body portion 341 of the tip tip 34 is provided with a holding portion 36 that holds the pusher shaft 33 in a slidable manner and guides the pusher shaft 33.
  • the pusher shaft 33 will be described. As shown in FIGS. 4 and 5, the pusher shaft 33 is arranged on the outer peripheral side of the stylet 321 so as to be separated from the stylet 321 and bends in a substantially arc shape following the arc of the stylet 321. ing. That is, the pusher shaft 33 has a larger radius of curvature than the stylet 321 and is disposed concentrically with the stylet 321.
  • the central angle of the pusher shaft 33 is not particularly limited, but can be approximately the same as that of the stylet 321.
  • the pusher shaft 33 may be disposed on the inner peripheral side of the stylet 321.
  • the stylet 321 and the pusher shaft 33 are juxtaposed along the long axis J32 (width direction) of the sheath 30.
  • the stylet 321 and the pusher shaft 33 can be made as thick as possible, and the rigidity of the operation member 31 can be further increased.
  • the sheath 30 can be effectively reinforced from the inside by the stylet 321 and the pusher shaft 33, unintentional deformation of the sheath 30 can be reduced.
  • the stylet 321 is disposed substantially at the center of the sheath 30, and the pusher shaft 33 is disposed on the outer peripheral side of the sheath 30.
  • the outer peripheral part of the sheath 30 is thinner than the central part, it is preferable to make the diameter of the pusher shaft 33 smaller than the diameter of the stylet 321 accordingly.
  • the tip of the pusher shaft 33 is fixed to the needle body 39.
  • a step see FIGS. 10 and 21 in which the needle body 39 is pushed out by the pusher shaft 33 and the sheath 30 is extended during the procedure (see FIGS. 10 and 21), but by fixing the pusher shaft 33 to the needle body 39.
  • the pushing force of the pusher shaft 33 can be efficiently transmitted to the needle body 39, and the needle body 39 can be pushed out efficiently. Therefore, the procedure can be performed smoothly.
  • the pusher shaft 33 having such a configuration is configured to have higher rigidity than the sheath 30.
  • the constituent material of the pusher shaft 33 is not particularly limited, and for example, the same material as that of the main body 32 described above can be used.
  • the holding portion 36 that holds the pusher shaft 33 as described above has a pair of guide portions 361 and 362 that protrude to the outer peripheral side of the stylet 321. These guide portions 361 and 362 are arranged apart from each other in the extending direction of the stylet 321. Further, insertion holes 361a and 362a are formed at the distal ends of the guide portions 361 and 362, and the pusher shaft 33 is slidably inserted into the insertion holes 361a and 362a. As a result, the pusher shaft 33 is held by the tip tip 34 and can slide with respect to the stylet 321.
  • the pusher shaft 33 is held by two guide portions 361 and 362 that are separated in the sliding direction of the pusher shaft 33, so that the axis of the pusher shaft 33 as indicated by an arrow Z in FIG. Prevents rotation around.
  • the pusher shaft 33 is curved in an arc shape, if the pusher shaft 33 rotates with respect to the stylet 321, the pusher shaft 33 can be slid in the intended direction. Disappear.
  • the cross-sectional shape of the pusher shaft 33 is an ellipse other than a circle, a quadrangle, a triangle, and the like, and the insertion holes 361a and 362a are formed in a cross-sectional shape of the pusher shaft 33. It is good also as a shape according to. In the present embodiment, the rotation of the pusher shaft 33 is also suppressed by the sheath 30.
  • the distance D1 between the tip tip 34 and the pusher shaft 33 is substantially constant between the guide portions 361 and 362 (insertion holes 361a and 362a). (Within a predetermined distance). Therefore, the function (third function) of the contact portion 37 described later can be more reliably exhibited.
  • the separation distance between the guide portions 361 and 362 varies depending on the rigidity of the pusher shaft 33, but is 0.5 cm to 2.0 cm. It is preferable that it is a grade.
  • the tip tip 34 is provided with an elastically deformable contact portion 37 for restricting the relative positional relationship with the pusher shaft 33.
  • the contact portion 37 protrudes obliquely from between the guide portions 361 and 362 toward the distal end side (the needle body 39 side) of the pusher shaft 33.
  • a concave portion 331 as a relief portion is provided at the distal end portion of the pusher shaft 33, and a concave portion 332 as an engaging portion is provided at the proximal end portion.
  • the distal end portion of the contact portion 37 is located in the recess 331.
  • the contact portion 37 is not elastically deformed and is in a natural state.
  • the time during which the contact portion 37 is elastically deformed can be significantly shortened, and the shape change ( ⁇ ⁇ ) And a decrease in elasticity can be prevented.
  • the function of the contact part 37 can be more reliably exhibited.
  • the shaft portion 300 there is a step of extending the shaft portion 300 by sliding the stylet 321 toward the proximal side with respect to the pusher shaft 33 during the procedure using the puncture device 1 (see FIG. 9). .
  • the tip end portion of the contact portion 37 is positioned in the recess 332.
  • the surface on the distal end side of the recess 332 is a contact surface 332a that is substantially orthogonal to the central axis of the pusher shaft 33 and faces the proximal end side of the pusher shaft 33.
  • the contact surface 332a and the contact portion 37 are provided. Is opposed to or in contact with the front end surface 371.
  • the contact portion 37 is provided in the region (between the guide portions 361 and 262) where the distance D1 between the tip tip 34 and the pusher shaft 33 is maintained constant.
  • the front end surface 371 and the contact surface 332a of the contact portion 37 are more reliably in contact with each other, and the above function can be more reliably exhibited. Therefore, malfunction etc. of the puncture apparatus 1 can be prevented.
  • the surface on the proximal end side of the recess 332 is an inclined surface 332b. Therefore, the stylet 321 can be further slid to the proximal end side with respect to the pusher shaft 33 from the extended state, whereby the pusher shaft 33 can be detached from the distal tip 34.
  • the puncture member 3 can be easily removed from the living body.
  • the contact tip 37 is provided on the tip tip 34, and the recess 332 is provided on the pusher shaft 33.
  • the chip 34 may be provided with a recess 332 and the pusher shaft 33 may be provided with a contact portion 37.
  • the abutting portion 37 is provided on the pusher shaft 33, the design must be made so that the abutting portion 37 does not come into contact with the guide portion 362 when the pusher shaft 33 is slid. There is. Therefore, from the viewpoint of simple design, it is preferable to provide the contact tip 37 on the tip tip 34 and the recess 332 on the pusher shaft 33 as in this embodiment.
  • a portion having a flat shape is included in at least a part of the extending direction of the main body portion 341, and the portion having the flat shape rotates the sheath 30. It preferably functions to prevent. Thereby, unintended displacement and deformation of the sheath 30 can be prevented, and the puncture member 3 can be punctured into the living body more smoothly.
  • the slide lock portion 38 is used to extend the shaft portion 300. As shown in FIG. 4, the slide lock portion 38 is slidably held by the stylet 321. Specifically, the slide lock portion 38 has an insertion hole 389, and the stylet 321 is inserted through the insertion hole 389. Further, the slide lock portion 38 is in contact with the connecting portion 322, thereby preventing the stylet 321 from being detached from the base end side. In such a configuration, when the handle 324 is rotated forward from the initial state, the slide lock portion 38 is pressed by the connecting portion 322, and the slide lock portion 38 moves to the distal end side together with the stylet 321, the pusher shaft 33 and the sheath 30. .
  • the slide lock portion 38 is positioned on the proximal end side of the sheath 30 and the pusher shaft 33 and is in contact with at least the proximal end of the sheath 30. Accordingly, the sheath 30 can be prevented from shifting toward the proximal end during puncturing, and the sheath 30 can be prevented from being detached from the needle body 39.
  • the slide lock portion 38 may not be in contact with the proximal end of the sheath 30 and may be separated. However, the separation distance in this case is preferably shorter than the length of the proximal end portion 392 of the needle body 39 (insertion depth into the inner tube 302). Also by this, the detachment of the sheath 30 from the needle body 39 can be prevented.
  • the slide lock portion 38 is attached to the frame 2 as shown in FIG. Fixed.
  • the slide lock portion 38 is fixed to the frame 2 with a projection (male engagement portion) 381 provided on the slide lock portion 38 and an engagement hole (female engagement) provided on the guide portion 22 of the frame 2. This is performed by engagement with the joint portion 229.
  • the tip of the protrusion 381 is divided into two elastic pieces 382 and 383, and the elastic pieces 382 and 383 are provided with claw portions 382a and 383a.
  • the projection 381 is inserted into the engagement hole 229, and the claw portions 382 a and 383 a pass through the engagement hole 229 and engage with the end surface 229 a, so that the slide lock portion 38 is fixed to the frame 2.
  • the slide lock portion 38 can be fixed to the frame 2 with a simple configuration.
  • the end of the engagement hole 229 on the side where the protrusion 381 is inserted is tapered, and the opening is widened so that the protrusion 381 can be inserted smoothly.
  • the end surface 229 a is a surface facing the outside of the frame 2, and the claw portions 382 a and 383 a are exposed to the outside of the frame 2 when the slide lock portion 38 is fixed to the frame 2. To do. Therefore, the surgeon can visually recognize that the slide lock portion 38 is fixed to the frame 2. Therefore, malfunction of the puncture apparatus 1 can be effectively prevented. Further, since the nail portions 382a and 383a are exposed to the outside of the frame 2, the fixed state can be released by the operator holding the nail portions 382a and 383a and pushing them inward. Therefore, the operability of the puncture device 1 is improved.
  • the arrangement of the protrusions 381 and the engagement holes 229 is not limited to the present embodiment. Contrary to the present embodiment, the slide holes 38 may be provided with the engagement holes 229 and the frame 2 may be provided with the protrusions 381. Good.
  • the pusher shaft 33 protrudes from the distal end side of the stylet 321 and the shaft portion 300 is extended. Further, as described above, in the extended state, as shown in FIG. 9, the contact portion 37 of the tip tip 34 is positioned in the recess 332 of the pusher shaft 33. In this state, since the slide of the stylet 321 to the tip side with respect to the pusher shaft 33 is restricted, after the extended state, the extended state is maintained, that is, the relative position of the stylet 321 and the pusher shaft 33. The shaft portion 300 can be moved to the tip side while maintaining the relationship. Therefore, when the handle 324 is rotated forward again, as shown in FIG.
  • the shaft portion 300 moves to the distal end side while maintaining the extended state, and the needle body 39 moves to the distal end side with it.
  • the inner tube 302 connected to the needle body 39 also moves to the distal end side together with the needle body 39, whereby the inner tube 302 protrudes from the outer tube 301 and the sheath 30 is extended.
  • the shaft portion 300 can be easily extended, and the sheath 30 can be easily extended by the subsequent operation. Therefore, the procedure using the puncture device 1 can be performed smoothly and accurately.
  • the slide lock unit 38 is automatically fixed to the frame 2 when the stylet 321 is moved from the initial state to the distal end side, so that the operation of the puncture apparatus 1 is simplified. Further, as in this embodiment, after the stylet 321 is moved from the initial state to the distal end side, the slide lock portion 38 is fixed to the frame 2, so the stylet 321 is attached to the proximal end side of the stylet 321. Sufficient space for movement is secured. Therefore, the movement of the stylet 321 to the base end side when changing from the restricted state to the extended state can be performed smoothly and reliably.
  • the frame 2 holds the puncture member 3 in a rotatable manner, and fixes the insertion tool 6 in a detachable manner.
  • a frame 2 has a function of determining a puncture route of the needle body 39 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 39 passes between the urethra insertion tool 4 and the vaginal insertion tool 5 without colliding with them. 3.
  • the positional relationship between the urethral insertion tool 4 and the vaginal insertion tool 5 is defined.
  • the frame 2 connects the bearing portion 21 that supports the shaft portion 323 of the puncture member 3, the guide portion 22 that guides the puncture member 3, and the bearing portion 21 and the guide portion 22. And a fixing portion 24 for fixing the insertion tool 6.
  • the bearing portion 21 is located on the proximal end side of the puncture device 1 and extends in a direction substantially orthogonal to the axis J1.
  • a through hole 211 is formed on the shaft J ⁇ b> 1 of the bearing portion 21, and the shaft portion 323 is rotatably inserted into the through hole 211.
  • the puncture member 3 is supported by the frame 2 so as to be rotatable around the axis J1.
  • a handle 324 is disposed behind the bearing portion 21.
  • 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. 4, the guide portion 22 has an arcuate guide groove 221 that guides the puncture member 3, and the sheath 30 is disposed in the guide groove 221. Further, the aforementioned engagement hole 229 is provided at the tip of the guide groove 221.
  • the opening 221a on the distal end side of the guide groove 221 is an opening for projecting the needle body 39 to the outside, and the opening 221b on the proximal end side is formed between the needle body 39 and the guide portion 22 that are projected back to the outside. It is an opening for preventing contact.
  • the opening 221b on the base end side is largely open to the outer side surface and the upper surface of the guide portion 22, thereby making it easy to visually recognize the returned needle body 39, and the returned needle body 39 and the guide portion 22. Effectively prevents contact with Furthermore, the returned needle body 39 can be easily grasped.
  • the needle body 39 is in a state of protruding from the opening 221a on the distal end side of the guide groove 221. Thereby, since the position of the needle body 39 can be visually recognized, the positioning of the needle body 39 can be performed easily.
  • 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 connection part 23 also functions as a grip part. For example, the operator can use the puncture device 1 in a stable state by holding the connecting portion 23 with one hand and operating the handle 324 with the other hand.
  • the fixing part 24 is arranged to face the connecting part 23 via the axis J1.
  • the fixing portion 24 includes a concave portion 243 into which support portions 40 and 50 (described later) of the insertion tool 6 are fitted, and a male screw 244.
  • the insertion tool 6 can be fixed to the fixing part 24 by fitting the supporting parts 40 and 50 into the recessed part 243 and further tightening the male screw 244 into the supporting part 40.
  • the insertion tool 6 has a urethral insertion tool 4 and a vaginal insertion tool 5.
  • the urethral insertion device 4 includes a long urethral insertion portion 41 that is inserted into the urethra halfway and a support portion 40 that supports the urethral insertion portion 41.
  • the constituent materials of the urethral insertion portion 41 and the support portion 40 are not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials can be used. .
  • the length of the urethral insertion portion 41 is not particularly limited, and is appropriately set depending on the length of the urethra of the patient, the shape of the bladder, and the like. Therefore, the length is preferably about 50 mm to 100 mm.
  • the urethral insertion portion 41 has a straight tubular shape.
  • the distal end portion of the urethra insertion portion 41 is provided with a balloon 42 which is an expandable and expandable / contractable expandable body, and a urine discharge portion 47.
  • the balloon 42 is disposed so as to be located in the bladder when the urethral insertion portion 41 is inserted into the urethra.
  • the balloon 42 passes through the urethral insertion portion 41 and is connected to a balloon port 43 provided at the proximal end portion thereof.
  • a balloon expansion device such as a syringe can be connected to the balloon port 43.
  • a working fluid liquid such as physiological saline, gas, etc.
  • the balloon 42 expands
  • the balloon 42 is deflated.
  • a state where the balloon 42 is deflated is indicated by a two-dot chain line
  • a state where the balloon 42 is expanded is indicated by a solid line.
  • the urine discharge part 47 is used to discharge urine in the bladder with the urethra insertion part 41 inserted into the urethra.
  • the urine discharge part 47 is provided with a urine discharge hole 471 that communicates the inside and outside of the urine discharge part 47. Further, the urine drainage hole 471 passes through the urethral insertion portion 41 and is connected to a urine discharge port 48 provided at the base end portion thereof. Therefore, urine introduced from the urine drainage 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 marker 46 for confirming the insertion depth of the urethra insertion part 41 into the urethra is provided in the middle of the urethra insertion part 41.
  • the marker 46 is disposed so that the urethral insertion portion 41 is inserted into the urethra and the balloon 42 is located at the urethral opening when the balloon 42 is located in the bladder. Thereby, the insertion depth to the urethra of the urethra insertion part 41 can be confirmed easily.
  • the marker 46 only needs to be visible from the outside, and can be configured by, for example, a colored portion, an uneven portion, or the like. Further, instead of the marker 46, a scale on which the distance from the tip of the urethral insertion portion 41 is written may be provided.
  • a plurality of suction holes 44 are formed in the middle of the urethra insertion part 41 (at the tip side from the marker 46).
  • the plurality of suction holes 44 are arranged over the entire area in the circumferential direction of the urethral insertion portion 41.
  • Each suction hole 44 passes through the urethra insertion part 41 and is connected to a suction port 45 provided in the support part 40.
  • 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.
  • the urethra insertion part 41 is pushed into the body (the distal end side of the urethra insertion part 41) while the urethra wall is adsorbed and fixed to the urethra insertion part 41, the urethra and the bladder are pushed into the body together with this, and the bladder Can be shifted to a position that does not overlap the puncture path of the needle 39. Therefore, a larger puncture path of the needle body 39 can be secured, and the puncture of the puncture member 3 can be performed accurately and safely.
  • the axis J1 of the puncture member 3 is inclined with respect to the axis J2 so that the separation distance from the axis J2 of the urethral insertion portion 41 increases toward the distal end side.
  • the inclination angle of the axis J1 with respect to the axis J2, in other words, the inclination angle ⁇ 2 of the plane f9 (plane f1) with respect to the plane f2 orthogonal to the axis J2, is not particularly limited, but is preferably about 20 ° to 60 °, preferably 30 More preferably, the angle is about 45 ° to 45 °, and further preferably about 35 ° to 40 °.
  • the puncture of the puncture member 3 can be performed easily, and the puncture distance by the puncture member 3 can be further shortened.
  • the needle body 39 can widely capture the closed holes 1101 and 1102 of the pelvis 1100 in a plane, A wide puncture space for the needle body 39 can be secured.
  • the needle body 39 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 needle body 39 can be punctured easily.
  • the needle body 39 passes through a shallow portion of the living body. Pass in a short distance. Therefore, as shown in FIG. 13B, the needle body 39 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 needle body 39 can be punctured safely by passing through the safety zone S5. Therefore, the procedure using the puncture device 1 becomes less invasive, and the burden on the patient can be kept small.
  • the inclination angle ⁇ 2 within the above range, it is possible to more appropriately puncture the needle body 39 to the patient.
  • 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 suitable location for implanting the urinary incontinence by implanting the implant 9, so that more effective treatment can be achieved by targeting the tissue between the middle urethra and the vagina. It can be carried out.
  • the needle body 39 When the inclination angle ⁇ 2 is less than the above lower limit value or exceeds the above upper limit value, the needle body 39 widely captures the closed holes 1101 and 1102 in a plan view depending on individual differences of patients, postures during the procedure, and the like. In some cases, the puncture route of the needle 39 cannot be shortened sufficiently.
  • the urethral insertion portion 41 may not be slidable with respect to the support portion 40, and may be slidable with respect to the support portion 40.
  • 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 may be configured to be fixed to the support part 40. According to this configuration, since the length of the urethral insertion portion 41 can be adjusted, the urethral insertion tool 4 is more convenient to use. This also applies to the vaginal insertion tool 5 described later.
  • the urethral insertion tool 4 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. As a result, the inclination angle ⁇ 2 can be adjusted in accordance with individual differences of patients and postures during the procedure, so that the puncture device 1 is more convenient to use.
  • the vaginal insertion tool 5 includes a long vaginal insertion portion 51 that is inserted into the vagina partway and a support portion 50 that supports the vaginal insertion portion 51.
  • the vaginal insertion portion 51 has a distal end portion 52 located on the distal end side and a shaft portion 53 connected to the proximal end portion of the distal end portion 52, and the shaft portion 53 is supported by the support portion 50.
  • the support portion 50 is provided with a male screw 501, and the vaginal insert 5 can be fixed to the urethral insert 4 by tightening the male screw 501 into a female screw (not shown) of the support 40. it can.
  • the constituent materials of the vaginal insertion part 51 and the support part 50 are not particularly limited.
  • the urethra insertion device 4 urethra insertion part 41 and support part 40
  • stainless steel aluminum or an aluminum alloy
  • titanium or titanium Various metal materials such as alloys and various resin materials can be used.
  • the distal end portion 52 is a portion to be inserted into the vagina, and has an almost constant width as a whole as shown in FIG. 14, and the distal end portion is rounded. Moreover, the front-end
  • the length L2 of the distal end portion 52 is not particularly limited, but is preferably about 20 mm to 100 mm, and more preferably about 30 mm to 60 mm.
  • the width W1 of the tip 52 is not particularly limited, but is preferably about 10 mm to 50 mm, and more preferably about 20 mm to 40 mm. By setting such length (L2) ⁇ width (W1), the tip 52 has a shape and size suitable for a general vagina. Therefore, the stability of the puncture device 1 in the mounted state is increased, and the burden on the patient is reduced.
  • the top surface 52a (surface on the urethra insertion portion 41 side) 52a is inclined with respect to the urethra insertion portion 41 so that the distal end portion 52 is separated from the urethra insertion portion 41 toward the distal end. ing.
  • the positional relationship between the urethral insertion portion 41 and the distal end portion 52 can be made closer to the actual positional relationship between the urethra and the vagina. Therefore, the puncture device 1 is more stably held by the patient in the wearing state, and the burden on the patient is reduced.
  • the inclination angle ⁇ 3 (see FIG. 3) of the upper surface 52a with respect to the urethral insertion portion 41 is not particularly limited, but is preferably about 0 ° to 45 °, and more preferably about 0 ° to 30 °. Thereby, the said effect can be exhibited more notably.
  • 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.
  • a suction part 523 is provided on the upper surface 52a of the tip part 52.
  • the suction portion 523 includes a bottomed recess 524 that opens to the upper surface 52a, a plurality of suction holes 525 provided in the bottom surface of the recess 524, and a lattice-like rib 526 that divides the interior of the recess 524 into a plurality of regions. Have.
  • Each of the plurality of suction holes 525 is connected to a suction port 54 provided at the proximal end portion of the distal end portion 52.
  • the suction port 54 is provided so as to be located outside the living body in the mounted state.
  • the rib 526 is erected from the bottom surface of the recess 524, and has a plurality of wall portions extending in the length direction of the distal end portion 52 and a plurality of wall portions extending in the width direction.
  • a plurality of suction holes 525 are arranged so as to overlap these intersections. By arranging the suction hole 525 in this manner, it is possible to prevent the suction hole 525 from being blocked by the vagina wall by the vagina wall that has bitten into the recess 524 when adsorbing the vagina wall. For this reason, the vaginal wall can be more reliably adsorbed.
  • the height of the rib 526 is not particularly limited, and may be, for example, the same height as the recess 524, may be higher than the recess 524, or may be lower than the recess 524.
  • a suction device such as a pump can be connected to the suction port 54.
  • the suction device When the suction device is operated with the tip 52 inserted into the vagina, the front wall of the vagina is adsorbed and fixed to the tip 52.
  • the vaginal insertion portion 51 When the vaginal insertion portion 51 is pushed into the body (the distal end side of the vaginal insertion portion 51) with the front wall of the vagina adsorbed and fixed to the distal end portion 52, the vagina can be pushed together with this. Therefore, the arrangement and shape of the vagina can be adjusted, and the puncture route of the needle body 39 can be sufficiently secured. As a result, the puncture member 3 can be punctured accurately and safely.
  • the region S2 in which the suction part 523 is formed is opposed to the region S1 in which the suction hole 44 is formed.
  • the puncture apparatus 1 is comprised so that the needle body 39 may pass between these area
  • the urethra wall is adsorbed by the urethral insertion portion 41, and in the region S2, the vagina wall is adsorbed by the tip 52, so that the urethra wall and the vagina wall are wider and more reliably between the regions S1 and S2. It is separated.
  • the needle body 39 By passing the needle body 39 through such a region, the needle body 39 can be punctured more safely.
  • the region S2 covers substantially the entire width direction of the upper surface 52a.
  • the width W2 of the region S2 is not particularly limited, but is preferably about 9 to 49 mm, and more preferably about 19 to 39 mm. Accordingly, the vaginal wall can be more reliably adsorbed to the distal end portion 52 without being affected by the shape of the vaginal wall of each patient.
  • the central part 1401 of the anterior vagina hangs down into the vagina and dents (parts called “button holes”) 1402 exist on both sides thereof. May have.
  • dents parts called “button holes”
  • FIG. 15B not only the central portion 1401 but also the recessed portion 1402 can be more reliably adsorbed. In this way, by reliably adsorbing the recessed portion 1402 by the distal end portion 52, the recessed portion 1402 can be moved away from the urethra 1300, and it is effective that the needle body 39 is punctured into the recessed portion 1402. Can be prevented.
  • a marker 57 that can confirm the puncture route of the needle body 39 is provided at the distal end portion 52. Since the marker 57 is provided so that the needle body 39 passes above the marker 57, by confirming the position of the marker 57, the puncture route of the needle body 39 can be easily confirmed, and the operability of the puncture apparatus 1 can be improved. Safety is improved.
  • the marker 57 is preferably provided at least on the lower surface of the distal end portion 52. The lower surface is the surface that faces the vaginal opening in the inserted state and is visible to the operator through the vaginal opening. By providing the marker 57 on the lower surface, the puncture route of the needle body 39 can be confirmed more reliably. can do.
  • the marker 57 is only required to be visible from the outside, and can be constituted by, for example, a colored portion, an uneven portion, or the like.
  • the separation distance D2 (see FIG. 3) between the distal end portion 52 and the urethral insertion portion 41 as described above is not particularly limited, but may be 5 corresponding to the separation distance between the urethral opening and the vaginal opening in a general woman. It is preferably about ⁇ 40 mm.
  • the shaft portion 53 has a thin rod shape extending substantially parallel to the urethral insertion portion 41.
  • the length of the shaft portion 53 (the separation distance between the distal end portion 52 and the support portion 50) is not particularly limited, but is preferably about 100 mm or less, and more preferably about 20 to 50 mm. Thereby, the axial part 53 can be made into appropriate length and the operativity of the puncture apparatus 1 improves. If the length of the shaft portion 53 exceeds the above upper limit value, the center of gravity of the puncture device 1 is greatly separated from the patient depending on the configuration of the frame 2 and the stability of the puncture device 1 in the mounted state is lowered. There is a case.
  • the patient is crushed on the operating table, and the insertion tool 6 is attached to the patient as shown in FIG.
  • the urethral insertion portion 41 of the urethral insertion device 4 is inserted into the urethra 1300, and the balloon 42 is placed in the bladder 1310.
  • the urethra 1300 is corrected to a predetermined shape (linear shape) by the urethra insertion part 41.
  • the balloon 42 is expanded, and urine is discharged from the bladder 1310 through the urine drain 471 as necessary.
  • the distal end portion 52 of the vagina insertion tool 5 is inserted into the vagina 1400.
  • the support portion 50 is fixed to the support portion 40. Thereby, mounting
  • a suction device is connected to the suction ports 45 and 54, the suction device is operated, the urethral wall is sucked and fixed to the suction hole 44, and the vagina wall is sucked and fixed to the suction portion 523.
  • the suction hole 44 is blocked by the urethra wall, so that suction from the suction port 45 is stopped or weakened.
  • the vaginal wall is properly adsorbed by the suction part 523, the suction from the suction port 54 is stopped or weakened.
  • the surgeon determines whether or not the urethral wall and the vagina wall are properly adsorbed to the urethral insertion portion 41 and the vagina insertion portion 51 based on the suction state from the suction ports 45 and 54 (for example, the magnitude of sound generated by suction). Can be confirmed.
  • 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.
  • a flow rate measurement unit negative pressure gauge
  • a measurement result from the flow rate measurement unit are used. It can be set as the structure which has a judgment part which judges whether adsorption
  • the puncture needle of the syringe 2000 is punctured into the anterior wall of the vagina from between the urethra insertion part 41 and the vaginal insertion part 51 (between the urethral opening and the vaginal opening)
  • a liquid such as physiological saline or a local anesthetic is injected into the living tissue between the urethra 1300 and the vagina 1400 (between the regions S1 and S2).
  • the living tissue between the regions S1 and S2 expands, whereby the urethral wall is pressed against the urethral insertion portion 41 and the vagina front wall is pressed against the distal end portion 52.
  • the suction from the suction ports 45 and 54 it is preferable to continue the suction from the suction ports 45 and 54 even during the liquid separation described above.
  • the urethra wall is pressed against the suction hole 44 by liquid peeling, the urethra wall is further brought into close contact with the suction hole 44, and suction from the suction port 45 is stopped or weakened.
  • the vagina wall is pressed against the suction part 523, the vagina wall is more closely adhered to the suction part 523, and suction from the suction port 54 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 frame 2 After performing liquid exfoliation as described above and sufficiently separating the urethral wall and the vagina wall, the frame 2 is fixed to the insertion tool 6 as shown in FIG. Thereby, it will be in the mounting state with which the puncture apparatus 1 was mounted
  • the puncture device 1 is pushed into the body.
  • the urethra wall is adsorbed to the urethra insertion part 41 and the vagina wall is adsorbed to the vagina insertion part 51. Therefore, when the puncture device 1 is pushed into the body, the urethra 1300 and the vagina 1400 are simultaneously pushed. Is pushed in and the tissue between them is extended.
  • the sagging of the tissue is reduced, the shapes of the urethra 1300 and the vagina 1400 are adjusted, and the needle 39 can be easily punctured into the tissue. Further, as described above, since the bladder 1310 can be pushed inward, the needle body 39 can be punctured more safely. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.
  • the puncture device 1 is positioned so that the puncture path of the puncture member 3 passes through the safety zones S5 of the left and right closure holes 1101, 1102 of the pelvis.
  • the handle 324 is rotated forward to obtain the above-described restricted state as shown in FIG.
  • the needle 39 enters the body by puncturing the body surface H of the right buttocks or in the vicinity thereof, for example, passing through the obturator 1101, the urethra 1300 and the vagina 1400, and the obturator 1102 in order. Then, it is in a state where it has moved to a location beyond the closing hole 1102.
  • the position of the needle body 39 in this state is not particularly limited, and may not reach between the urethra 1300 and the vagina 1400, for example.
  • the needle body 39 is advanced to the point where it has passed through the closing hole 1102, so that the puncture member 3 has a high rigidity (the inner tube 302 in the outer tube 301). Can be punctured for a longer distance in the living body in a state where the sheath 30 is short and the sheath 30 is short), so that puncture can be performed more accurately and smoothly.
  • the position of the needle body 39 at the time when the first puncturing step is completed is not limited to this, for example, a state in which the needle body 39 passes between the urethra 1300 and the vagina 1400 and moves to the front of the closing hole 1102. It may be.
  • the handle 324 is rotated in the reverse direction, and the shaft 300 is extended as shown in FIG.
  • the handle 324 is rotated forward again to move the shaft portion 300 toward the tip as shown in FIG.
  • the needle body 39 is pressed by the pusher shaft 33, and the needle body 39 moves together with the pusher shaft 33 toward the distal end side.
  • the inner tube 302 connected to the needle body 39 protrudes from the outer tube 301 so as to be pulled by the needle body 39, whereby the sheath 30 is extended (second puncturing step).
  • the needle body 39 protrudes from the body surface H of the left buttocks or its vicinity.
  • the puncture member 3 is punctured substantially perpendicularly to the left and right closing holes 1101 and 1102 of the pelvis, whereby a passage can be formed at a position suitable for placement of the implant 9.
  • the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.
  • the shaft portion 300 and the needle body 39 are removed from the sheath 30 and the frame 2 is removed from the insertion tool 6. Accordingly, as shown in FIG. 23A, the sheath 30 is placed 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 procedure is not particularly limited. For example, first, the handle 324 is rotated in the reverse direction, the stylet 321 is removed from the proximal end opening of the sheath 30, and then the frame 2 is removed from the insertion tool 6. Finally, the needle body 39 may be removed from the inner tube 302 together with the pusher shaft 33.
  • the needle body 39 is removed from the inner tube 302 together with the pusher shaft 33, and then the handle 324 is rotated in the reverse direction to remove the stylet 321 from the proximal end opening of the sheath 30, and finally, the insertion tool 6 You may make it remove the flame
  • the position of the sheath 30 is adjusted as necessary. Specifically, the left and right protruding lengths of the sheath 30 are aligned, and the central portion S4 of the sheath 30 is positioned between the urethra 1300 and the vagina 1400.
  • the central portion S 4 of the sheath 30 is arranged such that its width direction (long axis J 32 direction) W is substantially parallel to the urethra 1300. That is, the urethra 1300 that has been corrected by inserting the urethral insertion portion 41 and the width direction W of the central portion S4 of the sheath 30 are substantially parallel.
  • the implant 9 is inserted into the sheath 30 while being taken out from the packaging material 90, and the implant body 91 is projected from the proximal end opening and the distal end opening of the sheath 30 as shown in FIG. To do.
  • contamination of the implant 9 can be prevented by accommodating the implant 9 in the wrapping material 90 until just before being disposed in the sheath 30.
  • the sheath 30 has a flat shape
  • the posture of the implant main body 91 follows this flat shape. That is, the implant body 91 is disposed in the sheath 30 so that the width direction thereof coincides with the width direction of the sheath 30 as shown in FIG. From the relationship with the urethra 1300, the implant body 91 is arranged in parallel with the corrected urethra 1300.
  • the adsorption of the urethral wall by the urethra insertion part 41 and the adsorption of the vagina wall by the vagina insertion part 51 are stopped.
  • the positions and shapes of the urethra 1300 and the vagina 1400 return to the original natural state.
  • the inner tube 302 is pulled out from the living body toward the distal end side, and the outer tube 301 is pulled out from the living body toward the proximal end side.
  • the inner tube 302 and the outer tube 301 are moved almost simultaneously in opposite directions, and the inner tube 302 and the outer tube 301 are moved in an arc shape so as to follow the shape of each. Thereby, the sheath 30 is smoothly removed from the living body.
  • the inner tube 302 and the outer tube 301 are removed from the living body as described above, the surrounding tissue that has been spread out by the sheath 30 returns to the original position, from the central portion of the implant body 91 toward both ends.
  • the tissue gradually comes into contact with the implant body 91.
  • the inner tube 302 and the outer tube 301 are moved in the direction along the shape thereof, and the sheath 30 has an inner space in which the implant body 91 can be moved with low sliding, thereby providing the implant body.
  • An unnecessary tensile force is not applied to 91, and it can be left 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 implant body 91 In the state where the implant 9 is embedded in the living body, the implant body 91 is disposed substantially parallel to the urethra 1300 in the region between the urethra 1300 and the vagina 1400 as shown in FIG. Therefore, the urethra 1300 can be supported in a wider area by the implant body 91.
  • the sheath 30 can be easily removed from the living body. Further, since the outer tube 301 and the inner tube 302 being removed hardly affect the posture of the implant body 91 in the region between the urethra 1300 and the vagina 1400, the implant body 91 can be embedded in a desired posture. . In addition, since the outer tube 301 and the inner tube 302 are removed from the living body with the urethra insertion portion 41 inserted into the urethra 1300, an excessive tension is applied to the urethra 1300 by the implant body 91 placed in the living body. Can be prevented.
  • the insertion tool 6 is removed from the living body. That is, the urethral insertion part 41 is removed from the urethra 1300 and the vagina insertion part 51 is removed from the vagina 1400. After the urethral insertion tool 4 is removed, the urethra 1300 returns to the natural state, but the urinary tract 1300 in the natural state and the implant main body 91 remain parallel because the implant body 91 is embedded in the living tissue. can do. Thereafter, unnecessary portions of the implant body 91 are excised, and the procedure is finished.
  • the central angle (length) of the sheath 30 can be made sufficiently large, and both end portions of the sheath 30 are formed on the patient's body shape. It can be reliably exposed from the body surface H regardless. And the implant main body 91 can be inserted easily and reliably from this exposed both ends (both ends opening).
  • the sheath 30 In the initial state, since the sheath 30 is in a contracted state, almost the entire area of the sheath 30 can be accommodated in the guide groove 221. On the other hand, for example, when the sheath 30 having the same central angle (length) as that in the extended state cannot be used as in the present embodiment, and the sheath 30 has the same central angle (length) as that in the extended state, the sheath 30 has the guide groove 221. It does n’t fit inside. Therefore, the base end portion of the sheath 30 protrudes from the guide groove 221 and a problem such as hitting the living body occurs, and the operability of the puncture device 1 is deteriorated.
  • the implant 9 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 large invasive incision or the like. High safety. Further, since the implant body 91 can be embedded in parallel with the urethra 1300, the urethra 1300 can be supported in a wider area. Further, the living body can be punctured by avoiding the urethra 1300 and the vagina 1400 with the needle body 39, and the needle body 39 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.
  • the puncture device is applied to a device used when an implantable implant for treating urinary incontinence in women is embedded in a living body. It is not limited.
  • the present invention relates to excretion disorder (urinary urgency, frequent urination, urinary incontinence, stool incontinence, urinary retention, difficulty in urination, etc.), pelvic organ prolapse, vesicovaginal fistula, urethral vagina, as the pelvic floor muscles weaken Pelvic floor diseases including epilepsy, pelvic pain, etc. are included in the target of application.
  • Pelvic organ prolapse includes diseases such as cystocele, small intestinal aneurysm, rectal aneurysm, and uterine prolapse.
  • 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, transobturatorpetape; TOT), and transvaginal mesh surgery (Tension-free Vaginal Mesh; TVM), elevation using sacral uterine ligament (Uterosacral Ligament Suspension; USLS), fusion using sacrospinous ligament (Sacrospinous Ligament Fixation; SSLF), fusion using iliac coccyx fascia, tailbone Includes fusion using the fascia.
  • the puncture member of the present invention has a tubular medical tube and a needle body connected to a distal end portion of the medical tube, the needle body has a widened portion, and the width of the widened portion is The width of the distal end portion of the medical tube is larger. According to such a characteristic, since the width
  • the slidability of the puncture member within the puncture hole can be improved, and the formation of the puncture hole for indwelling the living tissue supporting indwelling object can be performed smoothly and with minimal invasiveness. Therefore, the procedure for embedding the living tissue supporting indwelling object in the living body can be performed smoothly and safely.
  • the puncture member of the present invention has industrial applicability.

Abstract

A puncturing member (3) is equipped with: a tubular sheath (30); and a needle unit (39) which is connected to the tip part of the sheath (30). The needle unit (39) has a widened portion (391a) between the tip part and the base end part thereof, wherein the width of the widened portion (391a) is larger than the width of a portion located on the tip side of the needle unit (39) and the width of a portion located on the base end side of the needle unit (39), and the width of the widened portion (391a) is larger than the width of the tip part of the sheath (30). The needle unit (39) has a flat transverse cross-section shape having a shorter axis (J41) and a longer axis (J42).

Description

穿刺部材Puncture member
　本発明は、穿刺部材に関するものである。 The present invention relates to a puncture member.
　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 surgeon 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 the closing 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、生体組織支持用留置物を生体内に埋設する手技を安全に行うことのできる穿刺部材を提供することにある。 An object of the present invention is to provide a puncture member that can safely perform a procedure of embedding a living tissue supporting indwelling object in a living body.
　このような目的は、下記（１）～（１３）の本発明により達成される。また、下記（１４）～（４２）であることが好ましい。 Such an object is achieved by the present invention as described in (1) to (13) below. Further, the following (14) to (42) are preferable.
　（１）　管状の医療用チューブと、
　前記医療用チューブの先端部に接続された針体と、を有し、
　前記針体は、拡幅部を有し、
　前記拡幅部の幅は、前記医療用チューブの先端部の幅よりも大きいことを特徴とする穿刺部材。 (1) a tubular medical tube;
A needle body connected to the distal end of the medical tube,
The needle body has a widened portion,
The puncture member according to claim 1, wherein a width of the widened portion is larger than a width of a distal end portion of the medical tube.
　（２）　前記針体は、前記漸減部の基端側に、前記医療用チューブの先端部と当接する当接面を有している上記（１）に記載の穿刺部材。 (2) The puncture member according to (1), wherein the needle body has a contact surface that contacts a distal end portion of the medical tube on a proximal end side of the gradually decreasing portion.
　（３）　前記医療用チューブは、外管と、前記外管内に配置され、前記外管に対してスライド可能な内管と、を有し、前記外管と前記内管の少なくとも一方に前記当接面を有している上記（２）に記載の穿刺部材。 (3) The medical tube includes an outer tube and an inner tube disposed in the outer tube and slidable with respect to the outer tube, and the medical tube is applied to at least one of the outer tube and the inner tube. The puncture member according to (2), which has a contact surface.
　（４）　前記医療用チューブは、前記外管と前記内管とがスライドすることで延長可能となっている上記（３）に記載の穿刺部材。 (4) The puncture member according to (3), wherein the medical tube can be extended by sliding the outer tube and the inner tube.
　（５）　前記外管の先端部は、前記医療用チューブの内側へ向けて傾斜している上記（３）または（４）に記載の穿刺部材。 (5) The puncture member according to (3) or (4), wherein a distal end portion of the outer tube is inclined toward the inside of the medical tube.
　（６）　前記拡幅部の幅は、前記外管の先端部の幅よりも大きく、
　前記外管の先端部の幅は、前記内管の先端部の幅よりも大きい上記（３）ないし（５）のいずれかに記載の穿刺部材。 (6) The width of the widened portion is larger than the width of the distal end portion of the outer tube,
The puncture member according to any one of (3) to (5), wherein a width of the distal end portion of the outer tube is larger than a width of the distal end portion of the inner tube.
　（７）　前記針体は、前記拡幅部を有する針部と、前記針部の基端側に位置する基端部と、を有し、前記基端部が前記医療用チューブに挿入されている上記（１）ないし（６）のいずれかに記載の穿刺部材。 (7) The needle body has a needle portion having the widened portion and a proximal end portion located on the proximal end side of the needle portion, and the proximal end portion is inserted into the medical tube. The puncture member according to any one of (1) to (6) above.
　（８）　前記拡幅部は、生体組織を剥離可能である上記（１）ないし（７）のいずれかに記載の穿刺部材。 (8) The puncture member according to any one of (1) to (7), wherein the widened portion is capable of peeling a biological tissue.
　（９）　前記針体は、先端と基端の間に、その先端側および基端側よりも幅が大きい前記拡幅部を有している上記（１）ないし（８）のいずれかに記載の穿刺部材。 (9) The needle according to any one of (1) to (8), wherein the needle body includes the widened portion having a width larger than that of the distal end side and the proximal end side between the distal end and the proximal end. Puncture member.
　（１０）　前記針体は、前記拡幅部よりも基端側に位置し、幅が先端側へ向けて漸増する幅漸増部を有している上記（１）ないし（９）のいずれかに記載の穿刺部材。 (10) The needle body according to any one of (1) to (9), wherein the needle body has a width gradually increasing portion that is located on a proximal end side with respect to the widened portion and whose width gradually increases toward a distal end side. Puncture member.
　（１１）　前記針体は、短軸および長軸を有する偏平の横断面形状を有している上記（１）ないし（１０）のいずれかに記載の穿刺部材。 (11) The puncture member according to any one of (1) to (10), wherein the needle body has a flat cross-sectional shape having a short axis and a long axis.
　（１２）　前記針体の横断面形状は、前記長軸の中心部が膨らんだ紡錘形状である上記（１１）に記載の穿刺部材。 (12) The puncture member according to (11), wherein a cross-sectional shape of the needle body is a spindle shape in which a central portion of the long axis is swollen.
　（１３）　前記医療用チューブに挿入された長尺な軸部を有し、
　前記軸部と前記針体とが離脱可能に接続されている上記（１）ないし（１２）のいずれかに記載の穿刺部材。 (13) having a long shaft portion inserted into the medical tube;
The puncture member according to any one of (1) to (12), wherein the shaft portion and the needle body are detachably connected.
　（１４）　生体を穿刺する針体と、
　前記針体の基端側に位置し、前記針体と共に生体内へ挿入される第１の軸部を有する軸部と、
　前記第１の軸部の先端部に設けられ、前記第１の軸部と前記針体とを離脱可能に連結する連結部と、を有することを特徴とする穿刺部材。 (14) a needle that punctures a living body;
A shaft portion having a first shaft portion located on the proximal end side of the needle body and inserted into the living body together with the needle body;
A puncture member comprising: a connecting portion that is provided at a distal end portion of the first shaft portion and removably connects the first shaft portion and the needle body.
　（１５）　前記針体が前記生体内に位置している状態で前記第１の軸部が基端側へ移動すると、前記第１の軸部と連結した状態を維持したまま前記針体が前記第１の軸部と共に基端側へ移動する上記（１４）に記載の穿刺部材。 (15) When the first shaft portion moves to the proximal end side in a state where the needle body is located in the living body, the needle body is kept in a state of being connected to the first shaft portion. The puncture member according to (14), which moves to the proximal end side together with the first shaft portion.
　（１６）　前記第１の軸部の基端側への移動を許容しつつ、前記針体の基端側への移動を規制する規制部を有し、
　前記規制部によって前記針体の基端側への移動が規制された状態で、前記第１の軸部が基端側へ移動すると前記針体と前記第１の軸部とが離脱する上記（１４）または（１５）に記載の穿刺部材。 (16) A restricting portion that restricts movement of the needle body to the proximal end side while allowing movement of the first shaft portion to the proximal end side,
When the movement of the needle body to the proximal end side is restricted by the restricting portion, the needle body and the first shaft portion are separated from each other when the first shaft portion moves to the proximal end side ( The puncture member according to 14) or (15).
　（１７）　前記針体および前記連結部の一方に突起が設けられ、他方に前記突起と連結する連結孔が設けられ、
　前記突起を前記連結孔に挿入することで、前記第１の軸部と前記針体とが連結される上記（１４）ないし（１６）のいずれかに記載の穿刺部材。 (17) A protrusion is provided on one of the needle body and the connection portion, and a connection hole connected to the protrusion is provided on the other,
The puncture member according to any one of (14) to (16), wherein the first shaft portion and the needle body are connected by inserting the protrusion into the connection hole.
　（１８）　前記突起は、弾性変形によって自然状態に対して縮幅可能な弾性変形部を有し、
　前記連結孔は、前記自然状態での弾性変形部よりも小さい幅の導入部と、前記導入部の奥側に位置し、前記導入部よりも大きい幅の拡幅部と、を有し、
　前記拡幅部内に前記弾性変形部が位置することで、前記第１の軸部と前記針体とが連結する上記（１７）に記載の穿刺部材。 (18) The protrusion has an elastically deformable portion that can be reduced with respect to a natural state by elastic deformation,
The connection hole has an introduction part having a smaller width than the elastically deforming part in the natural state, and a widening part located on the back side of the introduction part and having a width larger than the introduction part,
The puncture member according to (17), wherein the first shaft portion and the needle body are connected by the elastic deformation portion being positioned in the widened portion.
　（１９）　連結部は、扁平形状を有する部分を有している上記（１８）に記載の穿刺部材。 (19) The puncture member according to (18), wherein the connecting portion has a flat portion.
　（２０）　前記軸部は、前記第１の軸部と、前記第１の軸部に対してスライド可能な第２の軸部とを有し、前記第１の軸部と前記第２の軸部とがスライドすることで延長可能となっている上記（１４）ないし（１９）のいずれかに記載の穿刺部材。 (20) The shaft portion includes the first shaft portion and a second shaft portion slidable with respect to the first shaft portion, and the first shaft portion and the second shaft. The puncture member according to any one of (14) to (19), wherein the puncture member can be extended by sliding with a portion.
　（２１）　前記軸部が挿入された管状の医療用チューブを有し、
　前記医療用チューブの先端部に前記針体が接続されている上記（１４）ないし（２０）のいずれかに記載の穿刺部材。 (21) having a tubular medical tube into which the shaft portion is inserted;
The puncture member according to any one of (14) to (20), wherein the needle body is connected to a distal end portion of the medical tube.
　（２２）　前記医療用チューブは、外管と、前記外管内に配置され、前記外管に対してスライド可能な内管とを有し、前記外管と前記内管とがスライドすることで延長可能となっており、
　前記内管の先端部に前記針体が接続されている上記（２１）に記載の穿刺部材。 (22) The medical tube includes an outer tube and an inner tube which is disposed in the outer tube and is slidable with respect to the outer tube, and is extended by sliding the outer tube and the inner tube. Is possible,
The puncture member according to (21), wherein the needle body is connected to a distal end portion of the inner tube.
　（２３）　針体と、
　前記針体の基端側に位置し、前記針体に離脱可能に連結された第１の軸部と、前記第１の軸部にスライド可能に連結された第２の軸部と、を有する軸部と、
　前記第１の軸部の基端側への移動を許容しつつ、前記第２の軸部の基端側への移動を規制する規制状態とする規制部と、
　前記軸部を支持する支持部と、を有することを特徴とする穿刺装置。 (23) a needle body;
A first shaft portion that is positioned on the proximal end side of the needle body and is detachably coupled to the needle body; and a second shaft portion that is slidably coupled to the first shaft portion. The shaft,
A restricting portion that restricts movement of the second shaft portion to the proximal end side while allowing movement of the first shaft portion to the proximal end side; and
A puncture apparatus comprising: a support portion that supports the shaft portion.
　（２４）　前記規制部は、初期状態では前記支持部に対して移動可能であり、前記支持部に固定されることで前記規制状態となる上記（２３）に記載の穿刺装置。 (24) The puncture device according to (23), wherein the restriction portion is movable with respect to the support portion in an initial state, and is in the restriction state by being fixed to the support portion.
　（２５）　前記初期状態から前記第１の軸部および前記第２の軸部が共に先端側へ移動すると、前記規制部が前記支持部に固定される上記（２４）に記載の穿刺装置。 (25) The puncture device according to (24), wherein when the first shaft portion and the second shaft portion are both moved to the distal end side from the initial state, the restriction portion is fixed to the support portion.
　（２６）　前記規制部は、前記第１の軸部にスライド可能に連結されている上記（２５）に記載の穿刺装置。 (26) The puncture device according to (25), wherein the restriction portion is slidably connected to the first shaft portion.
　（２７）　前記第１の軸部の基端部に連結され、前記第１の軸部の基端側からの前記規制部の離脱を規制する連結部を有し、
　前記規制部は、前記連結部に押圧されることで、前記第１の軸部と共に先端側へ移動する上記（２６）に記載の穿刺装置。 (27) having a connecting portion that is connected to the proximal end portion of the first shaft portion and restricts the detachment of the restricting portion from the proximal end side of the first shaft portion;
The puncture apparatus according to (26), wherein the restricting portion moves to the distal end side together with the first shaft portion when pressed by the connecting portion.
　（２８）　前記規制部および前記支持部の一方に設けられた雄型係合部と、他方に設けられた雌型係合部とを有し、
　前記雄型係合部と前記雌型係合部とが係合することで、前記規制部が前記支持部に固定される上記（２３）ないし（２７）のいずれかに記載の穿刺装置。 (28) having a male engaging portion provided on one of the restricting portion and the supporting portion, and a female engaging portion provided on the other;
The puncture device according to any one of (23) to (27), wherein the restriction portion is fixed to the support portion by the engagement of the male engagement portion and the female engagement portion.
　（２９）　前記軸部が挿入される管状の医療用チューブを有している上記（２３）ないし（２８）のいずれかに記載の穿刺装置。 (29) The puncture device according to any one of (23) to (28), wherein the puncture device has a tubular medical tube into which the shaft portion is inserted.
　（３０）　前記規制部は、前記医療用チューブの基端側に位置し、前記規制状態で前記医療用チューブの基端部と当接する上記（２９）に記載の穿刺装置。 (30) The puncture device according to (29), wherein the restricting portion is located on a proximal end side of the medical tube and contacts the proximal end portion of the medical tube in the restricted state.
　（３１）　前記医療用チューブは、外管と、前記外管内に配置され、前記外管に対してスライド可能な内管とを有し、前記外管と前記内管とがスライドすることで延長可能となっている上記（２９）または（３０）に記載の穿刺装置。 (31) The medical tube has an outer tube and an inner tube that is disposed in the outer tube and is slidable with respect to the outer tube, and is extended by sliding the outer tube and the inner tube. The puncture device according to (29) or (30), which is enabled.
　（３２）　針体と、
　前記針体の基端側に位置し、前記針体に離脱可能に連結された第１の軸部と、前記第１の軸部と並んで設けられた第２の軸部と、を有する軸部と、
　前記第１の軸部の先端部に設けられ、前記第２の軸部をスライド可能に保持するとともに、前記第１の軸部と前記第２の軸部との相対的位置関係を規制する連結部と、を有することを特徴とする穿刺部材。 (32) the needle body;
A shaft having a first shaft portion that is located on the proximal end side of the needle body and is detachably coupled to the needle body, and a second shaft portion that is provided alongside the first shaft portion. And
A connection that is provided at the tip of the first shaft portion, holds the second shaft portion so as to be slidable, and restricts the relative positional relationship between the first shaft portion and the second shaft portion. And a puncture member characterized by comprising:
　（３３）　前記連結部は、該連結部の近傍において前記第１の軸部と前記第２の軸部の離間距離を所定距離以内に維持する上記（３２）に記載の穿刺部材。 (33) The puncture member according to (32), wherein the connecting portion maintains a separation distance between the first shaft portion and the second shaft portion within a predetermined distance in the vicinity of the connecting portion.
　（３４）　前記連結部は、前記第２の軸部の延在方向に離間して設けられた少なくとも一対の挿通孔を有し、前記一対の挿通孔に前記第２の軸部が挿通され、
　前記一対の挿通孔の間にて前記第１の軸部と前記第２の軸部の離間距離が前記所定距離以内に維持されている上記（３３）に記載の穿刺部材。 (34) The connecting portion has at least a pair of insertion holes that are spaced apart in the extending direction of the second shaft portion, and the second shaft portion is inserted through the pair of insertion holes,
The puncture member according to (33), wherein a distance between the first shaft portion and the second shaft portion is maintained within the predetermined distance between the pair of insertion holes.
　（３５）　前記連結部は、初期状態から前記第１の軸部が前記第２の軸部に対して基端側へ相対移動し、前記軸部が延長された延長状態となった後に、前記第１の軸部が前記第２の軸部に対して先端側へ相対移動するのを規制する上記（３４）に記載の穿刺部材。 (35) After the first shaft portion has moved relative to the second shaft portion from the initial state to the proximal end side and the shaft portion has been extended, The puncture member according to (34), wherein the first shaft portion is restricted from moving relative to the distal end side with respect to the second shaft portion.
　（３６）　前記連結部は、前記延長状態となった後に、前記第１の軸部が前記第２の軸部に対して基端側へ相対移動するのを許容し、
　前記第１の軸部が前記第２の軸部に対して基端側へ相対移動することで、前記連結部が前記第２の軸部から離脱する上記（３５）に記載の穿刺部材。 (36) The connecting portion allows the first shaft portion to move relative to the second shaft portion toward the proximal end side after being in the extended state,
The puncture member according to (35), wherein the connection portion is detached from the second shaft portion by the relative movement of the first shaft portion toward the proximal end side with respect to the second shaft portion.
　（３７）　前記連結部および前記第２の軸部の一方に設けられ、前記第２の軸部の基端側を向く当接面と、他方に設けられ、前記当接面に前記基端側から当接する当接部とを有し、前記延長状態において前記当接面と前記当接部とが当接または対向する上記（３５）または（３６）に記載の穿刺部材。 (37) A contact surface provided on one of the connecting portion and the second shaft portion and facing the base end side of the second shaft portion; and provided on the other, the base end side on the contact surface The puncture member according to the above (35) or (36), wherein the puncture member is in contact with or is opposed to the contact surface in the extended state.
　（３８）　前記連結部に当接部が設けられ、
　前記第２の軸部に前記当接面が設けられている上記（３７）に記載の穿刺部材。 (38) A contact portion is provided in the connecting portion,
The puncture member according to (37), wherein the contact surface is provided on the second shaft portion.
　（３９）　前記当接部は、前記一対の挿通孔の間に位置している上記（３８）に記載の穿刺部材。 (39) The puncture member according to (38), wherein the contact portion is located between the pair of insertion holes.
　（４０）　前記連結部は、扁平形状を有する部分を有している上記（３２）ないし（３９）のいずれかに記載の穿刺部材。 (40) The puncture member according to any one of (32) to (39), wherein the connecting portion has a flat portion.
　（４１）　前記軸部が挿入される管状の医療用チューブを有し、
　前記医療用チューブは、短軸および長軸を有する偏平の横断面形状をなし、
　前記第１の軸部および前記第２の軸部は、前記医療用チューブ内にて前記医療用チューブの長軸方向に沿って並設されている上記（３２）ないし（４０）のいずれかに記載の穿刺部材。 (41) having a tubular medical tube into which the shaft portion is inserted;
The medical tube has a flat cross-sectional shape having a short axis and a long axis,
In any one of the above (32) to (40), the first shaft portion and the second shaft portion are juxtaposed along the long axis direction of the medical tube in the medical tube. The puncture member as described.
　（４２）　前記医療用チューブの先端部に前記針体が接続されている上記（４１）に記載の穿刺部材。 (42) The puncture member according to (41), wherein the needle body is connected to a distal end portion of the medical tube.
　本発明の穿刺部材によれば、針体の幅が医療用チューブの幅よりも大きいため、穿刺部材の生体への穿刺をスムーズに行うことができる。具体的には、本発明の穿刺部材では、針体が生体を穿刺し、当該穿刺によって形成された穿刺孔内を当該穿刺孔よりも小さい医療用チューブの先端部が通過していくため、医療用チューブの先端部が穿刺孔の壁部に引っ掛かり難い。したがって、穿刺部材の穿刺孔内での摺動性を高めることができ、生体組織支持用留置物を留置するための前記穿刺孔の形成をスムーズに低侵襲で行うことができる。そのため、生体組織支持用留置物を生体内に埋設する手技をスムーズにかつ安全に行うことができる。 According to the puncture member of the present invention, since the width of the needle body is larger than the width of the medical tube, the puncture member can be smoothly punctured into the living body. Specifically, in the puncture member of the present invention, the needle body punctures the living body, and the distal end portion of the medical tube smaller than the puncture hole passes through the puncture hole formed by the puncture. The tip of the tube for use is not easily caught on the wall of the puncture hole. Therefore, the slidability of the puncture member within the puncture hole can be improved, and the formation of the puncture hole for indwelling the living tissue supporting indwelling object can be performed smoothly and with minimal invasiveness. Therefore, the procedure for embedding the living tissue supporting indwelling object in the living body can be performed smoothly and safely.
図１は、インプラントの一例を示す斜視図である。FIG. 1 is a perspective view showing an example of an implant. 図２は、好適な実施形態に係る穿刺装置を示す斜視図である。FIG. 2 is a perspective view showing a puncture device according to a preferred embodiment. 図３は、図２に示す穿刺装置の側面図である。FIG. 3 is a side view of the puncture device shown in FIG. 図４は、図２に示す穿刺装置が有する穿刺部材の平面図（断面図）である。4 is a plan view (sectional view) of a puncture member included in the puncture apparatus shown in FIG. 図５は、図４の部分拡大図である。FIG. 5 is a partially enlarged view of FIG. 図６は、図４に示す穿刺部材が有するシースの図であり、（ａ）が斜視図、（ｂ）が（ａ）中のＡ－Ａ線断面図である。6 is a view of the sheath of the puncture member shown in FIG. 4, wherein (a) is a perspective view and (b) is a cross-sectional view taken along line AA in (a). 図７は、図４中のＣ－Ｃ線断面図である。7 is a cross-sectional view taken along the line CC in FIG. 図８は、図４に示す穿刺部材の動作を説明する平面図（断面図）である。FIG. 8 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG. 図９は、図４に示す穿刺部材の動作を説明する平面図（断面図）である。FIG. 9 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG. 図１０は、図４に示す穿刺部材の動作を説明する平面図（断面図）である。FIG. 10 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG. 図１１は、図２に示す穿刺装置が備えるフレームの固定部の平面図である。FIG. 11 is a plan view of a fixing portion of a frame included in the puncture device shown in FIG. 図１２は、図２に示す穿刺装置が有する挿入具の側面図である。FIG. 12 is a side view of the insertion tool included in the puncture device shown in FIG. 2. 図１３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. 13 is a diagram showing the positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view. 図１４は、図１２に示す膣挿入具が有する先端部の上面図である。FIG. 14 is a top view of the distal end portion of the vaginal insertion tool shown in FIG. 図１５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。15A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 15B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. 図１６は、図２に示す穿刺装置の操作手順を説明するための図である。FIG. 16 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. 図１７は、図２に示す穿刺装置の操作手順を説明するための図である。FIG. 17 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. 図１８は、図２に示す穿刺装置の操作手順を説明するための図である。FIG. 18 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. 図１９は、図２に示す穿刺装置の操作手順を説明するための図である。FIG. 19 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG. 図２０は、図２に示す穿刺装置の操作手順を説明するための図である。FIG. 20 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. 図２１は、図２に示す穿刺装置の操作手順を説明するための図である。FIG. 21 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. 図２２は、図２に示す穿刺装置の操作手順を説明するための図である。FIG. 22 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. 図２３は、図２に示す穿刺装置の操作手順を説明するための図である。FIG. 23 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2. 図２４は、図２に示す穿刺装置の操作手順を説明するための図である。FIG. 24 is a diagram for explaining an operation procedure of the puncture apparatus shown in FIG. 図２５は、図２に示す穿刺装置の操作手順を説明するための図である。FIG. 25 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
　以下、本発明の穿刺部材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。
　図１は、インプラントの一例を示す斜視図である。図２は、好適な実施形態に係る穿刺装置を示す斜視図である。図３は、図２に示す穿刺装置の側面図である。図４は、図２に示す穿刺装置が有する穿刺部材の平面図（断面図）である。図５は、図４の部分拡大図である。図６は、図４に示す穿刺部材が有するシースの図であり、（ａ）が斜視図、（ｂ）が（ａ）中のＡ－Ａ線断面図である。図７は、図４中のＣ－Ｃ線断面図である。図８は、図４に示す穿刺部材の動作を説明する平面図（断面図）である。図９は、図４に示す穿刺部材の動作を説明する平面図（断面図）である。図１０は、図４に示す穿刺部材の動作を説明する平面図（断面図）である。図１１は、図２に示す穿刺装置が備えるフレームの固定部の平面図である。図１２は、図２に示す穿刺装置が有する挿入具の側面図である。図１３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１４は、図１２に示す膣挿入具が有する先端部の上面図である。図１５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１６ないし図２５は、それぞれ、図２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 member of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
FIG. 1 is a perspective view showing an example of an implant. FIG. 2 is a perspective view showing a puncture device according to a preferred embodiment. FIG. 3 is a side view of the puncture device shown in FIG. 4 is a plan view (sectional view) of a puncture member included in the puncture apparatus shown in FIG. FIG. 5 is a partially enlarged view of FIG. 6 is a view of the sheath of the puncture member shown in FIG. 4, wherein (a) is a perspective view and (b) is a cross-sectional view taken along line AA in (a). 7 is a cross-sectional view taken along the line CC in FIG. FIG. 8 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG. FIG. 9 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG. FIG. 10 is a plan view (sectional view) for explaining the operation of the puncture member shown in FIG. FIG. 11 is a plan view of a fixing portion of a frame included in the puncture device shown in FIG. FIG. 12 is a side view of the insertion tool included in the puncture device shown in FIG. 2. FIG. 13 is a diagram showing the positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view. FIG. 14 is a top view of the distal end portion of the vaginal insertion tool shown in FIG. 15A is a cross-sectional view showing an example of the shape of the vagina wall, and FIG. 15B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG. FIG. 16 to FIG. 25 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３中の左側を「先端」、右側を「基端」、上側を「上」、下側を「下」とも言う。また、図２、図３および図４は、それぞれ、まだ使用されていない状態（手技を始めるときの状態）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、説明の便宜上、図２および図３に示す穿刺装置が患者に装着された状態を「装着状態」とも言う。 In the following, for convenience of explanation, the left side in FIG. 3 is also referred to as “tip”, the right side is referred to as “base end”, the upper side is also referred to as “upper”, and the lower side is also referred to as “lower”. 2, 3, and 4 each show a state that is not yet used (a state when a procedure is started), and hereinafter, this state is also referred to as an “initial state” for convenience of explanation. For convenience of explanation, the state where the puncture device shown in FIGS. 2 and 3 is attached to the patient is also referred to as “attached state”.
　１．インプラント
　まず、穿刺装置によって生体内に埋設されるインプラント（生体組織支持用留置物）９の一例について説明する。 1. Implant First, an example of an implant (living tissue supporting indwelling object) 9 embedded in a living body by a puncture device will be described.
　図１に示すインプラント９は、女性の尿失禁の治療のための生体内に埋設可能な器具である。具体的には、インプラント９は、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。このようなインプラント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。 1 is an instrument that can be implanted in a living body for the treatment of female urinary incontinence. Specifically, the implant 9 is an instrument that supports the urethra, for example, an instrument that supports movement of the urethra in a direction away from the vagina wall when the urethra is about to move toward the vagina wall. It is. As such an implant 9, for example, a long object having flexibility can be used.
　図１に示すように、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の片端に連結された帯（連結部）９２とを有している。なお、帯９２に替えて、例えば、ガイドワイヤ、紐、糸等を用いてもよい。インプラント本体９１は、網状をなし、その全体形状は、帯状である。インプラント本体９１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。 As shown in FIG. 1, the implant 9 has an implant body 91 and a band (connecting portion) 92 connected to one end of the implant body 91. In place of the band 92, for example, a guide wire, string, thread, or the like may be used. The implant body 91 has a net shape, and the entire shape thereof is a band shape. The implant main body 91 can be configured by, for example, a braided body in which a linear body is crossed, that is, a braided body. Examples of the linear body include a circular cross section, a flat cross section, that is, a strip.
　インプラント本体９１、帯９２および包材９０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 implant body 91, the band 92, and the packaging material 90 are not particularly limited, and for example, various resin materials having biocompatibility such as polypropylene, polyester, and nylon, fibers, and the like can be used. .
　このような構成のインプラント９は、未使用状態で滅菌された包材９０に収容されている。これにより、インプラント９の汚染を防止することができる。 The implant 9 having such a configuration is accommodated in a packaging material 90 sterilized in an unused state. Thereby, contamination of the implant 9 can be prevented.
　以上、インプラント９について説明したが、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。 Although the implant 9 has been described above, the implant 9 is not limited to the net shape as long as the same effect can be exhibited.
　２．穿刺装置
　図２および図３に示す穿刺装置１は、前述したインプラント９を生体内に埋設するのに用いる装置である。 2. Puncture device The puncture device 1 shown in FIGS. 2 and 3 is a device used to embed the above-described implant 9 in a living body.
　図２および図３に示すように、穿刺装置１は、フレーム２と、挿入具６と、穿刺部材３とを備えており、フレーム２に穿刺部材３と、挿入具６とが支持されている。また、挿入具６は、尿道挿入具４と、膣挿入具５とを有している。 As shown in FIGS. 2 and 3, the puncture device 1 includes a frame 2, an insertion tool 6, and a puncture member 3, and the puncture member 3 and the insertion tool 6 are supported by the frame 2. . The insertion tool 6 includes a urethral insertion tool 4 and a vaginal insertion tool 5.
　以下、これら各部について順に説明する。
　≪穿刺部材≫
　穿刺部材３は、生体を穿刺する部材である。図４に示すように、穿刺部材３は、操作部材３１と、操作部材３１に装着される長尺なシース（医療用チューブ）３０と、シース３０の先端側に設けられた針体３９と、シース３０の基端側に設けられたスライドロック部（規制部）３８と、を有している。以下、シース３０、針体３９、操作部材３１およびスライドロック部３８について順番に説明する。 Hereinafter, each of these units will be described in order.
≪Puncture member≫
The puncture member 3 is a member that punctures a living body. As shown in FIG. 4, the puncture member 3 includes an operation member 31, a long sheath (medical tube) 30 attached to the operation member 31, a needle body 39 provided on the distal end side of the sheath 30, And a slide lock portion (regulation portion) 38 provided on the proximal end side of the sheath 30. Hereinafter, the sheath 30, the needle body 39, the operation member 31, and the slide lock portion 38 will be described in order.
　－シース－
　図４ないし図６に示すように、シース３０は、円弧状に湾曲した湾曲形状をなしている。また、シース３０は、管状であり、シース３０の内側は、操作部材３１（後述するスタイレット３２１およびプッシャーシャフト３３）を挿入する空間およびインプラント９を挿入する空間として機能する。 -sheath-
As shown in FIGS. 4 to 6, the sheath 30 has a curved shape curved in an arc shape. The sheath 30 is tubular, and the inside of the sheath 30 functions as a space for inserting the operation member 31 (a stylet 321 and a pusher shaft 33 described later) and a space for inserting the implant 9.
　図４に示すように、シース３０は、外管３０１と、外管３０１内に挿入されている内管３０２とを有し、内管３０２が外管３０１に対してスライド可能となっている。そのため、内管３０２は、外管３０１内に退避した初期状態から、外管３０１の先端側開口から突出することができる。これにより、延長可能なシース３０が得られる。また、内管３０２は、外管３０１の先端側開口から離脱可能となっている。これにより、シース３０を外管３０１と内管３０２とに分割することができ、生体内に配置したシース３０を生体から取り除き易くなる。なお、外管３０１に対する内管３０２の摺動性を高めるために、内管３０２の外表面に低摩擦処理を施してもよい。また、内管３０２は、外管３０１の先端側へスライド可能であれば、基端側へスライドできなくてもよい。すなわち、シース３０は、初期状態から延長することができれば、延長した状態から収縮することができなくてもよい。 As shown in FIG. 4, the sheath 30 includes an outer tube 301 and an inner tube 302 inserted into the outer tube 301, and the inner tube 302 is slidable with respect to the outer tube 301. Therefore, the inner tube 302 can protrude from the distal end side opening of the outer tube 301 from the initial state retracted into the outer tube 301. Thereby, the extendable sheath 30 is obtained. Further, the inner tube 302 can be detached from the opening on the distal end side of the outer tube 301. Thereby, the sheath 30 can be divided | segmented into the outer tube | pipe 301 and the inner tube | pipe 302, and it becomes easy to remove the sheath 30 arrange | positioned in the biological body from the biological body. In addition, in order to improve the slidability of the inner tube 302 with respect to the outer tube 301, a low friction process may be performed on the outer surface of the inner tube 302. Further, if the inner tube 302 can slide to the distal end side of the outer tube 301, the inner tube 302 may not slide to the proximal end side. That is, the sheath 30 may not be able to contract from the extended state as long as it can be extended from the initial state.
　また、図４に示すように、外管３０１の基端部には、体表面Ｈに当接する当接部３０１ｂが設けられている。当接部３０１ｂは、外管３０１から突出して設けられた突出片で構成されている。この当接部３０１ｂは、穿刺部材３（シース３０）を生体に穿刺したときに体表面Ｈに当接し、それ以上の外管３０１の生体内への挿入を阻止するストッパーとして機能する。これにより、外管３０１の基端側開口が生体内に埋没して、隠れてしまうのを防止することができる。 Further, as shown in FIG. 4, a contact portion 301 b that contacts the body surface H is provided at the proximal end portion of the outer tube 301. The abutting portion 301b is constituted by a protruding piece provided to protrude from the outer tube 301. The abutting portion 301b abuts on the body surface H when the puncture member 3 (sheath 30) is punctured into the living body, and functions as a stopper that prevents further insertion of the outer tube 301 into the living body. Thereby, it is possible to prevent the proximal end side opening of the outer tube 301 from being buried and hidden in the living body.
　また、図５に示すように、外管３０１の先端部３０１ａは、内側（中心軸側）へ向けて傾斜する傾斜面となっており、先端側に向けて縮径（縮幅）するテーパー状をなしている。そして、外管３０１の先端部３０１ａは、内管３０２の外周との間に実質的に隙間が形成されないように、内管３０２の外周と密接している。これにより、穿刺部材３を生体へ穿刺する際に、生体組織が外管３０１と内管３０２の間に侵入し難くなるため、外管３０１に対する内管３０２の摺動性の低下が抑制され、内管３０２を外管３０１に対してスムーズにスライドさせることができる。 Further, as shown in FIG. 5, the distal end portion 301a of the outer tube 301 is an inclined surface that is inclined toward the inner side (center axis side), and has a tapered shape that is reduced in diameter (reduced width) toward the distal end side. I am doing. And the front-end | tip part 301a of the outer tube | pipe 301 is closely_contact | adhered with the outer periphery of the inner tube | pipe 302 so that a clearance gap may not be formed substantially between the outer periphery of the inner tube | pipe 302. Thereby, when the puncture member 3 is punctured into the living body, it is difficult for the living tissue to enter between the outer tube 301 and the inner tube 302, so that a decrease in the slidability of the inner tube 302 with respect to the outer tube 301 is suppressed. The inner tube 302 can be smoothly slid with respect to the outer tube 301.
　また、次のような効果もある。穿刺部材３を生体へ穿刺すると、針体３９に図５中矢印方向の応力Ｆ１が加わり、この応力Ｆ１の大きさや外管３０１の硬さ等によっては、外管３０１の先端部３０１ａが変形する場合がある。本実施形態のように、予め外管３０１の先端部３０１ａを内側に傾斜させておけば、応力Ｆ１を受けた際、さらに内側へ撓むように変形する。これに対して、先端部３０１ａがストレート状になっていると、応力Ｆ１を受けた際、内側へ撓むように変形する場合もあるが、外側へ拡径するように変形する場合もある。外側へ変形してしまうと、外管３０１の先端部３０１ａが針体３９より外側にはみ出してしまい、はみ出した部分が生体組織に引っ掛かる場合がある。はみ出した部分が生体組織に引っ掛かってしまうと、穿刺部材３の穿刺抵抗が増大して、スムーズな穿刺が阻害されるおそれがある。したがって、本実施形態のように、先端部３０１ａをテーパー状とすることが好ましい。 Also, there are the following effects. When the puncture member 3 is punctured into the living body, a stress F1 in the direction of the arrow in FIG. 5 is applied to the needle body 39, and the distal end portion 301a of the outer tube 301 is deformed depending on the magnitude of the stress F1 and the hardness of the outer tube 301. There is a case. If the tip portion 301a of the outer tube 301 is inclined inward as in the present embodiment, when the stress F1 is applied, the outer tube 301 is further deformed to bend inward. On the other hand, when the tip portion 301a has a straight shape, when it receives the stress F1, it may be deformed to bend inward or may be deformed to be expanded outward. If the outer tube 301 is deformed to the outside, the distal end portion 301a of the outer tube 301 may protrude outward from the needle body 39, and the protruding portion may be caught by the living tissue. If the protruding part is caught in the living tissue, the puncture resistance of the puncture member 3 increases, and smooth puncture may be hindered. Therefore, it is preferable that the tip portion 301a is tapered as in this embodiment.
　このようなシース３０の中心角は、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、針体３９が、患者の一方の鼠蹊部から体内に入り、一方の閉鎖孔、尿道と膣の間、他方の閉鎖孔を順に通過して、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、中心角は、図６（ａ）や図２１に示すような、内管３０２を外管３０１から突出させた延長状態において、１５０°～２７０°程度であることが好ましく、１７０°～２５０°程度であることがより好ましく、１９０°～２３０°程度であることがさらに好ましい。 The central angle of the sheath 30 is not particularly limited and is appropriately set according to various conditions. The needle 39 enters the body from one of the buttocks of the patient, Between the urethra and the vagina, it is set so that it can pass through the other closing hole in order and protrude outside the body from the other buttocks. Specifically, the central angle is preferably about 150 ° to 270 ° in the extended state in which the inner tube 302 protrudes from the outer tube 301 as shown in FIG. 6A and FIG. More preferably, the angle is from about ° to 250 °, and more preferably from about 190 ° to 230 °.
　また、図６（ｂ）に示すように、シース３０は、短軸Ｊ３１および長軸Ｊ３２を有する扁平な横断面形状を有している。このように、シース３０の断面を扁平形状とすることで、シース３０内でインプラント本体９１の幅方向をシース３０の幅方向に揃えることができ、インプラント本体９１を所望の姿勢に制御することができる。なお、シース３０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）紡錘形等とすることができる。 Further, as shown in FIG. 6B, the sheath 30 has a flat cross-sectional shape having a short axis J31 and a long axis J32. Thus, by making the cross section of the sheath 30 flat, the width direction of the implant body 91 can be aligned with the width direction of the sheath 30 in the sheath 30, and the implant body 91 can be controlled to a desired posture. it can. The flat shape of the sheath 30 is not particularly limited, and is, for example, an oval shape, a convex lens shape in cross section, a rhombus with rounded corners, a rectangle with rounded corners (flat shape), and a central portion at both ends. A spindle shape or the like that is larger (expanded) than the portion can be used.
　また、シース３０の内部空間の幅（長軸Ｊ３２方向の長さ）は、インプラント本体９１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９とシース３０との摩擦抵抗が低くなり、インプラント９に不要な力が掛からず、インプラント本体９１を十分に展開した状態でシース３０内に配置することができる。ただし、シース３０の内部空間の幅は、インプラント本体９１の幅よりも短くてもよい。この場合は、シース３０の幅を抑えられるため、より低侵襲な穿刺部材３となる。 Also, the width of the internal space of the sheath 30 (the length in the direction of the long axis J32) is designed to be substantially the same as the width of the implant body 91. Thereby, the frictional resistance between the implant 9 and the sheath 30 is reduced, and unnecessary force is not applied to the implant 9, and the implant body 91 can be disposed in the sheath 30 in a sufficiently deployed state. However, the width of the internal space of the sheath 30 may be shorter than the width of the implant body 91. In this case, since the width of the sheath 30 can be suppressed, the puncture member 3 is less invasive.
　なお、以下では、説明の便宜上、図６（ｂ）に示すように、長軸Ｊ３２方向の内側（中心に対して近位な側）に位置する端部を「内周部Ａ１」とも言い、長軸Ｊ３２方向の外側（中心に対して遠位な側）に位置する端部を「外周部Ａ２」とも言い、図中上側に向く面を「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. 6B, the end located on the inner side in the major axis J32 direction (the side proximal to the center) is also referred to as “inner peripheral part A1”. An end located on the outer side (distal side with respect to the center) in the direction of the long axis J32 is also referred to as “outer peripheral part A2”, a surface facing upward in the drawing is also referred to as “surface A3”, and a surface facing downward Also referred to as “back A4”.
　図６（ｂ）に示すように、シース３０の円弧の中心点とシース３０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（シース３０の中心軸を含む面）を平面ｆ９とし、この平面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、後述するように、インプラント本体９１を尿道とほぼ平行に配置することができる。そのため、尿道をより効果的に支持することができる。 As shown in FIG. 6B, a plane including both the center point of the arc of the sheath 30 and the center point of the cross-sectional shape with respect to the longitudinal direction of the sheath 30 (plane including the center axis of the sheath 30) is defined as a plane f9. When the angle formed by the plane f9 and the minor axis J31 at the central portion S4 is the inclination angle θ1, the inclination angle θ1 is preferably an acute angle. By setting the inclination angle θ1 to an acute angle, the implant body 91 can be disposed substantially parallel to the urethra, as will be described later. Therefore, the urethra can be supported more effectively.
　傾斜角θ１としては、鋭角であれば特に限定されないが、例えば、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、上述の効果がより一層向上する。なお、傾斜角θ１の上記数値範囲は、少なくとも中央部Ｓ４にて満足しているのが好ましく、シース３０の延在方向のほぼ全域で満足しているのがより好ましい。ここで、「中央部Ｓ４」とは、図６（ａ）に示すような延長状態のシース３０を生体内に配置した状態において、少なくとも、尿道と膣との間に位置する部位を含む領域を言う。 The inclination angle θ1 is not particularly limited as long as it is an acute angle. For example, it is preferably about 20 ° to 60 °, more preferably 30 ° to 45 °, and about 35 ° to 40 °. Is more preferable. Thereby, the above-mentioned effect improves further. In addition, it is preferable that the numerical range of the inclination angle θ1 is satisfied at least in the central portion S4, and it is more preferable that it is satisfied in almost the entire region in the extending direction of the sheath 30. Here, the “central portion S4” refers to an area including at least a portion located between the urethra and the vagina in the state where the extended sheath 30 as shown in FIG. To tell.
　このようなシース３０の構成は、次のように言い換えることもできる。すなわち、図６（ｂ）に示すように、シース３０は、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、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に対する延長線Ｊ３２’の傾斜角θ５が傾斜角θ１と等しくなる。また、別の言い方をすれば、図６（ｂ）に示すように、シース３０は、中心軸Ｊ５（軸Ｊ１）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、内周部Ａ１と外周部Ａ２とが中心軸Ｊ５方向にずれて位置するように構成されているとも言える。 Such a configuration of the sheath 30 can be rephrased as follows. That is, as shown in FIG. 6B, the sheath 30 is formed such that the long axis J32 is inclined with respect to the central axis J5 of the arc, and an extension line J32 ′ between the central axis J5 and the long axis J32 is formed. It can also be said that it is configured to have an intersection P. In this case, the inclination angle θ5 of the extension line J32 'with respect to the central axis J5 is equal to the inclination angle θ1. In other words, as shown in FIG. 6B, the sheath 30 is located on the inner periphery of the sheath 30 when viewed from the direction of the central axis J5 (axis J1), and has a minimum radius of curvature r1. An inner peripheral portion A1 and an outer peripheral portion A2 located at the outer peripheral edge and having a maximum radius of curvature r2, and the inner peripheral portion A1 and the outer peripheral portion A2 are configured to be shifted in the direction of the central axis J5. It can also be said.
　また、シース３０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、シース３０の内部に挿入された部材の状態等を外部から簡単に確認することができる。 Moreover, it is preferable that the sheath 30 is light transmissive and visible from the outside. Thereby, for example, the state of the member inserted into the sheath 30 can be easily confirmed from the outside.
　また、シース３０（外管３０１および内管３０２）の構成材料としては、特に限定されないが、体内に挿入された状態で形状や内部空間を維持でき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、シース３０の構成として、硬質材料以外の材料を採用する場合は、例えば、壁を補強部材で補強することでも達成される。例えば、高強度の編組体をシース３０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、シース３０に螺旋状物を埋め込むことによりインプラント９が摺動可能な程度に内部空間を保持しつつ、さらに可撓性を備えることが可能となる。 Further, the constituent material of the sheath 30 (the outer tube 301 and the inner tube 302) is not particularly limited, but a hard material that can maintain the shape and the 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, when employ | adopting materials other than a hard material as a structure of the sheath 30, it is achieved also by reinforcing a wall with a reinforcement member, for example. For example, by embedding a high-strength braided body in the sheath 30, 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 sheath 30, it is possible to further provide flexibility while maintaining the internal space to the extent that the implant 9 can slide.
　－針体－
　図５に示すように、針体３９は、先端が先細りした針部３９１と、針部３９１の基端側に設けられた基端部３９２と、針部３９１と基端部３９２との境界部に設けられた当接面３９３とを有している。そして、基端部３９２をシース３０の内管３０２の先端部に嵌入することで、針体３９は、シース３０の先端部に離脱可能に接続されている。このように、基端部３９２を内管３０２に嵌入することで、適度な力で針体３９とシース３０とを接続することができる。 -Needle body-
As shown in FIG. 5, the needle body 39 includes a needle portion 391 having a tapered tip, a base end portion 392 provided on the base end side of the needle portion 391, and a boundary portion between the needle portion 391 and the base end portion 392. And an abutting surface 393. The needle body 39 is detachably connected to the distal end portion of the sheath 30 by fitting the proximal end portion 392 into the distal end portion of the inner tube 302 of the sheath 30. Thus, by fitting the proximal end portion 392 into the inner tube 302, the needle body 39 and the sheath 30 can be connected with an appropriate force.
　針体３９がシース３０に接続された状態では、当接面３９３にシース３０の先端部が当接している。このように、針体３９に当接面３９３を設け、当接面３９３にシース３０の先端部が当接するまで針体３９を内管３０２に嵌入することで、針体３９を内管３０２に適切に接続することができる。また、当接面３９３にシース３０の先端部を当接させておくことで、前述した応力Ｆ１が加わった際の針体３９とシース３０との位置ずれを防止することができる。なお、当接面３９３は、針体３９の軸に略直交する面で構成されていることが好ましい。 In a state where the needle body 39 is connected to the sheath 30, the distal end portion of the sheath 30 is in contact with the contact surface 393. As described above, the contact surface 393 is provided on the needle body 39, and the needle body 39 is fitted into the inner tube 302 until the distal end portion of the sheath 30 contacts the contact surface 393. It can be connected properly. Further, by causing the distal end portion of the sheath 30 to contact the contact surface 393, it is possible to prevent the positional deviation between the needle body 39 and the sheath 30 when the stress F1 is applied. Note that the contact surface 393 is preferably formed of a surface substantially orthogonal to the axis of the needle body 39.
　また、針部３９１は、シース３０と同様に、長軸および短軸を有する扁平な横断面形状となっている。また、図５に示すように、針部３９１は、その長軸Ｊ４２および短軸Ｊ４１がシース３０の長軸Ｊ３２および短軸Ｊ３１と略一致するように配置されている。このように、針部３９１を扁平形状とすることで、生体への穿刺抵抗が低減され、穿刺部材３の生体への穿刺をよりスムーズに行うことができる。なお、針部３９１の扁平形状としては、特に限定されず、シース３０と同様に、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、中央部が両端部よりも拡大した紡錘形等とすることができる。 Further, the needle portion 391 has a flat cross-sectional shape having a major axis and a minor axis, like the sheath 30. Further, as shown in FIG. 5, the needle portion 391 is arranged so that the major axis J42 and the minor axis J41 thereof substantially coincide with the major axis J32 and the minor axis J31 of the sheath 30. Thus, by making the needle part 391 flat, puncture resistance to the living body is reduced, and puncture of the puncture member 3 to the living body can be performed more smoothly. The flat shape of the needle portion 391 is not particularly limited, and is similar to the sheath 30, for example, an oval shape, a convex lens shape in cross section, a diamond shape with rounded corners, a rectangle with rounded corners, a center A spindle shape or the like in which the portion is larger than both end portions can be used.
　また、針部３９１は、その延在方向（軸方向）の途中に最も外径（幅）の大きい、すなわち、その先端側および基端側の部分よりも外径の大きい拡径部（拡幅部）３９１ａを有している。具体的に説明すると、針部３９１は、基端側に配置され、先端側へ向けて外径（幅）が漸増する外径漸増部（幅漸増部）３９１ｂと、外径漸増部３９１ｂの先端側に配置され、先端側へ向けて外径（幅）が漸減する外径漸減部（幅漸減部）３９１ｃと、これらの間に位置する拡径部３９１ａと、を有している。拡径部３９１ａは、穿刺部材３を生体に穿刺した際に、生体組織を剥離する剥離部としても機能する。これにより、穿刺部材３の生体への穿刺をよりスムーズに行うことができる。 Further, the needle portion 391 has the largest outer diameter (width) in the middle of the extending direction (axial direction), that is, the enlarged diameter portion (widened portion) having a larger outer diameter than the distal end side and the proximal end side portions. 391a. Specifically, the needle portion 391 is arranged on the proximal end side, and an outer diameter gradually increasing portion (width gradually increasing portion) 391b whose outer diameter (width) gradually increases toward the distal end side, and a distal end of the outer diameter gradually increasing portion 391b. It has an outer diameter gradually decreasing portion (width gradually decreasing portion) 391c, which is disposed on the side and gradually decreases in outer diameter (width) toward the distal end side, and an enlarged diameter portion 391a positioned therebetween. The enlarged diameter portion 391a also functions as a peeling portion that peels the living tissue when the puncture member 3 is punctured into the living body. Thereby, the biopsy of the puncture member 3 can be performed more smoothly.
　また、図５に示すように、拡径部３９１ａの外径は、シース３０の先端部の外径よりも大きくなっている。すなわち、拡径部３９１ａの長軸Ｊ４２の幅は、シース３０の先端部の長軸Ｊ３２の幅よりも大きく、拡径部３９１ａの短軸Ｊ４１の幅は、シース３０の先端部の短軸Ｊ３１の幅よりも大きい。これにより、穿刺部材３の穿刺をスムーズに行うことができる。具体的に説明すると、穿刺部材３では、針体３９が生体を穿刺し、当該穿刺によって形成された穿刺孔内を当該穿刺孔よりも小さいシース３０の先端部が通過していくため、シース３０の先端部が穿刺孔の壁部に引っ掛かり難い。したがって、穿刺部材３の穿刺孔内での摺動性を高めることができ、穿刺部材３の生体への穿刺をスムーズに行うことができる。特に、シース３０の先端部が当接面３９３に接触し、針体３９の先端側から見たときにシース３０の先端部が当接面３９３の後側に隠れているため、シース３０の先端部が穿刺孔の壁部により引っ掛かり難くなっている。このように、本実施形態では、生体を穿刺し、生体組織を剥離するのは針体３９であって、シース３０は、生体を穿刺する機能も生体組織を剥離する機能も実質的に有していない。 Further, as shown in FIG. 5, the outer diameter of the enlarged diameter portion 391 a is larger than the outer diameter of the distal end portion of the sheath 30. That is, the width of the major axis J42 of the enlarged diameter portion 391a is larger than the width of the major axis J32 of the distal end portion of the sheath 30, and the width of the minor axis J41 of the enlarged diameter portion 391a is smaller than the minor axis J31 of the distal end portion of the sheath 30. Greater than the width of Thereby, the puncture member 3 can be punctured smoothly. Specifically, in the puncture member 3, the needle body 39 punctures the living body, and the distal end portion of the sheath 30 smaller than the puncture hole passes through the puncture hole formed by the puncture. Is difficult to be caught on the wall of the puncture hole. Therefore, the slidability in the puncture hole of the puncture member 3 can be improved, and the puncture member 3 can be smoothly punctured into the living body. In particular, the distal end portion of the sheath 30 is in contact with the contact surface 393, and the distal end portion of the sheath 30 is hidden behind the contact surface 393 when viewed from the distal end side of the needle body 39. The part is difficult to be caught by the wall of the puncture hole. As described above, in this embodiment, the needle body 39 punctures the living body and peels off the living tissue, and the sheath 30 substantially has a function of piercing the living body and a function of peeling the living tissue. Not.
　なお、後述する手技でも説明するが、穿刺部材３の生体への穿刺は、途中までは外管３０１内に内管３０２を退避させた状態で行い、途中からは外管３０１から内管３０２を突出させながら行う。したがって、前述した「先端部の外径」とは、前記途中までは、外管３０１の先端部３０１ａの外径を言い、前記途中からは、内管３０２の先端部の外径を言う。そのため、より詳しく説明すれば、拡径部３９１ａの外径が外管３０１の先端部の外径よりも大きく、外管３０１の先端部の外径が内管３０２の先端部の外径よりも大きくなっていると言える。 As will be described later, the puncture member 3 is punctured into the living body with the inner tube 302 retracted into the outer tube 301 until halfway, and from the outer tube 301 to the inner tube 302 from the middle. Do this while protruding. Therefore, the “outer diameter of the distal end portion” described above refers to the outer diameter of the distal end portion 301a of the outer tube 301 up to the middle, and the outer diameter of the distal end portion of the inner tube 302 from the middle. Therefore, in more detail, the outer diameter of the enlarged diameter portion 391a is larger than the outer diameter of the distal end portion of the outer tube 301, and the outer diameter of the distal end portion of the outer tube 301 is larger than the outer diameter of the distal end portion of the inner tube 302. It can be said that it is getting bigger.
　ここで、本実施形態では、内管３０２の先端部を外管３０１内に退避させるために、内管３０２の先端部の外径が外管３０１の内径と等しいか若干小さくなっているが、例えば、シース３０を、初期状態で内管３０２の先端部が外管３０１から突出している構成とした場合には、内管３０２の先端部を拡径して、その外径を外管３０１の先端部の外径よりも大きくしてもよい。 Here, in this embodiment, in order to retract the distal end portion of the inner tube 302 into the outer tube 301, the outer diameter of the distal end portion of the inner tube 302 is equal to or slightly smaller than the inner diameter of the outer tube 301. For example, when the sheath 30 is configured so that the distal end portion of the inner tube 302 protrudes from the outer tube 301 in the initial state, the distal end portion of the inner tube 302 is expanded, and the outer diameter of the outer tube 301 is increased. You may make it larger than the outer diameter of a front-end | tip part.
　また、針体３９は、外径漸増部３９１ｂを有しているため、次のような効果を発揮することができる。例えば、穿刺部材３の穿刺途中で、穿刺ルートがずれてしまった場合などは、穿刺孔内で穿刺部材３を後退させる必要がある。この場合に、外径漸増部３９１ｂが形成されていないと、針部３９１の基端が「かえし」のようになり、穿刺孔の壁部に引っ掛かり、穿刺部材３をスムーズに後退させることができなくなるおそれがある。これに対して、針部３９１に外径漸増部３９１ｂを設けておくと、上述したような引っ掛かりが低減され、穿刺部材３をスムーズに後退させることができる。 Further, since the needle body 39 has the outer diameter gradually increasing portion 391b, the following effects can be exhibited. For example, when the puncture route is shifted during puncturing of the puncture member 3, it is necessary to retract the puncture member 3 within the puncture hole. In this case, if the outer diameter gradually increasing portion 391b is not formed, the proximal end of the needle portion 391 becomes “barbed” and can be caught in the wall portion of the puncture hole, and the puncture member 3 can be smoothly retracted. There is a risk of disappearing. On the other hand, when the outer diameter gradually increasing portion 391b is provided in the needle portion 391, the above-described catch is reduced, and the puncture member 3 can be smoothly retracted.
　このような針体３９の構成材料としては、特に限定されず、例えば、前述したシース３０と同様の材料を用いることができる。また、針体３９は、中実であってもよいし、中空であってもよい。 The constituent material of the needle body 39 is not particularly limited, and for example, the same material as that of the sheath 30 described above can be used. The needle body 39 may be solid or hollow.
　－操作部材－
　操作部材３１は、シース３０を操作する部材である。図４に示すように、操作部材３１は、本体３２と、プッシャーシャフト（第２の軸部）３３とを有している。また、本体３２は、スタイレット（第１の軸部）３２１と、軸部３２３と、スタイレット３２１および軸部３２３を連結する連結部３２２とを有している。このような操作部材３１では、スタイレット３２１とプッシャーシャフト３３とで軸部３００を構成し、この軸部３００は、延長可能となっている。 -Operation member-
The operation member 31 is a member that operates the sheath 30. As shown in FIG. 4, the operation member 31 includes a main body 32 and a pusher shaft (second shaft portion) 33. The main body 32 includes a stylet (first shaft portion) 321, a shaft portion 323, and a connecting portion 322 that connects the stylet 321 and the shaft portion 323. In such an operation member 31, the stylet 321 and the pusher shaft 33 constitute a shaft portion 300, and the shaft portion 300 can be extended.
　スタイレット３２１は、プッシャーシャフト３３と共にシース３０に挿入され、シース３０を内側から補強する補強部としても機能する。このようなスタイレット３２１は、シース３０の形状に対応して略円弧状（湾曲形状）となっている。なお、スタイレット３２１の中心角や曲率半径は、シース３０の中心角や曲率半径に合わせて設定されている。また、軸部３２３は、スタイレット３２１の中心Ｏと交わり、スタイレット３２１を含む平面ｆ１と直交する軸Ｊ１上に延在している（図３参照）。また、連結部３２２は、スタイレット３２１の基端部と軸部３２３の先端部とを連結している。連結部３２２は、途中でほぼ直角に屈曲したほぼＬ字状をなしている。 The stylet 321 is inserted into the sheath 30 together with the pusher shaft 33, and also functions as a reinforcing portion that reinforces the sheath 30 from the inside. Such a stylet 321 has a substantially arc shape (curved shape) corresponding to the shape of the sheath 30. The center angle and the radius of curvature of the stylet 321 are set according to the center angle and the radius of curvature of the sheath 30. Further, the shaft portion 323 intersects the center O of the stylet 321 and extends on an axis J1 orthogonal to the plane f1 including the stylet 321 (see FIG. 3). Further, the connecting portion 322 connects the base end portion of the stylet 321 and the distal end portion of the shaft portion 323. The connecting portion 322 has a substantially L shape bent at a substantially right angle on the way.
　このような構成の本体３２は、シース３０よりも剛性が高くなるように構成されている。本体３２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。なお、本実施形態では、スタイレット３２１、軸部３２３および連結部３２２が共にほぼ同じ太さとなっているが、本体３２の剛性を十分に高め、本体３２の撓み等を抑制するために、例えば、連結部３２２および軸部３２３をスタイレット３２１よりも太くしてもよい。 The main body 32 having such a configuration is configured to have higher rigidity than the sheath 30. The constituent material of the main body 32 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. In this embodiment, the stylet 321, the shaft portion 323, and the connecting portion 322 are all substantially the same thickness, but in order to sufficiently increase the rigidity of the main body 32 and suppress the bending of the main body 32, for example, The connecting part 322 and the shaft part 323 may be thicker than the stylet 321.
　また、図３に示すように、軸部３２３の基端部にはハンドル（操作部）３２４が固定されている。そして、このハンドル３２４を回転操作することで、操作部材３１を軸Ｊ１まわりに回転操作することができる。これにより、穿刺装置１をスムーズに操作することができる。なお、ハンドル３２４を省略してもよく、その場合は、例えば、連結部３２２を把持して操作部材３１を回転操作してもよい。なお、以下では、スタイレット３２１を先端側へ回転移動させるときのハンドル３２４の回転を「順回転」とも言い、基端側へ回転移動させるときのハンドル３２４の回転を「逆回転」とも言う。 Further, as shown in FIG. 3, a handle (operation unit) 324 is fixed to the base end portion of the shaft portion 323. Then, by rotating the handle 324, the operating member 31 can be rotated around the axis J1. Thereby, the puncture apparatus 1 can be operated smoothly. Note that the handle 324 may be omitted, and in this case, for example, the operation member 31 may be rotated by holding the connecting portion 322. Hereinafter, the rotation of the handle 324 when the stylet 321 is rotationally moved to the distal end side is also referred to as “forward rotation”, and the rotation of the handle 324 when the stylet 321 is rotationally moved to the proximal end side is also referred to as “reverse rotation”.
　また、図４および図５に示すように、スタイレット３２１の先端部には先端チップ（連結部）３４が設けられている。先端チップ３４は、主に、針体３９とスタイレット３２１とを離脱可能に接続する第１の機能と、スタイレット３２１とプッシャーシャフト３３とをスライド可能に連結する第２の機能と、スタイレット３２１とプッシャーシャフト３３との相対的位置関係を規制する第３の機能と、を有している。 Further, as shown in FIGS. 4 and 5, the tip of the stylet 321 is provided with a tip (connecting portion) 34. The distal tip 34 mainly includes a first function for detachably connecting the needle body 39 and the stylet 321, a second function for slidably connecting the stylet 321 and the pusher shaft 33, and a stylet. And a third function for restricting the relative positional relationship between the 321 and the pusher shaft 33.
　まず、第１の機能について説明する。図５に示すように、先端チップ３４は、スタイレット３２１が接続されている本体部３４１を有し、この本体部３４１の先端部には突起３５が設けられている。一方、針体３９の基端部３９２には端面に開放する連結孔３９４が設けられている。そして、突起３５を連結孔３９４に挿入し、これらを連結することで、針体３９とスタイレット３２１とを先端チップ３４を介して離脱可能に連結することができる。このように、針体３９とスタイレット３２１とを連結することで、針体３９を介してスタイレット３２１とシース３０とが連結されるため、スタイレット３２１に対するシース３０の変位、具体的にはスタイレット３２１に対するシース３０の回転や幅方向へのずれ等を抑制することができる。そのため、生体への穿刺部材３の穿刺をより円滑に行うこともできる。 First, the first function will be described. As shown in FIG. 5, the tip tip 34 has a main body 341 to which a stylet 321 is connected, and a protrusion 35 is provided at the tip of the main body 341. On the other hand, the base end portion 392 of the needle body 39 is provided with a connecting hole 394 that opens to the end face. Then, by inserting the protrusion 35 into the connecting hole 394 and connecting them, the needle body 39 and the stylet 321 can be detachably connected via the tip tip 34. In this way, by connecting the needle body 39 and the stylet 321, the stylet 321 and the sheath 30 are connected via the needle body 39, so that the displacement of the sheath 30 with respect to the stylet 321, specifically, Rotation of the sheath 30 relative to the stylet 321 and displacement in the width direction can be suppressed. Therefore, the puncture member 3 can be punctured more smoothly into the living body.
　突起３５の先端部には、弾性変形によって自然状態に対して縮径（縮幅）可能な弾性変形部３５１が設けられている。弾性変形部３５１は、離間配置された２つの弾性片３５２、３５３と、弾性片３５２、３５３の間に設けられた隙間３５４とを有している。このような弾性変形部３５１は、弾性片３５２、３５３が内側（隙間３５４）に向けて弾性変形することで自然状態に対して縮径する。このような構成とすることで、弾性変形部３５１の構成が簡単となる。特に、本実施形態では、弾性片３５２、３５３の先端を自由端としているため、弾性片３５２、３５３が弾性変形し易くなっている。 At the tip of the protrusion 35, an elastic deformation part 351 is provided that can be reduced in diameter (reduced width) relative to the natural state by elastic deformation. The elastic deformation portion 351 includes two elastic pieces 352 and 353 that are spaced apart from each other, and a gap 354 that is provided between the elastic pieces 352 and 353. Such an elastic deformation portion 351 is reduced in diameter relative to a natural state by elastic deformation of the elastic pieces 352 and 353 toward the inner side (gap 354). By setting it as such a structure, the structure of the elastic deformation part 351 becomes simple. In particular, in the present embodiment, since the tips of the elastic pieces 352 and 353 are free ends, the elastic pieces 352 and 353 are easily elastically deformed.
　また、弾性片３５２、３５３には外側へ向けて突出する突出部３５２ａ、３５３ａが設けられており、自然状態において、弾性変形部３５１の外径がそれよりも基端側の部分の外径よりも大きくなっている。突出部３５２ａ、３５３ａは、基端側が突起３５の中心軸側に傾斜する傾斜面となるように略半球状となっている。 In addition, the elastic pieces 352 and 353 are provided with protrusions 352a and 353a that protrude outward, and in the natural state, the outer diameter of the elastic deformation portion 351 is larger than the outer diameter of the proximal end portion. Is also getting bigger. The protrusions 352a and 353a are substantially hemispherical so that the base end side is an inclined surface inclined toward the central axis side of the protrusion 35.
　一方、連結孔３９４は、自然状態での弾性変形部３５１の外径（幅）よりも小さい導入部３９４ａと、導入部３９４ａよりも奥側に位置し、自然状態での弾性変形部３５１の外径（幅）よりも大きい拡径部（拡幅部）３９４ｂとを有している。そして、突起３５と連結孔３９４とが連結されている状態では、図５に示すように、弾性変形部３５１が拡径部３９４ｂ内に位置している。この状態では、弾性変形部３５１が拡径部３９４ｂと導入部３９４ａの境界部に引っ掛かり、突起３５と連結孔３９４との連結状態が維持される。そして、図５に示す連結状態のときに、所定の力以上で先端チップ３４が基端側へ引っ張られると、弾性変形部３５１が縮径することで、連結が解除され、針体３９から突起３５が離脱する。 On the other hand, the connecting hole 394 is positioned on the back side of the introduction portion 394a and the introduction portion 394a smaller than the outer diameter (width) of the elastic deformation portion 351 in the natural state, and is outside the elastic deformation portion 351 in the natural state. And an enlarged diameter portion (widened portion) 394b larger than the diameter (width). In a state where the protrusion 35 and the connection hole 394 are connected, the elastic deformation portion 351 is located in the enlarged diameter portion 394b as shown in FIG. In this state, the elastically deformable portion 351 is hooked on the boundary portion between the enlarged diameter portion 394b and the introduction portion 394a, and the connection state between the protrusion 35 and the connection hole 394 is maintained. When the distal tip 34 is pulled toward the proximal end with a predetermined force or more in the connected state shown in FIG. 5, the elastic deformation portion 351 is reduced in diameter, thereby releasing the connection and protruding from the needle body 39. 35 leaves.
　ここで、前述したように、穿刺部材３の穿刺途中で穿刺ルートがずれてしまった場合などは、穿刺部材３を後退させて正しい穿刺ルートに修正する必要がある。穿刺部材３の後退は、ハンドル３２４を逆回転させて行われるため、スタイレット３２１を退避させることで、スタイレット３２１に連結されている針体３９およびシース３０も一体的に退避させることになる。そのため、突起３５と連結孔３９４との連結強度は、スタイレット３２１を後退させてもスタイレット３２１と針体３９との連結状態が維持されるように設計されている。すなわち、シース３０の表面にかかる生体組織の摺動摩擦に対して、突起３５と連結孔３９４との連結強度が高くなっているため、穿刺部材３を引き戻した際に針体３９からスタイレット３２１が外れないようになっている。これにより、後退時に針体３９からスタイレット３２１が離脱してしまうことを防止することができる。 Here, as described above, when the puncture route is shifted during the puncture of the puncture member 3, it is necessary to retract the puncture member 3 to correct the puncture route. Since the puncture member 3 is retracted by rotating the handle 324 in the reverse direction, the needle body 39 and the sheath 30 connected to the stylet 321 are also retracted integrally by retracting the stylet 321. . Therefore, the connection strength between the protrusion 35 and the connection hole 394 is designed so that the connection state between the stylet 321 and the needle body 39 is maintained even when the stylet 321 is retracted. That is, since the connection strength between the projection 35 and the connection hole 394 is high with respect to the sliding friction of the living tissue on the surface of the sheath 30, the stylet 321 is moved from the needle body 39 when the puncture member 3 is pulled back. It is designed not to come off. Thereby, it is possible to prevent the stylet 321 from detaching from the needle body 39 during retraction.
　なお、図５に示す連結状態では、弾性変形部３５１は、自然状態となっているのが好ましい。穿刺装置１は、初期状態のときに図５に示す連結状態となっているため、連結状態となっている時間（例えば、製造されてから使用されるまでの時間）が長い。したがって、連結状態にて弾性片３５２、３５３を自然状態とすることで、弾性片３５２、３５３が弾性変形している時間を大幅に短くすることができ、弾性片３５２、３５３の形状変化（癖付き）や弾性の低下を防止することができる。その結果、連結状態を解除するのに必要な力の過度な低下を防止でき、スタイレット３２１からの針体３９の意図しない離脱を効果的に防止することができる。 In addition, in the connected state shown in FIG. 5, it is preferable that the elastic deformation part 351 is in a natural state. Since the puncture device 1 is in the connected state shown in FIG. 5 in the initial state, the time for which the puncture device 1 is in the connected state (for example, the time from manufacture to use) is long. Therefore, by setting the elastic pieces 352 and 353 to the natural state in the connected state, the time during which the elastic pieces 352 and 353 are elastically deformed can be significantly shortened, and the shape of the elastic pieces 352 and 353 can be changed (癖And a decrease in elasticity can be prevented. As a result, it is possible to prevent an excessive decrease in force required to release the connected state, and effectively prevent unintentional detachment of the needle body 39 from the stylet 321.
　以上、突起３５および連結孔３９４について説明した。なお、本実施形態では、先端チップ３４に突起３５を設け、針体３９に連結孔３９４を設けているが、突起３５および連結孔３９４の配置は、これに限定されず、例えば、先端チップ３４に連結孔３９４を設け、針体３９に突起３５を設けてもよい。ただし、先端チップ３４は、シース３０内に配置できるように薄く形成されるため、シース３０のサイズ等によっては、連結孔３９４を形成するスペースを確保するのが困難な場合がある。そのため、配置の自由度の観点からすると、本実施形態のように、先端チップ３４に突起３５を設け、針体３９に連結孔３９４を設けることが好ましい。 The protrusion 35 and the connecting hole 394 have been described above. In this embodiment, the tip 35 is provided with the protrusion 35 and the needle body 39 is provided with the connecting hole 394. However, the arrangement of the protrusion 35 and the connecting hole 394 is not limited to this, and for example, the tip tip 34 is provided. A connecting hole 394 may be provided on the needle body 39, and the protrusion 35 may be provided on the needle body 39. However, since the distal tip 34 is formed thin so that it can be disposed in the sheath 30, it may be difficult to secure a space for forming the connection hole 394 depending on the size of the sheath 30. Therefore, from the viewpoint of the degree of freedom of arrangement, it is preferable to provide the protrusion 35 on the tip tip 34 and provide the connection hole 394 in the needle body 39 as in this embodiment.
　次に、第２の機能について説明する。図５に示すように、先端チップ３４の本体部３４１には、プッシャーシャフト３３をスライド可能に保持し、プッシャーシャフト３３を案内する保持部３６が設けられている。 Next, the second function will be described. As shown in FIG. 5, the main body portion 341 of the tip tip 34 is provided with a holding portion 36 that holds the pusher shaft 33 in a slidable manner and guides the pusher shaft 33.
　まず、プッシャーシャフト３３について説明する。図４および図５に示すように、プッシャーシャフト３３は、スタイレット３２１の外周側にスタイレット３２１と離間して並んで配置されており、スタイレット３２１の円弧に倣って略円弧状に湾曲している。すなわち、プッシャーシャフト３３は、スタイレット３２１よりも大きな曲率半径を有し、スタイレット３２１と同心的に配置されている。なお、プッシャーシャフト３３の中心角は、特に限定されないが、スタイレット３２１と同程度とすることができる。なお、プッシャーシャフト３３は、スタイレット３２１の内周側に配置されていてもよい。 First, the pusher shaft 33 will be described. As shown in FIGS. 4 and 5, the pusher shaft 33 is arranged on the outer peripheral side of the stylet 321 so as to be separated from the stylet 321 and bends in a substantially arc shape following the arc of the stylet 321. ing. That is, the pusher shaft 33 has a larger radius of curvature than the stylet 321 and is disposed concentrically with the stylet 321. The central angle of the pusher shaft 33 is not particularly limited, but can be approximately the same as that of the stylet 321. The pusher shaft 33 may be disposed on the inner peripheral side of the stylet 321.
　また、図７に示すように、スタイレット３２１とプッシャーシャフト３３は、シース３０の長軸Ｊ３２（幅方向）に沿って並設されている。これにより、シース３０の内部空間を効率的に使用することができるため、例えば、スタイレット３２１およびプッシャーシャフト３３をなるべく太くすることができ、操作部材３１の剛性をより高めることができる。また、スタイレット３２１およびプッシャーシャフト３３によって、シース３０を内側から効果的に補強することができるため、シース３０の不本意な変形を低減することができる。なお、シース３０を装着した状態では、スタイレット３２１がシース３０のほぼ中央に配置され、プッシャーシャフト３３がシース３０の外周側に配置されている。ここで、シース３０の外周部は、中央部よりも厚みが薄いため、それに合わせて、プッシャーシャフト３３の径をスタイレット３２１の径よりも小さくすることが好ましい。これにより、シース３０を装着した状態でのシース３０の不本意な変形をより効果的に防止することができる。 Further, as shown in FIG. 7, the stylet 321 and the pusher shaft 33 are juxtaposed along the long axis J32 (width direction) of the sheath 30. Thereby, since the internal space of the sheath 30 can be used efficiently, for example, the stylet 321 and the pusher shaft 33 can be made as thick as possible, and the rigidity of the operation member 31 can be further increased. Further, since the sheath 30 can be effectively reinforced from the inside by the stylet 321 and the pusher shaft 33, unintentional deformation of the sheath 30 can be reduced. In the state in which the sheath 30 is attached, the stylet 321 is disposed substantially at the center of the sheath 30, and the pusher shaft 33 is disposed on the outer peripheral side of the sheath 30. Here, since the outer peripheral part of the sheath 30 is thinner than the central part, it is preferable to make the diameter of the pusher shaft 33 smaller than the diameter of the stylet 321 accordingly. Thereby, the unintentional deformation | transformation of the sheath 30 in the state which mounted | wore the sheath 30 can be prevented more effectively.
　また、図５に示すように、プッシャーシャフト３３の先端部は、針体３９に固定されている。後述するように、手技の途中で、プッシャーシャフト３３によって針体３９を押し出してシース３０を延長する工程（図１０、図２１参照）があるが、プッシャーシャフト３３を針体３９に固定することで、プッシャーシャフト３３の押圧力を針体３９に効率的に伝達することができ、針体３９を効率的に押し出すことができる。そのため、手技をスムーズに行うことができる。 Further, as shown in FIG. 5, the tip of the pusher shaft 33 is fixed to the needle body 39. As will be described later, there is a step (see FIGS. 10 and 21) in which the needle body 39 is pushed out by the pusher shaft 33 and the sheath 30 is extended during the procedure (see FIGS. 10 and 21), but by fixing the pusher shaft 33 to the needle body 39. The pushing force of the pusher shaft 33 can be efficiently transmitted to the needle body 39, and the needle body 39 can be pushed out efficiently. Therefore, the procedure can be performed smoothly.
　このような構成のプッシャーシャフト３３は、シース３０よりも剛性が高くなるように構成されている。プッシャーシャフト３３の構成材料としては、特に限定されず、例えば、前述した本体３２と同様の材料を用いることができる。 The pusher shaft 33 having such a configuration is configured to have higher rigidity than the sheath 30. The constituent material of the pusher shaft 33 is not particularly limited, and for example, the same material as that of the main body 32 described above can be used.
　以上のようなプッシャーシャフト３３を保持する保持部３６は、図５に示すように、スタイレット３２１の外周側へ突出する一対のガイド部３６１、３６２を有している。これらガイド部３６１、３６２は、スタイレット３２１の延在方向に離間して配置されている。また、ガイド部３６１、３６２の先端部には挿通孔３６１ａ、３６２ａが形成されており、これら挿通孔３６１ａ、３６２ａにプッシャーシャフト３３がスライド可能に挿通されている。これにより、プッシャーシャフト３３が先端チップ３４に保持され、スタイレット３２１に対してスライド可能となる。 As shown in FIG. 5, the holding portion 36 that holds the pusher shaft 33 as described above has a pair of guide portions 361 and 362 that protrude to the outer peripheral side of the stylet 321. These guide portions 361 and 362 are arranged apart from each other in the extending direction of the stylet 321. Further, insertion holes 361a and 362a are formed at the distal ends of the guide portions 361 and 362, and the pusher shaft 33 is slidably inserted into the insertion holes 361a and 362a. As a result, the pusher shaft 33 is held by the tip tip 34 and can slide with respect to the stylet 321.
　特に、本実施形態のように、プッシャーシャフト３３のスライド方向に離間した２つのガイド部３６１、３６２によってプッシャーシャフト３３を保持することで、図５中の矢印Ｚで示すようなプッシャーシャフト３３の軸まわりの回転を防止している。前述したように、プッシャーシャフト３３は、円弧状に湾曲しているため、プッシャーシャフト３３がスタイレット３２１に対して回転してしまうと、プッシャーシャフト３３を意図した方向に向けてスライドさせることができなくなる。なお、プッシャーシャフト３３の回転をより効果的に防止するために、例えば、プッシャーシャフト３３の断面形状を円以外の楕円形、四角形、三角形等とし、挿通孔３６１ａ、３６２ａをプッシャーシャフト３３の断面形状に合わせた形状としてもよい。また、本実施形態ではシース３０によっても、プッシャーシャフト３３の前記回転が抑制されている。 In particular, as in the present embodiment, the pusher shaft 33 is held by two guide portions 361 and 362 that are separated in the sliding direction of the pusher shaft 33, so that the axis of the pusher shaft 33 as indicated by an arrow Z in FIG. Prevents rotation around. As described above, since the pusher shaft 33 is curved in an arc shape, if the pusher shaft 33 rotates with respect to the stylet 321, the pusher shaft 33 can be slid in the intended direction. Disappear. In order to more effectively prevent the pusher shaft 33 from rotating, for example, the cross-sectional shape of the pusher shaft 33 is an ellipse other than a circle, a quadrangle, a triangle, and the like, and the insertion holes 361a and 362a are formed in a cross-sectional shape of the pusher shaft 33. It is good also as a shape according to. In the present embodiment, the rotation of the pusher shaft 33 is also suppressed by the sheath 30.
　また、２つのガイド部３６１、３６２によってプッシャーシャフト３３を保持することで、ガイド部３６１、３６２（挿通孔３６１ａ、３６２ａ）の間において、先端チップ３４とプッシャーシャフト３３との離間距離Ｄ１をほぼ一定（所定距離以内）に維持することができる。そのため、後述する当接部３７の機能（第３の機能）をより確実に発揮させることができる。なお、ガイド部３６１、３６２の間で離間距離Ｄ１を一定に保つ観点から言えば、ガイド部３６１、３６２の離間距離は、プッシャーシャフト３３の剛性等によっても異なるが、０．５ｃｍ～２．０ｃｍ程度であることが好ましい。 Further, by holding the pusher shaft 33 by the two guide portions 361 and 362, the distance D1 between the tip tip 34 and the pusher shaft 33 is substantially constant between the guide portions 361 and 362 ( insertion holes 361a and 362a). (Within a predetermined distance). Therefore, the function (third function) of the contact portion 37 described later can be more reliably exhibited. From the viewpoint of keeping the separation distance D1 between the guide portions 361 and 362 constant, the separation distance between the guide portions 361 and 362 varies depending on the rigidity of the pusher shaft 33, but is 0.5 cm to 2.0 cm. It is preferable that it is a grade.
　次に、第３の機能について説明する。図５に示すように、先端チップ３４には、プッシャーシャフト３３との相対的な位置関係を規制するための弾性変形可能な当接部３７が設けられている。当接部３７は、ガイド部３６１、３６２の間からプッシャーシャフト３３の先端側（針体３９側）へ向けて斜めに突出している。 Next, the third function will be described. As shown in FIG. 5, the tip tip 34 is provided with an elastically deformable contact portion 37 for restricting the relative positional relationship with the pusher shaft 33. The contact portion 37 protrudes obliquely from between the guide portions 361 and 362 toward the distal end side (the needle body 39 side) of the pusher shaft 33.
　一方、プッシャーシャフト３３の先端部には逃げ部としての凹部３３１が設けられており、基端部には係合部としての凹部３３２が設けられている。また、図５に示す初期状態では、当接部３７の先端部は、凹部３３１内に位置している。この状態では、当接部３７は、弾性変形しておらず、自然状態となっている。このように、初期状態での当接部３７の弾性変形を防止することで、当接部３７が弾性変形している時間を大幅に短くすることができ、当接部３７の形状変化（癖付き）や弾性の低下を防止することができる。その結果、当接部３７の機能をより確実に発揮することができる。 On the other hand, a concave portion 331 as a relief portion is provided at the distal end portion of the pusher shaft 33, and a concave portion 332 as an engaging portion is provided at the proximal end portion. In the initial state shown in FIG. 5, the distal end portion of the contact portion 37 is located in the recess 331. In this state, the contact portion 37 is not elastically deformed and is in a natural state. Thus, by preventing elastic deformation of the contact portion 37 in the initial state, the time during which the contact portion 37 is elastically deformed can be significantly shortened, and the shape change (変 化) And a decrease in elasticity can be prevented. As a result, the function of the contact part 37 can be more reliably exhibited.
　また、後述するように、穿刺装置１を用いた手技の途中で、スタイレット３２１をプッシャーシャフト３３に対して基端側へスライドさせて、軸部３００を延長する工程がある（図９参照）。このように、軸部３００を延長した状態では、当接部３７の先端部が凹部３３２内に位置する。凹部３３２の先端側の面は、プッシャーシャフト３３の中心軸に略直交し、プッシャーシャフト３３の基端側を向く当接面３３２ａとなっており、延長状態では当接面３３２ａと当接部３７の先端面３７１とが対向または接触している。そのため、延長状態では、スタイレット３２１のプッシャーシャフト３３に対する先端側への移動が規制される。したがって、スタイレット３２１を先端側へ移動させると、スタイレット３２１と共にプッシャーシャフト３３が一体的に（相対的位置関係を保ちつつ）先端側へ移動することとなる。 In addition, as will be described later, there is a step of extending the shaft portion 300 by sliding the stylet 321 toward the proximal side with respect to the pusher shaft 33 during the procedure using the puncture device 1 (see FIG. 9). . Thus, in the state where the shaft portion 300 is extended, the tip end portion of the contact portion 37 is positioned in the recess 332. The surface on the distal end side of the recess 332 is a contact surface 332a that is substantially orthogonal to the central axis of the pusher shaft 33 and faces the proximal end side of the pusher shaft 33. In the extended state, the contact surface 332a and the contact portion 37 are provided. Is opposed to or in contact with the front end surface 371. Therefore, in the extended state, the movement of the stylet 321 toward the distal end side with respect to the pusher shaft 33 is restricted. Therefore, when the stylet 321 is moved to the distal end side, the pusher shaft 33 is moved together with the stylet 321 to the distal end side (while maintaining the relative positional relationship).
　特に、前述したように、先端チップ３４とプッシャーシャフト３３との間の離間距離Ｄ１が一定に維持されている領域（ガイド部３６１、２６２の間）に当接部３７が設けられているため、当接部３７の先端面３７１と当接面３３２ａとがより確実に当接し、上記の機能をより確実に発揮することができる。そのため、穿刺装置１の誤作動等を防止することができる。 In particular, as described above, the contact portion 37 is provided in the region (between the guide portions 361 and 262) where the distance D1 between the tip tip 34 and the pusher shaft 33 is maintained constant. The front end surface 371 and the contact surface 332a of the contact portion 37 are more reliably in contact with each other, and the above function can be more reliably exhibited. Therefore, malfunction etc. of the puncture apparatus 1 can be prevented.
　一方で、凹部３３２の基端側の面は、傾斜面３３２ｂとなっている。そのため、延長状態から、さらに、スタイレット３２１をプッシャーシャフト３３に対して基端側にスライドさせることができ、これにより、プッシャーシャフト３３を先端チップ３４から離脱させることができる。このように、プッシャーシャフト３３を先端チップ３４から離脱可能とすることで、生体からの穿刺部材３の除去を簡単に行うことができる。 On the other hand, the surface on the proximal end side of the recess 332 is an inclined surface 332b. Therefore, the stylet 321 can be further slid to the proximal end side with respect to the pusher shaft 33 from the extended state, whereby the pusher shaft 33 can be detached from the distal tip 34. Thus, by making the pusher shaft 33 detachable from the distal tip 34, the puncture member 3 can be easily removed from the living body.
　なお、本実施形態では、先端チップ３４に当接部３７を設け、プッシャーシャフト３３に凹部３３２を設けているが、当接部３７および凹部３３２の配置は、これに限定されず、例えば、先端チップ３４に凹部３３２を設け、プッシャーシャフト３３に当接部３７を設けてもよい。ただし、プッシャーシャフト３３に当接部３７を設ける場合には、プッシャーシャフト３３をスライドさせる際に当接部３７がガイド部３６２と接触しないような設計としなければならず、設計が複雑化するおそれがある。そのため、簡単な設計の観点からすると、本実施形態のように、先端チップ３４に当接部３７を設け、プッシャーシャフト３３に凹部３３２を設けることが好ましい。 In the present embodiment, the contact tip 37 is provided on the tip tip 34, and the recess 332 is provided on the pusher shaft 33. However, the arrangement of the contact portion 37 and the recess 332 is not limited to this. The chip 34 may be provided with a recess 332 and the pusher shaft 33 may be provided with a contact portion 37. However, when the abutting portion 37 is provided on the pusher shaft 33, the design must be made so that the abutting portion 37 does not come into contact with the guide portion 362 when the pusher shaft 33 is slid. There is. Therefore, from the viewpoint of simple design, it is preferable to provide the contact tip 37 on the tip tip 34 and the recess 332 on the pusher shaft 33 as in this embodiment.
　以上、説明したような先端チップ３４では、本体部３４１の延在方向の少なくとも一部に、扁平形状を有している部分が含まれており、この扁平形状を有する部分がシース３０の回転を防止するように機能していることが好ましい。これにより、シース３０の意図しない変位や変形を防止でき、穿刺部材３の生体への穿刺をよりスムーズに行うことができる。 As described above, in the distal tip 34 described above, a portion having a flat shape is included in at least a part of the extending direction of the main body portion 341, and the portion having the flat shape rotates the sheath 30. It preferably functions to prevent. Thereby, unintended displacement and deformation of the sheath 30 can be prevented, and the puncture member 3 can be punctured into the living body more smoothly.
　－スライドロック部３８－
　スライドロック部３８は、軸部３００の延長を行うのに用いられる。図４に示すように、スライドロック部３８は、スタイレット３２１にスライド可能に保持されている。具体的には、スライドロック部３８は、挿通孔３８９を有しており、この挿通孔３８９にスタイレット３２１が挿通されている。また、スライドロック部３８は、連結部３２２と当接することで、スタイレット３２１の基端側からの離脱が防止されている。このような構成では、初期状態からハンドル３２４を順回転させると、連結部３２２によってスライドロック部３８が押圧され、スライドロック部３８がスタイレット３２１、プッシャーシャフト３３およびシース３０と共に先端側へ移動する。 -Slide lock 38-
The slide lock portion 38 is used to extend the shaft portion 300. As shown in FIG. 4, the slide lock portion 38 is slidably held by the stylet 321. Specifically, the slide lock portion 38 has an insertion hole 389, and the stylet 321 is inserted through the insertion hole 389. Further, the slide lock portion 38 is in contact with the connecting portion 322, thereby preventing the stylet 321 from being detached from the base end side. In such a configuration, when the handle 324 is rotated forward from the initial state, the slide lock portion 38 is pressed by the connecting portion 322, and the slide lock portion 38 moves to the distal end side together with the stylet 321, the pusher shaft 33 and the sheath 30. .
　また、スライドロック部３８は、シース３０およびプッシャーシャフト３３の基端側に位置し、少なくとも、シース３０の基端と接触している。これにより、穿刺時のシース３０の基端側へのずれを防止し、針体３９からのシース３０の離脱を防止することができる。なお、スライドロック部３８は、シース３０の基端と接触していなくてもよく、離間していてもよい。ただし、この場合の離間距離は、針体３９の基端部３９２の長さ（内管３０２への挿入深さ）よりも短いことが好ましい。これによっても、針体３９からのシース３０の離脱を防止することができる。 Further, the slide lock portion 38 is positioned on the proximal end side of the sheath 30 and the pusher shaft 33 and is in contact with at least the proximal end of the sheath 30. Accordingly, the sheath 30 can be prevented from shifting toward the proximal end during puncturing, and the sheath 30 can be prevented from being detached from the needle body 39. Note that the slide lock portion 38 may not be in contact with the proximal end of the sheath 30 and may be separated. However, the separation distance in this case is preferably shorter than the length of the proximal end portion 392 of the needle body 39 (insertion depth into the inner tube 302). Also by this, the detachment of the sheath 30 from the needle body 39 can be prevented.
　図４に示す初期状態から、ハンドル３２４を順回転させて、スライドロック部３８を軸部３００およびシース３０と共に先端側へ移動させると、図８に示すように、スライドロック部３８がフレーム２に固定される。なお、スライドロック部３８のフレーム２への固定は、スライドロック部３８に設けられた突起（雄型係合部）３８１と、フレーム２の案内部２２に設けられた係合孔（雌型係合部）２２９との係合により行われる。突起３８１の先端部は、２つの弾性片３８２、３８３に分割されており、この弾性片３８２、３８３には爪部３８２ａ、３８３ａが設けられている。そして、突起３８１が係合孔２２９に挿入され、爪部３８２ａ、３８３ａが係合孔２２９を通過して、その端面２２９ａに係合することでスライドロック部３８がフレーム２に固定される。このような構成によれば、簡単な構成で、スライドロック部３８をフレーム２に固定することができる。特に、本実施形態では、係合孔２２９の突起３８１が挿入される側の端部をテーパー状とし、開口を広げることで、突起３８１をスムーズに挿入することができるようになっている。 When the handle 324 is rotated forward from the initial state shown in FIG. 4 and the slide lock portion 38 is moved to the distal end side together with the shaft portion 300 and the sheath 30, the slide lock portion 38 is attached to the frame 2 as shown in FIG. Fixed. The slide lock portion 38 is fixed to the frame 2 with a projection (male engagement portion) 381 provided on the slide lock portion 38 and an engagement hole (female engagement) provided on the guide portion 22 of the frame 2. This is performed by engagement with the joint portion 229. The tip of the protrusion 381 is divided into two elastic pieces 382 and 383, and the elastic pieces 382 and 383 are provided with claw portions 382a and 383a. Then, the projection 381 is inserted into the engagement hole 229, and the claw portions 382 a and 383 a pass through the engagement hole 229 and engage with the end surface 229 a, so that the slide lock portion 38 is fixed to the frame 2. According to such a configuration, the slide lock portion 38 can be fixed to the frame 2 with a simple configuration. In particular, in the present embodiment, the end of the engagement hole 229 on the side where the protrusion 381 is inserted is tapered, and the opening is widened so that the protrusion 381 can be inserted smoothly.
　また、図８に示すように、端面２２９ａは、フレーム２の外部に臨んだ面であり、スライドロック部３８がフレーム２に固定された状態では、爪部３８２ａ、３８３ａがフレーム２の外部に露出する。そのため、術者は、スライドロック部３８がフレーム２に固定されたことを視認することができる。したがって、穿刺装置１の誤動作を効果的に防止することができる。さらに、爪部３８２ａ、３８３ａがフレーム２の外部に露出するため、術者が爪部３８２ａ、３８３ａを摘まんで内側へ押し込むことで、固定状態を解除することができる。そのため、穿刺装置１の操作性が向上する。なお、突起３８１と係合孔２２９の配置は、本実施形態に限定されず、本実施形態とは反対に、スライドロック部３８に係合孔２２９を設け、フレーム２に突起３８１を設けてもよい。 Further, as shown in FIG. 8, the end surface 229 a is a surface facing the outside of the frame 2, and the claw portions 382 a and 383 a are exposed to the outside of the frame 2 when the slide lock portion 38 is fixed to the frame 2. To do. Therefore, the surgeon can visually recognize that the slide lock portion 38 is fixed to the frame 2. Therefore, malfunction of the puncture apparatus 1 can be effectively prevented. Further, since the nail portions 382a and 383a are exposed to the outside of the frame 2, the fixed state can be released by the operator holding the nail portions 382a and 383a and pushing them inward. Therefore, the operability of the puncture device 1 is improved. Note that the arrangement of the protrusions 381 and the engagement holes 229 is not limited to the present embodiment. Contrary to the present embodiment, the slide holes 38 may be provided with the engagement holes 229 and the frame 2 may be provided with the protrusions 381. Good.
　スライドロック部３８がフレーム２に固定された規制状態（図８の状態）では、連結部３２２がスライドロック部３８に当接することで、スタイレット３２１のそれ以上の先端側への移動が規制される。一方で、ハンドル３２４を逆回転させれば、スタイレット３２１をスライドロック部３８に対してスライドさせながら、基端側へ移動させることができる。しかしながら、シース３０は、基端部がスライドロック部３８に当接するため、基端側への移動が規制される。また、シース３０に連結している針体３９と、針体３９を介してシース３０に連結しているプッシャーシャフト３３とも、基端側への移動が規制される。そのため、規制状態とした後にハンドル３２４を逆回転させると、図９に示すように、スタイレット３２１のみが基端側へ移動し、針体３９からスタイレット３２１が離脱する。 In the restricted state where the slide lock portion 38 is fixed to the frame 2 (the state shown in FIG. 8), the further movement of the stylet 321 toward the tip side is restricted by the connection portion 322 coming into contact with the slide lock portion 38. The On the other hand, if the handle 324 is rotated in the reverse direction, the stylet 321 can be moved toward the proximal end while sliding the stylet 321 with respect to the slide lock portion 38. However, since the base end portion of the sheath 30 abuts on the slide lock portion 38, the movement to the base end side is restricted. Further, the movement of the needle body 39 connected to the sheath 30 and the pusher shaft 33 connected to the sheath 30 via the needle body 39 are also regulated. Therefore, when the handle 324 is rotated in the reverse direction after being in the restricted state, only the stylet 321 moves to the proximal end side and the stylet 321 is detached from the needle body 39 as shown in FIG.
　このように、規制状態からスタイレット３２１のみを基端側へ移動させることで、スタイレット３２１の先端側からプッシャーシャフト３３が突出し、軸部３００が延長された延長状態となる。また、前述したように、延長状態では、図９に示すように、先端チップ３４の当接部３７がプッシャーシャフト３３の凹部３３２内に位置している。この状態では、スタイレット３２１のプッシャーシャフト３３に対する先端側へのスライドが規制されるため、延長状態とした後は、延長状態を維持したまま、すなわち、スタイレット３２１とプッシャーシャフト３３の相対的位置関係を維持したまま、軸部３００を先端側へ移動させることができる。そのため、再び、ハンドル３２４を順回転させると、図１０に示すように、軸部３００が延長状態を保ちつつ先端側へ移動し、それとともに針体３９が先端側へ移動する。また、このとき、針体３９に連結している内管３０２も針体３９と共に先端側へ移動し、これにより、内管３０２が外管３０１から突出してシース３０が延長される。 Thus, by moving only the stylet 321 from the restricted state to the proximal end side, the pusher shaft 33 protrudes from the distal end side of the stylet 321 and the shaft portion 300 is extended. Further, as described above, in the extended state, as shown in FIG. 9, the contact portion 37 of the tip tip 34 is positioned in the recess 332 of the pusher shaft 33. In this state, since the slide of the stylet 321 to the tip side with respect to the pusher shaft 33 is restricted, after the extended state, the extended state is maintained, that is, the relative position of the stylet 321 and the pusher shaft 33. The shaft portion 300 can be moved to the tip side while maintaining the relationship. Therefore, when the handle 324 is rotated forward again, as shown in FIG. 10, the shaft portion 300 moves to the distal end side while maintaining the extended state, and the needle body 39 moves to the distal end side with it. At this time, the inner tube 302 connected to the needle body 39 also moves to the distal end side together with the needle body 39, whereby the inner tube 302 protrudes from the outer tube 301 and the sheath 30 is extended.
　このようなスライドロック部３８を設けることで、軸部３００を簡単に延長することができ、さらに、その後の動作によってシース３０を簡単に延長することができる。そのため、穿刺装置１による手技をスムーズにかつ正確に行うことができる。特に、本実施形態では、初期状態からスタイレット３２１を先端側へ移動させれば自動的にスライドロック部３８がフレーム２に固定されるので、穿刺装置１の操作が簡単となる。また、本実施形態のように、初期状態からスタイレット３２１を先端側へ移動させた後に、スライドロック部３８がフレーム２に固定されるので、スタイレット３２１の基端側に、スタイレット３２１を移動させるための空間が十分に確保される。そのため、規制状態から延長状態とする際のスタイレット３２１の基端側への移動をスムーズにかつ確実に行うことができる。 By providing such a slide lock portion 38, the shaft portion 300 can be easily extended, and the sheath 30 can be easily extended by the subsequent operation. Therefore, the procedure using the puncture device 1 can be performed smoothly and accurately. In particular, in this embodiment, the slide lock unit 38 is automatically fixed to the frame 2 when the stylet 321 is moved from the initial state to the distal end side, so that the operation of the puncture apparatus 1 is simplified. Further, as in this embodiment, after the stylet 321 is moved from the initial state to the distal end side, the slide lock portion 38 is fixed to the frame 2, so the stylet 321 is attached to the proximal end side of the stylet 321. Sufficient space for movement is secured. Therefore, the movement of the stylet 321 to the base end side when changing from the restricted state to the extended state can be performed smoothly and reliably.
　≪フレーム≫
　フレーム２は、穿刺部材３を回動自在に保持し、また、挿入具６を着脱自在に固定する。このようなフレーム２は、穿刺部材３が生体組織を穿刺する際に、針体３９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３９が尿道挿入具４と膣挿入具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、尿道挿入具４および膣挿入具５の位置関係を定めている。 ≪Frame≫
The frame 2 holds the puncture member 3 in a rotatable manner, and fixes the insertion tool 6 in a detachable manner. Such a frame 2 has a function of determining a puncture route of the needle body 39 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 39 passes between the urethra insertion tool 4 and the vaginal insertion tool 5 without colliding with them. 3. The positional relationship between the urethral insertion tool 4 and the vaginal insertion tool 5 is defined.
　図２および図３に示すように、フレーム２は、穿刺部材３の軸部３２３を軸受する軸受部２１と、穿刺部材３を案内する案内部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を固定する固定部２４とを有している。 As shown in FIGS. 2 and 3, the frame 2 connects the bearing portion 21 that supports the shaft portion 323 of the puncture member 3, the guide portion 22 that guides the puncture member 3, and the bearing portion 21 and the guide portion 22. And a fixing portion 24 for fixing the insertion tool 6.
　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３２３が回動自在に挿入されている。これにより、フレーム２に穿刺部材３が軸Ｊ１まわりに回動可能な状態で支持される。なお、この軸受部２１の後方に、ハンドル３２４が配置されている。 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 J <b> 1 of the bearing portion 21, and the shaft portion 323 is rotatably inserted into the through hole 211. Thereby, the puncture member 3 is supported by the frame 2 so as to be rotatable around the axis J1. A handle 324 is disposed behind the bearing portion 21.
　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４に示すように、案内部２２は、穿刺部材３をガイドする円弧状のガイド溝２２１を有しており、このガイド溝２２１内にシース３０が配置されている。また、ガイド溝２２１の先端部に、前述した係合孔２２９が設けられている。ガイド溝２２１の先端側の開口２２１ａは、針体３９を外部へ突出させるための開口であり、基端側の開口２２１ｂは、外部へ突出させて戻ってきた針体３９と案内部２２との接触を防止するための開口である。基端側の開口２２１ｂは、案内部２２の外側面および上面に大きく開放し、これにより、戻ってきた針体３９を視認し易くなっており、また、戻ってきた針体３９と案内部２２との接触を効果的に防止している。さらに、戻ってきた針体３９を容易に把持することもできる。 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. 4, the guide portion 22 has an arcuate guide groove 221 that guides the puncture member 3, and the sheath 30 is disposed in the guide groove 221. Further, the aforementioned engagement hole 229 is provided at the tip of the guide groove 221. The opening 221a on the distal end side of the guide groove 221 is an opening for projecting the needle body 39 to the outside, and the opening 221b on the proximal end side is formed between the needle body 39 and the guide portion 22 that are projected back to the outside. It is an opening for preventing contact. The opening 221b on the base end side is largely open to the outer side surface and the upper surface of the guide portion 22, thereby making it easy to visually recognize the returned needle body 39, and the returned needle body 39 and the guide portion 22. Effectively prevents contact with Furthermore, the returned needle body 39 can be easily grasped.
　また、初期状態で、針体３９がガイド溝２２１の先端側の開口２２１ａから突出した状態となっている。これにより、針体３９の位置を視認することができるので、針体３９の位置決めを簡単に行うことができる。 Also, in the initial state, the needle body 39 is in a state of protruding from the opening 221a on the distal end side of the guide groove 221. Thereby, since the position of the needle body 39 can be visually recognized, the positioning of the needle body 39 can be performed easily.
　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する。術者は、例えば、一方の手で連結部２３を把持し、他方の手でハンドル３２４を操作することで、穿刺装置１を安定した状態で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 connection part 23 also functions as a grip part. For example, the operator can use the puncture device 1 in a stable state by holding the connecting portion 23 with one hand and operating the handle 324 with the other hand.
　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１１に示すように、固定部２４は、挿入具６の後述する支持部４０、５０を嵌め込む凹部２４３と、雄ネジ２４４とを有している。このような固定部２４では、支持部４０、５０を凹部２４３へ嵌め込み、さらに、雄ネジ２４４を支持部４０に締め込むことで、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. 11, the fixing portion 24 includes a concave portion 243 into which support portions 40 and 50 (described later) of the insertion tool 6 are fitted, and a male screw 244. In such a fixing part 24, the insertion tool 6 can be fixed to the fixing part 24 by fitting the supporting parts 40 and 50 into the recessed part 243 and further tightening the male screw 244 into the supporting part 40.
　≪挿入具≫
　図１２に示すように、挿入具６は、尿道挿入具４と、膣挿入具５とを有している。 ≪Inserting tool≫
As shown in FIG. 12, the insertion tool 6 has a urethral insertion tool 4 and a vaginal insertion tool 5.
　－尿道挿入具－
　尿道挿入具４は、その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。尿道挿入部４１および支持部４０の構成材料としては、それぞれ、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。 -Urethral insert-
The urethral insertion device 4 includes a long urethral insertion portion 41 that is inserted into the urethra halfway and a support portion 40 that supports the urethral insertion portion 41. The constituent materials of the urethral insertion portion 41 and the support portion 40 are not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials can be used. .
　また、尿道挿入部４１（支持部４０より先端側の部分）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が、一般的な女性の尿道の長さが３０ｍｍ～５０ｍｍ程度であるため、それに合わせて５０ｍｍ～１００ｍｍ程度とするのが好ましい。 Further, the length of the urethral insertion portion 41 (portion on the distal end side from the support portion 40) is not particularly limited, and is appropriately set depending on the length of the urethra of the patient, the shape of the bladder, and the like. Therefore, the length is preferably about 50 mm to 100 mm.
　尿道挿入部４１は、真っ直ぐな管状をなしている。このような尿道挿入部４１の先端部には、伸展性を有し、拡張／収縮自在な拡張体であるバルーン４２と、尿排出部４７とが設けられている。 The urethral insertion portion 41 has a straight tubular shape. The distal end portion of the urethra insertion portion 41 is provided with a balloon 42 which is an expandable and expandable / contractable expandable body, and a urine discharge portion 47.
　バルーン４２は、尿道挿入部４１を尿道に挿入したときに、膀胱内に位置するように配置されている。また、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、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１２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 is disposed so as to be located in the bladder when the urethral insertion portion 41 is inserted into the urethra. The balloon 42 passes through the urethral insertion portion 41 and is connected to a balloon port 43 provided at the proximal end portion thereof. A balloon expansion device such as a syringe can be connected to the balloon port 43. When a working fluid (liquid such as physiological saline, gas, etc.) is supplied from the balloon expansion device to the balloon 42, the balloon 42 expands, In addition, when the working fluid is extracted from the balloon 42 by the balloon expanding device, the balloon 42 is deflated. In FIG. 12, a state where the balloon 42 is deflated is indicated by a two-dot chain line, and a state where the balloon 42 is expanded is indicated by a solid line.
　尿排出部４７は、尿道挿入部４１を尿道に挿入した状態で、膀胱内の尿を排出するために用いられる。この尿排出部４７には尿排出部４７の内外を連通する尿排孔４７１が設けられている。また、尿排孔４７１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、尿排孔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。 The urine discharge part 47 is used to discharge urine in the bladder with the urethra insertion part 41 inserted into the urethra. The urine discharge part 47 is provided with a urine discharge hole 471 that communicates the inside and outside of the urine discharge part 47. Further, the urine drainage hole 471 passes through the urethral insertion portion 41 and is connected to a urine discharge port 48 provided at the base end portion thereof. Therefore, urine introduced from the urine drainage 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、尿道挿入部４１の途中には、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、例えば、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に尿道口に位置するように配置されている。これにより、簡単に、尿道挿入部４１の尿道への挿入深さを確認することができる。なお、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。また、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。 Further, a marker 46 for confirming the insertion depth of the urethra insertion part 41 into the urethra is provided in the middle of the urethra insertion part 41. For example, the marker 46 is disposed so that the urethral insertion portion 41 is inserted into the urethra and the balloon 42 is located at the urethral opening when the balloon 42 is located in the bladder. Thereby, the insertion depth to the urethra of the urethra insertion part 41 can be confirmed easily. Note that the marker 46 only needs to be visible from the outside, and can be configured by, for example, a colored portion, an uneven portion, or the like. Further, instead of the marker 46, a scale on which the distance from the tip of the urethral insertion portion 41 is written may be provided.
　また、尿道挿入部４１の途中（マーカー４６より先端側）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内を通って支持部４０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、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、吸引孔４４に尿道壁を吸着固定することができる。特に、本実施形態のように、複数の吸引孔４４を尿道挿入部４１の周方向の全域にわたって設けることで、尿道挿入部４１に尿道壁の広い範囲を吸着・固定することができる。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。 Further, a plurality of suction holes 44 are formed in the middle of the urethra insertion part 41 (at the tip side from the marker 46). The plurality of suction holes 44 are arranged over the entire area in the circumferential direction of the urethral insertion portion 41. Each suction hole 44 passes through the urethra insertion part 41 and is connected to a suction port 45 provided in the support part 40. 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 portion 41 inserted into the urethra, the urethra wall can be adsorbed and fixed to the suction hole 44. In particular, as in the present embodiment, by providing a plurality of suction holes 44 over the entire area in the circumferential direction of the urethra insertion part 41, a wide range of the urethra wall can be adsorbed and fixed to the urethra insertion part 41. The number of suction holes 44 is not particularly limited, and may be one, for example. The arrangement of the suction holes 44 is not particularly limited, and may be formed only in a part of the circumferential direction of the urethral insertion portion 41, for example.
　なお、尿道挿入部４１に尿道壁を吸着・固定した状態で、尿道挿入部４１を体内側（尿道挿入部４１の先端側）へ押し込むと、これとともに尿道および膀胱が体内側へ押し込まれ、膀胱を針体３９の穿刺経路と重ならない位置にずらすことができる。そのため、針体３９の穿刺経路をより大きく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。 In addition, when the urethra insertion part 41 is pushed into the body (the distal end side of the urethra insertion part 41) while the urethra wall is adsorbed and fixed to the urethra insertion part 41, the urethra and the bladder are pushed into the body together with this, and the bladder Can be shifted to a position that does not overlap the puncture path of the needle 39. Therefore, a larger puncture path of the needle body 39 can be secured, and the puncture of the puncture member 3 can be performed accurately and safely.
　次に、尿道挿入部４１と穿刺部材３との傾きについて説明する。図３に示すように、穿刺部材３の軸Ｊ１は、尿道挿入部４１の軸Ｊ２との間の離間距離が先端側に向かって増大するように、軸Ｊ２に対して傾斜している。軸Ｊ１の軸Ｊ２に対する傾斜角、言い換えると、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としては、特に限定されないが、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。これにより、穿刺部材３の穿刺を容易に行うことができ、また、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。 Next, the inclination between the urethra insertion part 41 and the puncture member 3 will be described. As shown in FIG. 3, the axis J1 of the puncture member 3 is inclined with respect to the axis J2 so that the separation distance from the axis J2 of the urethral insertion portion 41 increases toward the distal end side. The inclination angle of the axis J1 with respect to the axis J2, in other words, the inclination angle θ2 of the plane f9 (plane f1) with respect to the plane f2 orthogonal to the axis J2, is not particularly limited, but is preferably about 20 ° to 60 °, preferably 30 More preferably, the angle is about 45 ° to 45 °, and further preferably about 35 ° to 40 °. Thereby, the puncture of the puncture member 3 can be performed easily, and the puncture distance by the puncture member 3 can be further shortened.
　具体的に説明すると、傾斜角θ２を上記範囲内とすることで、図１３（ａ）に示すように、針体３９が骨盤１１００の閉鎖孔１１０１、１１０２を平面的に広く捉えることができ、針体３９の穿刺スペースを広く確保することができる。すなわち、患者を所定の体位（砕石位）にした状態で、閉鎖孔１１０１、１１０２に対して針体３９を比較的垂直方向に穿刺することができる。そのため、針体３９の穿刺を容易に行うことができる。 Specifically, by setting the inclination angle θ2 within the above range, as shown in FIG. 13A, the needle body 39 can widely capture the closed holes 1101 and 1102 of the pelvis 1100 in a plane, A wide puncture space for the needle body 39 can be secured. In other words, the needle body 39 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 needle body 39 can be punctured easily.
　このように、閉鎖孔１１０１、１１０２に対して針体３９を垂直方向に穿刺することで、針体３９が生体の浅い部分を通過するため、針体３９が閉鎖孔１１０１、１１０２の間をより短い距離で通過する。そのため、図１３（ｂ）に示すように、針体３９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、セーフティゾーンＳ５を通過させることで、針体３９を安全に穿刺することができる。そのため、穿刺装置１を用いた手技が、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。 In this way, by puncturing the needle body 39 in the vertical direction with respect to the closing holes 1101 and 1102, the needle body 39 passes through a shallow portion of the living body. Pass in a short distance. Therefore, as shown in FIG. 13B, the needle body 39 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 needle body 39 can be punctured safely by passing through the safety zone S5. Therefore, the procedure using the puncture device 1 becomes less invasive, and the burden on the patient can be kept small.
　このように、傾斜角θ２を上記範囲とすることで、患者への針体３９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ため、中部尿道と膣の間の組織を目標とすることで、より効果的な治療を行うことができる。 Thus, by setting the inclination angle θ2 within the above range, it is possible to more appropriately puncture the needle body 39 to the patient. 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 suitable location for implanting the urinary incontinence by implanting the implant 9, so that more effective treatment can be achieved by targeting the tissue between the middle urethra and the vagina. It can be carried out.
　なお、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、針体３９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、針体３９の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。 When the inclination angle θ2 is less than the above lower limit value or exceeds the above upper limit value, the needle body 39 widely captures the closed holes 1101 and 1102 in a plan view depending on individual differences of patients, postures during the procedure, and the like. In some cases, the puncture route of the needle 39 cannot be shortened sufficiently.
　以上、尿道挿入具４の構成について説明した。このような尿道挿入具４では、尿道挿入部４１は、支持部４０に対してスライドできないようになっていてもよく、支持部４０に対してスライド可能となっていてもよい。スライド可能となっている場合は、例えば、支持部４０に設けたネジ（図示せず）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してもよい。この構成によれば、尿道挿入部４１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尿道挿入具４となる。なお、このことは、後述する膣挿入具５についても同様である。 The configuration of the urethral insertion tool 4 has been described above. In such a urethral insertion device 4, the urethral insertion portion 41 may not be slidable with respect to the support portion 40, and may be slidable with respect to the support portion 40. In the case of being slidable, for example, if a screw (not shown) provided in the support 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 may be configured to be fixed to the support part 40. According to this configuration, since the length of the urethral insertion portion 41 can be adjusted, the urethral insertion tool 4 is more convenient to use. This also applies to the vaginal insertion tool 5 described later.
　また、穿刺装置１では、傾斜角θ２が一定となるように尿道挿入具４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、患者の個体差や手技中の姿勢に合わせて傾斜角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, the urethral insertion tool 4 is fixed to the frame 2 so that the inclination angle θ2 is constant, but the present invention is not limited to this, and the inclination angle θ2 may be variable. As a result, the inclination angle θ2 can be adjusted in accordance with individual differences of patients and postures during the procedure, so that the puncture device 1 is more convenient to use.
　－膣挿入具－
　図１２に示すように、膣挿入具５は、途中まで膣内に挿入される長尺状の膣挿入部５１と、膣挿入部５１を支持する支持部５０とを有している。また、膣挿入部５１は、先端側に位置する先端部５２と、先端部５２の基端部に接続された軸部５３とを有し、軸部５３が支持部５０に支持されている。また、支持部５０には雄ネジ５０１が設けられ、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、膣挿入具５を尿道挿入具４に固定することができる。 -Vaginal insertion tool-
As shown in FIG. 12, the vaginal insertion tool 5 includes a long vaginal insertion portion 51 that is inserted into the vagina partway and a support portion 50 that supports the vaginal insertion portion 51. The vaginal insertion portion 51 has a distal end portion 52 located on the distal end side and a shaft portion 53 connected to the proximal end portion of the distal end portion 52, and the shaft portion 53 is supported by the support portion 50. The support portion 50 is provided with a male screw 501, and the vaginal insert 5 can be fixed to the urethral insert 4 by tightening the male screw 501 into a female screw (not shown) of the support 40. it can.
　膣挿入部５１および支持部５０の構成材料としては、特に限定されず、例えば、尿道挿入具４（尿道挿入部４１および支持部４０）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。 The constituent materials of the vaginal insertion part 51 and the support part 50 are not particularly limited. For example, as with the urethra insertion device 4 (urethra insertion part 41 and support part 40), stainless steel, aluminum or an aluminum alloy, titanium or titanium Various metal materials such as alloys and various resin materials can be used.
　先端部５２は、膣内に挿入される部位であり、図１４に示すように、全体的にほぼ一定な幅を有しており、その先端部が丸みを帯びている。また、先端部５２は、その厚さ方向に潰れた扁平形状をなしている。先端部５２の長さＬ２としては特に限定されないが、２０ｍｍ～１００ｍｍ程度であるのが好ましく、３０ｍｍ～６０ｍｍ程度であるのがより好ましい。また、先端部５２の幅Ｗ１としては、特に限定されないが、１０ｍｍ～５０ｍｍ程度であるのが好ましく、２０ｍｍ～４０ｍｍ程度であるのがより好ましい。このような長さ（Ｌ２）×幅（Ｗ１）とすることにより、先端部５２が一般的な膣に適した形状および大きさとなる。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。 The distal end portion 52 is a portion to be inserted into the vagina, and has an almost constant width as a whole as shown in FIG. 14, and the distal end portion is rounded. Moreover, the front-end | tip part 52 has comprised the flat shape crushed in the thickness direction. The length L2 of the distal end portion 52 is not particularly limited, but is preferably about 20 mm to 100 mm, and more preferably about 30 mm to 60 mm. The width W1 of the tip 52 is not particularly limited, but is preferably about 10 mm to 50 mm, and more preferably about 20 mm to 40 mm. By setting such length (L2) × width (W1), the tip 52 has a shape and size suitable for a general vagina. Therefore, the stability of the puncture device 1 in the mounted state is increased, and the burden on the patient is reduced.
　また、図１２に示すように、先端部５２は、先端に向かう程、尿道挿入部４１から離間するように、上面（尿道挿入部４１側の面）５２ａが尿道挿入部４１に対して傾斜している。これにより、傾斜していない場合と比較して、尿道挿入部４１と先端部５２との位置関係を実際の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。 In addition, as shown in FIG. 12, the top surface 52a (surface on the urethra insertion portion 41 side) 52a is inclined with respect to the urethra insertion portion 41 so that the distal end portion 52 is separated from the urethra insertion portion 41 toward the distal end. ing. Thereby, compared with the case where it is not inclined, the positional relationship between the urethral insertion portion 41 and the distal end portion 52 can be made closer to the actual positional relationship between the urethra and the vagina. Therefore, the puncture device 1 is more stably held by the patient in the wearing state, and the burden on the patient is reduced.
　上面５２ａの尿道挿入部４１に対する傾斜角θ３（図３参照）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 inclination angle θ3 (see FIG. 3) of the upper surface 52a with respect to the urethral insertion portion 41 is not particularly limited, but is preferably about 0 ° to 45 °, and more preferably about 0 ° to 30 °. Thereby, the said effect can be exhibited more notably. On the other hand, when the inclination angle θ3 is less than the above lower limit value or exceeds the above upper limit value, the vagina and urethra deform unnaturally in the wearing state depending on individual differences of patients, posture during the procedure, etc. However, the puncture device 1 may not be stably held.
　このような先端部５２の上面５２ａには吸引部５２３が設けられている。吸引部５２３は、上面５２ａに開口する有底の凹部５２４と、凹部５２４の底面に設けられた複数の吸引孔５２５と、凹部５２４の内部を複数の領域に区画する格子状のリブ５２６とを有している。また、複数の吸引孔５２５は、それぞれ、先端部５２の基端部に設けられた吸引ポート５４に接続されている。また、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。 A suction part 523 is provided on the upper surface 52a of the tip part 52. The suction portion 523 includes a bottomed recess 524 that opens to the upper surface 52a, a plurality of suction holes 525 provided in the bottom surface of the recess 524, and a lattice-like rib 526 that divides the interior of the recess 524 into a plurality of regions. Have. Each of the plurality of suction holes 525 is connected to a suction port 54 provided at the proximal end portion of the distal end portion 52. The suction port 54 is provided so as to be located outside the living body in the mounted state.
　リブ５２６は、凹部５２４の底面から立設しており、先端部５２の長さ方向に延びる複数の壁部と、幅方向に延びる複数の壁部とを有している。そして、これらの交差部に重なるようにして、複数の吸引孔５２５が配置されている。吸引孔５２５をこのように配置することで、膣壁を吸着する際に、凹部５２４に食い込んだ膣壁で吸引孔５２５が膣壁で塞がれてしまうことを防止することができる。そのため、膣壁の吸着をより確実に行うことができる。なお、リブ５２６の高さとしては、特に限定されず、例えば、凹部５２４と同じ高さであってもよいし、凹部５２４よりも高くてもよいし、凹部５２４よりも低くてもよい。 The rib 526 is erected from the bottom surface of the recess 524, and has a plurality of wall portions extending in the length direction of the distal end portion 52 and a plurality of wall portions extending in the width direction. A plurality of suction holes 525 are arranged so as to overlap these intersections. By arranging the suction hole 525 in this manner, it is possible to prevent the suction hole 525 from being blocked by the vagina wall by the vagina wall that has bitten into the recess 524 when adsorbing the vagina wall. For this reason, the vaginal wall can be more reliably adsorbed. Note that the height of the rib 526 is not particularly limited, and may be, for example, the same height as the recess 524, may be higher than the recess 524, or may be lower than the recess 524.
　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、先端部５２を膣内に挿入した状態で吸引装置を作動させると、先端部５２に膣前壁が吸着・固定される。膣前壁を先端部５２に吸着・固定させた状態で、膣挿入部５１を体内側（膣挿入部５１の先端側）へ押し込むと、これとともに膣を押し込むことができる。そのため、膣の配置や形状を整えることができ、針体３９の穿刺経路を十分に確保することができる。その結果、穿刺部材３の穿刺を正確かつ安全に行うことができる。 A suction device such as a pump can be connected to the suction port 54. When the suction device is operated with the tip 52 inserted into the vagina, the front wall of the vagina is adsorbed and fixed to the tip 52. When the vaginal insertion portion 51 is pushed into the body (the distal end side of the vaginal insertion portion 51) with the front wall of the vagina adsorbed and fixed to the distal end portion 52, the vagina can be pushed together with this. Therefore, the arrangement and shape of the vagina can be adjusted, and the puncture route of the needle body 39 can be sufficiently secured. As a result, the puncture member 3 can be punctured accurately and safely.
　ここで、図１２に示すように、吸引部５２３が形成されている領域Ｓ２は、吸引孔４４が形成されている領域Ｓ１と対向している。そして、穿刺装置１は、これら領域Ｓ１、Ｓ２の間を針体３９が通過するように構成されている。領域Ｓ１では尿道壁が尿道挿入部４１に吸着され、領域Ｓ２では膣壁が先端部５２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且つより確実に離間している。このような領域に針体３９を通過させることで、針体３９をより安全に穿刺することができる。 Here, as shown in FIG. 12, the region S2 in which the suction part 523 is formed is opposed to the region S1 in which the suction hole 44 is formed. And the puncture apparatus 1 is comprised so that the needle body 39 may pass between these area | regions S1 and S2. In the region S1, the urethra wall is adsorbed by the urethral insertion portion 41, and in the region S2, the vagina wall is adsorbed by the tip 52, so that the urethra wall and the vagina wall are wider and more reliably between the regions S1 and S2. It is separated. By passing the needle body 39 through such a region, the needle body 39 can be punctured more safely.
　なお、図１４に示すように、領域Ｓ２は、上面５２ａの幅方向のほぼ全域にわたっているのが好ましい。領域Ｓ２の幅Ｗ２としては、特に限定されないが、９～４９ｍｍ程度であるのが好ましく、１９～３９ｍｍ程度であるのがより好ましい。これにより、各患者の膣壁の形状にあまり影響を受けずに、膣壁をより確実に先端部５２に吸着させることができる。 In addition, as shown in FIG. 14, it is preferable that the region S2 covers substantially the entire width direction of the upper surface 52a. The width W2 of the region S2 is not particularly limited, but is preferably about 9 to 49 mm, and more preferably about 19 to 39 mm. Accordingly, the vaginal wall can be more reliably adsorbed to the distal end portion 52 without being affected by the shape of the vaginal wall of each patient.
　特に、患者によっては、図１５（ａ）に示すように、膣前壁の中央部１４０１が膣内へ垂れ下がり、その両側に窪んだ部分（「ボタンホール」とも呼ばれる部位）１４０２が存在した膣１４００を有している場合がある。このような場合でも、図１５（ｂ）に示すように、中央部１４０１のみならず、窪んだ部分１４０２もより確実に吸着することができる。このように、窪んだ部分１４０２を先端部５２により確実に吸着することで、窪んだ部分１４０２を尿道１３００から遠ざけることができ、窪んだ部分１４０２に針体３９が穿刺されてしまうことを効果的に防止することができる。 In particular, depending on the patient, as shown in FIG. 15 (a), the central part 1401 of the anterior vagina hangs down into the vagina and dents (parts called “button holes”) 1402 exist on both sides thereof. May have. Even in such a case, as shown in FIG. 15B, not only the central portion 1401 but also the recessed portion 1402 can be more reliably adsorbed. In this way, by reliably adsorbing the recessed portion 1402 by the distal end portion 52, the recessed portion 1402 can be moved away from the urethra 1300, and it is effective that the needle body 39 is punctured into the recessed portion 1402. Can be prevented.
　また、先端部５２には、針体３９の穿刺経路を確認することのできるマーカー５７が設けられている。マーカー５７は、その上方を針体３９が通過するように設けられているため、マーカー５７の位置を確認することで、針体３９の穿刺経路を容易に確認でき、穿刺装置１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、先端部５２の下面に設けられていることが好ましい。下面は、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、下面にマーカー５７を設けることで、より確実に、針体３９の穿刺経路を確認することができる。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。 Further, a marker 57 that can confirm the puncture route of the needle body 39 is provided at the distal end portion 52. Since the marker 57 is provided so that the needle body 39 passes above the marker 57, by confirming the position of the marker 57, the puncture route of the needle body 39 can be easily confirmed, and the operability of the puncture apparatus 1 can be improved. Safety is improved. The marker 57 is preferably provided at least on the lower surface of the distal end portion 52. The lower surface is the surface that faces the vaginal opening in the inserted state and is visible to the operator through the vaginal opening. By providing the marker 57 on the lower surface, the puncture route of the needle body 39 can be confirmed more reliably. can do. The marker 57 is only required to be visible from the outside, and can be constituted by, for example, a colored portion, an uneven portion, or the like.
　以上のような先端部５２と尿道挿入部４１との離間距離Ｄ２（図３参照）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、５～４０ｍｍ程度であるのが好ましい。 The separation distance D2 (see FIG. 3) between the distal end portion 52 and the urethral insertion portion 41 as described above is not particularly limited, but may be 5 corresponding to the separation distance between the urethral opening and the vaginal opening in a general woman. It is preferably about ˜40 mm.
　軸部５３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。軸部５３の長さ（先端部５２と支持部５０の離間距離）としては、特に限定されないが、例えば、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、軸部５３を適切な長さとすることができ、穿刺装置１の操作性が向上する。仮に、軸部５３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 shaft portion 53 has a thin rod shape extending substantially parallel to the urethral insertion portion 41. The length of the shaft portion 53 (the separation distance between the distal end portion 52 and the support portion 50) is not particularly limited, but is preferably about 100 mm or less, and more preferably about 20 to 50 mm. Thereby, the axial part 53 can be made into appropriate length and the operativity of the puncture apparatus 1 improves. If the length of the shaft portion 53 exceeds the above upper limit value, the center of gravity of the puncture device 1 is greatly separated from the patient depending on the configuration of the frame 2 and the stability of the puncture device 1 in the mounted state is lowered. There is a case.
　３．穿刺装置１の使用方法
　次に、穿刺装置１の使用方法、すなわち、穿刺装置１を用いてインプラント９を生体内に埋設する方法について説明する。 3. Next, a method of using the puncture device 1, that is, a method of embedding the implant 9 in the living body using the puncture device 1 will be described.
　まず、患者を手術台上で砕石位とし、図１６（ａ）に示すように、挿入具６を患者に装着する。 First, the patient is crushed on the operating table, and the insertion tool 6 is attached to the patient as shown in FIG.
　具体的には、まず、尿道挿入具４の尿道挿入部４１を尿道１３００内に挿入し、バルーン４２を膀胱１３１０内に配置する。これにより、尿道１３００は、尿道挿入部４１により所定形状（直線状）に矯正される。次に、バルーン４２を拡張させるとともに、必要に応じて尿排孔４７１を介して膀胱１３１０内から尿を排出する。一方で、膣挿入具５の先端部５２を膣１４００内に挿入する。そして、マーカー５７を用いて針体３９の穿刺経路を確認しながら位置決めした後、支持部５０を支持部４０に固定する。これにより、患者への挿入具６の装着が完了する。 Specifically, first, the urethral insertion portion 41 of the urethral insertion device 4 is inserted into the urethra 1300, and the balloon 42 is placed in the bladder 1310. As a result, the urethra 1300 is corrected to a predetermined shape (linear shape) by the urethra insertion part 41. Next, the balloon 42 is expanded, and urine is discharged from the bladder 1310 through the urine drain 471 as necessary. On the other hand, the distal end portion 52 of the vagina insertion tool 5 is inserted into the vagina 1400. Then, after positioning while confirming the puncture route of the needle body 39 using the marker 57, the support portion 50 is fixed to the support portion 40. Thereby, mounting | wearing of the insertion tool 6 to a patient is completed.
　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、尿道壁を吸引孔４４に吸着・固定すると共に、膣壁を吸引部５２３に吸着・固定する。ここで、例えば、尿道壁が吸引孔４４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、膣壁が吸引部５２３にきちんと吸着されれば、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、尿道壁および膣壁が尿道挿入部４１および膣挿入部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。 Next, a suction device is connected to the suction ports 45 and 54, the suction device is operated, the urethral wall is sucked and fixed to the suction hole 44, and the vagina wall is sucked and fixed to the suction portion 523. Here, for example, if the urethra wall is properly adsorbed by the suction hole 44, 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 vaginal wall is properly adsorbed by the suction part 523, the suction from the suction port 54 is stopped or weakened. Therefore, the surgeon determines whether or not the urethral wall and the vagina wall are properly adsorbed to the urethral insertion portion 41 and the vagina insertion portion 51 based on the suction state from the suction ports 45 and 54 (for example, the magnitude of sound generated by suction). Can be confirmed.
　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４５、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。 Note that the insertion tool 6 may have a confirmation mechanism that mechanically confirms the suction state. The confirmation mechanism is not particularly limited as long as the adsorption state can be confirmed. For example, a flow rate measurement unit (negative pressure gauge) that measures the flow rate from the suction ports 45 and 54 and a measurement result from the flow rate measurement unit are used. It can be set as the structure which has a judgment part which judges whether adsorption | suction is performed properly based on.
　次に、必要に応じて、液性剥離を行う。具体的には、図１６（ｂ）に示すように、尿道挿入部４１と膣挿入部５１との間（尿道口と膣口の間）から注射器２０００の穿刺針を膣前壁に穿刺し、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、それによって、尿道壁が尿道挿入部４１に押し付けられるとともに、膣前壁が先端部５２へ押し付けられる。 Next, liquid peeling is performed as necessary. Specifically, as shown in FIG. 16 (b), the puncture needle of the syringe 2000 is punctured into the anterior wall of the vagina from between the urethra insertion part 41 and the vaginal insertion part 51 (between the urethral opening and the vaginal opening) A liquid such as physiological saline or a local anesthetic is injected into the living tissue between the urethra 1300 and the vagina 1400 (between the regions S1 and S2). As a result, the living tissue between the regions S1 and S2 expands, whereby the urethral wall is pressed against the urethral insertion portion 41 and the vagina front wall is pressed against the distal end portion 52.
　ここで、上述の液性剥離を行っている最中も吸引ポート４５、５４からの吸引を継続するのが好ましい。液性剥離によって尿道壁が吸引孔４４に押し付けられると、尿道壁が吸引孔４４により一層密着し、吸引ポート４５からの吸引が停止または弱まる。同様に、膣壁が吸引部５２３に押し付けられると、膣壁が吸引部５２３により一層密着し、吸引ポート５４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 ports 45 and 54 even during the liquid separation described above. When the urethra wall is pressed against the suction hole 44 by liquid peeling, the urethra wall is further brought into close contact with the suction hole 44, and suction from the suction port 45 is stopped or weakened. Similarly, when the vagina wall is pressed against the suction part 523, the vagina wall is more closely adhered to the suction part 523, and suction from the suction port 54 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.
　上述のような液性剥離を行い、尿道壁と膣壁とを十分に離間させた後、図１７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装着状態となる。次に、穿刺装置１を体内側へ押し込む。前述したように、尿道挿入部４１には尿道壁が吸着されており、膣挿入部５１には膣壁が吸着されているため、穿刺装置１を体内へ押し込むと、それと共に尿道１３００および膣１４００が押し込まれ、これらの間の組織が延ばされる。そのため、当該組織のたるみが減るとともに、尿道１３００および膣１４００の形状が整えられ、当該組織への針体３９の穿刺が容易となる。また、前述したように膀胱１３１０を奥側へ押し込むことができるので、針体３９の穿刺をより安全に行うことができる。この状態では、骨盤１１００と穿刺装置１との位置関係が、図１８に示すような状態となる。 After performing liquid exfoliation as described above and sufficiently separating the urethral wall and the vagina wall, the frame 2 is fixed to the insertion tool 6 as shown in FIG. Thereby, it will be in the mounting state with which the puncture apparatus 1 was mounted | worn with the patient. Next, the puncture device 1 is pushed into the body. As described above, the urethra wall is adsorbed to the urethra insertion part 41 and the vagina wall is adsorbed to the vagina insertion part 51. Therefore, when the puncture device 1 is pushed into the body, the urethra 1300 and the vagina 1400 are simultaneously pushed. Is pushed in and the tissue between them is extended. Therefore, the sagging of the tissue is reduced, the shapes of the urethra 1300 and the vagina 1400 are adjusted, and the needle 39 can be easily punctured into the tissue. Further, as described above, since the bladder 1310 can be pushed inward, the needle body 39 can be punctured more safely. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.
　次に、穿刺装置１を体内側へ押し込んだ状態で、穿刺部材３の穿刺経路が骨盤の左右の閉鎖孔１１０１、１１０２のセーフティゾーンＳ５を通過するように穿刺装置１を位置決めし、この状態を維持しつつ、ハンドル３２４を順回転させて、図１９に示すように、前述した規制状態とする。この際、針体３９は、右側の鼠蹊部またはその近傍の部位の体表面Ｈを穿刺して体内に入り、例えば、閉鎖孔１１０１、尿道１３００と膣１４００との間、閉鎖孔１１０２を順に通過して、閉鎖孔１１０２を超えたあたりまで移動した状態となる。また、シース３０の外管３０１に設けられた当接部３０１ｂが体表面Ｈに当接し、それ以上の生体内へ挿入が規制された状態となる。ただし、この状態での針体３９の位置は、特に限定されず、例えば、尿道１３００と膣１４００との間に到達していなくてもよい。 Next, in a state where the puncture device 1 is pushed into the body, the puncture device 1 is positioned so that the puncture path of the puncture member 3 passes through the safety zones S5 of the left and right closure holes 1101, 1102 of the pelvis. While maintaining, the handle 324 is rotated forward to obtain the above-described restricted state as shown in FIG. At this time, the needle 39 enters the body by puncturing the body surface H of the right buttocks or in the vicinity thereof, for example, passing through the obturator 1101, the urethra 1300 and the vagina 1400, and the obturator 1102 in order. Then, it is in a state where it has moved to a location beyond the closing hole 1102. Moreover, the contact part 301b provided in the outer tube | pipe 301 of the sheath 30 contact | abuts to the body surface H, and it will be in the state by which insertion into the biological body beyond it was controlled. However, the position of the needle body 39 in this state is not particularly limited, and may not reach between the urethra 1300 and the vagina 1400, for example.
　このように、本工程の穿刺（第１穿刺工程）で、針体３９を、閉鎖孔１１０２を通過したあたりまで進めることで、穿刺部材３の剛性が高い状態（外管３０１内に内管３０２が退避しシース３０が短い状態）で生体内のより長い距離を穿刺することができるので、より正確にかつスムーズに穿刺を行うことができる。ただし、第１穿刺工程を終えた時点での針体３９の位置は、これに限定されず、例えば、尿道１３００と膣１４００との間を通過して、閉鎖孔１１０２の手前まで移動した状態となってもよい。 In this way, in the puncture of this step (first puncture step), the needle body 39 is advanced to the point where it has passed through the closing hole 1102, so that the puncture member 3 has a high rigidity (the inner tube 302 in the outer tube 301). Can be punctured for a longer distance in the living body in a state where the sheath 30 is short and the sheath 30 is short), so that puncture can be performed more accurately and smoothly. However, the position of the needle body 39 at the time when the first puncturing step is completed is not limited to this, for example, a state in which the needle body 39 passes between the urethra 1300 and the vagina 1400 and moves to the front of the closing hole 1102. It may be.
　次に、ハンドル３２４を逆回転させ、図２０に示すように、軸部３００を延長状態とする。次に、再びハンドル３２４を順回転させ、図２１に示すように、軸部３００を先端側へ移動させる。これにより、プッシャーシャフト３３によって針体３９が押圧され、針体３９がプッシャーシャフト３３とともに先端側へ移動する。また、針体３９と連結している内管３０２が、針体３９に引っ張られるようにして外管３０１から突出し、これにより、シース３０が延長される（第２穿刺工程）。 Next, the handle 324 is rotated in the reverse direction, and the shaft 300 is extended as shown in FIG. Next, the handle 324 is rotated forward again to move the shaft portion 300 toward the tip as shown in FIG. Accordingly, the needle body 39 is pressed by the pusher shaft 33, and the needle body 39 moves together with the pusher shaft 33 toward the distal end side. Further, the inner tube 302 connected to the needle body 39 protrudes from the outer tube 301 so as to be pulled by the needle body 39, whereby the sheath 30 is extended (second puncturing step).
　そして、この移動により、針体３９は、左側の鼠蹊部またはその近傍の部位の体表面Ｈから体外に突出する。この際、前述したように、穿刺部材３を骨盤の左右の閉鎖孔１１０１、１１０２に対して略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。この状態では、骨盤１１００と穿刺装置１との位置関係が、図２２に示す状態となる。 And by this movement, the needle body 39 protrudes from the body surface H of the left buttocks or its vicinity. At this time, as described above, the puncture member 3 is punctured substantially perpendicularly to the left and right closing holes 1101 and 1102 of the pelvis, whereby a passage can be formed at a position suitable for placement of the implant 9. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.
　次に、シース３０を生体内に配置したまま、シース３０から軸部３００および針体３９を抜去するとともにフレーム２を挿入具６から取り外す。これにより、図２３（ａ）に示すように、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シース３０が生体内に配置された状態となる。なお、この手順としては、特に限定されず、例えば、初めに、ハンドル３２４を逆回転させてスタイレット３２１をシース３０の基端側開口から抜去し、次に、挿入具６からフレーム２を取り外し、最後に、内管３０２から針体３９をプッシャーシャフト３３と共に取り除くようにしてもよい。また、初めに、内管３０２から針体３９をプッシャーシャフト３３と共に取り除き、次に、ハンドル３２４を逆回転させてスタイレット３２１をシース３０の基端側開口から抜去し、最後に、挿入具６からフレーム２を取り外すようにしてもよい。いずれの手順も、スタイレット３２１とプッシャーシャフト３３とが離脱可能となっていることで実現されるものである。したがって、スタイレット３２１とプッシャーシャフト３３とを離脱可能とすることで、手技をよりスムーズに行うことができる。 Next, while the sheath 30 is disposed in the living body, the shaft portion 300 and the needle body 39 are removed from the sheath 30 and the frame 2 is removed from the insertion tool 6. Accordingly, as shown in FIG. 23A, the sheath 30 is placed 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 procedure is not particularly limited. For example, first, the handle 324 is rotated in the reverse direction, the stylet 321 is removed from the proximal end opening of the sheath 30, and then the frame 2 is removed from the insertion tool 6. Finally, the needle body 39 may be removed from the inner tube 302 together with the pusher shaft 33. First, the needle body 39 is removed from the inner tube 302 together with the pusher shaft 33, and then the handle 324 is rotated in the reverse direction to remove the stylet 321 from the proximal end opening of the sheath 30, and finally, the insertion tool 6 You may make it remove the flame | frame 2 from. Both procedures are realized by allowing the stylet 321 and the pusher shaft 33 to be separated. Therefore, by making the stylet 321 and the pusher shaft 33 detachable, the procedure can be performed more smoothly.
　次に、必要に応じて、シース３０の位置を整える。具体的には、シース３０の左右の突出長さを揃えて、シース３０の中央部Ｓ４を尿道１３００と膣１４００との間に位置させる。この状態では、図２３（ｂ）に示すように、シース３０の中央部Ｓ４は、その幅方向（長軸Ｊ３２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４１が挿入されて矯正された尿道１３００とシース３０の中央部Ｓ４の幅方向Ｗとが実質的に平行となっている。 Next, the position of the sheath 30 is adjusted as necessary. Specifically, the left and right protruding lengths of the sheath 30 are aligned, and the central portion S4 of the sheath 30 is positioned between the urethra 1300 and the vagina 1400. In this state, as shown in FIG. 23 (b), the central portion S 4 of the sheath 30 is arranged such that its width direction (long axis J 32 direction) W is substantially parallel to the urethra 1300. That is, the urethra 1300 that has been corrected by inserting the urethral insertion portion 41 and the width direction W of the central portion S4 of the sheath 30 are substantially parallel.
　次に、インプラント９を包材９０から取り出しつつシース３０内に挿入し、図２４（ａ）に示すように、インプラント本体９１をシース３０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、シース３０内に配設する直前まで、インプラント９を包材９０に収容することで、インプラント９の汚染を防止することができる。なお、前述したように、シース３０が扁平形状をなしているため、この扁平形状にインプラント本体９１の姿勢が倣う。すなわち、インプラント本体９１は、図２４（ｂ）に示すように、その幅方向がシース３０の幅方向と一致するように、シース３０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 9 is inserted into the sheath 30 while being taken out from the packaging material 90, and the implant body 91 is projected from the proximal end opening and the distal end opening of the sheath 30 as shown in FIG. To do. Thus, contamination of the implant 9 can be prevented by accommodating the implant 9 in the wrapping material 90 until just before being disposed in the sheath 30. As described above, since the sheath 30 has a flat shape, the posture of the implant main body 91 follows this flat shape. That is, the implant body 91 is disposed in the sheath 30 so that the width direction thereof coincides with the width direction of the sheath 30 as shown in FIG. From the relationship with the urethra 1300, the implant body 91 is arranged in parallel with the corrected urethra 1300.
　次に、尿道挿入部４１による尿道壁の吸着と膣挿入部５１による膣壁の吸着を停止する。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。次に、内管３０２を先端側へ向けて生体から引き抜くとともに、外管３０１を基端側へ向けて生体から引き抜く。この際、内管３０２と外管３０１を反対方向にほぼ同時に移動させ、内管３０２および外管３０１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、シース３０が生体からスムーズに取り除かれる。 Next, the adsorption of the urethral wall by the urethra insertion part 41 and the adsorption of the vagina wall by the vagina insertion part 51 are stopped. As a result, the positions and shapes of the urethra 1300 and the vagina 1400 return to the original natural state. Next, the inner tube 302 is pulled out from the living body toward the distal end side, and the outer tube 301 is pulled out from the living body toward the proximal end side. At this time, the inner tube 302 and the outer tube 301 are moved almost simultaneously in opposite directions, and the inner tube 302 and the outer tube 301 are moved in an arc shape so as to follow the shape of each. Thereby, the sheath 30 is smoothly removed from the living body.
　内管３０２および外管３０１を前述のようにして生体から取り除いていくと、シース３０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、内管３０２および外管３０１をその形状に沿った方向に移動させていることと、シース３０がインプラント本体９１を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２５（ａ）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。なお、インプラント９が生体に埋設された状態では、インプラント本体９１は、図２５（ｂ）に示すように、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。 When the inner tube 302 and the outer tube 301 are removed from the living body as described above, the surrounding tissue that has been spread out by the sheath 30 returns to the original position, from the central portion of the implant body 91 toward both ends. The tissue gradually comes into contact with the implant body 91. As described above, the inner tube 302 and the outer tube 301 are moved in the direction along the shape thereof, and the sheath 30 has an inner space in which the implant body 91 can be moved with low sliding, thereby providing the implant body. An unnecessary tensile force is not applied to 91, and it can be left as it is. Thereby, adjustment of the tension of the implant main body 91 becomes unnecessary. As described above, as shown in FIG. 25A, the implant body 91 is embedded in the living body. In the state where the implant 9 is embedded in the living body, the implant body 91 is disposed substantially parallel to the urethra 1300 in the region between the urethra 1300 and the vagina 1400 as shown in FIG. Therefore, the urethra 1300 can be supported in a wider area by the implant body 91.
　このように、シース３０を分割して生体から取り除くことによって、シース３０の生体からの抜去を容易に行うことができる。また、抜去中の外管３０１および内管３０２が尿道１３００と膣１４００の間の領域でのインプラント本体９１の姿勢にほとんど影響を及ぼさないため、インプラント本体９１を所望の姿勢で埋設することができる。また、尿道挿入部４１が尿道１３００に挿入された状態で外管３０１および内管３０２を生体内から抜去するため、生体内に留置するインプラント本体９１により、過度のテンションが尿道１３００にかかることを防ぐことができる。 Thus, by removing the sheath 30 from the living body by dividing it, the sheath 30 can be easily removed from the living body. Further, since the outer tube 301 and the inner tube 302 being removed hardly affect the posture of the implant body 91 in the region between the urethra 1300 and the vagina 1400, the implant body 91 can be embedded in a desired posture. . In addition, since the outer tube 301 and the inner tube 302 are removed from the living body with the urethra insertion portion 41 inserted into the urethra 1300, an excessive tension is applied to the urethra 1300 by the implant body 91 placed in the living body. Can be prevented.
　次に、挿入具６を生体から抜去する。すなわち、尿道挿入部４１を尿道１３００から抜去し、膣挿入部５１を膣１４００から抜去する。尿道挿入具４を抜去した後、尿道１３００は、自然状態の形状に戻るが、インプラント本体９１が生体組織に埋め込まれているため、自然状態の尿道１３００とインプラント本体９１とが平行な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, the insertion tool 6 is removed from the living body. That is, the urethral insertion part 41 is removed from the urethra 1300 and the vagina insertion part 51 is removed from the vagina 1400. After the urethral insertion tool 4 is removed, the urethra 1300 returns to the natural state, but the urinary tract 1300 in the natural state and the implant main body 91 remain parallel because the implant body 91 is embedded in the living tissue. can do.
Thereafter, unnecessary portions of the implant body 91 are excised, and the procedure is finished.
　以上説明したように、穿刺装置１によれば、シース３０を延長することができるため、シース３０の中心角（長さ）を十分に大きくすることができ、シース３０の両端部を患者の体型によらず体表面Ｈから確実に露出させることができる。そして、この露出した両端部（両端開口）からインプラント本体９１を容易かつ確実に挿入することができる。 As described above, according to the puncture device 1, since the sheath 30 can be extended, the central angle (length) of the sheath 30 can be made sufficiently large, and both end portions of the sheath 30 are formed on the patient's body shape. It can be reliably exposed from the body surface H regardless. And the implant main body 91 can be inserted easily and reliably from this exposed both ends (both ends opening).
　また、初期状態では、シース３０が収縮した状態となっているため、シース３０のほぼ全域をガイド溝２２１に収容することができる。これに対して、例えば、本実施形態のように延長することができず、初めから延長状態の場合と同じ中心角（長さ）のシース３０を用いた場合には、シース３０がガイド溝２２１内に収まりきらない。そのため、シース３０の基端部がガイド溝２２１から突出し、生体にぶつかってしまう等の問題が生じ、穿刺装置１の操作性が悪化する。 In the initial state, since the sheath 30 is in a contracted state, almost the entire area of the sheath 30 can be accommodated in the guide groove 221. On the other hand, for example, when the sheath 30 having the same central angle (length) as that in the extended state cannot be used as in the present embodiment, and the sheath 30 has the same central angle (length) as that in the extended state, the sheath 30 has the guide groove 221. It does n’t fit inside. Therefore, the base end portion of the sheath 30 protrudes from the guide groove 221 and a problem such as hitting the living body occurs, and the operability of the puncture device 1 is deteriorated.
　また、インプラント９を留置する際、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、針体３９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、針体３９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。 Further, when the implant 9 is placed, it can be handled only by a minimally invasive technique such as puncture of the puncture member 3, and it is not necessary to perform a large invasive incision or the like. High safety. Further, since the implant body 91 can be embedded in parallel with the urethra 1300, the urethra 1300 can be supported in a wider area. Further, the living body can be punctured by avoiding the urethra 1300 and the vagina 1400 with the needle body 39, and the needle body 39 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.
　以上、本発明の穿刺部材を、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。 As mentioned above, although the puncture member of this invention was demonstrated based on embodiment of illustration, this invention is not limited to this, The structure of each part is substituted by the thing of the arbitrary structures which have the same function. be able to. In addition, any other component may be added to the present invention.
　また、前述した実施形態では、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、穿刺装置の用途は、それに限定されるものではない。 In the above-described embodiment, the case where the puncture device is applied to a device used when an implantable implant for treating urinary incontinence in women is embedded in a living body has been described. It is not limited.
　例えば、本発明は、骨盤底筋群の弱体化にともなう、排泄障害（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, vesicovaginal fistula, urethral vagina, as the pelvic floor muscles weaken Pelvic floor diseases including epilepsy, pelvic pain, etc. are included in the target of application. Pelvic organ prolapse includes diseases such as cystocele, small intestinal aneurysm, rectal aneurysm, and uterine prolapse. Alternatively, diseases such as anterior vaginal wall prolapse, posterior vaginal wall prolapse, vaginal stump prolapse, and vaginal vault prolapse are classified according to the vagina wall site being removed.
　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, transobturatorpetape; TOT), and transvaginal mesh surgery (Tension-free Vaginal Mesh; TVM), elevation using sacral uterine ligament (Uterosacral Ligament Suspension; USLS), fusion using sacrospinous ligament (Sacrospinous Ligament Fixation; SSLF), fusion using iliac coccyx fascia, tailbone Includes fusion using the fascia.
　本発明の穿刺部材は、管状の医療用チューブと、前記医療用チューブの先端部に接続された針体と、を有し、前記針体は、拡幅部を有し、前記拡幅部の幅は、前記医療用チューブの先端部の幅よりも大きいことを特徴とする。このような特徴によれば、針体の幅が医療用チューブの幅よりも大きいため、穿刺部材の生体への穿刺をスムーズに行うことができる。具体的には、本発明の穿刺部材では、針体が生体を穿刺し、当該穿刺によって形成された穿刺孔内を当該穿刺孔よりも小さい医療用チューブの先端部が通過していくため、医療用チューブの先端部が穿刺孔の壁部に引っ掛かり難い。したがって、穿刺部材の穿刺孔内での摺動性を高めることができ、生体組織支持用留置物を留置するための前記穿刺孔の形成をスムーズに低侵襲で行うことができる。そのため、生体組織支持用留置物を生体内に埋設する手技をスムーズにかつ安全に行うことができる。 The puncture member of the present invention has a tubular medical tube and a needle body connected to a distal end portion of the medical tube, the needle body has a widened portion, and the width of the widened portion is The width of the distal end portion of the medical tube is larger. According to such a characteristic, since the width | variety of a needle body is larger than the width | variety of a medical tube, the puncture to the biological body of a puncture member can be performed smoothly. Specifically, in the puncture member of the present invention, the needle body punctures the living body, and the distal end portion of the medical tube smaller than the puncture hole passes through the puncture hole formed by the puncture. The tip of the tube for use is not easily caught on the wall of the puncture hole. Therefore, the slidability of the puncture member within the puncture hole can be improved, and the formation of the puncture hole for indwelling the living tissue supporting indwelling object can be performed smoothly and with minimal invasiveness. Therefore, the procedure for embedding the living tissue supporting indwelling object in the living body can be performed smoothly and safely.
　したがって、本発明の穿刺部材は、産業上の利用可能性を有している。 Therefore, the puncture member 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　　ガイド溝
　２２１ａ　開口
　２２１ｂ　開口
　２２９　　係合孔
　２２９ａ　端面
　２３　　　連結部
　２４　　　固定部
　２４３　　凹部
　２４４　　雄ネジ
　３　　　　穿刺部材
　３０　　　シース
　３００　　軸部
　３０１　　外管
　３０１ａ　先端部
　３０１ｂ　当接部
　３０２　　内管
　３１　　　操作部材
　３２　　　本体
　３２１　　スタイレット
　３２２　　連結部
　３２３　　軸部
　３２４　　ハンドル
　３３　　　プッシャーシャフト
　３３１　　凹部
　３３２　　凹部
　３３２ａ　当接面
　３３２ｂ　傾斜面
　３４　　　先端チップ
　３４１　　本体部
　３５　　　突起
　３５１　　弾性変形部
　３５２　　弾性片
　３５２ａ　突出部
　３５３　　弾性片
　３５３ａ　突出部
　３５４　　隙間
　３６　　　保持部
　３６１　　ガイド部
　３６１ａ　挿通孔
　３６２　　ガイド部
　３６２ａ　挿通孔
　３７　　　当接部
　３７１　　先端面
　３８　　　スライドロック部
　３８１　　突起
　３８２　　弾性片
　３８２ａ　爪部
　３８３　　弾性片
　３８３ａ　爪部
　３８９　　挿通孔
　３９　　　針体
　３９１　　針部
　３９１ａ　拡径部
　３９１ｂ　外径漸増部
　３９１ｃ　外径漸減部
　３９２　　基端部
　３９３　　当接面
　３９４　　連結孔
　３９４ａ　導入部
　３９４ｂ　拡径部
　４　　　　尿道挿入具
　４０　　　支持部
　４１　　　尿道挿入部
　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　　尿排孔
　４８　　　尿排出ポート
　５　　　　膣挿入具
　５０　　　支持部
　５０１　　雄ネジ
　５１　　　膣挿入部
　５２　　　先端部
　５２ａ　　上面
　５２３　　吸引部
　５２４　　凹部
　５２５　　吸引孔
　５２６　　リブ
　５３　　　軸部
　５４　　　吸引ポート
　５７　　　マーカー
　６　　　　挿入具
　９　　　　インプラント
　９０　　　包材
　９１　　　インプラント本体
　９２　　　帯
　１１００　骨盤
　１１０１　閉鎖孔
　１１０２　閉鎖孔
　１２００　恥骨結合
　１３００　尿道
　１３１０　膀胱
　１４００　膣
　１４０１　中央部
　１４０２　部分
　２０００　注射器
　Ａ１　　　内周部
　Ａ２　　　外周部
　Ａ３　　　表面
　Ａ４　　　裏面
　Ｄ１　　　離間距離
　Ｄ２　　　離間距離
　Ｆ１　　　応力
　Ｈ　　　　体表面
　Ｊ１　　　軸
　Ｊ２　　　軸
　Ｊ３１　　短軸
　Ｊ３２　　長軸
　Ｊ３２’　延長線
　Ｊ４１　　短軸
　Ｊ４２　　長軸
　Ｊ５　　　中心軸
　Ｌ２　　　長さ
　Ｏ　　　　中心
　Ｐ　　　　交点
　Ｓ１　　　領域
　Ｓ２　　　領域
　Ｓ４　　　中央部
　Ｓ５　　　セーフティゾーン
　ｆ１　　　平面
　ｆ２　　　平面
　ｆ９　　　平面
　ｒ１　　　最少曲率半径
　ｒ２　　　最大曲率半径
　Ｗ　　　　幅方向
　Ｗ１　　　幅
　Ｗ２　　　幅
　θ１　　　傾斜角
　θ２　　　傾斜角
　θ３　　　傾斜角
　θ５　　　傾斜角 DESCRIPTION OF SYMBOLS 1 Puncture apparatus 2 Frame 21 Bearing part 211 Through-hole 22 Guide part 221 Guide groove 221a Opening 221b Open 229 Engagement hole 229a End face 23 Connection part 24 Fixing part 243 Recessed part 244 Male screw 3 Puncture member 30 Sheath 300 Shaft part 301 Outer pipe 301a Tip portion 301b Contact portion 302 Inner tube 31 Operation member 32 Main body 321 Stylet 322 Connection portion 323 Shaft portion 324 Handle 33 Pusher shaft 331 Recess 332 Recess 332a Contact surface 332b Inclined surface 34 Tip tip 341 Main body portion 35 Projection 351 Elastic deformation Part 352 Elastic piece 352a Protruding part 353 Elastic piece 353a Protruding part 354 Clearance 36 Holding part 361 Guide part 361a Insertion hole 362 Guide part 362a Insertion hole 37 Contact part 3 71 Front end surface 38 Slide lock portion 381 Protrusion 382 Elastic piece 382a Claw portion 383 Elastic piece 383a Claw portion 389 Insertion hole 39 Needle body 391 Needle portion 391a Widened portion 391b Outer diameter gradually increasing portion 391c Outer diameter gradually decreasing portion 392 Base end portion 393 Contact surface 394 Connecting hole 394a Introducing portion 394b Expanding portion 4 Urethral insertion tool 40 Supporting portion 41 Urethral inserting portion 42 Balloon 43 Balloon port 44 Suction hole 45 Suction port 46 Marker 47 Urine drainage portion 471 Urine drainage port 48 Urine drainage port 5 Vagina Insertion tool 50 Support part 501 Male screw 51 Vaginal insertion part 52 Tip part 52a Upper surface 523 Suction part 524 Concave part 525 Suction hole 526 Rib 53 Shaft part 54 Suction port 57 Marker 6 Insertion tool 9 Implant 90 Packaging material 91 Implant Body 92 Band 1100 Pelvis 1101 Closure hole 1102 Closure hole 1200 Pubic joint 1300 Urethra 1310 Bladder 1400 Vagina 1401 Central part 1402 Part 2000 Syringe A1 Inner peripheral part A2 Outer peripheral part A3 Surface A4 Back surface D1 Separated distance D2 Separated distance D2 Axis J2 Axis J31 Short Axis J32 Long Axis J32 'Extension Line J41 Short Axis J42 Long Axis J5 Central Axis L2 Length O Center P Intersection S1 Region S2 Region S4 Central S5 Safety Zone f1 Plane f2 Plane f9 Plane radius r1 r2 radius r1 r Maximum curvature radius W Width direction W1 Width W2 Width θ1 Tilt angle θ2 Tilt angle θ3 Tilt angle θ5 Tilt angle

Claims (13)

  1. 　管状の医療用チューブと、
    　前記医療用チューブの先端部に接続された針体と、を有し、
    　前記針体は、拡幅部を有し、
    　前記拡幅部の幅は、前記医療用チューブの先端部の幅よりも大きいことを特徴とする穿刺部材。     A tubular medical tube;
    A needle body connected to the distal end of the medical tube,
    The needle body has a widened portion,
    The puncture member according to claim 1, wherein a width of the widened portion is larger than a width of a distal end portion of the medical tube.
  2. 　前記針体は、前記漸減部の基端側に、前記医療用チューブの先端部と当接する当接面を有している請求項１に記載の穿刺部材。 The puncture member according to claim 1, wherein the needle body has a contact surface that contacts the distal end portion of the medical tube on a proximal end side of the gradually decreasing portion.
  3. 　前記医療用チューブは、外管と、前記外管内に配置され、前記外管に対してスライド可能な内管と、を有し、前記外管と前記内管の少なくとも一方に前記当接面を有している請求項２に記載の穿刺部材。 The medical tube includes an outer tube and an inner tube disposed in the outer tube and slidable with respect to the outer tube, and the contact surface is provided on at least one of the outer tube and the inner tube. The puncture member according to claim 2.
  4. 　前記医療用チューブは、前記外管と前記内管とがスライドすることで延長可能となっている請求項３に記載の穿刺部材。 The puncture member according to claim 3, wherein the medical tube can be extended by sliding the outer tube and the inner tube.
  5. 　前記外管の先端部は、前記医療用チューブの内側へ向けて傾斜している請求項３または４に記載の穿刺部材。 The puncture member according to claim 3 or 4, wherein a distal end portion of the outer tube is inclined toward the inside of the medical tube.
  6. 　前記拡幅部の幅は、前記外管の先端部の幅よりも大きく、
    　前記外管の先端部の幅は、前記内管の先端部の幅よりも大きい請求項３ないし５のいずれか１項に記載の穿刺部材。     The width of the widened portion is greater than the width of the tip of the outer tube,
    The puncture member according to any one of claims 3 to 5, wherein a width of a distal end portion of the outer tube is larger than a width of a distal end portion of the inner tube.
  7. 　前記針体は、前記拡幅部を有する針部と、前記針部の基端側に位置する基端部と、を有し、前記基端部が前記医療用チューブに挿入されている請求項１ないし６のいずれか１項に記載の穿刺部材。 The needle body has a needle part having the widened part and a base end part located on a base end side of the needle part, and the base end part is inserted into the medical tube. 7. The puncture member according to any one of items 6 to 6.
  8. 　前記拡幅部は、生体組織を剥離可能である請求項１ないし７のいずれか１項に記載の穿刺部材。 The puncture member according to any one of claims 1 to 7, wherein the widened portion is capable of peeling biological tissue.
  9. 　前記針体は、先端と基端の間に、その先端側および基端側よりも幅が大きい前記拡幅部を有している請求項１ないし８のいずれか１項に記載の穿刺部材。 The puncture member according to any one of claims 1 to 8, wherein the needle body has the widened portion having a width larger than that of the distal end side and the proximal end side between the distal end and the proximal end.
  10. 　前記針体は、前記拡幅部よりも基端側に位置し、幅が先端側へ向けて漸増する幅漸増部を有している請求項１ないし９のいずれか１項に記載の穿刺部材。 The puncture member according to any one of claims 1 to 9, wherein the needle body has a width gradually increasing portion that is located on a proximal end side with respect to the widened portion and whose width gradually increases toward a distal end side.
  11. 　前記針体は、短軸および長軸を有する偏平の横断面形状を有している請求項１ないし１０のいずれか１項に記載の穿刺部材。 The puncture member according to any one of claims 1 to 10, wherein the needle body has a flat cross-sectional shape having a short axis and a long axis.
  12. 　前記針体の横断面形状は、前記長軸の中心部が膨らんだ紡錘形状である請求項１１に記載の穿刺部材。 The puncture member according to claim 11, wherein a cross-sectional shape of the needle body is a spindle shape in which a central portion of the long axis is swollen.
  13. 　前記医療用チューブに挿入された長尺な軸部を有し、
    　前記軸部と前記針体とが離脱可能に接続されている請求項１ないし１２のいずれか１項に記載の穿刺部材。     Having a long shank inserted into the medical tube;
    The puncture member according to any one of claims 1 to 12, wherein the shaft portion and the needle body are detachably connected.
PCT/JP2015/055359 2014-03-13 2015-02-25 Puncturing member WO2015137116A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2014-050887 2014-03-13
JP2014050887 2014-03-13

Publications (1)

Publication Number Publication Date
WO2015137116A1 true WO2015137116A1 (en) 2015-09-17

Family

ID=54071564

Family Applications (1)

Application Number Title Priority Date Filing Date
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Country Status (1)

Country Link
WO (1) WO2015137116A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022039699A1 (en) * 2020-08-17 2022-02-24 Orhan Seyfi Aksakal An advanced secure tissue tunnel opener

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997047246A1 (en) * 1996-06-10 1997-12-18 Influence Medical Technologies Ltd. Suture insertion device for the treatment of urinary stress incontinence
JP2008100090A (en) * 1992-09-04 2008-05-01 Boston Scient Corp Endoscopic suture system
WO2010094730A1 (en) * 2009-02-20 2010-08-26 Commissariat A L'energie Atomique Et Aux Energies Alternatives Device for connecting two hollow biological tissues by sutures

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008100090A (en) * 1992-09-04 2008-05-01 Boston Scient Corp Endoscopic suture system
WO1997047246A1 (en) * 1996-06-10 1997-12-18 Influence Medical Technologies Ltd. Suture insertion device for the treatment of urinary stress incontinence
WO2010094730A1 (en) * 2009-02-20 2010-08-26 Commissariat A L'energie Atomique Et Aux Energies Alternatives Device for connecting two hollow biological tissues by sutures

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022039699A1 (en) * 2020-08-17 2022-02-24 Orhan Seyfi Aksakal An advanced secure tissue tunnel opener

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