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WO2015041140A1 - Dispositif de ponction et procédé de ponction - Google Patents

Dispositif de ponction et procédé de ponction Download PDF

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Publication number
WO2015041140A1
WO2015041140A1 PCT/JP2014/074096 JP2014074096W WO2015041140A1 WO 2015041140 A1 WO2015041140 A1 WO 2015041140A1 JP 2014074096 W JP2014074096 W JP 2014074096W WO 2015041140 A1 WO2015041140 A1 WO 2015041140A1
Authority
WO
WIPO (PCT)
Prior art keywords
puncture
urethra
urethral
vagina
distal end
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2014/074096
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English (en)
Japanese (ja)
Inventor
政克 川浦
奈央 横井
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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 Terumo Corp filed Critical Terumo Corp
Publication of WO2015041140A1 publication Critical patent/WO2015041140A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • A61B17/04—Surgical instruments, devices or methods 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0491—Sewing machines for surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B17/04—Surgical instruments, devices or methods 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
    • A61B17/30—Surgical pincettes, i.e. surgical tweezers without pivotal connections
    • A61B2017/306—Surgical pincettes, i.e. surgical tweezers without pivotal connections holding by means of suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3409—Needle locating or guiding means using mechanical guide means including needle or instrument drives

Definitions

  • the present invention relates to a puncture device and a puncture method.
  • Urinary incontinence particularly stress urinary incontinence, urine leakage occurs due to abdominal pressure applied during normal exercise, laughing, coughing, sneezing, etc.
  • the cause of this is, for example, that the pelvic floor muscle, which is a muscle that supports the urethra, is loosened due to childbirth and the like.
  • Surgical therapy is effective for treating urinary incontinence.
  • a band-like implant called a “sling”
  • the sling is placed in the body, and the urethra is supported by the sling (see, for example, Patent Document 1).
  • the operator incises the vagina with a scalpel, peels off the space between the urethra and the vagina, and uses a puncture needle or the like to connect the peeled portion and the outside through a closed hole ( Hereinafter, this operation is referred to as “puncture operation”). In such a state, the sling is left in the body.
  • An object of the present invention is to provide a puncture device and a puncture method that can reliably puncture a target site.
  • the operation unit has a long shape,
  • the puncture apparatus according to (1), wherein the high-rigidity portion is a portion where the thickness of the operation portion is larger than the thickness of the puncture portion.
  • the puncture portion has an arc shape, and the center of the arc coincides with the rotation axis
  • the operation portion includes a shaft portion disposed on the rotation shaft, and a connecting portion that connects the shaft portion and the puncture portion,
  • a puncture method for puncturing a living body with a puncture device having a highly rigid portion with higher rigidity and an operation portion for rotating the puncture portion about the rotation axis When the puncture unit punctures a living body, deformation of the operation unit is prevented or suppressed by the high-rigidity unit.
  • the operation portion is a highly rigid portion having higher rigidity than the puncture portion, it is possible to prevent the operation portion from being deformed by puncture resistance when the puncture portion punctures a living body. Thereby, the puncture part can puncture a target site reliably.
  • FIG. 1 is a perspective view showing an example of an implant.
  • FIG. 2 is a perspective view showing the puncture device according to the first embodiment of the present invention.
  • FIG. 3 is a side view of the puncture device shown in FIG. 4 is a side view of the insertion tool of the puncture device shown in FIG.
  • FIG. 5 is a cross-sectional view for explaining the function of the marker provided in the urethral insertion portion, in which (a) shows an inappropriate case, and (b) shows an appropriate case.
  • FIG. 6 is a cross-sectional view for explaining the function of the marker provided in the urethra insertion part.
  • FIG. 7 is a view showing the positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view.
  • FIG. 8 is a partially enlarged view of the vaginal insertion tool included in the insertion tool shown in FIG. 2, wherein (a) is a top view and (b) is a cross-sectional view.
  • 9A is a cross-sectional view showing an example of the shape of the vagina wall
  • FIG. 9B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG.
  • FIG. 10 is a cross-sectional view showing a state where the vaginal insertion portion shown in FIG. 2 is inserted into the vagina.
  • FIG. 11A and 11B are diagrams for explaining the maintenance mechanism and the displacement mechanism of the insertion tool shown in FIG. 2, in which FIG. 11A shows a locked state, and FIG. 11B shows a released state.
  • . 12 is a view showing a puncture member included in the puncture apparatus shown in FIG. 2, wherein (a) is a perspective view and (b) is a cross-sectional view taken along line AA in (a). 13 is a cross-sectional view of the puncture member shown in FIG.
  • FIG. 14 is a view showing a state maintaining mechanism of the puncture member shown in FIG. 2, wherein (a) is a top view, and (b) and (c) are cross-sectional views.
  • FIG. 15 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 2, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. is there.
  • 16 is a cross-sectional view of the guide portion shown in FIG.
  • FIG. 17 is a perspective view showing an operation member included in the puncture device shown in FIG. 18 is a view as seen from the direction of arrow A in FIG.
  • FIG. 19 is a view as seen from the direction of arrow B in FIG.
  • FIG. 20 is a plan view showing a frame fixing portion provided in the puncture device shown in FIG. 2.
  • FIG. 21 is a view of the puncture device shown in FIG. 2 as viewed from the distal end side.
  • FIG. 22 is a view showing a pelvis and a closing hole.
  • 23A and 23B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 24A and 24B are diagrams for explaining the operation procedure of the puncture device shown in FIG.
  • FIGS. 25A and 25B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2.
  • FIG. 26 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG.
  • FIG. 27 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIGS. 28A and 28B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2.
  • FIGS. 29A and 29B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2.
  • FIG. 30 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG.
  • FIG. 31 is a cross-sectional view showing the posture of the puncture member relative to the urethra in the state shown in FIG. 32A and 32B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • FIG. 33 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 34 is a perspective view of an operation member included in the puncture device according to the second embodiment of the present invention.
  • FIG. 35 is a perspective view of an operation member included in the puncture device according to the third embodiment of the present invention.
  • FIG. 36 is a perspective view of an operation member included in the puncture device according to the fourth embodiment of the present invention.
  • FIG. 37 is a view showing a guide part provided in the puncture device according to the fifth embodiment of the present invention, where (a) is a view seen from the distal end side, and (b) is an arrow C in (a). It is the figure seen from the direction.
  • FIGS. 38A and 38B are views showing a guide part provided in the puncture device according to the sixth embodiment of the present invention, wherein FIG. 38A is a view seen from the distal end side, and FIG. 38B is an arrow D in FIG. It is the figure seen from the direction.
  • FIG. 39 is a side view showing an insertion tool included in the puncture device according to the seventh embodiment of the present invention.
  • FIG. 40 is a side view showing an insertion tool included in the puncture device according to the eighth embodiment of the present invention.
  • FIG. 41 is a side view showing an insertion tool included in the puncture device according to the ninth embodiment of the present invention.
  • FIG. 42 is a cross-sectional view showing a state where the urethral insertion tool of the insertion tool shown in FIG. 41 is inserted into the urethra.
  • FIG. 43 is a side view of the insertion tool included in the puncture device according to the tenth embodiment of the present invention, in which (a) shows a state locked by the maintenance mechanism, and (b) shows a state in which the maintenance mechanism is released.
  • FIG. 44 (a) is a side view of an insertion tool included in the puncture device according to the eleventh embodiment of the present invention
  • FIG. 44 (b) is a side view showing a state locked by the maintenance mechanism
  • FIG. 44 (c) is the maintenance mechanism. It is a side view which shows the state released
  • FIG. 45 is a side view of an insertion tool included in the puncture device according to the twelfth embodiment of the present invention.
  • FIG. 46 is a cross-sectional view showing a state in which the vaginal insertion tool shown in FIG. 45 is inserted into the vagina.
  • FIG. 47 is a side view of an insertion tool included in the puncture device according to the thirteenth embodiment of the present invention.
  • FIG. 48 is a view showing the distal end portion of the vaginal insertion tool shown in FIG. 47, in which (a) is a top view and (b) is a cross-sectional view taken along line BB in (a).
  • 49 is a diagram showing a state in which the distal end portion shown in FIG. 48 is inserted into the vagina, in which (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed.
  • FIG. FIG. 50 is a cross-sectional view showing the distal end portion of the vaginal insertion tool included in the puncture device according to the fourteenth embodiment of the present invention.
  • 51 is a diagram showing a state in which the distal end portion shown in FIG.
  • FIG. 50 is inserted into the vagina, in which (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed.
  • FIG. FIG. 52 is a cross-sectional view showing the distal end portion of the vaginal insertion tool included in the puncture device according to the fifteenth embodiment of the present invention.
  • FIGS. 53A and 53B are views showing the distal end portion of the vaginal insertion tool included in the puncture device according to the sixteenth embodiment of the present invention, wherein FIG. 53A is a side view, FIG. 53B is a top view, and FIG. is there. 54 is a diagram showing a state in which the distal end portion shown in FIG.
  • FIG. 53 is inserted into the vagina, where (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed.
  • FIG. FIG. 55 is a view showing a distal end portion of a vaginal insertion tool included in a puncture device according to a seventeenth embodiment of the present invention.
  • 56A and 56B are views showing the distal end portion of the vaginal insertion tool included in the puncture device according to the eighteenth embodiment of the present invention, wherein FIG. 56A is a side view and FIG. 56B is a cross-sectional view.
  • FIGS. 57A and 57B are diagrams for explaining the function of the tip shown in FIG. 56, respectively.
  • FIG. 58 is a side view showing a urethra insertion tool included in the puncture device according to the nineteenth embodiment of the present invention.
  • FIG. 59 is a side view showing a urethra insertion part included in the puncture device according to the twentieth embodiment of the present invention.
  • 60 (a) and 60 (b) are partial cross-sectional views showing a urethra insertion part included in the puncture device according to the twenty-first embodiment of the present invention.
  • FIG. 61 is a perspective view showing a puncture member included in the puncture apparatus according to the twenty-second embodiment of the present invention.
  • 62 is a cross-sectional view showing a modification of the puncture member shown in FIG.
  • FIG. 63 is a cross-sectional view showing an operation member included in the puncture device according to the twenty-third embodiment of the present invention.
  • FIG. 1 is a perspective view showing an example of an implant.
  • FIG. 2 is a perspective view showing the puncture device according to the first embodiment of the present invention.
  • FIG. 3 is a side view of the puncture device shown in FIG. 4 is a side view of the insertion tool of the puncture device shown in FIG.
  • FIG. 5 is a cross-sectional view for explaining the function of the marker provided in the urethral insertion portion, in which (a) shows an inappropriate case, and (b) shows an appropriate case.
  • FIG. 6 is a cross-sectional view for explaining the function of the marker provided in the urethra insertion part.
  • FIG. 7 is a view showing the positional relationship between the puncture member and the closing hole (pelvis), in which (a) is a side view and (b) is a front view.
  • FIG. 8 is a partially enlarged view of the vaginal insertion tool included in the insertion tool shown in FIG. 2, wherein (a) is a top view and (b) is a cross-sectional view.
  • 9A is a cross-sectional view showing an example of the shape of the vagina wall
  • FIG. 9B is a cross-sectional view showing a state where the vaginal insertion portion is inserted into the vagina shown in FIG.
  • FIG. 10 is a cross-sectional view showing a state where the vaginal insertion portion shown in FIG. 2 is inserted into the vagina.
  • FIG. 11A and 11B are diagrams for explaining the maintenance mechanism and the displacement mechanism of the insertion tool shown in FIG. 2, in which FIG. 11A shows a locked state, and FIG. 11B shows a released state.
  • . 12 is a view showing a puncture member included in the puncture apparatus shown in FIG. 2, wherein (a) is a perspective view and (b) is a cross-sectional view taken along line AA in (a). 13 is a cross-sectional view of the puncture member shown in FIG.
  • FIG. 14 is a view showing a state maintaining mechanism of the puncture member shown in FIG. 2, wherein (a) is a top view, and (b) and (c) are cross-sectional views.
  • FIG. 15 is a partially enlarged view showing a state maintaining mechanism of the puncture member shown in FIG. 2, wherein (a) and (b) are plan views showing modifications, and (c) is a plan view showing this embodiment. is there.
  • 16 is a cross-sectional view of the guide portion shown in FIG.
  • FIG. 17 is a perspective view showing an operation member included in the puncture device shown in FIG. 18 is a view as seen from the direction of arrow A in FIG.
  • FIG. 19 is a view as seen from the direction of arrow B in FIG.
  • FIG. 20 is a plan view showing a frame fixing portion provided in the puncture device shown in FIG. 2.
  • FIG. 21 is a view of the puncture device shown in FIG. 2 as viewed from the distal end side.
  • FIG. 22 is a view showing a pelvis and a closing hole.
  • 23A and 23B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 24A and 24B are diagrams for explaining the operation procedure of the puncture device shown in FIG.
  • FIGS. 25A and 25B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2.
  • FIG. 26 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG.
  • FIG. 27 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIGS. 28A and 28B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2.
  • FIGS. 29A and 29B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG. 2.
  • FIG. 30 is a side view showing the relationship between the puncture device and the pelvis in the state shown in FIG.
  • FIG. 31 is a cross-sectional view showing the posture of the puncture member relative to the urethra in the state shown in FIG. 32A and 32B are diagrams for explaining the operation procedure of the puncture apparatus shown in FIG.
  • FIG. 33 is a diagram for explaining an operation procedure of the puncture device shown in FIG. 2.
  • FIG. 3 shows a state that is not yet used. Hereinafter, for convenience of explanation, this state is also referred to as an “initial state”.
  • this state is also referred to as an “initial state”.
  • the state where the puncture device (insertion tool) shown in FIG. 3 is attached to the patient is also referred to as “wearing state”.
  • the puncture member currently extended in circular arc shape is linearly extended and shown for convenience of explanation, respectively.
  • 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 supports an instrument that supports the urethra, for example, when the urethra is about to move toward the vagina wall, so as to restrict movement of the urethra in a direction away from the vagina wall. It is an instrument. As such an implant 9, for example, a long object having flexibility can be used.
  • the implant 9 has an implant body 91 and a band 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 implant 9 having such a configuration is accommodated in a packaging material 90 sterilized in an unused state. Thereby, contamination of the implant 9 can be prevented.
  • the constituent materials of the implant body 91, the band 92, and the packaging material 90 are not particularly limited, and for example, various resin materials having biocompatibility such as polypropylene, polyester, and nylon, fibers, and the like can be used. .
  • 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.
  • Such an implant 9 and a sheath 30 described later can constitute a “pelvic treatment kit”.
  • Puncture device A puncture device 1 shown in FIG. 2 is a device used to embed the above-described implant 9 in a living body.
  • the puncture device 1 includes a frame (support portion) (support member) 2, an insertion tool 6, an operation member 7, and a puncture member 3.
  • the insertion tool 6 and the operation member 7 are supported, and the puncture member 3 is supported by the operation member 7.
  • the insertion tool 6 includes 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 (urethra insertion portion support portion) 40 that supports the urethral insertion portion 41.
  • the constituent materials of the urethral insertion portion 41 and the support portion 40 are not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and various resin materials can be used. .
  • 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.
  • a distal end portion of the urethra insertion portion 41 is provided with a balloon (engagement portion) 42 that has extensibility and can be expanded / contracted, and a urine discharge portion 47.
  • the balloon 42 is disposed so as to be located in the bladder when the urethral insertion portion 41 is inserted into the urethra.
  • the balloon 42 passes through the urethral insertion portion 41 and is connected to a balloon port 431 provided at the proximal end portion thereof.
  • a balloon expansion device such as a syringe can be connected to the balloon port 431.
  • 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.
  • the urine drainage hole 471 passes through the urethral insertion portion 41 and is connected to a urine discharge port 432 provided at the base end portion thereof. Therefore, urine introduced from the urine drainage hole 471 can be discharged from the urine discharge port 432.
  • These balloon 42 and urine discharge part 47 can be constituted by a double lumen, for example.
  • a plurality of suction holes 44 are formed in the middle of the urethra insertion part 41 as suction parts for adsorbing the urethra wall to the urethra insertion part 41.
  • the plurality of suction holes 44 are arranged over the entire circumferential direction of the urethral insertion portion 41.
  • Each suction hole 44 passes through the urethral insertion portion 41 and is connected to a suction port 433 provided in the support portion 40.
  • a suction device such as a pump can be connected to the suction port 433.
  • the suction device 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.
  • 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 When the urethra insertion part 41 is pushed into the body inside (the distal end side of the urethra insertion part 41) with the urethra wall adsorbed and fixed to the urethra insertion part 41 in this way, the urethra and bladder are pushed into the body along with this, The bladder can be shifted to a position that does not overlap the puncture route (puncture target site) X of the puncture member 3. Therefore, a larger puncture path X of the puncture member 3 can be ensured, and the puncture member 3 can be punctured accurately and safely.
  • a visible marker (detection unit) 46 is provided in the middle of the urethra insertion unit 41 and on the proximal side of the balloon 42. This marker 46 is used to detect the distance between the bladder and the urethral opening, in other words, the length of the urethra.
  • the urethral insertion portion 41 is inserted into the urethra 1300, and the balloon 42 is expanded. In the state of being engaged with the bladder neck, the marker 46 is exposed from the urethral opening 1320.
  • FIG. 5 (a) when the separation distance between the bladder 1310 and the urethral orifice 1320 is less than a predetermined distance, the urethral insertion portion 41 is inserted into the urethra 1300, and the balloon 42 is expanded. In the state of being engaged with the bladder neck, the marker 46 is exposed from the urethral opening 1320.
  • the urethra insertion part 41 is inserted into the urethra 1300 and the balloon 42 is expanded to expand the bladder neck
  • the marker 46 is located in the urethra 1300 and is not exposed from the urethral opening 1320.
  • the puncture member 3 cannot be punctured.
  • the puncture member 3 is punctured between them. It is expected that there will be sufficient space for Therefore, in this case, it is determined that the puncture member 3 can be punctured.
  • the marker 46 it is possible to easily determine whether or not the puncture member 3 can be punctured by the puncture apparatus 1, in other words, whether or not the puncture apparatus 1 is applicable to the patient. .
  • the separation distance between the bladder 1310 and the urethral opening 1320 can be accurately detected, and the above-described determination can be performed more accurately. Can do.
  • the configuration of the marker 46 is not particularly limited as long as the surgeon can be visually recognized from the outside.
  • the marker 46 may be configured by a colored portion colored in a color different from the surroundings (the distal end side and the proximal end side). It may be configured by a concave portion or a convex portion.
  • the marker 46 may be a scale on which the distance from the base end of the balloon 42 is written. In this case, since it is not possible to determine whether or not the puncture member 3 can be punctured based on whether or not the marker 46 is exposed from the urethral opening 1320 as in this embodiment, the scale of the urethra 1300 can be determined using the scale. It is only necessary to measure the length and determine whether or not the puncture member 3 can be punctured according to the length.
  • a sliding resistance amplifying section 49 is provided at the distal end of the urethra insertion portion 41 to increase the sliding resistance against the urethra by contacting the urethra wall (tissue in the urethra). Is provided. As described above, during the procedure using the puncture device 1, the urethra wall is adsorbed and fixed to the urethra insertion part 41, and the urethra insertion part 41 is pushed into the body, whereby the bladder 1310 is punctured by the puncture member 3.
  • the urethral wall may come off from the suction hole 44, and the bladder 1310 may not be pushed in sufficiently. Therefore, as in the present embodiment, the sliding resistance amplifying portion 49 is provided in the urethra insertion portion 41 so that the urethral insertion portion 41 is not easily slid with respect to the urethra wall. Even in such a case, if the suction through the suction hole 44 is sufficient, the bladder 1310 can be pushed into the body more reliably by a synergistic effect therewith. Therefore, the puncture member 3 can be punctured more safely.
  • the configuration of the sliding resistance amplifying unit 49 is not particularly limited as long as the above effects can be exhibited.
  • it is composed of fine irregularities (rough surface) formed on the surface of the urethral insertion portion 41.
  • the sliding resistance amplifying unit 49 is provided over the entire circumferential direction of the urethral insertion unit 41. Thereby, since the area of the sliding resistance amplification part 49 can be enlarged more, the sliding resistance with respect to the urethra 1300 can be raised more.
  • the sliding resistance amplifier 49 can be formed by embossing, sandblasting, laser processing, or the like.
  • the sliding resistance amplifying part 49 is provided so as to overlap with the region S1 where the suction hole 44 is formed.
  • the suction hole 44 is formed in the sliding resistance amplifying portion 49.
  • the urethra wall bites into the suction hole 44 and is caught.
  • the sliding resistance of the urethral insertion section 41 with respect to the urethra can be further increased.
  • both the sliding resistance amplifying portion 49 and the region S1 can be widely arranged, so that the mutual effects can be exerted more greatly. .
  • a cylindrical marker (positioning part) 45 is slidably provided in the urethra insertion part 41.
  • a restricting portion 48 is mounted between the marker 45 of the urethral insertion portion 41 and the support portion 40, and when the marker 45 abuts on the restricting portion 48, further to the proximal end side of the marker 45. Sliding is regulated.
  • the restriction part 48 can be easily removed from the urethra insertion part 41. When the restriction part 48 is removed from the urethra insertion part 41, the marker 45 can slide to the proximal end side.
  • the configuration of the regulating portion 48 is not particularly limited as long as the above effect can be exhibited.
  • it has a main body 481 having a semi-cylindrical shape with a substantially C-shaped cross section, and a knob 482 provided on the main body 481.
  • the main body 481 is attached to the urethra insertion part 41 in a slightly expanded diameter so as not to be separated from the urethra insertion part 41 by its own weight or to slide with respect to the urethra insertion part 41.
  • the marker 45 is in contact with the restricting portion 48 and in a state where further sliding toward the proximal end is restricted (the state shown in FIG. 4), the puncture route of the puncture member 3 and a predetermined relative positional relationship It is positioned so that Therefore, as shown in FIG. 6, the puncture route X of the puncture member 3 can be positioned with respect to the urethral opening 1320 by inserting the urethral insertion portion 41 into the urethra 1300 and positioning the marker 45 at the urethral opening 1320. it can.
  • the puncture route X with respect to the urethral opening 1320, for example, compared with the case of positioning with respect to the bladder 1310, positioning accuracy is increased, and the puncture member 3 is accurately punctured.
  • the “predetermined relative positional relationship” means, for example, a positional relationship in which the puncture route X of the puncture member 3 does not overlap the bladder 1310 in a state where the marker 45 is positioned at the urethral opening 1320. Can do.
  • the marker 45 has a larger outer diameter than the urethra insertion part 41 and protrudes to the outer periphery of the urethra insertion part 41, and therefore cannot enter the urethra 1300. Therefore, when the urethra insertion part 41 is inserted into the urethra 1300, the marker 45 abuts on the urethral opening 1320 (or tissue around the urethral opening 1320; the same applies hereinafter), and the marker 45 is naturally placed in the urethra. It can be located at the mouth 1320. In this way, the marker 45 can be positioned at the urethral opening 1320 easily and reliably by using physical catching.
  • the marker 45 comes into contact with the urethral opening 1320, the further insertion of the urethra insertion part 41 into the urethra 1300 is restricted, so that excessive insertion of the urethra insertion part 41 into the urethra 1300 can be prevented. This increases the safety of the puncture device 1.
  • Such a marker 45 has a function of positioning the puncture route of the puncture member 3 with respect to the urethral opening 1320 as described above, and the urethral insertion portion 41 is inserted into the urethra 1300 via the urethral opening 1320. It has a function as an inflow reduction unit 450 that suppresses the inflow of air into the urethra 1300. More specifically, as shown in FIG. 6, when the urethral insertion portion 41 is inserted into the urethra 1300 and the marker 45 is in contact with the urethral opening 1320, the urethral opening 1320 is covered with the marker 45. ing.
  • the marker 45 also serves as the inflow reduction portion 450, the configuration of the urethral insertion tool 4 is simplified and the operation thereof is also simplified. In addition, the number of components is reduced, which contributes to cost reduction.
  • the inclination angle of the plane f9 (plane f1) with respect to the plane f2 orthogonal to the axis J2 of the urethra insertion portion 41 is particularly Although not limited, it is preferably about 20 ° to 60 °, more preferably about 30 ° to 45 °, and further preferably about 35 ° to 40 °.
  • 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 puncture member 3 can widely grasp the left and right closure holes 1101 and 1102 of the pelvis 1100 in a plane as shown in FIG. It is possible to secure a wide puncture space for the puncture member 3. That is, the puncture member 3 can be punctured in a relatively vertical direction with respect to the closing holes 1101 and 1102 in a state where the patient is in a predetermined body position (crushed stone position). Therefore, the puncture member 3 can be punctured easily.
  • the puncture member 3 passes through a shallow portion of the tissue by puncturing the puncture member 3 in a relatively vertical direction with respect to the closure holes 1101 and 1102, the needle body 35 of the puncture member 3 is closed to the left and right closure holes. It passes between 1101 and 1102 at a shorter distance. Therefore, as shown in FIG. 7B, the puncture member 3 can pass through the closure holes 1101 and 1102 near the pubic joint 1200, preferably through the safety zone S5. Since the safety zone S5 is a region where there are few nerves and blood vessels to avoid damage, the puncture member 3 can be punctured safely by passing through the safety zone S5. Therefore, it becomes less invasive and can reduce the burden on the patient.
  • the inclination angle ⁇ 2 within the above range, it is possible to more appropriately puncture the patient with the puncture member 3.
  • 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.
  • the position between the middle urethra and the vagina is suitable as a site for implanting the implant 9 and treating urinary incontinence, targeting the tissue between the middle urethra and the vagina is more effective. Can be treated.
  • the puncture member 3 planarly closes the closing holes 1101 and 1102 depending on individual differences in the patient, the posture during the procedure, and the like. There are cases where it is not possible to capture widely or the puncture route cannot be shortened sufficiently.
  • the 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 urethral insertion portion 41 is slidable with respect to the support portion 40, and the screw is tightened.
  • the urethral insertion part 41 may be configured to be fixed to the support part 40. According to this configuration, since the length of the urethral insertion portion 41 can be adjusted, the urethral insertion tool 4 is more convenient to use. This also applies to the vaginal insertion tool 5 described later.
  • 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. Thereby, since inclination-angle (theta) 2 can be adjusted according to a patient, it becomes the puncture apparatus 1 which is more convenient.
  • the vaginal insertion tool 5 includes a long vagina insertion portion 51 inserted into the vagina partway and a support portion (vaginal insertion portion support portion) that supports the vagina insertion portion 51. 50.
  • the vaginal insertion portion 51 has a distal end portion 52 located on the distal end side and a shaft portion 53 connected to the proximal end portion of the distal end portion 52, and the shaft portion 53 is supported by the support portion 50.
  • the constituent materials of the vaginal insertion part 51 and the support part 50 are not particularly limited.
  • the urethra insertion device 4 urethra insertion part 41 and support part 40
  • stainless steel aluminum or an aluminum alloy
  • titanium or titanium Various metal materials such as alloys and various resin materials can be used.
  • the tip 52 is a part that is inserted into the vagina.
  • the length L2 from the distal end to the proximal end of the distal end portion 52 is not particularly limited, but is preferably about 20 mm to 100 mm, and more preferably about 30 mm to 60 mm.
  • the width W1 of the tip 52 is not particularly limited, but is preferably about 10 mm to 50 mm, and more preferably about 20 mm to 40 mm.
  • the tip 52 has a generally constant width as a whole, and the tip is rounded.
  • the distal end portion 52 is located on the distal end side, and the tapered portion 521 whose height gradually increases toward the proximal end side, and the inflow reduction portion 522 located on the proximal end side of the tapered portion 521 and having a substantially constant height. And have.
  • the inflow reduction unit 522 has a function of suppressing the inflow of air into the vagina via the vaginal opening with the tip 52 inserted into the vagina.
  • the upper surface (the surface on the urethral insertion portion 41 side) 521a is inclined with respect to the urethral insertion portion 41 so as to move away from the urethral insertion portion 41 toward the distal end.
  • the inclination angle ⁇ 3 of the upper surface 521a with respect to the urethral insertion portion 41 is not particularly limited, but is preferably about 0 ° to 45 °, and more preferably about 0 ° to 30 °. Thereby, the said effect can be exhibited more notably.
  • 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. However, the puncture device 1 may not be stably held.
  • a suction hole 54 is provided in the distal end portion 52 as a suction portion for adsorbing the vagina wall to the distal end portion 52.
  • the suction hole 54 has a bottomed recess 541 that opens to the upper surface 521a of the tapered portion 521. Thereby, as will be described later, the front wall of the vagina can be adsorbed to the tip portion 52.
  • the suction hole 54 is provided in the distal end portion 52 and has a connection hole 542 that connects the bottom surface of the concave portion 541 and the suction port 543 provided in the proximal end portion of the distal end portion 52.
  • the suction port 543 is provided so as to be located outside the living body in the mounted state.
  • a suction device such as a pump can be connected to the suction port 543.
  • the vaginal front wall which is the upper surface of the vagina wall, is adsorbed to the recess 541. Fixed.
  • the vaginal insertion part 51 is pushed into the body (the distal end side of the vaginal insertion part 51) with the front wall of the vagina adsorbed and fixed to the concave part 541, the vaginal wall can be pushed together. Therefore, the arrangement and shape of the vagina wall can be adjusted, and the puncture route of the puncture member 3 can be sufficiently secured. As a result, the puncture member 3 can be punctured accurately and safely.
  • the number of suction holes 54 is not limited to one, and a plurality of suction holes 54 may be provided.
  • the arrangement of the recesses 541 is not particularly limited, and may be arranged side by side in the length direction, may be arranged side by side in the width direction, or may be long. They may be arranged in rows and columns in the horizontal direction and in the width direction, or may be arranged irregularly.
  • the region S2 where the recess 541 is formed is opposed to the region S1 where the suction hole 44 is formed.
  • the puncture device 1 is configured such that the needle tip of the puncture member 3 passes between these regions S1 and S2.
  • the urethral wall is adsorbed by the urethral insertion portion 41 in the region S1 and the vagina wall is adsorbed by the distal end portion 52 in the region S2, the urethral wall and the vagina wall are more closely spaced between the regions S1 and S2. Wide and more reliably spaced. By passing the puncture member 3 through such a region, the puncture member 3 can be punctured more safely.
  • region S2 covers substantially the whole area of the width direction of the upper surface 521a.
  • the width W2 of the region S2 is not particularly limited, but is preferably about 9 to 49 mm, and more preferably about 19 to 39 mm. Thereby, the vaginal wall can be more reliably adsorbed to the distal end portion 52 without being greatly affected by the shape of the vaginal wall.
  • the central part 1401 of the anterior wall of the vagina hangs down into the vagina and dents (parts called “button holes”) 1402 exist on both sides thereof. May have.
  • dents parts called “button holes”
  • FIG. 9B not only the central portion 1401 but also the recessed portion 1402 can be more reliably adsorbed. In this way, by reliably adsorbing the recessed portion 1402 by the distal end portion 52, the recessed portion 1402 can be moved away from the urethra 1300, and it is effective that the puncture member 3 is punctured into the recessed portion 1402. Can be prevented.
  • the inflow reduction part 522 is located in the position.
  • the inflow reducing portion 522 is higher than the tapered portion 521 on the distal end side, and its entire circumference (cross-sectional area) is also longer than the tapered portion 521. Therefore, the vicinity of the vaginal opening 1410 and the vaginal opening 1410 of the vagina 1400 extend greatly, and the contraction force strongly adheres to the outer periphery of the inflow reduction unit 522. Therefore, the inflow of air into the vagina 1400 (recessed portion 541) through the vaginal opening 1410 is suppressed, and the suction of the vagina wall by the suction hole 54 can be performed more reliably and effectively.
  • the inflow reduction part 522 if the above-mentioned effect can be exhibited, it will not be limited to the shape of this embodiment,
  • height H1 may increase gradually toward the base end side.
  • the upper surface of the inflow reducing portion 522 may be a continuous surface having the same inclination as the upper surface 521a of the tapered portion 521, or may be a discontinuous surface having a different inclination.
  • a marker 57 that can confirm the puncture route of the puncture device 1 is provided at the distal end portion 52. Since the marker 57 is provided so that the puncture member 3 punctures between the vagina wall and the urethra wall located above, the puncture route of the puncture member 3 can be easily confirmed by confirming the position of the marker 57. As a result, the operability and safety of the puncture apparatus 1 are improved. It is preferable that the marker 57 is provided on at least one of the lower surface and the side surface of the distal end portion 52. Since the lower surface and the side surface are easily visible to the operator even when the distal end 52 is inserted into the vagina, the puncture route of the puncture member 3 can be easily confirmed by providing the marker 57 at such a position.
  • Such a marker 57 is only required to be visible from the outside, and can be constituted by, for example, a colored portion, an uneven portion, or the like.
  • the distance D between the distal end portion 52 and the urethral insertion portion 41 as described above is not particularly limited, but is about 10 to 40 mm corresponding to the distance between the urethral opening and the vaginal opening in a general woman. Is preferred.
  • the shaft portion 53 has a thin rod shape extending substantially parallel to the urethral insertion portion 41.
  • the length of the shaft portion 53 (the distance between the tip portion 52 and the support portion 50) is not particularly limited, but is preferably about 100 mm or less, and more preferably about 20 to 50 mm. Thereby, the axial part 53 can be made into appropriate length and the operativity of the puncture apparatus 1 improves. If the length of the shaft portion 53 exceeds the above upper limit value, the center of gravity of the puncture device 1 is greatly separated from the patient depending on the configuration of the frame 2 and the stability of the puncture device 1 in the mounted state is lowered. There is a case.
  • the urethral insert 4 and vaginal insert 5 have been described above.
  • the insertion tool 6 having the urethral insertion tool 4 and the vaginal insertion tool 5 is further maintained by the maintenance mechanism 61 that maintains the relative positional relationship between the urethral insertion part 41 and the vaginal insertion part 51, and the maintenance mechanism 61. It has the displacement mechanism 62 which can make the front-end
  • the displacement mechanism 62 has a hinge portion 621, and the support portions 40 and 50 are rotatably connected by the hinge portion 621.
  • a displacement mechanism 62 having a simple configuration can be obtained, and further, an operation of bringing the distal end portion 52 closer to the urethra insertion portion 41 can be easily performed. Will be able to do.
  • the maintenance mechanism 61 fixes the urethral insertion tool 4 and the vaginal insertion tool 5 to maintain the relative positional relationship between them, and releases the fixation between the urethral insertion tool 4 and the vaginal insertion tool 5.
  • the vaginal insertion tool 5 can be rotated with respect to the urethral insertion tool 4.
  • the maintenance mechanism 61 includes an operation unit 611 provided in the support unit 50 and an engagement unit 612 provided in the support unit 40 and engaged with the operation unit 611.
  • the operation unit 611 includes a shaft portion 611a capable of bending deformation (elastic deformation), a knob 611b connected to the shaft portion 611a, and a claw portion 611c provided at the tip of the knob 611b.
  • One engaging portion 612 includes a concave portion 612 a formed in the support portion 40.
  • claw part 611c is made into the state engaged with the recessed part 612a, the support part 50 is fixed to the support part 40, and the relative position of the urethral insertion tool 4 and the vaginal insertion tool 5 is shown. A relationship can be maintained.
  • the maintenance state is released by pulling the knob 611b downward and removing the claw portion 611c from the recess 612a, and the vaginal insert 5 is rotated with respect to the urethra insert 4 It becomes possible.
  • the vagina insertion part 51 front-end
  • the vagina insertion part 41 can be made to approach the urethra insertion part 41 rather than the maintenance state shown to Fig.11 (a).
  • the engaging portion 612 is provided on the support portion 40, and the operation portion 611 is provided on the support portion 50. On the contrary, the engaging portion 612 is provided on the support portion 50.
  • the operation unit 611 may be provided on the support unit 40. Moreover, the structure of the operation part 611 is not limited to this embodiment, as long as the same effect can be exhibited.
  • the insertion tool 6 may further include a biasing portion (for example, a spring) that biases the vaginal insertion portion 51 toward the urethral insertion portion 41 side.
  • a biasing portion for example, a spring
  • the vagina insertion part 51 is automatically moved to the urethra insertion part 41 side by the urging force of the urging part. Therefore, the operation of the insertion tool 6 becomes easier.
  • Puncture member 3 is a member for puncturing a living body. As shown in FIG. 12A, the puncture member 3 has a long sheath (medical tube) 30 and a needle body 35 provided at the distal end of the sheath 30.
  • the sheath 30 includes a tubular main body 31 and a state maintaining mechanism 34.
  • the main body 31 is composed of a long tubular body (tube), and the distal end and the proximal end are open.
  • the inside of the main body 31 functions as a space for inserting the insertion portion 71 and a space for inserting the implant 9.
  • the main body 31 has a curved shape that is curved in an arc shape. Further, as shown in FIG. 12B, the main body 31 has a flat cross-sectional shape having a short axis J31 and a long axis J32. By making the main body 31 into a flat shape, the implant main body 91 can be controlled in a desired posture within the main body 31.
  • the flat shape of the main body 31 is not particularly limited, and for example, an oval shape, a convex lens shape in cross section, a rhombus with rounded corners, a rectangle with rounded corners (flat shape), and a central portion at both ends
  • a spindle shape or the like that is larger (expanded) than the portion can be used.
  • the width of the internal space of the main body 31 (the length in the direction of the long axis J32) is designed to be substantially the same as the width of the implant main body 91. Thereby, the frictional resistance between the implant 9 and the main body 31 is reduced, and unnecessary force is not applied to the implant 9, and the implant main body 91 can be disposed in the main body 31 in a sufficiently expanded state.
  • the width of the internal space of the main body 31 may be shorter than the width of the implant main body 91. In this case, since the width of the main body 31 can be suppressed, the puncture member 3 is less invasive.
  • the end located on the inner side in the major axis J32 direction is also referred to as “inner peripheral portion A1”, and the end located on the outer side in the major axis J32 direction.
  • the portion is also referred to as “outer peripheral portion A2”, the surface facing upward is also referred to as “front surface A3”, and the surface facing downward is also referred to as “back surface A4”.
  • a plane (plane including the central axis of the main body 31) including both the central point of the arc of the central portion S4 and the central point of the cross-sectional shape with respect to the longitudinal direction of the main body 31 is defined as a plane f9.
  • the angle formed between the plane f9 and the short axis J31 at the central portion S4 is defined as an inclination angle ⁇ 1
  • the inclination angle ⁇ 1 is preferably an acute angle.
  • the inclination angle ⁇ 1 is not particularly limited as long as it is an acute angle.
  • 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 “central portion S4” means at least a region including a portion located between the urethra and the vagina in a state where the puncture member 3 is punctured into the living body (a state where the main body 31 is disposed in the living body).
  • Markers may be provided on both ends of the main body 31 at positions that are equal from the central portion S4 and project outside the living body in a state where the main body 31 is disposed on the living body. Thereby, the position in the living body of center part S4 can be confirmed by comparing the position of both markers.
  • the configuration of the main body 31 can be rephrased as follows. That is, as shown in FIG. 12B, the main body 31 is formed such that the long axis J32 is inclined with respect to the central axis J5 of the arc, and an extension line J32 ′ between the central axis J5 and the long axis J32 is formed. It can also be said that it is configured to have an intersection P. In this case, the angle ⁇ 5 formed by the central axis J5 and the extension line J32 ′ is equal to the inclination angle ⁇ 1.
  • the main body 31 has an inner peripheral portion that is located at the inner peripheral edge and has a minimum radius of curvature r1 in a plan view when viewed from the direction of the central axis J5 of the main body 31.
  • A1 and an outer peripheral portion A2 located at the outer peripheral edge and having a maximum radius of curvature r2 as shown in FIG. 12B, the inner peripheral portion A1 and the outer peripheral portion A2 are shifted from each other in the direction of the central axis J5. It can be said that it is configured as follows.
  • Such a main body 31 has a configuration in which two divided pieces are connected so that they can be divided in the middle. Specifically, the main body 31 has a tip split piece 32 positioned on the needle body 35 side and a base end split piece 33 positioned on the base end side of the tip split piece 32, which are separated. Connected as possible. Moreover, in the main body 31, the front-end
  • the distal end divided piece 32 has a tube shape and has a distal end side opening 321 and a proximal end side opening 322.
  • the base end split piece 33 also has a tube shape and has a front end side opening 331 and a base end side opening 332. And the front-end
  • the split pieces 32 and 33 may be connected by inserting the base end of the tip split piece 32 into the base split piece 33.
  • the state maintaining mechanism 34 includes holes 342a, 342b, and 342c, an endless thread 341 inserted through the holes 342a, 342b, and 342c, and an exposure hole 345 that exposes the thread 341. 346 and a slit 347 that connects the exposure holes 345 and 346.
  • the hole 342a is a base end portion of the base end split piece 33 and is provided near the inner peripheral portion A1 of the surface A3.
  • the holes 342b and 342c are the base end portions of the tip split piece 32, and are provided facing the inner peripheral portion A1 of the front surface A3 and the back surface A4.
  • the yarn 341 is disposed in the main body 31 and is routed outside the main body 31 between the hole 342b and the hole 342c and between the hole 342a and the proximal end opening 332, respectively. Thereby, the connection state of the division
  • the thread 341 is prepared, for example, as a thread with ends, and one end of the thread 341 is inserted into the main body 31 from the proximal end opening 332, pulled out of the main body 31 from the hole 342b, and inserted into the main body 31 from the hole 342c It is obtained by pulling it out of the main body 31 from the hole 342a and finally tying it with the other end in the vicinity of the proximal end opening 332.
  • the position of the knot is not limited.
  • each hole 342a, 342b, 342c can be extended along the path
  • the number and arrangement of the holes through which the thread 341 passes are not particularly limited as long as the connection state between the distal end divided piece 32 and the proximal end divided piece 33 can be maintained by the thread 341.
  • yarn 341 does not need to be endless shape, and the end shape which has one end and the other end may be sufficient as it.
  • an end-shaped thread may be prepared, and one end thereof may be a loop that passes through the hole 342a and the proximal end opening 332, and the other end may be a loop that passes through the holes 342b and 342c.
  • the thread 341 includes a string, a band, and the like that can be used in the same manner as the thread 341.
  • the exposure holes 345 and 346 are provided to face the front surface A3 and the back surface A4 of the base end portion of the base end split piece 33. Further, the exposure holes 345 and 346 are provided in a portion exposed from the body surface when the main body 31 is disposed in the living body. The exposure holes 345 and 346 are located on the path of the yarn 341, and the yarn 341 is exposed from the exposure holes 345 and 346. Further, the exposure holes 345 and 346 are connected by a slit 347 provided in the inner peripheral portion A1 along the circumferential direction of the main body 31.
  • the thread 341 can be easily cut by providing the exposure holes 345 and 346 and the slit 347 as in the present embodiment. For example, a scissors is prepared, one blade is inserted into the exposure holes 345 and 346, and the thread 341 is positioned between the other blade. When the heel is closed, at least one of the pair of blades passes through the slit 347 and the pair of blades overlap, and the thread 341 is cut in the process.
  • the slit 347 is used as the blade passage. Accordingly, the thread 341 can be easily cut as described above, and deformation of the main body 31 due to the tension of the thread 341 is prevented.
  • the passage path of the blade may be configured by a hole 348 instead of the slit 347.
  • the hole 348 may buckle and collapse due to the tension of the thread 341, and the main body 31 may be deformed.
  • the slit 347 as shown in FIG. 15C, the portions 347a and 347b sandwiching the slit 347 are in contact with each other and are stretched. Is prevented.
  • a needle body 35 is provided at the tip of the main body 31 as described above. As shown in FIG. 13, the needle body 35 has a tapered needle tip 351 and a proximal end portion 352 provided on the proximal end side of the needle tip 351. Then, the base end portion 352 is inserted into the main body 31, whereby the needle body 35 is detachably held on the main body 31. The proximal end portion 352 is fitted into the main body 31 with a force that can prevent unintentional detachment of the needle body 35 from the main body 31.
  • the needle body 35 may be integrally formed with the main body 31. In this case, the needle body 35 may be cut from the main body 31 with a scissors or the like.
  • the base end portion 352 is provided with an engaging portion 353 that engages with the distal end portion 711 of the insertion portion 71.
  • the engaging portion 353 is configured by a concave portion, and the distal end portion 711 is positioned in the engaging portion 353 in the inserted state in which the puncture member 3 is inserted into the inserting portion 71. Thereby, the displacement of the puncture member 3 with respect to the insertion part 71 is suppressed, and puncture of the puncture member 3 to a living body can be performed more smoothly.
  • the cross-sectional shape of the engaging portion 353 is formed in accordance with the cross-sectional shape of the tip end portion 711. That is, it is preferable that the cross-sectional shape of the tip portion 711 is also flat. Thereby, in the state where the engaging portion 353 and the tip portion 711 are engaged, the flat shapes of the engaging portion 353 and the tip portion 711 overlap each other. By this overlap, the sheath 30 is restricted from rotating around the axis with respect to the insertion portion 71.
  • the flat shape is not particularly limited.
  • the puncture member 3 has been described above.
  • the central angle ⁇ 4 (see FIG. 21) of the puncture member 3 is not particularly limited and is appropriately set according to various conditions.
  • the needle body 35 enters the body from one buttock of the patient, and the urethra It is set so that it can pass between the vagina and protrude from the other buttocks.
  • the central angle ⁇ 4 is preferably about 150 ° to 270 °, more preferably about 170 ° to 250 °, and further preferably about 190 ° to 230 °.
  • a hard material that maintains the shape and internal space in a state of being inserted into the body is preferable.
  • a hard material include various resin materials such as polyethylene, polyimide, polyamide, polyester elastomer, and polypropylene, and various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like.
  • the wall can be reinforced with a reinforcing member.
  • a reinforcing member For example, by embedding a high-strength braided body in the wall, the shape and the internal space can be maintained while being inserted into the body.
  • the reinforcing member by embedding a spiral object in the wall of the main body 31, it is possible to provide flexibility while maintaining the internal space to the extent that the insert can slide.
  • the main body 31 has light permeability and is visible from the outside. Thereby, for example, it is possible to easily confirm from the outside whether the distal end portion 711 of the insertion portion 71 inserted inside is engaged with the engagement portion 353 or whether the thread 341 is not broken.
  • the puncture member 3 is arranged on the guide portion 22 of the frame 2 so that the back surface A4 of the puncture member 3 is located on the distal end side and the front surface A3 is located on the proximal end side. .
  • the medical tube assembly 10 is configured by the puncture member 3 (main body 31) as described above and the insertion portion 71 of the operation member 7 inserted into the main body 31, and these are the medical tube assembly. Use starts in the state of the solid 10.
  • the operation member 7 shown in FIG. 17 is a member for rotating the puncture member 3 about the rotation axis J1.
  • the operation member 7 has a long shape and a circular cross section.
  • the operation member 7 can be divided into an insertion portion 71, a shaft portion 73, and a connection portion 72 that connects the insertion portion 71 and the shaft portion 73.
  • the boundary portion between the insertion portion 71 and the connecting portion 72 is a first bent portion 75 bent substantially at a right angle, and the boundary portion between the shaft portion 73 and the connecting portion 72 is bent at a substantially right angle. Two bent portions 76 are formed.
  • the insertion portion 71 is a part that is inserted into the puncture member 3 and functions as a stylet that reinforces the puncture member 3 from the inside. As shown in FIG. 3, the insertion portion 71 is provided on a plane f1 having the rotation axis J1 as a normal line, and is configured to rotate on the plane f1. By inserting the insertion portion 71 into the puncture member 3, the puncture member 3 is connected to the operation member 7, and the operation member 7 can be operated by the operation member 7.
  • the insertion portion 71 has a long shape, is curved in an arc shape, and has a bending portion 713 whose center coincides with the rotation axis J1, and a distal end portion 711 provided on the distal end side of the bending portion 713. Can be divided into The central angle of the bending portion 713 is set according to the central angle of the puncture member 3.
  • the thickness of the curved portion 713 is constant over the entire length in the longitudinal direction of the curved portion 713. Further, as shown in FIG. 18, the diameter D1 of the curved portion 713 is preferably 1 to 10 mm, and more preferably 2 to 5 mm. Thereby, the bending rigidity and the torsional rigidity at the curved portion 713 can be sufficiently secured, and the function as a stylet can be sufficiently exhibited.
  • the bending rigidity and the torsional rigidity are collectively referred to as “stiffness”.
  • the tip portion 711 has a tapered shape in which the outer diameter gradually decreases in the tip direction. Thereby, when inserting the insertion part 71 in the puncture member 3, the operation can be performed smoothly.
  • the shaft portion 73 has a long shape and is provided on the rotation shaft J1. Further, the shaft portion 73 rotates around the rotation axis J1 during the rotation operation.
  • the diameter D2 of the shaft portion 73 is constant over the entire length in the longitudinal direction of the shaft portion 73 and is larger than the diameter D1 of the curved portion 713. That is, the shaft portion 73 is thicker than the curved portion 713.
  • Such a curved portion 713 and the needle tip 351 of the sheath 30 constitute a puncture portion.
  • the connecting portion 72 connects the proximal end portion of the insertion portion 71 and the distal end portion of the shaft portion 73.
  • the connecting portion 72 has an L-shape that is bent at a substantially right angle, and the bent portion is a third bent portion 77.
  • the diameter D3 of the connecting portion 72 is the same as the diameter D2 of the shaft portion 73 and is thicker than the diameter D1 of the bending portion 713.
  • the diameter D3 of the connecting portion 72 and the diameter D2 of the shaft portion 73 are preferably 2 to 20 mm, and more preferably 7 to 15 mm.
  • the connecting portion 72 and the shaft portion 73 as described above constitute an operation portion that rotates the bending portion 713.
  • the thickness of the connecting portion 72 and the shaft portion 73 is larger than the thickness of the insertion portion 71. Therefore, the connecting portion 72 and the shaft portion 73 are high-rigidity portions having higher rigidity than the insertion portion 71.
  • a handle 74 is fixed to the base end portion of the shaft portion 73. By rotating the handle 74, the operation member 7 can be rotated around the rotation axis J1. Yes.
  • the handle 74 corresponds to a force point
  • the shaft portion 73 corresponds to a fulcrum
  • the needle tip 351 of the puncture member 3 corresponds to an action point.
  • the puncture member 3 punctures a living body
  • an external force is applied to the puncture member 3 due to the puncture resistance received from the living tissue. Due to the external force, in the operation member 7, the portion between them is easily deformed because the needle tip 351 corresponding to the action point is far from the handle 74 corresponding to the force point.
  • the connecting portion 72 and the shaft portion 73 are likely to be deformed by bending or twisting like the connecting portion 72 ′ and the shaft portion 73 ′ indicated by a two-dot chain line in the drawing. become.
  • the connecting portion 72 and the shaft portion 73 are high-rigidity portions, deformation or deformation like the connecting portion 72 ′ and the shaft portion 73 ′ is prevented or suppressed. Can do. Therefore, the needle tip 351 can reliably pass through the puncture route X, and can puncture the target site with certainty.
  • first bent portion 75, the second bent portion 76, and the third bent portion 77 are portions that are relatively easily deformed.
  • the bent portion 75, the second bent portion 76, and the third bent portion 77 are also included in the high-rigidity portion. Thereby, the deformation
  • the insertion part 71, the connection part 72, and the axial part 73 are comprised with the same material.
  • the constituent material is not particularly limited, and for example, various metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, and the like can be used.
  • the frame 2 rotatably holds the operation member 7 to which the puncture member 3 is attached, and fixes the insertion tool 6 in a detachable manner.
  • the frame 2 has a function of determining a puncture route X of the needle body 35 when the puncture member 3 punctures a living tissue.
  • the frame 2 is configured so that when the puncture member 3 punctures a living tissue, the needle body 35 passes between the urethra insertion tool 4 and the vaginal insertion tool 5 without colliding with them. 3.
  • the positional relationship between the urethral insertion tool 4 and the vaginal insertion tool 5 is defined. That is, the frame 2 regulates the positional relationship between the urethral insertion tool 4 and the vaginal insertion tool 5 so that the puncture member 3 passes between the urethral insertion tool 4 and the vaginal insertion tool 5.
  • the frame 2 includes a bearing portion 21 that supports the shaft portion 73 of the operation member 7, a guide portion (contact member) 22 that guides the puncture member 3, and the bearing portion 21 and the guide. It has the connection part 23 which connects the part 22, and the fixing
  • the bearing portion 21 is located on the proximal end side of the puncture device 1 and extends in a direction substantially orthogonal to the rotation axis J1.
  • a through hole 211 is formed on the rotation shaft J1 of the bearing portion 21, and the shaft portion 73 is rotatably inserted into the through hole 211.
  • the fixed portion 24 is disposed to face the connecting portion 23 via the rotation axis J1.
  • the fixing portion 24 includes a concave portion 243 into which the support portions 40 and 50 of the insertion tool 6 described above are fitted, and a male screw 244.
  • the insertion tool 6 can be fixed to the fixing part 24 by fitting the supporting parts 40 and 50 into the recessed part 243 and further tightening the male screw 244 into the supporting part 40.
  • the connecting portion 23 connects the bearing portion 21 and the guide portion 22. Moreover, the connection part 23 has comprised the rod shape extended substantially parallel to the rotating shaft J1. The connection part 23 also functions as a grip part. The operator can use the puncture device 1 in a stable state by gripping the connecting portion 23.
  • the guide portion 22 is provided at the distal end portion of the puncture device 1 and is disposed to face the bearing portion 21.
  • the guide portion 22 has a long shape and is configured by a plate member curved in a substantially arc shape.
  • the guide portion 22 is provided along the puncture member 3 inside the puncture member 3.
  • the guide portion 22 has a function of guiding the puncture member 3 when the puncture member 3 rotates.
  • the cross-sectional shape of the guide part 22 is curving toward the rotation axis J1 over the entire length of the guide part 22 in the longitudinal direction.
  • both end portions of the guide portion 22 are contact portions (pressing portions) 221 and 222 that are portions that contact the body surface H when the living body is punctured by the puncture device 1. .
  • a pair of the contact portions 221 and 222 are provided via the rotation axis J1, and the left side in FIG. 21 is the contact portion 221 and the right side in FIG.
  • the contact portions 221 and 222 have a fixed positional relationship with respect to the puncture route X of the needle tip 351.
  • the distance L1 between the contact portion 221 and the rotation axis J1 (the rotation center of the puncture member 3) in the direction orthogonal to the rotation axis J1 is the rotation axis J1 between the contact portion 222 and the rotation axis J1. This is the same as the distance L3 in the orthogonal direction (see FIG. 21).
  • the distance L1 between the contact portion 221 and the rotation axis J1 and the distance L3 between the contact portion 222 and the rotation axis J1 are in a direction orthogonal to the rotation axis J1 between the puncture member 3 and the rotation axis J1. It is shorter than the distance L6.
  • the positional relationship between the contact portions 221 and 222 and the needle tip 351 (puncture member 3) is regulated by the frame 2 so as to satisfy the above conditions regardless of the rotation angle of the puncture member 3. Yes. Furthermore, the positional relationship between the contact portions 221 and 222 and the urethral insertion device 4 is regulated by the frame 2 so that the distance between them is constant.
  • each of the contact portions 221 and 222 can function as a positioning portion that positions the puncture path X (the position of the needle tip 351) with respect to the living body in a contact state in contact with the body surface H.
  • Each contact part 221, 222 has a closed hole (one closed hole) 1102, between the urethral cavity and the vaginal cavity, and the closed hole (the other closed hole) after the needle tip 351 passes through the body surface H. ) It positions with respect to each closing hole 1101 and 1102 so that it may pass in order of 1101. This will be described below.
  • the abutting part 221 is brought into contact with a part corresponding to the closing hole 1101 of the body surface H, and the abutting part 222 is brought into contact with a part corresponding to the closing hole 1102 on the body surface H, Press toward the living body.
  • the abutting portion 221 passes through the biological tissue covering the pelvis 1100 from the body surface H, and is on the midline 1500 side of the edge of the closing hole 1101 of the pelvis 1100.
  • the portion 1103 is pressed.
  • the “midline” refers to a line passing through the center of the front and back of the human body and along the spine.
  • the contact portion 222 presses the portion 1104 on the midline 1500 side of the edge of the closed hole 1102 of the pelvis 1100 through the body tissue covering the pelvis 1100 from the body surface H.
  • the contact portion 221 presses the portion 1103 in the direction of arrow A (toward the median line 1500), and the contact portion 222 presses the portion 1104 in the direction of arrow B (median point). (Toward the line 1500).
  • each contact part 221 and 222 will be in the state which pinches
  • the contact portions 221 and 222 are restricted from moving in the left-right direction and the up-down direction in FIG.
  • the contact portions 221 and 222 are positioned with respect to the closing holes 1101 and 1102.
  • the contact portions 221 and 222 can be positioned so that the needle tip 351 passes through the closing holes 1101 and 1102 regardless of the patient's body shape and the like. That is, the puncture device 1 is excellent in versatility.
  • the distance L4 between the contact portions 221 and 222 is preferably 50 to 200 mm, and more preferably 80 to 100 mm.
  • the contact portion 221 can press the portion 1103 and the contact portion 222 can press the portion 1104.
  • each of the contact portions 221 and 222 has a cross-sectional shape curved toward the rotation axis J1.
  • each contact part 221,222 can be made into the shape along the curved shape of the part 1103,1104. For this reason, the contact parts 221 and 222 can hold the positioning state more stably.
  • the distance L1 between the contact part 221 and the rotation axis J1 and the distance L3 between the contact part 221 and the rotation axis J1 are 50 to 100% of the distance L6 between the puncture member 3 and the rotation axis J1. Preferably, it is 90 to 100%.
  • the needle tip 351 can pass outside the contact portions 221 and 222 and in the vicinity of the contact portions 221 and 222. Therefore, the contact portions 221 and 222 are positioned, and the needle tip 351 can pass through the safety zone S5 of the closing holes 1101 and 1102 (see FIG. 22).
  • the positional relationship between the contact portions 221 and 222 with respect to the puncture member 3 is regulated by the frame 2. For this reason, the surgeon can detect the puncture route X with respect to the living body by the contact portions 221 and 222.
  • the puncture member 3 defines the closure hole 1102 between the closure hole 1101 and the urethra and the vagina. It can pass reliably. Combined with these, the puncture device 1 can puncture the target site more reliably.
  • the puncture member 3 is more reliably Can pass between the urethra 1300 and the vagina 1400. That is, the puncture member 3 can pass through the rotation axis J ⁇ b> 1 on the distal side of the urethral insertion tool 4 and on the proximal side of the vaginal insertion tool 5. Thereby, the puncture apparatus 1 can puncture a target site reliably.
  • 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 of the patient, and the vagina insertion portion 51 of the vaginal insertion device 5 is inserted into the vagina 1400 of the patient.
  • the urethra insertion part 41 is inserted into the urethra 1300, the urethra 1300 is corrected to a predetermined shape (in this embodiment, a straight line) by the urethra insertion part 41, and by inserting the vagina insertion part 51 into the vagina 1400, 1400 is corrected to the predetermined shape by the vaginal insertion portion 51 (tip portion 52).
  • the balloon 42 arranged in the bladder 1310 is expanded, and urine is discharged from the bladder 1310 through the urine drainage hole 471 as necessary.
  • the urethral insertion portion 41 is pulled to the outside of the body (base end side) until the balloon 42 comes into contact with the bladder neck, and in this state, the marker 46 is exposed from the urethral opening 1320.
  • the procedure is stopped at this point. On the other hand, when the marker 46 is not exposed from the urethral opening 1320, it is determined that the puncture apparatus 1 can be used, and the procedure is continued.
  • the urethra insertion part 41 is pushed into the body to bring the marker 45 into contact with the urethral opening 1320.
  • the puncture member 3 is positioned with respect to the urethral opening 1320, and the puncture route of the puncture member 3 is determined.
  • a safer procedure can be performed by confirming the puncture route of the puncture member 3 using the marker 57 provided at the distal end portion 52 of the vaginal insertion portion 51.
  • a suction device is connected to the suction ports 433 and 543, the suction device is operated, the urethral wall is adsorbed to the suction hole 44 of the urethral insertion portion 41, and the vagina wall is adsorbed to the suction hole 54 of the vaginal insertion portion 51.
  • the marker 45 covers and closes the urethral opening 1320 on the urethra 1300 side, the inflow of air into the urethra 1300 through the urethral opening 1320 is suppressed, and the urethra into the urethra insertion part 41 is suppressed.
  • the wall can be more reliably adsorbed.
  • vaginal opening 1410 is in close contact with the inflow reduction portion 522 on the vagina 1400 side, the inflow of air into the vagina 1400 through the vaginal opening 1410 is suppressed, and the vaginal wall 51 is adsorbed to the vaginal insertion portion 51. This can be done more reliably.
  • the lock of the maintenance mechanism 61 is released so that the vaginal insertion part 51 can rotate with respect to the urethral insertion part 41,
  • the insertion part 51 is moved to the urethral insertion part 41 side.
  • tip part 52 and the vagina front wall can be stuck more reliably.
  • the suction device connected to the suction port 543 the vagina wall can be more reliably adsorbed to the vagina insertion portion 51.
  • the vagina insertion portion 51 is moved away from the urethra insertion portion 41, the maintenance mechanism 61 is locked, and the vagina insertion portion 51 and the urethral insertion portion 41 are moved.
  • the relative positional relationship with is fixed. Thereby, the state where the urethra 1300 and the vagina 1400 are sufficiently separated can be maintained.
  • the surgeon determines whether or not the urethral wall and the vagina wall are properly adsorbed to the urethra insertion part 41 and the vagina insertion part 51 based on the suction state from the suction ports 433 and 543 (for example, the magnitude of the sound generated by the suction). Can be confirmed.
  • the insertion tool 6 may have a confirmation mechanism that mechanically confirms the suction state.
  • the confirmation mechanism is not particularly limited as long as the adsorption state can be confirmed.
  • the confirmation mechanism is based on a flow rate measurement unit (negative pressure gauge) that measures a flow rate from the suction port 543 and a measurement result from the flow rate measurement unit. It can be set as the structure which has a judgment part which judges whether adsorption
  • the frame 2 is fixed to the insertion tool 6 as shown in FIG. To do. Thereby, the puncture apparatus 1 will be in the state with which the patient was mounted
  • the restriction portion 48 is removed from the urethral insertion portion 41, and the insertion tool 6 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 insertion tool 6 is pushed into the body, the urethra 1300 and the vagina 1400 are simultaneously inserted. Is pushed in. Therefore, it becomes easier to puncture the tissue with the puncture member 3. Moreover, the puncture target site can be punctured more reliably.
  • the urethra insertion part 41 is provided with the sliding resistance amplifying part 49 for increasing the sliding resistance with the urethra, the urethra 1300 can be pushed in more reliably. Further, since the rubbing (displacement) between the urethra insertion part 41 and the urethra 1300 is suppressed, damage to the urethra can be suppressed.
  • the marker 45 slides toward the proximal end side of the urethral insertion portion 41 while abutting against the urethral opening 1320 and does not inhibit the above-described pushing of the urethral insertion portion 41.
  • the abutting portions 221 and 222 are brought into contact with the body surface H while the urethra 1300 and the vagina 1400 are pushed into the body. Further, the contact portions 221 and 222 are pressed toward the pelvis 1100 side. At this time, the contact portion 221 presses the portion 1103 via the biological tissue covering the pelvis 1100, and the contact portion 222 presses the portion 1104 via the biological tissue covering the pelvis 1100. Thereby, the puncture apparatus 1 will be in a positioning state (refer Fig.28 (a)).
  • the contact portions 221 and 222 may press portions other than the closed holes 1101 and 1102 of the pelvis 1100.
  • the contact portions 221 and 222 are moved toward the pelvis 1100 while moving in the left-right direction and the up-down direction in FIG. By this moving operation, the contact portions 221 and 222 are moved to the positions shown in FIG.
  • the contact parts 221 and 222 will move from the pelvis 1100 (hard part) to the closing holes 1101 and 1102 (soft part). The surgeon can recognize that the puncture device 1 is in the positioning state due to the change of the touch transmitted to the finger through the puncture device 1.
  • the contact portions 221 and 222 sandwich the portion between the closing hole 1101 and the closing hole 1102 of the pelvis 1100. Thereby, the operator can hold
  • the handle 74 is operated to rotate the operation member 7 as shown in FIG.
  • the needle body 35 of the puncture member 3 punctures the body surface H of the right buttocks of the patient or a portion in the vicinity thereof, enters the body, and between the obturator hole 1101, the urethra 1300 and the vagina 1400, the obturator hole 1102. , And then protrudes from the body surface H of the left buttock or the vicinity thereof (see FIG. 29A).
  • the puncture member 3 rotates and punctures the living body, the connection portion 72 and the shaft portion 73 are connected to each other by the puncture resistance received from the living tissue. It seems to be deformed by bending or twisting.
  • the connecting portion 72 and the shaft portion 73 are high-rigidity portions, deformation like the connecting portion 72 ′ and the shaft portion 73 ′ can be prevented or suppressed. Therefore, the needle tip 351 can reliably pass through the puncture route X, and can puncture the target site with certainty.
  • a passage can be formed at a position suitable for placement of the implant 9 by puncturing the puncture member 3 substantially perpendicularly to the left and right closure holes 1101 and 1102 of the pelvis. In this state, the positional relationship between the pelvis 1100 and the puncture device 1 is as shown in FIG.
  • the puncture member 3 is arranged in the living body.
  • the handle 74 is operated to rotate the operation member 7 in the opposite direction, and only the operation member 7 is removed from the living body while the puncture member 3 is placed in the living body.
  • the frame 2 is removed from the insertion tool 6, and the needle body 35 is removed from the main body 31.
  • the main body 31 is disposed in the living body with both the distal end side opening and the proximal end side opening exposed to the outside of the living body.
  • the position of the main body 31 is adjusted as necessary. Specifically, the left and right protruding lengths of the main body 31 are aligned, and the central portion S4 of the main body 31 is positioned between the urethra 1300 and the vagina 1400.
  • the central portion S4 is arranged such that the width direction (long axis J32 direction) W is substantially parallel to the urethra 1300. That is, the width direction W of the urethra 1300 that has been corrected by inserting the urethral insertion tool 4 and the central portion S4 is located substantially in parallel.
  • the implant 9 is inserted into the main body 31 while being taken out from the packaging material 90, and the implant main body 91 is projected from the proximal end opening and the distal end opening of the main body 31, as shown in FIG. To do.
  • contamination of the implant 9 can be prevented by accommodating the implant 9 in the wrapping material 90 until just before being disposed in the main body 31.
  • the main body 31 has a flat shape
  • the posture of the implant main body 91 follows this flat shape. That is, the implant main body 91 is disposed in the main body 31 such that the width direction thereof coincides with the width direction of the main body 31. From the relationship with the urethra 1300, the implant body 91 is disposed in parallel with the corrected urethra 1300.
  • the thread 341 exposed from the exposure holes 345 and 346 is cut.
  • the main body 31 can be divided into the tip split piece 32 and the base split piece 33.
  • adsorption of the urethral wall by the urethral insertion part 41 and adsorption of the vagina wall by the vagina insertion part 51 are stopped.
  • the positions and shapes of the urethra 1300 and the vagina 1400 return to the original natural state.
  • the connection between the distal end split piece 32 and the proximal end split piece 33 is released, the distal end split piece 32 is pulled out from the living body toward the distal end side, and the proximal end split piece 33 is pulled out from the living body toward the proximal end side.
  • the tip split piece 32 and the base end split piece 33 are moved substantially simultaneously in opposite directions, and the tip split piece 32 and the base end split piece 33 are each moved in an arc shape along the shape thereof. Thereby, the main body 31 is smoothly removed from the living body.
  • the distal-end divided piece 32 and the proximal-end divided piece 33 are removed from the living body as described above, the surrounding tissue that has been spread by the main body 31 returns to the original position, and both end portions from the central portion of the implant main body 91 are restored.
  • the tissue gradually comes into contact with the implant body 91 toward the end.
  • the distal end divided piece 32 and the proximal end divided piece 33 are moved in the direction along the shape thereof, and the main body 31 has an internal space in which the implant main body 91 can move with a sufficiently low sliding.
  • an unnecessary tensile force is not applied to the implant body 91, and the implant body 91 can be placed as it is. Thereby, adjustment of the tension of the implant main body 91 becomes unnecessary.
  • the implant main body 91 is embedded in the living body.
  • the implant body 91 In a state where the implant 9 is embedded in the living body, the implant body 91 is disposed in a region between the urethra 1300 and the vagina 1400 substantially parallel to the urethra 1300. Therefore, the urethra 1300 can be supported in a wider area by the implant body 91.
  • the main body 31 can be easily removed from the living body by dividing the main body 31 and removing it from the living body.
  • the divided pieces 32 and 33 being removed hardly affect the posture of the implant body 91 in the region between the urethra 1300 and the vagina 1400, the implant body 91 can be embedded in a desired posture.
  • the implant body 91 placed in the living body prevents excessive tension from being applied to the urethra 1300. I can do it.
  • 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 puncture apparatus 1 can puncture a living body easily and accurately.
  • the puncture apparatus 1 can puncture the living body more reliably.
  • the puncture device 1 when the implant 9 is placed, it can be handled only by a minimally invasive technique such as puncture of the puncture member 3, and it is not necessary to perform a highly invasive incision or the like. Therefore, the burden on the patient is small and the safety of the patient is high. Further, since the implant body 91 can be embedded in parallel with the urethra 1300, the urethra 1300 can be supported in a wider area. Further, the puncture member 3 can puncture the living body while avoiding the urethra 1300 and the vagina 1400, and the puncture member 3 can be prevented from puncturing the urethra 1300 and the vagina 1400, which is safe. Further, it is possible to prevent the occurrence of complications such as the exposure of the implant 9 into the vagina from the wound created by the incision and the infection from the wound as in the case of the conventional incision of the vagina. It is possible to embed the implant 9 reliably.
  • FIG. 34 is a perspective view showing an operation member included in the puncture apparatus according to the second embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the operation member is different.
  • the thickness of the shaft portion 73 is the same as that of the curved portion 713, and is thinner than the thickness of the connecting portion 72. Since the shaft portion 73 is supported by the bearing portion 21 of the frame 2, even if it has the same rigidity as the curved portion 713, it is a portion that is relatively difficult to deform.
  • the same effect as that of the first embodiment can be obtained by making only the connecting portion 72 that is relatively easily deformed into a high-rigidity portion.
  • FIG. 35 is a perspective view showing an operation member included in the puncture apparatus according to the third embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the operation member is different.
  • the connecting portion 72 has a linear shape and is inclined with respect to the rotation axis J1.
  • the 3rd bending part 77 can be abbreviate
  • FIG. 36 is a perspective view showing an operation member included in the puncture device according to the fourth embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the operation member is different.
  • the operation member 7C of the present embodiment has a boundary portion 722 located between the bending portion 713 and the connecting portion 72.
  • the boundary portion 722 is provided on the proximal end side extension line of the bending portion 713. Further, at the boundary portion 722, the thickness gradually increases toward the connecting portion 72 side. According to the boundary portion 722, the stress applied from the curved portion 713 to the first bent portion can be relaxed. Therefore, it can prevent or reduce more reliably that the 1st bending part 75 deform
  • FIG. 37 is a view showing a guide part provided in the puncture device according to the fifth embodiment of the present invention, where (a) is a view seen from the distal end side, and (b) is an arrow C in (a). It is the figure seen from the direction.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is different.
  • the guide portion 22A of the present embodiment has a tube shape curved in an arc shape.
  • a sheath 30 is inserted into the guide portion 22A.
  • a slit 223 penetrating from the inner periphery to the outer periphery is formed in the guide portion 22A.
  • the slit 223 is formed over the entire length of the guide portion 22A in the longitudinal direction.
  • the contact portions 221 and 222 are ring-shaped when viewed from the direction of arrow C in FIG. 37 (a). Thereby, the contact area of each contact part 221 and 222 and the body surface H can be made larger, and thus positioning can be performed more stably.
  • FIGS. 38A and 38B are views showing a guide part provided in the puncture device according to the sixth embodiment of the present invention, wherein FIG. 38A is a view seen from the distal end side, and FIG. 38B is an arrow D in FIG. It is the figure seen from the direction.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is different.
  • the guide portion 22B of the present embodiment is composed of a rod-like member that is curved in an arc shape. Further, a pair of guide portions 22B are provided via the sheath 30, and each guide portion 22B is provided side by side along the rotation axis J1.
  • the puncture member 3 passes between the contact portions 221 and passes between the contact portions 222. Therefore, in the positioning state, the operator can easily predict the position through which the puncture member 3 passes using each contact portion 221 and each contact portion 222 as a guide. Furthermore, since the sheath 30 is relatively easy to visually recognize, the prediction can be easily performed.
  • FIG. 39 is a side view showing an insertion tool included in the puncture device according to the seventh embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the urethral insertion tool is different.
  • a marker 45 is provided on the surface of the urethra insertion part 41. Further, the marker 45 does not substantially protrude from the surface of the urethral insertion portion 41. Therefore, the marker 45 can enter the urethra 1300 together with the urethra insertion part 41. Further, the marker 45 is fixed on the surface of the urethral insertion portion 41 and cannot move with respect to the urethral insertion portion 41. Such a marker 45 does not have a function as the inflow reduction unit 450.
  • the configuration of the puncture apparatus 1 can be simplified as compared with the first embodiment.
  • the puncture apparatus 1 can be easily operated at a predetermined stage. Specifically, for example, in the first embodiment described above, since the marker 45 protrudes from the urethra insertion part 41 and cannot enter the urethra 1300, the restriction part 48 is removed and the marker 45 slides with respect to the urethra insertion part 41. It had to be possible. On the other hand, in the present embodiment, since the marker 45 can enter the urethra 1300, the above-described operation is not necessary, and the operation can be smoothly performed correspondingly.
  • the configuration of the marker 45 is not particularly limited as long as the operator can visually recognize from the outside.
  • the marker 45 may be configured by a colored portion colored in a color different from the surroundings, or may be configured by a concave portion or a convex portion. May be.
  • the marker 45 does not substantially protrude from the outer periphery of the urethra insertion portion 41, but the marker 45 may protrude slightly from the outer periphery of the urethra insertion portion 41 as long as it can enter the urethra 1300. Good.
  • the sliding resistance amplifying part 49 is configured by a ring-shaped protrusion (protruding part) protruding from the outer periphery of the urethral insertion part 41. Even when the sliding resistance amplifying section 49 is configured as described above, the sliding resistance of the urethral insertion section 41 with respect to the urethra 1300 can be effectively increased.
  • one ring-shaped protrusion is provided, but the number of protrusions is not particularly limited, and for example, a plurality of protrusions may be provided side by side in the length direction of the urethral insertion portion 41. .
  • the protrusions do not have to be ring-shaped.
  • a plurality of hook-shaped protrusions may be arranged along the circumferential direction of the urethra insertion part 41, or the length of the urethra insertion part 41 may be long. It may be a spiral protrusion extending in the direction.
  • the sliding resistance amplifying unit 49 also serves as the marker 46. Therefore, the configuration of the urethral insertion tool 4 is further simplified.
  • the sliding resistance amplifying portion 49 is preferably colored in a color different from the surroundings (the distal end side and the proximal end side).
  • FIG. 40 is a side view showing an insertion tool included in the puncture device according to the eighth embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the urethral insertion tool is different.
  • the balloon 42 and the urine discharge part 47 are omitted in the urethral insertion device 4 of the present embodiment.
  • the configuration of the urethral insertion tool 4 can be simplified.
  • the puncture device 1 in order to position the puncture position of the puncture member 3 with respect to the urethral opening 1320, the urethra insertion portion 41 is mainly aligned by being engaged with the bladder neck. Even if the balloon 42 to be used is omitted, the operability of the puncture device 1 at the time of puncturing the puncture member 3 is hardly lowered.
  • FIG. 41 is a side view showing an insertion tool included in the puncture device according to the ninth embodiment of the present invention.
  • FIG. 42 is a cross-sectional view showing a state where the urethral insertion tool of the insertion tool shown in FIG. 41 is inserted into the urethra.
  • This embodiment is the same as the first embodiment described above except that the configuration of the urethral insertion tool is different.
  • the balloon 42 and the urine discharge part 47 are omitted.
  • the marker 45 is provided on the surface of the urethral insertion portion 41 and does not substantially protrude from the surface of the urethral insertion portion 41. Therefore, the marker 45 can enter the urethra 1300. Further, the marker 45 is fixed on the surface of the urethral insertion portion 41 and cannot move with respect to the urethral insertion portion 41. The configuration of such a marker 45 is the same as that of the second embodiment described above.
  • the inflow reduction unit 450 is provided separately from the marker 45 in the present embodiment.
  • the inflow reduction part 450 is provided between the marker 45 and the region S1, and is located in the urethra 1300 when the urethra insertion part 41 is inserted into the urethra 1300 and the marker 45 is located at the urethral opening 1320.
  • the inflow reduction part 450 is configured by a ring-shaped protrusion (protrusion part) provided so as to protrude from the outer periphery of the urethral insertion part 41.
  • the outer diameter of the inflow reducing portion 450 is gradually reduced from the central portion toward both ends (the distal end and the proximal end), and the outer diameters at both ends substantially coincide with the outer diameter of the urethral insertion portion 41. Therefore, a step is not substantially formed between the inflow reducing portion 450 and the urethral insertion portion 41, and the urethral insertion portion 41 can be inserted into the urethra 1300 with less invasiveness.
  • the inflow reduction portion 450 is located in the urethra 1300 in a state where the urethra insertion portion 41 is inserted into the urethra 1300. Since the inflow reduction part 450 has a larger outer diameter than the other part of the urethral insertion part 41 (the front end side and the base end side part of the inflow reduction part 450), the inflow reduction part 450 is more than the other part. Even the urethral wall is more closely attached.
  • the urethra 1300 can be sealed in the inflow reduction portion 450, and the inflow of air from the urethral opening 1320 to the back side of the inflow reduction portion 450 of the urethra 1300, that is, the portion where the suction hole 44 is located. Can be suppressed. As a result, the suction of the urethra wall by the suction hole 44 can be performed more reliably and effectively.
  • the sliding resistance amplifying part 49 has a groove 491 extending in the circumferential direction of the urethra insertion part 41.
  • a plurality of the grooves 491 are provided along the longitudinal direction of the urethral insertion portion 41.
  • the number of grooves 491 disposed along the circumferential direction of the urethral insertion portion 41 is not particularly limited, and may be one or may be two or more.
  • Such a sliding resistance amplifying section 49 can also increase the sliding resistance of the urethral insertion section 41 with respect to the urethra 1300 with a simple configuration.
  • the groove 491 is a groove extending in the circumferential direction of the urethral insertion portion 41, for example, compared with a case where the groove 491 is a circular groove, a groove extending in the longitudinal direction of the urethral insertion portion 41, The sliding resistance with the urethra 1300 when the urethral insertion part 41 is pushed into the body can be increased. Also, by providing a plurality of grooves 491 in the longitudinal direction of the urethral insertion portion 41, the sliding resistance with the urethra 1300 when the urethral insertion portion 41 is pushed into the body can be increased. Therefore, according to this embodiment, the above-mentioned effect is further enhanced.
  • At least one groove 491 also serves as the suction hole 44. That is, the groove 491 that also serves as the suction hole 44 passes through the urethral insertion portion 41 and is connected to the suction port 433. By setting it as such a structure, the structure of the urethral insertion tool 4 becomes a simpler thing.
  • the groove 491 also serves as the suction hole 44, the urethral wall and the groove 491 are more strongly caught when the urethral wall is adsorbed. Therefore, the sliding resistance of the urethra insertion part 41 with respect to the urethra can be further increased.
  • the urethral insertion tool 4 of the present embodiment has a suction hole 440 facing the tip of the urethral insertion portion 41.
  • the suction hole 440 is positioned in the bladder 1310 when the urethral insertion portion 41 is inserted into the urethra 1300 and the marker 45 is positioned at the urethral opening 1320. Therefore, the bladder wall can be adsorbed by the suction hole 440. Thereby, the bladder 1310 can be pushed into the body more effectively together with the urethral insertion portion 41.
  • the suction hole 440 may also serve as the urine discharge part 47 for discharging urine in the bladder 1310.
  • FIG. 43 is a side view of the insertion tool included in the puncture device according to the tenth embodiment of the present invention, in which (a) shows a state locked by the maintenance mechanism, and (b) shows a state in which the maintenance mechanism is released.
  • FIG. 43 shows a side view of the insertion tool included in the puncture device according to the tenth embodiment of the present invention, in which (a) shows a state locked by the maintenance mechanism, and (b) shows a state in which the maintenance mechanism is released.
  • This embodiment is the same as the first embodiment described above except that the configuration of the urethral insertion tool, specifically, the configuration of the displacement mechanism and the maintenance mechanism is different.
  • the displacement mechanism 62 included in the insertion tool 6 of the present embodiment connects the urethral insertion portion 41 and the vaginal insertion portion 51 so that they can approach and separate.
  • the displacement mechanism 62 has a slide shaft 622 protruding downward from the support portion 40, and the support portion 50 is slidably connected to the slide shaft 622.
  • the support portion 50 is provided so as not to rotate with respect to the slide shaft 622.
  • a flange (engaging portion) 614 is provided at the distal end portion of the slide shaft 622, and the flange 614 prevents the support portion 50 from being detached from the slide shaft 622.
  • the maintenance mechanism 61 can take a state in which the relative positional relationship between the urethral insertion tool 4 and the vaginal insertion tool 5 is maintained, and a state in which the vaginal insertion tool 5 can slide with respect to the urethral insertion tool 4.
  • a maintenance mechanism 61 includes the flange 614 described above and an operation unit 613 provided on the support unit 50. Further, the operation unit 613 includes a shaft portion 613a that can be bent and deformed, a knob 613b that is connected to the shaft portion 613a, and a claw portion 613c that is provided at the tip of the tab 613b. Engageable.
  • the claw portion 613c is engaged with the flange 614, whereby the support portion 40 and the support portion 50 are fixed, and the relative relationship between the urethral insert 4 and the vaginal insert 5 is relative. The positional relationship can be maintained.
  • the lock maintenance state
  • the lock is released by pulling the knob 613 b upward and detaching the claw portion 613 c from the flange 614, and the vaginal insert 5 is moved relative to the urethra insert 4.
  • tip part 52 (vagina insertion part 51) can be made to approach the urethra insertion part 41 rather than the maintenance state shown to Fig.43 (a).
  • the slide shaft 622 is provided on the support portion 40 and the operation portion 613 is provided on the support portion 50.
  • the slide shaft 622 is provided on the support portion 50 and the operation portion 613 is operated.
  • the part 613 may be provided on the support part 40.
  • the structure of the operation part 613 is not limited to this embodiment, as long as the same effect can be exhibited.
  • FIG. 44 (a) is a side view of an insertion tool included in the puncture device according to the eleventh embodiment of the present invention
  • FIG. 44 (b) is a side view showing a state locked by the maintenance mechanism
  • FIG. 44 (c) is the maintenance mechanism. It is a side view which shows the state released
  • This embodiment is the same as the first embodiment described above except that the configuration of the urethral insertion tool, specifically, the configuration of the displacement mechanism and the maintenance mechanism is different.
  • the support portions 40 and 50 are fixed in the insertion tool 6 of the present embodiment.
  • the shaft part 53 of the vagina insertion part 51 can be bent and deformed in the middle by the displacement mechanism 62.
  • the shaft portion 53 is divided into a distal end side shaft portion 531 located on the distal end side and a proximal end side shaft portion 532 located on the proximal end side, and these can be rotated by a hinge portion 625. It is connected to. Then, by rotating the distal end side shaft portion 531 relative to the proximal end side shaft portion 532, the distal end portion 52 can be easily approached and separated from the urethral insertion portion 41.
  • the maintenance mechanism 61 can maintain the distal end side shaft portion 531 and the proximal end side shaft portion 532 in a linear posture, and can rotate the distal end side shaft portion 531 with respect to the proximal end side shaft portion 532. The state to perform can be taken.
  • Such a maintenance mechanism 61 has a cylindrical slider (operation unit) 615 provided on the outer periphery of the shaft portion 53 and slidable (movable) in the longitudinal direction with respect to the shaft portion 53. Yes.
  • FIG. 45 is a side view of an insertion tool included in the puncture device according to the twelfth embodiment of the present invention.
  • FIG. 46 is a cross-sectional view showing a state in which the vaginal insertion tool shown in FIG. 45 is inserted into the vagina.
  • This embodiment is the same as the first embodiment described above except that the configuration of the vaginal insertion tool is different.
  • the distal end portion 52 has a flat shape that is crushed in the height direction. Therefore, for example, the front-end
  • a ring-shaped inflow reducing portion 59 that protrudes from the outer periphery of the distal end portion 52 is provided on the proximal end portion of the distal end portion 52, more specifically, on the proximal end side of the recessed portion 541.
  • Such an inflow reducing portion 59 is not inserted into the vagina 1400 together with the distal end portion 52. Furthermore, it protrudes sufficiently so that the vaginal opening 1410 can be covered.
  • the inflow reducing portion 59 preferably has airtightness and flexibility, and is made of, for example, a rubber material.
  • such an inflow reduction unit 59 abuts against the vaginal opening 1410 with the tip 52 inserted into the vagina 1400 to cover and close the vaginal opening 1410, and the vagina 1400 through the vaginal opening 1410. Suppresses the inflow of air into the inside. Thereby, the suction of the vaginal wall by the suction hole 54 can be performed more reliably and effectively.
  • FIG. 47 is a side view of an insertion tool included in the puncture device according to the thirteenth embodiment of the present invention.
  • 48 is a view showing the distal end portion of the vaginal insertion tool shown in FIG. 47, in which (a) is a top view and (b) is a cross-sectional view taken along line BB in (a).
  • 49 is a diagram showing a state in which the distal end portion shown in FIG. 48 is inserted into the vagina, in which (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed.
  • This embodiment is the same as the first embodiment described above except that the configuration of the vaginal insertion tool is different.
  • the vaginal insertion tool 5 of this embodiment has a flat shape in which the distal end portion 52 is crushed in the height direction as in the twelfth embodiment. Therefore, for example, the front-end
  • the tip portion 52 connects the upper surface (first surface) 52a and the lower surface 52d, the upper surface 52a and the lower surface 52d, and the upper surface 52a.
  • Side surfaces (second surfaces) 52b and 52c, and the cross-sectional shape is substantially trapezoidal.
  • the tip portion 52 includes a suction hole (first suction hole) 54A that opens to the upper surface 52a, a suction hole (second suction hole) 54B that opens to the side surface 52b, and a suction hole (first suction hole) that opens to the side surface 52c. 2 suction holes) 54C. That is, the distal end portion 52 of the present embodiment has a configuration in which a pair of suction holes 54B and 54C are arranged on both sides of the suction hole 54A. These three suction holes 54A, 54B, and 54C are connected to the suction port 543 through the distal end portion 52, respectively.
  • the suction hole 54A has a recess 541A that opens to a wide range on the upper surface 52a
  • the suction hole 54B has a recess 541B that opens to a wide range on the side surface 52b
  • the suction hole 54C opens to a wide range on the side surface 52c.
  • a recess 541C is provided.
  • the depth of the recess 541A is deeper than the depth of the recesses 541B and 541C, and the width of the recess 541A is wider than the width of the recesses 541B and 541C.
  • suction holes 54A, 54B, 54C are different from each other.
  • the suction hole 54A has the normal of the upper surface 52a as the suction direction (first suction direction) Ia
  • the suction hole 54B has the normal of the side surface 52b as the suction direction (second suction direction) Ib
  • the suction hole 54C has The normal line of the side surface 52c is the suction direction (second suction direction) Ic.
  • the concave portion 541A faces the central portion 1401 (hanging portion) of the front wall of the vagina and the concave portion 541B is in the center.
  • the concave portion 541C faces the concave portion 1402 ′ adjacent to the portion 1401, and the concave portion 541C faces the concave portion 1402 ′′ adjacent to the central portion 1401. Therefore, when the suction of the vaginal wall by the suction holes 54A, 54B, 54C is performed, FIG.
  • the central portion 1401 is adsorbed to the concave portion 541A
  • the concave portion 1402 ′ (1402) is adsorbed to the concave portion 541B
  • the concave portion 1402 ′′ (1402) is adsorbed to the concave portion 541C.
  • the distal end portion 52 of the present embodiment not only the central portion 1401 but also the recessed portions 1402 ′ and 1402 ′′ can be adsorbed, and the entire vaginal front wall can be adsorbed more reliably. Can do.
  • the depth of the concave portion 541A is made deeper than the depth of the concave portions 541B and 541C, and the width of the concave portion 541A is made wider than the width of the concave portions 541B and 541C, thereby making the central portion 1401 deeper.
  • the angle ⁇ 6 formed by the suction direction Ia of the suction hole 54A and the suction direction Ib of the suction hole 54B is not particularly limited, but is preferably about 20 ° to 70 °, for example, 30 ° to 50 °. It is preferable that it is about. Accordingly, the concave portions 541B and 541C can be more accurately directed to the recessed portions 1402 'and 1402 ".
  • FIG. 50 is a cross-sectional view showing the distal end portion of the vaginal insertion tool included in the puncture device according to the fourteenth embodiment of the present invention.
  • 51 is a diagram showing a state in which the distal end portion shown in FIG. 50 is inserted into the vagina, in which (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed.
  • FIG. FIG. 50 is a cross-sectional view corresponding to FIG.
  • This embodiment is the same as the thirteenth embodiment described above except that the configuration of the vaginal insertion tool, specifically, the shape of the tip is different.
  • the vaginal insertion tool 5 of the present embodiment has a substantially trapezoidal cross-sectional shape, and the upper surface 52a is recessed inwardly (lower surface 52d side). Since the upper surface 52a has a concave shape in this way, the tip 52 has suction holes 54B and 54C that open to the side surfaces 52b and 52c, rather than the suction holes 54A that open to the upper surface 52a. The shape protrudes toward the outer periphery.
  • the concave portions 541B and 541C can be disposed close to the recessed portions 1402 ′ and 1402 ′′.
  • the portions 1402 ′ and 1402 ′′ recessed in the recesses 541B and 541C can be sucked more reliably.
  • FIG. 52 is a cross-sectional view showing the distal end portion of the vaginal insertion tool included in the puncture device according to the fifteenth embodiment of the present invention.
  • FIG. 52 is a cross-sectional view corresponding to FIG.
  • This embodiment is the same as the eleventh embodiment described above except that the configuration of the vaginal insertion tool, specifically, the shape of the tip is different.
  • the vaginal insertion tool 5 of the present embodiment is provided with a suction hole 54 having a recess 541 that opens across the upper surface 52a and the side surfaces 52b and 52c.
  • the suction direction is different between a portion 541a that opens to the upper surface 52a of the recess 541, a portion 541b that opens to the side surface 52b, and a portion 541c that opens to the side surface 52c.
  • the upper surface 52a and the side surfaces 52b and 52c are each configured as a flat surface, and the side surfaces 52b and 52c are inclined with respect to the upper surface 52a.
  • the shape of the distal end portion 52 is not limited to this.
  • the upper surface 52a and the side surfaces 52b and 52c may be formed of curved surfaces that are continuous with each other. Even with such a shape, the same effect as the present embodiment can be exhibited.
  • FIGS. 53A and 53B are views showing the distal end portion of the vaginal insertion tool included in the puncture device according to the sixteenth embodiment of the present invention, wherein FIG. 53A is a side view, FIG. 53B is a top view, and FIG. is there. 54 is a diagram showing a state in which the distal end portion shown in FIG. 53 is inserted into the vagina, where (a) shows a state before adsorbing the vagina wall, and (b) shows a state where the vagina wall is adsorbed.
  • FIG. 53A and 53B are views showing the distal end portion of the vaginal insertion tool included in the puncture device according to the sixteenth embodiment of the present invention, wherein FIG. 53A is a side view, FIG. 53B is a top view, and FIG. is there. 54 is a diagram showing a state in which the distal end portion shown in FIG. 53 is inserted into the vagina, where (a) shows a state before adsorbing the vagina wall, and
  • This embodiment is the same as the first embodiment described above except that the configuration of the vaginal insertion tool is different.
  • a plurality of suction holes 54 are provided over the entire area in the circumferential direction of the tapered portion 521 of the distal end portion 52.
  • a plurality of suction holes 54 are provided along the circumferential direction of the tip portion 52, and a plurality of suction holes 54 are provided along the longitudinal direction of the tip portion 52, and are arranged over the entire taper portion 521.
  • the suction holes 54 can be arranged in a wider range while suppressing the size of each suction hole 54 to an appropriate size, so that the vagina wall can be more effectively prevented while preventing damage to the vagina wall during suction. Can be adsorbed.
  • the concave portion 541 of each suction hole 54 has a substantially circular opening shape, but the opening shape of the concave portion 541 is not particularly limited and, for example, extends in the circumferential direction of the distal end portion 52.
  • a longitudinal shape may be sufficient and the longitudinal shape extended in the longitudinal direction of the front-end
  • the recesses 541 may have opening shapes having different shapes or sizes.
  • the inflow reduction part 522 is provided on the proximal end side of the taper part 521 in which the suction hole 54 is provided, the above-described effect is more remarkably exhibited in combination with the effect of the inflow reduction part 522. can do.
  • FIG. 55 is a view showing a distal end portion of a vaginal insertion tool included in a puncture device according to a seventeenth embodiment of the present invention.
  • This embodiment is the same as the sixteenth embodiment described above except that the configuration of the vaginal insertion tool is different.
  • the vaginal insertion tool 5 of the present embodiment has a flat shape in which the tip 52 is crushed in the height direction. Similar to the eleventh embodiment described above, a plurality of suction holes 54 are also provided in such a tip portion 52 over the entire area in the circumferential direction. Further, an inflow reduction portion 59 protruding from the distal end portion 52 is provided on the proximal end side of the region where the suction hole 54 of the distal end portion 52 is formed.
  • 56A and 56B are views showing the distal end portion of the vaginal insertion tool included in the puncture device according to the eighteenth embodiment of the present invention, wherein FIG. 56A is a side view and FIG. 56B is a cross-sectional view.
  • 57 (a) and 57 (b) are diagrams for explaining the function of the tip shown in FIG.
  • This embodiment is the same as the fourteenth embodiment described above except that the distal end portion of the vaginal insertion tool is deformable.
  • the distal end portion 52 is divided into a base portion 52A and a movable portion 52B.
  • the base portion 52A is connected to the shaft portion 53, and the movable portion 52B can be displaced vertically (the arrangement direction of the urethral insertion portion 41 and the vaginal insertion portion 51) with respect to the base portion 52A.
  • the displacement mechanism 58 for displacing the movable part 52B with respect to the base part 52A is not particularly limited.
  • the movable part 52B is located above (distant from) the base part 52A.
  • a string (operation part) 582 that is connected to the movable part 52B and is hooked on the base part 52A.
  • the string 582 is preferably pulled out to the vicinity of the support portion 50 through, for example, the shaft portion 53 so that the operator can easily hold it.
  • the movable portion 52B can be displaced toward the base 52A against the urging force of the spring 581 by pulling the string 582. After the displacement of the movable portion 52B, the tip portion 52 is thinner than before the displacement.
  • the tip 52 having such a configuration is used as follows, for example. First, as shown in FIG. 57 (a), the distal end portion 52 is inserted into the vagina 1400. Next, the vaginal wall is adsorbed by the suction hole 54. Next, as shown in FIG. 57 (b), the string 582 is pulled to displace the movable portion 52B downward. At this time, since the front wall of the vagina adsorbed by the movable portion 52B is displaced downward together with the movable portion 52B, the space between the vagina 1400 and the urethra 1300 is widened. Thereby, the puncture space of the puncture member 3 can be ensured more widely, and the puncture of the puncture member 3 can be performed more safely.
  • the movable portion 52B since the movable portion 52B is pressed against the vagina front wall by the spring 581, the movable portion 52B and the vagina front wall can be brought into close contact with each other, and the vagina front wall is adsorbed to the movable portion 52B. Can be performed more reliably.
  • FIG. 58 is a side view showing a urethra insertion tool included in the puncture device according to the nineteenth embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the urethral insertion tool is different.
  • the middle of the urethra insertion portion 41 (portion located in the urethra in the mounted state) is curved in a convex shape, and this convex curved portion Constitutes the sliding resistance amplifying section 49.
  • the middle of the urethra insertion part 41 (the part located in the urethra in the attached state) is curved a plurality of times in a wave shape, and this curved part is the sliding resistance amplifying part 49. May be configured.
  • FIG. 59 is a side view showing a urethra insertion part included in the puncture device according to the twentieth embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the urethral insertion tool is different.
  • a coating layer 492 that covers the urethra insertion part 41 is provided in the middle of the urethra insertion part 41 (portion located in the urethra in a mounted state). Yes.
  • the coating layer 492 has a higher sliding resistance with respect to the urethra than the surface of the urethral insertion portion 41, and the sliding resistance amplification unit 49 is configured by the coating layer 492.
  • the suction hole 44 is formed so as to penetrate the coating layer 492.
  • the constituent material of the covering layer 492 is not particularly limited, and for example, materials having a high coefficient of friction such as various rubber materials such as natural rubber, acrylic rubber, styrene-butadiene rubber, urethane rubber, and silicone rubber can be used. .
  • a step due to the thickness of the covering layer 492 occurs at the boundary between the covering layer 492 and the urethral insertion portion 41.
  • the urethral insertion portion 41 and the covering portion are covered.
  • a concave portion corresponding to the thickness of the covering layer 492 may be formed in advance in a region where the covering layer 492 of the urethral insertion portion 41 is provided so that the outer peripheral surfaces of the layer 492 are flush with each other. Thereby, the urethral insertion part 41 can be more smoothly inserted into the urethra.
  • 60 (a) and 60 (b) are partial cross-sectional views showing a urethra insertion part included in the puncture device according to the twenty-first embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the urethral insertion tool is different.
  • the sliding resistance amplifying unit 49 provided in the urethral insertion device 4 of the present embodiment is provided in the middle of the urethra insertion unit 41 (portion located in the urethra when attached).
  • the protrusion 493 is inclined toward the tip side and is a “barbed”. Further, the slider 494 can move between a state where the protrusion 493 is covered and a state where the protrusion 493 is exposed. In the state where the protrusion 493 is covered, the protrusion 493 is tilted.
  • the protrusion 493 can be elastically deformed, and is made of various rubber materials such as natural rubber, acrylic rubber, styrene-butadiene rubber, urethane rubber, and silicone rubber.
  • the sliding resistance amplifying unit 49 configured as described above is in a state in which the protrusion 493 is covered with the slider 494 until the urethra insertion portion 41 is inserted into the urethra. After the portion 41 is inserted into the urethra and positioned by the marker 45, as shown in FIG. 60A, the slider 494 is slid to the proximal end side so that the projection 493 is exposed.
  • the urethral insertion portion 41 is inserted into the urethra without the function of the sliding resistance amplifying portion 49 being exhibited, the insertion can be performed smoothly.
  • the urethra insertion part 41 is pushed into the body with the urethra wall adsorbed and fixed to the urethra insertion part 41, the function of the sliding resistance amplifying part 49 is exhibited. It can be pushed in more reliably.
  • the sliding resistance at the time of pushing can be further increased.
  • protrusion 493 only one protrusion 493 is provided, but the number of protrusions 493 is not particularly limited.
  • FIG. 61 is a perspective view showing a puncture member included in the puncture apparatus according to the twenty-second embodiment of the present invention.
  • 62 is a cross-sectional view showing a modification of the puncture member shown in FIG.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is different.
  • the puncture member 3 of the present embodiment is configured with a sheath 30. That is, the puncture member 3 has a configuration in which the needle body 35 is omitted from the puncture member 3 of the first embodiment described above. Further, in a state (initial state) in which the insertion portion 71 is inserted into the puncture member 3, the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31. The tip 711 protruding from the main body 31 also serves as the needle tip of the puncture member 3.
  • the distal end portion 711 of the insertion portion 71 also serves as the needle body of the puncture member 3, for example, the number of members can be reduced as compared with the first embodiment described above. Moreover, if the puncture member 3 is punctured into a living body and the insertion portion 71 is removed from the puncture member 3, the distal end side opening of the main body 31 can be opened. In other words, according to the present embodiment, unlike the first embodiment described above, it is not necessary to remove the needle body 35 in order to open the distal end side opening of the main body 31, so that surgery can be performed more smoothly. .
  • the outer diameter of the insertion portion 71 and the inner diameter of the opening on the distal end side of the main body 31 are set to be substantially the same, the displacement of the insertion portion 71 with respect to the main body 31 is prevented, and the operability is improved.
  • a tapered portion 319 in which the outer diameter from the distal end side opening gradually increases toward the proximal end is provided at the distal end of the main body 31.
  • the tapered portion 319 functions as a peeling portion that peels off the living body gradually so as to gradually expand following the distal end portion 711 as the distal end portion 711 of the insertion portion 71 punctures the living body.
  • the taper angle of the taper portion 319 and the taper angle of the tip portion 711 may be the same, but are preferably different. In this case, it is preferable that the taper angle of the taper portion 319 is smaller than the taper angle of the tip portion 711. Thereby, smooth puncture can be performed.
  • the puncture member 3 is configured with a sheath 30. That is, the puncture member 3 has a configuration in which the needle body 35 is omitted from the puncture member 3 of the first embodiment described above. Further, in a state (initial state) in which the insertion portion 71 is inserted into the puncture member 3, the distal end portion 711 that is the distal end portion of the insertion portion 71 protrudes from the distal end side opening of the main body 31.
  • the tip portion 711 is provided so as to be removable from the insertion portion 71 by screwing, fitting, or the like. Further, the distal end portion 711 has a needle tip 712 protruding from the distal end of the sheath 30.
  • the needle tip 712 has a flat shape following the sheath 30. Further, the needle tip 712 has an area gradually increasing portion 712a where the cross-sectional area gradually increases toward the tip, and an area gradually decreasing portion 712b which is provided on the tip side of the area gradually increasing portion 712a and whose cross-sectional area gradually decreases toward the tip. ing.
  • the short axis of the boundary portion 712c between the area gradually increasing portion 712a and the area gradually decreasing portion 712b is longer than the short axis of the distal end of the sheath 30, and the long axis of the boundary portion 712c is longer than the long axis of the distal end of the sheath 30.
  • the living body can be punctured substantially only with the needle tip 712. Therefore, puncture resistance can be reduced and puncture into a living body can be performed more smoothly.
  • the short axis of the boundary portion 712c may be equal to the short axis of the distal end of the sheath 30, and the long axis of the boundary portion 712c may be equal to the long axis of the sheath 30 distal end.
  • FIG. 63 is a cross-sectional view showing an operation member included in the puncture device according to the twenty-third embodiment of the present invention.
  • This embodiment is the same as the first embodiment described above except that the configuration of the puncture member is different.
  • the bending portion 713, the coupling portion 72, and the shaft portion 73 have a constant thickness. Further, the material constituting the bending portion 713 is different from the material constituting the connecting portion 72 and the shaft portion 73.
  • the rigidity of the material constituting the coupling part 72 and the shaft part 73 is higher than the rigidity of the material constituting the bending part 713. Thereby, the rigidity of the connection part 72 and the axial part 73 can be made into a highly rigid part.
  • the combination of these materials is not particularly limited, and examples thereof include a combination of stainless steel and titanium, a combination of stainless steel and tungsten, and a combination of stainless steel and alumina.
  • the thickness of the bending part 713, the connection part 72, and the axial part 73 may be constant, and the bending part 713, the connection part 72, and the axial part 73 may be comprised with the same material.
  • the connecting portion 72 and the shaft portion 73 are processed so as to have higher rigidity than the bending portion 713.
  • this processing method For example, the method etc. which set the temperature conditions suitably in the heat processing process in the process (process) which manufactures an operation member are mentioned.
  • the operation member which has a highly rigid part can be obtained by setting (adjusting) the mixing ratio of the composition which comprises it suitably.
  • the puncture device and the puncture method of the present invention have been described based on the illustrated embodiment.
  • the present invention is not limited to this, and the configuration of each part is an arbitrary configuration having the same function. Can be substituted.
  • any other component may be added to the present invention. Moreover, you may combine each embodiment suitably.
  • each contact portion is positioned with respect to each closing hole.
  • the present invention is not limited to this, and when the puncture member punctures a living body, the abutment portion passes through the closing hole. Positioning may be performed with respect to this. In this case, the contact part on the side of the closed hole that passes through later can be omitted.
  • the connecting portion of the operation member has a bent shape, but the present invention is not limited to this, and may have a curved shape.
  • the configuration in which the main body is separable into the distal end divided piece and the proximal end divided piece has been described.
  • the configuration of the main body is not limited to this, and is separated into the distal end side and the proximal end side.
  • the structure which cannot be used may be sufficient. That is, the main body may have a single tube shape. In this case, the state maintaining mechanism is also omitted.
  • the sheath is configured as a part of the puncture member, but is not limited thereto. That is, a sheath may be inserted into a through-hole formed in a living body using some means first.
  • a puncture device 1 is prepared in which the puncture member 3 is omitted, and the insertion portion 71 is used as a puncture member, and the distal end portion 711 is punctured into the right hip of the patient. Then, after passing through one obturator hole, between the urethra and the vagina, and the other obturator hole in order, it is projected from the left buttocks.
  • the insertion portion 71 is inserted into the interior, the sheath 30 (main body 31) is advanced into the body along the insertion portion 71, and both ends protrude from the body surface H. Next, the insertion portion 71 is removed from the body. Thereby, the sheath 30 is arrange
  • the distal end portion 711 of the insertion portion 71 is punctured into the right hip of the patient, passes through one obturator hole, between the urethra and the vagina, and the other obturator hole in order, and then from the left hip to the outside of the body. Then, the distal end portion of the sheath 30 is fixed to the distal end portion 711. Next, the insertion portion 71 is rotated in the reverse direction to remove the insertion portion 71 from the body, and the sheath 30 is placed in the living body. And if the implant main body 91 is arrange
  • the present invention is not limited thereto, and the implant main body is the puncture member (main body) from the beginning. It may be housed inside. In this case, for example, it is preferable to fix the thread located on the needle tip side of the two threads of the implant body to the needle tip. Thereby, when the needle tip is removed from the main body, the thread can be protruded out of the main body. Therefore, subsequent fine adjustment of the arrangement of the implant body can be performed smoothly.
  • 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 device has an elongated shape, is curved at least partially in the longitudinal direction, is supported so as to be rotatable around a rotation axis, and is connected to the puncture unit and a puncture unit that punctures a living tissue. And an operation portion that rotates the puncture portion about the rotation axis, and the operation portion includes a highly rigid portion that is higher in rigidity than the puncture portion.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif de ponction (1) présentant une section de ponction et une section de maniement. La section de ponction présente : une section incurvée (713) incurvée en forme d'arc ; et une pointe d'aiguille (351) qui ponctionne du tissu in vivo. La section de maniement présente : une section de tige (73) située sur une tige rotative (J1) ; et une section d'accouplement (72) qui accouple l'extrémité de pointe de la section de tige (73) à l'extrémité arrière de la section incurvée (713). Le centre d'arc de la section incurvée (713) se situe sur la tige rotative (J1). La section d'accouplement (72) et la section de tige (73) sont plus épaisses que la section incurvée (713) et ainsi la rigidité de la section d'accouplement (72) et de la section de tige (73) est supérieure à la rigidité de la section incurvée (713). Lorsque la section de tige (73) tourne au moyen d'une poignée (74), la section incurvée (713) tourne sur une voie de ponction (X) de manière telle que la tige rotative (J1) est le centre correspondant de la section incurvée (713) et la pointe d'aiguille (351) ponctionne le tissu in vivo. À ce moment, bien qu'une force externe provenant de la résistance de ponction soit appliquée à la section d'accouplement (72) et à la section de tige (73), la section d'accouplement (72) et la section de tige (73) ne se déforment pas en raison du fait qu'elles présentent une rigidité élevée.
PCT/JP2014/074096 2013-09-20 2014-09-11 Dispositif de ponction et procédé de ponction Ceased WO2015041140A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2013-196167 2013-09-20
JP2013196167 2013-09-20

Publications (1)

Publication Number Publication Date
WO2015041140A1 true WO2015041140A1 (fr) 2015-03-26

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113648078A (zh) * 2021-09-27 2021-11-16 王�锋 一种脑血管介入的穿刺定位辅助装置

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050075660A1 (en) * 2003-10-03 2005-04-07 Chu Michael S. H. Systems and methods for delivering a medical implant to an anatomical location in a patient
JP2006513788A (ja) * 2003-07-25 2006-04-27 ユニベルシテ・ド・リエージュ 女性尿失禁の外科治療用装置
US20100318139A1 (en) * 2009-06-16 2010-12-16 Marc Beauchamp Method and apparatus for arthroscopic rotator cuff repair using transosseous tunnels
WO2013146220A1 (fr) * 2012-03-30 2013-10-03 テルモ株式会社 Instrument de perforation et dispositif de perforation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006513788A (ja) * 2003-07-25 2006-04-27 ユニベルシテ・ド・リエージュ 女性尿失禁の外科治療用装置
US20050075660A1 (en) * 2003-10-03 2005-04-07 Chu Michael S. H. Systems and methods for delivering a medical implant to an anatomical location in a patient
US20100318139A1 (en) * 2009-06-16 2010-12-16 Marc Beauchamp Method and apparatus for arthroscopic rotator cuff repair using transosseous tunnels
WO2013146220A1 (fr) * 2012-03-30 2013-10-03 テルモ株式会社 Instrument de perforation et dispositif de perforation

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113648078A (zh) * 2021-09-27 2021-11-16 王�锋 一种脑血管介入的穿刺定位辅助装置
CN113648078B (zh) * 2021-09-27 2022-09-27 苏州市立医院 一种脑血管介入的穿刺定位辅助装置

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